WorldWideScience

Sample records for risk evaluation guidance

  1. D & D screening risk evaluation guidance

    Energy Technology Data Exchange (ETDEWEB)

    Robers, S.K.; Golden, K.M.; Wollert, D.A.

    1995-09-01

    The Screening Risk Evaluation (SRE) guidance document is a set of guidelines provided for the uniform implementation of SREs performed on decontamination and decommissioning (D&D) facilities. Although this method has been developed for D&D facilities, it can be used for transition (EM-60) facilities as well. The SRE guidance produces screening risk scores reflecting levels of risk through the use of risk ranking indices. Five types of possible risk are calculated from the SRE: current releases, worker exposures, future releases, physical hazards, and criticality. The Current Release Index (CRI) calculates the current risk to human health and the environment, exterior to the building, from ongoing or probable releases within a one-year time period. The Worker Exposure Index (WEI) calculates the current risk to workers, occupants and visitors inside contaminated D&D facilities due to contaminant exposure. The Future Release Index (FRI) calculates the hypothetical risk of future releases of contaminants, after one year, to human health and the environment. The Physical Hazards Index (PHI) calculates the risks to human health due to factors other than that of contaminants. Criticality is approached as a modifying factor to the entire SRE, due to the fact that criticality issues are strictly regulated under DOE. Screening risk results will be tabulated in matrix form, and Total Risk will be calculated (weighted equation) to produce a score on which to base early action recommendations. Other recommendations from the screening risk scores will be made based either on individual index scores or from reweighted Total Risk calculations. All recommendations based on the SRE will be made based on a combination of screening risk scores, decision drivers, and other considerations, as determined on a project-by-project basis.

  2. Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

    International Nuclear Information System (INIS)

    Baeckstroem, Ola; Haeggstroem, Anna; Maennistoe, Ilkka

    2010-04-01

    This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

  3. Guidance to risk-informed evaluation of technical specifications using PSA

    International Nuclear Information System (INIS)

    Baeckstroem, O.; Haeggstroem, A.; Maennistoe, I.

    2010-10-01

    This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

  4. Guidance to risk-informed evaluation of technical specifications using PSA

    Energy Technology Data Exchange (ETDEWEB)

    Baeckstroem, O.; Haeggstroem, A. (Scandpower AB, Stockholm (Sweden)); Maennistoe, I. (VTT, Helsingfors (Finland))

    2010-04-15

    This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

  5. Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

    Energy Technology Data Exchange (ETDEWEB)

    Baeckstroem, Ola; Haeggstroem, Anna (Scandpower AB, Stockholm (Sweden)); Maennistoe, Ilkka (VTT, Helsingfors (Finland))

    2010-04-15

    This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

  6. D ampersand D screening risk evaluation guidance

    International Nuclear Information System (INIS)

    Robers, S.K.; Golden, K.M.; Wollert, D.A.

    1995-09-01

    The Screening Risk Evaluation (SRE) guidance document is a set of guidelines provided for the uniform implementation of SREs performed on decontamination and decommissioning (D ampersand D) facilities. Although this method has been developed for D ampersand D facilities, it can be used for transition (EM-60) facilities as well. The SRE guidance produces screening risk scores reflecting levels of risk through the use of risk ranking indices. Five types of possible risk are calculated from the SRE: current releases, worker exposures, future releases, physical hazards, and criticality. The Current Release Index (CRI) calculates the current risk to human health and the environment, exterior to the building, from ongoing or probable releases within a one-year time period. The Worker Exposure Index (WEI) calculates the current risk to workers, occupants and visitors inside contaminated D ampersand D facilities due to contaminant exposure. The Future Release Index (FRI) calculates the hypothetical risk of future releases of contaminants, after one year, to human health and the environment. The Physical Hazards Index (PHI) calculates the risks to human health due to factors other than that of contaminants. Criticality is approached as a modifying factor to the entire SRE, due to the fact that criticality issues are strictly regulated under DOE. Screening risk results will be tabulated in matrix form, and Total Risk will be calculated (weighted equation) to produce a score on which to base early action recommendations. Other recommendations from the screening risk scores will be made based either on individual index scores or from reweighted Total Risk calculations. All recommendations based on the SRE will be made based on a combination of screening risk scores, decision drivers, and other considerations, as determined on a project-by-project basis

  7. Guidance on a harmonised framework for pest risk assessment and the identification and evaluation of pest risk management options by EFSA

    DEFF Research Database (Denmark)

    Baker, R.; Candresse, T.; Dormannsné Simon, E.

    2010-01-01

    The Scientific Panel on Plant Health was requested by EFSA to develop a guidance document on a harmonised framework for risk assessment of organisms harmful to plants and plant products and the identification and evaluation of risk management options. The document provides guiding principles on a...

  8. Guidance on the environmental risk assessment of plant pests

    DEFF Research Database (Denmark)

    Baker, R.; Candresse, T.; Dormannsne Simon, E.

    2011-01-01

    The European Food Safety Authority (EFSA) requested the Panel on Plant Health to develop a methodology for assessing the environmental risks posed by harmful organisms that may enter, establish and spread in the European Union. To do so, the Panel first reviewed the methods for assessing...... the environmental risks of plant pests that have previously been used in pest risk assessment. The limitations identified by the review led the Panel to define the new methodology for environmental risk assessment which is described in this guidance document. The guidance is primarily addressed to the EFSA PLH...... (biodiversity) and the functional (ecosystem services) aspects of the environment, this new approach includes methods for assessing both aspects for the first time in a pest risk assessment scheme. A list of questions has been developed for the assessor to evaluate the consequences for structural biodiversity...

  9. 78 FR 4848 - Social Media: Consumer Compliance Risk Management Guidance

    Science.gov (United States)

    2013-01-23

    ...: Consumer Compliance Risk Management Guidance AGENCY: Federal Financial Institutions Examination Council... Media: Consumer Compliance Risk Management Guidance'' (guidance). Upon completion of the guidance, and... management practices adequately address the consumer compliance and legal risks, as well as related risks...

  10. Guidance for Identifying, Selecting and Evaluating Open Literature Studies

    Science.gov (United States)

    This guidance for Office of Pesticide Program staff will assist in their evaluation of open literature studies of pesticides. It also describes how we identify, select, and ensure that data we use in risk assessments is of sufficient scientific quality.

  11. Guidance on the environmental risk assessment of genetically modified plants

    DEFF Research Database (Denmark)

    Bartsch, Detlef; Chueca, Cristina; De-Schrijver, Adinda

    risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible......This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified...... organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach...

  12. Evaluation Of Career Guidance Program In Vocational High School

    Directory of Open Access Journals (Sweden)

    Martaningsih Sri Tutur

    2018-01-01

    This review of career guidance program evaluation is conducted qualitatively through surveys, interviews and leiterature studies to provide an overview of evaluation program and its relevance to the necessity. Understanding the quality, weaknesses, obstacles to service implementation, and potential utilization are expected to improve career guidance effectiveness services in vocational high school. An evaluation on the overall career guidance program, will provide feedback for ongoing improvement. Various evaluation models are available, it needs to be selected about the relevance to the career counseling program characteristics, so that evaluation feedback is more optimal.

  13. International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.

    Science.gov (United States)

    2006-06-02

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.

  14. [International trend of guidance for nanomaterial risk assessment].

    Science.gov (United States)

    Hirose, Akihiko

    2013-01-01

    In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

  15. Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document

    Energy Technology Data Exchange (ETDEWEB)

    Astuto-Gribble, Lisa M; Caskey, Susan Adele

    2014-07-01

    The purpose of this document is threefold: 1) to describe the laboratory bio safety and biosecurity risk assessment process and its conceptual framework; 2) provide detailed guidance and suggested methodologies on how to conduct a risk assessment; and 3) present some practical risk assessment process strategies using realistic laboratory scenarios.

  16. Comparison of the guidance documents in support of EU risk assessments with those for the derivation of EU water quality standards

    NARCIS (Netherlands)

    Vos JH; Janssen MPM; SEC

    2005-01-01

    Risks of both new and existing substances and of biocides in Europe are being evaluated using the Technical Guidance Document (TGD). The European Water Framework Directive refers to this document for establishing Environmental Quality Standards (EQSs) for water. Another guidance document for the

  17. Guidance Manual for Conducting Screening Level Ecological Risk Assessments at the INEL

    Energy Technology Data Exchange (ETDEWEB)

    R. L. VanHorn; N. L. Hampton; R. C. Morris

    1995-06-01

    This document presents reference material for conducting screening level ecological risk assessments (SLERAs)for the waste area groups (WAGs) at the Idaho National Engineering Laboratory. Included in this document are discussions of the objectives of and processes for conducting SLERAs. The Environmental Protection Agency ecological risk assessment framework is closely followed. Guidance for site characterization, stressor characterization, ecological effects, pathways of contaminant migration, the conceptual site model, assessment endpoints, measurement endpoints, analysis guidance, and risk characterization are included.

  18. Risk-based Regulatory Evaluation Program methodology

    International Nuclear Information System (INIS)

    DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

    1987-01-01

    The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

  19. Guidance on methodology for evaluation of the effectiveness of options for reducing the risk of introduction and spread of organisms harmful to plant health in the EU territory

    DEFF Research Database (Denmark)

    Baker, R.; Candresse, T.; Dormannsné Simon, E.

    2012-01-01

    The European Food Safety Authority (EFSA) requested the Panel on Plant Health (PLH Panel) to provide guidance for the evaluation of the effectiveness of the options for plants and plant products for reducing the risk of introduction and spread of harmful organisms in the European Union territory...... and guidance documents for assessing a proposed RRO. In addition, the current document provides recommendations for assessing RROs, specifically: on experimental design; on the use of statistical methods including approaches for studying uncertainty; on the use of quantitative pathway analysis and spread...

  20. Radionuclide Data Quality Evaluation Guidance

    International Nuclear Information System (INIS)

    Tucker, B.J.; Winters, M.S.; Evans, D.

    2009-01-01

    A considerable amount of radioanalytical data is generated during various phases of the characterization and remediation of radiologically-contaminated sites and properties. It is critical that data generated from the analysis of collected samples be to a level of quality usable by the project and acceptable to stakeholders. In July 2004, the final version of a multi-agency guidance manual entitled Multi-Agency Radiological Analytical Protocols Manual (MARLAP) was issued by the Environmental Protection Agency, Department of Energy, Department of Homeland Security, Nuclear Regulatory Commission, Department of Defense, National Institute of Standards and Technology, U. S. Geological Survey, Food and Drug Administration, and the States of Kentucky and California. The authors' purpose is to introduce readers to some key elements of MARLAP as it relates to radioanalytical lab quality control, and to demonstrate how these guidance elements can be effectively incorporated into mature radioanalytical lab operations and data validation regimes. Based upon the logic and statistical methodologies presented in MARLAP, the authors have revised existing project-specific Radioanalytical Data Evaluation Guidance (RadDEG) used at the FUSRAP Maywood Site in Maywood, NJ. The RadDEG allows users to qualify data in a meaningful way by tying the usability of the data to its activity and uncertainty relative to project action levels and QC results. This exercise may be useful to other projects looking to implement a MARLAP-based approach into their project/site-specific data evaluation methodologies. (authors)

  1. Issuance of Final Guidance: Ecological Risk Assessment and Risk Management Principles for Superfund Sites, October 7, 1999

    Science.gov (United States)

    This guidance is intended to help Superfund risk managers make ecological risk management decisions that are based on sound science, consistent across Regions, and present a characterization of site risks that is transparent to the public.

  2. Tiered guidance for risk-informed environmental health and safety testing of nanotechnologies

    International Nuclear Information System (INIS)

    Collier, Zachary A.; Kennedy, Alan J.; Poda, Aimee R.; Cuddy, Michael F.; Moser, Robert D.; MacCuspie, Robert I.; Harmon, Ashley; Plourde, Kenton; Haines, Christopher D.; Steevens, Jeffery A.

    2015-01-01

    Provided the rapid emergence of novel technologies containing engineered nanomaterials, there is a need to better understand the potential environmental, health, and safety effects of nanotechnologies before wide-scale deployment. However, the unique properties of nanomaterials and uncertainty regarding applicable test methods have led to a lack of consensus regarding the collection and evaluation of data related to hazard and exposure potentials. Often, overly conservative approaches to characterization and data collection result in prolonged, unfocused, or irrelevant testing, which increases costs and delays deployment. In this paper, we provide a novel testing guidance framework for determining whether a nanotechnology has the potential to release material with nano-specific parameters that pose a risk to humans or the environment. The framework considers methods to categorize nanotechnologies by their structure and within their relevant-use scenarios to inform testing in a time- and resource-limited reality. Based on the precedent of dredged sediment testing, a five-tiered approach is proposed in which opportunities are presented to conclude testing once sufficient risk-related information has been collected, or that the technology in question does not require nano-specific scrutiny. A series of screening stages are suggested, covering relevant aspects including size, surface area, distribution, unique behaviors, and release potential. The tiered, adaptive guidance approach allows users to concentrate on collecting the most relevant data, thus accelerating technology deployment while minimizing risk

  3. Supplementary guidance for the investigation and risk-assessment of potentially contaminated sediments

    Energy Technology Data Exchange (ETDEWEB)

    Baker, K.; Spadaro, P.; Starr, J.; Thomas, J. [Arcadis, Arnhem (Netherlands); Hildenbrand, B. [Energy Institute, London (United Kingdom); Smith, J.W.N.; Dunk, M.; Grosjean, T.; De Ibarra, M.; Medve, A.; Den Haan, K.

    2013-11-15

    This report provides guidance on the investigation and assessment of potentially contaminated sediments, focusing on the inland, estuarine and coastal environments. It is designed as a complementary, technical companion document to Energy Institute and CONCAWE (2013) report 'Guidance on characterising, assessing and managing risks associated with potentially contaminated sediments' (Report E1001). It highlights a number of significant challenges associated with assessing the aquatic and water bottom environment, which means that a sediment assessment should not be undertaken lightly. Where a decision is taken to undertake a site assessment, this report promotes the use of an iterative process of Conceptual Site Model (CSM) development, data collection, data evaluation and a continuous CSM refinement, taking into account the results obtained. Risk-based assessment is described throughout the report, entailing four tiers of assessment, which progress from a qualitative assessment (Tier 0) through to a detailed cause-attribution assessment (Tier 3), in which the decrease in uncertainty in the assessment process is balanced against the increased costs and timescales with progress to a higher tier assessment. The application of this evidence-driven risk-based approach to sediment site management, including remedial control measures, should help to overcome at least some of the challenges associated with contaminants in sediment sites in Europe, and promote a sustainable approach to sediment management on a case-by-case basis.

  4. Screening Risk Evaluation methodology

    International Nuclear Information System (INIS)

    Hopper, K.M.

    1994-01-01

    The Screening Risk Evaluation (SRE) Guidance document is a set of guidelines provided for the uniform implementation of SREs performed on D ampersand D facilities. These guidelines are designed specifically for the completion of the second (semi-quantitative screening) phase of the D ampersand D Risk-Based Process. The SRE Guidance produces screening risk scores reflecting levels of risk through the use of risk ranking indices. Five types of possible risk are calculated from the SRE: current releases, worker exposures, future releases, physical hazards, and criticality. The Current Release Index (CRI) calculates the risk to human health and the environment from ongoing or probable releases within a one year time period. The Worker Exposure Index (WEI) calculates the risk to workers, occupants, and visitors in D ampersand D facilities of contaminant exposure. The Future Release Index (FRI) calculates the risk of future releases of contaminants, after one year, to human health and the environment. The Physical Hazards Index (PHI) calculates the risk-to human health due to factors other than that of contaminants. The index of Criticality is approached as a modifying factor to the entire SRE, due to the fact that criticality issues are strictly regulated under DOE. Screening risk results will be tabulated in matrix form and Total Risk will be calculated (weighted equation) to produce a score on which to base early action recommendations. Other recommendations from the screening risk scores will be made based either on individual index scores or from reweighted Total Risk calculations. All recommendations based on the SRE will be made based on a combination of screening risk scores, decision drivers, and other considerations, determined on a project by project basis. The SRE is the first and most important step in the overall D ampersand D project level decision making process

  5. An Evaluation of Guidance and Counselling Services Offered to ...

    African Journals Online (AJOL)

    This paper sought to evaluate the guidance and counselling services offered to students in Gwanda urban and peri-urban secondary schools. Guidance and counselling is regarded as a programme and service in the education system, providing advice with regards to students' education, career planning, social issues or ...

  6. 78 FR 13097 - Electric Power Research Institute; Seismic Evaluation Guidance

    Science.gov (United States)

    2013-02-26

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0038] Electric Power Research Institute; Seismic... Electric Power Research Institute (EPRI)-1025287, ``Seismic Evaluation Guidance: Screening, Prioritization... guidance and clarification of an acceptable approach to assist nuclear power reactor licensees when...

  7. Air pollution and public health: a guidance document for risk managers.

    Science.gov (United States)

    Craig, Lorraine; Brook, Jeffrey R; Chiotti, Quentin; Croes, Bart; Gower, Stephanie; Hedley, Anthony; Krewski, Daniel; Krupnick, Alan; Krzyzanowski, Michal; Moran, Michael D; Pennell, William; Samet, Jonathan M; Schneider, Jurgen; Shortreed, John; Williams, Martin

    2008-01-01

    This guidance document is a reference for air quality policymakers and managers providing state-of-the-art, evidence-based information on key determinants of air quality management decisions. The document reflects the findings of five annual meetings of the NERAM (Network for Environmental Risk Assessment and Management) International Colloquium Series on Air Quality Management (2001-2006), as well as the results of supporting international research. The topics covered in the guidance document reflect critical science and policy aspects of air quality risk management including i) health effects, ii) air quality emissions, measurement and modeling, iii) air quality management interventions, and iv) clean air policy challenges and opportunities.

  8. Risk evaluation of remedial alternatives for the Hanford Site

    International Nuclear Information System (INIS)

    Clark, S.W.; Lane, N.K.; Swenson, L.

    1994-01-01

    Risk assessment is one of the many tools used to evaluate and select remedial alternatives and evaluate the risk associated with selected remedial alternatives during and after implementation. The risk evaluation of remedial alternatives (RERA) is performed to ensure selected alternatives are protective of human health and the environment. Final remedy selection is promulgated in a record of decision (ROD) and risks of the selected alternatives are documented. Included in the ROD documentation are the risk-related analyses for long-term effectiveness, short-term effectiveness, and overall protection of human health and the environment including how a remedy will eliminate, reduce or control risks and whether exposure will be reduced to acceptable levels. A major goal of RERA in the process leading to a ROD is to provide decision-makers with specific risk information that may be needed to choose among alternatives. For the Hanford Site, there are many considerations that must be addressed from a risk perspective. These include the large size of the Hanford Site, the presence of both chemical and radionuclide contamination, one likelihood of many analogues sites, public and worker health and safety, and stakeholder concern with ecological impacts from site contamination and remedial actions. A RERA methodology has been promulgated to (1) identify the points in the process leading to a ROD where risk assessment input is either required or desirable and (2) provide guidance on how to evaluate risks associated with remedial alternatives under consideration. The methodology and evaluations parallel EPA guidance requiring consideration of short-term impacts and the overall protectiveness of remedial actions for evaluating potential human health and ecological risks during selection of remedial alternatives, implementation of remedial measures, and following completion of remedial action

  9. 76 FR 71577 - Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication...

    Science.gov (United States)

    2011-11-18

    ...] Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in... guidance for industry entitled ``Medication Guides-- Distribution Requirements and Inclusion in Risk... Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This guidance provides...

  10. HUMAN FACTORS GUIDANCE FOR CONTROL ROOM EVALUATION

    International Nuclear Information System (INIS)

    OHARA, J.; BROWN, W.; STUBLER, W.; HIGGINS, J.; WACHTEL, J.; PERSENSKY, J.J.

    2000-01-01

    The Human-System Interface Design Review Guideline (NUREG-0700, Revision 1) was developed by the US Nuclear Regulatory Commission (NRC) to provide human factors guidance as a basis for the review of advanced human-system interface technologies. The guidance consists of three components: design review procedures, human factors engineering guidelines, and a software application to provide design review support called the ''Design Review Guideline.'' Since it was published in June 1996, Rev. 1 to NUREG-0700 has been used successfully by NRC staff, contractors and nuclear industry organizations, as well as by interested organizations outside the nuclear industry. The NRC has committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool in the face of emerging and rapidly changing technology. This paper addresses the current research to update of NUREG-0700 based on the substantial work that has taken place since the publication of Revision 1

  11. [Function of the present systematic evaluation in establishment of guidance for clinical practice].

    Science.gov (United States)

    Yang, Jin-Hong; Hu, Jing; Yang, Feng-Chun; Zhang, Ning; Wang, Bing; Li, Xin

    2012-07-01

    Treatment of insomnia with acupuncture is taken as an example to explore the significance and problems existed in the present systematic evaluation in establishment of guidance for clinical practice. Fifteen articles on systematic evaluation of both English and Chinese were retrieved and studied carefully, their basic information was analyzed. Through study on the establishing process of the guidance of clinical practice, researches were focused on the possible significance of the articles to the guidance as well as the notes in the reuse of those articles since problem still existed. It is held that the systematic evaluation has great significance on the establishment of the guidance from the aspects of applicable people, recommended standards of diagnosis and therapeutic evaluation, extended recommendation and methodology. Great importance should also be attached to the direct application of the research result and understanding of the evaluation result. The data should be rechecked when necessary. Great guiding function can be found on the systematic evaluation of articles to the guidance. Moreover, if information needed to be taken into a full play, specific analysis should also be done on the concrete research targets.

  12. Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies.

    Science.gov (United States)

    Chawla, Anita J; Mytelka, Daniel S; McBride, Stephan D; Nellesen, Dave; Elkins, Benjamin R; Ball, Daniel E; Kalsekar, Anupama; Towse, Adrian; Garrison, Louis P

    2014-03-01

    To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health. We applied the incremental net health benefit (INHB) framework to quantify the benefits and risks of investigational diabetes drugs using a common survival metric (life-years [LYs]). We constructed a decision analytic model for clinical program development consistent with the requirements of each guidance and simulated diabetes drugs, some of which had elevated CV risk. Assuming constant research budgets, we estimate the impact of increased trial size on drugs investigated. We aggregate treatment benefit and CV risks for each approved drug over a 35-year horizon under each guidance. The quantitative analysis suggests that the December 2008 guidance adversely impacts diabetes population health. INHB was -1.80 million LYs, attributable to delayed access to diabetes therapies (-0 .18 million LYs) and fewer drugs (-1.64 million LYs), but partially offset by reduced CV risk exposure (0.02 million LYs). Results were robust in sensitivity analyses. The health outcomes impact of all potential benefits and risks should be evaluated in a common survival measure, including health gain from avoided adverse events, lost health benefits from delayed or for gone efficacious products, and impact of alternative policy approaches. Quantitative analysis of the December 2008 FDA guidance for diabetes therapies indicates that negative impact on patient health will result. Copyright © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

  13. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  14. Risk evaluation of remedial alternatives for the Hanford Site

    International Nuclear Information System (INIS)

    1994-09-01

    This document provides guidance on the process of risk evaluation of remedial alternatives (RERA) at the Hanford Site. Remediation activities at the Hanford Site are being conducted pursuant to the Comprehensive Environmental Restoration, Compensation, and Liability Act and the Resource Conservation and Recovery Act. This document identifies points in the remedial alternative selection process where risk assessment input is either required or desirable. For each of these points of application, the document identifies issues to consider and address, and suggests possible approaches, techniques, and appropriate levels of detail. The level of detail of a RERA is driven by the need to use risk as a criterion for selecting a remedial alternative. Such a document is needed to ensure that RERA is conducted in a consistent manner, and to prevent restating or creating guidance within each RERA

  15. The Consideration of a Constructivist Evaluation Framework in Adult Guidance Practice

    Science.gov (United States)

    Hearne, Lucy

    2011-01-01

    This article explores the findings of a doctoral study that examined the measurement of individual progression in the Irish Adult Education Guidance Initiative. The critical constructivist stance of the study challenges the prevalence of the positivist paradigm to evaluate long-term outcomes in adult guidance. The research highlights the…

  16. Drug interactions evaluation: An integrated part of risk assessment of therapeutics

    International Nuclear Information System (INIS)

    Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping; Huang, Shiew-Mei

    2010-01-01

    Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industry and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.

  17. Guidance on risk analysis and safety implications of a large liquefied natural gas (LNG) spill over water.

    Energy Technology Data Exchange (ETDEWEB)

    Wellman, Gerald William; Melof, Brian Matthew; Luketa-Hanlin, Anay Josephine; Hightower, Marion Michael; Covan, John Morgan; Gritzo, Louis Alan; Irwin, Michael James; Kaneshige, Michael Jiro; Morrow, Charles W.

    2004-12-01

    While recognized standards exist for the systematic safety analysis of potential spills or releases from LNG (Liquefied Natural Gas) storage terminals and facilities on land, no equivalent set of standards or guidance exists for the evaluation of the safety or consequences from LNG spills over water. Heightened security awareness and energy surety issues have increased industry's and the public's attention to these activities. The report reviews several existing studies of LNG spills with respect to their assumptions, inputs, models, and experimental data. Based on this review and further analysis, the report provides guidance on the appropriateness of models, assumptions, and risk management to address public safety and property relative to a potential LNG spill over water.

  18. A review of Grey and academic literature of evaluation guidance relevant to public health interventions.

    Science.gov (United States)

    Denford, Sarah; Abraham, Charles; Callaghan, Margaret; Aighton, Peter; De Vocht, Frank; Arris, Steven

    2017-09-12

    Public Health evaluation is essential to understanding what does and does not work, and robust demonstration of effectiveness may be crucial to securing future funding. Despite this, programs are often implemented with poor, incomplete or no evaluation. Public health practitioners are frequently required to provide evidence for the effectiveness of their services; thus, there is a growing need for evaluation guidance on how to evaluate public health programs. The aim of this study is to identify accessible high-quality, evaluation guidance, available to researchers and practitioners and to catalogue, summarise and categorise the content of a subset of accessible, quality guides to evaluation. We systematically reviewed grey and academic literature for documents providing support for evaluation of complex health interventions. Searches were conducted January to March 2015, and included academic databases, internet search engines, and consultations with academic and practicing public health experts. Data were extracted by two authors and sent to the authors of the guidance documents for comments. Our initial search identified 402 unique documents that were screened to identify those that were (1) developed by or for a national or international organization (2) freely available to all (3) published during or after 2000 (4) specific to public health. This yielded 98 documents from 43 organisations. Of these, 48 were reviewed in detail. This generated a detailed catalogue of quality evaluation guidance. The content included in documents covers 37 facets of evaluation. A wide range of guidance on evaluation of public health initiatives is available. Time and knowledge constraints may mean that busy practitioners find it challenging to access the most, up-to-date, relevant and useful guidance. This review presents links to and reviews of 48 quality guides to evaluation as well as categorising their content. This facilitates quick and each access to multiple selected

  19. Prototype of evaluation guidance system in Integrated Nuclear Data Evaluation System

    International Nuclear Information System (INIS)

    Fukahori, T.; Nakagawa, T.

    1992-01-01

    Integrated Nuclear Data Evaluation System (INDES) is being developed to keep experiences of nuclear data evaluation for JENDL-3 and to support new evaluations. One of the INDES functions is to set up input data of theoretical calculation codes automatically. In order to use INDES effectively, a prototype of nuclear data evaluation guidance system (E.T.; Evaluation Tutor) was made to help users in selecting a set of suitable theoretical calculation codes by applying knowledge engineering technology. E.T. consists of an inference engine, frames, a rule-base, two example-bases and calculating modules of certainty factors. The inference engine and the calculating modules are written in FORTRAN77. (author)

  20. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Science.gov (United States)

    2011-02-28

    ...] Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication... a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion... Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance is...

  1. Evaluation of the use of low-cost GPS receivers in the autonomous guidance of agricultural tractors

    Energy Technology Data Exchange (ETDEWEB)

    Alonso-Garcia, S.; Gomez-Gil, J.; Arribas, J. I.

    2011-07-01

    This paper evaluates the use of low-cost global positioning system (GPS) receivers in the autonomous guidance of agricultural tractors. An autonomous guidance system was installed in a 6400 John Deere agricultural tractor. A low cost GPS receiver was used as positioning sensor. Three different control laws were implemented in order to evaluate the autonomous guidance of the tractor with the low-cost receiver. The guidance was experimentally tested with the tracking of straight trajectories and with the step response. The total guidance error was obtained from the receiver accuracy and from the guidance error. For the evaluation of the receivers accuracy, positioning data from several low cost receivers were recorded and analyzed. For the evaluation of the guidance error, tests were performed with each control law at three different speeds. The conclusions obtained were that relative accuracy of low-cost receivers decreases with the time; that for an interval lower than 15 min, the error usually remains below 1 m; that all the control laws have a similar behavior and it is conditioned by the control law adjustment; that automatic guidance with low cost receivers is possible with speeds that went up to 9 km h{sup -}1; and finally, that the total error in the guidance is mainly determined by the receivers accuracy. (Author) 46 refs.

  2. Understanding the implementation of 'sick day guidance' to prevent acute kidney injury across a primary care setting in England: a qualitative evaluation.

    Science.gov (United States)

    Martindale, Anne-Marie; Elvey, Rebecca; Howard, Susan J; McCorkindale, Sheila; Sinha, Smeeta; Blakeman, Tom

    2017-11-08

    The study sought to examine the implementation of sick day guidance cards designed to prevent acute kidney injury (AKI), in primary care settings. Qualitative semistructured interviews were conducted and comparative analysis informed by normalisation process theory was undertaken to understand sense-making, implementation and appraisal of the cards and associated guidance. A single primary care health setting in the North of England. 29 participants took part in the qualitative evaluation: seven general practitioners, five practice nurses, five community pharmacists, four practice pharmacists, two administrators, one healthcare assistant and five patients. The sick day guidance intervention was rolled out (2015-2016) in general practices (n=48) and community pharmacies (n=60). The materials consisted of a 'medicine sick day guidance' card, provided to patients who were taking the listed drugs. The card provided advice about medicines management during episodes of acute illness. An information leaflet was provided to healthcare practitioners and administrators suggesting how to use and give the cards. Implementation of sick day guidance cards to prevent AKI entailed a new set of working practises across primary care. A tension existed between ensuring reach in administration of the cards to at risk populations while being confident to ensure patient understanding of their purpose and use. Communicating the concept of temporary cessation of medicines was a particular challenge and limited their administration to patient populations at higher risk of AKI, particularly those with less capacity to self-manage. Sick day guidance cards that focus solely on medicines management may be of limited patient benefit without adequate resourcing or if delivered as a standalone intervention. Development and evaluation of primary care interventions is urgently warranted to tackle the harm associated with AKI. © Article author(s) (or their employer(s) unless otherwise stated in the

  3. 78 FR 15956 - Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Science.gov (United States)

    2013-03-13

    ...] Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation; Availability...) is announcing the availability of a guidance for industry entitled ``Tablet Scoring: Nomenclature... evaluating and labeling tablets that have been scored. (A scoring feature facilitates tablet splitting, which...

  4. The Evaluation of School Guidance and Counselling Services in ...

    African Journals Online (AJOL)

    This paper sought to establish the status of the Zimbabwean School Guidance and Counselling Services (SGC services) evaluation from school counsellors' perspectives. A descriptive survey design was used. A questionnaire was administered to 314 participants. The SAS/STAT version 9.1 was used to analyse the data.

  5. THE EVALUATION OF COUNSELING AND GUIDANCE SERVICES BASED ON TEACHER VIEWS AND THEIR PREDICTION BASED ON SOME VARIABLES

    Directory of Open Access Journals (Sweden)

    Fulya Yuksel-Sahin

    2009-01-01

    Full Text Available This study evaluated psychological counseling and guidance services based on elementary and secondary education teachers’ views. Participants were 204 teachers. “School Guidance Services Scale” and “Teacher Personal Information Form” were used for gathering the necessary information. Percentage calculations and multiple regression analysis were used for data analysis. The results showed that teachers listed the guidance services from the most utilized to the least as follows: consultation, counseling, information gathering and outreach, appraisal, orientation, placement, research and evaluation public and family relations and follow-up services. Results of this study showed that overall an approximately 46% of all counseling and guidance services were offered. Moreover, according to the results of the study, the grade being taught and holding the view that schools should definitely have a school counselor were significant predictors of teachers’ evaluation of counseling and guidance services. However, taking counseling and guidance lessons during undergraduate studies, the length of service and gender were not significant predictors of teachers’ evaluation of counseling and guidance services.

  6. Ecological risk assessment guidance for preparation of remedial investigation/feasibility study work plans

    International Nuclear Information System (INIS)

    Pentecost, E.D.; Vinikour, W.S.

    1993-08-01

    This guidance document (1) provides instructions on preparing the components of an ecological work plan to complement the overall site remedial assessment investigation/feasibility study (RI/FS) work plan and (2) directs the user on how to implement ecological tasks identified in the plan. Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfired Amendments and Reauthorization Act of 1986 (SARA), an RI/FS work plan win have to be developed as part of the site-remediation scoping the process. Specific guidance on the RI/FS process and the preparation of work plans has been developed by the US Environmental Protection Agency (EPA 1988a). This document provides guidance to US Department of Energy (DOE) staff and contractor personnel for incorporation of ecological information into environmental remediation planning and decision making at CERCLA sites. An overview analysis of early ecological risk assessment methods (i.e., in the 1980s) at Superfund sites was conducted by the EPA (1989a). That review provided a perspective of attention given to ecological issues in some of the first RI/FS studies. By itself, that reference is of somewhat limited value; it does, however, establish a basis for comparison of past practices in ecological risk with current, more refined methods

  7. Evaluation of a mobile augmented reality application for image guidance of neurosurgical interventions.

    Science.gov (United States)

    Kramers, Matthew; Armstrong, Ryan; Bakhshmand, Saeed M; Fenster, Aaron; de Ribaupierre, Sandrine; Eagleson, Roy

    2014-01-01

    Image guidance can provide surgeons with valuable contextual information during a medical intervention. Often, image guidance systems require considerable infrastructure, setup-time, and operator experience to be utilized. Certain procedures performed at bedside are susceptible to navigational errors that can lead to complications. We present an application for mobile devices that can provide image guidance using augmented reality to assist in performing neurosurgical tasks. A methodology is outlined that evaluates this mode of visualization from the standpoint of perceptual localization, depth estimation, and pointing performance, in scenarios derived from a neurosurgical targeting task. By measuring user variability and speed we can report objective metrics of performance for our augmented reality guidance system.

  8. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Science.gov (United States)

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals... Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for...

  9. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Science.gov (United States)

    2011-08-30

    ...] Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tablet Scoring... should be met to facilitate the evaluation and labeling of tablets that have been scored. (A scoring...

  10. Interim guidance risk assessment of the device assembly facility at the Nevada test site

    International Nuclear Information System (INIS)

    Altenbach, T.J.

    1996-05-01

    The risks of plutonium dispersal and/or high explosive detonation from nuclear explosive operations at the Device Assembly Facility were examined in accordance with DOE Order 5610.11 and the Interim Guidance. The assessment consisted of a qualitative task and hazards analysis, and a quantitative risk screening. Results are displayed on risk matrices for the major types of operations. Most accident scenarios were considered to have Low risk; a few scenarios have Moderate risk; and none have High risk. The highest risk scenarios (Moderate category) consist of a high explosive detonation during assembly operations in a cell, with bare conventional high explosive surrounding the pit

  11. Guidance for treatment of variability and uncertainty in ecological risk assessments of contaminated sites

    International Nuclear Information System (INIS)

    1998-06-01

    Uncertainty is a seemingly simple concept that has caused great confusion and conflict in the field of risk assessment. This report offers guidance for the analysis and presentation of variability and uncertainty in ecological risk assessments, an important issue in the remedial investigation and feasibility study processes. This report discusses concepts of probability in terms of variance and uncertainty, describes how these concepts differ in ecological risk assessment from human health risk assessment, and describes probabilistic aspects of specific ecological risk assessment techniques. The report ends with 17 points to consider in performing an uncertainty analysis for an ecological risk assessment of a contaminated site

  12. Eating nanomaterials: cruelty-free and safe? the EFSA guidance on risk assessment of nanomaterials in food and feed.

    Science.gov (United States)

    Sauer, Ursula G

    2011-12-01

    Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.

  13. Climate risk screening tools and their application: A guide to the guidance

    Energy Technology Data Exchange (ETDEWEB)

    Traerup, S.; Olhoff, A.

    2011-07-01

    Climate risk screening is an integral part of efforts to ascertain current and future vulnerabilities and risks related to climate change. It is a prerequisite for identifying and designing adaptation measures, and an important element in the process of integrating, or mainstreaming, climate change adaptation into development project, planning and policy processes. There is an increasing demand and attention among national stakeholders in developing countries to take into account potential implications of climate variability and change for planning and prioritizing of development strategies and activities. Subsequently, there is a need for user friendly guidance on climate risk screening tools and their potentials for application that targets developing country stakeholders. This need is amplified by the sheer volume of climate change mainstreaming guidance documents and risk screening and assessment tools available and currently under development. Against this background, this paper sets out to provide potential users in developing countries, including project and programme developers and managers, with an informational entry point to climate risk screening tools. The emphasis in this report is on providing: 1) An overview of available climate risk screening and assessment tools along with indications of the tools available and relevant for specific purposes and contexts (Section 3). 2) Examples of application of climate risk screening and assessment tools along with links to further information (Section 4). Before turning to the respective sections on available climate risk screening tools and examples of their application, a delimitation of the tools included in this paper is included in Section 2. This section also provides a brief overview of how climate screening and related tools fit into decision making steps at various planning and decision making levels in conjunction with an outline of overall considerations to make when choosing a tool. The paper is

  14. 78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

    Science.gov (United States)

    2013-02-25

    ...; formerly 2005D-0183] Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... 20852. FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug Evaluation and Research, Food...

  15. Focus on Chronic Exposure for Deriving Drinking Water Guidance Underestimates Potential Risk to Infants

    Directory of Open Access Journals (Sweden)

    Helen Goeden

    2018-03-01

    Full Text Available In 2007, the Minnesota Department of Health (MDH developed new risk assessment methods for deriving human health-based water guidance (HBG that incorporated the assessment of multiple exposure durations and life stages. The methodology is based on US Environmental Protection Agency recommendations for protecting children’s health (US EPA 2002. Over the last 10 years, the MDH has derived multiple duration (e.g., short-term, subchronic, and chronic water guidance for over 60 chemicals. This effort involved derivation of multiple duration reference doses (RfDs and selection of corresponding water intake rates (e.g., infant, child, and lifetime. As expected, RfDs typically decreased with increasing exposure duration. However, the corresponding HBG frequently did not decrease with increasing duration. For more than half of the chemicals, the shorter duration HBG was lower than chronic HBG value. Conventional wisdom has been that chronic-based values will be the most conservative and will therefore be protective of less than chronic exposures. However, the MDH’s experience highlights the importance of evaluating short-term exposures. For many chemicals, elevated intake rates early in life, coupled with short-term RfDs, resulted in the lowest HBG. Drinking water criteria based on chronic assessments may not be protective of short-term exposures in highly exposed populations such as formula-fed infants.

  16. EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

    NARCIS (Netherlands)

    Arnold, G.; Boesten, J.J.T.I.; Clook, M.

    2013-01-01

    The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of plant protection products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific opinion on the science behind the development of a risk assessment of plant

  17. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  18. DEVELOPMENT OF HUMAN FACTORS ENGINEERING GUIDANCE FOR SAFETY EVALUATIONS OF ADVANCED REACTORS

    International Nuclear Information System (INIS)

    O'HARA, J.; PERSENSKY, J.; SZABO, A.

    2006-01-01

    Advanced reactors are expected to be based on a concept of operations that is different from what is currently used in today's reactors. Therefore, regulatory staff may need new tools, developed from the best available technical bases, to support licensing evaluations. The areas in which new review guidance may be needed and the efforts underway to address the needs will be discussed. Our preliminary results focus on some of the technical issues to be addressed in three areas for which new guidance may be developed: automation and control, operations under degraded conditions, and new human factors engineering methods and tools

  19. Medical homes for at-risk children: parental reports of clinician-parent relationships, anticipatory guidance, and behavior changes.

    Science.gov (United States)

    Nelson, Catherine S; Higman, Susan M; Sia, Calvin; McFarlane, Elizabeth; Fuddy, Loretta; Duggan, Anne K

    2005-01-01

    Family-centeredness, compassion, and trust are 3 attributes of the clinician-parent relationship in the medical home. Among adults, these attributes are associated with patients' adherence to clinicians' advice. The objectives were (1) to measure medical home attributes related to the clinician-parent relationship, (2) to measure provision of anticipatory guidance regarding injury and illness prevention, (3) to relate anticipatory guidance to parental behavior changes, and (4) to relate medical home attributes to anticipatory guidance and parental behavior changes. A cross-sectional study of data collected among at-risk families when children were 1 year of age, in a randomized, controlled trial of a home-visiting program to prevent child abuse and neglect, was performed. Modified subscales of the Primary Care Assessment Survey were used to measure parental ratings of clinicians' family-centeredness, compassion, and trust. Parental reports of provision of anticipatory guidance regarding injury and illness prevention topics (smoke alarms, infant walkers, car seats, hot water temperature, stair guards, sunscreen, firearm safety, and bottle propping) and behavior changes were recorded. Of the 564 mothers interviewed when their children were 1 year of age, 402 (71%) had a primary care provider and had complete data for anticipatory guidance items. By definition, poverty, partner violence, poor maternal mental health, and maternal substance abuse were common in the study sample. Maternal ratings of clinicians' family-centeredness, compassion, and trust were fairly high but ranged widely and varied among population subgroups. Families reported anticipatory guidance for a mean of 4.6 +/- 2.2 topics relevant for discussion. Each medical home attribute was positively associated with parental reports of completeness of anticipatory guidance, ie, family-centeredness (beta = .026, SE = .004), compassion (beta = .019, SE = .005), and trust (beta = .016, SE = .005). Parents

  20. Evaluation of school counseling and guidance services based on views of high school students

    OpenAIRE

    Fulya Yüksel-Şahin

    2008-01-01

    This study evaluated school psychological counseling services based on high school students’ views. Participants were 235 students. “Student Personal Information Form” and “the School Guidance Services Scale” were used for data analysis. MANOVA and multiple regression procedures were used for data analysis. Results showed that students listed the guidance services from the most utilized to the least as follows: consultation, placement, follow-up, public and famil...

  1. A comparative evaluation of static and functional methods for recording centric relation and condylar guidance: a clinical study.

    Science.gov (United States)

    Thakur, Mridul; Jain, Veena; Parkash, Hari; Kumar, Pravesh

    2012-09-01

    To evaluate and compare the centric relation and horizontal condylar guidance using interocclusal wax and extra oral Gothic arch methods and subjective evaluation of dentures thus fabricated. Centric relation and horizontal condylar guidance was recorded by using interocclusal wax and gothic arch tracing in 28 completely edentulous patients. These records were transferred to the articulator and difference in both values was recorded. After that patients were divided in two groups according to the centric relation and horizontal condylar guidance recording method used to achieve balanced occlusion. Response of the dentures was subjectively evaluated using "Woelfel subjective evaluation criteria". Centric relation recorded by both the methods did coincide in 7.14 % of patients. Centric relation recorded by interocclusal wax was posterior to Gothic centric relation in 21.43 % of patients, and anterior to Gothic centric relation in 71.42 % patients. Gothic arch tracings gave higher mean guidance values on both the sides as compared to protrusive wax record in all the subjects, although the difference was statistically insignificant (P > 0.05). Subjective evaluation showed statistical insignificance for all the parameters in both groups. Gothic arch method records the centric relation at a more posterior position than the Static method, but it does not make any difference in clinical performance of the complete denture. Horizontal condylar guidance angle was approximately similar by both the methods.

  2. Development of regulatory guidance for risk-informing digital system reviews

    International Nuclear Information System (INIS)

    Arndt, S. A.

    2006-01-01

    In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

  3. Guidance on the European Framework for Psychosocial Risk Management: a resource for employers and worker representatives

    NARCIS (Netherlands)

    Leka, S.; Cox, T.; Jain, A.; Hassard, J.; Ertel, M.; Stilijanow, U.; Cvitkovic, J.; Lenhardt, U.; Lavicoli, S.; Deitinger, P.; Petyx, C.; Natali, E.; Houtman, I.L.D.; Zwetsloot, G.I.J.M.; Bakhuys Roozeboom, M.M.C.; Bossche, S.M.J. van den; Widerszal-Bazyl, M.; Zolmierczyk-Zreda, D.; Vartia, M.; Pahkin, K.; Lindstrom, K.; Sutela, S.

    2008-01-01

    The overarching aim of this document is the promotion of the translation of policy and knowledge into practice. As such, guidance is provided in relation to key issues including risk assessment, social dialogue and employee participation, key indicators, best practice interventions and corporate

  4. Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues.

    Science.gov (United States)

    Edwards, Rhiannon Tudor; Charles, Joanna Mary; Lloyd-Williams, Huw

    2013-10-24

    If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Electronic databases and organisation websites were searched using a 22 year time horizon (1990-2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may find it useful to think in this broader

  5. Chance-Constrained Guidance With Non-Convex Constraints

    Science.gov (United States)

    Ono, Masahiro

    2011-01-01

    Missions to small bodies, such as comets or asteroids, require autonomous guidance for descent to these small bodies. Such guidance is made challenging by uncertainty in the position and velocity of the spacecraft, as well as the uncertainty in the gravitational field around the small body. In addition, the requirement to avoid collision with the asteroid represents a non-convex constraint that means finding the optimal guidance trajectory, in general, is intractable. In this innovation, a new approach is proposed for chance-constrained optimal guidance with non-convex constraints. Chance-constrained guidance takes into account uncertainty so that the probability of collision is below a specified threshold. In this approach, a new bounding method has been developed to obtain a set of decomposed chance constraints that is a sufficient condition of the original chance constraint. The decomposition of the chance constraint enables its efficient evaluation, as well as the application of the branch and bound method. Branch and bound enables non-convex problems to be solved efficiently to global optimality. Considering the problem of finite-horizon robust optimal control of dynamic systems under Gaussian-distributed stochastic uncertainty, with state and control constraints, a discrete-time, continuous-state linear dynamics model is assumed. Gaussian-distributed stochastic uncertainty is a more natural model for exogenous disturbances such as wind gusts and turbulence than the previously studied set-bounded models. However, with stochastic uncertainty, it is often impossible to guarantee that state constraints are satisfied, because there is typically a non-zero probability of having a disturbance that is large enough to push the state out of the feasible region. An effective framework to address robustness with stochastic uncertainty is optimization with chance constraints. These require that the probability of violating the state constraints (i.e., the probability of

  6. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

    Science.gov (United States)

    Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

    2017-07-01

    The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

  7. Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues

    Science.gov (United States)

    2013-01-01

    Background If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Methods Electronic databases and organisation websites were searched using a 22 year time horizon (1990–2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. Results We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. Conclusions In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may

  8. 76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

    Science.gov (United States)

    2011-08-29

    ... 200N, Rockville, MD 20852-1448; or the Office of Communication, Education and Radiation Programs... describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies... appropriate, and other forms of information technology. Title: Draft Guidance for Industry: Oversight of...

  9. Fuzzy Comprehensive Evaluation of Ecological Risk Based on Cloud Model: Taking Chengchao Iron Mine as Example

    Science.gov (United States)

    Ruan, Jinghua; Chen, Yong; Xiao, Xiao; Yong, Gan; Huang, Ranran; Miao, Zuohua

    2018-01-01

    Aimed at the fuzziness and randomness during the evaluation process, this paper constructed a fuzzy comprehensive evaluation method based on cloud model. The evaluation index system was established based on the inherent risk, present level and control situation, which had been proved to be able to convey the main contradictions of ecological risk in mine on the macro level, and be advantageous for comparison among mines. The comment sets and membership functions improved by cloud model could reflect the uniformity of ambiguity and randomness effectively. In addition, the concept of fuzzy entropy was introduced to further characterize the fuzziness of assessments results and the complexities of ecological problems in target mine. A practical example in Chengchao Iron Mine evidenced that, the assessments results can reflect actual situations appropriately and provide a new theoretic guidance for comprehensive ecological risk evaluation of underground iron mine.

  10. Evaluation of Hanau's formula in determination of lateral condylar guidance: A clinical research study

    Science.gov (United States)

    Bhawsar, Sanjay Vasant; Marathe, Ashlesha Subhash; Ansari, Sadekh Abdul

    2015-01-01

    Statement of Problem: The accuracy and reliability of the methods used for programming the semi-adjustable articulators determine the accuracy in occlusion. The current recommended average settings using the Hanau's formula commonly used by clinicians is questionable, and thus reassessment is needed. This study was carried out to evaluate and compare the lateral condylar guidance: (1) Using the Hanau's formula and the computerized jaw tracking device (Kinesiograph). (2) On the right and left sides using both these methods. Materials and Methods: A total of 20 completely edentulous patients (14 male and 6 females) within 40–60 years of age were selected. Jaw relation was recorded followed by face bow transfer. Extraoral Gothic arch tracing was recorded; three protrusive records were obtained and condylar guidance was calculated. Lateral condylar guidance was then calculated using Hanau's formula, followed by the computerized jaw tracking device. A comparative evaluation was done of the obtained values. The same investigator worked with each of the study participants for the purpose of standardization. Results: The lateral condylar guidance values obtained using the Hanau's formula ranged from 14 to 17° while those obtained using the computerized K7 jaw tracking device ranged from 8 to 40°. Bennett angle values, obtained using the jaw tracking device and Hanau's formula showed statistically significant differences (P 0.05). Conclusion: Based on the results, dentist and dental technicians should consider reassessing the current recommended average settings and use of the Hanau's formula for programming the semi-adjustable articulators. PMID:26929535

  11. Public health guidance on cardiovascular benefits and risks related to fish consumption

    Directory of Open Access Journals (Sweden)

    Stern Alan H

    2007-10-01

    Full Text Available Abstract Historically, concerns with fish consumption have addressed risks from contaminants (e.g., methylmercury (MeHg, and PCBs. More recently public health concerns have widened in appreciation of the specific benefits of fish consumption such as those arising from polyunsaturated fatty acids (PUFAs in fish oil. Fish contains varying levels of PUFAs and MeHg. Since both address the same health outcomes (in opposite directions and occur together in fish, great care must be exercised in providing public health guidance. Mozaffarian and Rimm in a recent article (JAMA. 2006, 296:1885–99 have made a strong case for the beneficial effects of PUFAs in reducing the risk of coronary heart disease, but at the same time, have also broadly discounted the increased risks of coronary heart disease posed by MeHg in fish, stating that "... among adults... the benefits of fish intake exceed the potential risks." This conclusion appears to be based on an inaccurate and insufficiently critical analysis of the literature. This literature is re-examined in light of their conclusions, and the available and appropriate public health options are considered.

  12. WODA Technical Guidance on Underwater Sound from Dredging.

    Science.gov (United States)

    Thomsen, Frank; Borsani, Fabrizio; Clarke, Douglas; de Jong, Christ; de Wit, Pim; Goethals, Fredrik; Holtkamp, Martine; Martin, Elena San; Spadaro, Philip; van Raalte, Gerard; Victor, George Yesu Vedha; Jensen, Anders

    2016-01-01

    The World Organization of Dredging Associations (WODA) has identified underwater sound as an environmental issue that needs further consideration. A WODA Expert Group on Underwater Sound (WEGUS) prepared a guidance paper in 2013 on dredging sound, including a summary of potential impacts on aquatic biota and advice on underwater sound monitoring procedures. The paper follows a risk-based approach and provides guidance for standardization of acoustic terminology and methods for data collection and analysis. Furthermore, the literature on dredging-related sounds and the effects of dredging sounds on marine life is surveyed and guidance on the management of dredging-related sound risks is provided.

  13. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

    Science.gov (United States)

    Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

    2012-07-01

    Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

  14. Evaluating physical protection systems of licensed nuclear facilities using systems engineered inspection guidance

    International Nuclear Information System (INIS)

    Bradley, R.T.; Olson, A.W.; Rogue, F.; Scala, S.; Richard, E.W.

    1980-01-01

    The Lawrence Livermore National Laboratory (LLNL) and the US Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) have applied a systems engineering approach to provide the NRC Office of Inspection and Enforcement (IE) with improved methods and guidance for evaluating the physical protection systems of licensed nuclear facilities

  15. 75 FR 9607 - National Protection and Programs Directorate; Guidance Document Request and Evaluation

    Science.gov (United States)

    2010-03-03

    ... information for continuous improvement to its documents. Guidance document request forms and evaluation forms... Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the... will be accepted until May 3, 2010. This process is conducted in accordance with 5 CFR 1320.1...

  16. Guidance for Facilities on Risk Management Programs (RMP)

    Science.gov (United States)

    Includes supplemental guidance specific to ammonia refrigeration, wastewater treatment, propane storage, warehouses, chemical distributors, offsite consequence analysis, retail agriculture, applicability of program levels, prevention, emergency response.

  17. Review of guidance on recurrence risk management for general practitioners in breast cancer, colorectal cancer and melanoma guidelines.

    NARCIS (Netherlands)

    Spronk, I.; Korevaar, J.C.; Burgers, J.S.; Albreht, T.; Schellevis, F.G.

    2017-01-01

    Background. General practitioners (GPs) will face cancer recurrences more frequently due to the rising number of cancer survivors and greater involvement of GPs in the follow-up care. Currently, GPs are uncertain about managing recurrence risks and may need more guidance. Objective. To explore what

  18. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  19. Risk assessment guidance document for the UMTRA project groundwater remediation phase

    International Nuclear Information System (INIS)

    1992-05-01

    The purpose of the groundwater remedial activities at the Uranium Mill Tailings Remedial Action (UMTRA) sites is to reduce, control, or eliminate risks to human health and the environment. This is in accordance with Subpart B of 40 CFR 192. According to this regulation, the need for groundwater restoration is based upon US Environmental Protection Agency (EPA)-defined groundwater cleanup standards and must be consistent with the National Environmental Policy Act (NEPA) process. Risk assessments will be used in the UMTRA Groundwater Program to aid in the evaluation of sites. Risk assessments are conducted for four purposes: (1) Preliminary risk assessments are used to aid in prioritizing sites, scope data collection, end determine if a site presents immediate health risks. (2) Baseline risk assessments provide a comprehensive integration and interpretation of demographic, geographic, physical, chemical, and biological factors at a site to determine the extent of actual or potential harm. This information Is used to determine the need for remedial action. (3) Risk evaluation of remedial alternatives is performed to evaluate risks to humans or the environment associated with the various remedial strategies. (4) After remediation, an evaluation of residual risks is conducted. The information gathered for each of these risk evaluations is used to determine the need for subsequent evaluation. Several sites may be eliminated after a preliminary risk assessment if there is no current or future threat to humans or the environment. Likewise, much of the data from a baseline risk assessment can be used to support alternate concentration limits or supplemental standards demonstrations, or identify sensitive habitats or receptors that may be of concern in selecting a remedy

  20. Hanford Site baseline risk assessment methodology

    International Nuclear Information System (INIS)

    1993-03-01

    This methodology has been developed to prepare human health and environmental evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act remedial investigations (RIs) and the Resource Conservation and Recovery Act facility investigations (FIs) performed at the Hanford Site pursuant to the Hanford Federal Facility Agreement and Consent Order referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies Site-specific risk assessment considerations and integrates them with approaches for evaluating human and environmental risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site

  1. Review of UCN 3,4 PSA model based on NEI PRA peer review process guidance, rev.0

    International Nuclear Information System (INIS)

    Yang, Joon Eon; Kang, D. I.; Kim, K. Y.; Lee, Y. H.; Jang, S. C.; Ha, J. J.; Han, S. H.; Han, S. J.; Hwang, M. J.

    2003-05-01

    Recently, under the de-regulation environment, nuclear industry has attempted various approaches to improve the economics of Nuclear Power Plants (NPP). One of these efforts is the Risk Informed/Performance-Based Operation (RIPBO). This approach uses the risk and performance information to manage the resources effectively and efficiently that are used in the operation of NPP. In RIPBO, PSA quality is one of the most important things. The nuclear industry and regulatory body of U.S.A have developed a measure to evaluate the quality of PSA. NEI (Nuclear Energy Institute) has developed a guidance called 'NEI PRA Peer Review Guidance,' and NRC (Nuclear Regulatory Committee) and ASME have developed the 'PRA Standard.' In Korea, several projects are on going now, such as the extension of AOT/STI of RPS/ESFAS, Risk-Informed In-Service Inspection (RI-ISI). However, in Korea, there have been no attempts to evaluate the quality of PSA model itself. Therefore, we cannot be sure about the quality of PSA whether or not the present PSA model can be used for the risk-informed applications such as mentioned above. We can say that the evaluation of PSA model quality is the basis for the RIPBO. In this report, we have evaluated the quality of PSA model for Ulchin 3 and 4 units based on the NEI guidance. We, also, have derived what items are to be improved to upgrade the quality of PSA model and how it can be improved. This report can be used as the base of RIPBO work in Korea. The review result based on ASME Standard is published as the separated technical report of KAERI

  2. Numerical evaluation of guidance force decay of HTS bulk exposed to AC magnetic field over a NdFeB guideway

    Energy Technology Data Exchange (ETDEWEB)

    Zhang Longcai [P.O. Box 152, Applied Superconductivity Laboratory, Southwest Jiaotong University, Chengdu, Sichuan 610031 (China)], E-mail: zhlcai2000@163.com; Wang Jiasu; Wang Suyu; Zheng Jun; He Qingyong [P.O. Box 152, Applied Superconductivity Laboratory, Southwest Jiaotong University, Chengdu, Sichuan 610031 (China)

    2007-12-01

    The guidance force of the YBCO bulk over a NdFeB guideway used in the high-temperature superconducting maglev vehicle system was decayed by the application of the AC external magnetic field. In our previous work, we explained that the decay was due to the temperature rise of the HTS bulk caused by AC losses. In this paper, we adopted an analytic model to evaluate the decay of the critical current density of the bulk. And based on the analytic results and the Bean critical-state model, we calculated the guidance force as a function of times. Compared with the experimental results, the calculation results have almost the same trend and can qualitatively reveal the characteristics of guidance force of HTS bulk in this situation. Therefore, the guidance force decay of HTS bulk in the maglev vehicle system can be evaluated simply by this numerical method.

  3. Risk-informed design guidance for future reactor systems

    International Nuclear Information System (INIS)

    Delaney, Michael J.; Apostolakis, George E.; Driscoll, Michael J.

    2005-01-01

    Future reactor designs face an uncertain regulatory environment. It is anticipated that there will be some level of probabilistic insights in the regulations and supporting regulatory documents for Generation-IV nuclear reactors. Central to current regulations are design basis accidents (DBAs) and the general design criteria (GDC), which were established before probabilistic risk assessments (PRAs) were developed. These regulations implement a structuralist approach to safety through traditional defense in depth and large safety margins. In a rationalist approach to safety, accident frequencies are quantified and protective measures are introduced to make these frequencies acceptably low. Both approaches have advantages and disadvantages and future reactor design and licensing processes will have to implement a hybrid approach. This paper presents an iterative four-step risk-informed methodology to guide the design of future-reactor systems using a gas-cooled fast reactor emergency core cooling system as an example. This methodology helps designers to analyze alternative designs under potential risk-informed regulations and to anticipate design justifications the regulator may require during the licensing process. The analysis demonstrated the importance of common-cause failures and the need for guidance on how to change the quantitative impact of these potential failures on the frequency of accident sequences as the design changes. Deliberation is an important part of the four-step methodology because it supplements the quantitative results by allowing the inclusion in the design choice of elements such as best design practices and ease of online maintenance, which usually cannot be quantified. The case study showed that, in some instances, the structuralist and the rationalist approaches were inconsistent. In particular, GDC 35 treats the double-ended break of the largest pipe in the reactor coolant system with concurrent loss of offsite power and a single

  4. Management of mediastinal syndromes in pediatrics: a new challenge of ultrasound guidance to avoid high-risk general anesthesia.

    Science.gov (United States)

    Sola, Chrystelle; Choquet, Olivier; Prodhomme, Olivier; Capdevila, Xavier; Dadure, Christophe

    2014-05-01

    Adverse events associated with anesthetic management of anterior mediastinal masses in pediatrics are common. To avoid an extremely hazardous general anesthesia, the use of real-time ultrasonography offers an effective alternative in high-risk cases. We report the anesthetic management including a light sedation and ultrasound guidance for regional anesthesia, surgical node biopsy, and placement of a central venous line in two children with an anterior symptomatic mediastinal mass. For pediatric patients with clinical and/or radiologic signs of airway compression, ultrasound guidance provides safety technical assistance to avoid general anesthesia and should be performed for the initial diagnostic and therapeutic procedures. © 2013 John Wiley & Sons Ltd.

  5. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    International Nuclear Information System (INIS)

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed

  6. EPA guidance on the early detection of clinical high risk states of psychoses

    DEFF Research Database (Denmark)

    Schultze-Lutter, F; Michel, C; Schmidt, S J

    2015-01-01

    The aim of this guidance paper of the European Psychiatric Association is to provide evidence-based recommendations on the early detection of a clinical high risk (CHR) for psychosis in patients with mental problems. To this aim, we conducted a meta-analysis of studies reporting on conversion rates...... to psychosis in non-overlapping samples meeting any at least any one of the main CHR criteria: ultra-high risk (UHR) and/or basic symptoms criteria. Further, effects of potential moderators (different UHR criteria definitions, single UHR criteria and age) on conversion rates were examined. Conversion rates...... in the identified 42 samples with altogether more than 4000 CHR patients who had mainly been identified by UHR criteria and/or the basic symptom criterion 'cognitive disturbances' (COGDIS) showed considerable heterogeneity. While UHR criteria and COGDIS were related to similar conversion rates until 2-year follow...

  7. Use of toxicity assessment to develop site specific remediation criteria for oil and gas facilities : guidance manual

    International Nuclear Information System (INIS)

    1996-01-01

    The results of a two year study into the evaluation of toxicity-based methods to develop site-specific, risk-based cleanup objectives for the decommissioning of oil and gas facilities were compiled into a manual of guidance. The two basic approaches used in determining remediation criteria for contaminated sites are: (1) comparison of the concentrations of chemicals found on-site with broad regional or national soil and water quality objectives developed for the chemicals involved, and (2) site-specific risk assessment. Toxicity tests are used to test organisms such as earthworms, lettuce seeds, or larval fish directly in the soil, water or sediment suspected of being contaminated. The effects of any contamination on the survival, growth, reproduction, and behaviour of the test organisms are then evaluated. The manual provides guidance in: (1) using toxicity assessments within the regulatory framework of site decommissioning, (2) performing a toxicity assessment, and (3) developing site-specific criteria for a risk assessment. 18 refs., 3 tabs., 5 figs

  8. 78 FR 63221 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2013-10-23

    ..., MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert King, Sr., Center for Drug... Spring, MD 20993-0002, 301- 796-1242; or Stephen Ripley, Center for Biologics Evaluation and Research...

  9. Guidance for performing preliminary assessments under CERCLA

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1991-09-01

    EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.

  10. European Universities' Guidance on Research Integrity and Misconduct.

    Science.gov (United States)

    Aubert Bonn, Noémie; Godecharle, Simon; Dierickx, Kris

    2017-02-01

    Research integrity is imperative to good science. Nonetheless, many countries and institutions develop their own integrity guidance, thereby risking incompatibilities with guidance of collaborating institutions. We retrieved guidance for academic integrity and misconduct of 18 universities from 10 European countries and investigated accessibility, general content, principles endorsed, and definitions of misconduct. Accessibility and content differ substantially between institutions. There are general trends of common principles of integrity and definitions of misconduct, yet differences remain. Parallel with previous research, we distinguish different approaches in integrity guidance; one emphasizes broad values of integrity, and the other details negative behaviors of misconduct. We propose that a balance between both approaches is necessary to preserve trust, meaning, and realism of guidance on research integrity.

  11. Radon: guidance on protective measures for new dwellings

    International Nuclear Information System (INIS)

    1991-01-01

    This report gives guidance for reducing the presence of radon in new dwellings and hence reducing the risk to occupants of exposure to radon. This is a follow-up to the interim guidance of 1988. The report provides comprehensive practical details on the methods of protection including both primary and secondary measures. (UK)

  12. A case study for evaluating ecological risks at the Idaho National Engineering Laboratory (INEL)

    International Nuclear Information System (INIS)

    Peterson, S.; Brewer, R.; Morris, R.; VanHorn, R.

    1994-01-01

    A case study was conducted as a component of the development of guidance for ecological risk assessment at the Department of Energy's Idaho National Engineering Laboratory (INEL). The INEL is a large facility in southeastern Idaho, encompassing expanses of sagebrush-steppe that harbor numerous wildlife species. Nuclear research and waste disposal activities have resulted in releases of radionuclides at various sites. Due to the size and number of potentially contaminated areas, a cost-effective method was needed to evaluate ecological risks and to identify data needs for remedial investigations. Screening-level assessment approaches were developed to evaluate data collected from previous site investigations. Above-background concentrations of radionuclides and other contaminants in media were compared to risk-based criteria, which were derived from sources such as recent publications of the International Atomic Energy Agency (IAEA) and National Council on Radiation Protection and Measurements (NCRP). Site-specific risks to plants and wildlife were estimated for contaminants exceeding criteria. Dose rates derived using various estimation methods were compared to reference doses for wildlife obtained from IAEA, NCRP, and other publications

  13. Planning required in the development of radiation protection guidance for underground engineering applications

    Energy Technology Data Exchange (ETDEWEB)

    Neill, R H [U.S. Public Health Service, Rockville, MD (United States)

    1969-07-01

    The potential variety of engineering applications from the peaceful uses of underground nuclear explosives indicates an increased need for applicable radiation protection guidance to protect the public health of potentially exposed populations. To insure the orderly development of such uses, additional operational data as well as bioeffects data will be required to develop appropriate criteria and guidance to inform health officials and the public of the significance of possible exposures. The required planning includes an evaluation of the potential benefits and risks as well as the size and age of population, multiplicity of sources, likely and unlikely future uses, and the total environmental impact. (author)

  14. Planning required in the development of radiation protection guidance for underground engineering applications

    International Nuclear Information System (INIS)

    Neill, R.H.

    1969-01-01

    The potential variety of engineering applications from the peaceful uses of underground nuclear explosives indicates an increased need for applicable radiation protection guidance to protect the public health of potentially exposed populations. To insure the orderly development of such uses, additional operational data as well as bioeffects data will be required to develop appropriate criteria and guidance to inform health officials and the public of the significance of possible exposures. The required planning includes an evaluation of the potential benefits and risks as well as the size and age of population, multiplicity of sources, likely and unlikely future uses, and the total environmental impact. (author)

  15. Guidelines for developing NASA (National Aeronautics and Space Administration) ADP security risk management plans

    Science.gov (United States)

    Tompkins, F. G.

    1983-01-01

    This report presents guidance to NASA Computer security officials for developing ADP security risk management plans. The six components of the risk management process are identified and discussed. Guidance is presented on how to manage security risks that have been identified during a risk analysis performed at a data processing facility or during the security evaluation of an application system.

  16. Safety of magnetic fusion facilities: Guidance

    International Nuclear Information System (INIS)

    1996-05-01

    This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities

  17. 78 FR 68461 - Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives...

    Science.gov (United States)

    2013-11-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1994-D-0007] Guidance for Industry: Studies To Evaluate the Utility of Anti- Salmonella Chemical Food Additives in Feeds... Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is...

  18. The integrated performance evaluation program quality assurance guidance in support of EM environmental sampling and analysis activities

    International Nuclear Information System (INIS)

    1994-05-01

    EM's (DOE's Environmental Restoration and Waste Management) Integrated Performance Evaluation Program (IPEP) has the purpose of integrating information from existing PE programs with expanded QA activities to develop information about the quality of radiological, mixed waste, and hazardous environmental sample analyses provided by all laboratories supporting EM programs. The guidance addresses the goals of identifying specific PE sample programs and contacts, identifying specific requirements for participation in DOE's internal and external (regulatory) programs, identifying key issues relating to application and interpretation of PE materials for EM headquarters and field office managers, and providing technical guidance covering PE materials for site-specific activities. (PE) Performance Evaluation materials or samples are necessary for the quality assurance/control programs covering environmental data collection

  19. Hanford Site baseline risk assessment methodology. Revision 2

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-01

    This methodology has been developed to prepare human health and environmental evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act remedial investigations (RIs) and the Resource Conservation and Recovery Act facility investigations (FIs) performed at the Hanford Site pursuant to the Hanford Federal Facility Agreement and Consent Order referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies Site-specific risk assessment considerations and integrates them with approaches for evaluating human and environmental risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site.

  20. Career Guidance and Social Exclusion: A Cautionary Tale.

    Science.gov (United States)

    Watts, A. G.

    2001-01-01

    Examines the relationship of career guidance to public-policy interventions designed to address social exclusion. Analyzes the nature and origin of the concept of social exclusion and reviews the roles of career guidance in response to it, particularly in relation to young people who have dropped out of formal education or are at high risk of…

  1. Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A. [Nuclear Regulatory Commission, Washington, DC (United States). Div. of Industrial and Medical Nuclear Safety; Tingle, W. [Dept. of Environment, Health, and Natural Resources, Raleigh, NC (United States). Div. of Radiation Protection

    1997-05-01

    As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ``Applications for the Use of Sealed Sources in Portable Gauging Devices,`` and in NMSs Policy and guidance Directive 2-07, ``Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.`` This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications.

  2. Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

    International Nuclear Information System (INIS)

    Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A.; Tingle, W.

    1997-05-01

    As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ''Applications for the Use of Sealed Sources in Portable Gauging Devices,'' and in NMSs Policy and guidance Directive 2-07, ''Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.'' This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications

  3. Laser Guidance Analysis Facility

    Data.gov (United States)

    Federal Laboratory Consortium — This facility, which provides for real time, closed loop evaluation of semi-active laser guidance hardware, has and continues to be instrumental in the development...

  4. SPAR-H Step-by-Step Guidance

    Energy Technology Data Exchange (ETDEWEB)

    April M. Whaley; Dana L. Kelly; Ronald L. Boring; William J. Galyean

    2012-06-01

    Step-by-step guidance was developed recently at Idaho National Laboratory for the US Nuclear Regulatory Commission on the use of the Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method for quantifying Human Failure Events (HFEs). This work was done to address SPAR-H user needs, specifically requests for additional guidance on the proper application of various aspects of the methodology. This paper overviews the steps of the SPAR-H analysis process and highlights some of the most important insights gained during the development of the step-by-step directions. This supplemental guidance for analysts is applicable when plant-specific information is available, and goes beyond the general guidance provided in existing SPAR-H documentation. The steps highlighted in this paper are: Step-1, Categorizing the HFE as Diagnosis and/or Action; Step-2, Rate the Performance Shaping Factors; Step-3, Calculate PSF-Modified HEP; Step-4, Accounting for Dependence, and; Step-5, Minimum Value Cutoff.

  5. Hanford Site Risk Assessment Methodology. Revision 3

    International Nuclear Information System (INIS)

    1995-05-01

    This methodology has been developed to prepare human health and ecological evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) remedial investigations (RI) and the Resource conservation and Recovery Act of 1976 (RCRA) facility investigations (FI) performed at the Hanford Site pursuant to the hanford Federal Facility Agreement and Consent Order (Ecology et al. 1994), referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies site-specific risk assessment considerations and integrates them with approaches for evaluating human and ecological risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site

  6. A New Approach to Lane Guidance Systems

    OpenAIRE

    Eidehall, Andreas; Pohl, Jochen; Gustafsson, Fredrik

    2005-01-01

    This paper presents a new automotive safety function called Emergency Lane Assist (ELA). ELA combines conventional lane guidance systems with a threat assessment module that tries to activate and deactivate the lane guidance interventions according to the actual risk level of lane departure. The goal is to only prevent dangerous lane departure manoeuvres. Such a threat assessment algorithm is dependent on detailed information about the vehicle surroundings, i.e., positions and motion of other...

  7. Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

    Science.gov (United States)

    Fahim, Germin; Toscani, Michael; Barone, Joseph A; Wang, Chris; Gandhi, Shivani

    2018-01-01

    The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. Lack of consistency exists between risks versus benefit proportions among different drug products.

  8. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  9. Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance.

    Science.gov (United States)

    Sveistrup, Joen; af Rosenschöld, Per Munck; Deasy, Joseph O; Oh, Jung Hun; Pommer, Tobias; Petersen, Peter Meidahl; Engelholm, Svend Aage

    2014-02-04

    Image-guided radiotherapy (IGRT) facilitates the delivery of a very precise radiation dose. In this study we compare the toxicity and biochemical progression-free survival between patients treated with daily image-guided intensity-modulated radiotherapy (IG-IMRT) and 3D conformal radiotherapy (3DCRT) without daily image guidance for high risk prostate cancer (PCa). A total of 503 high risk PCa patients treated with radiotherapy (RT) and endocrine treatment between 2000 and 2010 were retrospectively reviewed. 115 patients were treated with 3DCRT, and 388 patients were treated with IG-IMRT. 3DCRT patients were treated to 76 Gy and without daily image guidance and with 1-2 cm PTV margins. IG-IMRT patients were treated to 78 Gy based on daily image guidance of fiducial markers, and the PTV margins were 5-7 mm. Furthermore, the dose-volume constraints to both the rectum and bladder were changed with the introduction of IG-IMRT. The 2-year actuarial likelihood of developing grade > = 2 GI toxicity following RT was 57.3% in 3DCRT patients and 5.8% in IG-IMRT patients (p analysis, 3DCRT was associated with a significantly increased risk of developing grade > = 2 GI toxicity compared to IG-IMRT (p analysis there was no difference in biochemical progression-free survival between 3DCRT and IG-IMRT. The difference in toxicity can be attributed to the combination of the IMRT technique with reduced dose to organs-at-risk, daily image guidance and margin reduction.

  10. Association for Measurement and Evaluation in Counseling and Development, Committee to Screen Career Guidance Instruments Reports.

    Science.gov (United States)

    Association for Measurement and Evaluation in Counseling and Development.

    Reviews of 20 career guidance measures are reprinted from the Association for Measurement and Evaluation in Counseling and Development's "Newsnotes." Each entry includes author, title, publisher, purpose, format, scoring, norms, cost, review, concerns, and additional reviews. These tests cover the areas of occupational interests, career awareness,…

  11. Impact of NICE guidance on rates of haemorrhage after tonsillectomy: an evaluation of guidance issued during an ongoing national tonsillectomy audit.

    Science.gov (United States)

    Audit, National Prospective Tonsillectomy

    2008-08-01

    The National Institute for Health and Clinical Excellence (NICE) issued guidance on surgical techniques for tonsillectomy during a national audit of surgical practice and postoperative complications. To assess the impact of the guidance on tonsillectomy practice and outcomes. An interrupted time-series analysis of routinely collected Hospital Episodes Statistics data, and an analysis of longitudinal trends in surgical technique using data from the National Prospective Tonsillectomy Audit. Patients undergoing tonsillectomy in English NHS hospitals between January 2002 and December 2004. Postoperative haemorrhage within 28 days. The rate of haemorrhage increased by 0.5% per year from 2002, reaching 6.4% when the guidance was published. After publication, the rate of haemorrhage fell immediately to 5.7% (difference 0.7%: 95% CI -1.3% to 0.0%) and the rate of increase appeared to have stopped. Data from the National Prospective Tonsillectomy Audit showed that the fall coincided with a shift in surgical techniques, which was consistent with the guidance. NICE guidance influenced surgical tonsillectomy technique and in turn produced an immediate fall in postoperative haemorrhage. The ongoing national audit and strong support from the surgical specialist association may have aided its implementation.

  12. Evaluation of the Usefulness of the Respiratory Guidance System in the Respiratory Gating Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yeong Cheol; Kim, Sun Myung; Do, Gyeong Min; Park, Geun Yong; Kim, Gun Oh; Kim, Young Bum [Dept. of Radiation Oncology, Guro Hospital, Korea Univeristy, Seoul (Korea, Republic of)

    2012-09-15

    The respiration is one of the most important factors in respiratory gating radiation therapy (RGRT). We have developed an unique respiratory guidance system using an audio-visual system in order to support and stabilize individual patient's respiration and evaluated the usefulness of this system. Seven patients received the RGRT at our clinic from June 2011 to April 2012. After breathing exercise standard deviations by the superficial contents of respiratory cycles and functions, and analyzed them to examine changes in their breathing before and with the audio-visual system, we measured their spontaneous respiration and their respiration with the audio-visual system respectively. With the measured data, we yielded after the therapy. The PTP (peak to peak) of the standard deviations of the free breathing, the audio guidance system, and the respiratory guidance system were 0.343, 0.148, and 0.078 respectively. The respiratory cycles were 0.645, 0.345, and 0.171 respectively and the superficial contents of the respiratory functions were 2.591, 1.008, and 0.877 respectively. The average values of the differences in the standard deviations among the whole patients at the CT room and therapy room were 0.425 for the PTP, 1.566 for the respiratory cycles, and 3.671 for the respiratory superficial contents. As for the standard deviations before and after the application of the PTP respiratory guidance system, that of the PTP was 0.265, that of the respiratory cycles was 0.474, and that of the respiratory superficial contents. The results of t-test of the values before and after free breathing and the audio-visual guidance system showed that the P-value of the PTP was 0.035, that of the cycles 0.009, and that of the respiratory superficial contents 0.010. The respiratory control could be one of the most important factors in the RGRT which determines the success or failure of a treatment. We were able to get more stable breathing with the audio-visual respiratory

  13. Evaluation of the Usefulness of the Respiratory Guidance System in the Respiratory Gating Radiation Therapy

    International Nuclear Information System (INIS)

    Lee, Yeong Cheol; Kim, Sun Myung; Do, Gyeong Min; Park, Geun Yong; Kim, Gun Oh; Kim, Young Bum

    2012-01-01

    The respiration is one of the most important factors in respiratory gating radiation therapy (RGRT). We have developed an unique respiratory guidance system using an audio-visual system in order to support and stabilize individual patient's respiration and evaluated the usefulness of this system. Seven patients received the RGRT at our clinic from June 2011 to April 2012. After breathing exercise standard deviations by the superficial contents of respiratory cycles and functions, and analyzed them to examine changes in their breathing before and with the audio-visual system, we measured their spontaneous respiration and their respiration with the audio-visual system respectively. With the measured data, we yielded after the therapy. The PTP (peak to peak) of the standard deviations of the free breathing, the audio guidance system, and the respiratory guidance system were 0.343, 0.148, and 0.078 respectively. The respiratory cycles were 0.645, 0.345, and 0.171 respectively and the superficial contents of the respiratory functions were 2.591, 1.008, and 0.877 respectively. The average values of the differences in the standard deviations among the whole patients at the CT room and therapy room were 0.425 for the PTP, 1.566 for the respiratory cycles, and 3.671 for the respiratory superficial contents. As for the standard deviations before and after the application of the PTP respiratory guidance system, that of the PTP was 0.265, that of the respiratory cycles was 0.474, and that of the respiratory superficial contents. The results of t-test of the values before and after free breathing and the audio-visual guidance system showed that the P-value of the PTP was 0.035, that of the cycles 0.009, and that of the respiratory superficial contents 0.010. The respiratory control could be one of the most important factors in the RGRT which determines the success or failure of a treatment. We were able to get more stable breathing with the audio-visual respiratory guidance

  14. An evaluation of two guidance programmes to promote breast-feeding

    Directory of Open Access Journals (Sweden)

    M. Steyn

    1989-09-01

    Full Text Available During the past ten years a comprehensive research project has been undertaken to develop a guidance programme in three adjacent communities in the South- Western Cape with the aim o f lowering the high incidence o f coronary heart disease. The purpose o f this substudy was to determine whether the guidance provided in the different communities had any influence on the knowledge o f and attitudes towards the nutrition o f pregnant women, babies and infants as well as breast-feeding practices o f the women who gave birth during the period 1980 to 1986. In the first community guidance was provided by means o f small mass media and interpersonal communication whereas only the small mass media were employed in the second. The third served as the control community. The findings suggest that the combined interpersonal and mass media programme was more successful than the mass media programme alone.

  15. A CASE STUDY DEMONSTRATING U.S. EPA GUIDANCE FOR EVALUATING LANDFILL GAS EMISSIONS FROM CLOSED OR ABANDONED FACILITIES--BUSH VALLEY LANDFILL, HARFORD COUNTY, MARYLAND

    Science.gov (United States)

    The purpose of the activities described in this document is to provide a demonstration of the procedures and methodologies described within the "Guidance for Evaluating Landfill Gas Emissions from Closed or Abandoned Facilities" (Guidance). This demonstration provides an example ...

  16. HIV testing in Europe: Evaluating the impact, added value, relevance and usability of the European Centre for Disease Prevention and Control (ECDC)'s 2010 HIV testing guidance.

    Science.gov (United States)

    Sullivan, Ann K; Sperle, Ida; Raben, Dorthe; Amato-Gauci, Andrew J; Lundgren, Jens Dilling; Yazdanpanah, Yazdan; Jakobsen, Stine Finne; Tavoschi, Lara

    2017-11-01

    An evaluation of the 2010 ECDC guidance on HIV testing, conducted in October 2015-January 2016, assessed its impact, added value, relevance and usability and the need for updated guidance. Data sources were two surveys: one for the primary target audience (health policymakers and decision makers, national programme managers and ECDC official contact points in the European Union/European Economic Area (EU/EEA) countries and one for a broader target audience (clinicians, civil society organisations and international public health agencies); two moderated focus group discussions  (17 participants each); webpage access data; a literature citation review; and an expert consultation (18 participants) to discuss the evaluation findings. Twenty-three of 28 primary target audience and 31 of 51 broader target audience respondents indicated the guidance was the most relevant when compared with other international guidance. Primary target audience respondents in 11 of 23 countries reported that they had used the guidance in development, monitoring and/or evaluation of their national HIV testing policy, guidelines, programme and/or strategy, and 29 of 51 of the broader target audience respondents reported having used the guidance in their work. Both the primary and broader target audience considered it important or very important to have an EU/EEA-level HIV testing guidance (23/28 and 46/51, respectively). The guidance has been widely used to develop policies, guidelines, programmes and strategies in the EU/EEA and should be regularly updated due to continuous developments in the field in order to continue to serve as an important reference guidance in the region.

  17. Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

    DEFF Research Database (Denmark)

    Satya, Sneha; Wade, Mike; Hass, Ulla

    This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing and Asses......This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing...... on testing and assessment of endocrine disrupters (EDTA AG). In November 2010, comments were requested from the WNT, the EDTA AG, the Task Force on Hazard Assessment and experts involved in the assessment of chemicals. The EDTA AG addressed the comments from the WNT at a meeting held in April 2011...... the conclusions and next steps recommended in the draft guidance document are sensible and helpful when assessed in light of comprehensive datasets. The draft guidance document and the three case studies were reviewed again and revised at a meeting of the EDTA AG in December 2011. The draft guidance document...

  18. 77 FR 29458 - Supervisory Guidance on Stress Testing for Banking Organizations With More Than $10 Billion in...

    Science.gov (United States)

    2012-05-17

    ... of risk management, the final guidance provides principles that a banking organization should follow... integrated into overall risk management.\\8\\ The agencies expect such companies would follow the principles... risk management program. The guidance outlines broad principles for a [[Page 29464

  19. Pesticide Cumulative Risk Assessment: Framework for Screening Analysis

    Science.gov (United States)

    This document provides guidance on how to screen groups of pesticides for cumulative evaluation using a two-step approach: begin with evaluation of available toxicological information and, if necessary, follow up with a risk-based screening approach.

  20. An Evaluation of Unemployment Reduction in Akwa Ibom State using Career Guidance and Counselling

    OpenAIRE

    Nsikak-Abasi Udofia; Eno Daniel Inyang

    2013-01-01

    This study was carried out to examine the possibility of reducing unemployment in Akwa Ibom State using career guidance and counselling interventions. To guide the study, four research questions and four null hypotheses were formulated. Variables such as educational guidance, vocational, personality trait guidance and sociological guidance were used in the investigation. A survey design was used in studying a population of 6509 senior secondary two students in 58 public secondary schools that...

  1. Critical elements for human health risk assessment of less than lifetime exposures.

    Science.gov (United States)

    Geraets, Liesbeth; Nijkamp, Monique M; Ter Burg, Wouter

    2016-11-01

    Less than lifetime exposure has confronted risk assessors as to how to interpret the risks for human health in case a chronic health-based limit is exceeded. Intermittent, fluctuating and peak exposures do not match with the basis of the chronic limit values possibly leading to conservative outcomes. This paper presents guidance on how to deal with human risk assessment of less than lifetime exposure. Important steps to be considered are characterization of the human exposure situation, evaluation whether the human less than lifetime exposure scenario corresponds to a non-chronic internal exposure: toxicokinetic and toxicodynamic considerations, and, finally, re-evaluation of the risk assessment. Critical elements for these steps are the mode of action, Haber's rule, and toxicokinetics (ADME) amongst others. Previous work for the endpoints non-genotoxic carcinogenicity and developmental toxicity is included in the guidance. The guidance provides a way to consider the critical elements, without setting default factors to correct for the less than lifetime exposure in risk assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

    ... final version of the guidance, submit either electronic or written comments on the draft guidance by... electronic access to the guidance document. Submit electronic comments on the draft guidance to http://www... body tissue or fluid (e.g., blood, plasma, cerebrospinal fluid). Drug response results from the...

  3. Moisture Control Guidance for Commercial and Public ...

    Science.gov (United States)

    This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled

  4. The Design of a Modified PSO Guidance Law Using Predictor and LOS Rate Evaluation

    Directory of Open Access Journals (Sweden)

    Lee Yung-Lung

    2016-01-01

    Full Text Available This paper proposes a modified particle swarm optimization guidance (MPSOG for the pursuit-evasion optimization problem. If the line-of-sight (LOS rate equals zero, the curvature of the missile’s trajectory would be smaller and the probability of intercept greater. Thus, we propose using a MPSOG to improve the guidance performance. The MPSOG uses a Kalman filter to predict a target’s dynamic. The lateral acceleration commands of the y- and z-axis are optimized by the particle swarm optimization (PSO algorithm, respectively. Numerical simulation results show that the MPSOG have better guidance performance than proportional navigation guidance and particle swarm optimization guidance in miss distance, time-to-go, and final lateral acceleration commands.

  5. Evaluation of Image-Guidance Strategies in the Treatment of Localized Prostate Cancer

    International Nuclear Information System (INIS)

    Kupelian, Patrick A.; Lee, Choonik; Langen, Katja M.; Zeidan, Omar A.; Manon, Rafael R.; Willoughby, Twyla R.; Meeks, Sanford L.

    2008-01-01

    Purpose: To compare different image-guidance strategies in the alignment of prostate cancer patients. Using data from patients treated using daily image guidance, the remaining setup errors for several different strategies were retrospectively calculated. Methods and Materials: The alignment data from 74 patients treated with helical tomotherapy were analyzed, resulting in a data set of 2,252 fractions during which a megavoltage computed tomography image was used for image guidance with intraprostatic metallic fiducials. Given the daily positional adjustments, a variety of protocols, differing in imaging frequency and method, were retrospectively studied. The residual setup errors were determined for each protocol. Results: As expected, the systematic errors were effectively reduced with imaging. However, the random errors were unaffected. Even when image guidance was performed every other day with a running mean of the previous displacements, residual setup errors >5 mm occurred in 24% of all fractions. This frequency increased to about 40% if setup errors >3 mm were scored. Conclusion: Setup errors increased with decreasing frequency of image guidance. However, residual errors were still significant at the 5-mm level, even with imaging was performed every other day. This suggests that localizations must be performed daily in the set up of prostate cancer patients during a course of external beam radiotherapy

  6. Applicable value of real time interventional ultrasound guidance in family planning reproduction operation

    International Nuclear Information System (INIS)

    Wu Guoping; Zou Dongfang; Sun Jian; Dong Weihua

    2007-01-01

    Objective: To determine the clinical value of real time interventional ultrasound guidance in family planning reproduction operation. Methods: Under the guidance of ultrasound monitoring, 522 cases with high risk and difficult uterine operation were undertaken in our department. Results: The abdominal endoscopic contraceptive uterine operation under real time ultrasound monitoring was carried out for 522 cases in 4 years, with successful rates for high risk pregnancy as 287/289 cases, high risk troublesome withdrawal of contraceptive ring as 129/130 cases and puzzling uterine operation as 103/103 cases. The total successful rate reached 99.42%, without uterine rupture and other complications. Conclusion: The former complex, blind and difficult uterine operations turn to be simple, safe and reliable under the guidance of real time ultrasound. (authors)

  7. Uncertainties in Cancer Risk Coefficients for Environmental Exposure to Radionuclides. An Uncertainty Analysis for Risk Coefficients Reported in Federal Guidance Report No. 13

    Energy Technology Data Exchange (ETDEWEB)

    Pawel, David [U.S. Environmental Protection Agency; Leggett, Richard Wayne [ORNL; Eckerman, Keith F [ORNL; Nelson, Christopher [U.S. Environmental Protection Agency

    2007-01-01

    Federal Guidance Report No. 13 (FGR 13) provides risk coefficients for estimation of the risk of cancer due to low-level exposure to each of more than 800 radionuclides. Uncertainties in risk coefficients were quantified in FGR 13 for 33 cases (exposure to each of 11 radionuclides by each of three exposure pathways) on the basis of sensitivity analyses in which various combinations of plausible biokinetic, dosimetric, and radiation risk models were used to generate alternative risk coefficients. The present report updates the uncertainty analysis in FGR 13 for the cases of inhalation and ingestion of radionuclides and expands the analysis to all radionuclides addressed in that report. The analysis indicates that most risk coefficients for inhalation or ingestion of radionuclides are determined within a factor of 5 or less by current information. That is, application of alternate plausible biokinetic and dosimetric models and radiation risk models (based on the linear, no-threshold hypothesis with an adjustment for the dose and dose rate effectiveness factor) is unlikely to change these coefficients by more than a factor of 5. In this analysis the assessed uncertainty in the radiation risk model was found to be the main determinant of the uncertainty category for most risk coefficients, but conclusions concerning the relative contributions of risk and dose models to the total uncertainty in a risk coefficient may depend strongly on the method of assessing uncertainties in the risk model.

  8. Evaluation of the endocrine activity of 2,4,6-tribromophenol, benzanthrone and benzophenone-2 based on Appendix 7.8-5 of REACH guidance document

    DEFF Research Database (Denmark)

    Duis, Karen; Holbech, Henrik; Velasco-Santamaría, Yohana M.

    Within a project funded by the German Federal Environment Agency, the practicability of Appendix 7.8-5 of REACH guidance document R.7b was evaluated using three case study substances. Shortcomings in the guidance were identified. An assessment of potential endocrine activity in aquatic vertebrates...

  9. Remedial Investigation/Feasibility Study (RI/FS) process, elements and techniques guidance

    Energy Technology Data Exchange (ETDEWEB)

    1993-12-01

    This manual provides detailed guidance on Remedial Investigation/Feasibility Studies (RI/FSs) conducted pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) at Department of Energy (DOE) facilities. The purpose of the RI/FS, to assess the risk posed by a hazardous waste site and to determine the best way to reduce that risk, and its structure (site characterization, risk assessment, screening and detailed analysis of alternatives, etc.) is defined in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) and further explained in the Environmental Protection Agency`s (EPA`s) Guidance for Conducting Remedial Investigations and Feasibility Studies Under CERCLA (Interim Final) 540/G-89/004, OSWER Directive 9355.3-01, October 1988. Though issued in 1988, the EPA guidance remains an excellent source of information on the conduct and structure of an RI/FS. This document makes use of supplemental RI/FS-related guidance that EPA has developed since its initial document was issued in 1988, incorporates practical lessons learned in more than 12 years of experience in CERCLA hazardous site remediation, and drawing on those lessons, introduces the Streamlined Approach For Environmental Restoration (SAFER), developed by DOE as a way to proceed quickly and efficiently through the RI/FS process at DOE facilities. Thus as its title implies, this guidance is intended to describe in detail the process and component elements of an RI/FS, as well as techniques to manage the RI/FS effectively.

  10. Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance

    International Nuclear Information System (INIS)

    Sveistrup, Joen; Rosenschöld, Per Munck af; Deasy, Joseph O; Oh, Jung Hun; Pommer, Tobias; Petersen, Peter Meidahl; Engelholm, Svend Aage

    2014-01-01

    Image-guided radiotherapy (IGRT) facilitates the delivery of a very precise radiation dose. In this study we compare the toxicity and biochemical progression-free survival between patients treated with daily image-guided intensity-modulated radiotherapy (IG-IMRT) and 3D conformal radiotherapy (3DCRT) without daily image guidance for high risk prostate cancer (PCa). A total of 503 high risk PCa patients treated with radiotherapy (RT) and endocrine treatment between 2000 and 2010 were retrospectively reviewed. 115 patients were treated with 3DCRT, and 388 patients were treated with IG-IMRT. 3DCRT patients were treated to 76 Gy and without daily image guidance and with 1–2 cm PTV margins. IG-IMRT patients were treated to 78 Gy based on daily image guidance of fiducial markers, and the PTV margins were 5–7 mm. Furthermore, the dose-volume constraints to both the rectum and bladder were changed with the introduction of IG-IMRT. The 2-year actuarial likelihood of developing grade > = 2 GI toxicity following RT was 57.3% in 3DCRT patients and 5.8% in IG-IMRT patients (p < 0.001). For GU toxicity the numbers were 41.8% and 29.7%, respectively (p = 0.011). On multivariate analysis, 3DCRT was associated with a significantly increased risk of developing grade > = 2 GI toxicity compared to IG-IMRT (p < 0.001, HR = 11.59 [CI: 6.67-20.14]). 3DCRT was also associated with an increased risk of developing GU toxicity compared to IG-IMRT. The 3-year actuarial biochemical progression-free survival probability was 86.0% for 3DCRT and 90.3% for IG-IMRT (p = 0.386). On multivariate analysis there was no difference in biochemical progression-free survival between 3DCRT and IG-IMRT. The difference in toxicity can be attributed to the combination of the IMRT technique with reduced dose to organs-at-risk, daily image guidance and margin reduction

  11. Real-time image guidance in laparoscopic liver surgery

    DEFF Research Database (Denmark)

    Kenngott, Hannes G.; Wagner, Martin; Gondan, Matthias

    2014-01-01

    Background: Laparoscopic liver surgery is particularly challenging owing to restricted access, risk of bleeding and lack of haptic feedback. Navigation systems have the potential to improve information on the exact position of intrahepatic tumors, and thus facilitate oncological resection....... This study aims to evaluate the feasibility of a commercially available augmented reality (AR) guidance system employing intraoperative robotic C-arm cone-beam computed tomography (CBCT) for laparoscopic liver surgery. Methods: A human liver-like phantom with sixteen target fiducials was used to evaluate...... the Syngo iPilot® AR system. Subsequently, the system was used for the laparoscopic resection of a hepatocellular carcinoma in segment 7 of a 50-year-old male patient. Results: In the phantom experiment the AR system showed a mean target registration error of 0.96 mm ± 0.52 mm with a maximum error of 2...

  12. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Science.gov (United States)

    2013-04-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

  13. Guidance on the implementation of a risk based safety performance monitoring system for nuclear power plants

    International Nuclear Information System (INIS)

    Sewell, R.T.; Kuritzky, A.S.; Khatib-Rahbar, M.

    1997-05-01

    The principal objective of the present study is to review and evaluate existing Performance Indicator (PI) monitoring programs, and to develop and demonstrate an overall PSA-based methodology and framework for the monitoring and use of risk-based PIs and SIs (Safety Indicator), that would enable: Identification of trends and patterns in safety performance at a specific plant and a population of plants; Assessment of the significance of the trends and patterns; Identification of precursors of accident sequences and safety reductions; Identification of the most critical functional areas of concern, especially as they relate to a defense-in-depth safety philosophy; Comparison of safety performance trends at a plant with those at comparable plants; Incorporation of the PIs and SIs into a risk- and performance-based decision process. To support the overall project objective, it is important that information needs and data collection procedures are clearly outlined. Of key significance in this regard is the premise that a performance monitoring system should not be burdened by an excessive number of low-level PIs that may have only a peripheral relationship to safety. Other supporting objectives of the study include: To identify and discuss other issues pertaining to the practical implementation of a safety performance monitoring system (outlining the databases and algorithms needed); and to demonstrate implementation of the preliminary guidance for monitoring and use of the selected set of PIs and SIs, within the proposed framework, via application to the operating history of a NPP having a PSA and readily available event data

  14. Guidance concepts for time-based flight operations

    Science.gov (United States)

    Vicroy, Dan D.

    1990-01-01

    Airport congestion and the associated delays are severe in today's airspace system and are expected to increase. NASA and the FAA is investigating various methods of alleviating this problem through new technology and operational procedures. One concept for improving airspace productivity is time-based control of aircraft. Research to date has focused primarily on the development of time-based flight management systems and Air Traffic Control operational procedures. Flight operations may, however, require special onboard guidance in order to satisfy the Air Traffic Control imposed time constraints. The results are presented of a simulation study aimed at evaluating several time-based guidance concepts in terms of tracking performance, pilot workload, and subjective preference. The guidance concepts tested varied in complexity from simple digital time-error feedback to an advanced time-referenced-energy guidance scheme.

  15. A code guidance system for integrated nuclear data evaluation system on the basis of knowledge engineering technology

    International Nuclear Information System (INIS)

    Fukahori, Tokio; Nakagawa, Tsuneo

    1994-01-01

    The integrated nuclear data evaluation system (INDES) is being made in order to support the nuclear data evaluation work. A guidance system in INDES, 'Evaluation Tutor (ET)', is under development in order to support users in selecting the most suitable set of theoretical calculation codes by applying knowledge engineering technology and the experiences of evaluation work for JENDL-3. In this paper, the function of ET is introduced as well as the functions and databases of INDES. An example run of ET for 56 Fe in the 1-20 MeV neutron energy region is also explained. (author)

  16. A Best Practices Notebook for Disaster Risk Reduction and Climate Change Adaptation: Guidance and Insights for Policy and Practice from the CATALYST Project

    NARCIS (Netherlands)

    Hare, M.; Bers, van C.; Mysiak, J.; Calliari, E.; Haque, A.; Warner, K.; Yuzva, K.; Zissener, M.; Jaspers, A.M.J.; Timmerman, J.G.

    2014-01-01

    This publication, A Best Practices Notebook for Disaster Risk Reduction and Climate Change Adaptation: Guidance and Insights for Policy and Practice from the CATALYST Project is one of two main CATALYST knowledge products that focus on the transformative approaches and measures that can support

  17. 76 FR 65734 - Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption...

    Science.gov (United States)

    2011-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0733] Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  18. 78 FR 76297 - Social Media: Consumer Compliance Risk Management Guidance

    Science.gov (United States)

    2013-12-17

    ... encourage the application of uniform examination principles and standards by state and federal supervisory... marketing, providing incentives, facilitating applications for new accounts, inviting feedback from the... responsibilities. The revised Guidance clarifies and points to the longstanding principle that financial...

  19. Method for plant operation guidance by knowledge engineering technique

    International Nuclear Information System (INIS)

    Kiguchi, Takashi; Yoshida, Kenichi; Motoda, Hiroshi; Kobayashi, Setsuo

    1983-01-01

    A method for plant operation guidance has been developed by using the Knowledge Engineering technique. The method is characterized by its capability of handling plant dynamics. The knowledge-base includes plant simulation programs as tools to evaluate dynamic behaviors as well as production rules of ''if..., then...'' type. The inference engine is thus capable of predicting plant dynamics and making decisions in accordance with time progress. The performance of the guidance method was evaluated by simulation tests assuming various abnormal situations of a BWR power plant. It was shown that the method can detect each of the abnormal events along the course of their occurrence, and provide the guidance for corrective actions. The operation guidance method proposed in this paper is general and is applicable not only to nuclear power plants but also to other plants such as chemical production plants and fossile power plants. (author)

  20. Automatic guidance and control laws for helicopter obstacle avoidance

    Science.gov (United States)

    Cheng, Victor H. L.; Lam, T.

    1992-01-01

    The authors describe the implementation of a full-function guidance and control system for automatic obstacle avoidance in helicopter nap-of-the-earth (NOE) flight. The guidance function assumes that the helicopter is sufficiently responsive so that the flight path can be readily adjusted at NOE speeds. The controller, basically an autopilot for following the derived flight path, was implemented with parameter values to control a generic helicopter model used in the simulation. Evaluation of the guidance and control system with a 3-dimensional graphical helicopter simulation suggests that the guidance has the potential for providing good and meaningful flight trajectories.

  1. A novel approach for navigational guidance of ships using onboard monitoring systems

    DEFF Research Database (Denmark)

    Nielsen, Ulrik Dam; Jensen, Jørgen Juncher

    2011-01-01

    A novel approach and conceptual ideas are outlined for risk-based navigational guidance of ships using decision support systems in combination with onboard, in-service monitoring systems. The guidance has as the main objective to advise on speed and/or course changes; in particular with focus...

  2. Track 2 sites: Guidance for assessing low probability hazard sites at the INEL

    International Nuclear Information System (INIS)

    1994-01-01

    This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations

  3. Design and evaluation of a portable intra-operative unified-planning-and-guidance framework applied to distal radius fracture surgery.

    Science.gov (United States)

    Magaraggia, Jessica; Wei, Wei; Weiten, Markus; Kleinszig, Gerhard; Vetter, Sven; Franke, Jochen; John, Adrian; Egli, Adrian; Barth, Karl; Angelopoulou, Elli; Hornegger, Joachim

    2017-01-01

    During a standard fracture reduction and fixation procedure of the distal radius, only fluoroscopic images are available for planning of the screw placement and monitoring of the drill bit trajectory. Our prototype intra-operative framework integrates planning and drill guidance for a simplified and improved planning transfer. Guidance information is extracted using a video camera mounted onto a surgical drill. Real-time feedback of the drill bit position is provided using an augmented view of the planning X-rays. We evaluate the accuracy of the placed screws on plastic bones and on healthy and fractured forearm specimens. We also investigate the difference in accuracy between guided screw placement versus freehand. Moreover, the accuracy of the real-time position feedback of the drill bit is evaluated. A total of 166 screws were placed. On 37 plastic bones, our obtained accuracy was [Formula: see text] mm, [Formula: see text] and [Formula: see text] in tip position and orientation (azimuth and elevation), respectively. On the three healthy forearm specimens, our obtained accuracy was [Formula: see text] mm, [Formula: see text] and [Formula: see text]. On the two fractured specimens, we attained: [Formula: see text] mm, [Formula: see text] and [Formula: see text]. When screw plans were applied freehand (without our guidance system), the achieved accuracy was [Formula: see text] mm, [Formula: see text], while when they were transferred under guidance, we obtained [Formula: see text] mm, [Formula: see text]. Our results show that our framework is expected to increase the accuracy in screw positioning and to improve robustness w.r.t. freehand placement.

  4. Risk Scan: A Review of Risk Assessment Capability and Maturity within the Canadian Safety and Security Program

    Science.gov (United States)

    2014-06-01

    SCADA / ICS Cyber Test Lab initiated in 2013 Psychosocial – academic research exists,; opportunity for sharing and developing impact assessment...ecosystems and species at risk), accidents / system failure (rail; pipelines ; ferries CSSP strategy for the North Focus on regional l(and local) problem...Guidance; business planning; environmental scan; proposal evaluation; and performance measurement Program Risk Management – Guidelines for project

  5. 21 CFR 312.145 - Guidance documents.

    Science.gov (United States)

    2010-04-01

    ... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. [65 FR... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Guidance documents. 312.145 Section 312.145 Food...

  6. Application of image guidance in pituitary surgery

    Science.gov (United States)

    de Lara, Danielle; Filho, Leo F. S. Ditzel; Prevedello, Daniel M.; Otto, Bradley A.; Carrau, Ricardo L.

    2012-01-01

    Background: Surgical treatment of pituitary pathologies has evolved along the years, adding safety and decreasing morbidity related to the procedure. Advances in the field of radiology, coupled with stereotactic technology and computer modeling, have culminated in the contemporary and widespread use of image guidance systems, as we know them today. Image guidance navigation has become a frequently used technology that provides continuous three-dimensional information for the accurate performance of neurosurgical procedures. We present a discussion about the application of image guidance in pituitary surgeries. Methods: Major indications for image guidance neuronavigation application in pituitary surgery are presented and demonstrated with illustrative cases. Limitations of this technology are also presented. Results: Patients presenting a history of previous transsphenoidal surgeries, anatomical variances of the sphenoid sinus, tumors with a close relation to the internal carotid arteries, and extrasellar tumors are the most important indications for image guidance in pituitary surgeries. The high cost of the equipment, increased time of surgery due to setup time, and registration and the need of specific training for the operating room personnel could be pointed as limitations of this technology. Conclusion: Intraoperative image guidance systems provide real-time images, increasing surgical accuracy and enabling safe, minimally invasive interventions. However, the use of intraoperative navigation is not a replacement for surgical experience and a systematic knowledge of regional anatomy. It must be recognized as a tool by which the neurosurgeon can reduce the risk associated with surgical approach and treatment of pituitary pathologies. PMID:22826819

  7. Risk estimation and evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Ferguson, R A.D.

    1982-10-01

    Risk assessment involves subjectivity, which makes objective decision making difficult in the nuclear power debate. The author reviews the process and uncertainties of estimating risks as well as the potential for misinterpretation and misuse. Risk data from a variety of aspects cannot be summed because the significance of different risks is not comparable. A method for including political, social, moral, psychological, and economic factors, environmental impacts, catastrophes, and benefits in the evaluation process could involve a broad base of lay and technical consultants, who would explain and argue their evaluation positions. 15 references. (DCK)

  8. Syncope: Assessment of risk and an approach to evaluation in the emergency department and urgent care clinic

    Directory of Open Access Journals (Sweden)

    Baris Akdemir

    2015-03-01

    Full Text Available Syncope is among the most frequent forms of transient loss of consciousness (TLOC, and is characterized by a relatively brief and self-limited loss of consciousness that by definition is triggered by transient cerebral hypoperfusion. Most often, syncope is caused by a temporary drop of systemic arterial pressure below that required to maintain cerebral function, but brief enough not to cause permanent structural brain injury. Currently, approximately one-third of syncope/collapse patients seen in the emergency department (ED or urgent care clinic are admitted to hospital for evaluation. The primary objective of developing syncope/TLOC risk stratification schemes is to provide guidance regarding the immediate prognostic risk of syncope patients presenting to the ED or clinic; thereafter, based on that risk assessment physicians may be better equipped to determine which patients can be safely evaluated as outpatients, and which require hospital care. In general, the need for hospitalization is determined by several key issues: i the patient's immediate (usually considered 1 week to 1 month mortality risk and risk for physical injury (e.g., falls risk, ii the patient's ability to care for him/herself, and iii whether certain treatments inherently require in-hospital initiation (e.g., pacemaker implantation. However, at present no single risk assessment protocol appears to be satisfactory for universal application, and development of a consensus recommendation is an essential next step.

  9. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

    Science.gov (United States)

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."

  10. National Environmental Policy Act guidance: A model process

    International Nuclear Information System (INIS)

    Angle, B.M.; Lockhart, V.A.T.; Sema, B.; Tuott, L.C.; Irving, J.S.

    1995-04-01

    The ''Model National Environmental Policy Act (NEPA) Process'' includes: References to regulations, guidance documents, and plans; training programs; procedures; and computer databases. Legislative Acts and reference documents from Congress, US Department of Energy, and Lockheed Idaho Technologies Company provide the bases for conducting NEPA at the Idaho National Engineering Laboratory (INEL). Lockheed Idaho Technologies Company (LITCO) NEPA / Permitting Department, the Contractor Environmental Organization (CEO) is responsible for developing and maintaining LITCO NEPA and permitting policies, guidance, and procedures. The CEO develops procedures to conduct environmental evaluations based on NEPA, Council on Environmental Quality (CEQ) regulations, and DOE guidance. This procedure includes preparation or support of environmental checklists, categorical exclusion determinations, environmental assessment determinations, environmental assessments, and environmental impact statements. In addition, the CEO uses this information to train personnel conducting environmental evaluations at the INEL. Streamlining these procedures fosters efficient use of resources, quality documents, and better decisions on proposed actions

  11. Stall Recovery Guidance Algorithms Based on Constrained Control Approaches

    Science.gov (United States)

    Stepanyan, Vahram; Krishnakumar, Kalmanje; Kaneshige, John; Acosta, Diana

    2016-01-01

    Aircraft loss-of-control, in particular approach to stall or fully developed stall, is a major factor contributing to aircraft safety risks, which emphasizes the need to develop algorithms that are capable of assisting the pilots to identify the problem and providing guidance to recover the aircraft. In this paper we present several stall recovery guidance algorithms, which are implemented in the background without interfering with flight control system and altering the pilot's actions. They are using input and state constrained control methods to generate guidance signals, which are provided to the pilot in the form of visual cues. It is the pilot's decision to follow these signals. The algorithms are validated in the pilot-in-the loop medium fidelity simulation experiment.

  12. Piloted Simulator Evaluation Results of Flight Physics Based Stall Recovery Guidance

    Science.gov (United States)

    Lombaerts, Thomas; Schuet, Stefan; Stepanyan, Vahram; Kaneshige, John; Hardy, Gordon; Shish, Kimberlee; Robinson, Peter

    2018-01-01

    In recent studies, it has been observed that loss of control in flight is the most frequent primary cause of accidents. A significant share of accidents in this category can be remedied by upset prevention if possible, and by upset recovery if necessary, in this order of priorities. One of the most important upsets to be recovered from is stall. Recent accidents have shown that a correct stall recovery maneuver remains a big challenge in civil aviation, partly due to a lack of pilot training. A possible strategy to support the flight crew in this demanding context is calculating a recovery guidance signal, and showing this signal in an intuitive way on one of the cockpit displays, for example by means of the flight director. Different methods for calculating the recovery signal, one based on fast model predictive control and another using an energy based approach, have been evaluated in four relevant operational scenarios by experienced commercial as well as test pilots in the Vertical Motion Simulator at NASA Ames Research Center. Evaluation results show that this approach could be able to assist the pilots in executing a correct stall recovery maneuver.

  13. General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    to nutrition and health claims, and establishes rules governing the Community authorisation of health claims made on foods. This general guidance is a combined and updated version of two previous briefing documents (frequently asked question document related to the assessment of Article 14 and 13.5 health...... of available scientific evidence, pertinent studies for substantiation of health claims, wording of claims, the extent to which a food needs to be characterised for the claimed effect, claimed effects which are beneficial physiological effects, definition of a risk factor for the development of a human disease...

  14. Safety analysis and risk assessment handbook

    International Nuclear Information System (INIS)

    Peterson, V.L.; Colwell, R.G.; Dickey, R.L.

    1997-01-01

    This Safety Analysis and Risk Assessment Handbook (SARAH) provides guidance to the safety analyst at the Rocky Flats Environmental Technology Site (RFETS) in the preparation of safety analyses and risk assessments. Although the older guidance (the Rocky Flats Risk Assessment Guide) continues to be used for updating the Final Safety Analysis Reports developed in the mid-1980s, this new guidance is used with all new authorization basis documents. With the mission change at RFETS came the need to establish new authorization basis documents for its facilities, whose functions had changed. The methodology and databases for performing the evaluations that support the new authorization basis documents had to be standardized, to avoid the use of different approaches and/or databases for similar accidents in different facilities. This handbook presents this new standardized approach. The handbook begins with a discussion of the requirements of the different types of authorization basis documents and how to choose the one appropriate for the facility to be evaluated. It then walks the analyst through the process of identifying all the potential hazards in the facility, classifying them, and choosing the ones that need to be analyzed further. It then discusses the methods for evaluating accident initiation and progression and covers the basic steps in a safety analysis, including consequence and frequency binning and risk ranking. The handbook lays out standardized approaches for determining the source terms of the various accidents (including airborne release fractions, leakpath factors, etc.), the atmospheric dispersion factors appropriate for Rocky Flats, and the methods for radiological and chemical consequence assessments. The radiological assessments use a radiological open-quotes templateclose quotes, a spreadsheet that incorporates the standard values of parameters, whereas the chemical assessments use the standard codes ARCHIE and ALOHA

  15. OPP Guidance for Submission of State and Tribal Water Quality Monitoring Data

    Science.gov (United States)

    This guidance describes the process to submit state and tribal surface and groundwater monitoring data for consideration in exposure characterizations for ecological and and human health risk assessments and in risk management decisions for pesticides.

  16. Innovative human health and ecological risk assessment techniques at Hanford

    International Nuclear Information System (INIS)

    Clarke, S.; Jones, K.; Goller, E.

    1993-01-01

    The open-quotes Hanford Site Baseline Risk Assessment Methodologyclose quotes (HSBRAM) was developed to enhance the preparation of risk assessments supporting the Hanford site cleanup mission. This methodology satisfies a Hanford federal facility agreement and consent order (tri-party agreement) milestone and is used to evaluate the risk to human health and the environment under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the Resource Conservation and Recovery Act (RCRA). The methodology was prepared by the Hanford Risk Assessment Committee (RAC) consisting of tri-party representatives: the U.S. Department of Energy, the State of Washington Department of Ecology, and the U.S. Environmental Protection Agency (EPA), with associated contractors. The risk assessment guidance provided by EPA is sufficiently general to permit tailoring of specific parameters to meet the risk assessment needs of individual sites. The RAC utilized EPA's Risk Assessment Guidance for Superfund, (RAGS) as the cornerstone of the HSBRAM. The RAC added necessary Hanford-specific elements to construct a complete risk assessment guidance for utilization as an independent document. The HSBRAM is a living document because the RAC charter emphasizes the importance of continued methodology reevaluation. The HSBRAM also provides guidelines for the application of EPA's open-quotes Framework for Ecological Risk Assessmentclose quotes to Hanford-specific environmental baseline risk assessments by including endangered and threatened species in addition to sensitive habitats potentially associated with the Hanford site and guidance for selection of ecotoxicological data. Separate negotiations for the selection of risk parameters for each operable unit were avoided by defining parameters in the HSBRAM. There are 78 past-practice operable units at Hanford requiring risk assessments

  17. Career guidance in communities

    DEFF Research Database (Denmark)

    Thomsen, Rie

    for the development of a critically reflexive career guidance practice. The considerations are organised around seven elements. 1. Creating opportunity, structure and access 2. Entering a community and increasing visibility 3. Providing guidance in communities 4. Exploring potentials in guidance situations 5...... in career guidance practices as well as in the lives of the people in the communities. This paper falls into two parts: The first part considers the collective as the starting point for the development of meaningful career guidance activities. Based on previous research on career guidance in communities......The aim of this paper is to inspire practitioners and professionals to leave their offices to bring career guidance into communities that might not identify with career guidance in the first instance. By making the effort to engage with communities, practitioners may bring about a critical change...

  18. 78 FR 18273 - Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of...

    Science.gov (United States)

    2013-03-26

    .... FDA-2013-D-0269] Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the... availability of a draft guidance entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated With... seafood processors who purchase reef fish how to minimize the risk of ciguatera fish poisoning (CFP) from...

  19. Risk-based and deterministic regulation

    International Nuclear Information System (INIS)

    Fischer, L.E.; Brown, N.W.

    1995-07-01

    Both risk-based and deterministic methods are used for regulating the nuclear industry to protect the public safety and health from undue risk. The deterministic method is one where performance standards are specified for each kind of nuclear system or facility. The deterministic performance standards address normal operations and design basis events which include transient and accident conditions. The risk-based method uses probabilistic risk assessment methods to supplement the deterministic one by (1) addressing all possible events (including those beyond the design basis events), (2) using a systematic, logical process for identifying and evaluating accidents, and (3) considering alternative means to reduce accident frequency and/or consequences. Although both deterministic and risk-based methods have been successfully applied, there is need for a better understanding of their applications and supportive roles. This paper describes the relationship between the two methods and how they are used to develop and assess regulations in the nuclear industry. Preliminary guidance is suggested for determining the need for using risk based methods to supplement deterministic ones. However, it is recommended that more detailed guidance and criteria be developed for this purpose

  20. Evaluations and utilizations of risk importances

    International Nuclear Information System (INIS)

    Vesely, W.E.; Davis, T.C.

    1985-08-01

    This report presents approaches for utilizing Probabilistic Risk Analyses (PRA's) to determine risk importances. Risk importances are determined for design features, plant operations, and other factors that can affect risk. PRA's can be used to identify the importances of risk contributors or proposed changes to designs or operations. The objective of this report is to serve as a handbook and guide in evaluating and applying risk importances. The utilization of both qualitative risk importances and quantitative risk importances is described in this report. Qualitative risk importances are based on the logic models in the PRA, while quantitative risk importances are based on the quantitative results of the PRA. Both types of importances are among the most robust and meaningful information a PRA can provide. A wide variety of risk importance evaluations are described including evaluations of the importances of design changes, testing, maintenance, degrading environments, and aging. Specific utilizations are described in inspection and in reliability assurance programs, however the general approaches have widespread applicability. The role of personal computers and decision support programs in applying risk importance evaluations is also described

  1. Guidance for a harmonized emission scenario document (ESD) on ballast water discharge

    Energy Technology Data Exchange (ETDEWEB)

    Zipperle, Andreas [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Gils, Jos van [DELTARES, Delft (Netherlands); Hattum, Bert van [Amsterdam Univ. (Netherlands). IVM - Institute for Environmental Studies; Heise, Susanne [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Hamburg Univ. of Applied Sciences (Germany)

    2011-05-15

    The present report provides guidance for a harmonized Emission Scenario Document (ESD) for the exposure assessment as part of the environmental risk assessment process which applicants seeking approval of a ballast water management system (BWMS) need to perform prior to notification and authorisation procedures. Despite the global variability of the marine environment, ballast water discharges and treatment methods, exposure assessments need to be comparable between different applications. In order to achieve this, this ESD points out the following aspects: - Applicants should use standardized scenarios in order to predict mean exposure. These should reflect generic situations, independent of region or port so that results are widely applicable. In addition to a harbour scenario, a standardized shipping lane scenario should be considered, - During or right after ballast water discharge, high concentrations may persist in a water body for a certain length of time until extensive mixing results in mean concentrations. Not taking exposure to peak concentrations within gradients into account could lead to an underestimation of risk, especially for rapidly degrading substances. Efforts have been made to approximate maximum exposure concentration with simple dilution factors. Their applicability was checked by near-field-evaluations. - Chemical properties determine the environmental fate of substances. If they are ambiguous, selection of a specific set of data strongly influences the result of an exposure assessment. Guidance is given on what to do about lacking data. - In order to harmonize the exposure assessments, reliable chemical model software should be used. A discussion on the requirements of suitable software and an evaluation of MAMPEC is given in this report. (orig.)

  2. Active instrumental guidance in interventional magnetic resonance imaging

    International Nuclear Information System (INIS)

    Wildermuth, S.; Erhart, P.; Leung, D.A.; Goehde, S.; Schoenenberger, A.; Debatin, J.F.

    1998-01-01

    Purpose: An active MR-based guidance system for visualisation of invasive instruments is described. Methods: The principle of MR tracking is based on the integration of a miniaturised coil into the tip of the instrument itself. A phantom experiment was designed to demonstrate the localising accuracy of this technique. In [dition, bicompatibility and warming effects were evaluated. Preliminary intravascular applications that were performed in animal experiments under MR guidance included embolisation, vascular occlusion as well as transjugular intrahepatic punctures. Percutaneous biopsies, cholecystostomies and laparoscopic applications were also evaluated with MR tracking. Results: Phantom experiments confirmed an excellent localisation accuracy of MR tracking compared to conventional r[iography. At a field strength of 0.5 T, the temperature increase remained below 2 C. Results of phantom experiments revealed a potential of significant heating dependent on the sequence parameters employed. MR tracking allowed a robust, simultaneously biplanar visualisation of the instrument tips in real time. Based on MR 'ro[ map' images, various intravascular and percutaneous interventions were successfully performed in vivo under MR guidance. Conclusions: MR tracking is a flexible concept permitting monitoring in the guidance of instruments in an MR environment. Various preliminary in vitro and in vivo experiments demonstrate safety, localisation accuracy and feasibility of this biplanar localisation technique in real time. (orig.) [de

  3. Hypotheses and fundamental study design characteristics for evaluating potential reduced-risk tobacco products. Part I: Heuristic.

    Science.gov (United States)

    Murrelle, Lenn; Coggins, Christopher R E; Gennings, Chris; Carchman, Richard A; Carter, Walter H; Davies, Bruce D; Krauss, Marc R; Lee, Peter N; Schleef, Raymond R; Zedler, Barbara K; Heidbreder, Christian

    2010-06-01

    The risk-reducing effect of a potential reduced-risk tobacco product (PRRP) can be investigated conceptually in a long-term, prospective study of disease risks among cigarette smokers who switch to a PRRP and in appropriate comparison groups. Our objective was to provide guidance for establishing the fundamental design characteristics of a study intended to (1) determine if switching to a PRRP reduces the risk of lung cancer (LC) compared with continued cigarette smoking, and (2) compare, using a non-inferiority approach, the reduction in LC risk among smokers who switched to a PRRP to the reduction in risk among smokers who quit smoking entirely. Using standard statistical methods applied to published data on LC incidence after smoking cessation, we show that the sample size and duration required for a study designed to evaluate the potential for LC risk reduction for an already marketed PRRP, compared with continued smoking, varies depending on the LC risk-reducing effectiveness of the PRRP, from a 5-year study with 8000-30,000 subjects to a 15-year study with <5000 to 10,000 subjects. To assess non-inferiority to quitting, the required sample size tends to be about 10 times greater, again depending on the effectiveness of the PRRP. (c) 2009 Elsevier Inc. All rights reserved.

  4. Guidance for Evaluating the Safety of Experimental Releases of Mosquitoes, Emphasizing Mark-Release-Recapture Techniques.

    Science.gov (United States)

    Benedict, Mark Q; Charlwood, J Derek; Harrington, Laura C; Lounibos, L Philip; Reisen, William K; Tabachnick, Walter J

    2018-01-01

    Experimental releases of mosquitoes are performed to understand characteristics of populations related to the biology, ability to transmit pathogens, and ultimately their control. In this article, we discuss considerations related to the safety of experimental releases of living mosquitoes, applying principles of good practice in vector biology that protect human health and comfort. We describe specific factors of experimental releases of mosquitoes that we believe are critical to inform institutional biosafety committees and similar review boards to which proposals to conduct mosquito release experiments have been submitted. In this study, "experimental releases" means those that do not significantly increase vector capacity or nuisance biting relative to the unperturbed natural baseline. This document specifically does not address releases of mosquitoes for ongoing control programs or trials of new control methods for which broader assessments of risk are required. It also does not address releases of transgenic or exotic (non-native) mosquito species, both of which require particular regulatory approval. Experimental releases may include females and males and evaluation must consider their effects based on the number released, their genotype and phenotype, the environment into which they are released, and postrelease collection activities. We consider whether increases of disease transmission and nuisance biting might result from proposed experimental releases against the backdrop of natural population size variation. We recommend that experimental releases be conducted in a manner that can be reasonably argued to have insignificant negative effects. Reviewers of proposals for experimental releases should expect applicants to provide such an argument based on evidence from similar studies and their planned activities. This document provides guidance for creating and evaluating such proposals.

  5. Checklist Usage as a Guidance on Read-Back Reducing the Potential Risk of Medication Error

    Directory of Open Access Journals (Sweden)

    Ida Bagus N. Maharjana

    2014-06-01

    Full Text Available Hospital as a last line of health services shall provide quality service and oriented on patient safety, one responsibility in preventing medication errors. Effective collaboration and communication between the profession needed to achieve patient safety. Read-back is one way of doing effective communication. Before-after study with PDCA TQM approach. The samples were on the medication chart patient medical rd rd records in the 3 week of May (before and the 3 week in July (after 2013. Treatment using the check list, asked for time 2 minutes to read-back by the doctors and nurses after the visit together. Obtained 57 samples (before and 64 samples (after. Before charging 45.54% incomplete medication chart on patient medical records that have the potential risk of medication error to 10.17% after treatment with a read back check list for 10 weeks, with 77.78% based on the achievement of the PDCA TQM approach. Checklist usage as a guidance on Read-back as an effective communication can reduce charging incompleteness drug records on medical records that have the potential risk of medication errors, 45.54% to 10.17%.

  6. Framework for ecological risk assessment

    International Nuclear Information System (INIS)

    Rodier, D.; Norton, S.

    1992-02-01

    Increased interest in ecological issues such as global climate change, habitat loss, acid deposition, reduced biological diversity, and the ecological impacts of pesticides and toxic chemicals prompts this U.S. Environmental Protection Agency (EPA) report, A Framework for Ecological Risk Assessment ('Framework Report'). The report describes basic elements, or a framework, for evaluating scientific information on the adverse effects of physical and chemical stressors on the environment. The framework offers starting principles and a simple structure as guidance for current ecological risk assessments and as a foundation for future EPA proposals for risk assessment guidelines

  7. Safety of magnetic fusion facilities: Volume 2, Guidance

    International Nuclear Information System (INIS)

    1995-01-01

    This document provides guidance for the implementation of the requirements identified in Vol. 1 of this Standard. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While Vol. 1 is generally applicable in that requirements there apply to a wide range of fusion facilities, this volume is concerned mainly with large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This volume is oriented toward regulation in the Department of Energy (DOE) environment

  8. Track 2 sites: Guidance for assessing low probability hazard sites at the INEL. Revision 6

    Energy Technology Data Exchange (ETDEWEB)

    1994-01-01

    This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations.

  9. Soil Vapor Extraction System Optimization, Transition, and Closure Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Truex, Michael J.; Becker, Dave; Simon, Michelle A.; Oostrom, Martinus; Rice, Amy K.; Johnson, Christian D.

    2013-02-08

    Soil vapor extraction (SVE) is a prevalent remediation approach for volatile contaminants in the vadose zone. A diminishing rate of contaminant extraction over time is typically observed due to 1) diminishing contaminant mass, and/or 2) slow rates of removal for contamination in low-permeability zones. After a SVE system begins to show indications of diminishing contaminant removal rate, SVE performance needs to be evaluated to determine whether the system should be optimized, terminated, or transitioned to another technology to replace or augment SVE. This guidance specifically addresses the elements of this type of performance assessment. While not specifically presented, the approach and analyses in this guidance could also be applied at the onset of remediation selection for a site as a way to evaluate current or future impacts to groundwater from vadose zone contamination. The guidance presented here builds from existing guidance for SVE design, operation, optimization, and closure from the U.S. Environmental Protection Agency, U.S. Army Corps of Engineers, and the Air Force Center for Engineering and the Environment. The purpose of the material herein is to clarify and focus on the specific actions and decisions related to SVE optimization, transition, and/or closure.

  10. Fine Guidance Sensing for Coronagraphic Observatories

    Science.gov (United States)

    Brugarolas, Paul; Alexander, James W.; Trauger, John T.; Moody, Dwight C.

    2011-01-01

    Three options have been developed for Fine Guidance Sensing (FGS) for coronagraphic observatories using a Fine Guidance Camera within a coronagraphic instrument. Coronagraphic observatories require very fine precision pointing in order to image faint objects at very small distances from a target star. The Fine Guidance Camera measures the direction to the target star. The first option, referred to as Spot, was to collect all of the light reflected from a coronagraph occulter onto a focal plane, producing an Airy-type point spread function (PSF). This would allow almost all of the starlight from the central star to be used for centroiding. The second approach, referred to as Punctured Disk, collects the light that bypasses a central obscuration, producing a PSF with a punctured central disk. The final approach, referred to as Lyot, collects light after passing through the occulter at the Lyot stop. The study includes generation of representative images for each option by the science team, followed by an engineering evaluation of a centroiding or a photometric algorithm for each option. After the alignment of the coronagraph to the fine guidance system, a "nulling" point on the FGS focal point is determined by calibration. This alignment is implemented by a fine alignment mechanism that is part of the fine guidance camera selection mirror. If the star images meet the modeling assumptions, and the star "centroid" can be driven to that nulling point, the contrast for the coronagraph will be maximized.

  11. Update: Interim Guidance for the Diagnosis, Evaluation, and Management of Infants with Possible Congenital Zika Virus Infection - United States, October 2017.

    Science.gov (United States)

    Adebanjo, Tolulope; Godfred-Cato, Shana; Viens, Laura; Fischer, Marc; Staples, J Erin; Kuhnert-Tallman, Wendi; Walke, Henry; Oduyebo, Titilope; Polen, Kara; Peacock, Georgina; Meaney-Delman, Dana; Honein, Margaret A; Rasmussen, Sonja A; Moore, Cynthia A

    2017-10-20

    CDC has updated its interim guidance for U.S. health care providers caring for infants with possible congenital Zika virus infection (1) in response to recently published updated guidance for health care providers caring for pregnant women with possible Zika virus exposure (2), unknown sensitivity and specificity of currently available diagnostic tests for congenital Zika virus infection, and recognition of additional clinical findings associated with congenital Zika virus infection. All infants born to mothers with possible Zika virus exposure* during pregnancy should receive a standard evaluation at birth and at each subsequent well-child visit including a comprehensive physical examination, age-appropriate vision screening and developmental monitoring and screening using validated tools (3-5), and newborn hearing screen at birth, preferably using auditory brainstem response (ABR) methodology (6). Specific guidance for laboratory testing and clinical evaluation are provided for three clinical scenarios in the setting of possible maternal Zika virus exposure: 1) infants with clinical findings consistent with congenital Zika syndrome regardless of maternal testing results, 2) infants without clinical findings consistent with congenital Zika syndrome who were born to mothers with laboratory evidence of possible Zika virus infection, † and 3) infants without clinical findings consistent with congenital Zika syndrome who were born to mothers without laboratory evidence of possible Zika virus infection. Infants in the first two scenarios should receive further testing and evaluation for Zika virus, whereas for the third group, further testing and clinical evaluation for Zika virus are not recommended. Health care providers should remain alert for abnormal findings (e.g., postnatal-onset microcephaly and eye abnormalities without microcephaly) in infants with possible congenital Zika virus exposure without apparent abnormalities at birth.

  12. Impact of connected vehicle guidance information on network-wide average travel time

    Directory of Open Access Journals (Sweden)

    Jiangfeng Wang

    2016-12-01

    Full Text Available With the emergence of connected vehicle technologies, the potential positive impact of connected vehicle guidance on mobility has become a research hotspot by data exchange among vehicles, infrastructure, and mobile devices. This study is focused on micro-modeling and quantitatively evaluating the impact of connected vehicle guidance on network-wide travel time by introducing various affecting factors. To evaluate the benefits of connected vehicle guidance, a simulation architecture based on one engine is proposed representing the connected vehicle–enabled virtual world, and connected vehicle route guidance scenario is established through the development of communication agent and intelligent transportation systems agents using connected vehicle application programming interface considering the communication properties, such as path loss and transmission power. The impact of connected vehicle guidance on network-wide travel time is analyzed by comparing with non-connected vehicle guidance in response to different market penetration rate, following rate, and congestion level. The simulation results explore that average network-wide travel time in connected vehicle guidance shows a significant reduction versus that in non–connected vehicle guidance. Average network-wide travel time in connected vehicle guidance have an increase of 42.23% comparing to that in non-connected vehicle guidance, and average travel time variability (represented by the coefficient of variance increases as the travel time increases. Other vital findings include that higher penetration rate and following rate generate bigger savings of average network-wide travel time. The savings of average network-wide travel time increase from 17% to 38% according to different congestion levels, and savings of average travel time in more serious congestion have a more obvious improvement for the same penetration rate or following rate.

  13. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... 20852. FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug Evaluation and Research, Food...

  14. Spacecraft intercept guidance using zero effort miss steering

    Science.gov (United States)

    Newman, Brett

    The suitability of proportional navigation, or an equivalent zero effort miss formulation, for spacecraft intercepts during midcourse guidance, followed by a ballistic coast to the endgame, is addressed. The problem is formulated in terms of relative motion in a general 3D framework. The proposed guidance law for the commanded thrust vector orientation consists of the sum of two terms: (1) along the line of sight unit direction and (2) along the zero effort miss component perpendicular to the line of sight and proportional to the miss itself and a guidance gain. If the guidance law is to be suitable for longer range targeting applications with significant ballistic coasting after burnout, determination of the zero effort miss must account for the different gravitational accelerations experienced by each vehicle. The proposed miss determination techniques employ approximations for the true differential gravity effect. Theoretical results are applied to a numerical engagement scenario and the resulting performance is evaluated in terms of the miss distances determined from nonlinear simulation.

  15. Ablation of lumbar sympathetic ganglia by absolute ethanol injection and paravertebral catheter placement under CT guidance: evaluation of the efficacy

    International Nuclear Information System (INIS)

    Xu Hua; Xiong Yuanchang; Shao Chengwei; Zuo Changjing; Sheng Jing; Tian Jianming

    2009-01-01

    Objective: To evaluate the ablation of lumbar sympathetic ganglia by using single injection of absolute ethanol and retaining a paravertebral catheter under CT guidance for the treatment of lower extremity ischemia. Methods: Single absolute ethanol injection of L2 sympathetic ganglia was done in 25 cases (group B), single absolute ethanol injection of L2 sympathetic ganglia together with placement of a paravertebral catheter at L3 was carried out in 23 cases (group BT). All the procedures were performed under CT guidance. Three days after the procedure, the pain severity of the lower limbs was evaluated based on VAS method. If the patient in group BT still had a VAS score ≥4 on the third day, 3 ml of 1% lidocaine was infected via the retained catheter in the prone position. If VAS score became ≤3 at 5 min after the injection, additional 5 ml of ethanol was given through the catheter. The pain severity was evaluated again one week later. VAS score, analgesic dose and temperature of lower limbs were recorded. Results: One week after the procedure the excellent rate and effective rate for group B were 32% and 80% respectively, while for group BT were 60.9% and 95.7% respectively, with a significant difference between two groups (P<0.01). Conclusion: For the ablation of lumbar sympathetic ganglia the combination of single absolute ethanol injection with paravertebral catheter placement under CT guidance is superior to the single absolute ethanol injection. This technique is more individual with better results and is more likely to be accepted by the patients. (authors)

  16. Judging risk behaviour and risk preference: the role of the evaluative connotation of risk terms.

    NARCIS (Netherlands)

    van Schie, E.C.M.; van der Pligt, J.; van Baaren, K.

    1993-01-01

    Two experiments investigated the impact of the evaluative connotation of risk terms on the judgment of risk behavior and on risk preference. Exp 1 focused on the evaluation congruence of the risk terms with a general risk norm and with Ss' individual risk preference, and its effects on the extremity

  17. A novel biased proportional navigation guidance law for close approach phase

    Directory of Open Access Journals (Sweden)

    Su Wenshan

    2016-02-01

    Full Text Available A novel biased proportional navigation guidance (BPNG law is proposed for the close approach phase, which aims to make the spacecraft rendezvous with the target in specific relative range and direction. Firstly, in order to describe the special guidance requirements, the concept of zero effort miss vector is proposed and the dangerous area where there exists collision risk for safety consideration is defined. Secondly, the BPNG, which decouples the range control and direction control, is designed in the line-of-sight (LOS rotation coordinate system. The theoretical analysis proves that BPNG meets guidance requirements quite well. Thirdly, for the consideration of fuel consumption, the optimal biased proportional navigation guidance (OBPNG law is derived by solving the Schwartz inequality. Finally, simulation results show that BPNG is effective for the close approach with the ability of evading the dangerous area and OBPNG consumes less fuel compared with BPNG.

  18. Simulation of enteric pathogen concentrations in locally-collected greywater and wastewater for microbial risk assessments

    Science.gov (United States)

    As decentralized water reuse continues to gain popularity, risk-based treatment guidance is increasingly sought for the protection of public health. However, efforts to evaluate pathogen risks and log-reduction requirements have been hindered by an incomplete understanding of pat...

  19. Guidance for performing site inspections under CERCLA

    Energy Technology Data Exchange (ETDEWEB)

    1992-09-01

    This guidance presents EPA`s site inspection (SI) strategy. The strategy discusses procedural guidelines to investigate potential Superfund (CERCLA) sites for evaluation pursuant to the Hazard Ranking System (HRS), revised in accordance with the Superfund Amendments and Reauthorization Act of 1986. The HRS is the primary means by which EPA evaluates sites for superfund`s National Priorities List (NPL).

  20. Data validation and risk assessment -- some pitfalls when evaluating VOC measurements

    International Nuclear Information System (INIS)

    Korte, N.; Kearl, P.

    1993-01-01

    Data validation, as described in Environmental Protection Agency (EPA) protocols under the Contract Laboratory Program (CLP), yields false confidence in the data and drives up costs while providing little benefit (Korte and Brown 1992). Commonly, these data are then used to perform a risk assessment. Much of the published guidance for risk assessments in and arid soils is inadequate because it does not take into account vapor migration due to density-driven flow (Korte and others 1992). Investigations into both of these problems have been performed by personnel of Oak Ridge National Laboratory (ORNL) and are described in this presentation

  1. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... products. This guidance revises the guidance for industry entitled ``Clinical Development Programs for... Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville...

  2. Volumetric image-guidance: Does routine usage prompt adaptive re-planning? An institutional review

    International Nuclear Information System (INIS)

    Tanyi, James A.; Fuss, Martin H.

    2008-01-01

    Purpose. To investigate how the use of volumetric image-guidance using an on-board cone-beam computed tomography (CBCT) system impacts on the frequency of adaptive re-planning. Material and methods. Treatment courses of 146 patients who have undergone a course of external beam radiation therapy (EBRT) using volumetric CBCT image-guidance were analyzed. Target locations included the brain, head and neck, chest, abdomen, as well as prostate and non-prostate pelvis. The majority of patients (57.5%) were treated with hypo-fractionated treatment regimens (three to 15 fraction courses). The frequency of image-guidance ranged from daily (87.7%) to weekly or twice weekly. The underlying medical necessity for adaptive re-planning as well as frequency and consequences of plan adaptation to dose-volume parameters was assessed. Results. Radiation plans of 34 patients (23.3%) were adapted at least once (up to six time) during their course of EBRT as a result of image-guidance CBCT review. Most common causes for adaptive planning were: tumor change (mostly shrinkage: 10 patients; four patients more than one re-plan), change in abdominal girth (systematic change in hollow organ filling; n=7, two patients more than one re-plan), weight loss (n=5), and systematic target setup deviation from simulation (n=5). Adaptive re-plan was required mostly for conventionally fractionated courses; only 5 patient plans undergoing hypo-fractionated treatment were adjusted. In over 91% of adapted plans, the dose-volume parameters did deviate from the prescribed plan parameters by more than 5% for at least 10% of the target volume, or organs-at-risk in close proximity to the target volume. Discussion. Routine use of volumetric image-guidance has in our practice increased the demand for adaptive re-planning. Volumetric CBCT image-guidance provides sufficient imaging information to reliably predict the need for dose adjustment. In the vast majority of cases evaluated, the initial and adapted dose

  3. 21 CFR 601.29 - Guidance documents.

    Science.gov (United States)

    2010-04-01

    ... Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Guidance documents. 601.29 Section 601.29 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS...

  4. Graphic Turbulence Guidance

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  5. A Fuzzy Comprehensive Evaluation Model for Sustainability Risk Evaluation of PPP Projects

    Directory of Open Access Journals (Sweden)

    Libiao Bai

    2017-10-01

    Full Text Available Evaluating the sustainability risk level of public–private partnership (PPP projects can reduce project risk incidents and achieve the sustainable development of the organization. However, the existing studies about PPP projects risk management mainly focus on exploring the impact of financial and revenue risks but ignore the sustainability risks, causing the concept of “sustainability” to be missing while evaluating the risk level of PPP projects. To evaluate the sustainability risk level and achieve the most important objective of providing a reference for the public and private sectors when making decisions on PPP project management, this paper constructs a factor system of sustainability risk of PPP projects based on an extensive literature review and develops a mathematical model based on the methods of fuzzy comprehensive evaluation model (FCEM and failure mode, effects and criticality analysis (FMECA for evaluating the sustainability risk level of PPP projects. In addition, this paper conducts computational experiment based on a questionnaire survey to verify the effectiveness and feasibility of this proposed model. The results suggest that this model is reasonable for evaluating the sustainability risk level of PPP projects. To our knowledge, this paper is the first study to evaluate the sustainability risk of PPP projects, which would not only enrich the theories of project risk management, but also serve as a reference for the public and private sectors for the sustainable planning and development. Keywords: sustainability risk eva

  6. Enhancing pediatric residents’ scholar role: the development of a Scholarly Activity Guidance and Evaluation program

    Directory of Open Access Journals (Sweden)

    Catherine M. Pound

    2015-06-01

    Full Text Available Background: Research training is essential to the development of well-rounded physicians. Although many pediatric residency programs require residents to complete a research project, it is often challenging to integrate research training into educational programs. Objective: We aimed to develop an innovative research program for pediatric residents, called the Scholarly Activity Guidance and Evaluation (SAGE program. Methods: We developed a competency-based program which establishes benchmarks for pediatric residents, while providing ongoing academic mentorship. Results: Feedback from residents and their research supervisors about the SAGE program has been positive. Preliminary evaluation data have shown that all final-year residents have met or exceeded program expectations. Conclusions: By providing residents with this supportive environment, we hope to influence their academic career paths, increase their research productivity, promote evidence-based practice, and ultimately, positively impact health outcomes.

  7. Non-cable vehicle guidance

    Energy Technology Data Exchange (ETDEWEB)

    Daugela, G.C.; Willott, A.M.; Chopiuk, R.G.; Thornton, S.E.

    1988-06-01

    The purpose is to determine the most promising driverless mine vehicle guidance systems that are not dependent on buried cables, and to plan their development. The project is presented in two phases: a preliminary study and literature review to determine whether suitable technologies exist to justify further work; and an in-depth assessment and selection of technologies for vehicle guidance. A large number of guidance elements are involved in a completely automated vehicle. The technologies that hold the best potential for development of guidance systems for mine vehicles are ultrasonics, radar, lasers, dead reckoning, and guidance algorithms. The best approach to adaptation of these technologies is on a step by step basis. Guidance modules that are complete in themselves and are designed to be integrated with other modules can provide short term benefits. Two modules are selected for development: the dragline operations monitor and automated machine control for optimized mining (AMCOM). 99 refs., 20 figs., 40 tabs.

  8. Evaluation of a Behavioral Guidance Structure at Bonneville Dam Second Powerhouse including Passage Survival of Juvenile Salmon and Steelhead using Acoustic Telemetry, 2008

    Energy Technology Data Exchange (ETDEWEB)

    Faber, Derrek M.; Ploskey, Gene R.; Weiland, Mark A.; Deng, Zhiqun; Hughes, James S.; McComas, Roy L.; Kim, Jina; Townsend, R. L.; Fu, Tao; Skalski, J. R.; Fischer, Eric S.

    2010-02-12

    Summarizes research conducted at Bonneville Dam in 2008 to evaluate a prototype Behavioral Guidance Structure, that was deployed by the US Army Corps of Engineers in an effort to increase survival of outmigrating smolts at Bonneville Dam.

  9. Intra-operative ultrasound-based augmented reality guidance for laparoscopic surgery.

    Science.gov (United States)

    Singla, Rohit; Edgcumbe, Philip; Pratt, Philip; Nguan, Christopher; Rohling, Robert

    2017-10-01

    In laparoscopic surgery, the surgeon must operate with a limited field of view and reduced depth perception. This makes spatial understanding of critical structures difficult, such as an endophytic tumour in a partial nephrectomy. Such tumours yield a high complication rate of 47%, and excising them increases the risk of cutting into the kidney's collecting system. To overcome these challenges, an augmented reality guidance system is proposed. Using intra-operative ultrasound, a single navigation aid, and surgical instrument tracking, four augmentations of guidance information are provided during tumour excision. Qualitative and quantitative system benefits are measured in simulated robot-assisted partial nephrectomies. Robot-to-camera calibration achieved a total registration error of 1.0 ± 0.4 mm while the total system error is 2.5 ± 0.5 mm. The system significantly reduced healthy tissue excised from an average (±standard deviation) of 30.6 ± 5.5 to 17.5 ± 2.4 cm 3 ( p < 0.05) and reduced the depth from the tumor underside to cut from an average (±standard deviation) of 10.2 ± 4.1 to 3.3 ± 2.3 mm ( p < 0.05). Further evaluation is required in vivo, but the system has promising potential to reduce the amount of healthy parenchymal tissue excised.

  10. 75 FR 29768 - Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of...

    Science.gov (United States)

    2010-05-27

    ... manufacturers of plasma derivatives with comprehensive FDA recommendations intended to minimize the possible...CJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance). DATES: Submit electronic... the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit...

  11. The evaluation of radiologic methods for access guidance in percutaneous nephrolithotomy

    DEFF Research Database (Denmark)

    Breda, Alberto; Territo, Angelo; Scoffone, Cesare

    2018-01-01

    is controversial? A systematic review of the literature was performed comparing image guidance modalities for obtaining access in PNL. Evidence acquisition and synthesis: A PubMed, Scopus and Cochrane search for peer-reviewed studies was performed using the keywords "ultrasound" AND "fluoroscopy" AND "Percutaneous...

  12. Health system guidance appraisal--concept evaluation and usability testing.

    Science.gov (United States)

    Ako-Arrey, Denis E; Brouwers, Melissa C; Lavis, John N; Giacomini, Mita K

    2016-01-05

    Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and test its usability. This study involved a two-step survey process. In step 1, respondents rated the 30 concepts for appropriateness to, relevance to, and priority for health system decisions and HSG. This led to a draft tool. In step 2, respondents reviewed HSG documents, appraised them using the tool, and answered a series of questions. Descriptive analyses were computed. Fifty participants were invited in step 1, and we had a response rate of 82 %. The mean response rates for each concept within each survey question were universally favorable. There was also an overall agreement about the need for a high-quality tool to systematically direct the development, appraisal, and reporting of HSG. Qualitative feedback and a consensus process by the team led to refinements to some of the concepts and the creation of a beta (draft) version of the HSG tool. In step 2, 35 participants were invited and we had a response rate of 74 %. Exploratory analyses showed that the quality of the HSGs reviewed varied as a function of the HSG item and the specific document assessed. A favorable consensus was reached with participants agreeing that the HSG items were easy to understand and easy to apply. Moreover, the overall agreement was high for the usability of the tool to systematically direct the development (85 %), appraisal (92 %), and reporting (81 %) of HSG. From this process, version 1.0 of the HSG appraisal tool was generated complete with 32 items (and their descriptions) and 4 domains. The final

  13. Fusion guidance in endovascular peripheral artery interventions: a feasibility study.

    Science.gov (United States)

    Sailer, Anna M; de Haan, Michiel W; de Graaf, Rick; van Zwam, Willem H; Schurink, Geert Willem H; Nelemans, Patricia J; Wildberger, Joachim E; Das, Marco

    2015-04-01

    This study was designed to evaluate the feasibility of endovascular guidance by means of live fluoroscopy fusion with magnetic resonance angiography (MRA) and computed tomography angiography (CTA). Fusion guidance was evaluated in 20 endovascular peripheral artery interventions in 17 patients. Fifteen patients had received preinterventional diagnostic MRA and two patients had undergone CTA. Time for fluoroscopy with MRA/CTA coregistration was recorded. Feasibility of fusion guidance was evaluated according to the following criteria: for every procedure the executing interventional radiologists recorded whether 3D road-mapping provided added value (yes vs. no) and whether PTA and/or stenting could be performed relying on the fusion road-map without need for diagnostic contrast-enhanced angiogram series (CEAS) (yes vs. no). Precision of the fusion road-map was evaluated by recording maximum differences between the position of the vasculature on the virtual CTA/MRA images and conventional angiography. Average time needed for image coregistration was 5 ± 2 min. Three-dimensional road-map added value was experienced in 15 procedures in 12 patients. In half of the patients (8/17), intervention was performed relying on the fusion road-map only, without diagnostic CEAS. In two patients, MRA roadmap showed a false-positive lesion. Excluding three patients with inordinate movements, mean difference in position of vasculature on angiography and MRA/CTA road-map was 1.86 ± 0.95 mm, implying that approximately 95 % of differences were between 0 and 3.72 mm (2 ± 1.96 standard deviation). Fluoroscopy with MRA/CTA fusion guidance for peripheral artery interventions is feasible. By reducing the number of CEAS, this technology may contribute to enhance procedural safety.

  14. Review of soil contamination guidance

    International Nuclear Information System (INIS)

    Mueller, M.A.; Kennedy, W.E. Jr.; Soldat, J.K.

    1981-08-01

    A review of existing and proposed radioactive soil contamination standards and guidance was conducted for United Nuclear Corporation (UNC), Office of Surplus Facilities Management. Information was obtained from both government agencies and other sources during a literature survey. The more applicable standards were reviewed, evaluated, and summarized. Information pertaining to soil contamination for both facility operation and facility decommissioning was obtained from a variety of sources. These sources included: the Code of Federal Regulations, regulatory guides, the Federal Register, topical reports written by various government agencies, topical reports written by national laboratories, and publications from the American National Standards Institute (ANSI). It was difficult to directly compare the standards and guidance obtained from these sources since each was intended for a specific situation and different units or bases were used. However, most of the information reviewed was consistent with the philosophy of maintaining exposures at levels as low as reasonably achievable

  15. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Science.gov (United States)

    2011-08-24

    ...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug...

  16. Ethical and affective evaluation of environmental risks

    International Nuclear Information System (INIS)

    Bohm, G.; Pfister, H.R.

    1998-01-01

    Full text of publication follows: the present paper will be concerned with environmental risk perception, with special emphasis on those environmental risks that pertain to global change phenomena, such as climate change and ozone depletion. Two determinants of risk judgments are investigated that seem particularly relevant to environmental risks: ethical and affective evaluations. It is assumed that the focus of risk evaluation can be on one of two aspects: a) on an evaluation of potential losses, or b) on ethical considerations. We assume that both, potential loss and violation of ethical principles elicit emotional evaluations, but that these two judgmental aspects are associated with different specific emotions. Following cognitive emotion theories, we distinguish loss-based emotions, such as worry and fear, from ethical emotions, e.g., guilt and anger. A study is presented that investigates the role of ethical and affective evaluations in risk judgments. Various environmental risks were presented to subjects, e.g., air pollution, ozone depletion, climate change and destruction of ecological balance. For each environmental risk, subjects indicated in free-response format as well as on rating scales the extent to which ethical principles were violated, and the intensity of both loss-based and ethical emotions. The correlational structure of the emotion ratings confirms the distinction between loss-based and ethical emotions. Risk judgments co-vary with the strength of ethical evaluation and with the intensity of loss-based emotions, but are independent of ethical emotions. The implications of these findings for the risk appraisal process are discussed. (authors)

  17. The Design of a Modified PSO Guidance Law Using Predictor and LOS Rate Evaluation

    OpenAIRE

    Lee Yung-Lung; Chen Kuei-Yi; Chen Yi-Wei; Chen Yen-Bin; Liao Sheng-Ju

    2016-01-01

    This paper proposes a modified particle swarm optimization guidance (MPSOG) for the pursuit-evasion optimization problem. If the line-of-sight (LOS) rate equals zero, the curvature of the missile’s trajectory would be smaller and the probability of intercept greater. Thus, we propose using a MPSOG to improve the guidance performance. The MPSOG uses a Kalman filter to predict a target’s dynamic. The lateral acceleration commands of the y- and z-axis are optimized by the particle swarm optimiza...

  18. 76 FR 39989 - Guidance on Deposit-Related Consumer Credit Products

    Science.gov (United States)

    2011-07-07

    ... Policy, (202) 874-4428; or Kevin Russell, Director, Retail Credit Risk, (202) 874-5170, Office of the...] Guidance on Deposit-Related Consumer Credit Products AGENCY: Office of the Comptroller of the Currency... principles of safe and sound banking practices in connection with deposit-related consumer credit products...

  19. Guidance and Control Architecture Design and Demonstration for Low Ballistic Coefficient Atmospheric Entry

    Science.gov (United States)

    Swei, Sean

    2014-01-01

    We propose to develop a robust guidance and control system for the ADEPT (Adaptable Deployable Entry and Placement Technology) entry vehicle. A control-centric model of ADEPT will be developed to quantify the performance of candidate guidance and control architectures for both aerocapture and precision landing missions. The evaluation will be based on recent breakthroughs in constrained controllability/reachability analysis of control systems and constrained-based energy-minimum trajectory optimization for guidance development operating in complex environments.

  20. Analysis of costs for compliance with Federal Radiation Protection Guidance for Occupational Exposure. Volume 1: cost of compliance with proposed radiation protection guidance for workers

    International Nuclear Information System (INIS)

    1983-11-01

    On January 23, 1981 the Office of Radiation Programs, U.S. Environmental Protection Agency published in the Federal Register proposals for revisions in the existing Federal Radiation Protection Guidance for Occupational Exposures. This report is a part of the continuing analysis by EPA of the cost/feasibility of the proposed revisions. Specifically, the report evaluates each of the proposed changes in the guidance to estimate the cost of compliance to all segments of the private sector wherein impacts are expected to be significant. This study concentrates its effort on estimating the direct resource costs for each industry that must comply with the regulations that result from the revision to the guidance. These costs that are met by industry participants will account for a significant portion of the total costs associated with the guidance. These costs were estimated through a series of case studies and independent research

  1. Issues in Value-at-Risk Modeling and Evaluation

    NARCIS (Netherlands)

    J. Daníelsson (Jón); C.G. de Vries (Casper); B.N. Jorgensen (Bjørn); P.F. Christoffersen (Peter); F.X. Diebold (Francis); T. Schuermann (Til); J.A. Lopez (Jose); B. Hirtle (Beverly)

    1998-01-01

    textabstractDiscusses the issues in value-at-risk modeling and evaluation. Value of value at risk; Horizon problems and extreme events in financial risk management; Methods of evaluating value-at-risk estimates.

  2. Dissecting Attending Surgeons' Operating Room Guidance: Factors That Affect Guidance Decision Making.

    Science.gov (United States)

    Chen, Xiaodong Phoenix; Williams, Reed G; Smink, Douglas S

    2015-01-01

    The amount of guidance provided by the attending surgeon in the operating room (OR) is a key element in developing residents' autonomy. The purpose of this study is to explore factors that affect attending surgeons' decision making regarding OR guidance provided to the resident. We used video-stimulated recall interviews (VSRI) throughout this 2-phase study. In Phase 1, 3 attending surgeons were invited to review separately 30 to 45 minute video segments of their prerecorded surgical operations to explore factors that influenced their OR guidance decision making. In Phase 2, 3 attending surgeons were observed and documented in the OR (4 operations, 341min). Each operating surgeon reviewed their videotaped surgical performance within 5 days of the operation to reflect on factors that affected their decision making during the targeted guidance events. All VSRI were recorded. Thematic analysis and manual coding were used to synthesize and analyze data from VSRI transcripts, OR observation documents, and field notes. A total of 255 minutes of VSRI involving 6 surgeons and 7 surgical operations from 5 different procedures were conducted. A total of 13 guidance decision-making influence factors from 4 categories were identified (Cohen's κ = 0.674): Setting (case schedule and patient morbidity), content (procedure attributes and case progress), resident (current competency level, trustworthiness, self-confidence, and personal traits), and attending surgeon (level of experience, level of comfort, preferred surgical technique, OR training philosophy, and responsibility as surgeon). A total of 5 factors (case schedule, patient morbidity, procedure attributes, resident current competency level, and trustworthiness) influenced attending surgeons' pre-OR guidance plans. "OR training philosophy" and "responsibility as surgeon" were anchor factors that affected attending surgeons' OR guidance decision-making patterns. Surgeons' OR guidance decision making is a dynamic process

  3. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

    ... performance of medical devices in women. This information can be of benefit to patients and their medical... draft guidance before it begins work on the final version of the guidance, submit either electronic or...

  4. Fusion Guidance in Endovascular Peripheral Artery Interventions: A Feasibility Study

    Energy Technology Data Exchange (ETDEWEB)

    Sailer, Anna M., E-mail: anni.sailer@mumc.nl; Haan, Michiel W. de, E-mail: m.de.haan@mumc.nl; Graaf, Rick de, E-mail: r.de.graaf@mumc.nl; Zwam, Willem H. van, E-mail: w.van.zwam@mumc.nl [Maastricht University Medical Center, Department of Radiology (Netherlands); Schurink, Geert Willem H., E-mail: gwh.schurink@mumc.nl [Maastricht University Medical Center, Department of Surgery (Netherlands); Nelemans, Patricia J., E-mail: patty.nelemans@maastrichtuniversity.nl [Maastricht University Medical Centre, Department of Epidemiology (Netherlands); Wildberger, Joachim E., E-mail: j.wildberger@mumc.nl; Das, Marco, E-mail: m.das@mumc.nl [Maastricht University Medical Center, Department of Radiology (Netherlands)

    2015-04-15

    PurposeThis study was designed to evaluate the feasibility of endovascular guidance by means of live fluoroscopy fusion with magnetic resonance angiography (MRA) and computed tomography angiography (CTA).MethodsFusion guidance was evaluated in 20 endovascular peripheral artery interventions in 17 patients. Fifteen patients had received preinterventional diagnostic MRA and two patients had undergone CTA. Time for fluoroscopy with MRA/CTA coregistration was recorded. Feasibility of fusion guidance was evaluated according to the following criteria: for every procedure the executing interventional radiologists recorded whether 3D road-mapping provided added value (yes vs. no) and whether PTA and/or stenting could be performed relying on the fusion road-map without need for diagnostic contrast-enhanced angiogram series (CEAS) (yes vs. no). Precision of the fusion road-map was evaluated by recording maximum differences between the position of the vasculature on the virtual CTA/MRA images and conventional angiography.ResultsAverage time needed for image coregistration was 5 ± 2 min. Three-dimensional road-map added value was experienced in 15 procedures in 12 patients. In half of the patients (8/17), intervention was performed relying on the fusion road-map only, without diagnostic CEAS. In two patients, MRA roadmap showed a false-positive lesion. Excluding three patients with inordinate movements, mean difference in position of vasculature on angiography and MRA/CTA road-map was 1.86 ± 0.95 mm, implying that approximately 95 % of differences were between 0 and 3.72 mm (2 ± 1.96 standard deviation).ConclusionsFluoroscopy with MRA/CTA fusion guidance for peripheral artery interventions is feasible. By reducing the number of CEAS, this technology may contribute to enhance procedural safety.

  5. Fusion Guidance in Endovascular Peripheral Artery Interventions: A Feasibility Study

    International Nuclear Information System (INIS)

    Sailer, Anna M.; Haan, Michiel W. de; Graaf, Rick de; Zwam, Willem H. van; Schurink, Geert Willem H.; Nelemans, Patricia J.; Wildberger, Joachim E.; Das, Marco

    2015-01-01

    PurposeThis study was designed to evaluate the feasibility of endovascular guidance by means of live fluoroscopy fusion with magnetic resonance angiography (MRA) and computed tomography angiography (CTA).MethodsFusion guidance was evaluated in 20 endovascular peripheral artery interventions in 17 patients. Fifteen patients had received preinterventional diagnostic MRA and two patients had undergone CTA. Time for fluoroscopy with MRA/CTA coregistration was recorded. Feasibility of fusion guidance was evaluated according to the following criteria: for every procedure the executing interventional radiologists recorded whether 3D road-mapping provided added value (yes vs. no) and whether PTA and/or stenting could be performed relying on the fusion road-map without need for diagnostic contrast-enhanced angiogram series (CEAS) (yes vs. no). Precision of the fusion road-map was evaluated by recording maximum differences between the position of the vasculature on the virtual CTA/MRA images and conventional angiography.ResultsAverage time needed for image coregistration was 5 ± 2 min. Three-dimensional road-map added value was experienced in 15 procedures in 12 patients. In half of the patients (8/17), intervention was performed relying on the fusion road-map only, without diagnostic CEAS. In two patients, MRA roadmap showed a false-positive lesion. Excluding three patients with inordinate movements, mean difference in position of vasculature on angiography and MRA/CTA road-map was 1.86 ± 0.95 mm, implying that approximately 95 % of differences were between 0 and 3.72 mm (2 ± 1.96 standard deviation).ConclusionsFluoroscopy with MRA/CTA fusion guidance for peripheral artery interventions is feasible. By reducing the number of CEAS, this technology may contribute to enhance procedural safety

  6. Raising the Profile of Career Guidance: Educational and Vocational Guidance Practitioner

    Science.gov (United States)

    Hiebert, Bryan

    2009-01-01

    In 2007 the International Association for Educational and Vocational Guidance (IAEVG) launched the Educational and Vocational Guidance Practitioner credential (EVGP) as one means of formally acknowledging the knowledge, skills, and personal attributes that practitioners need in order to provide quality career development services to clients. This…

  7. Guidance for evidence-informed policies about health systems: rationale for and challenges of guidance development.

    Directory of Open Access Journals (Sweden)

    Xavier Bosch-Capblanch

    Full Text Available In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

  8. The effect of haptic guidance and visual feedback on learning a complex tennis task.

    Science.gov (United States)

    Marchal-Crespo, Laura; van Raai, Mark; Rauter, Georg; Wolf, Peter; Riener, Robert

    2013-11-01

    While haptic guidance can improve ongoing performance of a motor task, several studies have found that it ultimately impairs motor learning. However, some recent studies suggest that the haptic demonstration of optimal timing, rather than movement magnitude, enhances learning in subjects trained with haptic guidance. Timing of an action plays a crucial role in the proper accomplishment of many motor skills, such as hitting a moving object (discrete timing task) or learning a velocity profile (time-critical tracking task). The aim of the present study is to evaluate which feedback conditions-visual or haptic guidance-optimize learning of the discrete and continuous elements of a timing task. The experiment consisted in performing a fast tennis forehand stroke in a virtual environment. A tendon-based parallel robot connected to the end of a racket was used to apply haptic guidance during training. In two different experiments, we evaluated which feedback condition was more adequate for learning: (1) a time-dependent discrete task-learning to start a tennis stroke and (2) a tracking task-learning to follow a velocity profile. The effect that the task difficulty and subject's initial skill level have on the selection of the optimal training condition was further evaluated. Results showed that the training condition that maximizes learning of the discrete time-dependent motor task depends on the subjects' initial skill level. Haptic guidance was especially suitable for less-skilled subjects and in especially difficult discrete tasks, while visual feedback seems to benefit more skilled subjects. Additionally, haptic guidance seemed to promote learning in a time-critical tracking task, while visual feedback tended to deteriorate the performance independently of the task difficulty and subjects' initial skill level. Haptic guidance outperformed visual feedback, although additional studies are needed to further analyze the effect of other types of feedback visualization on

  9. Measuring Integrated Socioemotional Guidance at School: Factor Structure and Reliability of the Socioemotional Guidance Questionnaire (SEG-Q)

    Science.gov (United States)

    Jacobs, Karen; Struyf, Elke

    2013-01-01

    Socioemotional guidance of students has recently become an integral part of education, however no instrument exists to measure integrated socioemotional guidance. This study therefore examines the factor structure and reliability of the Socioemotional Guidance Questionnaire. Psychometric properties of the Socioemotional Guidance Questionnaire and…

  10. Graphical Turbulence Guidance - Composite

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  11. Applying Human-performance Models to Designing and Evaluating Nuclear Power Plants: Review Guidance and Technical Basis

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.M.

    2009-11-30

    Human performance models (HPMs) are simulations of human behavior with which we can predict human performance. Designers use them to support their human factors engineering (HFE) programs for a wide range of complex systems, including commercial nuclear power plants. Applicants to U.S. Nuclear Regulatory Commission (NRC) can use HPMs for design certifications, operating licenses, and license amendments. In the context of nuclear-plant safety, it is important to assure that HPMs are verified and validated, and their usage is consistent with their intended purpose. Using HPMs improperly may generate misleading or incorrect information, entailing safety concerns. The objective of this research was to develop guidance to support the NRC staff's reviews of an applicant's use of HPMs in an HFE program. The guidance is divided into three topical areas: (1) HPM Verification, (2) HPM Validation, and (3) User Interface Verification. Following this guidance will help ensure the benefits of HPMs are achieved in a technically sound, defensible manner. During the course of developing this guidance, I identified several issues that could not be addressed; they also are discussed.

  12. Applying Human-performance Models to Designing and Evaluating Nuclear Power Plants: Review Guidance and Technical Basis

    International Nuclear Information System (INIS)

    O'Hara, J.M.

    2009-01-01

    Human performance models (HPMs) are simulations of human behavior with which we can predict human performance. Designers use them to support their human factors engineering (HFE) programs for a wide range of complex systems, including commercial nuclear power plants. Applicants to U.S. Nuclear Regulatory Commission (NRC) can use HPMs for design certifications, operating licenses, and license amendments. In the context of nuclear-plant safety, it is important to assure that HPMs are verified and validated, and their usage is consistent with their intended purpose. Using HPMs improperly may generate misleading or incorrect information, entailing safety concerns. The objective of this research was to develop guidance to support the NRC staff's reviews of an applicant's use of HPMs in an HFE program. The guidance is divided into three topical areas: (1) HPM Verification, (2) HPM Validation, and (3) User Interface Verification. Following this guidance will help ensure the benefits of HPMs are achieved in a technically sound, defensible manner. During the course of developing this guidance, I identified several issues that could not be addressed; they also are discussed.

  13. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Science.gov (United States)

    2013-08-07

    ... guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. ``Qualifying for... to the pharmaceutical industry. In most cases, FDA has developed other guidances and resources to... guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients''--issued April 1998...

  14. Manual for summarising and evaluating the environmental aspects of pesticides

    NARCIS (Netherlands)

    Mensink BJWG; Montforts M; Wijkhuizen-Maslankiewicz L; Tibosch H; Linders JBHJ; ACT

    1995-01-01

    This Manual gives guidance in summarising and evaluating the environmental aspects of agricultural and non-agricultural pesticides. Actually this is the part of the pesticide registration process in the Netherlands preceding the risk assessment. The requirements of the Dutch government for

  15. Contextual cueing improves attentional guidance, even when guidance is supposedly optimal.

    Science.gov (United States)

    Harris, Anthony M; Remington, Roger W

    2017-05-01

    Visual search through previously encountered contexts typically produces reduced reaction times compared with search through novel contexts. This contextual cueing benefit is well established, but there is debate regarding its underlying mechanisms. Eye-tracking studies have consistently shown reduced number of fixations with repetition, supporting improvements in attentional guidance as the source of contextual cueing. However, contextual cueing benefits have been shown in conditions in which attentional guidance should already be optimal-namely, when attention is captured to the target location by an abrupt onset, or under pop-out conditions. These results have been used to argue for a response-related account of contextual cueing. Here, we combine eye tracking with response time to examine the mechanisms behind contextual cueing in spatially cued and pop-out conditions. Three experiments find consistent response time benefits with repetition, which appear to be driven almost entirely by a reduction in number of fixations, supporting improved attentional guidance as the mechanism behind contextual cueing. No differences were observed in the time between fixating the target and responding-our proxy for response related processes. Furthermore, the correlation between contextual cueing magnitude and the reduction in number of fixations on repeated contexts approaches 1. These results argue strongly that attentional guidance is facilitated by familiar search contexts, even when guidance is near-optimal. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  16. Moisture Control Guidance for Commercial and Public Buildings (EPA 402-F-13053)

    Science.gov (United States)

    This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled "Moisture Control Guida...

  17. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...

  18. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

  19. Risk effectiveness evaluation of surveillance testing

    International Nuclear Information System (INIS)

    Kim, I.S.; Samanta, P.K.; Martorell, S.; Vesely, W.E.

    1991-01-01

    To address the concerns about nuclear power plant surveillance tests, i.e., their adverse safety impact due to negative effects and too burdensome requirements, it is necessary to evaluate the safety significance or risk effectiveness of such tests explicitly considering both negative and positive effects. This paper defines the negative effects of surveillance testing from a risk perspective, and then presents a methodology to quantify the negative risk impact, i.e., the risk penalty or risk increase caused by the test. The method focuses on two important kinds of negative effects, namely, test-caused transients and test-caused equipment degradations. The concepts and quantitative methods for the risk evaluation can be used in the decision-making process to establish the safety significance of the tests and to screen the plant-specific surveillance test requirements. 6 refs., 2 figs., 2 tabs

  20. GUIDANCE ON SELECTING AGE GROUPS FOR ...

    Science.gov (United States)

    This guidance document provides a set of early-lifestage age groups for Environmental Protection Agency scientists to consider when assessing children’s exposure to environmental contaminants and the resultant potential dose. These recommended age groups are based on current understanding of differences in behavior and physiology which may impact exposures in children. A consistent set of early-life age groups, supported by an underlying scientific rationale, is expected to improve Agency exposure and risk assessments for children by increasing the consistency and comparability of risk assessments across the Agency; by improving accuracy and transparency in assessments for those cases where current practice might too broadly combine behaviorally and physiologically disparate age groups; and by fostering a consistent approach to future exposure surveys and monitoring efforts to generate improved exposure factors for children. see description

  1. Current materiality guidance for auditors

    OpenAIRE

    McKee, Thomas E.; Eilifsen, Aasmund

    2000-01-01

    Auditors have to make materiality judgments on every audit. This is a difficult process, as both quantitative and qualitative factors have to be evaluated. Additionally, there is no formal guidance for how to implement the materiality concepts discussed in the auditing standards. Although they are sometimes difficult to make, good materiality judgments are crucial for the conduct of a successful audit as poor judgments can result in an audit that is ineffective and/or inefficient. This report...

  2. Development of a treatability variance guidance document for US DOE mixed-waste streams

    International Nuclear Information System (INIS)

    Scheuer, N.; Spikula, R.; Harms, T.

    1990-03-01

    In response to the US Department of Energy's (DOE's) anticipated need for variances from the Resource Conservation and Recovery Act (RCRA) Land Disposal Restrictions (LDRs), a treatability variance guidance document was prepared. The guidance manual is for use by DOE facilities and operations offices. The manual was prepared as a part of an ongoing effort by DOE-EH to provide guidance for the operations offices and facilities to comply with the RCRA (LDRs). A treatability variance is an alternative treatment standard granted by EPA for a restricted waste. Such a variance is not an exemption from the requirements of the LDRs, but rather is an alternative treatment standard that must be met before land disposal. The manual, Guidance For Obtaining Variance From the Treatment Standards of the RCRA Land Disposal Restrictions (1), leads the reader through the process of evaluating whether a variance from the treatment standard is a viable approach and through the data-gathering and data-evaluation processes required to develop a petition requesting a variance. The DOE review and coordination process is also described and model language for use in petitions for DOE radioactive mixed waste (RMW) is provided. The guidance manual focuses on RMW streams, however the manual also is applicable to nonmixed, hazardous waste streams. 4 refs

  3. 78 FR 49372 - Notice of Availability of New Starts and Small Starts Policy Guidance

    Science.gov (United States)

    2013-08-14

    ... the final rule for Major Capital Investment Projects promulgated in January 2013. The rule sets the... publish policy guidance on the review and evaluation process and criteria for capital investment projects... final policy guidance accompanies the final rule for Major Capital Investment projects issued on January...

  4. Contextualising risk within enterprise risk management through the application of systems thinking

    CSIR Research Space (South Africa)

    Haywood, Lorren K

    2017-06-01

    Full Text Available New and emerging risks create growing uncertainty and unpredictability within enterprise risk management. While ISO 31000:2009 is a progressive risk management framework, it is limited in its guidance on how to contextualise complex risks...

  5. Consideration of health inequalities in systematic reviews: a mapping review of guidance.

    Science.gov (United States)

    Maden, Michelle

    2016-11-28

    Given that we know that interventions shown to be effective in improving the health of a population may actually widen the health inequalities gap while others reduce it, it is imperative that all systematic reviewers consider how the findings of their reviews may impact (reduce or increase) on the health inequality gap. This study reviewed existing guidance on incorporating considerations of health inequalities in systematic reviews in order to examine the extent to which they can help reviewers to incorporate such issues. A mapping review was undertaken to identify guidance documents that purported to inform reviewers on whether and how to incorporate considerations of health inequalities. Searches were undertaken in Medline, CINAHL and The Cochrane Library Methodology Register. Review guidance manuals prepared by international organisations engaged in undertaking systematic reviews, and their associated websites were scanned. Studies were included if they provided an overview or discussed the development and testing of guidance for dealing with the incorporation of considerations of health inequalities in evidence synthesis. Results are summarised in narrative and tabular forms. Twenty guidance documents published between 2009 and 2016 were included. Guidance has been produced to inform considerations of health inequalities at different stages of the systematic review process. The Campbell and Cochrane Equity Group have been instrumental in developing and promoting such guidance. Definitions of health inequalities and guidance differed across the included studies. All but one guidance document were transparent in their method of production. Formal methods of evaluation were reported for six guidance documents. Most of the guidance was operationalised in the form of examples taken from published systematic reviews. The number of guidance items to operationalise ranges from 3 up to 26 with a considerable overlap noted. Adhering to the guidance will require more

  6. Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

    Science.gov (United States)

    Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

    2016-01-01

    Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. Detection, Evaluation and Treatment of Diabetes Mellitus in Chronic Pancreatitis: Recommendations from PancreasFest 2012

    Science.gov (United States)

    Rickels, Michael R.; Bellin, Melena; Toledo, Frederico G.S.; Robertson, R. Paul; Andersen, Dana K.; Chari, Suresh T.; Brand, Randall; Frulloni, Luca; Anderson, Michelle A.; Whitcomb, David C.

    2013-01-01

    Description Diabetes and glucose intolerance are common complications of chronic pancreatitis, yet clinical guidance on their detection, classification, and management is lacking. Methods A working group reviewed the medical problems, diagnostic methods, and treatment options for chronic pancreatitis-associated diabetes for a consensus meeting at PancreasFest 2012. Results Guidance Statement 1.1 Diabetes mellitus is common in chronic pancreatitis. While any patient with chronic pancreatitis should be monitored for development of diabetes, those with long-standing duration of disease, prior partial pancreatectomy, and early onset of calcific disease may be at higher risk. Those patients developing diabetes mellitus are likely to have co-existing pancreatic exocrine insufficiency. Guidance Statement 1.2 Diabetes occurring secondary to chronic pancreatitis should be recognized as pancreatogenic diabetes (type 3c diabetes). Guidance Statement 2.1 The initial evaluation should include fasting glucose and HbA1c. These tests should be repeated annually. Impairment in either fasting glucose or HbA1c requires further evaluation. Guidance Statement 2.2 Impairment in either fasting glucose or HbA1c should be further evaluated by a standard 75 gram oral glucose tolerance test. Guidance Statement 2.3 An absent pancreatic polypeptide response to mixed-nutrient ingestion is a specific indicator of type 3c diabetes. Guidance Statement 2.4 Assessment of pancreatic endocrine reserve, and importantly that of functional beta-cell mass, should be performed as part of the evaluation and follow-up for total pancreatectomy with islet autotransplantation (TPIAT). Guidance Statement 3 Patients with pancreatic diabetes shall be treated with specifically tailored medical nutrition and pharmacologic therapies. Conclusions Physicians should evaluate and treat glucose intolerance in patients with pancreatitis. PMID:23890130

  8. Evaluation of heading performance with vibrotactile guidance: the benefits of information-movement coupling compared with spatial language.

    Science.gov (United States)

    Faugloire, Elise; Lejeune, Laure

    2014-12-01

    This study quantified the effectiveness of tactile guidance in indicating a direction to turn to and measured its benefits compared to spatial language. The device (CAYLAR), which was composed of 8 vibrators, specified the requested direction by a vibration at the corresponding location around the waist. Twelve participants were tested in normal light and in total darkness with 3 guidance conditions: spatial language, a long tactile rhythm (1 s on/4 s off vibrations) providing a single stimulation before movement, and a short rhythm (200 ms on/200 ms off vibrations) allowing information-movement coupling during body rotation. We measured response time, heading error, and asked participants to rate task easiness, intuitiveness and perceived accuracy for each guidance mode. Accuracy was higher and participants' ratings were more positive with the short tactile mode than with the 2 other modes. Compared to spatial language, tactile guidance, regardless of the vibration rhythm, also allowed faster responses and did not impair accuracy in the absence of vision. These findings quantitatively demonstrate that tactile guidance is particularly effective when it is reciprocally related to movement. We discuss implications of the benefits of perception-action coupling for the design of tactile navigation devices. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  9. Credit Risk Evaluation : Modeling - Analysis - Management

    OpenAIRE

    Wehrspohn, Uwe

    2002-01-01

    An analysis and further development of the building blocks of modern credit risk management: -Definitions of default -Estimation of default probabilities -Exposures -Recovery Rates -Pricing -Concepts of portfolio dependence -Time horizons for risk calculations -Quantification of portfolio risk -Estimation of risk measures -Portfolio analysis and portfolio improvement -Evaluation and comparison of credit risk models -Analytic portfolio loss distributions The thesis contributes to the evaluatio...

  10. Climate Risk Informed Decision Analysis (CRIDA): A novel practical guidance for Climate Resilient Investments and Planning

    Science.gov (United States)

    Jeuken, Ad; Mendoza, Guillermo; Matthews, John; Ray, Patrick; Haasnoot, Marjolijn; Gilroy, Kristin; Olsen, Rolf; Kucharski, John; Stakhiv, Gene; Cushing, Janet; Brown, Casey

    2016-04-01

    over time. They are part of the Dutch adaptive planning approach Adaptive Delta Management, executed and develop by the Dutch Delta program. Both decision scaling and adaptation pathways have been piloted in studies worldwide. The objective of CRIDA is to mainstream effective climate adaptation for professional water managers. The CRIDA publication, due in april 2016, follows the generic water design planning design cycle. At each step, CRIDA describes stepwise guidance for incorporating climate robustness: problem definition, stress test, alternatives formulation and recommendation, evaluation and selection. In the presentation the origin, goal, steps and practical tools available at each step of CRIDA will be explained. In two other abstracts ("Climate Risk Informed Decision Analysis: A Hypothetical Application to the Waas Region" by Gilroy et al., "The Application of Climate Risk Informed Decision Analysis to the Ioland Water Treatment Plant in Lusaka, Zambia, by Kucharski et al.), the application of CRIDA to cases is explained

  11. Interim Reliability Evaluation Program procedures guide

    International Nuclear Information System (INIS)

    Carlson, D.D.; Gallup, D.R.; Kolaczkowski, A.M.; Kolb, G.J.; Stack, D.W.; Lofgren, E.; Horton, W.H.; Lobner, P.R.

    1983-01-01

    This document presents procedures for conducting analyses of a scope similar to those performed in Phase II of the Interim Reliability Evaluation Program (IREP). It documents the current state of the art in performing the plant systems analysis portion of a probabilistic risk assessment. Insights gained into managing such an analysis are discussed. Step-by-step procedures and methodological guidance constitute the major portion of the document. While not to be viewed as a cookbook, the procedures set forth the principal steps in performing an IREP analysis. Guidance for resolving the problems encountered in previous analyses is offered. Numerous examples and representative products from previous analyses clarify the discussion

  12. GUIDANCE FOR NUCLEAR POWER PLANT CONTROL ROOM AND HUMAN-SYSTEM INTERFACE MODERNIZATION

    International Nuclear Information System (INIS)

    Naser, J.; Morris, G.

    2004-01-01

    Several nuclear power plants in the United States are starting instrumentation and control (I and C) modernization programs using digital equipment to address obsolescence issues and the need to improve plant performance while maintaining high levels of safety. As an integral part of the I and C modernization program at a nuclear power plant, the control room and other human-system interfaces (HSIs) are also being modernized. To support safe and effective operation, it is critical to plan, design, implement, train for, operate, and maintain the control room and HSI changes to take advantage of human cognitive processing abilities. A project, jointly funded by the Electric Power Research Institute (EPRI) and the United States Department of Energy (DOE) under the Nuclear Energy Plant Optimization (NEPO) Program, is developing guidance for specifying and designing control rooms, remote shut-down panels, HSIs etc. The guidance is intended for application by utilities and suppliers of control room and HSI modernization. The guidance will facilitate specification, design, implementation, operations, maintenance, training, and licensing activities. This guidance will be used to reduce the likelihood of human errors and licensing risk, to gain maximum benefit of implemented technology, and to increase performance. The guidance is of five types. The first is planning guidance to help a utility develop its plant-specific control room operating concepts, its plant-specific endpoint vision for the control room, its migration path to achieve that endpoint vision, and its regulatory, licensing, and human factors program plans. The second is process guidance for general HSI design and integration, human factors engineering analyses, verification and validation, in-service monitoring processes, etc. The third is detailed human factors engineering guidance for control room and HSI technical areas. The fourth is guidance for licensing. The fifth is guidance for special topics

  13. DEVELOPMENT OF A RISK SCREENING METHOD FOR CREDITED OPERATOR ACTIONS

    International Nuclear Information System (INIS)

    HIGGINS, J.C.; O'HARA, J.M.; LEWIS, P.M.; PERSENSKY, J.; BONGARRA, J.

    2002-01-01

    DEVELOPMENT OF A RISK SCREENING METHOD FOR CREDITED OPERATOR ACTIONS. THE U.S. NUCLEAR REGULATORY COMMISSION (NRC) REVIEWS THE HUMAN FACTORS ASPECTS OF PROPOSED LICENSE AMENDMENTS THAT IMPACT HUMAN ACTIONS THAT ARE CREDITED IN A PLANTS SAFETY ANALYSIS. THE STAFF IS COMMITTED TO A GRADED APPROACH TO THESE REVIEWS THAT FOCUS RESOURCES ON THE MOST RISK IMPORTANT CHANGES. THEREFORE, A RISK INFORMED SCREENING METHOD WAS DEVELOPED BASED ON AN ADAPTATION OF EXISTING GUIDANCE FOR RISK INFORMED REGULATION AND HUMAN FACTORS. THE METHOD USES BOTH QUANTITATIVE AND QUALITATIVE INFORMATION TO DIVIDE THE AMENDMENT REQUESTS INTO DIFFERENT LEVELS OF REVIEW. THE METHOD WAS EVALUATED USING A VARIETY OF TESTS. THIS PAPER WILL SUMMARIZE THE DEVELOPMENT OF THE METHODOLOGY AND THE EVALUATIONS THAT WERE PERFORMED TO VERIFY ITS USEFULNESS

  14. 75 FR 50801 - Reverse Mortgage Products: Guidance for Managing Compliance and Reputation Risks

    Science.gov (United States)

    2010-08-17

    ... recommended in this guidance when advertising reverse mortgages through certain forms of media, such as radio... organization commenter urged that loan originators should ensure that brokers do not advertise reverse... borrower was 73 years old, had a home valued at $261,500, and had financial assets of less than $33,000...

  15. Impact of risk considerations on dosimetry of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Eckerman, K.F.

    1981-01-01

    Estimates of the absorbed dose from clinical procedures involving the administration of radiopharmaceuticals are used primarily to determine the presumed risk of various procedures so that, in-so-far as possible, the selection of a given procedure can be based on a comparison of risk. Although this has been the basic objective, risk evaluation has generally been separated from the dosimetry considerations. In the recent revision of its radiation protection guidance, the International Commission on Radiological Protection (ICRP) has embodied risk considerations in its recommendations and risk concepts have become an integral part of the dosimetric framework. The impact of these considerations on the dosimetric assessments of radiopharmaceuticals and the resulting need for additional information is discussed

  16. Development of intelligent model for personalized guidance on wheelchair tilt and recline usage for people with spinal cord injury: methodology and preliminary report.

    Science.gov (United States)

    Fu, Jicheng; Jones, Maria; Jan, Yih-Kuen

    2014-01-01

    Wheelchair tilt and recline functions are two of the most desirable features for relieving seating pressure to decrease the risk of pressure ulcers. The effective guidance on wheelchair tilt and recline usage is therefore critical to pressure ulcer prevention. The aim of this study was to demonstrate the feasibility of using machine learning techniques to construct an intelligent model to provide personalized guidance to individuals with spinal cord injury (SCI). The motivation stems from the clinical evidence that the requirements of individuals vary greatly and that no universal guidance on tilt and recline usage could possibly satisfy all individuals with SCI. We explored all aspects involved in constructing the intelligent model and proposed approaches tailored to suit the characteristics of this preliminary study, such as the way of modeling research participants, using machine learning techniques to construct the intelligent model, and evaluating the performance of the intelligent model. We further improved the intelligent model's prediction accuracy by developing a two-phase feature selection algorithm to identify important attributes. Experimental results demonstrated that our approaches held the promise: they could effectively construct the intelligent model, evaluate its performance, and refine the participant model so that the intelligent model's prediction accuracy was significantly improved.

  17. International Scavenging for First Responder Guidance and Tools: IAEA Products

    Energy Technology Data Exchange (ETDEWEB)

    Stern, W. [Brookhaven National Lab. (BNL), Upton, NY (United States); Berthelot, L. [Brookhaven National Lab. (BNL), Upton, NY (United States); Bachner, K. [Brookhaven National Lab. (BNL), Upton, NY (United States)

    2017-05-05

    In fiscal years (FY) 2016 and 2017, with support from the U.S. Department of Homeland Security (DHS), Brookhaven National Laboratory (BNL) examined the International Atomic Energy Agency (IAEA) radiological emergency response and preparedness products (guidance and tools) to determine which of these products could be useful to U.S. first responders. The IAEA Incident and Emergency Centre (IEC), which is responsible for emergency preparedness and response, offers a range of tools and guidance documents for responders in recognizing, responding to, and recovering from radiation emergencies and incidents. In order to implement this project, BNL obtained all potentially relevant tools and products produced by the IAEA IEC and analyzed these materials to determine their relevance to first responders in the U.S. Subsequently, BNL organized and hosted a workshop at DHS National Urban Security Technology Laboratory (NUSTL) for U.S. first responders to examine and evaluate IAEA products to consider their applicability to the United States. This report documents and describes the First Responder Product Evaluation Workshop, and provides recommendations on potential steps the U.S. federal government could take to make IAEA guidance and tools useful to U.S. responders.

  18. Percutaneous drainage with ultrasound guidance in the intensive care unit

    International Nuclear Information System (INIS)

    Kang, Doo Kyung; Won, Je Hwan; Kim, Jai Keun; Lee, Kwang Hun; Kim, Ji Hyung

    2004-01-01

    To determine the efficacy and safety of bedside percutaneous drainage procedures with ultrasound guidance in critically ill patients in the intensive care unit (ICU). Sixty five percutaneous drainage procedures performed at the bedside, in 39 ICU patients, were evaluated. All of the procedures were performed with ultrasound guidance alone. The procedures consisted of percutaneous drainage of abdominal (n=35) and pleural (n=27) fluids, percutaneous cholecystostomy (n=2) and percutaneous nephrostomy (n=1). The clinical responses were classified as 'complete response', 'partial response', 'failure' or 'undetermined'. The medical records were reviewed retrospectively to evaluate the clinical response. Technical success was achieved in 64 of the 65 procedures (98.5%). The complication rate was 13.8% (9 cases). There was no immediate procedure-related death or worsening of the clinical condition of the patients. The clinical responses after drainage were 'complete response' in 39 cases (60.9%). 'partial response' in 14 (21.9%), 'failure' in 3 (4.7%), and 'undetermined' in 8 (12.5%). Bedside drainage procedures with ultrasound guidance are effective and safe to perform when patients are too critically ill to be moved from the ICU to the angiography room

  19. 76 FR 60503 - Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and...

    Science.gov (United States)

    2011-09-29

    ... Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended...

  20. Integration of existing systematic reviews into new reviews: identification of guidance needs

    Science.gov (United States)

    2014-01-01

    Background An exponential increase in the number of systematic reviews published, and constrained resources for new reviews, means that there is an urgent need for guidance on explicitly and transparently integrating existing reviews into new systematic reviews. The objectives of this paper are: 1) to identify areas where existing guidance may be adopted or adapted, and 2) to suggest areas for future guidance development. Methods We searched documents and websites from healthcare focused systematic review organizations to identify and, where available, to summarize relevant guidance on the use of existing systematic reviews. We conducted informational interviews with members of Evidence-based Practice Centers (EPCs) to gather experiences in integrating existing systematic reviews, including common issues and challenges, as well as potential solutions. Results There was consensus among systematic review organizations and the EPCs about some aspects of incorporating existing systematic reviews into new reviews. Current guidance may be used in assessing the relevance of prior reviews and in scanning references of prior reviews to identify studies for a new review. However, areas of challenge remain. Areas in need of guidance include how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. For instance, empiric evidence is needed regarding how to quality check data abstraction and when and how to use study-level risk of bias assessments from prior reviews. Conclusions There remain areas of uncertainty for how to integrate existing systematic reviews into new reviews. Methods research and consensus processes among systematic review organizations are needed to develop guidance to address these challenges. PMID:24956937

  1. Identification of technical guidance related to ground water monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.

    1987-05-01

    Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act.

  2. Identification of technical guidance related to ground water monitoring

    International Nuclear Information System (INIS)

    Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.

    1987-05-01

    Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act

  3. Early school leaving and lifelong guidance

    DEFF Research Database (Denmark)

    Plant, Peter; Oomen, Annemarie

    Early school leaving (ESL) is costly for the individual, for society and for the economy. Not just in economic terms, but also in terms of low self esteem, and the risk of social exclusion. More, and, in particular, better education can lead to positive outcomes, in relation to employment, level...... of salaries, better health, less crime, higher social cohesion, lower public and social costs and higher productivity. This is why ESL is a policy focal point. In these terms, lifelong guidance has a key role to play in terms of both prevention, intervention, and of compensation strategies....

  4. Configuration management: Phase II implementation guidance

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    Configuration management (CM) is essential to maintaining an acceptable level of risk to the public, workers, environment, or mission success. It is a set of activities and techniques used to maintain consistency among physical and functional configuration, applicable requirements, and key documents. This document provides guidance for continuing the implementation of CM in a phased and graded manner. It describes a cost-effective approach to documented consistency with requirements, with early emphasis on items most important to safety and environmental protection. It is intended to help responsible line managers and configuration management staff personnel in meeting the Energy Systems configuration management policy standard.

  5. An Approach for Integrating Toxicogenomic Data in Risk Assessment: The Dibutyl Phthalate Case Study

    Science.gov (United States)

    An approach for evaluating and integrating genomic data in chemical risk assessment was developed based on the lessons learned from performing a case study for the chemical dibutyl phthalate. A case study prototype approach was first developed in accordance with EPA guidance and ...

  6. 76 FR 50813 - Major Capital Investment Projects; Guidance on News Starts/Small Starts Policies and Procedures

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF TRANSPORTATION Federal Transit Administration Major Capital Investment Projects; Guidance on News Starts/Small Starts Policies and Procedures AGENCY: Federal Transit Administration (FTA... Administration (FTA) to publish policy guidance on the New and Small Starts capital project review and evaluation...

  7. The evaluation of radiologic methods for access guidance in percutaneous nephrolithotomy: a systematic review of the literature.

    Science.gov (United States)

    Breda, Alberto; Territo, Angelo; Scoffone, Cesare; Seitz, Christian; Knoll, Thomas; Herrmann, Thomas; Brehmer, Mariannhe; Osther, Palle J S; Liatsikos, Evangelos

    2017-11-12

    Percutaneous nephrolithotomy (PNL) is the treatment of choice for larger and complex renal calculi. First step in performing PNL is to obtain access to the renal cavity using either fluoroscopy or ultrasound (US) guidance or a combination of both. Which guiding method to choose is controversial? A systematic review of the literature was performed comparing image guidance modalities for obtaining access in PNL. Evidence acquisition and synthesis: A PubMed, Scopus and Cochrane search for peer-reviewed studies was performed using the keywords "ultrasound" AND "fluoroscopy" AND "Percutaneous nephrolithotomy". Eligible articles were reviewed according to PRISMA criteria. Two hundred and forty records were identified using the keywords. Of these twelve studies were considered relevant. US guidance seems to be associated with a slightly lower complication rate, which may be related to fewer puncture attempts needed for obtaining access and to better peri-renal organ visualization. On the other hand, US-guidance alone needs the adjunct of fluoroscopy in a significant number of cases for achieving access. Stone free rate (SFR) was comparable between groups. Using US for renal access unequivocally reduces radiation exposure. Current evidence indicates that both fluoroscopy and US guidance may be successfully used for obtaining percutaneous renal access. Combining the image-guiding modalities - US and fluoroscopy - seems to increase outcome in PNL both with regard to success in achieving access and reducing complications. Furthermore, including US in the access strategy of PNL reduces radiation exposure to surgeon and staff as well as patients.

  8. Evaluation of alignment error due to a speed artifact in stereotactic ultrasound image guidance

    International Nuclear Information System (INIS)

    Salter, Bill J; Wang, Brian; Szegedi, Martin W; Rassiah-Szegedi, Prema; Shrieve, Dennis C; Cheng, Roger; Fuss, Martin

    2008-01-01

    Ultrasound (US) image guidance systems used in radiotherapy are typically calibrated for soft tissue applications, thus introducing errors in depth-from-transducer representation when used in media with a different speed of sound propagation (e.g. fat). This error is commonly referred to as the speed artifact. In this study we utilized a standard US phantom to demonstrate the existence of the speed artifact when using a commercial US image guidance system to image through layers of simulated body fat, and we compared the results with calculated/predicted values. A general purpose US phantom (speed of sound (SOS) = 1540 m s -1 ) was imaged on a multi-slice CT scanner at a 0.625 mm slice thickness and 0.5 mm x 0.5 mm axial pixel size. Target-simulating wires inside the phantom were contoured and later transferred to the US guidance system. Layers of various thickness (1-8 cm) of commercially manufactured fat-simulating material (SOS = 1435 m s -1 ) were placed on top of the phantom to study the depth-related alignment error. In order to demonstrate that the speed artifact is not caused by adding additional layers on top of the phantom, we repeated these measurements in an identical setup using commercially manufactured tissue-simulating material (SOS = 1540 m s -1 ) for the top layers. For the fat-simulating material used in this study, we observed the magnitude of the depth-related alignment errors resulting from the speed artifact to be 0.7 mm cm -1 of fat imaged through. The measured alignment errors caused by the speed artifact agreed with the calculated values within one standard deviation for all of the different thicknesses of fat-simulating material studied here. We demonstrated the depth-related alignment error due to the speed artifact when using US image guidance for radiation treatment alignment and note that the presence of fat causes the target to be aliased to a depth greater than it actually is. For typical US guidance systems in use today, this will

  9. Evaluation of alignment error due to a speed artifact in stereotactic ultrasound image guidance.

    Science.gov (United States)

    Salter, Bill J; Wang, Brian; Szegedi, Martin W; Rassiah-Szegedi, Prema; Shrieve, Dennis C; Cheng, Roger; Fuss, Martin

    2008-12-07

    Ultrasound (US) image guidance systems used in radiotherapy are typically calibrated for soft tissue applications, thus introducing errors in depth-from-transducer representation when used in media with a different speed of sound propagation (e.g. fat). This error is commonly referred to as the speed artifact. In this study we utilized a standard US phantom to demonstrate the existence of the speed artifact when using a commercial US image guidance system to image through layers of simulated body fat, and we compared the results with calculated/predicted values. A general purpose US phantom (speed of sound (SOS) = 1540 m s(-1)) was imaged on a multi-slice CT scanner at a 0.625 mm slice thickness and 0.5 mm x 0.5 mm axial pixel size. Target-simulating wires inside the phantom were contoured and later transferred to the US guidance system. Layers of various thickness (1-8 cm) of commercially manufactured fat-simulating material (SOS = 1435 m s(-1)) were placed on top of the phantom to study the depth-related alignment error. In order to demonstrate that the speed artifact is not caused by adding additional layers on top of the phantom, we repeated these measurements in an identical setup using commercially manufactured tissue-simulating material (SOS = 1540 m s(-1)) for the top layers. For the fat-simulating material used in this study, we observed the magnitude of the depth-related alignment errors resulting from the speed artifact to be 0.7 mm cm(-1) of fat imaged through. The measured alignment errors caused by the speed artifact agreed with the calculated values within one standard deviation for all of the different thicknesses of fat-simulating material studied here. We demonstrated the depth-related alignment error due to the speed artifact when using US image guidance for radiation treatment alignment and note that the presence of fat causes the target to be aliased to a depth greater than it actually is. For typical US guidance systems in use today, this will

  10. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Science.gov (United States)

    2012-11-23

    ...] Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

  11. Comparison of CT and PET/CT for biopsy guidance in oncological patients

    Energy Technology Data Exchange (ETDEWEB)

    Cerci, Juliano J.; Bogoni, Mateos; Cunha Pereira, Carlos; Cerci, Rodrigo J.; Krauzer, Cassiano; Vicente Vitola, Joao [Quanta - Diagnostico e Terapia, Curitiba, PR (Brazil); Tabacchi, Elena; Fanti, Stefano [University Hospital S. Orsola-Malpighi, Nuclear Medicine Department, Bologna (Italy); Delbeke, Dominique [Vanderbilt University, Nashville, TN (United States); Giacometti Sakamoto, Danielle [Byori - Laboratorio de Patologia, Curitiba (Brazil)

    2017-08-15

    To compare FDG PET/CT and CT for the guidance of percutaneous biopsies with histological confirmation of lesions. We prospectively evaluated 323 patients of whom 181 underwent FDG PET/CT-guided biopsy (total 188 biopsies) and 142 underwent CT-guided biopsy (total 146 biopsies). Biopsies were performed using the same PET/CT scanner with a fluoroscopic imaging system. Technical feasibility, clinical success and complication rates in the two groups were evaluated. Of the 188 biopsies with PET/CT guidance, 182 (96.8%) were successful with conclusive tissue samples obtained and of the 146 biopsies with CT guidance, 137 (93.8%) were successful. Therefore, 6 of 188 biopsies (3.1%) with PET/CT guidance and 9 of 146 (6.1%) with CT guidance were inconclusive (p = 0.19). Due to inconclusive histological results, 4 of the 188 lesions (2.1%) were rebiopsied with PET/CT guidance and 3 of 146 lesions (2.0%) were rebiopsied with CT guidance. Histology demonstrated that 142 of 188 lesions (75.5%) were malignant, and 40 (21.2%) were benign in the PET/CT-guided group, while 89 of 146 lesions (60.9%) were malignant and 48 (32.8%) were benign in the CT-guided group (p = 0.004 and 0.01, respectively). Patients with a histological diagnosis of benign lesion had no recurrence of disease with a minimum of 6 months follow-up. Of the 188 PET/CT-guided biopsies, 6 (3.1%) were repeat biopsies due to a previous nondiagnostic CT-guided biopsy performed in a different diagnostic centre. The interval between the two biopsies was less than a month in all cases. Histology revealed five malignant lesions and one benign lesion among these. The complication rate in the PET/CT-guided biopsy group was 12.7% (24 of 188), while in the CT-guided group, was 9.5% (14 of 146, p = 0.26). Therefore, there was no significant difference in complication rates between PET/CT and CT guidance. PET/CT-guided biopsy is already known to be a feasible and accurate method in the diagnostic work-up of suspected malignant

  12. Comparison of CT and PET/CT for biopsy guidance in oncological patients

    International Nuclear Information System (INIS)

    Cerci, Juliano J.; Bogoni, Mateos; Cunha Pereira, Carlos; Cerci, Rodrigo J.; Krauzer, Cassiano; Vicente Vitola, Joao; Tabacchi, Elena; Fanti, Stefano; Delbeke, Dominique; Giacometti Sakamoto, Danielle

    2017-01-01

    To compare FDG PET/CT and CT for the guidance of percutaneous biopsies with histological confirmation of lesions. We prospectively evaluated 323 patients of whom 181 underwent FDG PET/CT-guided biopsy (total 188 biopsies) and 142 underwent CT-guided biopsy (total 146 biopsies). Biopsies were performed using the same PET/CT scanner with a fluoroscopic imaging system. Technical feasibility, clinical success and complication rates in the two groups were evaluated. Of the 188 biopsies with PET/CT guidance, 182 (96.8%) were successful with conclusive tissue samples obtained and of the 146 biopsies with CT guidance, 137 (93.8%) were successful. Therefore, 6 of 188 biopsies (3.1%) with PET/CT guidance and 9 of 146 (6.1%) with CT guidance were inconclusive (p = 0.19). Due to inconclusive histological results, 4 of the 188 lesions (2.1%) were rebiopsied with PET/CT guidance and 3 of 146 lesions (2.0%) were rebiopsied with CT guidance. Histology demonstrated that 142 of 188 lesions (75.5%) were malignant, and 40 (21.2%) were benign in the PET/CT-guided group, while 89 of 146 lesions (60.9%) were malignant and 48 (32.8%) were benign in the CT-guided group (p = 0.004 and 0.01, respectively). Patients with a histological diagnosis of benign lesion had no recurrence of disease with a minimum of 6 months follow-up. Of the 188 PET/CT-guided biopsies, 6 (3.1%) were repeat biopsies due to a previous nondiagnostic CT-guided biopsy performed in a different diagnostic centre. The interval between the two biopsies was less than a month in all cases. Histology revealed five malignant lesions and one benign lesion among these. The complication rate in the PET/CT-guided biopsy group was 12.7% (24 of 188), while in the CT-guided group, was 9.5% (14 of 146, p = 0.26). Therefore, there was no significant difference in complication rates between PET/CT and CT guidance. PET/CT-guided biopsy is already known to be a feasible and accurate method in the diagnostic work-up of suspected malignant

  13. Quality in career guidance: The Danish case

    DEFF Research Database (Denmark)

    Plant, Peter

    2011-01-01

    Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach......Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach...

  14. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Science.gov (United States)

    2012-06-11

    ... recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in..., submit either electronic or written comments on the draft guidance by September 10, 2012. ADDRESSES... electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http...

  15. 75 FR 54637 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-09-08

    ... conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH... approval) into class II (special controls). DATES: Submit written or electronic comments on this guidance... electronic access to the guidance. Submit electronic comments on the guidance to http://www.regulations.gov...

  16. Seamless Guidance System Combining GPS, BLE Beacon, and NFC Technologies

    Directory of Open Access Journals (Sweden)

    Rung-Shiang Cheng

    2016-01-01

    Full Text Available Users rely increasingly on Location-Based Services (LBS and automated navigation/guidance systems nowadays. However, while such services are easily implemented in outdoor environments using Global Positioning System (GPS technology, a requirement still exists for accurate localization and guidance schemes in indoor settings. Accordingly, the present study proposes a system based on GPS, Bluetooth Low Energy (BLE beacons, and Near Field Communication (NFC technology. Through establishing graphic information and the design of algorithm, this study develops a guidance system for indoors and outdoors on smart phones, wishing to give user perfect smart life through this system. The proposed system is implemented on a smart phone and evaluated on a student campus environment. The experimental results confirm the ability of the proposed app to switch automatically from an outdoor mode to an indoor mode and to guide the user to requested target destination via the shortest possible route.

  17. Lifelong guidance: How guidance and counselling support lifelong learning in the contrasting contexts of China and Denmark

    Science.gov (United States)

    Zhang, Zhixin

    2016-10-01

    Due to the effects of globalisation and rapid technological development, traditional linear life course patterns of the past are gradually disappearing, and this affects education and learning systems as well as labour markets. Individuals are forced to develop lifestyles and survival strategies to manage job insecurity and make their skills and interests meet labour market needs. In modern attempts to develop and implement institutional provision for lifelong learning, guidance and counselling play an important role. The current Danish guidance system is well-organised, highly structured and professionalised. By contrast, Chinese guidance is still fragmented and "sectorisational". This paper explores whether elements of the highly structured and professionalised Danish guidance system and practice might be applicable to the Chinese context. The author begins by outlining international and national factors which are affecting citizens' life and career planning. She then presents and discusses the evolution of guidance and the different elements of provision in each of the two countries. Next, She compares the concepts and goals of "lifelong guidance" in Denmark and China, pointing out their similarities and differences and their respective strengths and weaknesses. The paper concludes with some suggestions for the further development of guidance in China.

  18. Euro Chlor risk assessment for the marine environment Osparcom region, North Sea

    International Nuclear Information System (INIS)

    Garny, V.; Lecloux, A.; Boutonnet, J.C.; Papp, R.; De Rooij, C.; Thompson, R.S.; Wijk, D. van

    1999-01-01

    Euro Chlor has voluntarily agreed to carry out environmental risk assessments of 25 chemicals, related to the chlorine industry. The assessments were carried out specifically for the marine environment, according to the methodology laid down in the EU risk assessment Regulation (1488/94) and the Guidance Document of the EU New and Existing Substances Regulation (TGD, 1997). The study consists of the collection and evaluation of data on effects and environmental concentrations

  19. Video-Guidance Design for the DART Rendezvous Mission

    Science.gov (United States)

    Ruth, Michael; Tracy, Chisholm

    2004-01-01

    NASA's Demonstration of Autonomous Rendezvous Technology (DART) mission will validate a number of different guidance technologies, including state-differenced GPS transfers and close-approach video guidance. The video guidance for DART will employ NASA/Marshall s Advanced Video Guidance Sensor (AVGS). This paper focuses on the terminal phase of the DART mission that includes close-approach maneuvers under AVGS guidance. The closed-loop video guidance design for DART is driven by a number of competing requirements, including a need for maximizing tracking bandwidths while coping with measurement noise and the need to minimize RCS firings. A range of different strategies for attitude control and docking guidance have been considered for the DART mission, and design decisions are driven by a goal of minimizing both the design complexity and the effects of video guidance lags. The DART design employs an indirect docking approach, in which the guidance position targets are defined using relative attitude information. Flight simulation results have proven the effectiveness of the video guidance design.

  20. 78 FR 4150 - Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance

    Science.gov (United States)

    2013-01-18

    ... for predicting whether these particles pose a risk of adverse health effects and for providing...) Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2013-0001...

  1. Threshold guidance update

    International Nuclear Information System (INIS)

    Wickham, L.E.

    1986-01-01

    The Department of Energy (DOE) is developing the concept of threshold quantities for use in determining which waste materials must be handled as radioactive waste and which may be disposed of as nonradioactive waste at its sites. Waste above this concentration level would be managed as radioactive or mixed waste (if hazardous chemicals are present); waste below this level would be handled as sanitary waste. Last years' activities (1984) included the development of a threshold guidance dose, the development of threshold concentrations corresponding to the guidance dose, the development of supporting documentation, review by a technical peer review committee, and review by the DOE community. As a result of the comments, areas have been identified for more extensive analysis, including an alternative basis for selection of the guidance dose and the development of quality assurance guidelines. Development of quality assurance guidelines will provide a reasonable basis for determining that a given waste stream qualifies as a threshold waste stream and can then be the basis for a more extensive cost-benefit analysis. The threshold guidance and supporting documentation will be revised, based on the comments received. The revised documents will be provided to DOE by early November. DOE-HQ has indicated that the revised documents will be available for review by DOE field offices and their contractors

  2. HOW INTERNAL RISK - BASED AUDIT APPRAISES THE EVALUATION OF RISKS MANAGEMENT

    Directory of Open Access Journals (Sweden)

    N. Dorosh

    2017-09-01

    Full Text Available The article deals with the nature and function of the internal risk-based audit process approach to create patterns of risks and methods of evaluation. Deals with the relationship between the level of maturity of the risk of the company and the method of risk-based internal audit. it was emphasized that internal auditing provides an independent and objective opinion to an organization’s management as to whether its risks are being managed to acceptable levels.

  3. Equipment design guidance document for flammable gas waste storage tank new equipment

    International Nuclear Information System (INIS)

    Smet, D.B.

    1996-01-01

    This document is intended to be used as guidance for design engineers who are involved in design of new equipment slated for use in Flammable Gas Waste Storage Tanks. The purpose of this document is to provide design guidance for all new equipment intended for application into those Hanford storage tanks in which flammable gas controls are required to be addressed as part of the equipment design. These design criteria are to be used as guidance. The design of each specific piece of new equipment shall be required, as a minimum to be reviewed by qualified Unreviewed Safety Question evaluators as an integral part of the final design approval. Further Safety Assessment may be also needed. This guidance is intended to be used in conjunction with the Operating Specifications Documents (OSDs) established for defining work controls in the waste storage tanks. The criteria set forth should be reviewed for applicability if the equipment will be required to operate in locations containing unacceptable concentrations of flammable gas

  4. EVALUATION AND INTERPRETATION OF NEURODEVELOPMENTAL ENDPOINTS FOR HUMAN HEALTH RISK ASSESSMENT -- POSITIVE CONTROL STUDIES, NORMAL VARIABILITY AND STATISTICAL ISSUES.

    Science.gov (United States)

    ILSI Research Foundation/Risk Science Institute convened an expert working group to assess the lessons learned from the implementation of the EPA Developmental Neurotoxicity (DNT) Guideline and provide guidance for future use. The group prepared manuscripts in five areas: public ...

  5. At-Risk Youth Appearance and Job Performance Evaluation

    Science.gov (United States)

    Freeburg, Beth Winfrey; Workman, Jane E.

    2008-01-01

    The goal of this study was to identify the relationship of at-risk youth workplace appearance to other job performance criteria. Employers (n = 30; each employing from 1 to 17 youths) evaluated 178 at-risk high school youths who completed a paid summer employment experience. Appearance evaluations were significantly correlated with evaluations of…

  6. A hybrid optical system for broadband imaging in guidance and control

    Science.gov (United States)

    Wu, Xiaofang; Jiang, Yuesong; Shen, Chunyan; Zhao, Yiming

    2006-11-01

    A binary optics method has been adopted to improve upon a conventional optical system in guidance and control, and a hybrid broadband imaging system that includes a binary surface is analyzed and evaluated by optical design software ZEMAX. The practical design shows that the introduction of binary optics can simplify the structure of the imaging system and reduce the size and weight of the broadband guidance and control system. Moreover, it can help to acquire images of radiation of different wavelengths from targets; hence it will result in improved overall performance of missiles in wars.

  7. Silica dust control in small-scale building/structure demolition operations using good work practice guidance

    International Nuclear Information System (INIS)

    Muianga, C V; Rice, C H; Succop, P

    2009-01-01

    Work practices can influence exposure, especially in small-scale operations conducted by mobile work crews. This study evaluated the use of information on good work practice in control guidance sheets adapted from UK Silica Essentials guidance sheets by trained workers and supervisors employed in small-scale concrete and masonry demolition operations. A one-page employee silica task-based control guidance sheet for each of four demolition tasks and multiple-page silica control guidance for supervisors were developed. Interactive, hands-on worker training on these task-based good work practice controls was developed. Training was presented to 26 participants from two demolition crews. Feedback on the training and task-based good work practice control guidance sheets was elicited. Observations of work practices were made before and after training. Participants indicated gains in knowledge and checklists were used to document skill attainment. The quality of the training and usefulness of the material/skills was rated high by trainees. Increased use of water to suppress dust and wet cleaning methods on the job were documented following the training. Additional follow-up after training is required to determine long-term impact on sustained changes in work practices, and to evaluate the need for refresher training.

  8. Silica dust control in small-scale building/structure demolition operations using good work practice guidance

    Science.gov (United States)

    Muianga, C. V.; Rice, C. H.; Succop, P.

    2009-02-01

    Work practices can influence exposure, especially in small-scale operations conducted by mobile work crews. This study evaluated the use of information on good work practice in control guidance sheets adapted from UK Silica Essentials guidance sheets by trained workers and supervisors employed in small-scale concrete and masonry demolition operations. A one-page employee silica task-based control guidance sheet for each of four demolition tasks and multiple-page silica control guidance for supervisors were developed. Interactive, hands-on worker training on these task-based good work practice controls was developed. Training was presented to 26 participants from two demolition crews. Feedback on the training and task-based good work practice control guidance sheets was elicited. Observations of work practices were made before and after training. Participants indicated gains in knowledge and checklists were used to document skill attainment. The quality of the training and usefulness of the material/skills was rated high by trainees. Increased use of water to suppress dust and wet cleaning methods on the job were documented following the training. Additional follow-up after training is required to determine long-term impact on sustained changes in work practices, and to evaluate the need for refresher training.

  9. A Formal Investigation of the Organization of Guidance Behavior: Implications for Humans and Autonomous Guidance

    Science.gov (United States)

    Kong, Zhaodan

    Guidance behavior generated either by artificial agents or humans has been actively studied in the fields of both robotics and cognitive science. The goals of these two fields are different. The former is the automatic generation of appropriate or even optimal behavior, while the latter is the understanding of the underlying mechanism. Their challenges, though, are closely related, the most important one being the lack of a unified, formal and grounded framework where the guidance behavior can be modeled and studied. This dissertation presents such a framework. In this framework, guidance behavior is analyzed as the closed-loop dynamics of the whole agent-environment system. The resulting dynamics give rise to interaction patterns. The central points of this dissertation are that: first of all, these patterns, which can be explained in terms of symmetries that are inherent to the guidance behavior, provide building blocks for the organization of behavior; second, the existence of these patterns and humans' organization of their guidance behavior based on these patterns are the reasons that humans can generate successful behavior in spite of all the complexities involved in the planning and control. This dissertation first gives an overview of the challenges existing in both scientific endeavors, such as human and animal spatial behavior study, and engineering endeavors, such as autonomous guidance system design. It then lays out the foundation for our formal framework, which states that guidance behavior should be interpreted as the collection of the closed-loop dynamics resulting from the agent's interaction with the environment. The following, illustrated by examples of three different UAVs, shows that the study of the closed-loop dynamics should not be done without the consideration of vehicle dynamics, as is the common practice in some of the studies in both autonomous guidance and human behavior analysis. The framework, the core concepts of which are

  10. Treatment of calculus of upper urinary tract with mini-percutaneous nephrolithotomy under ultrasound guidance

    International Nuclear Information System (INIS)

    Gao Feng; Ye Chunhua; Wang Kanger; Sun Yan

    2009-01-01

    Objective: To evaluate the feasibility and availability of minimally invasive percutaneous nephrolithotomy (MPCNL) under ultrasound guidance for treatment of calculus of upper urinary tract. Methods: The clinical data of 48 cases with calculus of upper urinary tract undergoing MPCNL were reviewed. Results: In 48 cases, cutaneous-nephric passages were successfully constructed by ultrasound guidance, stone-free rate was 90%. The average operation time was 90 minutes, the average hospitalization was 8 days. No major complications were noted. Conclusion: Under ultrasound guidance, MPCNL with holmium laser is a simply, safe and effective method for treating calculus of upper urinary tract. (authors)

  11. Development and evaluation of probability density functions for a set of human exposure factors

    Energy Technology Data Exchange (ETDEWEB)

    Maddalena, R.L.; McKone, T.E.; Bodnar, A.; Jacobson, J.

    1999-06-01

    The purpose of this report is to describe efforts carried out during 1998 and 1999 at the Lawrence Berkeley National Laboratory to assist the U.S. EPA in developing and ranking the robustness of a set of default probability distributions for exposure assessment factors. Among the current needs of the exposure-assessment community is the need to provide data for linking exposure, dose, and health information in ways that improve environmental surveillance, improve predictive models, and enhance risk assessment and risk management (NAS, 1994). The U.S. Environmental Protection Agency (EPA) Office of Emergency and Remedial Response (OERR) plays a lead role in developing national guidance and planning future activities that support the EPA Superfund Program. OERR is in the process of updating its 1989 Risk Assessment Guidance for Superfund (RAGS) as part of the EPA Superfund reform activities. Volume III of RAGS, when completed in 1999 will provide guidance for conducting probabilistic risk assessments. This revised document will contain technical information including probability density functions (PDFs) and methods used to develop and evaluate these PDFs. The PDFs provided in this EPA document are limited to those relating to exposure factors.

  12. Development and evaluation of probability density functions for a set of human exposure factors

    International Nuclear Information System (INIS)

    Maddalena, R.L.; McKone, T.E.; Bodnar, A.; Jacobson, J.

    1999-01-01

    The purpose of this report is to describe efforts carried out during 1998 and 1999 at the Lawrence Berkeley National Laboratory to assist the U.S. EPA in developing and ranking the robustness of a set of default probability distributions for exposure assessment factors. Among the current needs of the exposure-assessment community is the need to provide data for linking exposure, dose, and health information in ways that improve environmental surveillance, improve predictive models, and enhance risk assessment and risk management (NAS, 1994). The U.S. Environmental Protection Agency (EPA) Office of Emergency and Remedial Response (OERR) plays a lead role in developing national guidance and planning future activities that support the EPA Superfund Program. OERR is in the process of updating its 1989 Risk Assessment Guidance for Superfund (RAGS) as part of the EPA Superfund reform activities. Volume III of RAGS, when completed in 1999 will provide guidance for conducting probabilistic risk assessments. This revised document will contain technical information including probability density functions (PDFs) and methods used to develop and evaluate these PDFs. The PDFs provided in this EPA document are limited to those relating to exposure factors

  13. A high-fidelity, six-degree-of-freedom batch simulation environment for tactical guidance research and evaluation

    Science.gov (United States)

    Goodrich, Kenneth H.

    1993-01-01

    A batch air combat simulation environment, the tactical maneuvering simulator (TMS), is presented. The TMS is a tool for developing and evaluating tactical maneuvering logics, but it can also be used to evaluate the tactical implications of perturbations to aircraft performance or supporting systems. The TMS can simulate air combat between any number of engagement participants, with practical limits imposed by computer memory and processing power. Aircraft are modeled using equations of motion, control laws, aerodynamics, and propulsive characteristics equivalent to those used in high-fidelity piloted simulations. Data bases representative of a modern high-performance aircraft with and without thrust-vectoring capability are included. To simplify the task of developing and implementing maneuvering logics in the TMS, an outer-loop control system, the tactical autopilot (TA), is implemented in the aircraft simulation model. The TA converts guidance commands by computerized maneuvering logics from desired angle of attack and wind-axis bank-angle inputs to the inner loop control augmentation system of the aircraft. The capabilities and operation of the TMS and the TA are described.

  14. Quality Assurance in University Guidance Services

    Science.gov (United States)

    Simon, Alexandra

    2014-01-01

    In Europe there is no common quality assurance framework for the delivery of guidance in higher education. Using a case study approach in four university career guidance services in England, France and Spain, this article aims to study how quality is implemented in university career guidance services in terms of strategy, standards and models,…

  15. Screening-Level Ecological Risk Assessment Methods, Revision 3

    Energy Technology Data Exchange (ETDEWEB)

    Mirenda, Richard J. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2012-08-16

    This document provides guidance for screening-level assessments of potential adverse impacts to ecological resources from release of environmental contaminants at the Los Alamos National Laboratory (LANL or the Laboratory). The methods presented are based on two objectives, namely: to provide a basis for reaching consensus with regulators, managers, and other interested parties on how to conduct screening-level ecological risk investigations at the Laboratory; and to provide guidance for ecological risk assessors under the Environmental Programs (EP) Directorate. This guidance promotes consistency, rigor, and defensibility in ecological screening investigations and in reporting those investigation results. The purpose of the screening assessment is to provide information to the risk managers so informed riskmanagement decisions can be made. This document provides examples of recommendations and possible risk-management strategies.

  16. Advanced approach for intraoperative MRI guidance and potential benefit for neurosurgical applications.

    Science.gov (United States)

    Busse, Harald; Schmitgen, Arno; Trantakis, Christos; Schober, Ralf; Kahn, Thomas; Moche, Michael

    2006-07-01

    To present an advanced approach for intraoperative image guidance in an open 0.5 T MRI and to evaluate its effectiveness for neurosurgical interventions by comparison with a dynamic scan-guided localization technique. The built-in scan guidance mode relied on successive interactive MRI scans. The additional advanced mode provided real-time navigation based on reformatted high-quality, intraoperatively acquired MR reference data, allowed multimodal image fusion, and used the successive scans of the built-in mode for quick verification of the position only. Analysis involved tumor resections and biopsies in either scan guidance (N = 36) or advanced mode (N = 59) by the same three neurosurgeons. Technical, surgical, and workflow aspects were compared. The image quality and hand-eye coordination of the advanced approach were improved. While the average extent of resection, neurologic outcome after functional MRI (fMRI) integration, and diagnostic yield appeared to be slightly better under advanced guidance, particularly for the main surgeon, statistical analysis revealed no significant differences. Resection times were comparable, while biopsies took around 30 minutes longer. The presented approach is safe and provides more detailed images and higher navigation speed at the expense of actuality. The surgical outcome achieved with advanced guidance is (at least) as good as that obtained with dynamic scan guidance. (c) 2006 Wiley-Liss, Inc.

  17. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-02

    .... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0971...

  18. Providing Career Guidance for Young Women.

    Science.gov (United States)

    Colby, Pamela G.

    This module is directed at personnel working or planning to work in the areas of guidance, counseling, placement and follow-through in junior and senior high school settings, grades 7-12. The module topic is career guidance for young women of junior and senior high school age, aand the focus will be on providing nonbiased career guidance which…

  19. Modified risk evaluation method

    International Nuclear Information System (INIS)

    Udell, C.J.; Tilden, J.A.; Toyooka, R.T.

    1993-08-01

    The purpose of this paper is to provide a structured and cost-oriented process to determine risks associated with nuclear material and other security interests. Financial loss is a continuing concern for US Department of Energy contractors. In this paper risk is equated with uncertainty of cost impacts to material assets or human resources. The concept provides a method for assessing the effectiveness of an integrated protection system, which includes operations, safety, emergency preparedness, and safeguards and security. The concept is suitable for application to sabotage evaluations. The protection of assets is based on risk associated with cost impacts to assets and the potential for undesirable events. This will allow managers to establish protection priorities in terms of the cost and the potential for the event, given the current level of protection

  20. ICRP guidance on radioactive waste disposal

    International Nuclear Information System (INIS)

    Cooper, J.R.

    2002-01-01

    The International Commission on Radiological Protection (ICRP) issued recommendations for a system of radiological protection in 1991 as the 1990 Recommendations. Guidance on the application of these recommendations in the general area of waste disposal was issued in 1997 as Publication 77 and guidance specific to disposal of solid long-lived radioactive waste was issued as Publication 81. This paper summarises ICRP guidance in radiological protection requirements for waste disposal concentrating on the ones of relevance to the geological disposal of solid radioactive waste. Suggestions are made for areas where further work is required to apply the ICRP guidance. (author)

  1. Risk Classification and Risk-based Safety and Mission Assurance

    Science.gov (United States)

    Leitner, Jesse A.

    2014-01-01

    Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.

  2. Clinical application of transnasal feeding tube placement under fluoroscopic guidance

    International Nuclear Information System (INIS)

    Ge Kunyuan; Ni Caifang; Liu Yizhi; Zhu Xiaoli; Zou Jianwei; Jin Yonghai; Chen Long; Sun Ge; Sun Lingfang; Zhang Dong

    2008-01-01

    Objective: To evaluate the feasibility and effectiveness of duodenal feeding tube placement under fluoroscopic guidance and its clinical application. Methods: The transnasal duodenal nutriment tubes placement under fluoroscopic guidance were performed in 59 patients from June 3th, 2003 to August 17th, 2007. The successful placement of the feeding tube was defined as that of the tube tip was fixed at or distal to the duodenojejunal junction. Results: 57 out of 59 patients were successfully managed by feeding tube placement, with primary successful rate of 96.6% (57/59). The remaining two failures were due to overdistention of the stomach and were further managed after gastrointestinal decompression thoroughly. The mean fluoroscopy time of the procedure was 17.8 minutes with no severe immediate or delayed complications. Conclusion: The transnasal duodenal nutrient feeding tube placement under fluoroscopic guidance is a safe,economic, and effective management for enteral nutrition, providing extensive clinical utilization. (authors)

  3. Regulatory Forum commentary: alternative mouse models for future cancer risk assessment.

    Science.gov (United States)

    Morton, Daniel; Sistare, Frank D; Nambiar, Prashant R; Turner, Oliver C; Radi, Zaher; Bower, Nancy

    2014-07-01

    International regulatory and pharmaceutical industry scientists are discussing revision of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) S1 guidance on rodent carcinogenicity assessment of small molecule pharmaceuticals. A weight-of-evidence approach is proposed to determine the need for rodent carcinogenicity studies. For compounds with high human cancer risk, the product may be labeled appropriately without conducting rodent carcinogenicity studies. For compounds with minimal cancer risk, only a 6-month transgenic mouse study (rasH2 mouse or p53+/- mouse) or a 2-year mouse study would be needed. If rodent carcinogenicity testing may add significant value to cancer risk assessment, a 2-year rat study and either a 6-month transgenic mouse or a 2-year mouse study is appropriate. In many cases, therefore, one rodent carcinogenicity study could be sufficient. The rasH2 model predicts neoplastic findings relevant to human cancer risk assessment as well as 2-year rodent models, produces fewer irrelevant neoplastic outcomes, and often will be preferable to a 2-year rodent study. Before revising ICH S1 guidance, a prospective evaluation will be conducted to test the proposed weight-of-evidence approach. This evaluation offers an opportunity for a secondary analysis comparing the value of alternative mouse models and 2-year rodent studies in the proposed ICH S1 weight-of-evidence approach for human cancer risk assessment. © 2014 by The Author(s).

  4. Twelve recommendations for integrating existing systematic reviews into new reviews: EPC guidance.

    Science.gov (United States)

    Robinson, Karen A; Chou, Roger; Berkman, Nancy D; Newberry, Sydne J; Fu, Rongwei; Hartling, Lisa; Dryden, Donna; Butler, Mary; Foisy, Michelle; Anderson, Johanna; Motu'apuaka, Makalapua; Relevo, Rose; Guise, Jeanne-Marie; Chang, Stephanie

    2016-02-01

    As time and cost constraints in the conduct of systematic reviews increase, the need to consider the use of existing systematic reviews also increases. We developed guidance on the integration of systematic reviews into new reviews. A workgroup of methodologists from Evidence-based Practice Centers developed consensus-based recommendations. Discussions were informed by a literature scan and by interviews with organizations that conduct systematic reviews. Twelve recommendations were developed addressing selecting reviews, assessing risk of bias, qualitative and quantitative synthesis, and summarizing and assessing body of evidence. We provide preliminary guidance for an efficient and unbiased approach to integrating existing systematic reviews with primary studies in a new review. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Guidance at the educational marketplace

    DEFF Research Database (Denmark)

    Lystbæk, Christian Tang

    in educational policies and institutions. As educational systems have expanded and, further, have been restructured with the expansion of choice opportunities since the 1980s, guidance has become prioritized as a form of counseling or coaching, which can support students. Thus, guidance has become an important...... `agent´ on the educational "market´, assisting (potential) students into and around the `marketplace´. Consequently, guidance is also an important `agent´ for educational institutions that increasingly use marketing strategies to promote themselves on the market to attract and hold on to their “customers......” in order for the institutions to increase their ´market value´, `sales” and “turnover”. Thus, the expansion of guidance is nurtured by the expansion of the logic of marketization and consumerism. Drawing on Foucauldian perspectives in educational research, which highlight the expansion of powerful...

  6. Revising REACH guidance on information requirements and chemical safety assessment for engineered nanomaterials for aquatic ecotoxicity endpoints: recommendations from the EnvNano project

    DEFF Research Database (Denmark)

    Hansen, Steffen Foss; Sørensen, Sara Nørgaard; Skjolding, Lars Michael

    2017-01-01

    be made applicable to nanomaterials. European Research Council project EnvNano—Environmental Effects and Risk Evaluation of Engineered, which ran from 2011 to 2016, took another outset by assuming that: “The behaviour of nanoparticles in suspension is fundamentally different from that of chemicals......The European Chemical Agency (ECHA) is in the process of revising its guidance documents on how to address the challenges of ecotoxicological testing of nanomaterials. In these revisions, outset is taken in the hypothesis that ecotoxicological test methods, developed for soluble chemicals, can...... in solution”. The aim of this paper is to present the findings of the EnvNano project and through these provide the scientific background for specific recommendations on how ECHA guidance could be further improved. Key EnvNano findings such as the need to characterize dispersion and dissolution rates in stock...

  7. Guidance for modeling causes and effects in environmental problem solving

    Science.gov (United States)

    Armour, Carl L.; Williamson, Samuel C.

    1988-01-01

    Environmental problems are difficult to solve because their causes and effects are not easily understood. When attempts are made to analyze causes and effects, the principal challenge is organization of information into a framework that is logical, technically defensible, and easy to understand and communicate. When decisionmakers attempt to solve complex problems before an adequate cause and effect analysis is performed there are serious risks. These risks include: greater reliance on subjective reasoning, lessened chance for scoping an effective problem solving approach, impaired recognition of the need for supplemental information to attain understanding, increased chance for making unsound decisions, and lessened chance for gaining approval and financial support for a program/ Cause and effect relationships can be modeled. This type of modeling has been applied to various environmental problems, including cumulative impact assessment (Dames and Moore 1981; Meehan and Weber 1985; Williamson et al. 1987; Raley et al. 1988) and evaluation of effects of quarrying (Sheate 1986). This guidance for field users was written because of the current interest in documenting cause-effect logic as a part of ecological problem solving. Principal literature sources relating to the modeling approach are: Riggs and Inouye (1975a, b), Erickson (1981), and United States Office of Personnel Management (1986).

  8. Consumer Evaluations of Food Risk Management Quality in Europe

    NARCIS (Netherlands)

    Kleef, van E.; Houghton, J.R.; Krystallis, A.; Pfenning, U.; Rowe, G.; Dijk, van H.; Lans, van der I.A.; Frewer, L.J.

    2007-01-01

    In developing and implementing appropriate food risk management strategies, it is important to understand how consumers evaluate the quality of food risk management practices. The aim of this study is to model the underlying psychological factors influencing consumer evaluations of food risk

  9. Regulatory guidance for license renewal

    International Nuclear Information System (INIS)

    Thoma, John A.

    1991-01-01

    The proposed 10 CFR Part 54 rule proceduralizes the process for license renewal by identifying both the administrative and technical requirements for a renewal application. To amplify and support this regulation, written guidance has been provided in the form of a draft Regulatory Guide (DG 1009) and a draft Standard Review Plan for License Renewal (NUREG 1299). This guidance is scheduled to be finalized in 1992. Similar guidance will be provided for the proposed revisions to 10 CFR Part 51 concerning the environmental aspects of license renewal. (author)

  10. Baseline risk evaluation for exposure to bulk wastes at the Weldon Spring Quarry, Weldon Spring, Missouri

    International Nuclear Information System (INIS)

    Haroun, L.A.; Peterson, J.M.; MacDonell, M.M.; Hlohowskyj, I.

    1990-01-01

    The US Department of Energy (DOE), under its Surplus Facilities Management Program (SFMP), is responsible for cleanup activities at the Weldon Spring site, Weldon Spring, Missouri. The site consists of a raffinate pits and chemical plant area and a quarry. This baseline risk evaluation has been prepared to support a proposed response action for management of contaminated bulk wastes in the quarry. The quarry became chemically and radioactively contaminated as a result of various wastes that were disposed of there between 1942 and 1969. This risk evaluation assesses potential impacts on human health and the environment that may result from exposure to releases of contaminants from the quarry under current site conditions. Risk assessment is a key component of the remedial investigation/feasibility study (RI/FS) process, as identified in guidance from the US Environmental Protection Agency (EPA); this process addresses sites subject to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended by the Superfund Amendments and Reauthorization Act of 1986. Response actions at the Weldon Spring quarry are subject to CERCLA requirements because the quarry is listed on the EPA's National Priorities List. The DOE is also responsible for complying with the requirements of the National Environmental Policy Act (NEPA) of 1969, which requires federal agencies to consider the environmental consequences of a proposed action as part of the decision-making process for that action. Although this document has not been prepared to fulfill specific NEPA requirements, the analyses contained herein --- along with the analyses provided in the remedial investigation, feasibility study, and other supporting documents --- are intended to meet the environmental assessment requirements of NEPA

  11. Gasbuggy Site Assessment and Risk Evaluation

    Energy Technology Data Exchange (ETDEWEB)

    None

    2011-03-01

    This report describes the geologic and hydrologic conditions and evaluates potential health risks to workers in the natural gas industry in the vicinity of the Gasbuggy, New Mexico, site, where the U.S. Atomic Energy Commission detonated an underground nuclear device in 1967. The 29-kiloton detonation took place 4,240 feet below ground surface and was designed to evaluate the use of a nuclear detonation to enhance natural gas production from the Pictured Cliffs Formation in the San Juan Basin, Rio Arriba County, New Mexico, on land administered by Carson National Forest. A site-specific conceptual model was developed based on current understanding of the hydrologic and geologic environment. This conceptual model was used for establishing plausible contaminant exposure scenarios, which were then evaluated for human health risk potential. The most mobile and, therefore, the most probable contaminant that could result in human exposure is tritium. Natural gas production wells were identified as having the greatest potential for bringing detonation-derived contaminants (tritium) to the ground surface in the form of tritiated produced water. Three exposure scenarios addressing potential contamination from gas wells were considered in the risk evaluation: a gas well worker during gas-well-drilling operations, a gas well worker performing routine maintenance, and a residential exposure. The residential exposure scenario was evaluated only for comparison; permanent residences on national forest lands at the Gasbuggy site are prohibited

  12. Evaluating emergency risk communications: a dialogue with the experts.

    Science.gov (United States)

    Thomas, Craig W; Vanderford, Marsha L; Crouse Quinn, Sandra

    2008-10-01

    Evaluating emergency risk communications is fraught with challenges since communication can be approached from both a systemic and programmatic level. Therefore, one must consider stakeholders' perspectives, effectiveness issues, standards of evidence and utility, and channels of influence (e.g., mass media and law enforcement). Evaluation issues related to timing, evaluation questions, methods, measures, and accountability are raised in this dialogue with emergency risk communication specialists. Besides the usual evaluation competencies, evaluators in this area need to understand and work collaboratively with stakeholders and be attuned to the dynamic contextual nature of emergency risk communications. Sample resources and measures are provided here to aid in this emerging and exciting field of evaluation.

  13. Mobile C-arm cone-beam CT for guidance of spine surgery: Image quality, radiation dose, and integration with interventional guidance

    Energy Technology Data Exchange (ETDEWEB)

    Schafer, S.; Nithiananthan, S.; Mirota, D. J.; Uneri, A.; Stayman, J. W.; Zbijewski, W.; Schmidgunst, C.; Kleinszig, G.; Khanna, A. J.; Siewerdsen, J. H. [Department of Biomedical Engineering, Johns Hopkins University, Baltimore, Maryland 21202 (United States); Department of Computer Science, Johns Hopkins University, Baltimore, Maryland 21218 (United States); Department of Biomedical Engineering, Johns Hopkins University, Baltimore, Maryland 21202 (United States); Siemens Healthcare XP Division, Erlangen (Germany); Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, Maryland 21239 (United States); Department of Biomedical Engineering, Johns Hopkins University, Baltimore, Maryland 21202 and Department of Computer Science, Johns Hopkins University, Baltimore, Maryland 21218 (United States)

    2011-08-15

    Purpose: A flat-panel detector based mobile isocentric C-arm for cone-beam CT (CBCT) has been developed to allow intraoperative 3D imaging with sub-millimeter spatial resolution and soft-tissue visibility. Image quality and radiation dose were evaluated in spinal surgery, commonly relying on lower-performance image intensifier based mobile C-arms. Scan protocols were developed for task-specific imaging at minimum dose, in-room exposure was evaluated, and integration of the imaging system with a surgical guidance system was demonstrated in preclinical studies of minimally invasive spine surgery. Methods: Radiation dose was assessed as a function of kilovolt (peak) (80-120 kVp) and milliampere second using thoracic and lumbar spine dosimetry phantoms. In-room radiation exposure was measured throughout the operating room for various CBCT scan protocols. Image quality was assessed using tissue-equivalent inserts in chest and abdomen phantoms to evaluate bone and soft-tissue contrast-to-noise ratio as a function of dose, and task-specific protocols (i.e., visualization of bone or soft-tissues) were defined. Results were applied in preclinical studies using a cadaveric torso simulating minimally invasive, transpedicular surgery. Results: Task-specific CBCT protocols identified include: thoracic bone visualization (100 kVp; 60 mAs; 1.8 mGy); lumbar bone visualization (100 kVp; 130 mAs; 3.2 mGy); thoracic soft-tissue visualization (100 kVp; 230 mAs; 4.3 mGy); and lumbar soft-tissue visualization (120 kVp; 460 mAs; 10.6 mGy) - each at (0.3 x 0.3 x 0.9 mm{sup 3}) voxel size. Alternative lower-dose, lower-resolution soft-tissue visualization protocols were identified (100 kVp; 230 mAs; 5.1 mGy) for the lumbar region at (0.3 x 0.3 x 1.5 mm{sup 3}) voxel size. Half-scan orbit of the C-arm (x-ray tube traversing under the table) was dosimetrically advantageous (prepatient attenuation) with a nonuniform dose distribution ({approx}2 x higher at the entrance side than at isocenter

  14. Evaluation of wholesale electric power market rules and financial risk management by agent-based simulations

    Science.gov (United States)

    Yu, Nanpeng

    As U.S. regional electricity markets continue to refine their market structures, designs and rules of operation in various ways, two critical issues are emerging. First, although much experience has been gained and costly and valuable lessons have been learned, there is still a lack of a systematic platform for evaluation of the impact of a new market design from both engineering and economic points of view. Second, the transition from a monopoly paradigm characterized by a guaranteed rate of return to a competitive market created various unfamiliar financial risks for various market participants, especially for the Investor Owned Utilities (IOUs) and Independent Power Producers (IPPs). This dissertation uses agent-based simulation methods to tackle the market rules evaluation and financial risk management problems. The California energy crisis in 2000-01 showed what could happen to an electricity market if it did not go through a comprehensive and rigorous testing before its implementation. Due to the complexity of the market structure, strategic interaction between the participants, and the underlying physics, it is difficult to fully evaluate the implications of potential changes to market rules. This dissertation presents a flexible and integrative method to assess market designs through agent-based simulations. Realistic simulation scenarios on a 225-bus system are constructed for evaluation of the proposed PJM-like market power mitigation rules of the California electricity market. Simulation results show that in the absence of market power mitigation, generation company (GenCo) agents facilitated by Q-learning are able to exploit the market flaws and make significantly higher profits relative to the competitive benchmark. The incorporation of PJM-like local market power mitigation rules is shown to be effective in suppressing the exercise of market power. The importance of financial risk management is exemplified by the recent financial crisis. In this

  15. Guidance for training program evaluation

    International Nuclear Information System (INIS)

    1984-01-01

    An increased concern about the training of nuclear reactor operators resulted from the incident at TMI-2 in 1979. Purpose of this guide is to provide a general framework for the systematic evaluation of training programs for DOE Category-A reactors. The primary goal of such evaluations is to promote continuing quality improvements in the selection, training and qualification programs

  16. Validation of severe accident management guidance for the wolsong plants

    International Nuclear Information System (INIS)

    Park, S. Y.; Jin, Y. H.; Kim, S. D.; Song, Y. M.

    2006-01-01

    Full text: Full text: The severe accident management(SAM) guidance has been developed for the Wolsong nuclear power plants in Korea. The Wolsong plants are 700MWe CANDU-type reactors with heavy water as the primary coolant, natural uranium-fueled pressurized, horizontal tubes, surrounded by heavy water moderator inside a horizontal calandria vessel. The guidance includes six individual accident management strategies: (1) injection into primary heat transport system (2) injection into calandria vessel (3) injection into calandria vault (4) reduction of fission product release (5) control of reactor building condition (6) reduction of reactor building hydrogen. The paper provides the approaches to validate the SAM guidance. The validation includes the evaluation of:(l) effectiveness of accident management strategies, (2) performance of mitigation systems or components, (3) calculation aids, (4) strategy control diagram, and (5) interface with emergency operation procedure and with radiation emergency plan. Several severe accident sequences with high probability is selected from the plant specific level 2 probabilistic safety analysis results for the validation of SAM guidance. Afterward, thermal hydraulic and severe accident phenomenological analyses is performed using ISAAC(Integrated Severe Accident Analysis Code for CANDU Plant) computer program. Furthermore, the experiences obtained from a table-top-drill is also discussed

  17. Exoatmospheric intercepts using zero effort miss steering for midcourse guidance

    Science.gov (United States)

    Newman, Brett

    The suitability of proportional navigation, or an equivalent zero effort miss formulation, for exatmospheric intercepts during midcourse guidance, followed by a ballistic coast to the endgame, is addressed. The problem is formulated in terms of relative motion in a general, three dimensional framework. The proposed guidance law for the commanded thrust vector orientation consists of the sum of two terms: (1) along the line of sight unit direction and (2) along the zero effort miss component perpendicular to the line of sight and proportional to the miss itself and a guidance gain. If the guidance law is to be suitable for longer range targeting applications with significant ballistic coasting after burnout, determination of the zero effort miss must account for the different gravitational accelerations experienced by each vehicle. The proposed miss determination techniques employ approximations for the true differential gravity effect and thus, are less accurate than a direct numerical propagation of the governing equations, but more accurate than a baseline determination, which assumes equal accelerations for both vehicles. Approximations considered are constant, linear, quadratic, and linearized inverse square models. Theoretical results are applied to a numerical engagement scenario and the resulting performance is evaluated in terms of the miss distances determined from nonlinear simulation.

  18. Constituent aspects of workplace guidance in secondary VET

    NARCIS (Netherlands)

    Swager, Robert; Klarus, Ruud; Van Merriënboer, Jeroen; Nieuwenhuis, Loek

    2018-01-01

    Purpose – This paper aims to present an integrated model of workplace guidance to enhance awareness of what constitutes good guidance, to improve workplace guidance practices in vocational education and training. Design/methodology/approach – To identify constituent aspects of workplace guidance,

  19. Evaluating risk management strategies in resource planning

    International Nuclear Information System (INIS)

    Andrews, C.J.

    1995-01-01

    This paper discusses the evaluation of risk management strategies as a part of integrated resource planning. Value- and scope-related uncertainties can be addressed during the process of planning, but uncertainties in the operating environment require technical analysis within planning models. Flexibility and robustness are two key classes of strategies for managing the risk posed by these uncertainties. This paper reviews standard capacity expansion planning models and shows that they are poorly equipped to compare risk management strategies. Those that acknowledge uncertainty are better at evaluating robustness than flexibility, which implies a bias against flexible options. Techniques are available to overcome this bias

  20. General RMP Guidance - Appendix D: OSHA Guidance on PSM

    Science.gov (United States)

    OSHA's Process Safety Management (PSM) Guidance on providing complete and accurate written information concerning process chemicals, process technology, and process equipment; including process hazard analysis and material safety data sheets.

  1. Amending the Characterization of Guidance in Visual Analytics

    OpenAIRE

    Ceneda, Davide; Gschwandtner, Theresia; May, Thorsten; Miksch, Silvia; Schulz, Hans-Jörg; Streit, Marc; Tominski, Christian

    2017-01-01

    At VAST 2016, a characterization of guidance has been presented. It includes a definition of guidance and a model of guidance based on van Wijk's model of visualization. This note amends the original characterization of guidance in two aspects. First, we provide a clarification of what guidance actually is (and is not). Second, we insert into the model a conceptually relevant link that was missing in the original version.

  2. Guidance and control, 1993; Annual Rocky Mountain Guidance and Control Conference, 16th, Keystone, CO, Feb. 6-10, 1993

    Science.gov (United States)

    Culp, Robert D.; Bickley, George

    Papers from the sixteenth annual American Astronautical Society Rocky Mountain Guidance and Control Conference are presented. The topics covered include the following: advances in guidance, navigation, and control; control system videos; guidance, navigation and control embedded flight control systems; recent experiences; guidance and control storyboard displays; and applications of modern control, featuring the Hubble Space Telescope (HST) performance enhancement study. For individual titles, see A95-80390 through A95-80436.

  3. Toxicity assessment strategies, data requirements, and risk assessment approaches to derive health based guidance values for non-relevant metabolites of plant protection products.

    Science.gov (United States)

    Dekant, Wolfgang; Melching-Kollmuss, Stephanie; Kalberlah, Fritz

    2010-03-01

    of animals. The testing strategies are similar to those used in the initial hazard assessment of high production volume (HPV) chemicals. For "non-relevant metabolites" which are also formed as products of the biotransformation of the parent AI in mammals, the proposed toxicity testing strategies uses the repeat-dose oral toxicity study combined with a reproductive/developmental screening as outlined in OECD test guidelines 407 and 422 with integration of determination of hormonal activities. For "non-relevant metabolites" not formed during biotransformation of the AI in mammals, the strategy relies on an "enhanced" 90-day oral study covering additional endpoints regarding hormonal effects and male and female fertility in combination with a prenatal developmental toxicity study (OECD test guideline 414). The integration of the results of these studies into the risk assessment process applies large minimal margins of exposure (MOEs) to compensate for the shorter duration of the studies. The results of the targeted toxicity testing will provide a science basis for setting tolerable drinking water limits for "non-relevant metabolites" based on their toxicology. Based on the recommendations given in the SANCO guidance document and the work described in this and the accompanying paper, a concise re-evaluation of the Guidance document is proposed. (c) 2009 Elsevier Inc. All rights reserved.

  4. Evaluating the Learning Curve for Percutaneous Nephrolithotomy under Total Ultrasound Guidance.

    Directory of Open Access Journals (Sweden)

    Yan Song

    Full Text Available To investigate the learning curve of percutaneous nephrolithotomy under total ultrasound guidance.One hundred and twenty consecutive PCNL operations under total ultrasound guidance performed by a novice surgeon in a tertiary referral center were studied. Operations were analyzed in cohorts of 15 to determine when a plateau was reached for the variables such as operation duration, ultrasound screening time, tract dilation time, stone-free rate and complication rate. Comparison was made with the results of a surgeon who had performed more than 1000 PCNLs. Fluoroscopy was not used at all during procedure.The mean operation time dropped from 82.5 min for the first 15 patients to a mean of 64.7 min for cases 46 through 60(P = 0.047. The ultrasound screening time was a peak of 6.4 min in the first 15 cases, whereas it dropped to a mean of 3.9 min for cases 46 through 60(P = 0.01. The tract dilation time dropped from 4.9 min for the first 15 patients to a mean of 3.8 min for cases 46 through 60(P = 0.036. The senior surgeon had a mean operating time, screening time and tract dilation time equivalent to those of the novice surgeon after 60 cases. There was no significant difference in stone free rate and complication rate.The competence of ultrasound guided PCNL is reached after 60 cases with good stone free rate and without major complications.

  5. Integration and evaluation of a needle-positioning robot with volumetric microcomputed tomography image guidance for small animal stereotactic interventions

    International Nuclear Information System (INIS)

    Waspe, Adam C.; McErlain, David D.; Pitelka, Vasek; Holdsworth, David W.; Lacefield, James C.; Fenster, Aaron

    2010-01-01

    Purpose: Preclinical research protocols often require insertion of needles to specific targets within small animal brains. To target biologically relevant locations in rodent brains more effectively, a robotic device has been developed that is capable of positioning a needle along oblique trajectories through a single burr hole in the skull under volumetric microcomputed tomography (micro-CT) guidance. Methods: An x-ray compatible stereotactic frame secures the head throughout the procedure using a bite bar, nose clamp, and ear bars. CT-to-robot registration enables structures identified in the image to be mapped to physical coordinates in the brain. Registration is accomplished by injecting a barium sulfate contrast agent as the robot withdraws the needle from predefined points in a phantom. Registration accuracy is affected by the robot-positioning error and is assessed by measuring the surface registration error for the fiducial and target needle tracks (FRE and TRE). This system was demonstrated in situ by injecting 200 μm tungsten beads into rat brains along oblique trajectories through a single burr hole on the top of the skull under micro-CT image guidance. Postintervention micro-CT images of each skull were registered with preintervention high-field magnetic resonance images of the brain to infer the anatomical locations of the beads. Results: Registration using four fiducial needle tracks and one target track produced a FRE and a TRE of 96 and 210 μm, respectively. Evaluation with tissue-mimicking gelatin phantoms showed that locations could be targeted with a mean error of 154±113 μm. Conclusions: The integration of a robotic needle-positioning device with volumetric micro-CT image guidance should increase the accuracy and reduce the invasiveness of stereotactic needle interventions in small animals.

  6. Integration and evaluation of a needle-positioning robot with volumetric microcomputed tomography image guidance for small animal stereotactic interventions

    Energy Technology Data Exchange (ETDEWEB)

    Waspe, Adam C.; McErlain, David D.; Pitelka, Vasek; Holdsworth, David W.; Lacefield, James C.; Fenster, Aaron [Biomedical Engineering Graduate Program and Imaging Research Laboratories, Robarts Research Institute, University of Western Ontario, London, Ontario N6A 5K8 (Canada); Department of Medical Biophysics and Imaging Research Laboratories, Robarts Research Institute, University of Western Ontario, London, Ontario N6A 5K8 (Canada); Department of Physiology and Pharmacology, University of Western Ontario, London, Ontario N6A 5C1 (Canada); Biomedical Engineering Graduate Program, Department of Medical Biophysics, Department of Medical Imaging, Department of Surgery, and Imaging Research Laboratories, Robarts Research Institute, University of Western Ontario, London, Ontario N6A 5K8 (Canada); Biomedical Engineering Graduate Program, Department of Electrical and Computer Engineering, Department of Medical Biophysics, and Imaging Research Laboratories, Robarts Research Institute, University of Western Ontario, London, Ontario N6A 5K8 (Canada); Biomedical Engineering Graduate Program, Department of Medical Biophysics, Department of Medical Imaging, and Imaging Research Laboratories, Robarts Research Institute, University of Western Ontario, London, Ontario N6A 5K8 (Canada)

    2010-04-15

    Purpose: Preclinical research protocols often require insertion of needles to specific targets within small animal brains. To target biologically relevant locations in rodent brains more effectively, a robotic device has been developed that is capable of positioning a needle along oblique trajectories through a single burr hole in the skull under volumetric microcomputed tomography (micro-CT) guidance. Methods: An x-ray compatible stereotactic frame secures the head throughout the procedure using a bite bar, nose clamp, and ear bars. CT-to-robot registration enables structures identified in the image to be mapped to physical coordinates in the brain. Registration is accomplished by injecting a barium sulfate contrast agent as the robot withdraws the needle from predefined points in a phantom. Registration accuracy is affected by the robot-positioning error and is assessed by measuring the surface registration error for the fiducial and target needle tracks (FRE and TRE). This system was demonstrated in situ by injecting 200 {mu}m tungsten beads into rat brains along oblique trajectories through a single burr hole on the top of the skull under micro-CT image guidance. Postintervention micro-CT images of each skull were registered with preintervention high-field magnetic resonance images of the brain to infer the anatomical locations of the beads. Results: Registration using four fiducial needle tracks and one target track produced a FRE and a TRE of 96 and 210 {mu}m, respectively. Evaluation with tissue-mimicking gelatin phantoms showed that locations could be targeted with a mean error of 154{+-}113 {mu}m. Conclusions: The integration of a robotic needle-positioning device with volumetric micro-CT image guidance should increase the accuracy and reduce the invasiveness of stereotactic needle interventions in small animals.

  7. Piloted "Well Clear" Performance Evaluation of Detect-and-Avoid Systems with Suggestive Guidance

    Science.gov (United States)

    Mueller, Eric R.; Santiago, Confesor; Watza, Spencer

    2016-01-01

    This study evaluated the performance of four prototype unmanned aircraft detect-and-avoid (DAA) display configurations, each with different informational elements driven by alerting and guidance algorithms. Sixteen unmanned aircraft pilots flew each combination of the display configurations, with half being given zero DAA surveillance sensor uncertainty and the other half experiencing errors that were comparable, and in some cases slightly better than, errors that were measured in DAA system flight tests. The displays that showed intruder alert information in altitude and heading bands had significantly fewer losses of well clear compared with alternative displays that lacked that information. This difference was significant from a statistical and practical perspective: those losses that did occur lasted for shorter periods and did not penetrate as far into the geometric "separation cylinder" as those in the non-banded displays. A modest level of DAA surveillance sensor uncertainty did not affect the proportion of losses of well clear or their severity. It is recommended that DAA traffic displays implement a band-type display in order to improve the safety of UAS operations in the National Airspace System. Finally, this report provides pilot response time distributions for responding to DAA alerts.

  8. Optimal guidance law in quantum mechanics

    International Nuclear Information System (INIS)

    Yang, Ciann-Dong; Cheng, Lieh-Lieh

    2013-01-01

    Following de Broglie’s idea of a pilot wave, this paper treats quantum mechanics as a problem of stochastic optimal guidance law design. The guidance scenario considered in the quantum world is that an electron is the flight vehicle to be guided and its accompanying pilot wave is the guidance law to be designed so as to guide the electron to a random target driven by the Wiener process, while minimizing a cost-to-go function. After solving the stochastic optimal guidance problem by differential dynamic programming, we point out that the optimal pilot wave guiding the particle’s motion is just the wavefunction Ψ(t,x), a solution to the Schrödinger equation; meanwhile, the closed-loop guidance system forms a complex state–space dynamics for Ψ(t,x), from which quantum operators emerge naturally. Quantum trajectories under the action of the optimal guidance law are solved and their statistical distribution is shown to coincide with the prediction of the probability density function Ψ ∗ Ψ. -- Highlights: •Treating quantum mechanics as a pursuit-evasion game. •Reveal an interesting analogy between guided flight motion and guided quantum motion. •Solve optimal quantum guidance problem by dynamic programming. •Gives a formal proof of de Broglie–Bohm’s idea of a pilot wave. •The optimal pilot wave is shown to be a wavefunction solved from Schrödinger equation

  9. Optimal guidance law in quantum mechanics

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Ciann-Dong, E-mail: cdyang@mail.ncku.edu.tw; Cheng, Lieh-Lieh, E-mail: leo8101@hotmail.com

    2013-11-15

    Following de Broglie’s idea of a pilot wave, this paper treats quantum mechanics as a problem of stochastic optimal guidance law design. The guidance scenario considered in the quantum world is that an electron is the flight vehicle to be guided and its accompanying pilot wave is the guidance law to be designed so as to guide the electron to a random target driven by the Wiener process, while minimizing a cost-to-go function. After solving the stochastic optimal guidance problem by differential dynamic programming, we point out that the optimal pilot wave guiding the particle’s motion is just the wavefunction Ψ(t,x), a solution to the Schrödinger equation; meanwhile, the closed-loop guidance system forms a complex state–space dynamics for Ψ(t,x), from which quantum operators emerge naturally. Quantum trajectories under the action of the optimal guidance law are solved and their statistical distribution is shown to coincide with the prediction of the probability density function Ψ{sup ∗}Ψ. -- Highlights: •Treating quantum mechanics as a pursuit-evasion game. •Reveal an interesting analogy between guided flight motion and guided quantum motion. •Solve optimal quantum guidance problem by dynamic programming. •Gives a formal proof of de Broglie–Bohm’s idea of a pilot wave. •The optimal pilot wave is shown to be a wavefunction solved from Schrödinger equation.

  10. A risk evaluation model and its application in online retailing trustfulness

    Science.gov (United States)

    Ye, Ruyi; Xu, Yingcheng

    2017-08-01

    Building a general model for risks evaluation in advance could improve the convenience, normality and comparability of the results of repeating risks evaluation in the case that the repeating risks evaluating are in the same area and for a similar purpose. One of the most convenient and common risks evaluation models is an index system including of several index, according weights and crediting method. One method to build a risk evaluation index system that guarantees the proportional relationship between the resulting credit and the expected risk loss is proposed and an application example is provided in online retailing in this article.

  11. 78 FR 12761 - Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy...

    Science.gov (United States)

    2013-02-25

    ...] (formerly 2006D-0169) Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived... on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food.... The guidance explained FDA's then current thinking on the labeling of certain uses of lecithin derived...

  12. Experimental composite guidance conduits for peripheral nerve repair: An evaluation of ion release

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, X.F. [Department of Biological Sciences and Medical Engineering Design and Innovation Centre, Cork Institute of Technology, Cork (Ireland); Coughlan, A. [Inamori School of Engineering, Alfred University, Alfred, NY. 14802 (United States); O' Shea, H. [Department of Biological Sciences and Medical Engineering Design and Innovation Centre, Cork Institute of Technology, Cork (Ireland); Towler, M.R. [Inamori School of Engineering, Alfred University, Alfred, NY. 14802 (United States); Kehoe, S., E-mail: sharonkehoe@dal.ca [Department of Applied Oral Sciences, Dalhousie University, Halifax, NS, B3H 4R2 (Canada); School of Biomedical Engineering, Dalhousie University, Halifax, NS, B3H 4R2 (Canada); Boyd, D., E-mail: d.boyd@dal.ca [Department of Applied Oral Sciences, Dalhousie University, Halifax, NS, B3H 4R2 (Canada); School of Biomedical Engineering, Dalhousie University, Halifax, NS, B3H 4R2 (Canada)

    2012-08-01

    Poly (lactide-co-glycolide) (PLGA) - Pluronic F127 - glass composites have demonstrated excellent potential, from the perspective of controlled mechanical properties and cytocompatibility, for peripheral nerve regeneration. In addition to controlling the mechanical properties and cytotoxicity for such composite devices, the glass component may mediate specific responses upon implantation via degradation in the physiological environment and release of constituent elements. However, research focused on quantifying the release levels of such therapeutic ions from these experimental medical devices has been limited. To redress the balance, this paper explores the ion release profiles for Si{sup 4+}, Ca{sup 2+}, Na{sup +}, Zn{sup 2+}, and Ce{sup 4+} from experimental composite nerve guidance conduits (CNGC) comprising PLGA (at 12.5, and 20 wt.%), F127 (at 0, 2.5 and 5 wt.%) and various loadings of Si-Ca-Na-Zn-Ce glass (at 20 and 40 wt.%) for incubation periods of up to 28 days. The concentration of each ion, at various time points, was determined using Inductively Coupled Plasma-Atomic Emission Spectrometry (Perkin Elmer Optima 3000). It was observed that the Si{sup 4+}, Na{sup +}, Ca{sup 2+}, Zn{sup 2+} release from CNGCs in this study ranged from 0.22 to 6.477 ppm, 2.307 to 3.277 ppm, 40 to 119 ppm, and 45 to 51 ppm, respectively. The Ce{sup 4+} concentrations were under the minimum detection limits for the ICP instrument utilized. The results indicate that the ion release levels may be appropriate to mediate therapeutic effects with respect to peripheral nerve regeneration. The data generated in this paper provides requisite evidence to optimize composition for pre-clinical evaluation of the experimental composite. - Graphical abstract: Highlights: Black-Right-Pointing-Pointer Time-dependent degradation studies of PLGA/glass composite nerve guidance conduits (NGCs). Black-Right-Pointing-Pointer Si{sup 4+}, Na{sup +}, Ca{sup 2+} and Zn{sup 2+} release levels for the

  13. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2012-02-29

    ...] Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and... the availability of a guidance for industry entitled ``Size of Beads in Drug Products Labeled for... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  14. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Science.gov (United States)

    2011-02-03

    ... this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to... Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of...

  15. Non-Participation in Guidance: An Opportunity for Development?

    Science.gov (United States)

    Thomsen, Rie

    2014-01-01

    This article discusses how new opportunities for guidance can emerge from an analysis of the interplay between the participation (or lack of participation) of the individuals in career guidance, and the career guidance practitioner's response. The article suggests critical psychology as a framework for career guidance research and presents…

  16. Constituent Aspects of Workplace Guidance in Secondary VET

    Science.gov (United States)

    Swager, Robert; Klarus, Ruud; van Merriënboer, Jeroen J. G.; Nieuwenhuis, Loek F. M.

    2015-01-01

    Purpose: This paper aims to present an integrated model of workplace guidance to enhance awareness of what constitutes good guidance, to improve workplace guidance practices in vocational education and training. Design/methodology/approach: To identify constituent aspects of workplace guidance, a systematic search of Web of Science was conducted,…

  17. Risk prediction, safety analysis and quantitative probability methods - a caveat

    International Nuclear Information System (INIS)

    Critchley, O.H.

    1976-01-01

    Views are expressed on the use of quantitative techniques for the determination of value judgements in nuclear safety assessments, hazard evaluation, and risk prediction. Caution is urged when attempts are made to quantify value judgements in the field of nuclear safety. Criteria are given the meaningful application of reliability methods but doubts are expressed about their application to safety analysis, risk prediction and design guidances for experimental or prototype plant. Doubts are also expressed about some concomitant methods of population dose evaluation. The complexities of new designs of nuclear power plants make the problem of safety assessment more difficult but some possible approaches are suggested as alternatives to the quantitative techniques criticized. (U.K.)

  18. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) t to draft guidance on scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. This guidance has been drawn from scientific...... opinions of the NDA Panel on such health claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document should include an exhaustive list of beneficial effects...

  19. Guidance and Counselling in the Universal Basic Education ...

    African Journals Online (AJOL)

    Quite a number of personnel has significant and diverse roles to play. The guidance counsellor whose role is to provide indispensable guidance services is the primary focus of this paper. The paper justifies the relevance of guidance services to the UBE scheme and also isolates a number of challenges facing the guidance ...

  20. Guidance on the import and export of radioactive sources

    International Nuclear Information System (INIS)

    2005-03-01

    The IAEA Code of Conduct on the Safety and Security of Radioactive Sources, published in January 2004 with the symbol IAEA/CODEOC/2004, provides guidance on how States can safely and securely manage radioactive sources that may pose a significant risk. The concept of such an international undertaking on the safety and security of radioactive sources was highlighted in the major findings of the International Conference on the Safety of Radiation Sources and Security of Radioactive Materials held in Dijon, France, in September 1998. Following that conference, the IAEA Board of Governors requested the Director General to initiate exploratory discussions relating to an international undertaking in the areas of the safety and security of radiation sources. This request was reflected in an Action Plan on the Safety of Radiation Sources and Security of Radioactive Materials, with the Secretariat organizing a series of open-ended meetings of technical and legal experts nominated by Member States to further explore the concept of such an undertaking. Noting comments made in the Board of Governors, the experts agreed that any international undertaking should, for the present, be in the form of a 'code of conduct'. The text of a Code of Conduct on the Safety and Security of Radioactive Sources was accordingly developed. Steps to strengthen the provisions of the Code were subsequently initiated following the International Conference of National Regulatory Authorities with Competence in the Safety of Radiation Sources and the Security of Radioactive Material held in Buenos Aires in December 2000. Moreover, growing international concern about the security of radioactive sources after the events of 11 September 2001 led to a number of issues being considered further by technical and legal experts. Furthermore, the International Conference on Security of Radioactive Sources held in Vienna in March 2003 made recommendations regarding additional actions that might be needed. In June

  1. Rethinking risk management

    International Nuclear Information System (INIS)

    Kloman, H.F.

    1992-01-01

    The purpose of this paper is to bring together the ideas of those who currently practice the many different forms of risk management on a global basis. These forms include guidance of public policy on macro risks, risk financing and insurance for many larger commercial organizations, managing credit, currency and interest rate risks for financial institutions, plus other extensions of risk management including security, quality control, and quality assurance in a health-care environment

  2. Risk evaluation system for operational events and inspection findings

    International Nuclear Information System (INIS)

    Lopez G, A.; Godinez S, V.; Lopez M, R.

    2010-10-01

    The Mexican Nuclear Regulatory Commission has developed an adaptation of the US NRC Significance Determination Process (SDP) to evaluate the risk significance of operational events and inspection findings in Laguna Verde nuclear power plant. The Mexican Nuclear Regulatory Commission developed a plant specific flow chart for preliminary screening instead of the open questionnaire used by the US NRC-SDP, with the aim to improve the accuracy of the screening process. Also, the work sheets and support information tables required by the SDP were built up in an Excel application which allows to perform the risk evaluation in an automatic way, focusing the regulator staff efforts in the risk significance analysis instead of the risk calculation tasks. In order to construct this tool a simplified PRA model was developed and validated with the individual plant examination model. This paper shows the Mexican Nuclear Regulatory Commission process and some risk events evaluations performed using the Risk Evaluation System for Operational Events and Inspection Findings (SERHE, by its acronyms in Spanish). (Author)

  3. Evaluation of Behavioral Guidance Structure on Juvenile Salmonid Passage and Survival at Bonneville Dam in 2009

    Energy Technology Data Exchange (ETDEWEB)

    Faber, Derrek M.; Ploskey, Gene R.; Weiland, Mark A.; Deng, Zhiqun; Hughes, James S.; Kim, Jin A.; Fu, Tao; Fischer, Eric S.; Monter, Tyrell J.; Skalski, J. R.

    2011-03-01

    Pacific Northwest National Laboratory (PNNL) conducted an acoustic-telemetry study at Bonneville Dam in 2009 to evaluate the effects of a behavioral guidance structure (BGS) in the Bonneville Dam second powerhouse forebay on fish passage and survival through the second powerhouse (B2), the dam as a whole, and through the first powerhouse and spillway combined. The BGS was deployed to increase the survival of fish passing through B2 by increasing the percentage of outmigrating smolts entering the B2 Corner Collector (B2CC)—a surface flow outlet known to be a relatively benign route for downstream passage at this dam. The study relied on releases of live Juvenile Salmon Acoustic Telemetry System tagged smolts in the Columbia River and used acoustic telemetry to evaluate the approach, passage, and survival of passing juvenile salmon. Study results indicated that having turbine 11 in service is important for providing flow conditions that are comparable to those observed in pre-BGS years (2004 and 2005) and in 2008. This study supports the U.S. Army Corps of Engineers continual effort to improve conditions for juvenile anadromous fish passing through Columbia River dams.

  4. Effectiveness of Stellate Ganglion Block Under Fuoroscopy or Ultrasound Guidance in Upper Extremity CRPS.

    Science.gov (United States)

    Imani, Farnad; Hemati, Karim; Rahimzadeh, Poupak; Kazemi, Mohamad Reza; Hejazian, Kokab

    2016-01-01

    Stellate Ganglion Block (SGB) is an effective technique which may be used to manage upper extremities pain due to Chronic Regional Pain Syndrome (CRPS), in this study we tried to evaluate the effectiveness of this procedure under two different guidance for management of this syndrome. The purpose of this study was to evaluate the effectiveness of ultrsound guide SGB by comparing it with the furoscopy guided SGB in upper extermities CRPS patients in reducing pain & dysfuction of the affected link. Fourteen patients with sympathetic CRPS in upper extremities in a randomized method with block randomization divided in two equal groups (with ultrasound or fluoroscopic guidance). First group was blocked under fluoroscopic guidance and second group blocked under ultrasound guidance. After correct positioning of the needle, a mixture of 5 ml bupivacaine 0.25% and 1 mL of triamcinolone was injected. These data represent no meaningful statistical difference between the two groups in terms of the number of pain attacks before the blocks, a borderline correlation between two groups one week and one month after the block and a significant statistical correlation between two groups three month after the block. These data represent no meaningful statistical difference between the patients of any group in terms of the pain intensity (from one week to six months after block), p-value = 0.61. These data represent a meaningful statistical difference among patients of any group and between the two groups in terms of the pain intensity (before the block until six months after block), p-values were 0.001, 0.031 respectively. According the above mentioned data, in comparison with fluoroscopic guidance, stellate ganglion block under ultrasound guidance is a safe and effective method with lower complication and better improvement in patient's disability indexes.

  5. The continuum of behavior guidance.

    Science.gov (United States)

    Nelson, Travis

    2013-01-01

    Behavior guidance is a continuum of techniques, basic and advanced, fundamental to the provision of quality dental care for pediatric patients. This practice must be individualized, pairing the correct method of behavior guidance with each child. To select the appropriate technique, the clinician must have a thorough understanding of each aspect of the continuum and anticipate parental expectations, child temperament, and the technical procedures necessary to complete care. By effectively using techniques within the continuum of behavior guidance, a healing relationship with the family is maintained while addressing dental disease and empowering the child to receive dental treatment throughout their lifetime. Copyright © 2013 Elsevier Inc. All rights reserved.

  6. GUIDANCE COUNSELOR INSTITUTE FOR HEALTH CAREERS (JULY 7-22, 1966).

    Science.gov (United States)

    MORGAN, PHILIP W.

    THE INSTITUTE, SPONSORED BY A FEDERATED CHARITY REPRESENTING 78 NONPROFIT VOLUNTARY HOSPITALS IN NEW YORK CITY, WAS ATTENDED BY 48 HIGH SCHOOL AND EMPLOYMENT SERVICE COUNSELORS. THE NEED FOR SUCH INSTITUTES WAS DOCUMENTED BY A PRE-INSTITUTE QUESTIONNAIRE TO LICENSED GUIDANCE COUNSELORS. TO EVALUATE THE INSTITUTE, THE PROFESSIONAL EXAMINATION…

  7. Municipal solid waste management health risk assessment from air emissions for China by applying life cycle analysis.

    Science.gov (United States)

    Li, Hua; Nitivattananon, Vilas; Li, Peng

    2015-05-01

    This study is to quantify and objectively evaluate the extent of environmental health risks from three waste treatment options suggested by the national municipal solid waste management enhancing strategy (No [2011] 9 of the State Council, promulgated on 19 April 2011), which includes sanitary landfill, waste-to-energy incineration and compost, together with the material recovery facility through a case study in Zhangqiu City of China. It addresses potential chronic health risks from air emissions to residential receptors in the impacted area. It combines field survey, analogue survey, design documents and life cycle inventory methods in defining the source strength of chemicals of potential concern. The modelling of life cycle inventory and air dispersion is via integrated waste management(IWM)-2 and Screening Air Dispersion Model (Version 3.0) (SCREEN3). The health risk assessment is in accordance with United States Environmental Protection Agency guidance Risk Assessment Guidance for Superfund (RAGS), Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance for Inhalation Risk Assessment). The exposure concentration is based on long-term exposure to the maximum ground level contaminant in air under the 'reasonable worst situation' emissions and then directly compared with reference for concentration and unit risk factor/cancer slope factor derived from the national air quality standard (for a conventional pollutant) and toxicological studies (for a specific pollutant). Results from this study suggest that the option of compost with material recovery facility treatment may pose less negative health impacts than other options; the sensitivity analysis shows that the landfill integrated waste management collection rate has a great influence on the impact results. Further investigation is needed to validate or challenge the findings of this study. © The Author(s) 2015.

  8. Evaluation of the Prostate Cancer Prevention Trial Risk Calculator in a High-Risk Screening Population

    Science.gov (United States)

    Kaplan, David J.; Boorjian, Stephen A.; Ruth, Karen; Egleston, Brian L.; Chen, David Y.T.; Viterbo, Rosalia; Uzzo, Robert G.; Buyyounouski, Mark K.; Raysor, Susan; Giri, Veda N.

    2009-01-01

    Introduction Clinical factors in addition to PSA have been evaluated to improve risk assessment for prostate cancer. The Prostate Cancer Prevention Trial (PCPT) risk calculator provides an assessment of prostate cancer risk based on age, PSA, race, prior biopsy, and family history. This study evaluated the risk calculator in a screening cohort of young, racially diverse, high-risk men with a low baseline PSA enrolled in the Prostate Cancer Risk Assessment Program. Patients and Methods Eligibility for PRAP include men ages 35-69 who are African-American, have a family history of prostate cancer, or have a known BRCA1/2 mutation. PCPT risk scores were determined for PRAP participants, and were compared to observed prostate cancer rates. Results 624 participants were evaluated, including 382 (61.2%) African-American men and 375 (60%) men with a family history of prostate cancer. Median age was 49.0 years (range 34.0-69.0), and median PSA was 0.9 (range 0.1-27.2). PCPT risk score correlated with prostate cancer diagnosis, as the median baseline risk score in patients diagnosed with prostate cancer was 31.3%, versus 14.2% in patients not diagnosed with prostate cancer (p<0.0001). The PCPT calculator similarly stratified the risk of diagnosis of Gleason score ≥7 disease, as the median risk score was 36.2% in patients diagnosed with Gleason ≥7 prostate cancer versus 15.2% in all other participants (p<0.0001). Conclusion PCPT risk calculator score was found to stratify prostate cancer risk in a cohort of young, primarily African-American men with a low baseline PSA. These results support further evaluation of this predictive tool for prostate cancer risk assessment in high-risk men. PMID:19709072

  9. Evaluation of human health risk from in situ recovery uranium mining, pre-and post-mining, and post-restoration

    Energy Technology Data Exchange (ETDEWEB)

    Ruedig, E.; Bhattacharyya, A.; Borch, T.; Johnson, T. [Colorado State University (United States); Till, J. [Risk Assessment Corporation (United States)

    2014-07-01

    In the United States, the restoration of in situ recovery (ISR) uranium mines is aimed at returning sites to pre-mining conditions. While this may seem an appropriate goal, little or no scientific information is available to justify utilizing baseline conditions for regulatory compliance. The chemical and radiological contaminants monitored for restoration compliance have not been evaluated to ensure they are proper indicators of the mitigation of risk. Pre-mining aquifers do not meet minimum United States drinking water standards, and must have an aquifer exemption in place prior to mining. Under these conditions, returning groundwater to near the original concentrations of contaminants may be unnecessary. Post-mining groundwater is also unlikely to meet standards for drinking water, but may be depleted in at least some toxic species as a result of the mining process. Here, we examine the risk to representative person from the personal use of groundwater sourced from an Uranium ISR mine. Water samples were collected from Cameco Resource's Smith Ranch-Highlands ISR Uranium mine near Casper, Wyoming, USA. Samples were acquired pre-mining, post-mining, and post-restoration. Concentrations of heavy metals and radionuclides were assessed by appropriate analytical techniques (e.g., mass spectroscopy or alpha spectroscopy) and these concentrations were used to estimate human health risk for three exposure scenarios: a scenario with high exposure, a scenario with medium exposure, and a scenario with low exposure. A simple biosphere transport model was constructed for each scenario to estimate the risk to humans from the use of contaminated waters for subsistence-related activities. Chemical and radiological risks were harmonized according to the United States Environmental Protection Agency's guidance for superfund sites. Each exposure scenario and its subsequent risk were evaluated individually for pre-mining, post-mining, and post-restoration aquifer waters

  10. Image Guidance

    Science.gov (United States)

    Guidance that explains the process for getting images approved in One EPA Web microsites and resource directories. includes an appendix that shows examples of what makes some images better than others, how some images convey meaning more than others

  11. Hierarchic Analysis Method to Evaluate Rock Burst Risk

    Directory of Open Access Journals (Sweden)

    Ming Ji

    2015-01-01

    Full Text Available In order to reasonably evaluate the risk of rock bursts in mines, the factors impacting rock bursts and the existing grading criterion on the risk of rock bursts were studied. By building a model of hierarchic analysis method, the natural factors, technology factors, and management factors that influence rock bursts were analyzed and researched, which determined the degree of each factor’s influence (i.e., weight and comprehensive index. Then the grade of rock burst risk was assessed. The results showed that the assessment level generated by the model accurately reflected the actual risk degree of rock bursts in mines. The model improved the maneuverability and practicability of existing evaluation criteria and also enhanced the accuracy and science of rock burst risk assessment.

  12. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  13. Using toxicokinetic-toxicodynamic modeling as an acute risk assessment refinement approach in vertebrate ecological risk assessment.

    Science.gov (United States)

    Ducrot, Virginie; Ashauer, Roman; Bednarska, Agnieszka J; Hinarejos, Silvia; Thorbek, Pernille; Weyman, Gabriel

    2016-01-01

    Recent guidance identified toxicokinetic-toxicodynamic (TK-TD) modeling as a relevant approach for risk assessment refinement. Yet, its added value compared to other refinement options is not detailed, and how to conduct the modeling appropriately is not explained. This case study addresses these issues through 2 examples of individual-level risk assessment for 2 hypothetical plant protection products: 1) evaluating the risk for small granivorous birds and small omnivorous mammals of a single application, as a seed treatment in winter cereals, and 2) evaluating the risk for fish after a pulsed treatment in the edge-of-field zone. Using acute test data, we conducted the first tier risk assessment as defined in the European Food Safety Authority (EFSA) guidance. When first tier risk assessment highlighted a concern, refinement options were discussed. Cases where the use of models should be preferred over other existing refinement approaches were highlighted. We then practically conducted the risk assessment refinement by using 2 different models as examples. In example 1, a TK model accounting for toxicokinetics and relevant feeding patterns in the skylark and in the wood mouse was used to predict internal doses of the hypothetical active ingredient in individuals, based on relevant feeding patterns in an in-crop situation, and identify the residue levels leading to mortality. In example 2, a TK-TD model accounting for toxicokinetics, toxicodynamics, and relevant exposure patterns in the fathead minnow was used to predict the time-course of fish survival for relevant FOCUS SW exposure scenarios and identify which scenarios might lead to mortality. Models were calibrated using available standard data and implemented to simulate the time-course of internal dose of active ingredient or survival for different exposure scenarios. Simulation results were discussed and used to derive the risk assessment refinement endpoints used for decision. Finally, we compared the

  14. Risk evaluation of medical and industrial radiation devices

    International Nuclear Information System (INIS)

    Jones, E.D.; Cunningham, R.E.; Rathbun, P.A.

    1994-03-01

    In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis

  15. 76 FR 4360 - Guidance for Industry on Process Validation: General Principles and Practices; Availability

    Science.gov (United States)

    2011-01-25

    ... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug...] Guidance for Industry on Process Validation: General Principles and Practices; Availability AGENCY: Food... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

  16. Risk evaluation system for facility safeguards and security planning

    International Nuclear Information System (INIS)

    Udell, C.J.; Carlson, R.L.

    1987-01-01

    The Risk Evaluation System (RES) is an integrated approach to determining safeguards and security effectiveness and risk. RES combines the planning and technical analysis into a format that promotes an orderly development of protection strategies, planing assumptions, facility targets, vulnerability and risk determination, enhancement planning, and implementation. In addition, the RES computer database program enhances the capability of the analyst to perform a risk evaluation of the facility. The computer database is menu driven using data input screens and contains an algorithm for determining the probability of adversary defeat and risk. Also, base case and adjusted risk data records can be maintained and accessed easily

  17. Risk evaluation system for facility safeguards and security planning

    International Nuclear Information System (INIS)

    Udell, C.J.; Carlson, R.L.

    1987-01-01

    The Risk Evaluation System (RES) is an integrated approach to determining safeguards and security effectiveness and risk. RES combines the planning and technical analysis into a format that promotes an orderly development of protection strategies, planning assumptions, facility targets, vulnerability and risk determination, enhancement planning, and implementation. In addition, the RES computer database program enhances the capability of the analyst to perform a risk evaluation of the facility. The computer database is menu driven using data input screens and contains an algorithm for determining the probability of adversary defeat and risk. Also, base case and adjusted risk data records can be maintained and accessed easily

  18. DOE Waste Treatability Group Guidance

    International Nuclear Information System (INIS)

    Kirkpatrick, T.D.

    1995-01-01

    This guidance presents a method and definitions for aggregating U.S. Department of Energy (DOE) waste into streams and treatability groups based on characteristic parameters that influence waste management technology needs. Adaptable to all DOE waste types (i.e., radioactive waste, hazardous waste, mixed waste, sanitary waste), the guidance establishes categories and definitions that reflect variations within the radiological, matrix (e.g., bulk physical/chemical form), and regulated contaminant characteristics of DOE waste. Beginning at the waste container level, the guidance presents a logical approach to implementing the characteristic parameter categories as part of the basis for defining waste streams and as the sole basis for assigning streams to treatability groups. Implementation of this guidance at each DOE site will facilitate the development of technically defined, site-specific waste stream data sets to support waste management planning and reporting activities. Consistent implementation at all of the sites will enable aggregation of the site-specific waste stream data sets into comparable national data sets to support these activities at a DOE complex-wide level

  19. DOE Waste Treatability Group Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Kirkpatrick, T.D.

    1995-01-01

    This guidance presents a method and definitions for aggregating U.S. Department of Energy (DOE) waste into streams and treatability groups based on characteristic parameters that influence waste management technology needs. Adaptable to all DOE waste types (i.e., radioactive waste, hazardous waste, mixed waste, sanitary waste), the guidance establishes categories and definitions that reflect variations within the radiological, matrix (e.g., bulk physical/chemical form), and regulated contaminant characteristics of DOE waste. Beginning at the waste container level, the guidance presents a logical approach to implementing the characteristic parameter categories as part of the basis for defining waste streams and as the sole basis for assigning streams to treatability groups. Implementation of this guidance at each DOE site will facilitate the development of technically defined, site-specific waste stream data sets to support waste management planning and reporting activities. Consistent implementation at all of the sites will enable aggregation of the site-specific waste stream data sets into comparable national data sets to support these activities at a DOE complex-wide level.

  20. Regulatory systems-based licensing guidance documentation

    International Nuclear Information System (INIS)

    Delligatti, M.S.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) has developed a series of licensing guidance documents based on the regulatory requirements in Part 60 of Title 10 of the Code of Federal Regulations (10 CFR Part 60). This regulatory systems-based approach to licensing guidance documentation relies on the definition of the high-level waste repository in 10 CFR Part 60. A document which is important for the frame-work it gives to other programmatic licensing guidance is the Draft Regulatory Guide open-quotes Format and Content for the License Application for the High-Level Waste Repositoryclose quotes (FCRG). The FCRG describes a format and content acceptable to NRC for a high-level waste repository license application pursuant to the requirements of 10 CFR Part 60. Other licensing guidance documents will be compatible with the FCRG

  1. Credit Risk Evaluation of Power Market Players with Random Forest

    Science.gov (United States)

    Umezawa, Yasushi; Mori, Hiroyuki

    A new method is proposed for credit risk evaluation in a power market. The credit risk evaluation is to measure the bankruptcy risk of the company. The power system liberalization results in new environment that puts emphasis on the profit maximization and the risk minimization. There is a high probability that the electricity transaction causes a risk between companies. So, power market players are concerned with the risk minimization. As a management strategy, a risk index is requested to evaluate the worth of the business partner. This paper proposes a new method for evaluating the credit risk with Random Forest (RF) that makes ensemble learning for the decision tree. RF is one of efficient data mining technique in clustering data and extracting relationship between input and output data. In addition, the method of generating pseudo-measurements is proposed to improve the performance of RF. The proposed method is successfully applied to real financial data of energy utilities in the power market. A comparison is made between the proposed and the conventional methods.

  2. A comparative study to evaluate the discrepancy in condylar guidance values between two commercially available arcon and non-arcon articulators: A clinical study

    Directory of Open Access Journals (Sweden)

    Mukesh Kumar Goyal

    2011-01-01

    Full Text Available Aim: The purpose of this study was comparative evaluation of sagittal condylar values of arcon and non-arcon articulators with cephalometric readings and to determine the amount of discrepancy in sagittal condylar guidance values between arcon and non-arcon articulators using same protrusive record. Materials and Methods: Twenty subjects in the age group of 19-35 years, free from temporomandibular joint dysfunction, and occlusal disharmony, with healthy dentition participated in the study. Hanau H2 (non-arcon type and Hanau Wide-Vue (arcon type articulators were programmed for sagittal condylar guidance values using the same protrusive record made in polysiloxane bite registration material with edge to edge degree of protrusion. The resultant values for both the articulators on either side were compared with values obtained from tracing of digital lateral cephalogram using Kodak Dental imaging Window software 6.6.3.0-C program. The tabulated data were subjected to statistical analysis, ANOVA (Fishers ′F′ test for group comparison, Tukey′s HSD test for inter-comparison, student′s unpaired ′t′ test for intra-group comparison, and level of significance (P was calculated using the same. Results: The mean sagittal condylar guidance values of the three different groups were found to be very highly significant (P=0.001 and highly significant (P=0.002 on the right and left sides respectively. There was a very highly significant difference (P=0.001 and highly significant difference (P=0.003 between the arcon and non-arcon group on the right and left side respectively. No significant difference was found between the arcon and cephalometric group (P=0.284 right, P=0.853 left and a statistically significant difference was found between the non-arcon and cephalometric group (P=0.049 right, P=0.015 left. On intragroup comparison there was no statistically significant difference in sagittal condylar values on the right and left sides. Conclusion

  3. Ultrasound Guidance for Botulinum Neurotoxin Chemodenervation Procedures

    Directory of Open Access Journals (Sweden)

    Katharine E. Alter

    2017-12-01

    Full Text Available Injections of botulinum neurotoxins (BoNTs are prescribed by clinicians for a variety of disorders that cause over-activity of muscles; glands; pain and other structures. Accurately targeting the structure for injection is one of the principle goals when performing BoNTs procedures. Traditionally; injections have been guided by anatomic landmarks; palpation; range of motion; electromyography or electrical stimulation. Ultrasound (US based imaging based guidance overcomes some of the limitations of traditional techniques. US and/or US combined with traditional guidance techniques is utilized and or recommended by many expert clinicians; authors and in practice guidelines by professional academies. This article reviews the advantages and disadvantages of available guidance techniques including US as well as technical aspects of US guidance and a focused literature review related to US guidance for chemodenervation procedures including BoNTs injection.

  4. Evaluating Process Effectiveness to Reduce Risk

    Science.gov (United States)

    Shepherd, Christena C.

    2017-01-01

    security; loss of confidence in government; failure of publicly funded projects; damage to the environment; ethics violations, and the list goes on; with local, national and even international consequences. The Plan-Do-Check-Act process, also known as the "process approach" can be used at any time to establish and standardize a process, and it can also be used to check periodically for "process creep" (i.e., informal, unauthorized changes that have occurred over time), any necessary updates and improvements. While ISO 9001 compliance is not mandated for all government agencies, if interpreted correctly, it can be useful in establishing a framework and implementing effective management systems and processes.4 Another method that can be used to evaluate effectiveness is the scorecard definitions in Mallory's Process Management Standard5 as a basis for evaluating work on the process level on effective, and continuously improved and improving processes. With processes on the lower end of the scale, agencies are vulnerable to a great many risks, with employees and managers making up many of the rules as they go, leading to the above listed negative results. Without clear guidance for nominal operations, off-nominal situations can, and do, increase the likelihood of chaos. In an increasingly technical environment, with inter-agency communication and collaboration becoming the norm, agencies need to come to grips with the fact that processes can become rapidly outdated, and that the technical community should take on an increased role in the maturation of the agency's processes. Industry has long known that effective processes are also efficient, and process improvement methods such as Kaizen, Lean, Six Sigma, 5S, and mistake proofing lead to increased productivity, improved quality, and decreased cost. Again, government agencies have different concerns, but inefficiencies and mistakes can have dire and wide reaching consequences for the public that they serve. While no one goes

  5. Assessment of three risk evaluation systems for patients aged ≥70 in East China: performance of SinoSCORE, EuroSCORE II and the STS risk evaluation system.

    Science.gov (United States)

    Shan, Lingtong; Ge, Wen; Pu, Yiwei; Cheng, Hong; Cang, Zhengqiang; Zhang, Xing; Li, Qifan; Xu, Anyang; Wang, Qi; Gu, Chang; Zhang, Yangyang

    2018-01-01

    To assess and compare the predictive ability of three risk evaluation systems (SinoSCORE, EuroSCORE II and the STS risk evaluation system) in patients aged ≥70, and who underwent coronary artery bypass grafting (CABG) in East China. Three risk evaluation systems were applied to 1,946 consecutive patients who underwent isolated CABG from January 2004 to September 2016 in two hospitals. Patients were divided into two subsets according to their age: elderly group (age ≥70) with a younger group (age evaluation system were 0.78(0.64)%, 1.43(1.14)% and 0.78(0.77)%, respectively. SinoSCORE achieved the best discrimination (the area under the receiver operating characteristic curve (AUC) = 0.829), followed by the STS risk evaluation system (AUC = 0.790) and EuroSCORE II (AUC = 0.769) in the entire cohort. In the elderly group, the observed mortality rate was 4.82% while it was 1.38% in the younger group. SinoSCORE (AUC = .829) also achieved the best discrimination in the elderly group, followed by the STS risk evaluation system (AUC = .730) and EuroSCORE II (AUC = 0.640) while all three risk evaluation systems all had good performances in the younger group. SinoSCORE, EuroSCORE II and the STS risk evaluation system all achieved positive calibrations in the entire cohort and subsets. The performance of the three risk evaluation systems was not ideal in the entire cohort. In the elderly group, SinoSCORE appeared to achieve better predictive efficiency than EuroSCORE II and the STS risk evaluation system.

  6. Automated low-thrust guidance for the orbital maneuvering vehicle

    Science.gov (United States)

    Rose, Richard E.; Schmeichel, Harry; Shortwell, Charles P.; Werner, Ronald A.

    1988-01-01

    This paper describes the highly autonomous OMV Guidance Navigation and Control system. Emphasis is placed on a key feature of the design, the low thrust guidance algorithm. The two guidance modes, orbit change guidance and rendezvous guidance, are discussed in detail. It is shown how OMV will automatically transfer from its initial orbit to an arbitrary target orbit and reach a specified rendezvous position relative to the target vehicle.

  7. Designing and evaluating risk-based surveillance systems

    DEFF Research Database (Denmark)

    Willeberg, Preben; Nielsen, Liza Rosenbaum; Salman, Mo

    2012-01-01

    Risk-based surveillance systems reveal occurrence of disease or infection in a sample of population units, which are selected on the basis of risk factors for the condition under study. The purpose of such systems for supporting practical animal disease policy formulations and management decisions...... with prudent use of resources while maintaining acceptable system performance. High-risk category units are selected for testing by identification of the presence of specific high-risk factor(s), while disregarding other factors that might also influence the risk. On this basis we argue that the most...... applicable risk estimate for use in designing and evaluating a risk-based surveillance system would be a crude (unadjusted) relative risk, odds ratio or apparent prevalence. Risk estimates found in the published literature, however, are often the results of multivariable analyses implicitly adjusting...

  8. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.

    Science.gov (United States)

    Lis, Yvonne; Roberts, Melissa H; Kamble, Shital; J Guo, Jeff; Raisch, Dennis W

    2012-12-01

    1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  9. European Lifelong Guidance Policy Network Representatives' Conceptions of the Role of Information and Communication Technologies Related to National Guidance Policies

    Science.gov (United States)

    Kettunen, Jaana; Vuorinen, Raimo; Ruusuvirta, Outi

    2016-01-01

    This article reports findings from a phenomenographic investigation into European Lifelong Guidance Policy Network representatives' conceptions of the role of information and communication technologies (ICT) related to national lifelong guidance policies. The role of ICT in relation to national lifelong guidance policies was conceived as (1)…

  10. Risk identification and evaluation of customer collaboration in product development

    Directory of Open Access Journals (Sweden)

    Xuefeng Zhang

    2015-05-01

    Full Text Available Purpose: The purpose of this paper is to identify risk factors that caused by customer collaboration in new product development systematically, and propose an approach to judge which risk factors are critical and catch substantial attention. Design/methodology/approach: This study identifies risk factors according to the results of case studies of enterprises in china. On this basis, an improved rough number approach is put forward to evaluate the importance of risk factors. Findings: Firstly, classify risk factors into three aspects. Then, present a risk factor set, which include thirty-seven risk factors. At last, determine which risk factors are critical by using an improved rough number approach. Originality/value: Considering there are few researches studying comprehensive risk factors of customer collaboration and assessing them, this paper explores a risk factor set of customer collaboration in product development stage, and proposes a novel approach, which can help to solve the problem of subjective, vague and lack of prior information of evaluation, to evaluate risk factors.

  11. Online thesis guidance management information system

    Science.gov (United States)

    Nasution, T. H.; Pratama, F.; Tanjung, K.; Siregar, I.; Amalia, A.

    2018-03-01

    The development of internet technology in education is still not maximized, especially in the process of thesis guidance between students and lecturers. Difficulties met the lecturers to help students during thesis guidance is the limited communication time and the compatibility of schedule between students and lecturer. To solve this problem, we designed an online thesis guidance management information system that helps students and lecturers to do thesis tutoring process anytime, anywhere. The system consists of a web-based admin app for usage management and an android-based app for students and lecturers.

  12. The use of image-guidance during transsphenoidal pituitary surgery in the United States

    Science.gov (United States)

    Chung, Thomas K.; Riley, Kristen O.

    2015-01-01

    Background: Intraoperative image guidance is a useful modality for transsphenoidal pituitary surgery. However, the outcomes associated with this technology have not been systematically evaluated. Objective: The purpose of the study was to quantify complication rates with and without the use of image guidance during transsphenoidal pituitary surgery using a nationwide database with broadly applicable results. Methods: A retrospective analysis of the Nationwide Inpatient Sample was performed from 2007 to 2011. Transsphenoidal pituitary resections for adenomas were identified by International Classification of Diseases-9th Revision, Clinical Modification code. The effect of image guidance on cerebrospinal fluid (CSF) leak complications and cost-benefit was analyzed. Results: A total of 48,848 transsphenoidal pituitary resections were identified, of which 77.5% were partial resections and 22.5% were complete. Pathologic indications included benign (89.3%), malignant primary (0.6%), and malignant secondary (0.4%). Complications included same-stay death (0.4%), CSF leak (8.8%), postoperative CSF rhinorrhea (1.9%), diabetes insipidus (12.4%), and meningitis (0.4%). Image guidance was employed in 7% (n = 3401) of all cases. When analyzed by modality, computed tomography (CT)-assisted procedures had lower CSF rhinorrhea rates (1.1%) compared with cases with no image guidance (1.9%), whereas magnetic resonance (MR)-assisted procedures had the highest rates (2.7%, χ2 p surgery had significantly shorter length of stay (2.9 days) versus no image guidance (3.7 days, p surgery is associated with a lower rate of CSF leak, shorter length of stay, and lower cost compared with patients without image guidance. Further studies that control for severity and extent of disease are warranted to confirm this finding. PMID:25975254

  13. HANDBOOK: HAZARDOUS WASTE INCINERATION MEASUREMENT GUIDANCE

    Science.gov (United States)

    This publication, Volume III of the Hazardous Waste Incineration Guidance Series, contains general guidance to permit writers in reviewing hazardous waste incineration permit applications and trial burn plans. he handbook is a how-to document dealing with how incineration measure...

  14. International comparative analyses of healthcare risk management.

    Science.gov (United States)

    Sun, Niuyun; Wang, Li; Zhou, Jun; Yuan, Qiang; Zhang, Zongjiu; Li, Youping; Liang, Minghui; Cheng, Lan; Gao, Guangming; Cui, Xiaohui

    2011-02-01

    Interpretation of the growing body of global literature on health care risk is compromised by a lack of common understanding and language. This series of articles aims to comprehensively compare laws and regulations, institutional management, and administration of incidence reporting systems on medical risk management in the United Kingdom, the United States, Canada, Australia, and Taiwan, so as to provide evidence and recommendations for health care risk management policy in China. We searched the official websites of the healthcare risk management agencies of the four countries and one district for laws, regulatory documents, research reports, reviews and evaluation forms concerned with healthcare risk management and assessment. Descriptive comparative analysis was performed on relevant documents. A total of 146 documents were included in this study, including 2 laws (1.4%), 17 policy documents (11.6%), 41 guidance documents (28.1%), 37 reviews (25.3%), and 49 documents giving general information (33.6%). The United States government implemented one law and one rule of patient safety management, while the United Kingdom and Australia each issued professional guidances on patient safety improvement. The four countries implemented patient safety management policy on four different levels: national, state/province, hospital, and non-governmental organization. The four countries and one district adopted four levels of patient safety management, and the administration modes can be divided into an "NGO-led mode" represented by the United States and Canada and a "government-led mode" represented by the United Kingdom, Australia, and Taiwan. © 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  15. Report 6: Guidance document. Man-made hazards and Accidental Aircraft Crash hazards modelling and implementation in extended PSA

    International Nuclear Information System (INIS)

    Kahia, S.; Brinkman, H.; Bareith, A.; Siklossy, T.; Vinot, T.; Mateescu, T.; Espargilliere, J.; Burgazzi, L.; Ivanov, I.; Bogdanov, D.; Groudev, P.; Ostapchuk, S.; Zhabin, O.; Stojka, T.; Alzbutas, R.; Kumar, M.; Nitoi, M.; Farcasiu, M.; Borysiewicz, M.; Kowal, K.; Potempski, S.

    2016-01-01

    The goal of this report is to provide guidance on practices to model man-made hazards (mainly external fires and explosions) and accidental aircraft crash hazards and implement them in extended Level 1 PSA. This report is a joint deliverable of work package 21 (WP21) and work package 22 (WP22). The general objective of WP21 is to provide guidance on all of the individual hazards selected at the first ASAMPSA-E End Users Workshop (May 2014, Uppsala, Sweden). The objective of WP22 is to provide the solutions for purposes of different parts of man-made hazards Level 1 PSA fulfilment. This guidance is focusing on man-made hazards, namely: external fires and explosions, and accidental aircraft crash hazards. Guidance developed refers to existing guidance whenever possible. The initial part of guidance (WP21 part) reflects current practices to assess the frequencies for each type of hazards or combination of hazards (including correlated hazards) as initiating event for PSAs. The sources and quality of hazard data, the elements of hazard assessment methodologies and relevant examples are discussed. Classification and criteria to properly assess hazard combinations as well as examples and methods for assessment of these combinations are included in this guidance. In appendixes additional material is presented with the examples of practical approaches to aircraft crash and man-made hazard. The following issues are addressed: 1) Hazard assessment methodologies, including issues related to hazard combinations. 2) Modelling equipment of safety related SSC, 3) HRA, 4) Emergency response, 5) Multi-unit issues. Recommendations and also limitations, gaps identified in the existing methodologies and a list of open issues are included. At all stages of this guidance and especially from an industrial end-user perspective, one must keep in mind that the development of man-made hazards probabilistic analysis must be conditioned to the ability to ultimately obtain a representative risk

  16. Integrated risk information system (IRIS)

    Energy Technology Data Exchange (ETDEWEB)

    Tuxen, L. [Environmental Protection Agency, Washington, DC (United States)

    1990-12-31

    The Integrated Risk Information System (IRIS) is an electronic information system developed by the US Environmental Protection Agency (EPA) containing information related to health risk assessment. IRIS is the Agency`s primary vehicle for communication of chronic health hazard information that represents Agency consensus following comprehensive review by intra-Agency work groups. The original purpose for developing IRIS was to provide guidance to EPA personnel in making risk management decisions. This original purpose for developing IRIS was to guidance to EPA personnel in making risk management decisions. This role has expanded and evolved with wider access and use of the system. IRIS contains chemical-specific information in summary format for approximately 500 chemicals. IRIS is available to the general public on the National Library of Medicine`s Toxicology Data Network (TOXNET) and on diskettes through the National Technical Information Service (NTIS).

  17. Current Brachytherapy Quality Assurance Guidance: Does It Meet the Challenges of Emerging Image-Guided Technologies?

    International Nuclear Information System (INIS)

    Williamson, Jeffrey F.

    2008-01-01

    In the past decade, brachytherapy has shifted from the traditional surgical paradigm to more modern three-dimensional image-based planning and delivery approaches. The role of intraoperative and multimodality image-based planning is growing. Published American Association of Physicists in Medicine, American College of Radiology, European Society for Therapeutic Radiology and Oncology, and International Atomic Energy Agency quality assurance (QA) guidelines largely emphasize the QA of planning and delivery devices rather than processes. These protocols have been designed to verify compliance with major performance specifications and are not risk based. With some exceptions, complete and clinically practical guidance exists for sources, QA instrumentation, non-image-based planning systems, applicators, remote afterloading systems, dosimetry, and calibration. Updated guidance is needed for intraoperative imaging systems and image-based planning systems. For non-image-based brachytherapy, the American Association of Physicists in Medicine Task Group reports 56 and 59 provide reasonable guidance on procedure-specific process flow and QA. However, improved guidance is needed even for established procedures such as ultrasound-guided prostate implants. Adaptive replanning in brachytherapy faces unsolved problems similar to that of image-guided adaptive external beam radiotherapy

  18. UK regulatory standards - the 'Guidance on requirements for authorisation'

    International Nuclear Information System (INIS)

    Williams, C.R.

    1999-01-01

    In the United Kingdom, disposal of radioactive waste requires an authorisation under the Radioactive Substances Act 1993. The power to grant such authorisations rests with the Environment Agency for disposals in England and Wales, and with similar Agencies in Scotland and Northern Ireland - namely the Scottish Environment Protection Agency (SEPA) and the Environment and Heritage Service (EHS) of the Department of the Environment for Northern Ireland. In 1997, following two rounds of consultation, the Environment Agency jointly with SEPA and EHS published a document 'Disposal Facilities on Land for Low and Intermediate Level Radioactive Wastes: Guidance on Requirements for Authorisation' - the GRA document. The GRA document outlines the regulatory framework governing the disposal of radioactive waste, general guidance on procedures, the principles and criteria against which proposals for a disposal facility will be assessed, and the radiological and technical requirements which a facility will be expected to meet. In particular, the document states that, in the period after control is withdrawn, the assessed radiological risk from a facility to a representative member of the potentially exposed group at greatest risk should be consistent with a risk target of 10 -6 per year. The document also specifies the information which a developer will need to provide, to demonstrate that a proposal is consistent with the principles and requirements, and identifies other, non-risk-based, criteria. In March 1997, the Secretary of State for the Environment rejected a planning appeal by United Kingdom Nirex Ltd for an underground Rock Characterisation Facility located near Sellafield in Cumbria. That decision has effectively delayed the construction of any deep repository in the UK. Subsequently a House of Lords Select Committee has commenced a major review of nuclear waste management. The Environment Agency continues to be responsible for the authorisation of the shallow

  19. Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients: A Guidance Report and Clinical Checklist by the Consensus on Managing Modifiable Risk in Transplantation (COMMIT) Group.

    Science.gov (United States)

    Neuberger, James M; Bechstein, Wolf O; Kuypers, Dirk R J; Burra, Patrizia; Citterio, Franco; De Geest, Sabina; Duvoux, Christophe; Jardine, Alan G; Kamar, Nassim; Krämer, Bernhard K; Metselaar, Herold J; Nevens, Frederik; Pirenne, Jacques; Rodríguez-Perálvarez, Manuel L; Samuel, Didier; Schneeberger, Stefan; Serón, Daniel; Trunečka, Pavel; Tisone, Giuseppe; van Gelder, Teun

    2017-04-01

    Short-term patient and graft outcomes continue to improve after kidney and liver transplantation, with 1-year survival rates over 80%; however, improving longer-term outcomes remains a challenge. Improving the function of grafts and health of recipients would not only enhance quality and length of life, but would also reduce the need for retransplantation, and thus increase the number of organs available for transplant. The clinical transplant community needs to identify and manage those patient modifiable factors, to decrease the risk of graft failure, and improve longer-term outcomes.COMMIT was formed in 2015 and is composed of 20 leading kidney and liver transplant specialists from 9 countries across Europe. The group's remit is to provide expert guidance for the long-term management of kidney and liver transplant patients, with the aim of improving outcomes by minimizing modifiable risks associated with poor graft and patient survival posttransplant.The objective of this supplement is to provide specific, practical recommendations, through the discussion of current evidence and best practice, for the management of modifiable risks in those kidney and liver transplant patients who have survived the first postoperative year. In addition, the provision of a checklist increases the clinical utility and accessibility of these recommendations, by offering a systematic and efficient way to implement screening and monitoring of modifiable risks in the clinical setting.

  20. On the design of fuzzified trajectory shaping guidance law.

    Science.gov (United States)

    Lin, Chun-Liang; Lin, Yu-Ping; Chen, Kai-Ming

    2009-04-01

    Midcourse guidance is commonly designed to save as much energy as possible so that the missile's final speed can be maximized while entering the homing stage. For this purpose, a competitive guidance design should be able to generate an admissible flight trajectory as to bring the interceptor to a superior altitude for a favorable target engagement. In this paper, a new adaptive trajectory shaping guidance scheme based on the adaptive fuzzy inference system, which is capable of generating a variety of trajectories for efficient target interception, is presented. The guidance law is developed with the aim of saving the interceptor's energy conservation while improving performance robustness. Applications of the presented approach have included a variety of mission oriented guidance, such as cruise missile guidance, anti-ballistic missile guidance, etc.

  1. Cone Beam Computed Tomography Guidance for Setup of Patients Receiving Accelerated Partial Breast Irradiation

    International Nuclear Information System (INIS)

    White, Elizabeth A.; Cho, John; Vallis, Katherine A.; Sharpe, Michael B.; Lee, Grace B.Sc.; Blackburn, Helen; Nageeti, Tahani; McGibney, Carol; Jaffray, David A.

    2007-01-01

    Purpose: To evaluate the role of cone-beam CT (CBCT) guidance for setup error reduction and soft tissue visualization in accelerated partial breast irradiation (APBI). Methods and Materials: Twenty patients were recruited for the delivery of radiotherapy to the postoperative cavity (3850 cGy in 10 fractions over 5 days) using an APBI technique. Cone-beam CT data sets were acquired after an initial skin-mark setup and before treatment delivery. These were registered online using the ipsilateral lung and external contours. Corrections were executed for translations exceeding 3 mm. The random and systematic errors associated with setup using skin-marks and setup using CBCT guidance were calculated and compared. Results: A total of 315 CBCT data sets were analyzed. The systematic errors for the skin-mark setup were 2.7, 1.7, and 2.4 mm in the right-left, anterior-posterior, and superior-inferior directions, respectively. These were reduced to 0.8, 0.7, and 0.8 mm when CBCT guidance was used. The random errors were reduced from 2.4, 2.2, and 2.9 mm for skin-marks to 1.5, 1.5, and 1.6 mm for CBCT guidance in the right-left, anterior-posterior, and superior-inferior directions, respectively. Conclusion: A skin-mark setup for APBI patients is sufficient for current planning target volume margins for the population of patients studied here. Online CBCT guidance minimizes the occurrence of large random deviations, which may have a greater impact for the accelerated fractionation schedule used in APBI. It is also likely to permit a reduction in planning target volume margins and provide skin-line visualization and dosimetric evaluation of cardiac and lung volumes

  2. Risk-benefit evaluation for large technological systems

    International Nuclear Information System (INIS)

    Okrent, D.

    1979-01-01

    The related topics of risk-benefit analysis, risk analysis, and risk-acceptance criteria (How safe is safe enough) are of growing importance. An interdisciplinary study on various aspects of these topics, including applications to nuclear power, was recently completed at the University of California, Los Angeles (UCLA), with the support of the National Science Foundation. In addition to more than 30 topical reports and various open-literature publications, a final report (UCLA-ENG-7777) to the study, titled ''A Generalized Evaluation Approach to Risk--Benefit for Large Technological Systems and Its Application to Nuclear Power'', was issued in early 1978. This article briefly summarizes portions of the final report dealing with general aspects of risk-benefit methodology, societal knowledge and perception of risk, and risk-acceptance criteria

  3. 76 FR 66925 - Guidance for 1-Hour SO2

    Science.gov (United States)

    2011-10-28

    ...The EPA is announcing an extension of the public comment period for its draft non-binding guidance titled, ``Guidance for 1-Hour SO2 SIP Submissions.'' The draft of the guidance document is currently on the EPA's Web site. The EPA is extending the comment period for an additional 30-day period and invites public comments on this guidance during this period. The EPA plans to issue an updated version of the guidance after reviewing timely submitted comments.

  4. Optimal Aerocapture Guidance

    Data.gov (United States)

    National Aeronautics and Space Administration — The main goal of my research is to develop, implement, verify, and validate an optimal numerical predictor-corrector aerocapture guidance algorithm that is...

  5. Evaluation of allowed outage times (AOTS) from a risk and reliability standpoint

    International Nuclear Information System (INIS)

    Vesely, W.E.

    1989-08-01

    This report describes the basic risks associated with allowed outage times (AOTS), defines strategies for selecting the risks to be quantified, and describes how the risks can be quantified. This report provides a basis for risk-based approaches for regulatory and plant implementation. The AOT risk evaluations can be applied to proposed one-time AOT changes, or to permanent changes. The evaluations can also be used to quantify risks associated with present AOTs, and in establishing AOTs from a risk perspective. The report shows that the standard way of calculating AOT risks in probabilistic risk analyses (PRAs) generally is not sufficient when evaluating all the risks associated with an AOT in order to assess its acceptability. The PRA calculates an average AOT risk which includes the frequency at which the AOT is expected to occur. Other risks associated with an AOT include the single downtime risk, which is the risk incurred when (given) the AOT has occurred. The single downtime risk is generally the most applicable risk in determining the acceptability of the AOT. The single downtime risks are generally much larger than the PRA-averaged risk. For more comprehensive evaluations, both risks should be calculated. The report also describes other risks which can be considered, including personnel and economic risks. Finally, the report discusses the detailed evaluations which are involved in calculating AOT risks, including considerations of uncertainty. (author)

  6. Intussusception in children: Hydrostatic reduction under US guidance - own experience

    International Nuclear Information System (INIS)

    Roik, D.; Brzewski, M.; Biejat, A.; Marcinski, M.

    2008-01-01

    Intussusception in children is a common abdominal emergency. Recent years have brought a New promising method of nonsurgical invagination treatment, hydrostatic reduction under sonographic (US) guidance. The major advantage of this method is lack of the ionized radiation. The aim of our study is to asses the safety and effectiveness of hydrostatic reduction under US guidance used as a first choice method of invagination treatment in our department. >From July 2006 to December 2007, 33 procedures of hydrostatic reduction under US guidance were performed in 27 children, aged from 7 months to 6 years and 10 months. The procedure was performed in US room by radiologist and surgeon with the use of self-constructed set for saline enema. The sedation of patient was routinely performed. The initial procedure was effective in 23 patients (pts) (85%). In 5 pts the recurrence of intussusception occurred and in 3 of them next attempt of the reduction was successful. In 4 cases the initial procedures failed, and those children were operated. Total amount of 6 pts underwent an operation. We do not observe any complications connected with the procedure. Hydrostatic reduction of children intusussception under US-guidance is safe and effective method. Our initial results meet the recommended limits of successful reduction rates. It encouraged us to evaluation and further implementation of this method. Water enema is a first choice method of invagination treatment in our hospital. (authors)

  7. IT Risk register

    OpenAIRE

    Kohout, Karel

    2011-01-01

    The theoretical part of the thesis analyzes several selected methodologies and best-practices related to information technology risks management, with focus on documents and guidance developed by ISACA. It builds a set of ideas and basic requirements for effective model of an IT risk register. Strong emphasis is placed on mapping CobiT 4.1 based Risk IT to COBIT 5. The practical part describes implementation of an exploratory web-based IT risk register in Python programming language utilizing...

  8. The Development of a Lifelong Guidance System in Hungary

    Science.gov (United States)

    Watts, A. G.; Borbely-Pecze, Bors Tibor

    2011-01-01

    The development of a lifelong guidance system in Hungary Systematic work is currently being undertaken in Hungary to develop a lifelong guidance system, in line with principles outlined by leading international organisations. The origins of career guidance in Hungary, and the nature of the current career guidance system, are outlined. The main…

  9. Framework for integrating human and animal data in chemical risk assessment.

    Science.gov (United States)

    Lavelle, Karlene S; Robert Schnatter, A; Travis, Kim Z; Swaen, Gerard M H; Pallapies, Dirk; Money, Chris; Priem, Peter; Vrijhof, Henk

    2012-03-01

    Although regulatory agencies formally encourage the integration of all available data in chemical risk assessment, consistent implementation of this practice has been constrained by the lack of a clear, systematic method for doing so. In this paper, we describe a methodology for evaluating, classifying and integrating human and animal data into the risk assessment process that incorporates: (1) a balanced appraisal of human and animal data, (2) relevance to different stages of the risk assessment process, and (3) accommodation for different data quality requirements. The proposed framework offers a flexible, step-wise approach for determining which set of available data best support the chemical risk assessment that involves the rating and relative ranking of human and animal data quality. The evaluation of human data incorporates seven data quality elements, nature and specificity of the lead effect; evaluation of animal data incorporates data quality and relevance to humans. Results of simulations with selected chemicals previously evaluated in a formal risk assessment generally agreed with existing regulatory guidance. Application of the proposed framework across a wider range of chemical agents will improve transparency of the risk assessment process and validity of results, while informing continuous refinements to this evolving methodology. Copyright © 2012 Elsevier Inc. All rights reserved.

  10. Advanced entry guidance algorithm with landing footprint computation

    Science.gov (United States)

    Leavitt, James Aaron

    The design and performance evaluation of an entry guidance algorithm for future space transportation vehicles is presented. The algorithm performs two functions: on-board trajectory planning and trajectory tracking. The planned longitudinal path is followed by tracking drag acceleration, as is done by the Space Shuttle entry guidance. Unlike the Shuttle entry guidance, lateral path curvature is also planned and followed. A new trajectory planning function for the guidance algorithm is developed that is suitable for suborbital entry and that significantly enhances the overall performance of the algorithm for both orbital and suborbital entry. In comparison with the previous trajectory planner, the new planner produces trajectories that are easier to track, especially near the upper and lower drag boundaries and for suborbital entry. The new planner accomplishes this by matching the vehicle's initial flight path angle and bank angle, and by enforcing the full three-degree-of-freedom equations of motion with control derivative limits. Insights gained from trajectory optimization results contribute to the design of the new planner, giving it near-optimal downrange and crossrange capabilities. Planned trajectories and guidance simulation results are presented that demonstrate the improved performance. Based on the new planner, a method is developed for approximating the landing footprint for entry vehicles in near real-time, as would be needed for an on-board flight management system. The boundary of the footprint is constructed from the endpoints of extreme downrange and crossrange trajectories generated by the new trajectory planner. The footprint algorithm inherently possesses many of the qualities of the new planner, including quick execution, the ability to accurately approximate the vehicle's glide capabilities, and applicability to a wide range of entry conditions. Footprints can be generated for orbital and suborbital entry conditions using a pre

  11. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

  12. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  13. Adapting haptic guidance authority based on user grip

    NARCIS (Netherlands)

    Smisek, J.; Mugge, W.; Smeets, J.B.J.; Van Paassen, M.M.; Schiele, A

    2014-01-01

    Haptic guidance systems support the operator in task execution using additional forces on the input device. Scaling of the guidance forces determines the control authority of the support system. As task complexity may vary, one level of the guidance scaling may be insufficient, and adaptation of the

  14. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ...] Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm...

  15. Image registration assessment in radiotherapy image guidance based on control chart monitoring.

    Science.gov (United States)

    Xia, Wenyao; Breen, Stephen L

    2018-04-01

    Image guidance with cone beam computed tomography in radiotherapy can guarantee the precision and accuracy of patient positioning prior to treatment delivery. During the image guidance process, operators need to take great effort to evaluate the image guidance quality before correcting a patient's position. This work proposes an image registration assessment method based on control chart monitoring to reduce the effort taken by the operator. According to the control chart plotted by daily registration scores of each patient, the proposed method can quickly detect both alignment errors and image quality inconsistency. Therefore, the proposed method can provide a clear guideline for the operators to identify unacceptable image quality and unacceptable image registration with minimal effort. Experimental results demonstrate that by using control charts from a clinical database of 10 patients undergoing prostate radiotherapy, the proposed method can quickly identify out-of-control signals and find special cause of out-of-control registration events.

  16. Study on risk insight for additional ILRT interval extension

    International Nuclear Information System (INIS)

    Seo, M. R.; Hong, S. Y.; Kim, M. K.; Chung, B. S.; Oh, H. C.

    2005-01-01

    In U.S., the containment Integrated Leakage Rate Test (ILRT) interval was extended from 3 times per 10 years to once per 10 years based on NUREG-1493 'Performance-Based Containment Leak-Test Program' in 1995. In September, 2001, ILRT interval was extended up to once per 15 years based on Nuclear Energy Industry (NEI) provisional guidance 'Interim Guidance for Performing Risk Impact Assessments In Support of One-Time Extensions for Containment Integrated Leakage Rate Test Surveillance Intervals'. In Korea, the containment ILRT was performed with 5 year interval. But, in MOST(Ministry of Science and Technology) Notice 2004-15 'Standard for the Leak- Rate Test of the Nuclear Reactor Containment', the extension of the ILRT interval to once per 10 year can be allowed if some conditions are met. So, the safety analysis for the extension of Yonggwang Nuclear (YGN) Unit 1 and 2 ILRT interval extension to once per 10 years was completed based on the methodology in NUREG-1493. But, during review process by regulatory body, KINS, it was required that some various risk insight or index for risk analysis should be developed. So, we began to study NEI interim report for 15 year ILRT interval extension. As previous analysis based on NUREG-1493, MACCS II (MELCOR Accident Consequence Code System) computer code was used for the risk analysis of the population, and the population dose was selected as a reference index for the risk evaluation

  17. Market Microstructure Effects on Firm Default Risk Evaluation

    Directory of Open Access Journals (Sweden)

    Flavia Barsotti

    2016-07-01

    Full Text Available Default probability is a fundamental variable determining the credit worthiness of a firm and equity volatility estimation plays a key role in its evaluation. Assuming a structural credit risk modeling approach, we study the impact of choosing different non parametric equity volatility estimators on default probability evaluation, when market microstructure noise is considered. A general stochastic volatility framework with jumps for the underlying asset dynamics is defined inside a Merton-like structural model. To estimate the volatility risk component of a firm we use high-frequency equity data: market microstructure noise is introduced as a direct effect of observing noisy high-frequency equity prices. A Monte Carlo simulation analysis is conducted to (i test the performance of alternative non-parametric equity volatility estimators in their capability of filtering out the microstructure noise and backing out the true unobservable asset volatility; (ii study the effects of different non-parametric estimation techniques on default probability evaluation. The impact of the non-parametric volatility estimators on risk evaluation is not negligible: a sensitivity analysis defined for alternative values of the leverage parameter and average jumps size reveals that the characteristics of the dataset are crucial to determine which is the proper estimator to consider from a credit risk perspective.

  18. 33 CFR 385.5 - Guidance memoranda.

    Science.gov (United States)

    2010-07-01

    ... ability of the Corps of Engineers, the South Florida Water Management District, and other non-Federal... § 385.5 Guidance memoranda. (a) General. (1) Technical guidance for internal management of Corps of...) General format and content of Project Implementation Reports (§ 385.26(a)); (ii) Instructions for...

  19. Why Guidance Works Better than Punishment.

    Science.gov (United States)

    Gartrell, Dan

    1995-01-01

    Examines how guidance techniques address the full spectrum of intervention methods, from prevention to conflict resolution to long-term management strategies. Discusses how punishment affects both children and teachers. Suggests that to put guidance into practice teachers should: be realistic, tailor activities to each child, practice positive…

  20. 76 FR 61098 - Guidance for 1-Hour SO2

    Science.gov (United States)

    2011-10-03

    ...Notice is hereby given that the EPA has posted its draft non- binding guidance titled, ``Guidance for 1-Hour SO2 NAAQS SIP Submissions'' on its Web site. The EPA invites public comments on this guidance document during the comment period specified below, and plans to issue an updated version of the guidance after reviewing timely submitted comments.

  1. Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

    Science.gov (United States)

    Zannad, Faiez; Stough, Wendy Gattis; Lipicky, Raymond J; Tamargo, Juan; Bakris, George L; Borer, Jeffrey S; Alonso García, Maria de Los Angeles; Hadjadj, Samy; Koenig, Wolfgang; Kupfer, Stuart; McCullough, Peter A; Mosenzon, Ofri; Pocock, Stuart; Scheen, André J; Sourij, Harald; Van der Schueren, Bart; Stahre, Christina; White, William B; Calvo, Gonzalo

    2016-07-01

    The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  2. Health Service use of ionising radiations: Guidance

    International Nuclear Information System (INIS)

    1995-01-01

    This booklet gives outline guidance on the use of ionising radiations in the Health Service in the United Kingdom. Extensive reference is made to documents where more detailed information may be found. The guidance covers general advice on the medical use of ionising radiations, statutory requirements, and guidance on selected Health Service issues such as patient identification procedures, information management systems, deviations from prescribed radiation dose, imaging and radiotherapy. (57 references) (U.K.)

  3. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-26

    ... Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is... Stimulation Systems.'' This guidance document describes a means by which a repetitive transcranial magnetic... guidance document is being immediately implemented as the special control for rTMS systems, but it remains...

  4. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-08-09

    ... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

  5. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...

  6. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...

  7. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

  8. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  9. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  10. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...

  11. Implementation of IAEA Code of Conduct and Guidance – Exporting State Perspective

    International Nuclear Information System (INIS)

    Hayes, T.

    2010-01-01

    Canadian Nuclear Safety Commission (CNSC) is a federal agency reporting to Parliament through Natural Resources Minister It Regulates all nuclear facilities and activities to protect the health, safety and security of persons and the environment, assure that Canada meets its international commitments and obligations on the peaceful use of nuclear energy by Implementation of the IAEA Code and Guidance. There were 99 States committed to the IAEA Code of Conduct (as of July 2010) while 59 States committed to the IAEA Guidance on Import and Export (as of July 2010) Use of risk-informed regulatory processes to optimize resource allocation and decision-making. Canadian Nuclear Safety Commission Control of Radioactive Sources. As such, the Canadian Government is a strong proponent of the establishment and maintenance of an effective, efficient and harmonized international regime for ensuring the safety and security of such sources

  12. Approved Risk Evaluation and Mitigation Strategies

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to...

  13. Coral Reef Guidance

    Science.gov (United States)

    Guidance prepared by EPA and Army Corps of Engineers concerning coral reef protection under the Clean Water Act, Marine Protection, Research, and Sanctuaries Act, Rivers and Harbors Act, and Federal Project Authorities.

  14. RMP Guidance for Chemical Distributors - Appendix D: OSHA Guidance on PSM

    Science.gov (United States)

    Guidance on the Process Safety Management standard says information (including MSDS) about chemicals, including process intermediates, must enable accurate assessment of fire/explosion characteristics, reactivity hazards, and corrosing/erosion effects.

  15. Clinical risk and depression (continuing education credit).

    Science.gov (United States)

    Sharkey, S

    1997-01-22

    This article provides information and guidance to nurses on clinical risks in mental health, particularly that of depression. It relates to UKCC professional development category: Reducing risk and Care enhancement.

  16. Conducting systematic reviews of economic evaluations.

    Science.gov (United States)

    Gomersall, Judith Streak; Jadotte, Yuri Tertilus; Xue, Yifan; Lockwood, Suzi; Riddle, Dru; Preda, Alin

    2015-09-01

    In 2012, a working group was established to review and enhance the Joanna Briggs Institute (JBI) guidance for conducting systematic review of evidence from economic evaluations addressing a question(s) about health intervention cost-effectiveness. The objective is to present the outcomes of the working group. The group conducted three activities to inform the new guidance: review of literature on the utility/futility of systematic reviews of economic evaluations and consideration of its implications for updating the existing methodology; assessment of the critical appraisal tool in the existing guidance against criteria that promotes validity in economic evaluation research and two other commonly used tools; and a workshop. The debate in the literature on the limitations/value of systematic review of economic evidence cautions that systematic reviews of economic evaluation evidence are unlikely to generate one size fits all answers to questions about the cost-effectiveness of interventions and their comparators. Informed by this finding, the working group adjusted the framing of the objectives definition in the existing JBI methodology. The shift is away from defining the objective as to determine one cost-effectiveness measure toward summarizing study estimates of cost-effectiveness and informed by consideration of the included study characteristics (patient, setting, intervention component, etc.), identifying conditions conducive to lowering costs and maximizing health benefits. The existing critical appraisal tool was included in the new guidance. The new guidance includes the recommendation that a tool designed specifically for the purpose of appraising model-based studies be used together with the generic appraisal tool for economic evaluations assessment to evaluate model-based evaluations. The guidance produced by the group offers reviewers guidance for each step of the systematic review process, which are the same steps followed in JBI reviews of other

  17. Risk-based SMA for Cubesats

    Science.gov (United States)

    Leitner, Jesse

    2016-01-01

    This presentation conveys an approach for risk-based safety and mission assurance applied to cubesats. This presentation accompanies a NASA Goddard standard in development that provides guidance for building a mission success plan for cubesats based on the risk tolerance and resources available.

  18. General scientific guidance for stakeholders on health claim applications

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2016-01-01

    of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5, 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need...... based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, when additional issues are addressed.......The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to update the General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims published in March 2011. Since then, the NDA Panel has completed the evaluation...

  19. Cochrane Qualitative and Implementation Methods Group guidance series-paper 6: reporting guidelines for qualitative, implementation, and process evaluation evidence syntheses.

    Science.gov (United States)

    Flemming, Kate; Booth, Andrew; Hannes, Karin; Cargo, Margaret; Noyes, Jane

    2018-05-01

    To outline contemporary and novel developments for the presentation and reporting of syntheses of qualitative, implementation, and process evaluation evidence and provide recommendations for the use of reporting guidelines. An overview of reporting guidelines for qualitative, implementation, and process evaluation evidence syntheses drawing on current international literature and the collective expert knowledge of the Cochrane Qualitative and Implementation Methods Group. Several reporting guidelines exist that can be used or adapted to report syntheses of qualitative, implementation, and process evaluation evidence. Methods to develop individual guidance varied. The use of a relevant reporting guideline can enhance the transparency, consistency, and quality of reporting. Guidelines that exist are generic, method specific, and for particular aspects of the reviewing process, searching. Caution is expressed over the potential for reporting guidelines to produce a mechanistic approach moving the focus away from the content and toward the procedural aspects of the review. The use of a reporting guideline is recommended and a five-step decision flowchart to guide the choice of reporting guideline is provided. Gaps remain in method-specific reporting guidelines such as mixed-study, implementation, and process evaluation evidence syntheses. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Risk for Travelers

    Science.gov (United States)

    ... publish guidance in 1999 and 2002 outlining a geography-based donor deferral policy to reduce the risk ... supplies [the Over Thirty Month (OTM) rule], was applied in the UK and appeared to be highly ...

  1. Guidance Counsellor Strategies for Handling Bullying

    Science.gov (United States)

    Power-Elliott, Michleen; Harris, Gregory E.

    2012-01-01

    The purpose of this exploratory-descriptive study was to examine how guidance counsellors in the province of Newfoundland and Labrador would handle a specific verbal-relational bullying incident. Also of interest was guidance counsellor involvement and training in bullying programmes and Positive Behaviour Supports. Data for this study was…

  2. Robot-assisted endoscope guidance versus manual endoscope guidance in functional endonasal sinus surgery (FESS).

    Science.gov (United States)

    Eichhorn, Klaus Wolfgang; Westphal, Ralf; Rilk, Markus; Last, Carsten; Bootz, Friedrich; Wahl, Friedrich; Jakob, Mark; Send, Thorsten

    2017-10-01

    Having one hand occupied with the endoscope is the major disadvantage for the surgeon when it comes to functional endoscopic sinus surgery (FESS). Only the other hand is free to use the surgical instruments. Tiredness or frequent instrument changes can thus lead to shaky endoscopic images. We collected the pose data (position and orientation) of the rigid 0° endoscope and all the instruments used in 16 FESS procedures with manual endoscope guidance as well as robot-assisted endoscope guidance. In combination with the DICOM CT data, we tracked the endoscope poses and workspaces using self-developed tracking markers. All surgeries were performed once with the robot and once with the surgeon holding the endoscope. Looking at the durations required, we observed a decrease in the operating time because one surgeon doing all the procedures and so a learning curve occurred what we expected. The visual inspection of the specimens showed no damages to any of the structures outside the paranasal sinuses. Robot-assisted endoscope guidance in sinus surgery is possible. Further CT data, however, are desirable for the surgical analysis of a tracker-based navigation within the anatomic borders. Our marker-based tracking of the endoscope as well as the instruments makes an automated endoscope guidance feasible. On the subjective side, we see that RASS brings a relief for the surgeon.

  3. 75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

    Science.gov (United States)

    2010-06-22

    ... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...

  4. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  5. Sustainability Risk Evaluation for Large-Scale Hydropower Projects with Hybrid Uncertainty

    Directory of Open Access Journals (Sweden)

    Weiyao Tang

    2018-01-01

    Full Text Available As large-scale hydropower projects are influenced by many factors, risk evaluations are complex. This paper considers a hydropower project as a complex system from the perspective of sustainability risk, and divides it into three subsystems: the natural environment subsystem, the eco-environment subsystem and the socioeconomic subsystem. Risk-related factors and quantitative dimensions of each subsystem are comprehensively analyzed considering uncertainty of some quantitative dimensions solved by hybrid uncertainty methods, including fuzzy (e.g., the national health degree, the national happiness degree, the protection of cultural heritage, random (e.g., underground water levels, river width, and fuzzy random uncertainty (e.g., runoff volumes, precipitation. By calculating the sustainability risk-related degree in each of the risk-related factors, a sustainable risk-evaluation model is built. Based on the calculation results, the critical sustainability risk-related factors are identified and targeted to reduce the losses caused by sustainability risk factors of the hydropower project. A case study at the under-construction Baihetan hydropower station is presented to demonstrate the viability of the risk-evaluation model and to provide a reference for the sustainable risk evaluation of other large-scale hydropower projects.

  6. Three-dimensional Image Fusion Guidance for Transjugular Intrahepatic Portosystemic Shunt Placement.

    Science.gov (United States)

    Tacher, Vania; Petit, Arthur; Derbel, Haytham; Novelli, Luigi; Vitellius, Manuel; Ridouani, Fourat; Luciani, Alain; Rahmouni, Alain; Duvoux, Christophe; Salloum, Chady; Chiaradia, Mélanie; Kobeiter, Hicham

    2017-11-01

    To assess the safety, feasibility and effectiveness of image fusion guidance with pre-procedural portal phase computed tomography with intraprocedural fluoroscopy for transjugular intrahepatic portosystemic shunt (TIPS) placement. All consecutive cirrhotic patients presenting at our interventional unit for TIPS creation from January 2015 to January 2016 were prospectively enrolled. Procedures were performed under general anesthesia in an interventional suite equipped with flat panel detector, cone-beam computed tomography (CBCT) and image fusion technique. All TIPSs were placed under image fusion guidance. After hepatic vein catheterization, an unenhanced CBCT acquisition was performed and co-registered with the pre-procedural portal phase CT images. A virtual path between hepatic vein and portal branch was made using the virtual needle path trajectory software. Subsequently, the 3D virtual path was overlaid on 2D fluoroscopy for guidance during portal branch cannulation. Safety, feasibility, effectiveness and per-procedural data were evaluated. Sixteen patients (12 males; median age 56 years) were included. Procedures were technically feasible in 15 of the 16 patients (94%). One procedure was aborted due to hepatic vein catheterization failure related to severe liver distortion. No periprocedural complications occurred within 48 h of the procedure. The median dose-area product was 91 Gy cm 2 , fluoroscopy time 15 min, procedure time 40 min and contrast media consumption 65 mL. Clinical benefit of the TIPS placement was observed in nine patients (56%). This study suggests that 3D image fusion guidance for TIPS is feasible, safe and effective. By identifying virtual needle path, CBCT enables real-time multiplanar guidance and may facilitate TIPS placement.

  7. Healthy habits: what kind of guidance the elderly population is receiving from health professionals?

    Science.gov (United States)

    Flores, Thaynã Ramos; Nunes, Bruno Pereira; Assunção, Maria Cecília Formoso; Bertoldi, Andréa Dâmaso

    2016-03-01

    To describe the prevalence of guidance on healthy habits received from health professionals by elderly and its relation to socioeconomic demographic, behavioral and health indicators, and the type of services. Cross sectional population based study including individuals aged 60 years or more in the urban area of Pelotas, Rio Grande do Sul, Brazil. Seven guidance on healthy habits were evaluated: weight control, reduction in salt, sugar and fat intake, physical activity practice, not smoking and not drinking alcohol. Among the 1,451 elderly interviewed, 1,281 (88.3%) consulted in the last year. The orientations more refereed were to fat (61.7%) and salt (61.5%) intake reduction and physical activity (58.2%). Elderly who consulted three times or more and in services financed by the Unified Health System received more guidance. Those elderly from the socioeconomic classes A/B were more likely to receive guidance for weight control (RP = 1.27; 95%CI 1.06 - 1.70) and physical activity (RP = 1.34; 95%CI 1.06 - 1.69). The orientation from health professionals were uncommon and, in some cases, unfocused.

  8. attitude of secondary school students towards guidance

    African Journals Online (AJOL)

    Elizabeth Egbochuku

    gender and school location significantly influenced students' attitude towards guidance ... students respond and perceive guidance and counselling services will, to ... counsellors will be appointed in post-primary institutions and tertiary levels.

  9. Information architecture. Volume 3: Guidance

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-04-01

    The purpose of this document, as presented in Volume 1, The Foundations, is to assist the Department of Energy (DOE) in developing and promulgating information architecture guidance. This guidance is aimed at increasing the development of information architecture as a Departmentwide management best practice. This document describes departmental information architecture principles and minimum design characteristics for systems and infrastructures within the DOE Information Architecture Conceptual Model, and establishes a Departmentwide standards-based architecture program. The publication of this document fulfills the commitment to address guiding principles, promote standard architectural practices, and provide technical guidance. This document guides the transition from the baseline or defacto Departmental architecture through approved information management program plans and budgets to the future vision architecture. This document also represents another major step toward establishing a well-organized, logical foundation for the DOE information architecture.

  10. Virtual Ultrasound Guidance for Inexperienced Operators

    Science.gov (United States)

    Caine, Timothy; Martin, David

    2012-01-01

    Medical ultrasound or echocardiographic studies are highly operator-dependent and generally require lengthy training and internship to perfect. To obtain quality echocardiographic images in remote environments, such as on-orbit, remote guidance of studies has been employed. This technique involves minimal training for the user, coupled with remote guidance from an expert. When real-time communication or expert guidance is not available, a more autonomous system of guiding an inexperienced operator through an ultrasound study is needed. One example would be missions beyond low Earth orbit in which the time delay inherent with communication will make remote guidance impractical. The Virtual Ultrasound Guidance system is a combination of hardware and software. The hardware portion includes, but is not limited to, video glasses that allow hands-free, full-screen viewing. The glasses also allow the operator a substantial field of view below the glasses to view and operate the ultrasound system. The software is a comprehensive video program designed to guide an inexperienced operator through a detailed ultrasound or echocardiographic study without extensive training or guidance from the ground. The program contains a detailed description using video and audio to demonstrate equipment controls, ergonomics of scanning, study protocol, and scanning guidance, including recovery from sub-optimal images. The components used in the initial validation of the system include an Apple iPod Classic third-generation as the video source, and Myvue video glasses. Initially, the program prompts the operator to power-up the ultrasound and position the patient. The operator would put on the video glasses and attach them to the video source. After turning on both devices and the ultrasound system, the audio-video guidance would then instruct on patient positioning and scanning techniques. A detailed scanning protocol follows with descriptions and reference video of each view along with

  11. 78 FR 5816 - Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical...

    Science.gov (United States)

    2013-01-28

    .... The guidance provides recommendations on when and how genomic principles should be considered and... recommendations on when and how genomic principles should be considered and applied in early-phase clinical... the larger, later adequate, and well-controlled trials (phase 3) that are needed to support marketing...

  12. Career Guidance and Public Mental Health

    Science.gov (United States)

    Robertson, Peter J.

    2013-01-01

    Career guidance may have the potential to promote public health by contributing positively to both the prevention of mental health conditions and to population level well-being. The policy implications of this possibility have received little attention. Career guidance agencies are well placed to reach key target groups. Producing persuasive…

  13. The vision guidance and image processing of AGV

    Science.gov (United States)

    Feng, Tongqing; Jiao, Bin

    2017-08-01

    Firstly, the principle of AGV vision guidance is introduced and the deviation and deflection angle are measured by image coordinate system. The visual guidance image processing platform is introduced. In view of the fact that the AGV guidance image contains more noise, the image has already been smoothed by a statistical sorting. By using AGV sampling way to obtain image guidance, because the image has the best and different threshold segmentation points. In view of this situation, the method of two-dimensional maximum entropy image segmentation is used to solve the problem. We extract the foreground image in the target band by calculating the contour area method and obtain the centre line with the least square fitting algorithm. With the help of image and physical coordinates, we can obtain the guidance information.

  14. Integrating mechanisms of visual guidance in naturalistic language production.

    Science.gov (United States)

    Coco, Moreno I; Keller, Frank

    2015-05-01

    Situated language production requires the integration of visual attention and linguistic processing. Previous work has not conclusively disentangled the role of perceptual scene information and structural sentence information in guiding visual attention. In this paper, we present an eye-tracking study that demonstrates that three types of guidance, perceptual, conceptual, and structural, interact to control visual attention. In a cued language production experiment, we manipulate perceptual (scene clutter) and conceptual guidance (cue animacy) and measure structural guidance (syntactic complexity of the utterance). Analysis of the time course of language production, before and during speech, reveals that all three forms of guidance affect the complexity of visual responses, quantified in terms of the entropy of attentional landscapes and the turbulence of scan patterns, especially during speech. We find that perceptual and conceptual guidance mediate the distribution of attention in the scene, whereas structural guidance closely relates to scan pattern complexity. Furthermore, the eye-voice span of the cued object and its perceptual competitor are similar; its latency mediated by both perceptual and structural guidance. These results rule out a strict interpretation of structural guidance as the single dominant form of visual guidance in situated language production. Rather, the phase of the task and the associated demands of cross-modal cognitive processing determine the mechanisms that guide attention.

  15. European Psychiatric Association (EPA) guidance on forensic psychiatry: Evidence based assessment and treatment of mentally disordered offenders.

    Science.gov (United States)

    Völlm, Birgit A; Clarke, Martin; Herrando, Vicenç Tort; Seppänen, Allan O; Gosek, Paweł; Heitzman, Janusz; Bulten, Erik

    2018-03-20

    Forensic psychiatry in Europe is a specialty primarily concerned with individuals who have either offended or present a risk of doing so, and who also suffer from a psychiatric condition. These mentally disordered offenders (MDOs) are often cared for in secure psychiatric environments or prisons. In this guidance paper we first present an overview of the field of forensic psychiatry from a European perspective. We then present a review of the literature summarising the evidence on the assessment and treatment of MDOs under the following headings: The forensic psychiatrist as expert witness, risk, treatment settings for mentally disordered offenders, and what works for MDOs. We undertook a rapid review of the literature with search terms related to: forensic psychiatry, review articles, randomised controlled trials and best practice. We searched the Medline, Embase, PsycINFO, and Cochrane library databases from 2000 onwards for adult groups only. We scrutinised publications for additional relevant literature, and searched the websites of relevant professional organisations for policies, statements or guidance of interest. We present the findings of the scientific literature as well as recommendations for best practice drawing additionally from the guidance documents identified. We found that the evidence base for forensic-psychiatric practice is weak though there is some evidence to suggest that psychiatric care produces better outcomes than criminal justice detention only. Practitioners need to follow general psychiatric guidance as well as that for offenders, adapted for the complex needs of this patient group, paying particular attention to long-term detention and ethical issues. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  16. [Anterior guidance in complete dentures].

    Science.gov (United States)

    Dubreuil, J; Trevelo, A

    1990-01-01

    Although the anterior guidance in complete dentures is not really a guide, the arrangement of the anterior maxillary and mandibular prosthetic teeth, defines a propulsive line called the virtual anterior guidance, a part from the cinematic criterias. The influence of this guide on cuspal movement is superior, in all mandibular points, to the influence of the condylar pathway. If this line is not respected, the practitioner may have to do excessive grindings during occlusal adjustments.

  17. The determination of allowed outage time using the evaluation of transition risk

    International Nuclear Information System (INIS)

    Kang, D. I.; Kim, K. Y.; Jang, S. C.

    2001-03-01

    he objectives of this study are to propose a new evaluation method for transition risk and to determine the AOT using the new method. We review and compare the evaluation methods of transition risk which was previously studied. We also identify important assumptions used in previous studies for the evaluation of transition risk. We select general items required for the development of evaluation method for the transition risk. Based on the items selected, we propose a new evaluation method for transition risk. The new evaluation method for the transition risk is based on following assumptions; 1)For the same time span, the risk occurred from the failure to the completion of component repair during power operation is the same as the total risk including the risk occurred from power operation to specific shutdown/low power operation and the risk from specific shutdown/low power operation to power operation. 2)Shutdown operation and the repair of components are initiated just after the identification of the failure of components. The evaluation of the transition risk is performed to incorporate the characteristics of shutdown operation into Ulchin Units 3 and 4 Level 1 internal PSA for power operation. The application results of the new method to the HPSIS and the LPSIS for Ulchin Units 3 and 4 show that the AOT of HPSIS is properly determined and the AOT of LPSIS can be greatly increased. In this study, the main factors affecting the determination of AOT using the evaluation for transition risk are identified as the time of shutdown operation, the consideration of the change on common cause failure probability, and the risk of shutdown operation. It is expected that the evaluation method for the transition risk proposed in this study will be used for the determination of AOT and for the decision, in the case of the components unavailable, whether power operation is continuously performed or shutdown operation is initiated

  18. Information risk management a practitioner's guide

    CERN Document Server

    Sutton, David

    2014-01-01

    Information risk management (IRM) is about identifying, assessing and prioritising risks to keep information secure and available. This accessible book provides practical guidance to the principles and development of a strategic approach to an IRM programme. The only textbook for the BCS Practitioner Certificate in Information Risk Management.

  19. Smart Ultrasound Remote Guidance Experiment (SURGE) Preliminary Findings

    Science.gov (United States)

    Hurst, Victor; Dulchavsky, Scott; Garcia, Kathleen; Sargsyan, Ashot; Ebert, Doug

    2009-01-01

    To date, diagnostic quality ultrasound images were obtained aboard the International Space Station (ISS) using the ultrasound of the Human Research Facility (HRF) rack in the Laboratory module. Through the Advanced Diagnostic Ultrasound in Microgravity (ADUM) and the Braslet-M Occlusion Cuffs (BRASLET SDTO) studies, non-expert ultrasound operators aboard the ISS have performed cardiac, thoracic, abdominal, vascular, ocular, and musculoskeletal ultrasound assessments using remote guidance from ground-based ultrasound experts. With exploration class missions to the lunar and Martian surfaces on the horizon, crew medical officers will necessarily need to operate with greater autonomy given communication delays (round trip times of up to 5 seconds for the Moon and 90 minutes for Mars) and longer periods of communication blackouts (due to orbital constraints of communication assets). The SURGE project explored the feasibility and training requirements of having non-expert ultrasound operators perform autonomous ultrasound assessments in a simulated exploration mission outpost. The project aimed to identify experience, training, and human factors requirements for crew medical officers to perform autonomous ultrasonography. All of these aims pertained to the following risks from the NASA Bioastronautics Road Map: 1) Risk 18: Major Illness and Trauna; 2) Risk 20) Ambulatory Care; 3) Risk 22: Medical Informatics, Technologies, and Support Systems; and 4) Risk 23: Medical Skill Training and Maintenance.

  20. Buried Waste Integrated Demonstration Technology Preparedness and Status Report Guidance

    International Nuclear Information System (INIS)

    Blacker, P.B.; Bonnenberg, R.W.; Cannon, P.G.; Hyde, R.A.; Watson, L.R.

    1994-04-01

    A Technology Preparedness and Status Report is required for each Technical Task Plan funded by the Buried Waste Integrated Demonstration. This document provides guidance for the preparation of that report. Major sections of the report will include a subset of the need for the technology, objectives of the demonstration, technology description and readiness evaluation, demonstration requirements, and preparedness checklist and action plan

  1. Guidance values for microcystins in water and cyanobacterial supplement products (blue-green algal supplements): a reasonable or misguided approach?

    International Nuclear Information System (INIS)

    Dietrich, Daniel; Hoeger, Stefan

    2005-01-01

    This article reviews current scientific knowledge on the toxicity and carcinogenicity of microcystins and compares this to the guidance values proposed for microcystins in water by the World Health Organization, and for blue-green algal food supplements by the Oregon State Department of Health. The basis of the risk assessment underlying these guidance values is viewed as being critical due to overt deficiencies in the data used for its generation: (i) use of one microcystin congener only (microcystin-LR), while the other presently known nearly 80 congeners are largely disregarded, (ii) new knowledge regarding potential neuro and renal toxicity of microcystins in humans and (iii) the inadequacies of assessing realistic microcystin exposures in humans and especially in children via blue-green algal food supplements. In reiterating the state-of-the-art toxicology database on microcystins and in the light of new data on the high degree of toxin contamination of algal food supplements, this review clearly demonstrates the need for improved kinetic data of microcystins in humans and for discussion concerning uncertainty factors, which may result in a lowering of the present guidance values and an increased routine control of water bodies and food supplements for toxin contamination. Similar to the approach taken previously by authorities for dioxin or PCB risk assessment, the use of a toxin equivalent approach to the risk assessment of microcystins is proposed

  2. RISK ANALYSIS AND EVALUATION FOR CRITICAL LOGISTICAL INFRASTRUCTURE

    Directory of Open Access Journals (Sweden)

    Sascha Düerkop

    2016-12-01

    Full Text Available Logistical infrastructure builds the backbone of an economy. Without an effective logistical infrastructure in place, the supply for both enterprises and consumers might not be met. But even a high-quality logistical infrastructure can be threatened by risks. Thus, it is important to identify, analyse, and evaluate risks for logistical infrastructure that might threaten logistical processes. Only if those risks are known and their impact estimated, decision makers can implement counteractive measures to reduce risks. In this article, we develop a network-based approach that allows for the evaluation of risks and their consequences onto the logistical network. We will demonstrate the relevance of this approach by applying it to the logistics network of the central German state of Hesse. Even though transport data is extensively tracked and recorded nowadays, typical daily risks, like accidents on a motorway, and extraordinary risks, like a bridge at risk to collapse, terrorist attacks or climate-related catastrophes, are not systematically anticipated. Several studies unveiled recently that the overall impact for an economy of possible failures of single nodes and/or edges in a network are not calculated, and particularly critical edges are not identified in advance. We address this information gap by a method that helps to identify and quantify risks in a given network. To reach this objective, we define a mathematical optimization model that quantifies the current “risk-related costs” of the overall network and quantify the risk by investigating the change of the overall costs in the case a risk is realized.

  3. Risk evaluation of accident management strategies

    International Nuclear Information System (INIS)

    Dingman, S.; Camp, A.

    1992-01-01

    The use of Probabilistic Risk Assessment (PRA) methods to evaluate accident management strategies in nuclear power plants discussed in this paper. The PRA framework allows an integrated evaluation to be performed to give the full implications of a particular strategy. The methodology is demonstrated for a particular accident management strategy, intentional depressurization of the reactor coolant system to avoid containment pressurization during the ejection of molten debris at vessel breach

  4. [Differences in attachment and personality in children from child guidance centers, child psychiatry units, and control families].

    Science.gov (United States)

    Zimmermann, Peter; Scheuerer-Englisch, Hermann

    2013-01-01

    Insecure attachment and deficits in self-regulation as personality traits are risk factors for the development of psychopathological symptoms from infancy on. This study examines differences in attachment and personality in late childhood, comparing children from non-clinical families, from a child guidance center, and child psychiatry units with in-patient care. Children's attachment representations, their attachment behavior strategy, reported distressing parental behavior, their emotional openness, and attachment coherency were assessed with the Late Childhood Attachment Interview (LCAI). Ego-resiliency, ego-undercontrol, field-independence, aggressiveness, and anxiety were assessed by means of the California Child Q-Sort. The results show clear attachment differences, with the child guidance group showing more attachment insecurity in the LCAI compared to the control group, and the psychiatric in-patient group even more attachment insecurity, more distressing parenting from both mother and father, and more attachment disorganization than the other two groups. Whereas children from the child guidance center and the child psychiatry unit did not differ in personality, both groups were significantly different from the control group in all personality dimensions. The results suggest that personality differences may be a risk factor for behaviour problems, however problem severity and the choice of the treatment institution seem to be influenced by attachment security.

  5. 48 CFR 427.104 - General guidance.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false General guidance. 427.104... REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS General 427.104 General guidance. As used in FAR part 27, the agency head or agency head designee is the Senior Procurement Executive, except under FAR 27.306(a) and (b...

  6. Overall strategy for risk evaluation and priority setting of risk regulations

    International Nuclear Information System (INIS)

    Hokstad, Per; Steiro, Trygve

    2006-01-01

    This paper presents the framework of an approach to support planning and priority setting for risk control. Such an approach could assist government/regulatory authorities in their allocation of resources among different sectors. The term risk will here be used in a very wide sense, and it will include, but not restrict to, the traditional HES (Health, Environment and Safety) concept. An overall classification of risk ('loss categories'), to be used across sectors and directorates is suggested. The risk evaluation includes a number of factors not accounted for in a standard risk assessment, but should be taken into account when authorities set priorities regarding risk control. Sociological, psychological and ethical perspectives are included, and the need for a discourse during the decision process is pinpointed. The paper also discusses the potential inclusion of cost benefit analyses in such an approach. The indicated approach is denoted Risk Across Sectors (RAS), and suggestions regarding the process to implement it are given. Such an implementation process will by itself increase the knowledge and competence of the involved parties

  7. Assessment of the effectiveness of guidance services in senior ...

    African Journals Online (AJOL)

    Guidance Service Assessment Questionnaire for Teacher/Students (GSAQTS) was used to measure the extent of guidance services and their perception of it. ... to counsellor, and a misconception of the counsellors role has made guidance ...

  8. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Science.gov (United States)

    2013-09-20

    ... the endocrine system. This draft guidance also discusses factors to consider in determining the need... interfere with some aspect of the endocrine system of an organism or its progeny. Any component of the endocrine system can be a target of endocrine disruptors, although the systems most commonly affected...

  9. Guidance documents relating to landfills and contaminants

    Energy Technology Data Exchange (ETDEWEB)

    Schomaker, N.B.; Zunt, D.A.

    1990-01-01

    The Environmental Protection Agency is developing and updating a series of Technical Guidance Documents to provide best engineering control technology to meet the needs of the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), respectively. These documents are the compilation of the research efforts to date relating to containment of pollutants from waste disposal to the land as relates to residuals management. The specific areas of research being conducted under the RCRA land disposal program relates to laboratory, pilot and field validation studies in cover systems, waste leaching and solidification, liner systems and disposal facility evaluation. The specific areas of research being conducted under the CERCLA uncontrolled waste sites (Superfund) program relate to in situ treatment, solidification/stabilization for treating hazardous waste, combustion technologies, best demonstrated available technology (BDAT), on-site treatment technologies, emerging biosystems, expert systems, personnel health protection equipment, and site and situation assessment. The Guidance Documents are intended to assist both the regulated community and the permitting authorities, as well as the Program Offices, and Regions, as well as the states and other interested parties, with the latest information relevant to waste management.

  10. New Department of Energy policy and guidance for cost-effectiveness in nuclear materials control and accountability programs

    International Nuclear Information System (INIS)

    Van Ryn, G.L.; Zack, N.R.

    1994-01-01

    Recent Department of Energy (DOE) initiatives have given Departmental nuclear facilities the opportunity to take more credit for certain existing safeguards and security systems in determining operational program protection requirements. New policies and guidance are coupled with these initiatives to enhance systems performance in a cost effective and efficient manner as well as to reduce operational costs. The application of these methods and technologies support safety, the reduction of personnel radiation exposure, emergency planning, and inspections by international teams. This discussion will review guidance and policies that support advanced systems and programs to decrease lifetime operational costs without increasing risk

  11. Risk management study for the retired Hanford Site facilities: Qualitative risk evaluation for the retired Hanford Site facilities

    International Nuclear Information System (INIS)

    Coles, G.A.; Shultz, M.V.; Taylor, W.E.

    1993-09-01

    This document provides a risk evaluation of the 100 and 200 Area retired, surplus facilities on the Hanford Site. Also included are the related data that were compiled by the risk evaluation team during investigations performed on the facilities. Results are the product of a major effort performed in fiscal year 1993 to produce qualitative information that characterizes certain risks associated with these facilities. The retired facilities investigated for this evaluation are located in the 100 and 200 Areas of the 1,450-km 2 (570-mi 2 ) Hanford Site. The Hanford Site is a semiarid tract of land in southeastern Washington State. The nearest population center is Richland, Washington, (population 32,000) 30-km (20 mi) southeast of the 200 Area. During walkdown investigations of these facilities, data on real and potential hazards that threatened human health or safety or created potential environmental release issues were identified by the risk evaluation team. Using these findings, the team categorized the identified hazards by facility and evaluated the risk associated with each hazard. The factors contributing to each risk, and the consequence and likelihood of harm associated with each hazard also are included in this evaluation

  12. Key Success Factors and Guidance for International Collaborative Design Projects

    Directory of Open Access Journals (Sweden)

    Robby Soetanto

    2015-11-01

    Full Text Available In the built environment (BE sector, the co-creation process of design demands understanding of requirements (as viewed by parties involved, mobilisation of tacit knowledge, negotiation, and complex exchange of information. The need to collaborate over distance has further exacerbated the complexity of the process, and, in itself, represents a significant challenge for BE professionals who are increasingly expected to undertake this process within globally distributed virtual teams. The research aims to identify key success factors and develop guidance for international collaborative design projects, via the implementation of collaborative design courses in UK and Canadian universities over three academic years. Questionnaire surveys, focus groups, observation of online meetings, personal reflections provided data for the analysis. The findings reveal the significance of the perceived risk of collaboration and a difference in preferred communication mode between architects and civil/structural engineers. These findings suggest the impact of training in the subject discipline, and that the opportunity for co-located working has helped the development of trust. The guidance is aimed at BE educators who wish to implement this activity in their courses.

  13. A Scalable Distribution Network Risk Evaluation Framework via Symbolic Dynamics

    Science.gov (United States)

    Yuan, Kai; Liu, Jian; Liu, Kaipei; Tan, Tianyuan

    2015-01-01

    Background Evaluations of electric power distribution network risks must address the problems of incomplete information and changing dynamics. A risk evaluation framework should be adaptable to a specific situation and an evolving understanding of risk. Methods This study investigates the use of symbolic dynamics to abstract raw data. After introducing symbolic dynamics operators, Kolmogorov-Sinai entropy and Kullback-Leibler relative entropy are used to quantitatively evaluate relationships between risk sub-factors and main factors. For layered risk indicators, where the factors are categorized into four main factors – device, structure, load and special operation – a merging algorithm using operators to calculate the risk factors is discussed. Finally, an example from the Sanya Power Company is given to demonstrate the feasibility of the proposed method. Conclusion Distribution networks are exposed and can be affected by many things. The topology and the operating mode of a distribution network are dynamic, so the faults and their consequences are probabilistic. PMID:25789859

  14. MRI-guidance in percutaneous core decompression of osteonecrosis of the femoral head

    Energy Technology Data Exchange (ETDEWEB)

    Kerimaa, Pekka; Vaeaenaenen, Matti; Ojala, Risto; Tervonen, Osmo; Blanco Sequeiros, Roberto [Oulu University Hospital, Department of Radiology (Finland); Hyvoenen, Pekka; Lehenkari, Petri [Oulu University Hospital, Department of Surgery (Finland)

    2016-04-15

    The purpose of this study was to evaluate the usefulness of MRI-guidance for core decompression of avascular necrosis of the femoral head. Twelve MRI-guided core decompressions were performed on patients with different stages of avascular necrosis of the femoral head. The patients were asked to evaluate their pain and their ability to function before and after the procedure and imaging findings were reviewed respectively. Technical success in reaching the target was 100 % without complications. Mean duration of the procedure itself was 54 min. All patients with ARCO stage 1 osteonecrosis experienced clinical benefit and pathological MRI findings were seen to diminish. Patients with more advanced disease gained less, if any, benefit and total hip arthroplasty was eventually performed on four patients. MRI-guidance seems technically feasible, accurate and safe for core decompression of avascular necrosis of the femoral head. Patients with early stage osteonecrosis may benefit from the procedure. (orig.)

  15. MRI-guidance in percutaneous core decompression of osteonecrosis of the femoral head

    International Nuclear Information System (INIS)

    Kerimaa, Pekka; Vaeaenaenen, Matti; Ojala, Risto; Tervonen, Osmo; Blanco Sequeiros, Roberto; Hyvoenen, Pekka; Lehenkari, Petri

    2016-01-01

    The purpose of this study was to evaluate the usefulness of MRI-guidance for core decompression of avascular necrosis of the femoral head. Twelve MRI-guided core decompressions were performed on patients with different stages of avascular necrosis of the femoral head. The patients were asked to evaluate their pain and their ability to function before and after the procedure and imaging findings were reviewed respectively. Technical success in reaching the target was 100 % without complications. Mean duration of the procedure itself was 54 min. All patients with ARCO stage 1 osteonecrosis experienced clinical benefit and pathological MRI findings were seen to diminish. Patients with more advanced disease gained less, if any, benefit and total hip arthroplasty was eventually performed on four patients. MRI-guidance seems technically feasible, accurate and safe for core decompression of avascular necrosis of the femoral head. Patients with early stage osteonecrosis may benefit from the procedure. (orig.)

  16. Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances

    Science.gov (United States)

    Matthiessen, Peter; Ankley, Gerald T.; Biever, Ronald C.; Bjerregaard, Poul; Borgert, Christopher; Brugger, Kristin; Blankinship, Amy; Chambers, Janice; Coady, Katherine K.; Constantine, Lisa; Dang, Zhichao; Denslow, Nancy D.; Dreier, David; Dungey, Steve; Gray, L. Earl; Gross, Melanie; Guiney, Patrick D.; Hecker, Markus; Holbech, Henrik; Iguchi, Taisen; Kadlec, Sarah; Karouna-Renier, Natalie K.; Katsiadaki, Ioanna; Kawashima, Yukio; Kloas, Werner; Krueger, Henry; Kumar, Anu; Lagadic, Laurent; Leopold, Annegaaike; Levine, Steven L.; Maack, Gerd; Marty, Sue; Meador, James P.; Mihaich, Ellen; Odum, Jenny; Ortego, Lisa; Parrott, Joanne L.; Pickford, Daniel; Roberts, Mike; Schaefers, Christoph; Schwarz, Tamar; Solomon, Keith; Verslycke, Tim; Weltje, Lennart; Wheeler, James R.; Williams, Mike; Wolf, Jeffery C.; Yamazaki, Kunihiko

    2017-01-01

    A SETAC Pellston Workshop® “Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)” was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS. Case studies were undertaken on 6 endocrine-active substances (EAS—not necessarily proven EDS, but substances known to interact directly with the endocrine system) that are representative of a range of perturbations of the endocrine system and considered to be data rich in relevant information at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17α-ethinylestradiol, perchlorate, propiconazole, 17β-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations for clarifying key issues and procedures that should be considered when assessing the ecotoxicological hazards and risks of EAS and EDS. The workshop also highlighted areas of scientific uncertainty, and made specific recommendations for research and methods-development to resolve some of the identified issues. The present paper provides broad guidance for scientists in regulatory authorities, industry, and academia on issues likely to arise during the ecotoxicological hazard and risk assessment of EAS and EDS. The primary conclusion of this paper, and of the SETAC Pellston Workshop on which it is based, is that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk

  17. Effects of Non-Guidance Activities, Supervision, and Student-to-Counselor Ratios on School Counselor Burnout

    Science.gov (United States)

    Moyer, Michael

    2011-01-01

    School counselors, like all mental health professionals are at high risk for burnout. High caseloads, job role ambiguity, and lack of supervision increase their propensity for burnout. Three areas were selected for study in this article due to their potential impact on burnout: supervision, student-to-counselor-ratios, and non-guidance related…

  18. Tank waste remediation system risk management plan

    International Nuclear Information System (INIS)

    Zimmerman, B.D.

    1998-01-01

    The purpose of the Tank Waste Remediation System (TWRS) Risk Management Plan is to describe a consistent approach to risk management such that TWRS Project risks are identified and managed to achieve TWRS Project success. The Risk Management Plan implements the requirements of the Tank Waste Remediation System Systems Engineering Management Plan in the area of risk management. Figure ES-1 shows the relationship of the TWRS Risk Management Plan to other major TWRS Project documents. As the figure indicates, the Risk Management Plan is a tool used to develop and control TWRS Project work. It provides guidance on how TWRS Project risks will be assessed, analyzed, and handled, and it specifies format and content for the risk management lists, which are a primary product of the risk management process. In many instances, the Risk Management Plan references the TWRS Risk Management Procedure, which provides more detailed discussion of many risk management activities. The TWRS Risk Management Plan describes an ongoing program within the TWRS Project. The Risk Management Plan also provides guidance in support of the TWRS Readiness To-Proceed (RTP) assessment package

  19. Evaluation of a constipation risk assessment scale.

    Science.gov (United States)

    Zernike, W; Henderson, A

    1999-06-01

    This project was undertaken in order to evaluate the utility of a constipation risk assessment scale and the accompanying bowel management protocol. The risk assessment scale was primarily introduced to teach and guide staff in managing constipation when caring for patients. The intention of the project was to reduce the incidence of constipation in patients during their admission to hospital.

  20. Career Guidance in India Based on O*NET and Cultural Variables

    Science.gov (United States)

    Bhatnagar, Mohit

    2018-01-01

    The Occupational Information Network (O*NET) is the primary source of occupational information in the United States (US). In this study, I review O*NET's usage for career guidance in India and conceive a career intervention based on it. In an empirical evaluation adopting a posttest-only experimental design with post-graduate management students…

  1. Evaluation of test intervals strategies with a risk monitor

    International Nuclear Information System (INIS)

    Soerman, J.

    2005-01-01

    The Swedish nuclear power utility Oskarshamn Power Group (OKG), is investigating how the use of a risk monitor can facilitate and improve risk-informed decision-making at their nuclear power plants. The intent is to evaluate if risk-informed decision-making can be accepted. A pilot project was initiated and carried out in 2004. The project included investigating if a risk monitor can be used for optimising test intervals for diesel- and gas turbine generators with regard to risk level. The Oskarhamn 2 (O2), PSA Level 1 model was converted into a risk monitor using RiskSpectrum RiskWatcher (RSRW) software. The converted PSA model included the complete PSA model for the power operation mode. RSRW then performs a complete requantification for every analysis. Time dependent reliability data are taken into account, i.e. a shorter test interval will increases the components availability (possibility to e.g. start on demand). The converted O2 model was then used to investigate whether it would be possible to balance longer test intervals for diesel generators, gas turbine generators and high pressure injection system with shorter test intervals for the low pressure injection system, while maintaining a low risk level at the plant. The results show that a new mixture of test intervals can be implemented with only marginally changes in the risk calculated with the risk monitor model. The results indicate that the total number of test activities for the systems included in the pilot study could be reduced by 20% with a maintained level of risk. A risk monitor taking into account the impact from test intervals in availability calculations for components is well suited for evaluation of test interval strategies. It also enables the analyst to evaluate the risk level over a period of time including the impact the actual status of the plant may have on the risk level. (author)

  2. Sources of uncertainty in characterizing health risks from flare emissions

    International Nuclear Information System (INIS)

    Hrudey, S.E.

    2000-01-01

    The assessment of health risks associated with gas flaring was the focus of this paper. Health risk assessments for environmental decision-making includes the evaluation of scientific data to identify hazards and to determine dose-response assessments, exposure assessments and risk characterization. Gas flaring has been the cause for public health concerns in recent years, most notably since 1996 after a published report by the Alberta Research Council. Some of the major sources of uncertainty associated with identifying hazardous contaminants in flare emissions were discussed. Methods to predict human exposures to emitted contaminants were examined along with risk characterization of predicted exposures to several identified contaminants. One of the problems is that elemental uncertainties exist regarding flare emissions which places limitations of the degree of reassurance that risk assessment can provide, but risk assessment can nevertheless offer some guidance to those responsible for flare emissions

  3. Handbook of methods for risk-based analysis of technical specifications

    International Nuclear Information System (INIS)

    Samanta, P.K.; Kim, I.S.; Mankamo, T.; Vesely, W.E.

    1996-01-01

    Technical Specifications (TS) requirements for nuclear power plants define the Limiting Conditions for Operations (LCOs) and Surveillance Requirements (SRs) to assure safety during operation. In general, these requirements are based on deterministic analyses and engineering judgments. Improvements in these requirements are facilitated by the availability of plant-specific Probabilistic Risk Assessments (PRAs). The US Nuclear Regulatory Commission (USNRC) Office of Research sponsored research to develop systematic, risk-based methods to improve various aspects of TS requirements. A handbook of methods summarizing such risk-based approaches has been completed in 1994. It is expected that this handbook will provide valuable input to NRC's present work in developing guidance for using PRA in risk-informed regulation. The handbook addresses reliability and risk-based methods for evaluating allowed outage times (AOTs), action statements requiring shutdown where shutdown risk may be substantial, surveillance test intervals (STIs), managing plant configurations, and scheduling maintenance

  4. Evaluation of AECB-1119, risk of energy production

    International Nuclear Information System (INIS)

    1978-01-01

    The Inhaber report, 'Risk of Energy Production', is evaluated based on how the conclusions of the report match its objectives, the methodology used to reach the report's conclusions, and the presentation of the report. The authors recommend that a second volume containing the pertinent data used in the report should be published; and that total risks should be calculated ignoring material acquisition, construction and transportation risks, using the actual energy output of the various systems without imposing a backup energy supply, and comparing systems in such a way that death, injury and disease risks may be considered separately. They propose that the Atomic Energy Control Board should show how the report results relate to nuclear safety, and that the AECB should clarify the criteria for evaluating the small probability of a catastrophic nuclear accident. The response of the author of AECB--1119 is given in a separate section

  5. 7 CFR 319.59-3 - Articles prohibited importation pending risk evaluation.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Articles prohibited importation pending risk... Diseases § 319.59-3 Articles prohibited importation pending risk evaluation. The articles listed in...(b), pending the completion of an evaluation by APHIS of the potential pest risks associated with the...

  6. Transsphenoidal pituitary resection with intraoperative MR guidance: preliminary results

    Science.gov (United States)

    Pergolizzi, Richard S., Jr.; Schwartz, Richard B.; Hsu, Liangge; Wong, Terence Z.; Black, Peter M.; Martin, Claudia; Jolesz, Ferenc A.

    1999-05-01

    The use of intraoperative MR image guidance has the potential to improve the precision, extent and safety of transsphenoidal pituitary resections. At Brigham and Women's Hospital, an open-bore configuration 0.5T MR system (SIGNA SP, GE Medical Systems, Milwaukee, WI) has been used to provide image guidance for nine transsphenoidal pituitary adenoma resections. The intraoperative MR system allowed the radiologist to direct the surgeon toward the sella turcica successfully while avoiding the cavernous sinus, optic chiasm and other sensitive structures. Imaging performed during the surgery monitored the extent of resection and allowed for removal of tumor beyond the surgeon's view in five cases. Dynamic MR imaging was used to distinguish residual tumor from normal gland and postoperative changes permitting more precise tumor localization. A heme-sensitive long TE gradient echo sequence was used to evaluate for the presence of hemorrhagic debris. All patients tolerated the procedure well without significant complications.

  7. Best Available Technology (BAT) guidance for radiological liquid effluents at US Department of Energy Facilities

    International Nuclear Information System (INIS)

    Wallo, A. III; Peterson, H.T. Jr.; Ikenberry, T.A.; Baker, R.E.

    1993-01-01

    The US Department of Energy (DOE), in DOE Order 5400.5 (1990), directs operators of DOE facilities to apply the Best Available Technology (BAT) to control radiological liquid effluents from these facilities when specific conditions are present. DOE has published interim guidance to assist facility operators in knowing when a BAT analysis is needed and how such an analysis should be performed and documented. The purpose of the guidance is to provide a uniform basis in determining BAT throughout DOE and to assist in evaluating BAT determinations during programmatic audits. The BAT analysis process involves characterizing the effluent source; identifying and selecting candidate control technologies; evaluating the potential environmental, operational, resource, and economic impacts of the control technologies; developing an evaluation matrix for comparing the technologies; selecting the BAT; and documenting the evaluation process. The BAT analysis process provides a basis for consistent evaluation of liquid effluent releases, yet allows an individual site or facility the flexibility to address site-specific issues or concerns in the most appropriate manner

  8. Risk assessment and remedial policy evaluation using predictive modeling

    International Nuclear Information System (INIS)

    Linkov, L.; Schell, W.R.

    1996-01-01

    As a result of nuclear industry operation and accidents, large areas of natural ecosystems have been contaminated by radionuclides and toxic metals. Extensive societal pressure has been exerted to decrease the radiation dose to the population and to the environment. Thus, in making abatement and remediation policy decisions, not only economic costs but also human and environmental risk assessments are desired. This paper introduces a general framework for risk assessment and remedial policy evaluation using predictive modeling. Ecological risk assessment requires evaluation of the radionuclide distribution in ecosystems. The FORESTPATH model is used for predicting the radionuclide fate in forest compartments after deposition as well as for evaluating the efficiency of remedial policies. Time of intervention and radionuclide deposition profile was predicted as being crucial for the remediation efficiency. Risk assessment conducted for a critical group of forest users in Belarus shows that consumption of forest products (berries and mushrooms) leads to about 0.004% risk of a fatal cancer annually. Cost-benefit analysis for forest cleanup suggests that complete removal of organic layer is too expensive for application in Belarus and a better methodology is required. In conclusion, FORESTPATH modeling framework could have wide applications in environmental remediation of radionuclides and toxic metals as well as in dose reconstruction and, risk-assessment

  9. A Cascading Storm-Flood-Landslide Guidance System: Development and Application in China

    Science.gov (United States)

    Zeng, Ziyue; Tang, Guoqiang; Long, Di; Ma, Meihong; Hong, Yang

    2016-04-01

    Flash floods and landslides, triggered by storms, often interact and cause cascading effects on human lives and property. Satellite remote sensing data has significant potential use in analysis of these natural hazards. As one of the regions continuously affected by severe flash floods and landslides, Yunnan Province, located in Southwest China, has a complex mountainous hydrometeorology and suffers from frequent heavy rainfalls from May through to late September. Taking Yunnan as a test-bed, this study proposed a Cascading Storm-Flood-Landslide Guidance System to progressively analysis and evaluate the risk of the multi-hazards based on multisource satellite remote sensing data. First, three standardized rainfall amounts (average daily amount in flood seasons, maximum 1h and maximum 6h amount) from the products of Topical Rainfall Measuring Mission (TRMM) Multi-satellite Precipitation Analysis (TMPA) were used as rainfall indicators to derive the StorM Hazard Index (SMHI). In this process, an integrated approach of the Analytic Hierarchy Process (AHP) and the Information-Entropy theory was adopted to determine the weight of each indicator. Then, land cover and vegetation cover data from the Moderate Resolution Imaging Spectroradiometer (MODIS) products, soil type from the Harmonized World Soil Database (HWSD) soil map, and slope from the Shuttle Radar Topography Mission (SRTM) data were add as semi-static geo-topographical indicators to derive the Flash Flood Hazard Index (FFHI). Furthermore, three more relevant landslide-controlling indicators, including elevation, slope angle and soil text were involved to derive the LandSlide Hazard Index (LSHI). Further inclusion of GDP, population and prevention measures as vulnerability indicators enabled to consecutively predict the risk of storm to flash flood and landslide, respectively. Consequently, the spatial patterns of the hazard indices show that the southeast of Yunnan has more possibility to encounter with storms

  10. A neural network model for credit risk evaluation.

    Science.gov (United States)

    Khashman, Adnan

    2009-08-01

    Credit scoring is one of the key analytical techniques in credit risk evaluation which has been an active research area in financial risk management. This paper presents a credit risk evaluation system that uses a neural network model based on the back propagation learning algorithm. We train and implement the neural network to decide whether to approve or reject a credit application, using seven learning schemes and real world credit applications from the Australian credit approval datasets. A comparison of the system performance under the different learning schemes is provided, furthermore, we compare the performance of two neural networks; with one and two hidden layers following the ideal learning scheme. Experimental results suggest that neural networks can be effectively used in automatic processing of credit applications.

  11. 78 FR 67442 - Congestion Mitigation and Air Quality Improvement Program Interim Guidance

    Science.gov (United States)

    2013-11-12

    ...] Congestion Mitigation and Air Quality Improvement Program Interim Guidance AGENCY: Federal Highway... Comment. SUMMARY: The FHWA is issuing Interim Guidance on the Congestion Mitigation and Air Quality.../environment/air_quality/cmaq/policy_and_guidance/2008_guidance/ guidance/. DATES: This Interim Guidance is...

  12. Risk variables in evaluation of transport projects

    Science.gov (United States)

    Vařbuchta, Petr; Kovářová, Hana; Hromádka, Vít; Vítková, Eva

    2017-09-01

    Depending on the constantly increasing demands on assessment of investment projects, especially assessment of large-scale projects in transport and important European projects with wide impacts, there is constantly increasing focus on risk management, whether to find mitigations, creating corrective measures or their implementation in assessment, especially in the context of Cost-Benefit analysis. To project assessment is often used implementation of certain risk variables, which can generate negative impacts of project outputs in framework of assess. Especially in case of transportation infrastructure projects is taken much emphasis on the influence of risk variables. However, currently in case of assessment of transportation projects is in Czech Republic used a few risk variables, which occur in the most projects. This leads to certain limitation in framework of impact assessment of risk variables. This papers aims to specify a new risk variables and process of applying them to already executed project assessment. Based on changes generated by new risk variables will be evaluated differences between original and adapted assessment.

  13. From risk analysis to risk control in land transport of dangerous materials. Contribution of quantitative evaluation

    International Nuclear Information System (INIS)

    Hubert, Ph.; Pages, P.

    1985-03-01

    The different approaches of risks and risk management system are described: statistics, potential risk, prevention, information and intervention. Quantitative evaluation is developed: data collection, purposes and methods. Two examples of application are given on risks associated to road transport of propane and of uranium hexafluoride. In conclusion level of risk and practical use of studies on risks are examined. 41 refs [fr

  14. Revised guidance of the principles for establishing intervention levels for the protection of the public in the event of a nuclear accident or radiological emergency

    International Nuclear Information System (INIS)

    1988-07-01

    An IAEA Advisory Group met in February 1987 to: i) review existing Agency guidance on intervention levels of dose and whether, and if so, what, revision is required; ii) consider whether, and if so, what additional guidance is required on limiting the stochastic risk and collective dose equivalent, and; iii) consider whether, and if so, what, additional guidance should be developed on derived intervention levels. The purpose of this Interim Report is to present to a broader audience the initial conclusions and recommendations of the Advisory Group in order that they may be used in conjunction with the guidance currently presented in Safety Series No. 72, pending publication of the revised Safety Series, scheduled for late 1989. 14 refs

  15. High Precision GNSS Guidance for Field Mobile Robots

    Directory of Open Access Journals (Sweden)

    Ladislav Jurišica

    2012-11-01

    Full Text Available In this paper, we discuss GNSS (Global Navigation Satellite System guidance for field mobile robots. Several GNSS systems and receivers, as well as multiple measurement methods and principles of GNSS systems are examined. We focus mainly on sources of errors and investigate diverse approaches for precise measuring and effective use of GNSS systems for real-time robot localization. The main body of the article compares two GNSS receivers and their measurement methods. We design, implement and evaluate several mathematical methods for precise robot localization.

  16. Percutaneous Transhepatic Drainage of Inaccessible Abdominal Abscesses Following Abdominal Surgery Under Real-Time CT-Fluoroscopic Guidance

    International Nuclear Information System (INIS)

    Yamakado, Koichiro; Takaki, Haruyuki; Nakatsuka, Atsuhiro; Kashima, Masataka; Uraki, Junji; Yamanaka, Takashi; Takeda, Kan

    2010-01-01

    This study evaluated the safety, feasibility, and clinical utility of transhepatic drainage of inaccessible abdominal abscesses retrospectively under real-time computed tomographic (CT) guidance. For abdominal abscesses, 12 consecutive patients received percutaneous transhepatic drainage. Abscesses were considered inaccessible using the usual access route because they were surrounded by the liver and other organs. The maximum diameters of abscesses were 4.6-9.5 cm (mean, 6.7 ± 1.4 cm). An 8-Fr catheter was advanced into the abscess cavity through the liver parenchyma using real-time CT fluoroscopic guidance. Safety, feasibility, procedure time, and clinical utility were evaluated. Drainage catheters were placed with no complications in abscess cavities through the liver parenchyma in all patients. The mean procedure time was 18.8 ± 9.2 min (range, 12-41 min). All abscesses were drained. They shrank immediately after catheter placement. In conclusions, this transhepatic approach under real-time CT fluoroscopic guidance is a safe, feasible, and useful technique for use of drainage of inaccessible abdominal abscesses.

  17. Sacro-iliac joint arthrography in low back pain: feasibility of MRI guidance

    International Nuclear Information System (INIS)

    Ojala, Risto; Klemola, Rauli; Karppinen, Jaro; Sequeiros, Roberto Blanco; Tervonen, Osmo

    2001-01-01

    Objective: Evaluation of the feasibility of MR-guidance in sacro-iliac joint arthrography in patients whose low back pain is suspected to arise from the sacro-iliac joint (SIJ). Methods and patients: Twenty patients with low back pain underwent MR-guided sacro-iliac joint arthrography. Needles made from titanium (size 20 G, MDTech, USA) were used. For image guidance a 0.23T open-configuration C arm magnet (Proview, Marconi Medical Systems, USA) with special interventional hardware and software package (I-Path 200, Marconi Medical Systems) containing an MR compatible in-room console, large-screen (36'') display, optical navigator and accompanying software with dedicated sequences was used. No other image guidance modalities were used. Results: MR-guided SIJ arthrography was successfully performed in all twenty patients without complications. The optimal imaging sequence both for preoperative and intraoperative images was 3D-Gradient Echo sequence. The dispersal of the injected saline and anaesthetic could be determined inside the joint in all cases with heavily T2-weighted fast spin echo sequence. In the present study, 60% of the patients had significant reduction of pain after sacro-iliac joint arthrography and sacro-iliac joint was considered to be the source of patients low back pain in these patients. Conclusion: The present study shows that MR guidance with open configuration low field scanner is an accurate guiding method for sacro-iliac joint arthrography

  18. 75 FR 23764 - Correspondent Concentration Risks

    Science.gov (United States)

    2010-05-04

    ... comments within the context of such a re-evaluation. IV. Text of Final CCR Guidance and Illustrations in Appendix A and Appendix B The text of the final CCR Guidance and the illustrations in Appendix A and...

  19. NASA Risk Management Handbook. Version 1.0

    Science.gov (United States)

    Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Maggio, Gaspare; Stamatelatos, Michael; Youngblood, Robert; Guarro, Sergio; Rutledge, Peter; Sherrard, James; Smith, Curtis; hide

    2011-01-01

    The purpose of this handbook is to provide guidance for implementing the Risk Management (RM) requirements of NASA Procedural Requirements (NPR) document NPR 8000.4A, Agency Risk Management Procedural Requirements [1], with a specific focus on programs and projects, and applying to each level of the NASA organizational hierarchy as requirements flow down. This handbook supports RM application within the NASA systems engineering process, and is a complement to the guidance contained in NASA/SP-2007-6105, NASA Systems Engineering Handbook [2]. Specifically, this handbook provides guidance that is applicable to the common technical processes of Technical Risk Management and Decision Analysis established by NPR 7123.1A, NASA Systems Engineering Process and Requirements [3]. These processes are part of the \\Systems Engineering Engine. (Figure 1) that is used to drive the development of the system and associated work products to satisfy stakeholder expectations in all mission execution domains, including safety, technical, cost, and schedule. Like NPR 7123.1A, NPR 8000.4A is a discipline-oriented NPR that intersects with product-oriented NPRs such as NPR 7120.5D, NASA Space Flight Program and Project Management Requirements [4]; NPR 7120.7, NASA Information Technology and Institutional Infrastructure Program and Project Management Requirements [5]; and NPR 7120.8, NASA Research and Technology Program and Project Management Requirements [6]. In much the same way that the NASA Systems Engineering Handbook is intended to provide guidance on the implementation of NPR 7123.1A, this handbook is intended to provide guidance on the implementation of NPR 8000.4A. 1.2 Scope and Depth This handbook provides guidance for conducting RM in the context of NASA program and project life cycles, which produce derived requirements in accordance with existing systems engineering practices that flow down through the NASA organizational hierarchy. The guidance in this handbook is not meant

  20. Lumbar sympathectomy under CT guidance: therapeutic option in critical limb ischaemia

    International Nuclear Information System (INIS)

    Pieri, Stefano; Agresti, Paolo; Di Cesare, Fabio; Ricci, Guiseppe

    2005-01-01

    Purpose: Lumbar sympathectomy is a complementary therapeutic option for patients with severe peripheral vascular occlusive disease presenting rest pain or gangrene and not eligible for surgical revascularisation. Traditional surgical sympathectomy was widely used in the past. However, due to its invasive character, it has increasingly been replaced by percutaneous techniques and, in some recent cases, by laparoscopic procedures. Percutaneous lumbar sympathectomy is a safe, cost-effective and widely available treatment option. We report our experience on 19 patients subjected to percutaneous sympathectomy under CT guidance. Materials and methods: Between 1998 and 2000, 19 patients underwent percutaneous sympathectomy under CT guidance. All patients had severe vascular disease of the lower extremities (Fontaine stage IV), with rest pain and gangrene. They were not eligible for surgical revascularization. Phenol was injected at the level of L2 and L4 using two 22 G needles (15 cm long). Signs of interrupted sympathetic activity usually occur 2'-15' after the procedure with warmth and flushing and dryness of the lower extremities. Results: Percutaneous sympathectomy under CT guidance is a simple, safe and well-tolerated procedure with a low rate of complications. Of the 19 patients, 9 (47.3%) showed clinical improvement, whereas 5 experienced a worsening of ischaemia in the month immediately following the procedure. Discussion: Results suggest that percutaneous lumbar sympathectomy causes a sympathetic blockade in patients with advanced vascular disease of the limb. CT guidance ensures a high level of precision in drug dosing, thus lowering the risk of complications. Although the results are demoralizing. the impossibility of achieving surgical revascularisation in advanced peripheral arteriosclerosis enhances the role of Ct-guided percutaneous sympathectomy in relieving rest pain and healing ulcers in order to postpone the amputation [it

  1. NSRD-10: Leak Path Factor Guidance Using MELCOR

    Energy Technology Data Exchange (ETDEWEB)

    Louie, David [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Humphries, Larry L. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-03-01

    Estimates of the source term from a U.S. Department of Energy (DOE) nuclear facility requires that the analysts know how to apply the simulation tools used, such as the MELCOR code, particularly for a complicated facility that may include an air ventilation system and other active systems that can influence the environmental pathway of the materials released. DOE has designated MELCOR 1.8.5, an unsupported version, as a DOE ToolBox code in its Central Registry, which includes a leak-path-factor guidance report written in 2004 that did not include experimental validation data. To continue to use this MELCOR version requires additional verification and validations, which may not be feasible from a project cost standpoint. Instead, the recent MELCOR should be used. Without any developer support and lack of experimental data validation, it is difficult to convince regulators that the calculated source term from the DOE facility is accurate and defensible. This research replaces the obsolete version in the 2004 DOE leak path factor guidance report by using MELCOR 2.1 (the latest version of MELCOR with continuing modeling development and user support) and by including applicable experimental data from the reactor safety arena and from applicable experimental data used in the DOE-HDBK-3010. This research provides best practice values used in MELCOR 2.1 specifically for the leak path determination. With these enhancements, the revised leak-path-guidance report should provide confidence to the DOE safety analyst who would be using MELCOR as a source-term determination tool for mitigated accident evaluations.

  2. Guidance Oriented Acquisition of Learning Skills (Project GOALS). Final Evaluation Report, 1992-93. OREA Report.

    Science.gov (United States)

    Musante, Patricia

    Guidance Oriented Acquisition of Learning Skills (Project GOALS) was a federally-funded project in three Brooklyn (New York) high schools in its fourth year of operation in 1992-93. It served 312 limited-English-proficient and 57 English-proficient students through instruction in English as a Second Language (ESL), native language arts (NLA) in…

  3. Credit Risk Evaluation of Swedish SMEs : A Banking Sector Perspective

    OpenAIRE

    Hörstedt, Maria; Linjamaa, Johanna

    2015-01-01

    As a result from the latest financial crisis, the banking industry has undergone major modifications during the last years in order to limit banks’ risks. A vast majority of existing literature tends to focus upon credit risk evaluation methods and techniques mainly concerning quantitative measures and large companies. Thus, the lack of research regarding credit risk evaluation of SMEs is profound, especially considering Sweden. With the dominant market share of SMEs compared to large corpora...

  4. Societal risk approach to safeguards design and evaluation

    International Nuclear Information System (INIS)

    Murphey, W.M.; Sherr, T.S.; Bennett, C.A.

    1975-01-01

    A comprehensive rationale for safeguards design and evaluation, and a framework for continuing systematic assessment of the system's effectiveness and efficient allocation of available safeguards resources for balanced protection, were developed. The societal risk approach employed considers the likelihood of successful destructive acts involving nuclear materials or facilities and the magnitude of the effects on society. The safeguards problem is described in terms of events affecting societal risk and adversary actions. Structure of the safeguards system and the evaluation of its adequacy are discussed. Adversary characteristics are also discussed

  5. Developing and evaluating distributions for probabilistic human exposure assessments

    Energy Technology Data Exchange (ETDEWEB)

    Maddalena, Randy L.; McKone, Thomas E.

    2002-08-01

    This report describes research carried out at the Lawrence Berkeley National Laboratory (LBNL) to assist the U. S. Environmental Protection Agency (EPA) in developing a consistent yet flexible approach for evaluating the inputs to probabilistic risk assessments. The U.S. EPA Office of Emergency and Remedial Response (OERR) recently released Volume 3 Part A of Risk Assessment Guidance for Superfund (RAGS), as an update to the existing two-volume set of RAGS. The update provides policy and technical guidance on performing probabilistic risk assessment (PRA). Consequently, EPA risk managers and decision-makers need to review and evaluate the adequacy of PRAs for supporting regulatory decisions. A critical part of evaluating a PRA is the problem of evaluating or judging the adequacy of input distributions PRA. Although the overarching theme of this report is the need to improve the ease and consistency of the regulatory review process, the specific objectives are presented in two parts. The objective of Part 1 is to develop a consistent yet flexible process for evaluating distributions in a PRA by identifying the critical attributes of an exposure factor distribution and discussing how these attributes relate to the task-specific adequacy of the input. This objective is carried out with emphasis on the perspective of a risk manager or decision-maker. The proposed evaluation procedure provides consistency to the review process without a loss of flexibility. As a result, the approach described in Part 1 provides an opportunity to apply a single review framework for all EPA regions and yet provide the regional risk manager with the flexibility to deal with site- and case-specific issues in the PRA process. However, as the number of inputs to a PRA increases, so does the complexity of the process for calculating, communicating and managing risk. As a result, there is increasing effort required of both the risk professionals performing the analysis and the risk manager

  6. An evaluation of the treatment of risk and uncertainties in the IPCC reports on climate change.

    Science.gov (United States)

    Aven, Terje; Renn, Ortwin

    2015-04-01

    Few global threats rival global climate change in scale and potential consequence. The principal international authority assessing climate risk is the Intergovernmental Panel on Climate Change (IPCC). Through repeated assessments the IPCC has devoted considerable effort and interdisciplinary competence to articulating a common characterization of climate risk and uncertainties. We have reviewed the assessment and its foundation for the Fifth Assessment Reports published in 2013 and 2014, in particular the guidance note for lead authors of the fifth IPCC assessment report on consistent treatment of uncertainties. Our analysis shows that the work carried out by the ICPP is short of providing a theoretically and conceptually convincing foundation on the treatment of risk and uncertainties. The main reasons for our assessment are: (i) the concept of risk is given a too narrow definition (a function of consequences and probability/likelihood); and (ii) the reports lack precision in delineating their concepts and methods. The goal of this article is to contribute to improving the handling of uncertainty and risk in future IPCC studies, thereby obtaining a more theoretically substantiated characterization as well as enhanced scientific quality for risk analysis in this area. Several suggestions for how to improve the risk and uncertainty treatment are provided. © 2014 Society for Risk Analysis.

  7. Towards 4D intervention guidance using compressed sensing

    Energy Technology Data Exchange (ETDEWEB)

    Kuntz, Jan; Bartling, Soenke [Deutsches Krebsforschungszentrum DKFZ, Heidelberg (Germany); Brehm, Marcus; Kachelriess, Marc [Erlangen-Nuernberg Univ., Erlangen (Germany). Inst. of Medical Physics (IMP)

    2011-07-01

    Interventional radiology is nowadays usually guided with projection radiography using mono- or biplane systems. Due to the projective nature of this guidance imaging certain intraprocedural situations remain unclear. Although helpful, the use of 3D CT is limited due to radiation dose. Using advanced reconstruction techniques incorporating prior knowledge, one could overcome these limitations without exceeding dose limitations. Intervention guidance is especially appealing to those algorithms, because certain constrains apply to useful images in intervention guidance that vary relevantly from other CT applications. These are: key relevance of high contrast structures, sparse temporal updates and little relevance of absolute CT values. In this paper the principal usability of reconstruction algorithms for intervention guidance is tested. Compressed sensing algorithms PICCS and ASD-POCS are compared to the McKinnon-Bates and Feldkamp-Davis-Kress algorithm. Animal experiments as well as simulations are performed. An outlook towards 4D intervention guidance is provided. (orig.)

  8. Driving change : sustainable development action plans Guidance

    OpenAIRE

    Sustainable Development Commission

    2008-01-01

    This guidance builds upon the Sustainable Development Commission’s previous guidance, Getting Started (August 2005), which set out the basic elements that the Sustainable Development Commission would expect to see in a good Sustainable Development Action Plan. Publisher PDF Original published August 2005.

  9. Accuracy Analysis of Lunar Lander Terminal Guidance Algorithm

    Directory of Open Access Journals (Sweden)

    E. K. Li

    2017-01-01

    Full Text Available This article studies a proposed analytical algorithm of the terminal guidance for the lunar lander. The analytical solution, which forms the basis of the algorithm, was obtained for a constant acceleration trajectory and thrust vector orientation programs that are essentially linear with time. The main feature of the proposed algorithm is a completely analytical solution to provide the lander terminal guidance to the desired spot in 3D space when landing on the atmosphereless body with no numerical procedures. To reach 6 terminal conditions (components of position and velocity vectors at the final time are used 6 guidance law parameters, namely time-to-go, desired value of braking deceleration, initial values of pitch and yaw angles and rates of their change. In accordance with the principle of flexible trajectories, this algorithm assumes the implementation of a regularly updated control program that ensures reaching terminal conditions from the current state that corresponds to the control program update time. The guidance law parameters, which ensure that terminal conditions are reached, are generated as a function of the current phase coordinates of a lander. The article examines an accuracy and reliability of the proposed analytical algorithm that provides the terminal guidance of the lander in 3D space through mathematical modeling of the lander guidance from the circumlunar pre-landing orbit to the desired spot near the lunar surface. A desired terminal position of the lunar lander is specified by the selenographic latitude, longitude and altitude above the lunar surface. The impact of variations in orbital parameters on the terminal guidance accuracy has been studied. By varying the five initial orbit parameters (obliquity, ascending node longitude, argument of periapsis, periapsis height, apoapsis height when the terminal spot is fixed the statistic characteristics of the terminal guidance algorithm error according to the terminal

  10. Cycle water chemistry based on film forming amines at power plants: evaluation of technical guidance documents

    Science.gov (United States)

    Dyachenko, F. V.; Petrova, T. I.

    2017-11-01

    Efficiency and reliability of the equipment in fossil power plants as well as in combined cycle power plants depend on the corrosion processes and deposit formation in steam/water circuit. In order to decrease these processes different water chemistries are used. Today the great attention is being attracted to the application of film forming amines and film forming amine products. The International Association for the Properties of Water and Steam (IAPWS) consolidated the information from all over the World, and based on the research studies and operating experience of researchers and engineers from 21 countries, developed and authorized the Technical Guidance Document: “Application of Film Forming Amines in Fossil, Combined Cycle, and Biomass Power Plants” in 2016. This article describe Russian and International technical guidance documents for the cycle water chemistries based on film forming amines at fossil and combined cycle power plants.

  11. Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/20131

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2015-01-01

    Following a request from the European Commission, the EFSA Panel on Dietetic products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. The guidance presented...... from the evaluation of dossiers for specific food products notified as FSMP, and in the light of future Community guidelines and legislation. The scope of this guidance is limited to FSMPs in the context of Article 3 of Regulation (EU) No 609/2013. Out of the scope of this guidance are: a) other...

  12. Significant Guidance Issued by the Federal Transit Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  13. Significant Guidance Issued by the Federal Aviation Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  14. Significant Guidance Issued by the Federal Highway Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  15. The use of current risk analysis tools evaluated towards preventing external domino accidents

    NARCIS (Netherlands)

    Reniers, Genserik L L; Dullaert, W.; Ale, B. J.M.; Soudan, K.

    Risk analysis is an essential tool for company safety policy. Risk analysis consists of identifying and evaluating all possible risks. The efficiency of risk analysis tools depends on the rigueur of identifying and evaluating all possible risks. The diversity in risk analysis procedures is such that

  16. Guidance levels, achievable doses and expectation levels

    International Nuclear Information System (INIS)

    Li, Lianbo; Meng, Bing

    2002-01-01

    The National Radiological Protection Board (NRPB), the International Atomic Energy Agency (IAEA) and the Commission of the European Communities (CEC) published their guidance levels and reference doses for typical X-ray examination and nuclear medicine in their documents in 1993, 1994 and 1996 respectively. From then on, the concept of guidance levels or reference doses have been applied to different examinations in the field of radiology and proved to be effective for reduction of patient doses. But the guidance levels or reference doses are likely to have some shortcomings and can do little to make further reduction of patient dose in the radiology departments where patient dose are already below them. For this reason, the National Radiological Protection Board (NRPB) proposed a concept named achievable doses which are based on the mean dose observed for a selected sample of radiology departments. This paper will review and discuss the concept of guidance levels and achievable doses, and propose a new concept referred to as Expectation Levels that will encourage the radiology departments where patient dose are already below the guidance levels to keep patient dose as low as reasonably achievable. Some examples of the expectation levels based on the data published by a few countries are also illustrated in this paper

  17. A study of risk evaluation methodology selection for the external hazards

    International Nuclear Information System (INIS)

    Kuramoto, Takahiro; Yamaguchi, Akira; Narumiya, Yosiyuki

    2014-01-01

    Since the accident at Fukushima Daiichi Nuclear Power Plant caused by the Great East Japan Earthquake in March 2011, there has been growing demands for assessing the effects of external hazards, including natural events, such as earthquake and tsunami, and external human behaviors, and taking actions to address those external hazards. The newly established Japanese regulatory requirements claim design considerations associated with external hazards. The primary objective of the risk assessment for external hazards is to establish countermeasures against such hazards rather than grasping the risk figures. Therefore, applying detailed risk assessment methods, such as probabilistic risk assessment (PRA), to all the external hazards is not always the most appropriate. Risk assessment methods can vary in types including qualitative evaluation, hazard analysis (analyzing hazard frequencies or their influence), and margin assessment. To resolve these issues, a process has been established that enables us to identify the external hazards in a comprehensive and systematic manner, which have potential risks leading to core damage and to select an appropriate evaluation method according to the risks associated with each of the external hazards. This paper discusses the comprehensive and systematic identification process for the external hazards which have potential risks leading to core damage, and the approaches of selecting an appropriate evaluation method for each external hazard. This paper also describes some applications of specific risk evaluation methods. (author)

  18. UV DISINFECTION GUIDANCE MANUAL FOR THE ...

    Science.gov (United States)

    Provides technical information on selection, design and operation of UV systems; provides regulatory agencies with guidance and the necessary tools to assess UV systems at the design, start-up, and routine operation phase; provides manufacturers with the testing and performance standards for UV components and systems for treating drinking water. Provide guidance to water systems, regulators and manufacturers on UV disinfection of drinking water.

  19. Prometheus unbound - challenges of risk evaluation, risk classification, and risk management

    Energy Technology Data Exchange (ETDEWEB)

    Klinke, A.; Renn, O.

    1999-11-01

    For dealing with risks in a rational fashion, it is necessary to characterize risks and use the parameters of characterization as tools for designing appropriate actions. This reports suggests a set of criteria that one can use in evaluating risks. These criteria include: - Damage potential, i.e. the amount of damage that the hazard can cause; - probability of occurrence, i.e. the likelihood that a specific damage will occur; - incertitude, i.e., the remaining uncertainties that are not covered by the assessment of probabilities (subdivided in statistical uncertainties, genuine uncertainty, and ignorance); - ubiquity which defines the geographic dispersion of potential damages (intragenerational justice); - persistency which defines the temporal extension of potential damages (intergenerational justice); - irreversibility which describes the impossible restoration of the situation to the state before the damage occurred (possible restoration are e.g. reforestation and cleaning of water); - delay effects which characterize the time of latency between the initial event and the actual impact of damage. The time of latency could be of physical, chemical or biological nature; and - potential of mobilization which is understood as violation of individual, social or cultural interests and values generating social conflicts and psychological reactions by affected people. (orig.)

  20. An Investigation of the Guidance Counselling Needs of Adults with Dyslexia in the Adult Educational Guidance Initiative (AEGI)

    Science.gov (United States)

    Elftorp, Petra; Hearne, Lucy

    2014-01-01

    The experiences of adult learners with dyslexia is an under-researched area in Ireland at present. This article will discuss the findings from phase one of a mixed methods research study, which is investigating the guidance counselling needs of clients with dyslexia within the Adult Education Guidance Initiative (AEGI). The research is underpinned…

  1. River City High School Guidance Services: A Conceptual Model.

    Science.gov (United States)

    American Coll. Testing Program, Iowa City, IA.

    This model describes how the guidance staff at a hypothetical high school communicated the effectiveness of the guidance program to students, parents, teachers, and administrators. A description of the high school is presented, and guidance services and personnel are described. A conceptual model responding to student needs is outlined along with…

  2. AN EVALUATION OF RISK MANAGEMENT STRATEGIES FOR DAIRY FARMS

    OpenAIRE

    Bosch, Darrell J.; Johnson, Christian J.

    1992-01-01

    Variability in feed prices and crop yields are important sources of risk to dairy farmers. A simulation model of a representative dairy farm was used to evaluate crop insurance and hedging as risk management strategies. These strategies lowered expected net returns but also reduced risk. The preferred set of strategies at lower levels of risk aversion included hedging and crop insurance, although a base scenario in which no risk management strategies were employed was also efficient. The pref...

  3. General RMP Guidance - Chapter 9: Risk Management Plan

    Science.gov (United States)

    You must submit one risk management plan (RMP) to EPA for all of your covered processes. The internet-based RMP*eSubmit allows you to submit your RMP in EPA's Central Data Exchange (CDX), where you can access and change/correct existing RMPs.

  4. Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

    Science.gov (United States)

    Badri, Adel; Nadeau, Sylvie; Gbodossou, André

    2012-09-01

    Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project. Copyright © 2011 Elsevier Ltd. All rights reserved.

  5. A risk-based approach to evaluating wildlife demographics for management in a changing climate: A case study of the Lewis's Woodpecker

    Science.gov (United States)

    Erin Towler; Victoria A. Saab; Richard S. Sojda; Katherine Dickinson; Cindy L. Bruyere; Karen R. Newlon

    2012-01-01

    Given the projected threat that climate change poses to biodiversity, the need for proactive response efforts is clear. However, integrating uncertain climate change information into conservation planning is challenging, and more explicit guidance is needed. To this end, this article provides a specific example of how a risk-based approach can be used to incorporate a...

  6. Communicating radon risk effectively: a mid-course evaluation. Interim report

    International Nuclear Information System (INIS)

    Smith, V.K.; Desvousges, W.H.; Fisher, A.; Johnson, F.R.

    1987-07-01

    A panel of 2300 homeowners was divided into subgroups to test the effectiveness of six alternative ways of explaining the risk from naturally occurring radon gas. The research design focused on two dimensions: qualitative vs. quantitative and directive vs. evaluative. These characteristics led to 4 experimental booklets, which were compared with EPA's Citizen's Guide and a one-page fact sheet. The evaluation examined how much people learned about radon; whether they could form risk perceptions consistent with their home's measured radon level; and whether they felt they had enough information to make a decision about mitigation. The fact sheet did not perform well on any of these evaluation criteria. None of the five booklets clearly was best for all 3 evaluation criteria; the report discusses the implications for designing an effective radon-risk communication program

  7. Evaluation Method of Collision Risk by Using True Motion

    Directory of Open Access Journals (Sweden)

    Hayama Imazu

    2017-03-01

    Full Text Available It is necessary to develop a useful application to use big data like as AIS for safety and efficiency of ship operation. AIS is very useful system to collect targets information, but this information is not effective use yet. The evaluation method of collision risk is one of the cause disturb. Usually the collision risk of ship is evaluated by the value of the Closest Point of Approach (CPA which is related to a relative motion. So, it becomes difficult to find out a safety pass in a congested water. Here, Line of Predicted Collision (LOPC and Obstacle Zone by Target (OZT for evaluation of collision risk are introduced, these values are related to a true motion and it became visible of dangerous place, so it will make easy to find out a safety pass in a congested water.

  8. 77 FR 31858 - Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk...

    Science.gov (United States)

    2012-05-30

    ... of the drug. This draft guidance is intended to assist applicants in designing trials to support...., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that... Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tatiana...

  9. Applied decision analysis and risk evaluation

    International Nuclear Information System (INIS)

    Ferse, W.; Kruber, S.

    1995-01-01

    During 1994 the workgroup 'Applied Decision Analysis and Risk Evaluation; continued the work on the knowledge based decision support system XUMA-GEFA for the evaluation of the hazard potential of contaminated sites. Additionally a new research direction was started which aims at the support of a later stage of the treatment of contaminated sites: The clean-up decision. For the support of decisions arising at this stage, the methods of decision analysis will be used. Computational aids for evaluation and decision support were implemented and a case study at a waste disposal site in Saxony which turns out to be a danger for the surrounding groundwater ressource was initiated. (orig.)

  10. A genomic pathway approach to a complex disease: axon guidance and Parkinson disease.

    Directory of Open Access Journals (Sweden)

    Timothy G Lesnick

    2007-06-01

    Full Text Available While major inroads have been made in identifying the genetic causes of rare Mendelian disorders, little progress has been made in the discovery of common gene variations that predispose to complex diseases. The single gene variants that have been shown to associate reproducibly with complex diseases typically have small effect sizes or attributable risks. However, the joint actions of common gene variants within pathways may play a major role in predisposing to complex diseases (the paradigm of complex genetics. The goal of this study was to determine whether polymorphism in a candidate pathway (axon guidance predisposed to a complex disease (Parkinson disease [PD]. We mined a whole-genome association dataset and identified single nucleotide polymorphisms (SNPs that were within axon-guidance pathway genes. We then constructed models of axon-guidance pathway SNPs that predicted three outcomes: PD susceptibility (odds ratio = 90.8, p = 4.64 x 10(-38, survival free of PD (hazards ratio = 19.0, p = 5.43 x 10(-48, and PD age at onset (R(2 = 0.68, p = 1.68 x 10(-51. By contrast, models constructed from thousands of random selections of genomic SNPs predicted the three PD outcomes poorly. Mining of a second whole-genome association dataset and mining of an expression profiling dataset also supported a role for many axon-guidance pathway genes in PD. These findings could have important implications regarding the pathogenesis of PD. This genomic pathway approach may also offer insights into other complex diseases such as Alzheimer disease, diabetes mellitus, nicotine and alcohol dependence, and several cancers.

  11. Visual search guidance is best after a short delay.

    Science.gov (United States)

    Schmidt, Joseph; Zelinsky, Gregory J

    2011-03-25

    Search displays are typically presented immediately after a target cue, but in the real-world, delays often exist between target designation and search. Experiments 1 and 2 asked how search guidance changes with delay. Targets were cued using a picture or text label, each for 3000ms, followed by a delay up to 9000ms before the search display. Search stimuli were realistic objects, and guidance was quantified using multiple eye movement measures. Text-based cues showed a non-significant trend towards greater guidance following any delay relative to a no-delay condition. However, guidance from a pictorial cue increased sharply 300-600ms after preview offset. Experiment 3 replicated this guidance enhancement using shorter preview durations while equating the time from cue onset to search onset, demonstrating that the guidance benefit is linked to preview offset rather than a more complete encoding of the target. Experiment 4 showed that enhanced guidance persists even with a mask flashed at preview offset, suggesting an explanation other than visual priming. We interpret our findings as evidence for the rapid consolidation of target information into a guiding representation, which attains its maximum effectiveness shortly after preview offset. Copyright © 2011 Elsevier Ltd. All rights reserved.

  12. Evaluating the risks of clinical research: direct comparative analysis.

    Science.gov (United States)

    Rid, Annette; Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S; Wendler, David

    2014-09-01

    Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. This study employed a conceptual and normative analysis, and use of an illustrative example. Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the "risks of daily life" standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Direct comparative analysis is a systematic method for applying the "risks of daily life" standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.

  13. A Three-Dimensional Cooperative Guidance Law of Multimissile System

    Directory of Open Access Journals (Sweden)

    Xing Wei

    2015-01-01

    Full Text Available In order to conduct saturation attacks on a static target, the cooperative guidance problem of multimissile system is researched. A three-dimensional guidance model is built using vector calculation and the classic proportional navigation guidance (PNG law is extended to three dimensions. Based on this guidance law, a distributed cooperative guidance strategy is proposed and a consensus protocol is designed to coordinate the time-to-go commands of all missiles. Then an expert system, which contains two extreme learning machines (ELM, is developed to regulate the local proportional coefficient of each missile according to the command. All missiles can arrive at the target simultaneously under the assumption that the multimissile network is connected. A simulation scenario is given to demonstrate the validity of the proposed method.

  14. Profiling event logs to configure risk indicators for process delays

    NARCIS (Netherlands)

    Pika, A.; Aalst, van der W.M.P.; Fidge, C.J.; Hofstede, ter A.H.M.; Wynn, M.T.; Salinesi, C.; Norrie, M.C.; Pastor, O.

    2013-01-01

    Risk identification is one of the most challenging stages in the risk management process. Conventional risk management approaches provide little guidance and companies often rely on the knowledge of experts for risk identification. In this paper we demonstrate how risk indicators can be used to

  15. Key performance indicators for the assessment of pediatric pharmacotherapeutic guidance.

    Science.gov (United States)

    Barrett, Jeffrey S; Patel, Dimple; Jayaraman, Bhuvana; Narayan, Mahesh; Zuppa, Athena

    2008-07-01

    Given the paucity of actual guidance provided for managing pediatric drug therapy, prescribing caregivers must be able to draw on the limited published information in pediatrics and/or guidance provided in adults with some account for expected pediatric response. Guidance for managing drug therapy in children is clearly desirable. Our objectives were to construct key performance indicators (KPIs) for pediatric pharmacotherapy guidance to identify drugs where pharmacotherapy guidance would be most beneficial. A pilot survey to assess variation in caregiver appreciation for pediatric dosing guidance has also been constructed to provide a complementary subjective assessment. Three KPI categories, drug utilization (based on hospital admission and billing data collected from 2001 through 2006), medical need, and guidance outcome value along with a KPI composite score have been proposed. Low scores are favored with respect to prioritization for pharmacotherapy guidance. The pilot survey consisted of 15 questions to assess 1) physician knowledge regarding dosing guidance, 2) attitudes toward dose modification and patient individualization, 3) the accessibility, ease of use and appropriateness of existing data stores, and 4) frequency of dosing modification, consultation of dosing compendiums and estimate of success rate in dosing guidance. Pilot results suggest that dosing guidance is generally viewed as important and that the existing resources are insufficient to guide recommendations for all drugs. While the majority of respondents check more than one resource less than 25% of the time, at least 25% of the respondents check more than one resource 25-50% of the time. The majority viewed the relevance of dosing guidance very important to the management of drug therapy. The questionnaire is being extended to the primary care centers, the Kids First Network and specialty care centers. Results will guide the development of decision support systems (DSS) that provide patient

  16. 'Tell us something we don't already know or do!' - The response of planning and transport professionals to public health guidance on the built environment and physical activity.

    Science.gov (United States)

    Allender, Steven; Cavill, Nick; Parker, Mike; Foster, Charles

    2009-04-01

    A large proportion of non-communicable disease can be attributed to modifiable risk factors such as poor nutrition and physical inactivity. We present data on planning and transport practitioners' perceptions and responses to government public health guidance aimed at modifying environmental factors to promote physical activity. This study was informed by questions on the role of evidence-based guidance, the views of professionals towards the guidance, the links between guidance and existing legislation and policy and the practicality of guidelines. A key informant 'snowball' sampling technique was used to recruit participants from the main professional planning organisations across England. Seventy-six people were interviewed in eight focus groups. We found that evidence-based public health guidance is a new voice in urban and town planning, although much of the advice is already reflected by the 'accepted wisdom' of these professions. Evidence-based health guidance could be a powerful driver affecting planning practice, but other legislated planning guidance may take priority for planning and transport professionals.

  17. Trajectory reshaping based guidance with impact time and angle constraints

    Directory of Open Access Journals (Sweden)

    Zhao Yao

    2016-08-01

    Full Text Available This study presents a novel impact time and angle constrained guidance law for homing missiles. The guidance law is first developed with the prior-assumption of a stationary target, which is followed by the practical extension to a maneuvering target scenario. To derive the closed-form guidance law, the trajectory reshaping technique is utilized and it results in defining a specific polynomial function with two unknown coefficients. These coefficients are determined to satisfy the impact time and angle constraints as well as the zero miss distance. Furthermore, the proposed guidance law has three additional guidance gains as design parameters which make it possible to adjust the guided trajectory according to the operational conditions and missile’s capability. Numerical simulations are presented to validate the effectiveness of the proposed guidance law.

  18. 75 FR 70254 - PSD and Title V Permitting Guidance for Greenhouse Gases

    Science.gov (United States)

    2010-11-17

    ... Guidance for Greenhouse Gases AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability..., ``PSD and Title V Permitting Guidance for Greenhouse Gases'' on its significant guidance Internet Web... guidance titled, ``PSD and Title V Permitting Guidance for Greenhouse Gases.'' This document has been...

  19. Conceptual Model of Offshore Wind Environmental Risk Evaluation System

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, Richard M.; Copping, Andrea E.; Van Cleve, Frances B.; Unwin, Stephen D.; Hamilton, Erin L.

    2010-06-01

    In this report we describe the development of the Environmental Risk Evaluation System (ERES), a risk-informed analytical process for estimating the environmental risks associated with the construction and operation of offshore wind energy generation projects. The development of ERES for offshore wind is closely allied to a concurrent process undertaken to examine environmental effects of marine and hydrokinetic (MHK) energy generation, although specific risk-relevant attributes will differ between the MHK and offshore wind domains. During FY10, a conceptual design of ERES for offshore wind will be developed. The offshore wind ERES mockup described in this report will provide a preview of the functionality of a fully developed risk evaluation system that will use risk assessment techniques to determine priority stressors on aquatic organisms and environments from specific technology aspects, identify key uncertainties underlying high-risk issues, compile a wide-range of data types in an innovative and flexible data organizing scheme, and inform planning and decision processes with a transparent and technically robust decision-support tool. A fully functional version of ERES for offshore wind will be developed in a subsequent phase of the project.

  20. Highly effective photonic cue for repulsive axonal guidance.

    Directory of Open Access Journals (Sweden)

    Bryan J Black

    Full Text Available In vivo nerve repair requires not only the ability to regenerate damaged axons, but most importantly, the ability to guide developing or regenerating axons along paths that will result in functional connections. Furthermore, basic studies in neuroscience and neuro-electronic interface design require the ability to construct in vitro neural circuitry. Both these applications require the development of a noninvasive, highly effective tool for axonal growth-cone guidance. To date, a myriad of technologies have been introduced based on chemical, electrical, mechanical, and hybrid approaches (such as electro-chemical, optofluidic flow and photo-chemical methods. These methods are either lacking in desired spatial and temporal selectivity or require the introduction of invasive external factors. Within the last fifteen years however, several attractive guidance cues have been developed using purely light based cues to achieve axonal guidance. Here, we report a novel, purely optical repulsive guidance technique that uses low power, near infrared light, and demonstrates the guidance of primary goldfish retinal ganglion cell axons through turns of up to 120 degrees and over distances of ∼90 µm.