Science.gov

Sample records for post authorization safety

  1. Linkage Between Post-Closure Safety Case Review and the Authorization Process for Radioactive Waste Disposal Facilities

    SciTech Connect

    Streatfield, I. J.; Duerden, S. L.; Yearsley, R. A.; Bennett, D. G.

    2003-02-27

    The Environment Agency (the Agency) has responsibilities under the Radioactive Substances Act of 1993 for regulating the disposal and storage of radioactive wastes in England and Wales, including regulation of the disposal site for UK solid low-level waste (LLW) at Drigg in Cumbria, NW England. To help inform the next review of the Drigg disposal authorization, the Agency has required the operator, British Nuclear Fuels plc to submit a Post-Closure Safety Case which will assess the potential long-term impacts from the site. With the aim of using best practice to determine authorization conditions, the Agency contracted Galson Sciences, Ltd to undertake an international survey of authorization procedures for comparable facilities in other countries. This paper provides an overview of the findings from the international survey.

  2. Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)

    PubMed Central

    Negrier, Claude; Voisin, Sophie; Baghaei, Fariba; Numerof, Robert; Novack, Aaron; Doralt, Jennifer E.; Romanov, Vadim; Gringeri, Alessandro

    2016-01-01

    This prospective, Post-Authorization Safety Surveillance (PASS) study was carried out in patients with hemophilia A or B and inhibitors treated with FEIBA for 1 year to collect real-world data on safety and effectiveness of FEIBA. The study followed a cohort design and did not make stipulations on treatment or observation schedule, as it was designed to observe routine medical practices based on physicians’ treatment decisions, including whether patients received on-demand or prophylaxis with FEIBA. The attending physician maintained documentation, including medical records, laboratory reports, adverse event reports, and so on and a subject diary was used. Eighty-one patients were treated with FEIBA at 40 sites in 10 countries over a 4-year period. Sixty-nine patients (85.2%) had hemophilia A, two had (2.5%) hemophilia B, and ten (12.3%) had acquired hemophilia A. At baseline 45 patients (55.6%) were prescribed prophylaxis and 36 (44.6%) on-demand treatment. This study was novel in following safety and effectiveness in ‘real world’ on-demand and prophylactic use of FEIBA, and was able to collect data in these rare patients under routine clinical practice. PMID:26829366

  3. Training in Post-authorization Pharmacovigilance.

    PubMed

    Ahuja, Vivek; Sharma, Varun

    2010-04-01

    Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.

  4. Evaluation of safety and effectiveness of factor VIII treatment in haemophilia A patients with low titre inhibitors or a personal history of inhibitor. Patient Data Meta-analysis of rAFH-PFM Post-Authorization Safety Studies.

    PubMed

    Romanov, Vadim; Marcucci, Maura; Cheng, Ji; Thabane, Lehana; Iorio, Alfonso

    2015-07-01

    There is no prospective evidence on inhibitor recurrence among haemophilia A patients with low titre inhibitors or history of inhibitors, and whether or how therapeutic choices affect the risk of recurrence. The aims of this study were to synthesise safety data in patients with moderate-severe haemophilia A and with low titre inhibitors or inhibitor history enrolled in the rAHF PFM (ADVATE) - Post-Authorization Safety Studies (ADVATE-PASS) international programme. The study was conducted in clinics participating to the ADVATE PASS programme. The patient population consisted of patients entering the studies with low titre (≤ 5 BU) inhibitors or a positive personal history of inhibitors. Patients on Immune Tolerance Induction at study entry were excluded. Primary outcome was new or recurrent inhibitor titre > 5 BU. Secondary outcomes were any increase of inhibitor titre not reaching 5 BU; any unexplained change in treatment regimen. Primary analysis was done by two-stage random effects meta-analysis. Secondary analysis was done by a hierarchical Bayesian random effects logistic model. A total of 219 patients from seven studies were included. Of these 214 (97.7 %) patients had been previously treated for more than 50 exposure days. Two hundred ten patients had positive history for inhibitors, nine a baseline measurable titre. No patient presented a primary outcome event (95 % confidence interval [CI] 0-1.6 %). Six patients with previous history developed a low titre recurrence (overall rate 2.2, 95 %CI 0-4.8 %). When any increase of inhibitor titre or any treatment change was accounted for, overall 3.7 % (95 % CI 0 %-8.0 %) of patients experienced the outcome. In conclusion, the observed rate of events does not support the definition of this population as at high risk for inhibitor development.

  5. School Safety in a Post-Sandy Hook World

    ERIC Educational Resources Information Center

    Trump, Kenneth S.

    2014-01-01

    In this report the author, who is a school safety expert, provides information about school safety in a post-Sandy Hook world. He presents the following: (1) Continuum of Threats and Responses; (2) The role social media plays; (3) Reliable Best Practices; (4) Policy and Funding--Climate and Context; (5) Policy and Funding--Things to Avoid; and (6)…

  6. 49 CFR 390.209 - Pre-authorization safety audit.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 5 2014-10-01 2014-10-01 false Pre-authorization safety audit. 390.209 Section... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL Unified Registration System § 390.209 Pre-authorization...

  7. [Post-authorization research, registries, and drug development].

    PubMed

    Patarnello, Francesca; Recchia, Giuseppe

    2013-06-01

    In the last decade regulators, payers and health care providers tried to react to three major problems in drug development and drug use in clinical practice: the pharmaceutical R&D productivity crisis, the immaturity of benefit-risk profile for several newly approved drugs and the overall impact on economic sustainability of reimbursing new high cost drugs in their systems. The potentiality of create a continuum between the evidence requirements relevant for registration, for reimbursement and for post authorization research is clear. All different parties involved, like regulators, HTA agencies, scientific communities and manufacturers, are working to improve the knowledge profile of new drugs in order to anticipate the patient access to innovation, limiting or preventing the clinical and economical risks deriving from an incomplete safety and effectiveness profile. The Italian example of "New Drugs AIFA Registries", with or without the application of risk sharing schemes (cost sharing, pay for performance, etc.), introduced a new process and increased the sensitivity on this topic. However this might probably represents only a partial answer to the problem of how to set up the governance of coverage with evidence, drug utilization monitoring, comparative effectiveness research, outcome research programs and may be how to link them to access, pricing and reimbursement. The step change in post authorization research could be to "integrate" different sources and stakeholders in a wider and continuous approach, in a well designed and inclusive "second generation" HTA approach, where all resources (competencies, data, funding) will concur to increase the evidence profile and reduce the risks, and where any "evidence generation approach" is really compliant with the standard and rules of best research practices.

  8. [Post-authorization research, registries, and drug development].

    PubMed

    Patarnello, Francesca; Recchia, Giuseppe

    2013-06-01

    In the last decade regulators, payers and health care providers tried to react to three major problems in drug development and drug use in clinical practice: the pharmaceutical R&D productivity crisis, the immaturity of benefit-risk profile for several newly approved drugs and the overall impact on economic sustainability of reimbursing new high cost drugs in their systems. The potentiality of create a continuum between the evidence requirements relevant for registration, for reimbursement and for post authorization research is clear. All different parties involved, like regulators, HTA agencies, scientific communities and manufacturers, are working to improve the knowledge profile of new drugs in order to anticipate the patient access to innovation, limiting or preventing the clinical and economical risks deriving from an incomplete safety and effectiveness profile. The Italian example of "New Drugs AIFA Registries", with or without the application of risk sharing schemes (cost sharing, pay for performance, etc.), introduced a new process and increased the sensitivity on this topic. However this might probably represents only a partial answer to the problem of how to set up the governance of coverage with evidence, drug utilization monitoring, comparative effectiveness research, outcome research programs and may be how to link them to access, pricing and reimbursement. The step change in post authorization research could be to "integrate" different sources and stakeholders in a wider and continuous approach, in a well designed and inclusive "second generation" HTA approach, where all resources (competencies, data, funding) will concur to increase the evidence profile and reduce the risks, and where any "evidence generation approach" is really compliant with the standard and rules of best research practices. PMID:23801233

  9. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES...

  10. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES...

  11. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES...

  12. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES...

  13. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES...

  14. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Pesticide Handlers § 170.235 Posted pesticide safety information. (a) Requirement. When handlers (except those employed by a commercial...

  15. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Workers § 170.135 Posted pesticide safety..., a pesticide covered by this subpart has been applied on the establishment or a...

  16. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Pesticide Handlers § 170.235 Posted pesticide safety information. (a) Requirement. When handlers (except those employed by a commercial...

  17. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Pesticide Handlers § 170.235 Posted pesticide safety information. (a) Requirement. When handlers (except those employed by a commercial...

  18. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Pesticide Handlers § 170.235 Posted pesticide safety information. (a) Requirement. When handlers (except those employed by a commercial...

  19. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Workers § 170.135 Posted pesticide safety..., a pesticide covered by this subpart has been applied on the establishment or a...

  20. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Workers § 170.135 Posted pesticide safety..., a pesticide covered by this subpart has been applied on the establishment or a...

  1. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Posted pesticide safety information...) PESTICIDE PROGRAMS WORKER PROTECTION STANDARD Standard for Workers § 170.135 Posted pesticide safety..., a pesticide covered by this subpart has been applied on the establishment or a...

  2. Tensoral for post-processing users and simulation authors

    NASA Technical Reports Server (NTRS)

    Dresselhaus, Eliot

    1993-01-01

    The CTR post-processing effort aims to make turbulence simulations and data more readily and usefully available to the research and industrial communities. The Tensoral language, which provides the foundation for this effort, is introduced here in the form of a user's guide. The Tensoral user's guide is presented in two main sections. Section one acts as a general introduction and guides database users who wish to post-process simulation databases. Section two gives a brief description of how database authors and other advanced users can make simulation codes and/or the databases they generate available to the user community via Tensoral database back ends. The two-part structure of this document conforms to the two-level design structure of the Tensoral language. Tensoral has been designed to be a general computer language for performing tensor calculus and statistics on numerical data. Tensoral's generality allows it to be used for stand-alone native coding of high-level post-processing tasks (as described in section one of this guide). At the same time, Tensoral's specialization to a minute task (namely, to numerical tensor calculus and statistics) allows it to be easily embedded into applications written partly in Tensoral and partly in other computer languages (here, C and Vectoral). Embedded Tensoral, aimed at advanced users for more general coding (e.g. of efficient simulations, for interfacing with pre-existing software, for visualization, etc.), is described in section two of this guide.

  3. Post Closure Safety of the Morsleben Repository

    SciTech Connect

    Preuss, J.; Eilers, G.; Mauke, R.; Moeller-Hoeppe, N.; Engelhardt, H.-J.; Kreienmeyer, M.; Lerch, C.; Schrimpf, C.

    2002-02-26

    After the completion of detailed studies of the suitability the twin-mine Bartensleben-Marie, situated in the Federal State of Saxony-Anhalt (Germany), was chosen in 1970 for the disposal of low and medium level radioactive waste. The waste emplacement started in 1978 in rock cavities at the mine's fourth level, some 500 m below the surface. Until the end of the operational phase in 1998 in total about 36,800 m{sup 3} of radioactive waste was disposed of. The Morsleben LLW/ILW repository (ERAM) is now under licensing for closure. After completing the licensing procedure the repository will be sealed and backfilled to exclude any undue future impact onto man or the environment. The main safety objective is to protect the biosphere from the harmful effects of the disposed radionuclides. Furthermore, classical or conventional requirements call for ruling out or minimizing other unfavorable environmental effects. The ERAM is an abandoned rock salt and potash mine. As a consequence it has a big void volume, however small parts of the cavities are backfilled with crushed salt rocks. Other goals of the closure concept are therefore a long-term stabilization of the cavities to prevent a dipping or buckling of the ground surface. In addition, groundwater protection shall be assured. For the sealing of the repository a closure concept was developed to ensure compliance with the safety protection objectives. The concept anticipates the backfilling of the cavities with hydraulically setting backfill materials (salt concretes). The reduction of the remaining void volume in the mine causes in the case of brine intrusions a limitation of the leaching processes of the exposed potash seams. However, during the setting process the hydration heat of the concrete will lead to an increase of the temperature and hence to thermally induced stresses of the concrete and the surrounding rocks. Therefore, the influence of these stresses and deformations on the stability of the salt body and

  4. Methods for observational post-licensure medical product safety surveillance.

    PubMed

    Nelson, Jennifer C; Cook, Andrea J; Yu, Onchee; Zhao, Shanshan; Jackson, Lisa A; Psaty, Bruce M

    2015-04-01

    Post-licensure medical product safety surveillance is important for detecting adverse events potentially not identified pre-licensure. Historically, post-licensure safety monitoring has been accomplished using passive reporting systems and by conducting formal Phase IV randomized trials or large epidemiological studies, also known as safety surveillance or pharmacovigilance studies. However, crucial gaps in the safety evidence base provided by these approaches have led to high profile product withdrawals and growing public concern about unknown health risks associated with licensed products. To address the limitations of existing surveillance systems and to facilitate more accurate and rapid detection of safety problems, new systems involving active surveillance of large, population-based cohorts using observational health care databases are being developed. In this article, we review common statistical methods that have been employed previously for post-licensure safety monitoring, including data mining and sequential hypothesis testing, and assess which methods may be promising for potential use within this newly proposed prospective observational cohort monitoring framework. We discuss gaps in existing approaches and identify areas where methodological development is needed to improve the success of safety surveillance efforts in this setting.

  5. Post-earthquake building safety inspection: Lessons from the Canterbury, New Zealand, earthquakes

    USGS Publications Warehouse

    Marshall, J.; Jaiswal, Kishor; Gould, N.; Turner, F.; Lizundia, B.; Barnes, J.

    2013-01-01

    The authors discuss some of the unique aspects and lessons of the New Zealand post-earthquake building safety inspection program that was implemented following the Canterbury earthquake sequence of 2010–2011. The post-event safety assessment program was one of the largest and longest programs undertaken in recent times anywhere in the world. The effort engaged hundreds of engineering professionals throughout the country, and also sought expertise from outside, to perform post-earthquake structural safety inspections of more than 100,000 buildings in the city of Christchurch and the surrounding suburbs. While the building safety inspection procedure implemented was analogous to the ATC 20 program in the United States, many modifications were proposed and implemented in order to assess the large number of buildings that were subjected to strong and variable shaking during a period of two years. This note discusses some of the key aspects of the post-earthquake building safety inspection program and summarizes important lessons that can improve future earthquake response.

  6. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used. PMID:25532410

  7. 77 FR 71454 - Notice of Atomic Safety And Licensing Board Reconstitution, Tennessee Valley Authority (Watts Bar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... COMMISSION Notice of Atomic Safety And Licensing Board Reconstitution, Tennessee Valley Authority (Watts Bar, Unit 2) Pursuant to 10 CFR 2.313(c) and 2.321(b), the Atomic Safety and Licensing Board (Board) in the... 16th day of November 2012. E. Roy Hawkens, Chief Administrative Judge, Atomic Safety and...

  8. Post-earthquake building safety assessments for the Canterbury Earthquakes

    USGS Publications Warehouse

    Marshall, J.; Barnes, J.; Gould, N.; Jaiswal, K.; Lizundia, B.; Swanson, David A.; Turner, F.

    2012-01-01

    This paper explores the post-earthquake building assessment program that was utilized in Christchurch, New Zealand following the Canterbury Sequence of earthquakes beginning with the Magnitude (Mw.) 7.1 Darfield event in September 2010. The aftershocks or triggered events, two of which exceeded Mw 6.0, continued with events in February and June 2011 causing the greatest amount of damage. More than 70,000 building safety assessments were completed following the February event. The timeline and assessment procedures will be discussed including the use of rapid response teams, selection of indicator buildings to monitor damage following aftershocks, risk assessments for demolition of red-tagged buildings, the use of task forces to address management of the heavily damaged downtown area and the process of demolition. Through the post-event safety assessment program that occurred throughout the Canterbury Sequence of earthquakes, many important lessons can be learned that will benefit future response to natural hazards that have potential to damage structures.

  9. Procedure-Authoring Tool Improves Safety on Oil Rigs

    NASA Technical Reports Server (NTRS)

    2014-01-01

    Dark, cold, and dangerous environments are plentiful in space and on Earth. To ensure safe operations in difficult surroundings, NASA relies heavily on procedures written well ahead of time. Houston-based TRACLabs Inc. worked with Ames Research Center through the SBIR program to create an electronic procedure authoring tool, now used by NASA and companies in the oil and gas industry.

  10. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug. PMID:26183623

  11. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

  12. 78 FR 28897 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... COMMISSION Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972, see 37 FR 28710 (1972), and the Commission's... that an Atomic Safety and Licensing Board (Board) is being established to preside over the...

  13. Authorization Basis Safety Classification of Transfer Bay Bridge Crane at the 105-K Basins

    SciTech Connect

    CHAFFEE, G.A.

    2000-04-06

    This supporting document provides the bases for the safety classification for the K Basin transfer bay bridge crane and the bases for the Structures, Systems, and Components (SSC) safety classification. A table is presented that delineates the safety significant components. This safety classification is based on a review of the Authorization Basis (AB). This Authorization Basis review was performed regarding AB and design baseline issues. The primary issues are: (1) What is the AB for the safety classification of the transfer bay bridge crane? (2) What does the SSC safety classification ''Safety Significant'' or ''Safety Significant for Design Only'' mean for design requirements and quality requirements for procurement, installation and maintenance (including replacement of parts) activities for the crane during its expected life time? The AB information on the crane was identified based on review of Department of Energy--Richland Office (RL) and Spent Nuclear Fuel (SNF) Project correspondence, K Basin Safety Analysis Report (SAR) and RL Safety Evaluation Reports (SERs) of SNF Project SAR submittals. The relevant correspondence, actions and activities taken and substantive directions or conclusions of these documents are provided in Appendix A.

  14. Reevaluating nuclear safety and security in a post 9/11 era.

    SciTech Connect

    Booker, Paul M.; Brown, Lisa M.

    2005-07-01

    This report has the following topics: (1) Changing perspectives on nuclear safety and security; (2) Evolving needs in a post-9/11 era; (3) Nuclear Weapons--An attractive terrorist target; (4) The case for increased safety; (5) Evolution of current nuclear weapons safety and security; (6) Integrated surety; (7) The role of safety and security in enabling responsiveness; (8) Advances in surety technologies; and (9) Reevaluating safety.

  15. The safety of liposome bupivacaine 2 years post-launch: a look back and a look forward.

    PubMed

    Viscusi, Eugene R

    2015-01-01

    The need for better post-surgical pain management continues to be unmet, despite clinicians' awareness and concern for many years. Opioids remain the standard of care because of their analgesic efficacy; however, opioid use is often associated with adverse effects and poor patient outcomes. Multimodal analgesic regimens have recently been endorsed as a way to provide adequate post-surgical pain control while reducing opioid consumption. Liposome bupivacaine is a liposomal formulation of bupivacaine indicated for a single administration into the surgical site. Based on the available clinical trial data compiled to date, as well as the author's review of publicly available post-marketing safety information, liposome bupivacaine may be a viable addition to currently available therapeutic options for post-surgical analgesia while reducing potential risks associated with use of opioid analgesics, and may represent a useful addition to the multimodal analgesic modalities currently used for post-operative pain management. The potential for its use in other areas is also being investigated. The purpose of this review is to examine the currently available post-marketing safety information on liposome bupivacaine.

  16. Scientific Method and the Regulation of Health and Nutritional Claims by the European Food Safety Authority

    ERIC Educational Resources Information Center

    Hoad, Darren

    2011-01-01

    The protection of European consumers from the false or misleading scientific and nutritional claims of food manufacturers took a step forward with the recent opinions of the European Food Safety Authority (EFSA). As a risk assessment agency, the EFSA recently assessed and rejected a vast number of food claim forcing the withdrawal of many claims…

  17. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... effect, the handler employer shall display, in accordance with this section, pesticide safety information... central location on the farm or in the nursery or greenhouse where it can be readily seen and read...

  18. [Post-marketing drug safety-risk management plan(RMP)].

    PubMed

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  19. Post-disaster housing reconstruction: Perspectives of the NGO and local authorities on delay issues

    NASA Astrophysics Data System (ADS)

    Khalid, Khairin Norhashidah; Nifa, Faizatul Akmar Abdul; Ismail, Risyawati Mohamed; Lin, Chong Khai

    2016-08-01

    Post disaster reconstruction is complex, dynamic and chaotic in nature and as such represents many challenges because it is unlike normal construction. However, the time scale of reconstruction is shorter than the normal construction, but it often deals with uncertainties and the scale of the construction activities required is relatively high. After a disaster impacts a country, many governments, institutions and aid organizations cooperate and involved with the reconstruction process. This is seen as a tool for applying policies and programs designed to remedy the weakness in developmental policies, infrastructure and institutional arrangements. This paper reports a part of an on-going research on post-disaster housing reconstruction in Malaysia. An extensive literature review and pilot interviews were undertaken to establish the factors that contribute to the delay in post-disaster reconstruction project. Accordingly, this paper takes the perspective of recovery from non-government organization (NGO) and local authorities which act as providers of social services, builders of infrastructure, regulators of economic activity and managers of the natural environment. As a result, it is important on how those decisions are made, who is involved in the decision-making, and what are the consequences of this decision.

  20. Radiation safety considerations for post-iodine-131 hyperthyroid therapy

    SciTech Connect

    Culver, C.M.; Dworkin, H.J. )

    1991-01-01

    The purpose of this study was to develop guidelines based on patient measurements as to when iodine-131- (131I) treated hyperthyroid patients may resume close personal contact. External exposure rates were measured on 59 patients using an ionization survey meter in the upright position. The initial measurement was recorded within 20 min post-dose administration at one meter. Exposure rates were measured 2-11 days post-dose administration at 1, 0.6, and 0.3 meters from the patient's thyroid. In the administered dose range of 3 to less than 12 mCi of 131I, all 40 patients measured less than or equal to 2.0 mR/hr at one meter on Day 0, and 25 patients (25/29) were less than or equal to 2.0 mR/hr at 0.6 meter on Days 2-4. Guidelines can be prepared based on the administered dose that are rational and in conformity with existing radiologic health standards.

  1. Teaching Safety: Using Mole Calculations To Teach Aspects of Safety in Post-16 Chemistry.

    ERIC Educational Resources Information Center

    Borrows, Peter; Vincent, Ray; Cochrane, Allen

    1998-01-01

    Recommends beginning certain chemistry courses with revision and consolidation of mole calculations. Argues that by choosing examples related to health and safety, mole calculations can be made less academic while raising student awareness of important issues. (DDR)

  2. The Environmental Agency's Assessment of the Post-Closure Safety Case for the BNFL DRIGG Low Level Radioactive Waste Disposal Facility

    SciTech Connect

    Streatfield, I. J.; Duerden, S. L.; Yearsley, R. A.

    2002-02-26

    The Environment Agency is responsible, in England and Wales, for authorization of radioactive waste disposal under the Radioactive Substances Act 1993. British Nuclear Fuels plc (BNFL) is currently authorized by the Environment Agency to dispose of solid low level radioactive waste at its site at Drigg, near Sellafield, NW England. As part of a planned review of this authorization, the Environment Agency is currently undertaking an assessment of BNFL's Post-Closure Safety Case Development Programme for the Drigg disposal facility. This paper presents an outline of the review methodology developed and implemented by the Environment Agency specifically for the planned review of BNFL's Post-Closure Safety Case. The paper also provides an overview of the Environment Agency's progress in its on-going assessment programme.

  3. 77 FR 10666 - Pipeline Safety: Post Accident Drug and Alcohol Testing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... and Alcohol Testing AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT... operators and operators of Liquefied Natural Gas (LNG) facilities to conduct post- accident drug and alcohol... incident, operators must drug and alcohol test each covered employee whose performance either...

  4. Structural safety assessment under the low temperature of KSTAR superconducting magnet-supporting post

    NASA Astrophysics Data System (ADS)

    Her, N. I.; Sa, J. W.; Cho, S.; Do, C. J.; Choi, C. H.; Kim, B. C.; Im, K. H.; Kyum, M.; Kim, W. C.; Kim, G. H.; Yoo, B. J.; Oh, Y. K.; Kim, D. L.; Kwon, M.; Lee, G. S.; Kstar Team

    2001-01-01

    A magnet-supporting post installed between the lower TF coil cooled by 4.5 K supercritical helium and the cryostat base is one of the most important components of the superconducting magnet-supporting structure for KSTAR Tokamak. This structure should be flexible to absorb thermal shrink of the magnet and should also be rigid to support the magnet weight and the plasma disruption load. The post was designed with stainless steel (SS) 316 LN and carbon fiber reinforced plastic (CFRP) that has low thermal conductivity and high structural strength at low temperature. In order to verify the fabricability and the structural safety, a whole scale prototype of the KSTAR magnet-supporting post was manufactured and tested. Both static and compressive cyclic load tests under the maximum plasma vertical disruption load and the magnet dead weight were performed. The test results showed that the magnet-supporting post of KSTAR Tokamak was fabricable and structurally rigid.

  5. Recent European Food Safety Authority toxicological evaluations of major phthalates used in food contact materials.

    PubMed

    Lhuguenot, Jean-Claude

    2009-08-01

    During the 1980s and 1990s, and at the EU level, the Scientific Committee for Food evaluated a number of phthalates that were being used, or were requested for use, as additives in plastics. At this time, peroxisome proliferation was considered as the pivotal effect on which toxicological evaluation of these chemicals was based. At the end of 1990s, a general consensus has been agreed that rodents are highly sensitive to the phenomenon of peroxisome proliferation and that this particular effect should not be used for human risk assessment. Consequently in 2004, it was requested from the newly created European Food Safety Authority to perform a new evaluation of the mainly used phthalates on the basis of existing data. This paper summarizes evaluations of butylbenzylphthalate, dibutylphthalate, diethylhexylphthalate.

  6. Drug packaging in 2014: authorities should direct more efforts towards medication safety.

    PubMed

    2015-05-01

    In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

  7. Health and safety inspection of hairdressing and nail salons by local authority environmental health practitioners.

    PubMed

    Harris-Roberts, Joanne; Bowen, Jo; Sumner, Jade; Fishwick, David

    2013-01-01

    The objective of the study described in this article was to provide environmental health practitioners (EHPs) with an evaluation of the levels of understanding of, and compliance with, health and safety legislation in hairdressing and nail salons. EHPs carried out a series of inspections of 205 salons in a large British city, consisting of a site assessment and an assessment of employee knowledge of relevant regulations, including those relating to control of exposure to hazardous substances. Two-fifths of senior salon employees understood Control of Substances Hazardous to Health (COSHH) assessments and could provide evidence of their completion. Most employees had been trained and made aware of the health hazards associated with carrying out their work and took suitable precautions to protect themselves and their clients. The results suggest that senior employees within the salons sampled, have knowledge of the risks to health and have been taking measures to control these risks. Initiatives such as the Health and Safety Executive's (in collaboration with local authorities and the hairdressing industry) "Bad Hand Day?" campaign and sector-specific COSHH essentials guidance help raise awareness levels and aim to support good control practice in salons. PMID:23397656

  8. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    PubMed

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research. PMID:26983223

  9. Why the European Food Safety Authority was right to reject health claims for probiotics.

    PubMed

    Katan, M B

    2012-06-01

    Probiotics are microbes that are claimed to promote health and well-being when added to foods. However, the European Food Safety Authority (EFSA) has so far advised negatively about health claims for probiotics. Companies and scientists have protested against these rejections, sometimes in vigorous language. I argue that EFSA could not have acted differently, given EU regulations and the lack of convincing evidence for some of the claimed effects of probiotics on human health and well-being. One EU regulation that makes it hard to demonstrate the benefits of probiotics is the prohibition of medical claims, i.e. claims that a food prevents or cures a disease. If this prohibition did not exist, manufacturers of nutritional treatments might circumvent the costly procedures required for drugs, and market their products to ill people without thorough proof that they are effective and safe. However, the prohibition is also a legal fiction, because promotion of health and prevention of disease is largely the same thing. EFSA has recently indicated that it will allow health claims based on the ability of probiotics to reduce infections. To a certain extent, this abolishes the distinction between health claims and medical claims. It remains to be seen if probiotics producers can convince EFSA that their products prevent or cure infections and other diseases in humans.

  10. Motor Vehicle Safety Authorization Act of 1986. House of Representatives, Ninety-Ninth Congress, Second Session, September 17, 1986

    SciTech Connect

    Not Available

    1986-01-01

    The House Committee on Energy and Commerce suggests several amendments to H.R. 2248, which authorizes National Highway Traffic Safety Administration appropriations for 1987-1988. The legislation addresses such safety issues as the requirement that dealers inform potential buyers of true odometer readings, tire registration, bumper strength, and defects. The report covers automobile recalls of the past decade, the need for safety standard equality certification for imports, and state safety inspection programs. Oversight hearings and findings of the committee also addressed mandatory seat belt use. The bill affects the National Traffic and Motor Vehicle Safety Act of 1966 and the Motor Vehicle Information and Cost Savings Act. The report notes several areas of compromise.

  11. Study of the post-derailment safety measures on low-speed derailment tests

    NASA Astrophysics Data System (ADS)

    Guo, Lirong; Wang, Kaiyun; Lin, Jianhui; Zhang, Bing; Chen, Zaigang; Song, Xinwu; Du, Gaofeng

    2016-07-01

    Prevention of train from derailment is the most important issue for the railway system. Keeping derailed vehicle close to the track centreline is beneficial to minimise the severe consequences associated with derailments. In this paper, the post-derailment safety measures are studied based on low-speed derailment tests. Post-derailment devices can prevent deviation of the train from the rail by catching the rail, and they are mounted under the axle box. Considering the different structures of vehicles, both trailer and motor vehicles are equipped with the safety device and then separately used in low-speed derailment tests. In derailment tests, two kinds of track, namely the CRTS-I slab ballastless track and the CRTS-II bi-block sleeper ballastless track, are adopted to investigate the effect of the track types on the derailment. In addition, the derailment speed and the weight of the derailed vehicle are also taken into account in derailment tests. The test results indicate that the post-derailment movement of the vehicle includes running and bounce. Reducing the derailment speed and increasing the weight of the head of the train are helpful to reduce the possibility for derailments. For the CRTS-I slab ballastless track, the safety device can prevent trailer vehicles from deviating from the track centreline. The gearbox plays an important role in controlling the lateral displacement of motor vehicle after a derailment while the safety device contributes less to keep derailed motor vehicles on the track centreline. The lateral distance between the safety device and rails should be larger than 181.5 mm for protecting the fasteners system. And for the CRTS-II bi-block sleeper ballastless track, it helps to decrease the post-derailment distance due to the longitudinal impacts with sleepers. It can also restrict the lateral movement of derailed vehicle due to the high shoulders. The results suggest that, CRTS-II bi-block sleeper ballastless track should be widely used

  12. Approaches in the risk assessment of genetically modified foods by the Hellenic Food Safety Authority.

    PubMed

    Varzakas, Theodoros H; Chryssochoidis, G; Argyropoulos, D

    2007-04-01

    Risk analysis has become important to assess conditions and take decisions on control procedures. In this context it is considered a prerequisite in the evaluation of GM food. Many consumers worldwide worry that food derived from genetically modified organisms (GMOs) may be unhealthy and hence regulations on GMO authorisations and labelling have become more stringent. Nowadays there is a higher demand for non-GM products and these products could be differentiated from GM products using the identity preservation system (IP) that could apply throughout the grain processing system. IP is the creation of a transparent communication system that encompasses HACCP, traceability and related systems in the supply chain. This process guarantees that certain characteristics of the lots of food (non-GM origin) are maintained "from farm to fork". This article examines the steps taken by the Hellenic Food Safety Authority to examine the presence of GMOs in foods. The whole integrated European legislation framework currently in place still needs to be implemented in Greece. Penalties should be enforced to those who import, process GMOs without special licence and do not label those products. Similar penalties should be enforced to those companies that issue false certificates beyond the liabilities taken by the food enterprises for farmers' compensation. We argue that Greece has no serious reasons to choose the use of GMOs due to the fact that the structural and pedologic characteristics of the Greek agriculture favour the biological and integrated cultivation more. Greece is not in favour of the politics behind coexistence of conventional and GM plants and objects to the use of GMOs in the food and the environment because the processor has a big burden in terms of money, time and will suffer a great deal in order to prove that their products are GMO free or that any contamination is adventitious or technically unavoidable. Moreover, Greece owns a large variety of genetic

  13. Assessing safety and immunogenicity of post-exposure prophylaxis following interchangeability of rabies vaccines in humans.

    PubMed

    Ravish, Hardanahalli S; Sudarshan, Mysore K; Madhusudana, Shampur N; Annadani, Rachana R; Narayana, Doddabele H Ashwath; Belludi, Ashwin Y; Anandaiah, Gangaboraiah; Vijayashankar, Veena

    2014-01-01

    Rabies post exposure prophylaxis with cell culture vaccines by either intramuscular route or intradermal route spans over a period of one month. World Health Organization recommends completing post exposure prophylaxis against rabies with the same cell culture or embryonated egg rabies vaccine and with same route of administration and any deviation from this shall be an exception. In the present study, the safety and immunogenicity of rabies post-exposure prophylaxis was studied prospectively in 90 animal bite cases that had interchangeability of rabies vaccines either by route of administration or brand/type and such changes had occurred due to logistical/financial problems. Among them, 47 had change in route of administration from intramuscular to intradermal or vice versa and 43 had change in the brand/type of cell culture rabies vaccine. All of them had category III rabies exposure and received equine rabies immunoglobulin along with the rabies vaccine. None of the study subjects had any adverse reactions. The rabies virus neutralizing antibody titers was assessed by rapid fluorescent focus inhibition test and all the vaccinees had titers ≥0.5 IU per mL on day 14 which is considered as adequate for protection against rabies. Thus, the present study showed that, rabies post-exposure prophylaxis was safe and immunogenic despite changes in the route of administration and brand/type of rabies vaccine.

  14. Influence of drivers' comprehension of posted signs on their safety related characteristics.

    PubMed

    Al-Madani, H

    2000-07-01

    The paper studies the relationship between drivers' understanding of posted signs in three of the Gulf Cooperation Council (GCC) states, Bahrain, Qatar and the United Arab Emirates (UAE), and some of their safety related characteristics. These characteristics are driving experience, accident involvement, experience per accident, citations received in the last 3 years on speed limit violations, and seat belt usage. A total of 28 posted signs were investigated. These were categorized as warning and regulatory. To achieve the above goals a questionnaire, specially prepared to collect the necessary data, was distributed to over 6000 drivers in the three states. Over 2820 (47%) responded back. Comprehension of posted signs for drivers with high years of driving experience proved to be significantly better than those with lesser experience. However, the results revealed no significant influence on their accident involvements, even when the effect of age is incorporated; experience per accident ratios, or speed citations. Further, the seat belt usage is also found to increase with understanding of posted signs.

  15. Will They Ever Speak with Authority? Race, Post-Coloniality and the Symbolic Violence of Language

    ERIC Educational Resources Information Center

    Ibrahim, Awad

    2011-01-01

    Intersecting authority-language-and-symbolic power, this article tells the story of a group of continental Francophone African youth who find themselves in an urban French-language high school in southwestern Ontario, Canada. Through their narrative, one is confronted by the trauma of one's own language being declared an illegitimate child, hence…

  16. Back to the Future: Leadership, Tradition, and Authority in a Post-Critical Age

    ERIC Educational Resources Information Center

    Hawkins, Andrew

    2010-01-01

    Both modern and postmodern approaches to knowledge view tradition and authority with suspicion, even contempt, though each approach does so in different ways. Our profession vacillates between those epistemological orientations, struggling to find direction and meaning. Leadership, in particular, is in a quandary; what does leadership look like in…

  17. Further Education outside the Jurisdiction of Local Education Authorities in Post-War England

    ERIC Educational Resources Information Center

    Simmons, Robin

    2014-01-01

    This article revisits the three decades following the end of World War Two--a time when, following the 1944 Education Act, local education authorities (LEAs) were the key agencies responsible for running the education system across England. For the first time, there was a statutory requirement for LEAs to secure adequate facilities for further…

  18. 76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... Management System published in the Federal Register on January 17, 2008 (73 FR 3316), or you may visit http..., FMCSA announced in the Federal Register [76 FR 40420] its intent to proceed with the initiation of a... Safety Audits AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice;...

  19. Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance

    PubMed Central

    Silva, I. R.; Kulldorff, M.

    2016-01-01

    Summary The use of sequential statistical analysis for post-market drug safety surveillance is quickly emerging. Both continuous and group sequential analysis have been used, but consensus is lacking as to when to use which approach. We compare the statistical performance of continuous and group sequential analysis in terms of type I error probability; statistical power; expected time to signal when the null hypothesis is rejected; and the sample size required to end surveillance without rejecting the null. We present a mathematical proposition to show that for any group sequential design there always exists a continuous sequential design that is uniformly better. As a consequence, it is shown that more frequent testing is always better. Additionally, for a Poisson based probability model and a flat rejection boundary in terms of the log likelihood ratio, we compare the performance of various continuous and group sequential designs. Using exact calculations, we found that, for the parameter settings used, there is always a continuous design with shorter expected time to signal than the best group design. The two key conclusions from this article are (i) that any post-market safety surveillance system should attempt to obtain data as frequently as possible, and (ii) that sequential testing should always be performed when new data arrives without deliberately waiting for additional data. PMID:26011024

  20. Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance.

    PubMed

    Silva, I R; Kulldorff, M

    2015-09-01

    The use of sequential statistical analysis for post-market drug safety surveillance is quickly emerging. Both continuous and group sequential analysis have been used, but consensus is lacking as to when to use which approach. We compare the statistical performance of continuous and group sequential analysis in terms of type I error probability; statistical power; expected time to signal when the null hypothesis is rejected; and the sample size required to end surveillance without rejecting the null. We present a mathematical proposition to show that for any group sequential design there always exists a continuous sequential design that is uniformly better. As a consequence, it is shown that more frequent testing is always better. Additionally, for a Poisson based probability model and a flat rejection boundary in terms of the log likelihood ratio, we compare the performance of various continuous and group sequential designs. Using exact calculations, we found that, for the parameter settings used, there is always a continuous design with shorter expected time to signal than the best group design. The two key conclusions from this article are (i) that any post-market safety surveillance system should attempt to obtain data as frequently as possible, and (ii) that sequential testing should always be performed when new data arrives without deliberately waiting for additional data.

  1. Preliminary Authorization Basis Documentation for the Proposed Bio Safety Level 3 (BSl-3) Facility

    SciTech Connect

    Altenbach, T J; Nguyen, S N

    2003-09-20

    Lawrence Livermore National Laboratory (LLNL) is proposing to construct a biosafety level (BSL-3) facility at Site 200 in Livermore, California. Biosafety level 3 (BSL-3) is a designation assigned by the Centers for Disease Control and Prevention (CDC) and National Institutes Health (NIH) for handling infectious organisms based on the specific microorganisms and associated operations. Biosafety levels range from BSL-1 (lowest hazard) to BSL-4 (highest hazard). Details about the BSL-3 criteria are described in the Center of Disease Control and Prevention (CDC)/National Institutes of Health (NIH)'s publication ''Biosafety Microbiological and Biomedical Laboratories'' (BMBL), 4th edition (CDC 1999): The BSL-3 facility will be built in accordance with the required BMBL guidelines. This Preliminary Authorization Basis Documentation (PABD) for the proposed BSL-3 facility has been prepared in accordance with the current contractual requirements at LLNL. This includes the LLNL Environment, Safety, and Health Manual (ES&H Manual) and applicable Work Smart Standards, including the biosafety standards, such as the aforementioned BMBL and the NIH Guidelines for Research Involving Recombinant DNA Molecules: The proposed BSL-3 facility is a 1,100 ft{sup 2}, one-story permanent prefabricated facility, which will have three individual BSL-3 laboratory rooms (one of which is an animal biosafety level-3 [ABSL-3] laboratory to handle rodents), a mechanical room, clothes-change and shower rooms, and small storage space (Figure 3.1). The BSL-3 facility will be designed and operated accordance with guidelines for BSL-3 laboratories established by the CDC and the NIH. No radiological, high explosives, fissile, or propellant material will be used or stored in the proposed BSL-3 facility. The BSL-3 facility will be used to develop scientific tools to identify and understand the pathogens of medical, environmental, and forensic importance. Microorganisms that are to be handled in this

  2. Post-soviet placebos: epistemology and authority in Russian treatments for alcoholism.

    PubMed

    Raikhel, Eugene

    2010-03-01

    The dominant modalities of treatment for alcoholism in Russia are suggestion-based methods developed by narcology-the subspecialty of Russian psychiatry which deals with addiction. A particularly popular method is the use of disulfiram-an alcohol antagonist-for which narcologists commonly substitute neutral substances. Drawing on 14 months of fieldwork at narcological clinics in St. Petersburg, this article examines the epistemological and institutional conditions which facilitate this practice of "placebo therapy." I argue that narcologists' embrace of such treatments has been shaped by a clinical style of reasoning specific to a Soviet and post-Soviet psychiatry, itself the product of contested Soviet politics over the knowledge of the mind and brain. This style of reasoning has facilitated narcologists' understanding of disulfiram as a behavioral, rather than a pharmacological, treatment and has disposed them to amplify patients' responses through attention to the performative aspects of the clinical encounter and through management of the treatment's broader reputation as an effective therapy. Moreover, such therapies have generally depended upon, and helped to reinforce, clinical encounters premised on a steeply hierarchical physician-patient relationship.

  3. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

    SciTech Connect

    Mladineo, Stephen V.; Frazar, Sarah L.; Kurzrok, Andrew J.; Martikka, Elina; Hack, Tapani; Wiander, Timo

    2013-05-30

    This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation with either a newcomer State, or to a State with a fully developed SRA.

  4. Composite sequential Monte Carlo test for post-market vaccine safety surveillance.

    PubMed

    Silva, Ivair R

    2016-04-30

    Group sequential hypothesis testing is now widely used to analyze prospective data. If Monte Carlo simulation is used to construct the signaling threshold, the challenge is how to manage the type I error probability for each one of the multiple tests without losing control on the overall significance level. This paper introduces a valid method for a true management of the alpha spending at each one of a sequence of Monte Carlo tests. The method also enables the use of a sequential simulation strategy for each Monte Carlo test, which is useful for saving computational execution time. Thus, the proposed procedure allows for sequential Monte Carlo test in sequential analysis, and this is the reason that it is called 'composite sequential' test. An upper bound for the potential power losses from the proposed method is deduced. The composite sequential design is illustrated through an application for post-market vaccine safety surveillance data.

  5. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... cover at least 50 percent of estimated truck traffic in any year. All records and documents must be made... basic safety management controls in place which function adequately to ensure minimum acceptable... provisional operating authority has basic safety management controls in place. (e) The safety audit...

  6. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... cover at least 50 percent of estimated truck traffic in any year. All records and documents must be made... basic safety management controls in place which function adequately to ensure minimum acceptable... provisional operating authority has basic safety management controls in place. (e) The safety audit...

  7. Efficacy and Safety of the Angioseal Vascular Closure Device Post Antegrade Puncture

    SciTech Connect

    Looby, S.; Keeling, A. N.; McErlean, A.; Given, M. F.; Geoghegan, T.; Lee, M. J.

    2008-05-15

    In this study, the efficacy and safety of the Angioseal vascular closure device post antegrade puncture of the common femoral artery (CFA) for lower limb vascular interventional procedures are evaluated. A retrospective analysis of the medical records of 60 consecutive patients who were referred for interventional procedures in the superficial femoral artery (SFA) or popliteal artery (popl. art.) was performed. Antegrade puncture was successfully performed in 58 of 60 patients (96.6%). Indications included right SFA angioplasty (n = 35), left SFA angioplasty (n = 17), right popl. art. angioplasty (n = 5), and left popl. art. angioplasty (n = 1). Hemostasis was achieved by, on an intention-to-treat basis, the Angioseal vascular closure device in 46 patients and manual compression in 12 patients. Manual compression was used instead of Angioseal because of severe calcified arterial wall plaques (n = 7), failed deployment of the Angioseal (n = 4), and left SFA dissection (n = 1). There were no major recorded complications in the Angioseal group despite the use of antiplatelet or anticoagulant medications. Twenty-three (50%) of the patients in the Angioseal group were discharged within 24 h. Thirty-seven of the 46 patients who received an Angioseal device had undergone a previous ipsilateral CFA puncture (time range, 2 days to 56 months; mean, 6.2 months). Nine of these patients had undergone ipsilateral Angioseal deployment in the previous 3 months. We conclude that the Angioseal vascular closure device is a safe and efficient means of achieving hemostasis post antegrade puncture.

  8. Efficacy and safety of the angioseal vascular closure device post antegrade puncture.

    PubMed

    Looby, S; Keeling, A N; McErlean, A; Given, M F; Geoghegan, T; Lee, M J

    2008-01-01

    In this study, the efficacy and safety of the Angioseal vascular closure device post antegrade puncture of the common femoral artery (CFA) for lower limb vascular interventional procedures are evaluated. A retrospective analysis of the medical records of 60 consecutive patients who were referred for interventional procedures in the superficial femoral artery (SFA) or popliteal artery (popl. art.) was performed. Antegrade puncture was successfully performed in 58 of 60 patients (96.6%). Indications included right SFA angioplasty (n = 35), left SFA angioplasty (n = 17), right popl. art. angioplasty (n = 5), and left popl. art. angioplasty (n = 1). Hemostasis was achieved by, on an intention-to-treat basis, the Angioseal vascular closure device in 46 patients and manual compression in 12 patients. Manual compression was used instead of Angioseal because of severe calcified arterial wall plaques (n = 7), failed deployment of the Angioseal (n = 4), and left SFA dissection (n = 1). There were no major recorded complications in the Angioseal group despite the use of antiplatelet or anticoagulant medications. Twenty-three (50%) of the patients in the Angioseal group were discharged within 24 h. Thirty-seven of the 46 patients who received an Angioseal device had undergone a previous ipsilateral CFA puncture (time range, 2 days to 56 months; mean, 6.2 months). Nine of these patients had undergone ipsilateral Angioseal deployment in the previous 3 months. We conclude that the Angioseal vascular closure device is a safe and efficient means of achieving hemostasis post antegrade puncture. PMID:18253787

  9. Index to Nuclear Safety: a technical progress review by chrology, permuted title, and author, Volume 11(1) through Volume 20(6)

    SciTech Connect

    Cottrell, W.B.; Passiakos, M.

    1980-06-01

    This index to Nuclear Safety, a bimonthly technical progress review, covers articles published in Nuclear Safety, Volume II, No. 1 (January-February 1970), through Volume 20, No. 6 (November-December 1979). It is divided into three sections: a chronological list of articles (including abstracts) followed by a permuted-title (KWIC) index and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center (NSIC), covers all safety aspects of nuclear power reactors and associated facilities. Over 600 technical articles published in Nuclear Safety in the last ten years are listed in this index.

  10. Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author, Volume 18 (1) through Volume 22 (6)

    SciTech Connect

    Cottrell, W.B.; Passiakos, M.

    1982-06-01

    This index to Nuclear Safety covers articles published in Nuclear Safety, Volume 18, Number 1 (January-February 1977) through Volume 22, Number 6 (November-December 1981). The index is divided into three section: a chronological list of articles (including abstracts), a permuted-title (KWIC) index, and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. Over 300 technical articles published in Nuclear Safety in the last 5 years are listed in this index.

  11. A Multi-Constraint Scheme with Authorized Mechanism for the Patient Safety.

    PubMed

    Hsu, Jen-Ming; Yu, Yao-Chang; Hou, Ting-Wei; Teng, Wei-Guang; Chiang, Tzu-Chiang; Yang, Ming-Chang

    2016-05-01

    Many research works have attempted to introduce passive RFID technology into medical systems to reduce medical errors. However, most of these proposed works focused on identifying patients and objects. If an RFID based medical system is only good for identifying patients and medical objects but not capable of halting any medical process immediately, then it is not possible to prevent medical errors from happening. Our research focuses on a mechanism to detect and to avoid medical harm before it occurs to patients. In this paper, we propose to incorporate multiple-constraints into the authorization scheme and used this scheme as a basis for implementing a medical management system avoiding medical errors to assist medical staff. Specifically, our scheme ensures that a medical operation is if and only if enabled when the constraints are being satisfied that an "identified patient" is being treated by a "certified medical staff member" within an "authorized area". In practical environments, our authorization scheme can be applied to various healthcare applications, and we develop a prototype system and test it in three applications: X-ray control, specimen collection, and blood transfusion management. The experimental results show that the system can be used to enable X-ray when the X-ray is in authorized location and operated by authorized operator. For the specimen collection and blood transfusion, the logs showing which medical staff has done specimen or blood transfusion on which patient at authorized location are correctly recorded into Hospital Information System (HIS). The locating process can be performed within 10 to 20 seconds, and the locating error is less than 2 meters. PMID:27037687

  12. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... the Time of Assignment § 302-9.170 Under what specific conditions may my agency...

  13. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... the Time of Assignment § 302-9.170 Under what specific conditions may my agency...

  14. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... Subsequent to the Time of Assignment § 302-9.170 Under what specific conditions may my agency...

  15. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... Subsequent to the Time of Assignment § 302-9.170 Under what specific conditions may my agency...

  16. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... Subsequent to the Time of Assignment § 302-9.170 Under what specific conditions may my agency...

  17. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy

    PubMed Central

    Lexchin, Joel

    2015-01-01

    Aims Health Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety warnings for NOC/c drugs with drugs with a priority and a standard review. Methods A list of drugs approved between January 1 1998 and March 31 2013 was developed and serious safety warnings for these drugs were identified. Drugs were put into one of three groups based on the way that they were approved. Kaplan−Meier curves were generated to examine the likelihood of NOC/c drugs receiving a serious safety warning compared with drugs with a priority and a standard review. The time spent in the review process for each of the groups was also measured. Results Compared with drugs with a priority review, NOC/c drugs were not more likely to receive a serious safety warning (P = 0.5940) but were more likely than drugs with a standard review (P = 0.0113). NOC/c drugs spent less time in the review process compared with drugs with a standard review. Conclusions Possible reasons for the increase likelihood of a serious safety warning are the limited knowledge of the safety of NOC/c drugs when they are approved and the length of time that they spend in the review process. Health Canada should consider spending longer reviewing these drugs and monitor their post-market safety more closely. PMID:25393960

  18. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

    PubMed Central

    D’Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D’Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

    2015-01-01

    Background Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. Methods We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50μg, placebo (both delivered via the Breezhaler® device), or tiotropium 18 μg (delivered via the HandiHaler® device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA™. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. Results The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. Conclusion The overall safety profile of glycopyrronium was

  19. PAT-1 safety analysis report addendum author responses to request for additional information.

    SciTech Connect

    Weiner, Ruth F.; Schmale, David T.; Kalan, Robert J.; Akin, Lili A.; Miller, David Russell; Knorovsky, Gerald Albert; Yoshimura, Richard Hiroyuki; Lopez, Carlos; Harding, David Cameron; Jones, Perry L.; Morrow, Charles W.

    2010-09-01

    The Plutonium Air Transportable Package, Model PAT-1, is certified under Title 10, Code of Federal Regulations Part 71 by the U.S. Nuclear Regulatory Commission (NRC) per Certificate of Compliance (CoC) USA/0361B(U)F-96 (currently Revision 9). The National Nuclear Security Administration (NNSA) submitted SAND Report SAND2009-5822 to NRC that documented the incorporation of plutonium (Pu) metal as a new payload for the PAT-1 package. NRC responded with a Request for Additional Information (RAI), identifying information needed in connection with its review of the application. The purpose of this SAND report is to provide the authors responses to each RAI. SAND Report SAND2010-6106 containing the proposed changes to the Addendum is provided separately.

  20. Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies.

    PubMed

    O'Neill, R T

    This paper deals with a conceptual discussion of a variety of statistical concepts, methods and strategies that are relevant to the quantitative assessment of risk derived from safety data collected during the pre- and post-marketing phase of a new drug's life cycle. A call is made for the use of more standard approaches to the analysis of safety data that are statistically and epidemiologically rigorous and for attempts to link the strategies for pre-market safety assessment with strategies for post-market safety evaluation. This link may be facilitated by recognizing the limitations and complementary roles played by pre- and post-market safety data collection schemes and by linking the quantitative analyses utilized for either exploratory or confirmatory purposes of risk assessment in each phase of safety data collection. Examples are provided of studies specifically designed to evaluate risk in a post approval setting and several available guidelines intended to improve the quality of these studies are discussed.

  1. Pre- and post-exposure safety and efficacy of attenuated rabies virus vaccines are enhanced by their expression of IFNγ

    SciTech Connect

    Barkhouse, Darryll A.; Faber, Milosz; Hooper, D. Craig

    2015-01-01

    Consistent with evidence of a strong correlation between interferon gamma (IFNγ) production and rabies virus (RABV) clearance from the CNS, we recently demonstrated that engineering a pathogenic RABV to express IFNγ highly attenuates the virus. Reasoning that IFNγ expression by RABV vaccines would enhance their safety and efficacy, we reverse-engineered two proven vaccine vectors, GAS and GASGAS, to express murine IFNγ. Mortality and morbidity were monitored during suckling mice infection, immunize/challenge experiments and mixed intracranial infections. We demonstrate that GASγ and GASγGAS are significantly attenuated in suckling mice compared to the GASGAS vaccine. GASγ better protects mice from lethal DRV4 RABV infection in both pre- and post-exposure experiments compared to GASGAS. Finally, GASγGAS reduces post-infection neurological sequelae, compared to control, during mixed intracranial infection with DRV4. These data show IFNγ expression by a vaccine vector can enhance its safety while increasing its efficacy as pre- and post-exposure treatment. - Highlights: • IFNγ expression improves attenuated rabies virus safety and immunogenicity. • IFNγ expression is safer and more immunogenic than doubling glycoprotein expression. • Co-infection with IFNγ-expressing RABV prevents wild-type rabies virus lethality. • Vaccine safety and efficacy is additive for IFNγ and double glycoprotein expression.

  2. 49 CFR Appendix to Subpart H of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North America-Domiciled...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... safety management controls of the motor carrier. (c) Critical regulations are those where noncompliance... 49 Transportation 5 2014-10-01 2014-10-01 false Explanation of Pre-Authorization Safety Audit... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER...

  3. One Year Post Collaborative Depression Care Trial Outcomes among Predominantly Hispanic Diabetes Safety Net Patients

    PubMed Central

    Ell, Kathleen; Katon, Wayne; Xie, Bin; Lee, Pey-Jiuan; Kapetanovic, Suad; Guterman, Jeffery; Chou, Chih-Ping

    2011-01-01

    Objective To determine sustained effectiveness in reducing depression symptoms and improving depression care one year following intervention completion. Method Of 387 low-income, predominantly Hispanic diabetes patients with major depression symptoms randomized to 12-month socio-culturally adapted collaborative care (psychotherapy and/or antidepressants, telephone symptom monitoring/relapse prevention) or enhanced usual care, 264 patients completed two-year follow-up. Depression symptoms (SCL-20, PHQ-9), treatment receipt, diabetes symptoms, and quality of life were assessed 24 months post-enrollment using intent-to-treat analyses. Results At 24 months, more intervention patients received ongoing antidepressant treatment (38% v 25%, chi-square=5.11, df=1, P=0.02); sustained depression symptom improvement (SCL-20<0.5 (adjusted OR=2.06, 95%CI=1.09–3.90, P=0.03), SCL-20 score (adjusted mean difference −0.22, P=0.001), and PHQ-9 ≥50% reduction (adjusted OR=1.87, 95%CI=1.05–3.32, P=0.03). Over 2 years, improved effects were found in significant study group by time interaction for SF-12 mental health, SDS functional impairment, diabetes symptoms, anxiety, and socioeconomic stressors (P=0.02 for SDS, P<0.0001 for all others); however, group differences narrowed over time and were no longer significant at 24 months. Conclusions Socio-culturally tailored collaborative care that included maintenance antidepressant medication, ongoing symptom monitoring and behavioral activation relapse prevention was associated with depression improvement over 24 months for predominantly Hispanic patients in primary safety net care. PMID:21774987

  4. Assessment of the safety of US nuclear weapons and related nuclear test requirements: A post-Bush Initiative update

    SciTech Connect

    Kidder, R.E.

    1991-12-10

    The Nuclear Weapons Reduction Initiative announced by President Bush on September 27, 1991, is described herein as set forth in Defense Secretary Cheney`s Nuclear Arsenal Reduction Order issued September 28, 1991. The implications of the Bush Initiative for improved nuclear weapons safety are assessed in response to a request by US Senators Harkin, Kennedy, and Wirth to the Lawrence Livermore National Laboratory that the author prepare such an assessment. The author provides an estimate of the number of nuclear tests needed to accomplish a variety of specified warhead safety upgrades, then uses the results of this estimate to answer three questions posed by the Senators. These questions concern pit reuse and the number of nuclear tests needed for specified safety upgrades of those ballistic missiles not scheduled for retirement, namely the Minuteman III, C4, and D5 missiles.

  5. [Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background].

    PubMed

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Song, Nian-bin

    2015-12-01

    This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety. PMID:27245017

  6. NOAC monitoring, reversal agents, and post-approval safety and effectiveness evaluation: A cardiac safety research consortium think tank.

    PubMed

    Reiffel, James A; Weitz, Jeffrey I; Reilly, Paul; Kaminskas, Edvardas; Sarich, Troy; Sager, Philip; Seltzer, Jonathan

    2016-07-01

    Four non-vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban, apixaban, and edoxaban) have been approved in the United States for treatment of atrial fibrillation (AF) and venous thromboembolic disease. They have been as or more effective than the prior standards of care, with less fatal or intracranial bleeding, fewer drug and dietary interactions, and greater patient convenience. Nonetheless, the absence of the ability for clinicians to assess compliance or washout with a simple laboratory test (or to adjust dosing with a similar assessment) and the absence of an antidote to rapidly stop major hemorrhage or to enhance safety in the setting of emergent or urgent surgery/procedures have been limitations to greater non-vitamin K antagonist oral anticoagulant usage and better thromboembolic prevention. Accordingly, a Cardiac Research Safety Consortium "think tank" meeting was held in February 2015 to address these concerns. This manuscript reports on the discussions held and the conclusions reached at that meeting. PMID:27297852

  7. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... Transportation Pov Transportation Subsequent to the Time of Assignment § 302-9.175 When I am authorized...

  8. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement,...

  9. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement,...

  10. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... Transportation Pov Transportation Subsequent to the Time of Assignment § 302-9.175 When I am authorized...

  11. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement,...

  12. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement,...

  13. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement,...

  14. 30 CFR 774.11 - Post-permit issuance requirements for regulatory authorities and other actions based on ownership...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Post-permit issuance requirements for... Section 774.11 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE... REGULATORY PROGRAMS REVISION; RENEWAL; TRANSFER, ASSIGNMENT, OR SALE OF PERMIT RIGHTS; POST-PERMIT...

  15. Institutional Response to Ohio's Campus Safety Initiatives: A Post-Virginia Tech Analysis

    ERIC Educational Resources Information Center

    Jackson, Natalie Jo

    2009-01-01

    The purpose of this study was to examine how institutions of higher education were responding to unprecedented state involvement in campus safety planning and policymaking in the aftermath of the Virginia Tech tragedy. Focused on Ohio, a state in which a state-level task force was convened and charged to promulgate campus safety recommendations…

  16. Full Bayesian evaluation of the safety effects of reducing the posted speed limit in urban residential area.

    PubMed

    Islam, Md Tazul; El-Basyouny, Karim

    2015-07-01

    Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads.

  17. The European post-marketing observational sertindole study: an investigation of the safety of antipsychotic drug treatment.

    PubMed

    Kasper, Siegfried; Möller, Hans-Jürgen; Hale, Anthony

    2010-02-01

    The objective of the European Post-marketing Observational Serdolect((R)) (EPOS) Study was to compare the safety of treatment with Serdolect (sertindole) with that of usual treatment in patients with schizophrenia, in normal European clinical practice. The EPOS was a multicentre, multinational, referenced, cohort study. Patients were enrolled at 226 centres in ten European countries. The study was prematurely terminated in 1998 as a result of the temporary market suspension of sertindole. Termination of the study reduced the number of patients recruited from the planned 12,000 to 2,321. While the power of the study was weakened, it did provide useful mortality information, which may be useful for future long-term studies. Crude mortality in the sertindole and non-sertindole groups was 1.45 (95% confidence interval, CI 0.53-3.16) and 1.50 (CI 0.72-2.76) deaths/100 patient-years exposed, respectively. There were no more cardiac deaths in the sertindole group than in the non-sertindole group. QT interval prolongation did not translate into an increased risk of death. Sertindole was well tolerated and caused few extrapyramidal symptoms. Although CIs remained large, this post-marketing study does not provide any evidence against the use of sertindole under normal conditions. Sertindole was well tolerated and posed no significant safety problems.

  18. Post-Disaster Safety Net: Instituting Leadership, Economic and Technological Arrangements

    ERIC Educational Resources Information Center

    Akaiso, Darlington

    2013-01-01

    This dissertation will present the findings of an in-depth study conducted on flood victims in Bangkok, Thailand. The objective of this study is to explore the feasibility of using modern technologies as a post-crisis remediation strategy to reconnect displaced families in the aftermath of a disaster. This will include investigating which modern…

  19. Incentivizing Primary Care Providers to Innovate: Building Medical Homes in the Post-Katrina New Orleans Safety Net

    PubMed Central

    Rittenhouse, Diane R; Schmidt, Laura A; Wu, Kevin J; Wiley, James

    2014-01-01

    ObjectiveTo evaluate safety-net clinics’ responses to a novel community-wide Patient-Centered Medical Home (PCMH) financial incentive program in post-Katrina New Orleans. Data Sources/Study SettingBetween June 2008 and June 2010, we studied 50 primary care clinics in New Orleans receiving federal funds to expand services and improve care delivery. Study DesignMultiwave, longitudinal, observational study of a local safety-net primary care system. Data CollectionClinic-level data from a semiannual survey of clinic leaders (89.3 percent response rate), augmented by administrative records. Principal FindingsOverall, 62 percent of the clinics responded to financial incentives by achieving PCMH recognition from the National Committee on Quality Assurance (NCQA). Higher patient volume, higher baseline PCMH scores, and type of ownership were significant predictors of achieving NCQA recognition. The steepest increase in adoption of PCMH processes occurred among clinics achieving the highest, Level 3, NCQA recognition. Following NCQA recognition, 88.9 percent stabilized or increased their use of PCMH processes, although several specific PCMH processes had very low rates of adoption overall. ConclusionsFindings demonstrate that widespread PCMH implementation is possible in a safety-net environment when external financial incentives are aligned with the goal of practice innovation. PMID:23800148

  20. Safety assessment of the post-harvest treatment of button mushrooms (Agaricus bisporus) using ultraviolet light.

    PubMed

    Simon, R R; Borzelleca, J F; DeLuca, H F; Weaver, C M

    2013-06-01

    Wild mushrooms are an excellent source of vitamin D. The presence of vitamin D in mushrooms is attributed to sunlight exposure, which catalyzes the conversion of fungal ergosterol to vitamin D2 via a series of photochemical/thermal reactions. Mushroom growers now incorporate UV light treatments during processing to produce mushrooms with levels of vitamin D that compare to those in wild mushrooms. Presented herein is a comprehensive review of information relevant to the safety of introducing vitamin D mushrooms, produced using UV light technologies, to the food supply. Historical reference to the use of UV light for production of vitamin D is discussed, and studies evaluating the nutritional value and safety of vitamin D mushrooms are reviewed. Traditional safety evaluation practices for food additives are not applicable to whole foods; therefore, the application of substantial equivalence and history-of-safe-use is presented. It was demonstrated that vitamin D in mushrooms, produced using UV light technologies, are equivalent to vitamin D in mushrooms exposed to sunlight, and that UV light has a long-history of safe use for production of vitamin D in food. Vitamin D mushrooms produced using UV light technologies were therefore considered safe and suitable for introduction to the marketplace.

  1. Post-marketing evaluation of the short term safety of COMVAX.

    PubMed

    Davis, Robert L; Black, Steven; Shinefield, Henry; Mahoney, Lisa; Zavitkovsky, Ann; Lewis, Edwin; Nikas, Alex; Guess, Harry; Coplan, Paul

    2004-01-01

    We report an evaluation of the short-term safety of a pediatric bivalent combination vaccine containing RECOMBIVAXHB and Liquid PedvaxHIB, COMVAX. Safety was assessed through identification of medical utilization; potential adverse events were identified through computerized clinical databases for deaths, hospitalizations, emergency room visits, and outpatient clinic visits. We calculated relative risks whenever there was at least one diagnosis-specific event in the risk period following vaccination and compared the rates in specific time windows following vaccination with rates at 31-60 days following vaccination and also with rates in a historical cohort of children. A total of 27,802 doses of COMVAX were administered, with 127 separate adverse event codes with statistically significant elevated risks, and 66 codes with significantly decreased risks. Most potentially serious diagnoses appeared in four major categories: "Respiratory Events"; "Gastroenteritis"; "Adverse Effect of Medicinal and Biological Substance, NOS"; and "Fever". There was no consistent pattern to indicate increased risks for serious respiratory or gastrointestinal illness. For fever, most of the findings appeared to be explained by changes in data collection or by concomitant vaccination with M-M-R(-)II. There was an increased risk for fever hospitalizations following shot 1. The total number of children hospitalized with fever was seven out of 12,468 children; all recovered fully. In this study population of 27,802 vaccine recipients, COMVAX appeared to have a favorable safety profile.

  2. Preliminary Authorization Basis Document For the Proposed Biological Safety Level 3 (BSL-3) Facility (B368) at Lawrence Livermore National Laboratory Revision 2

    SciTech Connect

    Altenbach, T; Nguyen, S

    2005-01-04

    The Lawrence Livermore National Laboratory Integrated Safety Management (ISM) System Description (LLNL 2002) and the Task Plan for the Preparation of Authorization Basis Documentation for the proposed Biosafety Level 3 Laboratory at Lawrence Livermore National Laboratory (DOE 2002a) require a PABD be prepared for the proposed BSL-3 Facility. NNSA-OAK approval is required prior to its construction. This Preliminary Authorization Basis Documentation (PABD) formalizes and documents the hazard evaluation and its results for the Biosafety level 3 (BSL-3) facility. The PABD for the proposed BSL-3 facility provides the following information: (1) BSL-3 facility's site description; (2) general description of the BSL-3 facility and its operations; (3) identification of facility hazards; (4) generic hazard analysis; (5) identification of controls important to safety; and (6) safety management programs. The PABD characterizes the level of intrinsic potential hazard associated with a facility and provides the basis for its hazard classification. The hazard classification determines the level of safety documentation required and the level of review and approval for the safety analysis. The hazards of primary concern associated with the BSL-3 facility are biological. The hazard classification is determined by comparing facility inventories of biological materials and activities with the BSL-3 threshold established by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) for BSL-3 facilities.

  3. Safety and tolerability of bivalent HPV vaccine: an Italian post-licensure study.

    PubMed

    Gasparini, Roberto; Bonanni, Paolo; Levi, Miriam; Bechini, Angela; Boccalini, Sara; Tiscione, Emilia; Amicizia, Daniela; Lai, Piero Luigi; Sulaj, Klodiana; Patria, Antonio Giuseppe; Panatto, Donatella

    2011-01-01

    One of the most important scientific discoveries of the last century was that persistent infection by some types of HPV is a precondition for the development of cervical cancer. The oncogenic types of HPV are also associated with other tumours (vaginal, vulvar and anal carcinomas, tumours of the head and neck, urethra and penis). Two preventive vaccines are currently available (Cervarix and Gardasil). Both have shown very good efficacy, safety and tolerability profiles. Nonetheless, extensive vaccination requires long-term monitoring of safety and tolerability. The aim of our study was to evaluate the safety and tolerability of the bivalent vaccine Cervarix in Italy. Every participant in the study completed a questionnaire after each dose of vaccine received, with a view to recording adverse events during the first 7 days after vaccination. We registered local (pain, redness, swelling) and systemic symptoms (fever, headache, myalgia, fatigue, arthralgia, itching, gastrointestinal disorders, rash and urticaria). A total of 4,643 subjects were recruited. In all, 7,107 questionnaires were collected: 3,064 after the first dose, 2,367 after the second and 1,676 after the third. No serious adverse events were observed. The most frequent local symptom was pain at the injection site, while fatigue, headache and myalgia were the most common systemic reactions. Pain was reported more frequently after the first dose than after the others, while all the other local and general symptoms were reported most frequently after the third dose. Almost all of the local and general reactions proved to be of negligible intensity and duration and required no medical intervention. Our results show better tolerability of the vaccine in comparison with the data from some controlled clinical studies and from other surveillance programmes conducted internationally. That tolerability proved to be better than in clinical studies could be explained by the absence of the typical apprehension felt

  4. Effectiveness and Safety of Arnica montana in Post-Surgical Setting, Pain and Inflammation.

    PubMed

    Iannitti, Tommaso; Morales-Medina, Julio César; Bellavite, Paolo; Rottigni, Valentina; Palmieri, Beniamino

    2016-01-01

    Arnica montana has been widely used as a homeopathic remedy for the treatment of several inflammatory conditions in pain management and postoperative settings. This review gives an overview of the therapeutic use of Arnica montana in the above-mentioned fields also focusing on its mechanisms of action learned from animal models and in vitro studies. Arnica montana is more effective than placebo when used for the treatment of several conditions including post-traumatic and postoperative pain, edema, and ecchymosis. However, its dosages and preparations used have produced substantial differences in the clinical outcome. Cumulative evidence suggests that Arnica montana may represent a valid alternative to non-steroidal anti-inflammatory drugs, at least when treating some specific conditions.

  5. New modes of regulation for health and safety: post-enlargement policy perspectives for the European Union.

    PubMed

    Woolfson, Charles

    2006-01-01

    The recent joining of ten new member states to the European Union, eight of which are former communist countries, has reopened inherent tensions in current European Union (EU) policy-making on safety and health in the workplace. These spring from seemingly incompatible objectives; the need to ensure broad EU member state compliance with regulation, around agreed minimum standards through active regulatory enforcement, and the promotion of "softer" voluntary initiatives in the management of workplace risks and hazards in order to create "a culture of prevention." The present EU strategy which ends in 2006, seeks to secure a balance between both sets of objectives. However, with respect to the post-communist new member states of Central and Eastern Europe, the appropriateness of the current strategy is doubtful. This article therefore focuses on the implications of the expansion of the European Union in May 2004 in the context of the elaboration of the new "soft law" modes of regulatory governance at the EU level. In turn, this provokes the question: will the "new" European policy for occupational health and safety from 2007 onwards, be "new," or simply more of the same? If the latter, it is suggested that the future for working environment standards in Europe as a whole may be significantly compromised.

  6. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  7. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data.

    PubMed

    Zhu, Xiao; Kruhlak, Naomi L

    2014-07-01

    Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure-activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI.

  8. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data.

    PubMed

    Zhu, Xiao; Kruhlak, Naomi L

    2014-07-01

    Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure-activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI. PMID:24721472

  9. Effectiveness and safety of post-induction phase bevacizumab treatment for patients with non-small-cell lung cancer: results from the ARIES observational cohort study.

    PubMed

    Kosty, Michael P; Wozniak, Antoinette J; Jahanzeb, Mohammad; Leon, Larry; Fish, Susan; Hazard, Sebastien J; Lynch, Thomas J

    2015-12-01

    Data from randomized, controlled trials suggest that post-induction phase (IP) treatment with bevacizumab may benefit patients with advanced non-small-cell lung cancer (NSCLC). Real-world clinical practice, however, can involve variable use and patterns of treatment in broader patient populations. To assess the effect of bevacizumab on post-IP overall survival (OS) following IP chemotherapy + bevacizumab, analyses were conducted in patients enrolled in the Avastin(®) Registry--Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) who received post-IP bevacizumab. ARIES was a large, prospective OCS of patients who received chemotherapy in combination with bevacizumab for the first-line treatment of NSCLC. This unplanned, post hoc analysis included patients who received chemotherapy and bevacizumab and who did not have progressive disease through the completion of IP treatment. A dichotomous analysis compared outcomes in patients who did and did not receive bevacizumab before a landmark date of day 30 post IP. A cumulative exposure analysis used a time-dependent Cox regression model to assess the effect of cumulative post-IP bevacizumab exposure on post-IP OS. In the dichotomous analysis, the duration of post-IP OS was significantly longer in patients who received post-IP bevacizumab; median post-IP OS was 15.6 vs. 11.3 months, respectively (hazard ratio [HR] = 0.80; 95 % confidence interval 0.71-0.91; P < 0.001). The cumulative exposure analysis observed that each additional cycle of cumulative bevacizumab exposure decreased the HR for post-IP OS by 2.7 %, on average. In conclusion, post-IP bevacizumab exposure was associated with improved post-IP OS in patients with advanced NSCLC who were enrolled in the ARIES OCS.

  10. Multi-Country Evaluation of Safety of Dihydroartemisinin/Piperaquine Post-Licensure in African Public Hospitals with Electrocardiograms

    PubMed Central

    Baiden, Rita; Ali, Ali M.; Mahende, Muhidin K.; Ogutu, Bernhards R.; Oduro, Abraham; Tinto, Halidou; Gyapong, Margaret; Sie, Ali; Sevene, Esperanca; Macete, Eusebio; Owusu-Agyei, Seth; Adjei, Alex; Compaoré, Guillaume; Valea, Innocent; Osei, Isaac; Yawson, Abena; Adjuik, Martin; Akparibo, Raymond; Kakolwa, Mwaka A.; Abdulla, Salim; Binka, Fred

    2016-01-01

    The antimalarial drug piperaquine is associated with delayed ventricular depolarization, causing prolonged QT interval (time taken for ventricular de-polarisation and re-polarisation). There is a lack of safety data regarding dihydroartemisinin/piperaquine (DHA/PPQ) for the treatment of uncomplicated malaria, which has limited its use. We created a platform where electrocardiograms (ECG) were performed in public hospitals for the safety assessment of DHA/PPQ, at baseline before the use of dihydroartemisinin/piperaquine (Eurartesim®), and on day 3 (before and after administration of the final dose) and day 7 post-administration. Laboratory analyses included haematology and clinical chemistry. The main objective of the ECG assessment in this study was to evaluate the effect of administration of DHA/PPQ on QTc intervals and the association of QTc intervals with changes in blood biochemistry, full and differential blood count over time after the DHA/PPQ administration. A total of 1315 patients gave consent and were enrolled of which 1147 (87%) had complete information for analyses. Of the enrolled patients 488 (42%), 323 (28%), 213 (19%) and 123 (11%) were from Ghana, Burkina Faso, Tanzania and Mozambique, respectively. Median (lower—upper quartile) age was 8 (5–14) years and a quarter of the patients were children under five years of age (n = 287). Changes in blood biochemistry, full and differential blood count were temporal which remained within clinical thresholds and did not require any intervention. The mean QTcF values were significantly higher than on day 1 when measured on day 3 before and after administration of the treatment as well as on day 7, four days after completion of treatment (12, 22 and 4 higher, p < 0.001). In all age groups the values of QT, QTcF and QTcB were highest on day 3 after drug intake. The mean extreme QTcF prolongation from baseline was lowest on day 3 before drug intake (33 ms, SD = 19) and highest on day 3 after the last dose

  11. [Discussion about relativity between post-marketed safety outcome and treatment course of traditional Chinese medicine drugs on basis of reinforced urn processes].

    PubMed

    Zhong, Cheng-Liang; Hu, Si-Yuan; Xie, Yan-Ming; Wang, Yong-Yan

    2013-09-01

    Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.

  12. The safety of quetiapine: results of a post-marketing surveillance study on 1728 patients in England.

    PubMed

    Twaites, Beverley R; Wilton, Lynda V; Shakir, Saad A W

    2007-06-01

    The safety of the atypical antipsychotic quetiapine as used in general practice in England was examined by prescription-event monitoring (PEM). Patients were identified from dispensed National Health Service (NHS) prescriptions issued by general practitioners (GPs) for quetiapine between October 1997 and July 1999. The outcome data were event reports obtained by sending questionnaires ('green forms') to the prescribing doctor at Least 6 months after the first prescription for an individual patient. Green forms with clinically useful information on 1728 patients (median age 39 years (IQR 30-56); 53% female) were received. The most frequently reported event during the first month of treatment was 'drowsiness/sedation' (47; 3% cohort). This was also the most frequently reported specified adverse drug reaction (ADR) to quetiapine (7; 11% of 65 reported ADRs) and the highest reported clinical reason for stopping quetiapine (51; 6% of the 734 reported reasons for stopping). There was a low incidence of extrapyramidal disease (21 during treatment, 1% of cohort) and hyperprolactinaemia (three during treatment, 0.2%) in this study. Three cases of diabetes mellitus in this cohort were reported to be a new diagnosis. Six pregnancies were reported during treatment with quetiapine, five of which were exposed during the first trimester only. There were four Live births with no reported congenital abnormaLities. Fifty-six deaths were reported during this study (3% cohort). The most frequently reported causes of death reLated to the cardiovascular (18) and respiratory (15) systems. The results of this post-marketing surveillance study demonstrated that quetiapine is generally well-tolerated when used in general practice. PMID:17656426

  13. Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006.

    PubMed

    McNicholas, Anne; Galloway, Yvonne; Stehr-Green, Paul; Reid, Stewart; Radke, Sarah; Sexton, Kerry; Kieft, Charlotte; Macdonald, Claire; Neutze, Jocelyn; Drake, Ross; Isaac, Dorothy; O'Donnell, Mary; Tatley, Michael; Oster, Philipp; O'Hallahan, Jane

    2007-01-01

    New Zealand introduced a new outer membrane vesicle vaccine in 2004 to combat an epidemic of group B meningococcal disease. An Independent Safety Monitoring Board oversaw intensive safety monitoring, which included hospital surveillance, health professional reporting (passive and active) and mortality monitoring. With over three million doses administered to individuals aged under 20 years, the monitoring results provide consistent evidence supporting the vaccine's safety.

  14. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience

    PubMed Central

    Angelo, Maria-Genalin; Zima, Julia; Tavares Da Silva, Fernanda; Baril, Laurence; Arellano, Felix

    2014-01-01

    Purpose To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium). Methods We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008–2010). Results Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain–Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information. Conclusion Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit–risk profile in adolescent girls and women. PMID:24644078

  15. Analysis of factors influencing the overall effect of racecadotril on childhood acute diarrhea. Results from a real-world and post-authorization surveillance study in Venezuela

    PubMed Central

    Chacón, Jose

    2010-01-01

    Drug efficacy might differ from clinical trial results when performed in clinical daily conditions. Therefore, it is mandatory to conduct trials about effectiveness to improve external validity. This post-authorization, open-label, noncontrolled, prospective, multicenter, observational, and naturalistic trial was designed to search for factors influencing the racecadotril overall effect on childhood acute watery diarrhea in a real-world setting of Venezuela. There were 3,873 children with acute watery diarrhea treated with racecadotril, an enkephalin breakdown blocker plus oral rehydration therapy by 97 pediatricians. Evaluations were carried out daily until emission of two consecutive formed stools or absence of watery bowel movements for 24 hours. The primary end-point was time-to-relief, defined as the time from first racecadotril dose to the last watery bowel movement time. Age, gender, nursing type, nursing status during diarrhea, diarrhea severity, and co-medication were considered as factors in the statistical analysis. The primary end-point was evaluated by factors using UNIANOVA, and post-hoc tests were done. A multiple regression analysis was carried out to identify factors affecting drug performance, racecadotril effectiveness and tolerability overall assessment was searched by physicians and patients, and inter-observer agreement was evaluated by kappa statistics. The mean time-to-relief was 18.5 ± 12.5 hours [95% confidence interval 17.9–19.0] and the diarrhea severity was the only variable with significant and independent weight on racecadotril effectiveness explaining 23% of time-to-relief variance, but even in severe diarrhea cases this time was less than 24 hours. High agreement about satisfactory perception on effectiveness and tolerability was reached among physicians and patients. In conclusion, the racecadotril overall effect, evaluated in a real-world setting of Venezuela, was in agreement with results of some earlier controlled trials. It

  16. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.

    PubMed

    Bravo, Lulu; Chitraka, Amarjeet; Liu, Aixue; Choudhury, Jaydeep; Kumar, Kishore; Berezo, Lennie; Cimafranca, Leonard; Chatterjee, Pallab; Garg, Pankaj; Siriwardene, Prasanna; Bernardo, Rommel; Mehta, Shailesh; Balasubramanian, Sundaram; Karkada, Naveen; Htay Han, Htay

    2014-01-01

    Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.

  17. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.

    PubMed

    Bravo, Lulu; Chitraka, Amarjeet; Liu, Aixue; Choudhury, Jaydeep; Kumar, Kishore; Berezo, Lennie; Cimafranca, Leonard; Chatterjee, Pallab; Garg, Pankaj; Siriwardene, Prasanna; Bernardo, Rommel; Mehta, Shailesh; Balasubramanian, Sundaram; Karkada, Naveen; Htay Han, Htay

    2014-01-01

    Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India. PMID:25424932

  18. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study

    PubMed Central

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    Purpose The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. Materials and methods The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4) in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. Main outcome measure(s) An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. Main results The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Conclusion Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce

  19. The role of the Therapeutic Goods Administration and the Medicine and Medical Devices Safety Authority in evaluating complementary and alternative medicines in Australia and New Zealand.

    PubMed

    Ghosh, Dilip; Skinner, Margot; Ferguson, Lynnette R

    2006-04-01

    Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines.

  20. The European Food Safety Authority recommendation for polyunsaturated fatty acid composition of infant formula overrules breast milk, puts infants at risk, and should be revised.

    PubMed

    Crawford, Michael A; Wang, Yiqun; Forsyth, Stewart; Brenna, J Thomas

    2015-12-01

    The European Food Safety Authority (EFSA) has concluded from a limited review of the literature that although docosahexaenoic acid (DHA) is required for infant formula, arachidonic acid is not required "even in the presence of DHA" (EFSA Journal, 12 (2014) 3760). This flawed opinion is grounded in human trials which tested functionality of DHA in neural outcomes and included arachidonic acid ostensibly to support growth. The EFSA report mistakes a nutrient ubiquitous in the diets of newborn infants, through breast milk and with wide-ranging health and neurodevelopmental effects, for an optional drug targeted to a particular outcome that is properly excluded when no benefit is found for that particular outcome. Arachidonic acid has very different biological functions compared to DHA, for example, arachidonic acid has unique functions in the vasculature and in specific aspects of immunity. Indeed, the overwhelming majority of trials include both DHA and arachidonic acid, and test development specific to DHA such as neural and visual development. DHA suppresses membrane arachidonic acid concentrations and its function. An infant formula with DHA and no arachidonic acid runs the risk of cardio and cerebrovascular morbidity and even mortality through suppression of the favorable oxylipin derivatives of arachidonic acid. The EFSA recommendation overruling breast milk composition should be revised forthwith, otherwise being unsafe, ungrounded in most of the evidence, and risking lifelong disability.

  1. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... safety management controls. (l) Notwithstanding FMCSA verification of the items listed in part III (a)(1... basic safety management controls of the motor carrier. (c) Critical regulations are those where... critical regulations are indicators of inadequate safety management controls and usually higher...

  2. 49 CFR Appendix to Subpart H of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North America-Domiciled...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... appendix and other basic safety management controls in place which function adequately to ensure minimum... safety audit will include: (1) Verification of available performance data and safety management programs... facilities or management systems, including verification of records of periodic vehicle inspections;...

  3. 77 FR 52633 - Public Safety and Homeland Security Bureau Seeks Comment on Post-Reconfiguration 800 MHz Band...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... interference to public safety and other land mobile communication systems operating in the band, 69 FR 67823... propose and adopt border area band plans once agreements are reached with Canada and Mexico, 72 FR 39756...) by filing paper copies. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR...

  4. Surveillance for adverse events following receipt of pandemic 2009 H1N1 vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) System, 2009-2010.

    PubMed

    Yih, W Katherine; Lee, Grace M; Lieu, Tracy A; Ball, Robert; Kulldorff, Martin; Rett, Melisa; Wahl, Peter M; McMahill-Walraven, Cheryl N; Platt, Richard; Salmon, Daniel A

    2012-06-01

    The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system is a cohort-based active surveillance network initiated by the US Department of Health and Human Services to supplement preexisting and other vaccine safety monitoring systems in tracking the safety of monovalent pandemic 2009 H1N1 influenza vaccine in the United States during 2009-2010. PRISM investigators conducted retrospective analysis to determine whether 2009 H1N1 vaccination was associated with increased risk of any of 14 prespecified outcomes. Five health insurance and associated companies with 38 million members and 9 state/city immunization registries contributed records on more than 2.6 million doses of 2009 H1N1 vaccine. Data on outcomes came from insurance claims. Complementary designs (self-controlled risk interval, case-centered, and current-vs.-historical comparison) were used to optimize control for confounding and statistical power. The self-controlled risk interval analysis of chart-confirmed Guillain-Barré syndrome found an elevated but not statistically significant incidence rate ratio following receipt of inactivated 2009 H1N1 vaccine (incidence rate ratio = 2.50, 95% confidence interval: 0.42, 15.0) and no cases following live attenuated 2009 H1N1 vaccine. The study did not control for infection prior to Guillain-Barré syndrome, which may have been a confounder. The risks of other health outcomes of interest were generally not significantly elevated after 2009 H1N1 vaccination.

  5. Author! Author! Beverly Cleary

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2005-01-01

    This article presents a brief biography of author Beverly Cleary. Born on April 12, 1916 in McMinnville, Oregon (Yamhill County), Beverly Cleary celebrated her eighty-ninth birthday in 2005. Cleary is probably best known for creating "Ramona" and the other children's book characters who live on Klickitat Street in Portland, Oregon. A selective…

  6. Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics: a post hoc analysis of the TIOSPIR trial

    PubMed Central

    Wise, Robert; Calverley, Peter MA; Dahl, Ronald; Dusser, Daniel; Metzdorf, Norbert; Müller, Achim; Fowler, Andy; Anzueto, Antonio

    2015-01-01

    Background: Patients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergics before the TIOtropium Safety and Performance In Respimat (TIOSPIR) trial may reflect patients seen in practice, in particular in primary care. In addition, investigating safety in these patients avoids the potential bias in patients who previously received anticholinergics and may be tolerant of their effects. Aims: The aim of this study was to evaluate whether patients naive to anticholinergic therapy who were treated with tiotropium Respimat 2.5 or 5 μg had different safety and efficacy outcomes than patients treated with tiotropium HandiHaler 18 μg. Methods: A post hoc analysis of patients who were not receiving anticholinergics before TIOSPIR (N=6,966/17,135) was conducted. Primary end points were risk of death from any cause and risk of COPD exacerbation. Secondary outcomes included severe exacerbation and major adverse cardiovascular events (MACE). Additional analysis of exacerbations was carried out in anticholinergic-naive patients with moderate (GOLD II) disease. Results: Anticholinergic-naive patients had less severe disease than the total TIOSPIR population. Discontinuations because of anticholinergic side effects were infrequent (0.9% overall). Similar to the primary study, patients in the tiotropium Respimat groups had no difference in the risk of death or risk of any or severe exacerbation than patients treated with tiotropium HandiHaler. Risk of MACE was similar across the Respimat and HandiHaler groups. Rates of exacerbations in the subgroup of patients with moderate disease were similar across the Respimat and HandiHaler groups. Conclusions: Tiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy. PMID:26540491

  7. "Locking the Door before We Got the Keys": Racial Realities of the Charter School Authorization Process in Post-Katrina New Orleans

    ERIC Educational Resources Information Center

    Henry, Kevin Lawrence, Jr.; Dixson, Adrienne D.

    2016-01-01

    Charter schools have become the hegemonic "solution" for urban educational reform initiatives aimed at curtailing longstanding race-based educational inequities. The "common sense" of neoliberal charter schools as the cure to persistent inequality is best illustrated in the post-Katrina New Orleans educational reforms. This…

  8. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... OWNED VEHICLE Transportation Pov Transportation Subsequent to the Time of Assignment § 302-9.175 When...

  9. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... OWNED VEHICLE Transportation Pov Transportation Subsequent to the Time of Assignment § 302-9.175 When...

  10. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... OWNED VEHICLE Transportation Pov Transportation Subsequent to the Time of Assignment § 302-9.175 When...

  11. 41 CFR 302-9.141 - What is the “authorized point of origin” when I transport a POV to my post of duty?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... Transportation Pov Transportation at Time of Assignment § 302-9.141 What is the “authorized point of origin”...

  12. 41 CFR 302-9.141 - What is the “authorized point of origin” when I transport a POV to my post of duty?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... Transportation Pov Transportation at Time of Assignment § 302-9.141 What is the “authorized point of origin”...

  13. Uncertainty and sensitivity analysis within the post closure Performance and Safety Assessment of the French deep geological radwaste disposal: methodology, tool and examples of results

    NASA Astrophysics Data System (ADS)

    Pepin, G.

    2009-04-01

    Within the framework of the December 30, 1991 french act, Andra submitted to the French Parliament in December 2005 a report on the feasibility of a high-level and long-lived radwaste disposal in the Callovo-Oxfodien clay layer (Meuse/Haute-Marne site). Further to 2006 french act, Andra is now involved in licensing of the reversible disposal up to 2015, which requires a great scientific and technical knowledge. Studies are based on many years of research carried out in France, in particular in Andra's Meuse/Haute-Marne Underground Research Laboratory (MHM URL), and international programs on radwastes, engineered barriers and deep clay formations. Intensive programs on hydraulic, solute transfer and radionuclides behaviour (solubility, retention) were and are carried out on Callovo-Oxfordian argilites (undisturbed and damaged), concrete materials and swelling clay based material, in order to provide a sound database. All these data allowed to perform firstly a sound description of the expected phenomenological evolution of the repository and its geological environment (including release and migration of radionuclides) from operating period to post closure period up to one million years, secondly a sound post-closure performance and safety assessment covering the different waste types (ILLW, HLW). Various safety scenarii were defined to quantify radiological impacts and to evaluate performance of the components and safety functions in post closure using specific indicators (concentration, molar rate, water flux…). According to the RFS III2.f (french safety rule related to deep geological radwaste disposad), there is no risk analysis in post closure and assessments are performed using deterministic situations, models and values. To complete analysis, propagation of uncertainties from models and input data in Performance and Safey Assessment (PA/SA) models is done using both deterministic and multiparametric probabilistic approach, with two main objectives: (i) to

  14. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    PubMed

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  15. Validation of a physically based catchment model for application in post-closure radiological safety assessments of deep geological repositories for solid radioactive wastes.

    PubMed

    Thorne, M C; Degnan, P; Ewen, J; Parkin, G

    2000-12-01

    The physically based river catchment modelling system SHETRAN incorporates components representing water flow, sediment transport and radionuclide transport both in solution and bound to sediments. The system has been applied to simulate hypothetical future catchments in the context of post-closure radiological safety assessments of a potential site for a deep geological disposal facility for intermediate and certain low-level radioactive wastes at Sellafield, west Cumbria. In order to have confidence in the application of SHETRAN for this purpose, various blind validation studies have been undertaken. In earlier studies, the validation was undertaken against uncertainty bounds in model output predictions set by the modelling team on the basis of how well they expected the model to perform. However, validation can also be carried out with bounds set on the basis of how well the model is required to perform in order to constitute a useful assessment tool. Herein, such an assessment-based validation exercise is reported. This exercise related to a field plot experiment conducted at Calder Hollow, west Cumbria, in which the migration of strontium and lanthanum in subsurface Quaternary deposits was studied on a length scale of a few metres. Blind predictions of tracer migration were compared with experimental results using bounds set by a small group of assessment experts independent of the modelling team. Overall, the SHETRAN system performed well, failing only two out of seven of the imposed tests. Furthermore, of the five tests that were not failed, three were positively passed even when a pessimistic view was taken as to how measurement errors should be taken into account. It is concluded that the SHETRAN system, which is still being developed further, is a powerful tool for application in post-closure radiological safety assessments.

  16. Safety of Japanese encephalitis live attenuated vaccination in post-marketing surveillance in Guangdong, China, 2005-2012.

    PubMed

    Liu, Yu; Lin, Hualiang; Zhu, Qi; Wu, Chenggang; Zhao, Zhanjie; Zheng, Huizhen

    2014-03-26

    We reviewed the adverse events following immunization of live attenuated Japanese encephalitis vaccine in Guangdong Province, China. During the period of 2005-2012, 23 million doses of live attenuated Japanese encephalitis vaccine were used and 1426 adverse events were reported (61.24 per million doses); of which, 570 (40%) were classified as allergic reactions (24.48 per million doses), 31 (2%) were neurologic events (1.33 per million doses), and 36 (2.5%) were diagnosed as serious adverse events (1.55 per million doses). This study suggests that the JEV-L has a reasonable safety profile, most adverse events are relatively mild, with relatively rare neurologic events being observed. PMID:24503272

  17. Post-marketing safety surveillance conducted in Korea (2008–2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™)

    PubMed Central

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-01-01

    ABSTRACT Purpose: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). Methods: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. Results: A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. Conclusions: We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice. PMID:27494163

  18. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

    PubMed Central

    2014-01-01

    Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance. PMID:24428898

  19. [Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

    PubMed

    Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings. PMID:24743364

  20. 41 CFR 302-9.141 - What is the “authorized point of origin” when I transport a POV to my post of duty?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 41 Public Contracts and Property Management 4 2014-07-01 2014-07-01 false What is the âauthorized... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... OWNED VEHICLE Transportation Pov Transportation at Time of Assignment § 302-9.141 What is...

  1. 41 CFR 302-9.141 - What is the “authorized point of origin” when I transport a POV to my post of duty?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 false What is the âauthorized... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... OWNED VEHICLE Transportation Pov Transportation at Time of Assignment § 302-9.141 What is...

  2. 41 CFR 302-9.141 - What is the “authorized point of origin” when I transport a POV to my post of duty?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 4 2013-07-01 2012-07-01 true What is the âauthorized... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... OWNED VEHICLE Transportation Pov Transportation at Time of Assignment § 302-9.141 What is...

  3. 41 CFR 302-9.604 - Under what condition may we authorize transportation of a POV to a post of duty?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 false Under what condition may... OWNED VEHICLE Agency Responsibilities § 302-9.604 Under what condition may we authorize...

  4. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study)

    PubMed Central

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients’ demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Results: Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Conclusion: Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs. PMID:27799968

  5. A right hemisphere safety backup at work: hypotheses for deep hypnosis, post-traumatic stress disorder, and dissociation identity disorder.

    PubMed

    Burnand, Gordon

    2013-09-01

    Problem theory points to an a priori relation between six key problems of living, to which people have adapted through evolution. Children are guided through the problems one by one, learning to switch between them automatically and unawares. The first problem of raising hope of certainty (about the environment), is dealt with in the right hemisphere (RH). The second of raising hope of freedom (or power to control), is dealt with in the left hemisphere (LH). Here adventurousness and ignoring the goodness of outcomes potentially create recklessness. When uncertainty rises the RH activates a backup with an override that substitutes immobility, takes over sensory inputs, but allows obedience to parental commands, and a cut-out that stops new work on the freedom problem. Support for the use of the backup by infants is found in the immobility that precedes the crying in strange conditions, and in childhood EEGs. The hypothesis that the backup is active in deep hypnosis imposes accord on findings that appear contradictory. For example it accounts for why observations during deep hypnosis emphasize the activity of the RH, but observations of responsive people not under hypnosis emphasize the activity of the LH. The hypothesis that the backup is active in post-traumatic stress disorder (PTSD) is supported by (a) fMRI observations that could reflect the cut-out, in that part of the precuneus has low metabolism, (b) the recall of motionlessness at the time of the trauma, (c) an argument that playing dead as a defence against predators is illogical, (d) the ease of hypnosis. With dissociative identity disorder (DID), the theory is consistent with up to six alters that have executive control and one trauma identity state where childhood traumas are re-experienced. Support for the cut-out affecting the trauma identity state comes from suppression of part of the precuneus and other parts of the parietal lobe when the trauma identity state is salient and a general script about a

  6. A right hemisphere safety backup at work: hypotheses for deep hypnosis, post-traumatic stress disorder, and dissociation identity disorder.

    PubMed

    Burnand, Gordon

    2013-09-01

    Problem theory points to an a priori relation between six key problems of living, to which people have adapted through evolution. Children are guided through the problems one by one, learning to switch between them automatically and unawares. The first problem of raising hope of certainty (about the environment), is dealt with in the right hemisphere (RH). The second of raising hope of freedom (or power to control), is dealt with in the left hemisphere (LH). Here adventurousness and ignoring the goodness of outcomes potentially create recklessness. When uncertainty rises the RH activates a backup with an override that substitutes immobility, takes over sensory inputs, but allows obedience to parental commands, and a cut-out that stops new work on the freedom problem. Support for the use of the backup by infants is found in the immobility that precedes the crying in strange conditions, and in childhood EEGs. The hypothesis that the backup is active in deep hypnosis imposes accord on findings that appear contradictory. For example it accounts for why observations during deep hypnosis emphasize the activity of the RH, but observations of responsive people not under hypnosis emphasize the activity of the LH. The hypothesis that the backup is active in post-traumatic stress disorder (PTSD) is supported by (a) fMRI observations that could reflect the cut-out, in that part of the precuneus has low metabolism, (b) the recall of motionlessness at the time of the trauma, (c) an argument that playing dead as a defence against predators is illogical, (d) the ease of hypnosis. With dissociative identity disorder (DID), the theory is consistent with up to six alters that have executive control and one trauma identity state where childhood traumas are re-experienced. Support for the cut-out affecting the trauma identity state comes from suppression of part of the precuneus and other parts of the parietal lobe when the trauma identity state is salient and a general script about a

  7. Efficacy and Safety of Remifemin on Peri-Menopausal Symptoms Induced by Post-Operative GnRH-a Therapy for Endometriosis: A Randomized Study versus Tibolone

    PubMed Central

    Chen, Jiming; Gao, Hongyan; Li, Qin; Cong, Jing; Wu, Jie; Pu, Dahua; Jiang, Guohua

    2014-01-01

    Background The aim of this study was to investigate clinical efficacy and safety of Remifemin on peri-menopausal symptoms in endometriosis patients with a post-operative GnRH-a therapy. Material/Methods We treated 116 women who had endometriosis with either Remifemin (n=56) 20 mg bid po or Tibolone (n=60) 2.5 mg qd po for 12 weeks after GnRH-a injection. The efficacy was evaluated by Kupperman menopausal index (KMI), and hot flash/sweating scores. The safety parameters such as liver and renal functions, lipid profile, endometrial thickness, and serum sex hormone level, as well as the incidence of adverse events were recorded. Results (1) After GnRH-a therapy, KMI and hot flash/sweating scores in both groups increased significantly (P<0.05) but we found no significant difference for KMI (2.87±1.40 for Remifemin and 2.70±1.26 for Tibolone) and hot flash/sweating scores (0.94±1.72 for Remifemin and 1.06±1.78 for Tibolone) between the 2 groups (P>0.05). (2) No statistical change was observed in liver or renal functions and lipid profile in both groups before and after the treatment (P>0.05). The post-therapeutic serum FSH, LH, and E2 level and endometrial thickness decreased remarkably in both groups (P<0.05). E2 level in the Remifemin group was obviously lower than that in the Tibolone group (P<0.05), and FSH and LH levels were strongly higher (P<0.05). No significant difference in thickness were found in either group (P>0.05). The Remifemin group had far fewer adverse events than the Tibolone group (P<0. 05). Conclusions Compared with Tibolone, Remifemin had a similar clinical efficacy and was safer for the peri-menopausal symptoms induced by GnRH-a in endometriosis patients. PMID:25321621

  8. Safety and efficacy of Intraurethral Mitomycin C Hydrogel for prevention of post-traumatic anterior urethral stricture recurrence after internal urethrotomy

    PubMed Central

    Moradi, Mahmoudreza; Derakhshandeh, Katayoun; Karimian, Babak; Fasihi, Mahtab

    2016-01-01

    Abstract: Background: Evaluation of the safety and efficacy of intraurethral Mitomycin C (MMC) hydrogel for prevention of post-traumatic anterior urethral stricture recurrence after internal urethrotomy. Methods: A thermoresponsive hydrogel base consisting of 0.8 mg MMC with 1cc water and propylene glycol to PF-127 poloxamer was used in theater. 40 male patients with short, non-obliterated, urethral stricture were randomized into 2 groups: control and MMC. After internal urethrotomy, the MMC group patients received the MMC-Hydrogel while the others were just catheterized. Both groups had their catheters for at least 1 week. After surgery, they were followed up by means of medical history and physical examination, monitoring voiding patterns and retrograde urethrogram at 1 month, 6 months and 1 year after surgery. Results: 40 male patients between 14 to 89 years old (Mean = 54.15) underwent internal urethrotomy. The average age for the control and MMC group was 54.55±21.25 and 53.75±24.75 respectively. In a comparison of age between the two groups, they were matched (P=0.574). Stricture length was 10.7±5.9 and 9.55±4.15 mm for the control and MMC group respectively. There were no statistically meaningful differences between the two groups (P=0.485). Fifteen patients had a history of one previous internal urethrotomy which in a comparison between the two groups meant there was no meaningful difference (P = 0.327). During postoperative follow up, total urethral stricture recurrence happened in 12 patients: 10 patients (50%) in control group and 2 patients (10%) in MMC group. The difference was statistically significant (P = 0.001). There were no significant complications associated with the MMC injection in our patients. Conclusions: Based on our results, MMC Hydrogel may have an anti-fibrotic action preventing post-traumatic anterior urethral stricture recurrence with no side effects on pre-urethral tissue. Due to our study limitations, our follow up time and the

  9. Immunogenicity and Safety of Four Different Dosing Regimens of Anthrax Vaccine Adsorbed for Post-Exposure Prophylaxis for Anthrax in Adults

    PubMed Central

    Bernstein, David I.; Jackson, Lisa; Patel, Shital M.; El Sahly, Hana M.; Spearman, Paul; Rouphael, Nadine; Rudge, Thomas L.; Hill, Heather; Goll, Johannes B.

    2014-01-01

    Background Strategies to implement post exposure prophylaxis (PEP) in case of an anthrax bioterror event are needed. To increase the number of doses of vaccine available we evaluated reducing the amount of vaccine administered at each of the vaccinations, and reducing the number of doses administered. Methods Healthy male and non-pregnant female subjects between the ages of 18 and 65 were enrolled and randomized 1:1:1:1 to one of four study arms to receive 0.5 mL (standard dose) of vaccine subcutaneously (SQ) at: A) days 0, 14; B) days 0 and 28; C) days 0, 14, and 28; or D) 0.25 ml at days 0, 14, and 28. A booster was provided on day 180. Safety was assessed after each dose. Blood was obtained on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84, 100, 180, and 201 and both Toxin Neutralizing antibody and anti-PA IgG antibody measured. Results Almost all subjects developed some local reactions with 46% to 64% reported to be of moderate severity and 3.3% severe during the primary series. Vaccine groups that included a day 14 dose induced a ≥4 fold antibody rise in more subjects on days 21, 28 and 35 than the arm without a day 14 dose. However, schedules with a full day 28 dose induced higher peak levels of antibody that persisted longer. The half dose regimen did not induce antibody as well as the full dose study arms. Conclusion Depending on the extent of the outbreak, effectiveness of antibiotics and availability of vaccine, the full dose 0, 28 or 0, 14, 28 schedules may have advantages. PMID:25239484

  10. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: Results of an open label, non-comparative, multi-centric, post marketing observational study

    PubMed Central

    Kumbla, D.K.; Kumar, S.; Reddy, Y.V.; Trailokya, A.; Naik, M.

    2014-01-01

    Background Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. Objective To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. Material and methods An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. Results A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Conclusion Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. PMID:24973841

  11. Highway Safety Program Manual: Volume 14: Pedestrian Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 14 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on pedestrian safety. The purpose and objectives of a pedestrian safety program are outlined. Federal authority in the area of pedestrian safety and policies regarding a safety program…

  12. Safety Evaluation Report for the Tennessee Valley Authority's Plan to Decommission its Low-Level Radioactive Waste Burial Site at Muscle Shoals, Alabama

    SciTech Connect

    Gant, K.S.; Kettelle, R.H.

    1998-11-01

    From 1966 to 1981, the Tennessee Valley Authority (TVA) operated a burial site, licensed under the former 10 CFR 20.304, for low-level radioactive waste on its Muscle Shoals, Alabama, reservation. TVA submitted a decommissioning plan for the burial site and requested approval for unrestricted use of the site. The Nuclear Regulatory Commission requested Oak Ridge National Laboratory (ORNL) to evaluate this plan to determine if the site meets the radiological requirements for unrestricted use as specified in 10 CFR 20.1402; that is, an average member of the critical group would not receive more than 25 mrem/y from residual radioactivity at the TVA Low-Level Radioactive Waste Burial Site and the radioactivity has been reduced to levels as low as reasonably achievable (ALARA).

  13. Estimating the costs of supporting safety-net transformation into patient-centered medical homes in post-Katrina New Orleans.

    PubMed

    Shao, Hui; Brown, Lisanne; Diana, Mark L; Schmidt, Laura A; Mason, Karen; Oronce, Carlos Irwin; Shi, Lizheng

    2016-09-01

    There is a need to understand the costs associated with supporting, implementing, and maintaining the system redesign of small and medium-sized safety-net clinics. The authors aimed to understand the characteristics of clinics that transformed into patient-centered medical homes and the incremental cost for transformation.The sample was 74 clinics in Greater New Orleans that received funds from the Primary Care Access and Stabilization Grant program between 2007 and 2010 to support their transformation. The study period was divided into baseline (September 21, 2007-March 21, 2008), transformation (March 22, 2008-March 21, 2009), and maintenance (March 22, 2009-September 20, 2010) periods, and data were collected at 6-month intervals. Baseline characteristics for the clinics that transformed were compared to those that did not. Fixed-effect models were conducted for cost estimation, controlling for baseline differences, using propensity score weights.Half of the 74 primary care clinics achieved transformation by the end of the study period. The clinics that transformed had higher total cost, more clinic visits, and a larger female patient proportion at baseline. The estimated incremental cost for clinics that underwent transformation was $37.61 per visit per 6 months, and overall it cost $24.86 per visit per 6 months in grant funds to support a clinic's transformation.Larger-sized clinics and those with a higher female proportion were more likely to transform. The Primary Care Access and Stabilization Grant program provided approximately $24.86 per visit over the 2 and 1/2 years. This estimated incremental cost could be used to guide policy recommendations to support primary care transformation in the United States. PMID:27684855

  14. 49 CFR 198.11 - Grant authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Grant authority. 198.11 Section 198.11... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY REGULATIONS FOR GRANTS TO AID STATE PIPELINE SAFETY PROGRAMS Grant Allocation § 198.11 Grant authority. The pipeline safety laws (49...

  15. Oxygen safety

    MedlinePlus

    COPD - oxygen safety; Chronic obstructive pulmonary disease - oxygen safety; Chronic obstructive airways disease - oxygen safety; Emphysema - oxygen safety; Heart failure - oxygen-safety; Palliative care - oxygen safety; ...

  16. 23 CFR 1251.3 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GENERAL PROVISIONS STATE HIGHWAY SAFETY AGENCY § 1251.3 Authority. Each State Highway Safety Agency shall... safety programs administered by other State and local agencies. (b) Periodically review and comment...

  17. Evaluation of World Health Organization Multi-Professional Patient Safety Curriculum Topics in Nursing Education: Pre-test, post-test, none-experimental study.

    PubMed

    Mansour, Mansour; Skull, Alice; Parker, Michael

    2015-01-01

    The Multi-professional Patient Safety Curriculum Guide was launched by the World Health Organization to develop a patient safety-friendly curriculum in health education. The aim of this study was to evaluate the impact of teaching related to two topics from the Patient Safety Curriculum Guide on student nurses' knowledge and attitudes toward patient safety. A pretest, posttest, nonexperimental design was used. Patient safety education questionnaires were distributed to a convenience sample of 181 nursing students before the intervention, and 141 questionnaires after the intervention in one university in the East of England. The intervention consisted of two face-to-face lectures and one facilitated group work discussion. Seventy-one responses from pre- and posttest stages were matched. Paired t test, McNemar's test, and frequency measures were used for data analysis. The findings suggest that there are statistically significant differences in the subscales of the error and patient safety and personal influence over safety. The differences in the students' answers on patient safety knowledge before and after the interventions were not statistically significant. Although the student nurses highly commended the teaching delivered in this study, the use of experimental design in future curriculum evaluation may provide a more complementary insight to the findings of this study.

  18. Hand Safety

    MedlinePlus

    ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ...

  19. Hand Safety

    MedlinePlus

    ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ...

  20. Safety First!

    ERIC Educational Resources Information Center

    Longfield, Judith

    2006-01-01

    In this article, the author relates how a hands-on chemistry investigation provided her the inspiration to develop an effective safety lesson for her third grade chemistry class. She began the lesson by demonstrating the use of pH indicator paper to show that ordinary household (white) vinegar was an acid. With the students, she wondered aloud…

  1. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Post-launch and post-flight-attempt hazard controls. 417.415 Section 417.415 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Ground Safety § 417.415 Post-launch and post-flight-attempt hazard...

  2. Highway Safety Program Manual: Volume 3: Motorcycle Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

  3. Author's response.

    PubMed

    Crane, Judy L

    2015-01-01

    This letter to the editor rebuts flawed analyses made by O'Reilly (2014) and points out duplicative comments that have already been rebutted in the peer-reviewed literature. O'Reilly (2014) provides little new scientific information on the source apportionment of polycyclic aromatic hydrocarbons (PAHs) in sediments, and the author stands by the results of her research.

  4. Military Authority.

    ERIC Educational Resources Information Center

    Martz, Carlton; Hayes, Bill

    2001-01-01

    This issue of "Bill of Rights in Action" explores questions of military authority. The first article looks at the French Army mutinies in World War I and how the French Army dealt with them. The second article examines President Truman's firing of popular and powerful General Douglas MacArthur during the Korean War. The final article looks at how…

  5. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.105 Exemption authority. (a) The head of...

  6. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.105 Exemption authority. (a) The head of...

  7. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.105 Exemption authority. (a) The head of...

  8. Post-licensure evaluation of vaccine safety: current status and future directions. Symposium organised by the International Alliance for Biological Standardization (IABS) in Barcelona, Spain, 27-28 April 2011.

    PubMed

    Black, Steven; Egan, William; Lambert, Paul-Henri

    2012-09-01

    Adverse events following immunization, while rare, unfortunately do occur. And when they do, the public's faith in vaccines waves. It's a known fact, for example, that vaccine safety concerns are among the most important factors contributing to parents refusing vaccination for their children. How best, then, to tackle these concerns and increase public confidence in the vaccine safety system? In an effort to contribute to identifying the right mechanisms, the International Alliance for Biological Standardization organized an international symposium on "Post-Licensure Evaluation of Vaccine Safety" in Barcelona in early Spring. Delegates from 24 countries took a close look at the current status of this challenging problem and identified several practical measures which could help address the situation. They suggested an integrated vaccine safety program to be in place in all countries and standardized so that information and data can be exchanged on a routine basis. Another proposal was to put in place simple measures such as the use of bar codes on vaccine vials.

  9. Visiting Author

    NASA Technical Reports Server (NTRS)

    1999-01-01

    Author of Rocket Boys Homer Hickam, Jr. (left) and Marshall Space Flight Center Director Art Stephenson during a conference at Morris Auditorium. Homer Hickam worked at MSFC during the Apollo project years. As a young man, Mr. Hickam always dreamed of becoming a rocket scientist and following in the footsteps fo Wernher von Braun. Years later he would see his dream realized and had written Rocket Boys commemorating his life and the people at MSFC.

  10. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  11. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  12. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  13. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  14. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  15. Medical Oxygen Safety

    MedlinePlus

    ... near the oxygen. Post No Smoking and No Open Flames signs in and outside the home to remind people not to smoke. Your Source for SAFETY Information NFPA Public Education Division • 1 Batterymarch Park, Quincy, MA 02169 Name ...

  16. Authors reply

    SciTech Connect

    Wilkinson, G.S.; Voelz, G.L.; Wiggs, L.D.; Galke, W.A.; Tietjen, G.L.; Acquavella, J.F.

    1988-05-01

    The authors reply to a letter by Johnson, C.J. which was critical of their report of mortality of plutonium workers at the Rocky Flats Plant. The letter clarifies the method by which the cohort was defined in their study, defends their use of urine bioassays for the assessment of plutonium body burden, and suggests that the report makes a significant contribution to the literature on the potential plutonium has to induce human disease. They state that the results of their studies suggest that increased risk for several cancers cannot be ruled out for persons with plutonium body burdens of 2 nanocuries or more. Their previous recommendation that studies of workers should be continued in future years was reemphasized.

  17. Safety, efficacy and prognostic analyses of sunitinib in the post-marketing surveillance study of Japanese patients with gastrointestinal stromal tumor

    PubMed Central

    Komatsu, Yoshito; Ohki, Emiko; Ueno, Naomi; Yoshida, Ai; Toyoshima, Yasuharu; Ueda, Eiji; Houzawa, Hiroyuki; Togo, Kanae; Nishida, Toshirou

    2015-01-01

    Objective This study was conducted to expand the sunitinib safety database in Japanese imatinib-resistant/-intolerant gastrointestinal stromal tumor patients. Retrospective analyses investigated common adverse events as potential prognostic markers. Methods Four hundred and seventy patients who received sunitinib between June 2008 and November 2009 were analyzed for safety, progression-free survival and overall survival; 386 for objective response rate; 88% received sunitinib on Schedule 4/2 starting at 50 mg/day. Results No unexpected safety issues occurred. Grade ≥ 3 adverse events occurred in 70%, most commonly thrombocytopenia (33%), neutropenia (22%) and leukopenia (15%). Objective response rate was 20% (95% confidence interval 16–24). Median progression-free survival was 22.4 weeks (95% confidence interval, 21.7–24.0). The overall survival rate at 24 weeks was 91% (95% confidence interval, 88–94). Higher relative dose intensity (≥70 vs. <70%) during the first 6 weeks and better Eastern Cooperative Oncology Group performance status (0 vs. ≥1) were associated with longer progression-free survival (24.0 vs. 20.1 weeks; P = 0.011; and 24.1 vs. 16.9 weeks; P < 0.001) and higher 24-week overall survival rate (94 vs. 83%; P < 0.001; and 96 vs. 83%; P < 0.001). Increased progression-free survival and overall survival rates were associated with specific adverse events. Cox proportional hazard modeling adjusted for relative dose intensity and performance status established hand–foot syndrome (hazard ratio = 0.636; 95% confidence interval, 0.456–0.888) and leukopenia (hazard ratio = 0.683; 95% confidence interval, 0.492–0.948) occurring within 12 weeks were significantly correlated with increased progression-free survival. Conclusion Sunitinib showed good efficacy and tolerable safety. Factors associated with greater efficacy were relative dose intensity, performance status and specific early adverse events. PMID:26373318

  18. Authorization basis for the 209-E Building

    SciTech Connect

    TIFFANY, M.S.

    1999-02-23

    This Authorization Basis document is one of three documents that constitute the Authorization Basis for the 209-E Building. Per the U.S. Department of Energy, Richland Operations Office (RL) letter 98-WSD-074, this document, the 209-E Building Preliminary Hazards Analysis (WHC-SD-WM-TI-789), and the 209-E Building Safety Evaluation Report (97-WSD-074) constitute the Authorization Basis for the 209-E Building. This Authorization Basis and the associated controls and safety programs will remain in place until safety documentation addressing deactivation of the 209-E Building is developed by the contractor and approved by RL.

  19. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  20. Study on the safety and efficacy of miltefosine for the treatment of children and adolescents with post-kala-azar dermal leishmaniasis in Bangladesh, and an association of serum vitamin E and exposure to arsenic with post-kala-azar dermal leishmaniasis: an open clinical trial and case–control study protocol

    PubMed Central

    Mondal, D; Hasnain, M G; Hossain, M S; Ghosh, D; Ghosh, P; Hossain, H; Baker, J; Nath, R; Haque, R; Matlashewski, G; Hamano, S

    2016-01-01

    Introduction Post-kala-azar dermal leishmaniasis (PKDL) is a dermatological complication that occurs primarily among treated visceral leishmaniasis (VL) patients, and sporadically in a few without a history of VL. It mostly affects children and adolescents but is also common in adults. The conventional treatment with 120 intramuscular injections of sodium stibogluconate (SSG) is phasing out. Miltefosine (MF) is the only eventual alternative to SSG; however, its efficacy and safety profiles for treatment of children and adolescents with PKDL are lacking. In addition, risk factors for PKDL are poorly investigated. Host genetic, nutritional and environmental factors could be potential risk factors. As such, here we propose to evaluate the efficacy and safety of MF for 12 weeks at an allometric dose for children and adolescents with PKDL, and also to explore potential risk factors for PKDL. Methods and analysis A cross-sectional survey will look for suspected participants with PKDL among treated VL children and adolescents, a subsequent open clinical trial with MF at allometric dose, with a follow-up at 12 months. A case–control study will be carried out for PKDL risk factors. Assuming 95% cure rate, 95% CI and α=0.05, a sample size of 73 children with PKDL is needed. Considering an attrition rate of 10%, the final sample size is 80 children in each group. Descriptive and analytical analyses will be performed. Primary outcome is safety and cure rate of 12 weeks of treatment with MF. Ethics and dissemination International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) Ethical Review Committee (ERC) approved the protocol (PR#013045). Written informed consent will be taken from all participants and their guardians (in case of minor). A Data and Safety Monitoring Board (DSMB) of ICDDR,B ERC will monitor all study activities to ensure the safety of the participants. Trial registration number NCT02193022; Pre-results. PMID:27188804

  1. FFTF Authorization Agreement

    SciTech Connect

    DAUTEL, W.A.

    2000-09-25

    The purpose of the Authorization Agreement is to serve as a mechanism whereby the U.S. Department of Energy, Richland Operations Office (RL) and Fluor Hanford (FH) jointly clarify and agree to key conditions for conducting work safely and efficiently in the Fast Flux Test Facility (FFTF). Work must be accomplished in a manner that achieves high levels of quality while protecting the environment and the safety and health of workers and the public, and complying with applicable contractual and regulatory requirements. It is the intent of this Agreement to address those items of significant importance in establishing and supporting the FFTF Authorization Envelope, but this Agreement in no way alters the terms and conditions of the Project Hanford Management Contract (PHMC), Contract Number DE-AC06-96RL13200.

  2. A Multidimensional Examination of Campus Safety: Victimization, Perceptions of Danger, Worry about Crime, and Precautionary Behavior among College Women in the Post-Clery Era

    ERIC Educational Resources Information Center

    Wilcox, Pamela; Jordan, Carol E.; Pritchard, Adam J.

    2007-01-01

    Using data from a spring 2004 telephone survey of 1,010 female undergraduate and graduate students at one southeastern state university, the authors examine the objective and subjective experiences with sexual assault or coercion, physical assault, and stalking among college women, paying particular attention to whether actual victimization…

  3. Highway Safety Program Manual: Volume 17: Pupil Transportation Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 17 of the 10-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on pupil transportation safety. The purpose and objectives of a pupil transportation safety program are outlined. Federal authority in the area of pupil transportation and policies…

  4. [Evidences of safety and tolerability of the zoledronic acid 5 mg yearly in the post-menopausal osteoporosis: the HORIZON project].

    PubMed

    Dalle Carbonare, L; Bertoldo, F; Lo Cascio, V

    2009-01-01

    Bisphosphonates are the most commonly prescribed medications for the treatment of osteoporosis. Despite evidence supporting the anti-fracture efficacy of aminobisphosphonates approximately 50% of patients do not follow their prescribed treatment regimen and/or discontinue treatment within the first year. Poor compliance is associated with negative outcomes, including increased fracture risk. Tolerability and safety are among the causes of poor compliance. Intravenous bisphosphonates avoids the gastrointestial intolerance and the complex dosing instruction of the oral route ensuring full compliance which may provide improved efficacy. However, there are some concerns regarding potent intravenous bisphosphonates as zoledronic acid with respect to tolerability, mainly the acute phase response and to safety, mainly a theoretical risk of over suppression of bone turnover, renal toxicity and osteonecrosis of the jaw. In the HORIZON study, 152 patients on active treatment (82) or placebo (70) underwent to a bone biopsy after double tetracycline labeling. Bone biopsies (iliac crest) were obtained at the final visit at month 36, 1 year after the last infusion. The biopsies were analyzed by histomorphometry on bone sections and by micro-CT (microCT) analysis. One hundred forthy-three biopsies (76 zoledronic acid, 67 placebo) had at least one microCT parameter measured and 111 were available for quantitative histomorphometry (59 zoledronic acid, 52 placebo). Micro-CT analysis of bone structure revealed higher trabecular bone volume (BV/TV), decreased trabecular separation (Tb.Sp), and a strong trend towards improvement in connectivity density in biopsies obtained from patients treated with zoledronic acid, indicating preservation of trabecular bone structure with respect to placebo. Histomorphometric analysis obtained from patients treated with zoledronic acid exhibited reduction of bone turnover, as suggested by decreased activation frequency (Ac.F) by 63%, mineralizing

  5. The Efficacy and Clinical Safety of Various Analgesic Combinations for Post-Operative Pain after Third Molar Surgery: A Systematic Review and Meta-Analysis

    PubMed Central

    Au, Alvin Ho Yeung; Choi, Siu Wai; Cheung, Chi Wai; Leung, Yiu Yan

    2015-01-01

    Objectives To run a systematic review and meta-analysis of randomized clinical trials aiming to answer the clinical question “which analgesic combination and dosage is potentially the most effective and safe for acute post-operative pain control after third molar surgery?”. Materials and Methods A systematic search of computer databases and journals was performed. The search and the evaluations of articles were performed by 2 independent reviewers in 3 rounds. Randomized clinical trials related to analgesic combinations for acute post-operative pain control after lower third molar surgery that matched the selection criteria were evaluated to enter in the final review. Results Fourteen studies with 3521 subjects, with 10 groups (17 dosages) of analgesic combinations were included in the final review. The analgesic efficacy were presented by the objective pain measurements including sum of pain intensity at 6 hours (SPID6) and total pain relief at 6 hours (TOTPAR6). The SPID6 scores and TOTPAR6 scores of the reported analgesic combinations were ranged from 1.46 to 6.44 and 3.24 – 10.3, respectively. Ibuprofen 400mg with oxycodone HCL 5mg had superior efficacy (SPID6: 6.44, TOTPAR6: 9.31). Nausea was the most common adverse effect, with prevalence ranging from 0-55%. Ibuprofen 200mg with caffeine 100mg or 200mg had a reasonable analgesic effect with fewer side effects. Conclusion This systematic review and meta-analysis may help clinicians in their choices of prescribing an analgesic combination for acute post-operative pain control after lower third molar surgery. It was found in this systematic review Ibuprofen 400mg combined with oxycodone HCL 5mg has superior analgesic efficacy when compared to the other analgesic combinations included in this study. PMID:26053953

  6. 32 CFR 643.120 - Post offices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 4 2013-07-01 2013-07-01 false Post offices. 643.120 Section 643.120 National... Additional Authority of Commanders § 643.120 Post offices. Title 10 U.S.C. 4779b, provides that the SA shall assign suitable space for post office purposes at military posts where post offices have been...

  7. 32 CFR 643.120 - Post offices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 4 2011-07-01 2011-07-01 false Post offices. 643.120 Section 643.120 National... Additional Authority of Commanders § 643.120 Post offices. Title 10 U.S.C. 4779b, provides that the SA shall assign suitable space for post office purposes at military posts where post offices have been...

  8. 32 CFR 643.120 - Post offices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 4 2014-07-01 2013-07-01 true Post offices. 643.120 Section 643.120 National... Additional Authority of Commanders § 643.120 Post offices. Title 10 U.S.C. 4779b, provides that the SA shall assign suitable space for post office purposes at military posts where post offices have been...

  9. 32 CFR 643.120 - Post offices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Post offices. 643.120 Section 643.120 National... Additional Authority of Commanders § 643.120 Post offices. Title 10 U.S.C. 4779b, provides that the SA shall assign suitable space for post office purposes at military posts where post offices have been...

  10. 32 CFR 643.120 - Post offices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 4 2012-07-01 2011-07-01 true Post offices. 643.120 Section 643.120 National... Additional Authority of Commanders § 643.120 Post offices. Title 10 U.S.C. 4779b, provides that the SA shall assign suitable space for post office purposes at military posts where post offices have been...

  11. Post-marketing safety evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir: A drug-use investigation in patients with high risk factors.

    PubMed

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2016-10-01

    Peramivir, the only injectable anti-influenza neuraminidase inhibitor medically available in Japan at present, is considered first-line treatment in patients with high risk factors for influenza exacerbation. We conducted a drug-use investigation of peramivir in inpatients with high risk factors (old age, pregnancy, and underlying disease such as chronic respiratory disease) from January 2010 to March 2013. Data of 772 patients from 124 facilities across Japan were collected; peramivir's safety in 770 patients and effectiveness in 688 patients were examined. In total, 412 adverse events were observed in 219 patients (28.4%). Of these, 155 events were adverse drug reactions (ADRs) observed in 98 patients (12.7%). Major ADRs (≥2%) were increased aspartate aminotransferase (5.1%), increased alanine aminotransferase (3.8%) and decreased white blood cell count (2.5%). Fourteen serious ADRs were observed in 12 patients (1.6%). All serious ADRs were resolved or improved except for two events for which outcomes were unknown. Multivariate analyses revealed that ADR incidences were significantly associated with these four backgrounds of patients: medical history, no influenza vaccination, renal impairment and other infection(s). With regard to its effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration, which was the same as in other previous surveillance studies. This surveillance study indicated the safety of peramivir in the treatment of influenza inpatients with high risk factors under routine clinical settings. PMID:27497712

  12. Efficacy and Safety of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for the Treatment of Acne and Acne-induced Post-inflammatory Hyperpigmentation in Patients with Skin of Color

    PubMed Central

    Young, Cherie M.; Kindred, Chesahna; Taylor, Susan C.

    2012-01-01

    Objective: To assess the efficacy and safety of a topical gel containing clindamycin 1.2% and tretinoin 0.025% for the treatment of acne and acne-induced postinflammatory hyperpigmentation (PIH) in darker skinned patients. Design: Randomized, double-blind, placebo-controlled study. Setting: Two United States clinical sites. Participants: Thirty-three patients 12 years of age or older with skin types IV to VI, mild-to-moderate facial acne, and PIH were enrolled. Measurements: Patients applied clindamycin phosphate/tretinoin gel or a nonmedicated vehicle each evening and a sun protection factor 30 sunscreen daily. Changes in skin erythema and hyperpigmentation were measured using a chromameter and photographic images. Efficacy was assessed using the Evaluators Global Acne Severity Scale, lesion counts, Post-inflammatory Hyperpigmentation Severity Scales and Patient’s Global Assessment Scale. Safety and tolerability were assessed by adverse event reports and a Safety Assessment Scale. Results: The mean (SD) baseline inflammatory lesion count was 11.9 (11.1) in clindamycin/tretinoin-treated patients, decreasing by 5.5 (6.56) after 12 weeks while the mean baseline inflammatory lesion count was 13.6 (11.15) in placebo-treated patients, decreasing by 4.1 (11.36) (p=0.05 for change from baseline, clindamycin/tretinoin vs. placebo). Clindamycin/tretinoin-treated patients generally demonstrated superior efficacy versus placebo treatment. The clindamycin/tretinoin topical gel was well tolerated, causing little or no irritation, although one patient withdrew due to periorbital edema of moderate severity possibly related to clindamycin/tretinoin gel. Conclusion: Although limited by small sample size, the results of this pilot study suggest clindamycin phosphate 1.2% and tretinoin 0.025% topical gel is a safe and effective option for treating mild-to-moderate acne in patients with skin of color. PMID:22798973

  13. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970...

  14. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970...

  15. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970...

  16. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970...

  17. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970...

  18. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public... Security Bureau, is hereby delegated authority to perform all functions of the Bureau, described in §§ 0... Safety and Homeland Security Bureau shall not have authority to issue notices of proposed...

  19. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public... Security Bureau, is hereby delegated authority to perform all functions of the Bureau, described in §§ 0... Safety and Homeland Security Bureau shall not have authority to issue notices of proposed...

  20. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public... Security Bureau, is hereby delegated authority to perform all functions of the Bureau, described in §§ 0... Safety and Homeland Security Bureau shall not have authority to issue notices of proposed...

  1. Safety and functional outcomes associated with short-term rehabilitation therapy in the post-operative management of tibial plateau leveling osteotomy

    PubMed Central

    Romano, Laura S.; Cook, James L.

    2015-01-01

    This retrospective cohort study using electronic questionnaires compared the perioperative complication rates of tibial plateau levelling osteotomy (TPLO) surgery and the 8-week, 6-month, and 1-year functional outcomes, between rehabilitation and traditional post-operative management. Dogs were placed into 1 of 2 cohort groups based on attending veterinarian’s selected management: i) “traditional” involving restriction to cage rest and leash walking, and ii) “rehabilitation” performed by a certified practitioner. There was no statistically significant difference in complication rates in the perioperative period between the 2 treatment cohorts (P > 0.1). The rehabilitation group was 1.9 times more likely to reach full function at 8 wk (P = 0.045). Conversely, the traditional group was 2.9 times more likely be categorized as having unacceptable function at 8 wk after surgery (P = 0.05). This study suggests that rehabilitation performed by a certified practitioner is safe and may improve short-term outcomes when used in the initial postoperative management for dogs treated with TPLO. PMID:26347395

  2. Safety and functional outcomes associated with short-term rehabilitation therapy in the post-operative management of tibial plateau leveling osteotomy.

    PubMed

    Romano, Laura S; Cook, James L

    2015-09-01

    This retrospective cohort study using electronic questionnaires compared the perioperative complication rates of tibial plateau levelling osteotomy (TPLO) surgery and the 8-week, 6-month, and 1-year functional outcomes, between rehabilitation and traditional post-operative management. Dogs were placed into 1 of 2 cohort groups based on attending veterinarian's selected management: i) "traditional" involving restriction to cage rest and leash walking, and ii) "rehabilitation" performed by a certified practitioner. There was no statistically significant difference in complication rates in the perioperative period between the 2 treatment cohorts (P > 0.1). The rehabilitation group was 1.9 times more likely to reach full function at 8 wk (P = 0.045). Conversely, the traditional group was 2.9 times more likely be categorized as having unacceptable function at 8 wk after surgery (P = 0.05). This study suggests that rehabilitation performed by a certified practitioner is safe and may improve short-term outcomes when used in the initial postoperative management for dogs treated with TPLO.

  3. Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data.

    PubMed

    Cameron, D M; Donahue, D A; Costin, G-E; Kaufman, L E; Avalos, J; Downey, M E; Billhimer, W L; Gilpin, S; Wilt, N; Simion, F A

    2013-12-01

    Behentrimonium chloride (BTC) is a straight-chain alkyltrimonium chloride compound commonly used as an antistatic, hair conditioning, emulsifier, or preservative agent in personal care products. Although the European Union recently restricted the use of alkyltrimonium chlorides and bromides as preservatives to ≤0.1%, these compounds have been safely used for many years at ≤5% in hundreds of cosmetic products for other uses than as a preservative. In vitro, clinical, and controlled consumer usage tests in barrier-impaired individuals were conducted to determine if whole body, leave-on skin care products containing 1-5% BTC cause dermal irritation or any other skin reaction with use. BTC-containing formulations were predicted to be non-irritants by the EpiDerm® skin irritation test and the bovine corneal opacity and permeability (BCOP)/chorioallantoic membrane vascular assay (CAMVA) ocular irritation test battery. No evidence of allergic contact dermatitis or cumulative dermal irritation was noted under the exaggerated conditions of human occlusive patch tests. No clinically assessed or self-reported adverse reactions were noted in adults or children with atopic, eczematous, and/or xerotic skin during two-week and four-week monitored home usage studies. These results were confirmed by post-marketing data for five body lotions, which showed only 0.69 undesirable effects (mostly skin irritation) reported per million shipped consumer units during 2006-2011; a value consistent with a non-irritating body lotion. No serious undesirable effects were reported during in-market use of the products. Therefore, if formulated in appropriate conditions at 1-5%, BTC will not cause dermal irritation or delayed contact sensitization when used in a whole-body, leave-on product.

  4. Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data.

    PubMed

    Cameron, D M; Donahue, D A; Costin, G-E; Kaufman, L E; Avalos, J; Downey, M E; Billhimer, W L; Gilpin, S; Wilt, N; Simion, F A

    2013-12-01

    Behentrimonium chloride (BTC) is a straight-chain alkyltrimonium chloride compound commonly used as an antistatic, hair conditioning, emulsifier, or preservative agent in personal care products. Although the European Union recently restricted the use of alkyltrimonium chlorides and bromides as preservatives to ≤0.1%, these compounds have been safely used for many years at ≤5% in hundreds of cosmetic products for other uses than as a preservative. In vitro, clinical, and controlled consumer usage tests in barrier-impaired individuals were conducted to determine if whole body, leave-on skin care products containing 1-5% BTC cause dermal irritation or any other skin reaction with use. BTC-containing formulations were predicted to be non-irritants by the EpiDerm® skin irritation test and the bovine corneal opacity and permeability (BCOP)/chorioallantoic membrane vascular assay (CAMVA) ocular irritation test battery. No evidence of allergic contact dermatitis or cumulative dermal irritation was noted under the exaggerated conditions of human occlusive patch tests. No clinically assessed or self-reported adverse reactions were noted in adults or children with atopic, eczematous, and/or xerotic skin during two-week and four-week monitored home usage studies. These results were confirmed by post-marketing data for five body lotions, which showed only 0.69 undesirable effects (mostly skin irritation) reported per million shipped consumer units during 2006-2011; a value consistent with a non-irritating body lotion. No serious undesirable effects were reported during in-market use of the products. Therefore, if formulated in appropriate conditions at 1-5%, BTC will not cause dermal irritation or delayed contact sensitization when used in a whole-body, leave-on product. PMID:24064305

  5. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Posting. 34.53 Section 34.53 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.53 Posting. All areas in which industrial radiography is...

  6. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of this... Assistant Commandant for Marine Safety, Security and Stewardship, the authority to make the...

  7. Safety and efficacy of photodynamic therapy using BCECF-AM compared to mitomycin C in controlling post-operative fibrosis in a rabbit model of subscleral trabeculectomy

    PubMed Central

    Said, Azza Mohamed Ahmed; Zaki, Rania Gamal Eldin; Mohamed, Thanaa Helmy; Salman, Manal Ibraheem

    2016-01-01

    AIM To evaluate the safety and efficacy of cellular photoablation using BCECF-AM [2′, 7′-bis-(2-carboxyethyl)-5-(and-6)-carboxyfluorescein, acetoxymethyl ester mixed isomers] as a method to control postoperative fibrosis in subscleral trabeculectomy (SST) compared to mitomycin C (MMC) in a rabbit model. METHODS A comparative prospective case-control animal study was conducted. Fourteen rabbits were subjected to SST with intraoperative use of wound modulating agents (MMC or BCECF-AM) of the right eye (study groups I and II respectively) and SST without use of intraoperative wound modulating agents for the left eye (control group II). Two rabbits 4 eyes were considered as control group I with no surgical intervention. BCECF-AM was injected subconjunctivally 30min before surgery followed by intraoperative illumination with diffuse blue light for 10min. Antifibrotic efficacy was established by clinical response and histological examination. Clinical response was assessed by measuring intraocular pressure (IOP) at day 1, 3, 5, 7, 14, 21 postoperatively. Success was defined by >20.0% reduction in IOP from the preoperative values without anti-glaucoma medications. RESULTS The mean percentage of reduction was 35.0% in the study group I with only one eye (14.3%) had 12.5% reduction. The mean percentage of reduction was 28.0 % in the study group II with two eyes (28.6%) in study group II had 14.2% reduction each. Regarding the control group II, the mean percentage of reduction was 14.3 % with 64.3% eyes had <20.0% reduction. There was a highly statistically significant difference between each of the study groups (right eyes) and the corresponding control group II (left eyes) as regards the mean postoperative IOP values started from day 5 in both study groups and this highly significant difference remained so till the end of the follow up period. Histologically, MMC treated blebs showed thinning of conjunctival epithelium with marked reduction of the goblet cells relative

  8. Recent legal developments and the authority of the Australian Therapeutic Goods Administration.

    PubMed

    Shirlow, Esme; Faunce, Thomas

    2009-05-01

    Recent legal developments have highlighted the need for greater support from the Federal Government for the authority of the Therapeutic Goods Administration (TGA) to ensure, by pre-approval assessments and post-approval regulation, the safety of listed medicines in Australia. One of these developments concerns the impact of ongoing civil litigation in Australian courts led by Pan Pharmaceuticals stakeholders to recover compensation from the government for the losses they incurred following the TGA's post-listing shut-down of that pharmaceutical manufacturing company in 2003. Another factor is the recently announced governmental policy to outsource to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) safety assessments of foreign drug manufacturers whose products will be used in Australia. PMID:19554858

  9. Recent legal developments and the authority of the Australian Therapeutic Goods Administration.

    PubMed

    Shirlow, Esme; Faunce, Thomas

    2009-05-01

    Recent legal developments have highlighted the need for greater support from the Federal Government for the authority of the Therapeutic Goods Administration (TGA) to ensure, by pre-approval assessments and post-approval regulation, the safety of listed medicines in Australia. One of these developments concerns the impact of ongoing civil litigation in Australian courts led by Pan Pharmaceuticals stakeholders to recover compensation from the government for the losses they incurred following the TGA's post-listing shut-down of that pharmaceutical manufacturing company in 2003. Another factor is the recently announced governmental policy to outsource to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) safety assessments of foreign drug manufacturers whose products will be used in Australia.

  10. Food safety educational intervention positively influences college students' food safety attitudes, beliefs, knowledge, and self-reported practices.

    PubMed

    Yarrow, Linda; Remig, Valentina M; Higgins, Mary Meck

    2009-01-01

    In this study, the authors evaluated college students' food safety attitudes, beliefs, knowledge, and self-reported practices and explored whether these variables were positively influenced by educational intervention. Students (n=59), were mostly seniors, health or non-health majors, and responsible for meal preparation. Subjects completed a food safety questionnaire (FSQ) prior to educational intervention, which consisted of three interactive modules. Subjects completed module pre-, post-, and post-posttests. The FSQ was also administered after exposure to intervention and five weeks later to determine changes in food safety attitudes, beliefs, knowledge, and self-reported practices. Students' FSQ attitude scores increased from 114 to 122 (p < or = .001); FSQ belief and knowledge scores improved from 86 to 98 (p < or = .001) and from 11 to 13 (p < or = .001), respectively. Food safety knowledge was also measured by module pre- and posttests, and improved significantly after intervention for all students, with health majors having the greatest increase. Intervention resulted in improved food safety self-reported practices for health majors only. The educational intervention appeared effective in improving food safety beliefs and knowledge. For health majors, attitudes and some self-reported practices improved. For all areas, the strongest effects were seen in health majors.

  11. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690)....

  12. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management....

  13. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690)....

  14. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. 41 U.S.C. chapter 81, Drug-Free Workplace....

  15. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management....

  16. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management....

  17. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management....

  18. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690)....

  19. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690)....

  20. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act..., Protection of Stratospheric Ozone (40 CFR part 82)....

  1. 30 CFR 57.6502 - Safety fuse.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Safety fuse. 57.6502 Section 57.6502 Mineral...-Surface and Underground § 57.6502 Safety fuse. (a) The burning rate of each spool of safety fuse to be used shall be measured, posted in locations which will be conspicuous to safety fuse users, and...

  2. 30 CFR 56.6502 - Safety fuse.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Safety fuse. 56.6502 Section 56.6502 Mineral....6502 Safety fuse. (a) The burning rate of each spool of safety fuse to be used shall be measured, posted in locations which will be conspicuous to safety fuse users, and brought to the attention of...

  3. Endovascular stent placement for chronic post-thrombotic symptomatic ilio-femoral venous obstructive lesions: a single-center study of safety, efficacy and quality-of-life improvement

    PubMed Central

    Falcoz, Marie-Tiphaine; Falvo, Nicolas; Aho-Glélé, Serge; Demaistre, Emmanuel; Galland, Christophe; Favelier, Sylvain; Pottecher, Pierre; Chevallier, Olivier; Bonnotte, Bernard; Audia, Sylvain; Samson, Maxime; Terriat, Béatrice; Midulla, Marco

    2016-01-01

    Background Post-thrombotic syndrome (PTS) is a frequent complication of deep vein thrombosis (DVT) despite adequate treatment. Venous angioplasty and stent placement has been progressively used to restore and maintain venous patency in PTS patients. This study reports our single-center experience with the use of endovascular treatment for chronic post-thrombotic symptomatic ilio-femoral venous obstructive lesions. Methods A prospective mono-centric observational cohort study of PTS patients with chronic symptomatic ilio-femoral venous obstructive lesions referred for endovascular treatment was conducted from March 2012 to April 2016. Procedure consisted in recanalization, pre-dilation and self-expandable stenting of stenotic or occluded iliac and/or femoral veins. Severity of PTS, quality-of-life and treatment outcomes were assessed using Villalta scale and Chronic Venous Insufficiency Questionnaire (CIVIQ-20) at baseline and 3 months after the procedure. Imaging follow-up was based on duplex ultrasound (US) and computed tomography (CT). Results Twenty-one patients (11 females, 10 males; median age, 41 years; range, 32–60) were included. Recanalization and stenting was successfully accomplished in all prime procedures, 4 patients benefitted from an additional procedure. Immediate technical success rate was 96% considering 25 procedures, performed without any complications. Median follow-up was 18 months (range, 6–30 months) with a 90.5% stent patency rate. Villalta score significantly decreased from baseline compared with 3 months after the procedure [14 (range, 11–22) and 5 (range, 1–10), respectively, P<0.0001], showing a significant decrease in the severity of PTS. CIVIQ-20 score significantly decreased from baseline compared with 3 months after stenting [48.5 (range, 39–73) and 26.5 (range, 21–45), respectively, P<0.0001] thus showing a significant improvement of quality-of-life. Post-procedural CIVIQ-20 score was significantly associated with

  4. The Strategy for Safety: Preventing Crises through Safety Audits

    ERIC Educational Resources Information Center

    Schwartz, Sara Goldsmith

    2013-01-01

    In this article the author demonstrates the importance of school safety audits and describes what schools should focus on in a safety audit. Ultimately, each school should determine its own safety audit strategy based on its unique circumstances, including the type of community within which it is located, the age of the students it serves, and the…

  5. Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

    ERIC Educational Resources Information Center

    Renfrew, Malcolm M., Ed.; Palladino, George F.

    1980-01-01

    Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

  6. [Safety monitoring of cell-based medicinal products (CBMPs)].

    PubMed

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  7. [Safety monitoring of cell-based medicinal products (CBMPs)].

    PubMed

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved. PMID:26391098

  8. Liquefied natural gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1977-01-01

    Bibliography, assembled from computer search of NASA Aerospace Safety Data Bank, including title of report, author, abstract, source, description of figures, key references, and key words or subject terms. Publication is indexed by key subjects and by authors. Items are relevant to design engineers and safety specialists.

  9. 33 CFR Appendix A to Part 173 - Issuing Authorities and Reporting Authorities

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Authorities A Appendix A to Part 173 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) BOATING SAFETY VESSEL NUMBERING AND CASUALTY AND ACCIDENT REPORTING Pt. 173, App. A Appendix A to Part 173—Issuing Authorities and Reporting Authorities (a) The State is the issuing...

  10. 47 CFR 97.111 - Authorized transmissions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized transmissions. 97.111 Section 97.111 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Station Operation Standards § 97.111 Authorized transmissions. (a) An amateur station may transmit the following types of...

  11. 47 CFR 97.111 - Authorized transmissions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized transmissions. 97.111 Section 97.111 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Station Operation Standards § 97.111 Authorized transmissions. (a) An amateur station may transmit the following types of...

  12. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... posts. 606.304-70 Section 606.304-70 Federal Acquisition Regulations System DEPARTMENT OF STATE... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  13. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... posts. 606.304-70 Section 606.304-70 Federal Acquisition Regulations System DEPARTMENT OF STATE... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  14. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... posts. 606.304-70 Section 606.304-70 Federal Acquisition Regulations System DEPARTMENT OF STATE... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  15. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... posts. 606.304-70 Section 606.304-70 Federal Acquisition Regulations System DEPARTMENT OF STATE... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  16. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... posts. 606.304-70 Section 606.304-70 Federal Acquisition Regulations System DEPARTMENT OF STATE... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  17. Randomized, double-blind, active-controlled study evaluating the safety and immunogenicity of three vaccination schedules and two dose levels of AV7909 vaccine for anthrax post-exposure prophylaxis in healthy adults.

    PubMed

    Hopkins, Robert J; Kalsi, Gurdyal; Montalvo-Lugo, Victor M; Sharma, Mona; Wu, Yukun; Muse, Derek D; Sheldon, Eric A; Hampel, Frank C; Lemiale, Laurence

    2016-04-19

    AV7909 vaccine being developed for post-exposure prophylaxis of anthrax disease may require fewer vaccinations and reduced amount of antigen to achieve an accelerated immune response over BioThrax(®) (Anthrax Vaccine Adsorbed). A phase 2, randomized, double-blind, BioThrax vacccine-controlled study was conducted to evaluate the safety and immunogenicity of three intramuscular vaccination schedules and two dose levels of AV7909 in 168 healthy adults. Subjects were randomized at a 4:3:2:4:2 ratio to 5 groups: (1) AV7909 on Days 0/14; (2) AV7909 on Days 0/28; (3) AV7909 on Days 0/14/28; (4) half dose AV7909 on Days 0/14/28; and (5) BioThrax vaccine on Days 0/14/28. Vaccinations in all groups were well tolerated. The incidences of adverse events (AEs) were 79% for AV7909 subjects and 65% for BioThrax subjects; 92% of AV7909 subjects and 87% of BioThrax subjects having AEs reported Grade 1-2 AEs. No serious AEs were assessed as potentially vaccine-related, and no AEs of potential autoimmune etiology were reported. There was no discernible pattern indicative of a safety concern across groups in the incidence or severity of reactogenicity events. Groups 2-4 achieved success for the primary endpoint, demonstrated by a lower 95% confidence limit of the percentage of subjects with protective toxin neutralizing antibody NF50 values (≥0.56) to be ≥40% at Day 63. Group 1 marginally missed the criterion (lower bound 95% confidence limit of 39.5%). Immune responses were above this threshold for Groups 1, 3 and 4 at Day 28 and all groups at Day 42. Further study of an AV7909 two-dose schedule given 2 weeks apart is warranted in light of the favorable tolerability profile and immunogenicity response relative to three doses of BioThrax vaccine, as well as preliminary data from nonclinical studies indicating similar immune responses correlate with higher survival for AV7909 than BioThrax vaccine.

  18. Microbial safety of fresh produce

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The book entitled “Microbial Safety of Fresh Produce” with 23 chapters is divided into following six sections: Microbial contamination of fresh produce, Pre-harvest strategies, post-harvest interventions, Produce safety during processing and handling, Public, legal, and economic Perspectives, and Re...

  19. Communicating vaccine safety during the development and introduction of vaccines.

    PubMed

    Kochhar, Sonali

    2015-01-01

    Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.

  20. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  1. Safety of high speed guided ground transportation systems: Magnetic and electric field testing of the Washington Metropolitan Area transit authority metrorail system. Volume 1. Analysis. Final report, September 1992-March 1993

    SciTech Connect

    Dietrich, F.M.; Papas, P.N.; Jacobs, W.L.; Ferro, W.E.

    1993-06-01

    The safety of magnetically levitated (maglev) and high speed rail (HSR) trains proposed for application in the United States is the responsibility of the Federal Railroad Administration (FRA). Plans for near future US applications include maglev technology (e.g. in Orlando, FL and Pittsburgh, PA) and high speed rail (e.g. the French Train a Grande Vitesse (TGV) in the Texas Triangle, between Dallas-Fort Worth, Houston and San Antonio, and along five designated high speed corridors). Concerns exist regarding the potential safety, environmental and health effects on the public and on transportation workers due to electrification along new or existing rail corridors, and to maglev and high speed rail operations. Therefore, the characterization of electric and magnetic fields (EMF) produced by both steady (dc) and alternating currents (ac) at power frequency (50 Hz in Europe and 60 Hz in the U.S.) and above, in the Extreme Low Frequency (ELF) range (3-3000 Hz) is of interest. An EMF survey of the Washington Metrorail (WMATA) transit system was performed, as part of a comprehensive comparative EMF safety assessment of the German Transrapid (TR-07) maglev system with other existing and advanced rail systems. The report provides the Analysis (Vol. I) of results, and detailed data and statistical summaries (Vol. II, Appendices) of representative EMF profiles on vehicles and facilities typical of this transit electrotechnology (third rail dc). EMF data represent a range of train operating conditions and locations (in vehicles, stations and waysides), as well as in traffic control and electrical power supply facilities.

  2. Authority in Educational Relationships.

    ERIC Educational Resources Information Center

    Steutel, Jan; Spiecker, Ben

    2000-01-01

    Summarizes John Wilson's account of authority in educational relationships by reconstructing his views on different types of authority. Explores the topic of parental authority arguing that parental authority differs from the authority of teachers. Comments on whether authoritative parental supervision is essential. Includes references. (CMK)

  3. Laboratory Safety in the Biology Lab.

    ERIC Educational Resources Information Center

    Ritch, Donna; Rank, Jane

    2001-01-01

    Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

  4. 48 CFR 923.7001 - Nuclear safety.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Nuclear safety. 923.7001... Efficiency, Renewable Energy Technologies, and Occupational Safety Programs 923.7001 Nuclear safety. The DOE regulates the nuclear safety of its major facilities under its own statutory authority derived from...

  5. Safety of high speed guided ground transportation systems: Magnetic and electric field testing of the massachusetts bay transportation authority (MBTA) urban transit system. Volume 1. Analysis. Final report, September 1992-March 1993

    SciTech Connect

    Dietrich, F.M.; Papas, P.N.; Ferro, W.E.; Jacobs, W.L.; Steiner, G.A.

    1993-06-01

    The safety of magnetically levitated (maglev) and high speed rail (HSR) trains proposed for application in the United States is the responsibility of the Federal Railroad Administration (FRA). Plans for near future US applications include maglev projects (e.g. in Orlando, FL and Pittsburgh, PA) and high speed rail (the French Train a Grande Vitesse (TGV) in the Texas Triangle). Concerns exist regarding the potential safety, environmental and health effects on the public and on transportation workers due to electrification along new or existing rail corridors, and to maglev and high speed rail operations. Therefore, the characterization of electric and magnetic fields (EMF) produced by both steady (dc) and alternating currents (ac) at power frequency (50 Hz in Europe and 60 Hz in the U.S.) and above, in the Extreme Low Frequency (ELF) range (3-3000 Hz) is of interest. A portable magnetic field monitoring system (augmented to include an electric fields probe) was used to sample, record and store 3 axis static and ac magnetic fields waveforms simultaneously, at multiple locations.

  6. Accelerator production of tritium authorization basis strategy

    SciTech Connect

    Miller, L.A.; Edwards, J.; Rose, S.

    1996-05-01

    The Accelerator Production of Tritium (APT) project has proposed a strategy to develop the APT authorization basis and safety case based on DOE orders and fundamental requirements for safe operation. The strategy is viable regardless of whether the APT is regulated by DOE or by an external regulatory body. Currently the operation of Department of Energy (DOE) facilities is authorized by DOE and regulated by DOE orders and regulations while meeting the environmental protection requirements of the Environmental Protection Agency (EPA) and the states. In the spring of 1994, Congress proposed legislation and held hearings related to requiring all DOE operations to be subject to external regulation. On January 25, 1995, DOE, with the support of the White House Council on Environmental Quality, created the Advisory Committee on External Regulation of Department of Energy Nuclear Safety. This committee divided its recommendations into three areas: (1) facility safety, (2) worker safety, and (3) environmental protection. In the area of facility safety the committee recommended external regulation of DOE nuclear facilities by either the Nuclear Regulatory Commission (NRC) or a restructured Defense Nuclear Facilities Safety Board (DNFSB). In the area of worker safety, the committee recommended that the Occupational Safety and Health Administration (OSHA) regulate DOE nuclear facilities. In the environmental protection area, the committee did not recommend a change in the regulation by the EPA and the states of DOE nuclear facilities. If these recommendations are accepted, all DOE nuclear facilities will be impacted to some extent.

  7. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Post hearing briefs. 3.544 Section 3.544 Public... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.544 Post hearing briefs. The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing...

  8. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... operator must file a post launch report with the FAA no later than 90 days after the launch. (c) The post... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report....

  9. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Post hearing briefs. 3.544 Section 3.544 Public... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.544 Post hearing briefs. The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing...

  10. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines.

    PubMed

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-03-24

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes.

  11. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines

    PubMed Central

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-01-01

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes. PMID:25444788

  12. Safety of obesity drugs.

    PubMed

    Greenway, Frank L; Caruso, Mary K

    2005-11-01

    The safety of obesity drugs has historically been poor. This and the stigmatisation of obesity in society ensured that a higher standard of safety for obesity drugs must be met. The authors review the safety disasters of obesity drugs that were withdrawn. The authors then review the safety of presently available drugs--benzphetamine, phendimetrazine, diethylpropion, phentermine, sibutramine and orlistat. The safety of rimonabant, a drug with a pending new drug application that has an independent effect on metabolic syndrome, is also reviewed. The authors compare the stage of obesity drug development to that of hypertension in the 1950s. As new and safer drugs with more downstream mechanisms are developed that have independent effects on the cardiovascular risks associated with obesity, third party reimbursement for obesity medicine is likely to improve. This may lead to obesity being treated like hypertension and other chronic diseases with long-term medication. With improved technological tools, the authors believe this process will be more rapid for obesity than it was for hypertension.

  13. Safety of high speed guided ground transportation systems: Magnetic and electric field testing of the Massachusetts Bay Transportation Authority (MBTA) urban transit system. Volume 2. Appendices. Final report, September 1992-March 1993

    SciTech Connect

    Jacobs, W.L.; Robertson, D.C.; Steiner, G.A.

    1993-06-01

    The safety of magnetically levitated (maglev) and high speed rail (HSR) trains proposed for application in the United States is the responsibility of the Federal Railroad Administration (FRA). Plans for near future US applications include maglev projects (e.g. in Orlando, FL and Pittsburgh, PA) and high speed rail (the French Train a Grande Vitesse (TGV) in the Texas Triangle). The report provides the Analysis (Vol. I) of results, and detailed data and statistical summaries (Vol. II, Appendices) of representative EMF profiles on vehicles and facilities typical of electrotechnologies used in the transit system (3rd rail dc, catenary with pantograph, trolley bus). Each electrotechnology has specific EMF frequency signatures. EMF data represent a range of system operating conditions and locations (in vehicles, stations and waysides), as well as traffic control and electrical power supply facilities.

  14. Ensuring patient safety.

    PubMed

    Novo, Ahmed; Masic, Izet

    2007-01-01

    Patient safety is key factor in the process of health care improvement. World Health Organization (WHO) as coordinating authority for health within the United Nations launched a World Alliance for Patient Safety dedicated to bringing significant benefits to patients. Patients for Patient Safety, one of ten action areas of the World Alliance, is designed to ensure that the perspective of patients and families, consumers and citizens, is a central reference point in shaping this important work. This action area is led by the patient safety consumer movement. In Bosnia and Herzegovina has not State Law to regulate patient safety, but Law on the System of Quality and Safety Improvement, and Accreditation in Healthcare in Federation of Bosnia and Herzegovina (FB&H) established Agency for Quality and Accreditation in the Health Care System of the FB&H as a competent entity in the field of improvement of quality and safety, and accreditation in healthcare. Beside the Agency, all service providers need to promote a culture of openness, fairness, accountability and transparency. Also, stakeholders involved in health care should recognize that patients can actively contribute to strengthening thũality and safety of health servicesthrough active participation and to insist on open dialogue, transparency and appropriate information on the potential risks that the health service incurs, as part of enhancing patient health literacy and involvement.

  15. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.53 Posting. All areas in which industrial radiography is being... listed in § 20.1903 of this chapter do not apply to industrial radiographic operations....

  16. Post-emergence herbicides useful in calendula

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Easy and effective weed control is required by growers who are considering new industrial crops. Post-emergence herbicides typically are the products of choice by today’s growers. Unfortunately, post-emergence herbicides with proven safety margins are not known for calendula (Calendula officinalis),...

  17. Vaccine Safety

    MedlinePlus

    ... During Pregnancy Frequently Asked Questions about Vaccine Recalls Historical Vaccine Safety Concerns FAQs about GBS and Menactra ... CISA Resources for Healthcare Professionals Evaluation Current Studies Historical Background 2001-12 Publications Technical Reports Vaccine Safety ...

  18. Highway Safety Program Manual: Volume 8: Alcohol in Relation to Highway Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 8 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on alcohol in relation to highway safety. The purpose and objectives of the alcohol program are outlined. Federal authority in the area of highway safety and general policies regarding…

  19. 77 FR 25179 - Patient Safety Organizations: Voluntary Relinquishment From Surgical Safety Institute

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality... of health care delivery. The Patient Safety Rule, 42 CFR part 3, authorizes AHRQ, on behalf of the... HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations:...

  20. Vaccine Safety Resources for Nurses

    PubMed Central

    Shimabukuro, Tom T.; Hibbs, Beth F.; Moro, Pedro L.; Broder, Karen R.; Vellozzi, Claudia

    2015-01-01

    Overview Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention’s (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. PMID:26222474

  1. Effectiveness of Enhanced Safety Management

    SciTech Connect

    Waterfall, K.W. )

    1988-01-01

    This paper discusses the development of an Enhanced Safety Management (ESM) campaign to improve safety and reduce risk in oil and gas exploration. The essentials of ESM are summarized by the author. The paper addresses the method developed to implement ESM and how the control of process designs to control operations minimizes the risk of a major accident.

  2. Safety Handbook.

    ERIC Educational Resources Information Center

    Montgomery County Public Schools, Rockville, MD.

    Safety policies, procedures, and related information are presented in this manual to assist school personnel in a continuing program of accident prevention. Chapter 1 discusses safety education and accident prevention in general. Chapter 2 covers traffic regulations relating to school safety patrols, school bus transportation, bicycles, and…

  3. And Speaking of Authority...

    ERIC Educational Resources Information Center

    Williams, Connie

    2010-01-01

    Over breakfast at the American Library Association (ALA) Annual Conference, this author was asked, "What is authority? What does one know about the ways in which he/she determines credibility? Whom do you trust?" In this article, the author focuses on these questions in terms of administrators who have control over libraries. She provides a…

  4. Authority in Engineering Education

    ERIC Educational Resources Information Center

    Stephan, Karl D.

    2012-01-01

    Authority as a philosophical concept is defined both in general and as it applies to engineering education. Authority is shown to be a good and necessary part of social structures, in contrast to some cultural trends that regard it as an unnecessary and outmoded evil. Technical, educational, and organizational authority in their normal functions…

  5. 23 CFR 1200.35 - Post-grant adjustments.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Post-grant adjustments. 1200.35 Section 1200.35 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF... Closeout § 1200.35 Post-grant adjustments. The closeout of a highway safety program in a fiscal year...

  6. 23 CFR 1200.35 - Post-grant adjustments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 23 Highways 1 2012-04-01 2012-04-01 false Post-grant adjustments. 1200.35 Section 1200.35 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF... Closeout § 1200.35 Post-grant adjustments. The closeout of a highway safety program in a fiscal year...

  7. 23 CFR 1200.35 - Post-grant adjustments.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 23 Highways 1 2011-04-01 2011-04-01 false Post-grant adjustments. 1200.35 Section 1200.35 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF... Closeout § 1200.35 Post-grant adjustments. The closeout of a highway safety program in a fiscal year...

  8. 23 CFR 1350.7 - Post-award requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 23 Highways 1 2012-04-01 2012-04-01 false Post-award requirements. 1350.7 Section 1350.7 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION INCENTIVE GRANT CRITERIA FOR MOTORCYCLIST SAFETY PROGRAM § 1350.7 Post-award requirements. (a) Within 30 days after notification of...

  9. 23 CFR 1350.7 - Post-award requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 23 Highways 1 2011-04-01 2011-04-01 false Post-award requirements. 1350.7 Section 1350.7 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION INCENTIVE GRANT CRITERIA FOR MOTORCYCLIST SAFETY PROGRAM § 1350.7 Post-award requirements. (a) Within 30 days after notification of...

  10. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Maximum load; posting. 77.1402-1 Section 77.1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... MINES Personnel Hoisting § 77.1402-1 Maximum load; posting. The operator shall designate the...

  11. Author! Author! Seymour Simon: Science Writer Extraordinaire

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2005-01-01

    This column presents a brief biography of author Seymour Simon, whose topics for children's photo essays include icebergs, gorillas, thunderstorms, optical illusions, snakes, air, water, planets, airplanes, volcanoes, cars, the brain, bridges, bugs, crocodiles, skyscrapers, sharks, and paper airplanes. Though he is best known in the style and an…

  12. Author! Author! Making Kids Laugh: Jon Scieszka

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2004-01-01

    This article presents a brief biography of author Jon Scieszka, best known for his first published title, "The True Story of the Three Little Pigs!" which has become a modern classic. The publication of this creative and inventive title led to the numerous fractured fairy tales published since its release in 1989. His books have received numerous…

  13. 77 FR 33495 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... Occupational Safety and Health Administration Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice of MACOSH..., Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of......

  14. System Safety Analysis Application Guide. Safety Analysis Report Update Program

    SciTech Connect

    Not Available

    1993-05-01

    Martin Marietta Energy Systems, Inc., (Energy Systems) is committed to performing and documenting safety analyses for facilities it manages for the Department of Energy (DOE). Safety analyses are performed to identify hazards and potential accidents; to analyze the adequacy of measures taken to eliminate, control, or mitigate hazards; and to evaluate potential accidents and determine associated risks. Safety Analysis Reports (SARs) are prepared to document the safety analysis to ensure facilities can be operated safely and in accordance with regulations. SARs include Technical Safety Requirements (TSRs), which are specific technical and administrative requirements that prescribe limits and controls to ensure safe operation of DOE facilities. These documented descriptions and analyses contribute to the authorization basis for facility operation. Energy Systems has established a process to perform Unreviewed Safety Question Determinations (USQDs) for planned changes and as-found conditions that are not described and analyzed in existing safety analyses. The process evaluates changes and as-found conditions to determine whether revisions to the authorization basis must be reviewed and approved by DOE. There is an Unreviewed Safety Question (USQ) if a change introduces conditions not bounded by the facility authorization basis. When it is necessary to request DOE approval to revise the authorization basis, preparation of a System Safety Analysis (SSA) is recommended. This application guide describes the process of preparing an SSA and the desired contents of an SSA. Guidance is provided on how to identify items and practices which are important to safety; how to determine the credibility and significance of consequences of proposed accident scenarios; how to evaluate accident prevention and mitigation features of the planned change; and how to establish special requirements to ensure that a change can be implemented with adequate safety.

  15. Comparison of efficacy and safety of two starting insulin regimens in non-Asian, Asian Indian, and East Asian patients with type 2 diabetes: a post hoc analysis of the PARADIGM study

    PubMed Central

    Ji, Linong; Min, Kyung Wan; Oliveira, Juliana; Lew, Thomas; Duan, Ran

    2016-01-01

    Objective The objective of this study was to explore the efficacy and safety of insulin lispro mix 25 (25% insulin lispro and 75% insulin lispro protamine suspension [LM25]) or insulin glargine plus insulin lispro (G+L) in insulin-naïve patients with type 2 diabetes from different racial/ethnic groups. Methods Three subgroups from the PARADIGM study were analyzed post hoc: non-Asian (n=130), Asian Indian (n=106), and East Asian (n=89). Results All subgroups recorded glycated hemoglobin (HbA1c) reductions: non-Asian (LM25, −2.07%; G+L, −2.05%), Asian Indian (LM25, −1.75%; G+L, −1.60%), and East Asian (LM25, −2.03%; G+L, −1.76%); end point HbA1c values were higher in Asian Indians and East Asians than in non-Asians. Fewer Asian Indians (LM25, 43.2%; G+L, 29.2%) and East Asians (LM25, 37.5%; G+L, 36.1%) reached HbA1c <7% versus non-Asians (LM25, 51.7%; G+L, 48.1%); differences were not significant (P=0.12 and P=0.06, respectively). The mean total daily insulin dose (U/kg) for non-Asians was 0.67 (LM25) and 0.61 (G+L), for Asian Indians was 0.91 (LM25) and 0.90 (G+L), and for East Asians was 0.53 (LM25) and 0.59 (G+L). The ratio of mealtime to total insulin dose in the G+L arm for non-Asians was 0.19±0.23, for Asian Indians was 0.33±0.25, and for East Asians was 0.34±0.27. Overall incidence (%) of hypoglycemia in non-Asians was 94.1 (LM25) and 91.8 (G+L), in Asian Indians was 90.4 (LM25) and 88.5 (G+L), and in East Asians was 69.8 (LM25) and 77.3 (G+L). Conclusion Asian Indians showed least improvement in glycemic HbA1c reduction despite greater insulin use. East Asians and non-Asians achieved similar HbA1c reduction in the LM25 arm with a lower rate of hypoglycemia. Asians required more mealtime insulin coverage than non-Asians. This study added important insight into the effect of ethnicity on insulin treatment outcomes in patients with type 2 diabetes. PMID:27563254

  16. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b,...

  17. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009,...

  18. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... facilitate definite improvements and at the same time to maintain full compliance with the spirit and...

  19. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... facilitate definite improvements and at the same time to maintain full compliance with the spirit and...

  20. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate...

  1. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate...

  2. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested...

  3. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested...

  4. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005,...

  5. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National...

  6. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009,...

  7. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b,...

  8. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b,...

  9. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005,...

  10. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005,...

  11. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National...

  12. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009,...

  13. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National...

  14. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b,...

  15. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b,...

  16. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate...

  17. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested...

  18. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005,...

  19. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009,...

  20. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National...

  1. 9 CFR 332.9 - Enforcement authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Enforcement authority. 332.9 Section 332.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION...

  2. 9 CFR 332.9 - Enforcement authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Enforcement authority. 332.9 Section 332.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION...

  3. 46 CFR 122.515 - Passenger safety bill.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Passenger safety bill. 122.515 Section 122.515 Shipping... Emergencies § 122.515 Passenger safety bill. (a) A passenger safety bill must be posted by the master in each... accommodations for more than 49 passengers. (b) Each passenger safety bill required by this section must list:...

  4. 46 CFR 122.515 - Passenger safety bill.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Passenger safety bill. 122.515 Section 122.515 Shipping... Emergencies § 122.515 Passenger safety bill. (a) A passenger safety bill must be posted by the master in each... accommodations for more than 49 passengers. (b) Each passenger safety bill required by this section must list:...

  5. 46 CFR 122.515 - Passenger safety bill.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Passenger safety bill. 122.515 Section 122.515 Shipping... Emergencies § 122.515 Passenger safety bill. (a) A passenger safety bill must be posted by the master in each... accommodations for more than 49 passengers. (b) Each passenger safety bill required by this section must list:...

  6. 46 CFR 122.515 - Passenger safety bill.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Passenger safety bill. 122.515 Section 122.515 Shipping... Emergencies § 122.515 Passenger safety bill. (a) A passenger safety bill must be posted by the master in each... accommodations for more than 49 passengers. (b) Each passenger safety bill required by this section must list:...

  7. 46 CFR 122.515 - Passenger safety bill.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Passenger safety bill. 122.515 Section 122.515 Shipping... Emergencies § 122.515 Passenger safety bill. (a) A passenger safety bill must be posted by the master in each... accommodations for more than 49 passengers. (b) Each passenger safety bill required by this section must list:...

  8. 12 CFR 1770.1 - Authority and scope.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Authority and scope. 1770.1 Section 1770.1 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE OVERSIGHT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS EXECUTIVE COMPENSATION § 1770.1 Authority and scope. (a) Authority....

  9. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the...

  10. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the...

  11. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the...

  12. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the...

  13. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the...

  14. 29 CFR 1926.1418 - Authority to stop operation.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 8 2011-07-01 2011-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418... Construction § 1926.1418 Authority to stop operation. Whenever there is a concern as to safety, the operator must have the authority to stop and refuse to handle loads until a qualified person has determined...

  15. 29 CFR 1926.1418 - Authority to stop operation.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 8 2013-07-01 2013-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418... Construction § 1926.1418 Authority to stop operation. Whenever there is a concern as to safety, the operator must have the authority to stop and refuse to handle loads until a qualified person has determined...

  16. 29 CFR 1926.1418 - Authority to stop operation.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 8 2014-07-01 2014-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418... Construction § 1926.1418 Authority to stop operation. Whenever there is a concern as to safety, the operator must have the authority to stop and refuse to handle loads until a qualified person has determined...

  17. 29 CFR 1926.1418 - Authority to stop operation.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 8 2012-07-01 2012-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418... Construction § 1926.1418 Authority to stop operation. Whenever there is a concern as to safety, the operator must have the authority to stop and refuse to handle loads until a qualified person has determined...

  18. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or...

  19. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or...

  20. 12 CFR 1253.9 - Preservation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of the Director to review all new and existing products or activities to determine that such products... PRODUCTS § 1253.9 Preservation of authority. (a) The Director's exercise of his or her authority pursuant to the prior approval authority for products under section 1321 of the Safety and Soundness Act (12...

  1. 5 CFR 572.101 - Agency authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS TRAVEL AND TRANSPORTATION EXPENSES; NEW APPOINTEES AND INTERVIEWS § 572.101 Agency authority. (a) An agency may determine which positions qualify for the payment of a new appointee's travel expenses to the first post of duty. Payment...

  2. 47 CFR 0.291 - Authority delegated.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., 315, 317) Editorial Note: For Federal Register citations affecting § 0.291, see the List of CFR... National Institute of Standards and Technology to perform accreditation of Telecommunication Certification... use for performing post-market surveillance. (h) Authority concerning petitions for...

  3. National Safety Council

    MedlinePlus

    ... Introduction Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ... Safety Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ...

  4. Biological post

    PubMed Central

    Kumar, B. Suresh; Kumar, Senthil; Mohan Kumar, N. S.; Karunakaran, J. V.

    2015-01-01

    Anterior tooth fracture as a result of traumatic injuries, is frequently encountered in endodontic practice. Proper reconstruction of extensively damaged teeth can be achieved through the fragment reattachment procedure known as “biological restoration.” This case report refers to the esthetics and functional recovery of extensively damaged maxillary central incisor through the preparation and adhesive cementation of “biological post” in a young patient. Biological post obtained through extracted teeth from another individual–represent a low-cost option and alternative technique for the morphofunctional recovery of extensively damaged anterior teeth. PMID:26538952

  5. Akenti Authorization System

    2000-06-01

    Akenti is an authorization service for distributed resources. The authorization policy is kept in distributed certificates signed by one or more stakeholders for the resources. The package consists of the following components: Java GUI tools to create and sign the policy certificates C++ libraries to do make acess decisions based on the policy certificates A standalone authorization server that make access decisions C interfaces to the libraries and server

  6. Authoring tool evaluation

    SciTech Connect

    Wilson, A.L.; Klenk, K.S.; Coday, A.C.; McGee, J.P.; Rivenburgh, R.R.; Gonzales, D.M.; Mniszewski, S.M.

    1994-09-15

    This paper discusses and evaluates a number of authoring tools currently on the market. The tools evaluated are Visix Galaxy, NeuronData Open Interface Elements, Sybase Gain Momentum, XVT Power++, Aimtech IconAuthor, Liant C++/Views, and Inmark Technology zApp. Also discussed is the LIST project and how this evaluation is being used to fit an authoring tool to the project.

  7. 12 CFR 380.25 - Post-insolvency interest.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Post-insolvency interest. 380.25 Section 380.25... ORDERLY LIQUIDATION AUTHORITY Priorities § 380.25 Post-insolvency interest. (a) Date of accrual. Post-insolvency interest shall be paid at the post-insolvency interest rate calculated on the principal amount...

  8. 12 CFR 380.25 - Post-insolvency interest.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Post-insolvency interest. 380.25 Section 380.25... ORDERLY LIQUIDATION AUTHORITY Priorities § 380.25 Post-insolvency interest. (a) Date of accrual. Post-insolvency interest shall be paid at the post-insolvency interest rate calculated on the principal amount...

  9. 12 CFR 380.25 - Post-insolvency interest.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Post-insolvency interest. 380.25 Section 380.25... ORDERLY LIQUIDATION AUTHORITY Priorities § 380.25 Post-insolvency interest. (a) Date of accrual. Post-insolvency interest shall be paid at the post-insolvency interest rate calculated on the principal amount...

  10. Parental authority questionnaire.

    PubMed

    Buri, J R

    1991-08-01

    A questionnaire was developed for the purpose of measuring Baumrind's (1971) permissive, authoritarian, and authoritative parental authority prototypes. It consists of 30 items per parent and yields permissive, authoritarian, and authoritative scores for both the mother and the father; each of these scores is derived from the phenomenological appraisals of the parents' authority by their son or daughter. The results of several studies have supported the Parental Authority Questionnaire as a psychometrically sound and valid measure of Baumrind's parental authority prototypes, and they have suggested that this questionnaire has considerable potential as a valuable tool in the investigation of correlates of parental permissiveness, authoritarianism, and authoritativeness.

  11. Parental authority questionnaire.

    PubMed

    Buri, J R

    1991-08-01

    A questionnaire was developed for the purpose of measuring Baumrind's (1971) permissive, authoritarian, and authoritative parental authority prototypes. It consists of 30 items per parent and yields permissive, authoritarian, and authoritative scores for both the mother and the father; each of these scores is derived from the phenomenological appraisals of the parents' authority by their son or daughter. The results of several studies have supported the Parental Authority Questionnaire as a psychometrically sound and valid measure of Baumrind's parental authority prototypes, and they have suggested that this questionnaire has considerable potential as a valuable tool in the investigation of correlates of parental permissiveness, authoritarianism, and authoritativeness. PMID:16370893

  12. 23 CFR 1350.7 - Post-award requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION INCENTIVE GRANT CRITERIA FOR MOTORCYCLIST SAFETY PROGRAM § 1350.7 Post-award requirements. (a) Within 30 days after notification of award... a Program Cost Summary (HS Form 217) obligating funds to the Motorcyclist Safety grant program....

  13. School Bus Fleet Safety: Planning and Development.

    ERIC Educational Resources Information Center

    Bieber, Robert M.

    1984-01-01

    To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

  14. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft....

  15. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations, and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on... insure the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft....

  16. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations, and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on... insure the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft....

  17. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft....

  18. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft....

  19. [Safety of intensive sweeteners].

    PubMed

    Lugasi, Andrea

    2016-04-01

    Nowadays low calorie or intesive sweeteners are getting more and more popular. These sweeteners can be placed to the market and used as food additives according to the recent EU legislation. In the meantime news are coming out one after the other stating that many of these artificial intensive sweeteners can cause cancer - the highest risk has been attributed to aspartam. Low calorie sweeteners, just like all the other additives can be authorized after strickt risk assessment procedure according to the recent food law. Only after the additive has gone through these procedure can be placed to the list of food additives, which contains not only the range of food these additives can be used, but also the recommended highest amount of daily consumption. European Food Safety Authority considering the latest scientific examination results, evaluates regularly the safety of sweeteners authorized earlier. Until now there is no evidence found to question the safety of the authorized intensive sweeteners. Orv. Hetil., 2016, 157(Suppl. 1), 14-28. PMID:27088715

  20. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post...

  1. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post...

  2. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post...

  3. 30 CFR 56.19094 - Posting signal code.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting signal code. 56.19094 Section 56.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling § 56.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  4. 30 CFR 57.19094 - Posting signal code.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting signal code. 57.19094 Section 57.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling § 57.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  5. Skateboard Safety.

    ERIC Educational Resources Information Center

    Della-Giustina, Daniel

    1979-01-01

    The growing number of skateboard injuries clearly indicates a need for both recreational facilities designed exclusively for skateboarders, and for accident- prevention-oriented safety education programs. (LH)

  6. Medication safety.

    PubMed

    Keohane, Carol A; Bates, David W

    2008-03-01

    Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

  7. [The safety of blood donors].

    PubMed

    Courchelle, J; Baudry, C; Bourboul, M-C; Coudurier, N

    2011-04-01

    For a long time, safety has been patient-centred and taken for granted. Indeed, it needed a dramatic accident and the study of post-donation information for the question to be looked into again. However, under various statutory, organizational aspects and the professionalization of the staffs, safety has always accompanied the donor throughout its course of donation. Self-sufficiency is, certainly, the first mission of the Établissement Français du Sang: while we have to supply patients with sufficient blood products complying with quality criteria, we must not however forget the essential respect for the safety of the donor.

  8. The Voice of Authority

    ERIC Educational Resources Information Center

    Wetterlund, Kris

    2012-01-01

    In the last part of 2011, conversations swirled around the Internet and print about the assault on museum authority. The Marcus Institute for Digital Education in the Arts (MIDEA) summarized some of the discussion in their blog entry "The Participatory Museum and a New Authority." Other sites joined in the discussion, for example, the Museum Geek…

  9. Talking Back to Authors

    ERIC Educational Resources Information Center

    Lewin, Larry

    2004-01-01

    Students will see writing as a powerful act when they learn to analyze a published author's writing style and send a written critique straight to the source. The author critiques help students to analyze their own writing and the Sentence Opening Sheet is an excellent device for this purpose as it reformats the text so that students can see their…

  10. The Authors Reply

    ERIC Educational Resources Information Center

    Guilloteaux, Marie J.; Dornyei, Zoltan

    2009-01-01

    This article presents the authors' reply to Rod Ellis's comments on their study on motivated classroom behavior. As Ellis correctly summarizes, the three student variables selected for investigation in the authors' study were attention, participation, and volunteering for teacher-fronted activity. These three components were then summed up in a…

  11. The Authors Reply

    ERIC Educational Resources Information Center

    File, Kieran A.; Adams, Rebecca

    2010-01-01

    This article presents the authors' reply to Beniko Mason and Stephen Krashen's comments on their recent article published in "TESOL Quarterly." Mason and Krashen have provided an interesting reinterpretation of the authors' results and have also brought up several valid points regarding the efficiency of vocabulary learning from instruction,…

  12. Bringing Authors to Students

    ERIC Educational Resources Information Center

    Harvey, Carl A., II

    2005-01-01

    Traditional story times begin with "The author of this book is..." and "The illustrator of this book is...". Although library media specialists emphasize the role of an author and an illustrator in creating a book, students often have difficulty making the connection between the name and a real person. Learning involves making connections and…

  13. Charter Authorizers Face Challenges

    ERIC Educational Resources Information Center

    Gustafson, Joey

    2013-01-01

    Since the first charter school opened 20 years ago in Minnesota, charters have been a focus of school reform advocates and the subject of substantial research. Yet the regulators of the charter industry (called "authorizers" or "sponsors") remain a mystery to many. In fact, many authorizers work in isolation, developing their…

  14. Authorization basis requirements comparison report

    SciTech Connect

    Brantley, W.M.

    1997-08-18

    The TWRS Authorization Basis (AB) consists of a set of documents identified by TWRS management with the concurrence of DOE-RL. Upon implementation of the TWRS Basis for Interim Operation (BIO) and Technical Safety Requirements (TSRs), the AB list will be revised to include the BIO and TSRs. Some documents that currently form part of the AB will be removed from the list. This SD identifies each - requirement from those documents, and recommends a disposition for each to ensure that necessary requirements are retained when the AB is revised to incorporate the BIO and TSRs. This SD also identifies documents that will remain part of the AB after the BIO and TSRs are implemented. This document does not change the AB, but provides guidance for the preparation of change documentation.

  15. Lab Safety.

    ERIC Educational Resources Information Center

    West, Sandra S.

    1991-01-01

    In response to the Texas Hazardous Communication Act (THCA) of 1986 which raised many new health and liability issues regarding students in science laboratories, a laboratory safety survey was generated for use in evaluating laboratory safety. This article contains the easy-to-use survey. (ZWH)

  16. Safety Systems

    ERIC Educational Resources Information Center

    Halligan, Tom

    2009-01-01

    Colleges across the country are rising to the task by implementing safety programs, response strategies, and technologies intended to create a secure environment for teachers and students. Whether it is preparing and responding to a natural disaster, health emergency, or act of violence, more schools are making campus safety a top priority. At…

  17. Safety First

    ERIC Educational Resources Information Center

    Taft, Darryl

    2011-01-01

    Ned Miller does not take security lightly. As director of campus safety and emergency management at the Des Moines Area Community College (DMACC), any threat requires serious consideration. As community college administrators adopt a more proactive approach to campus safety, many institutions are experimenting with emerging technologies, including…

  18. 45 CFR 675.1 - Purpose and authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROCESS FOR DEPLOYMENT TO ANTARCTICA § 675.1 Purpose and authority. (a) This part sets forth the... psychological conditions that would threaten the health or safety of the candidate or other USAP participants...

  19. 45 CFR 675.1 - Purpose and authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROCESS FOR DEPLOYMENT TO ANTARCTICA § 675.1 Purpose and authority. (a) This part sets forth the... psychological conditions that would threaten the health or safety of the candidate or other USAP participants...

  20. 45 CFR 675.1 - Purpose and authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROCESS FOR DEPLOYMENT TO ANTARCTICA § 675.1 Purpose and authority. (a) This part sets forth the... psychological conditions that would threaten the health or safety of the candidate or other USAP participants...

  1. 45 CFR 675.1 - Purpose and authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROCESS FOR DEPLOYMENT TO ANTARCTICA § 675.1 Purpose and authority. (a) This part sets forth the... psychological conditions that would threaten the health or safety of the candidate or other USAP participants...

  2. 29 CFR 1975.2 - Basis of authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) COVERAGE OF EMPLOYERS UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 § 1975.2 Basis of authority. The power of Congress to regulate employment conditions under the Williams-Steiger... the Williams-Steiger Act?...

  3. 47 CFR 0.314 - Additional authority delegated.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... the Communications Act Safety Radiotelephony Certificate for a period of up to 90 days beyond the... Director, District Director or Resident Agent at each installation is delegated authority to act upon... ships in accordance with applicable provisions of the Communications Act, the Safety Convention,...

  4. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Authority for distress transmission. 80.311 Section 80.311 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Distress,...

  5. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authority for distress transmission. 80.311 Section 80.311 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Distress,...

  6. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Authority for distress transmission. 80.311 Section 80.311 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Distress,...

  7. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Authority for distress transmission. 80.311 Section 80.311 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Distress,...

  8. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authority for distress transmission. 80.311 Section 80.311 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Distress,...

  9. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Banks and Banking FEDERAL HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS... implementing the prior approval authority for enterprise products, in accordance with section 1321 of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act) (12...

  10. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Banks and Banking FEDERAL HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS... implementing the prior approval authority for enterprise products, in accordance with section 1321 of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act) (12...

  11. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Banks and Banking FEDERAL HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS... implementing the prior approval authority for enterprise products, in accordance with section 1321 of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act) (12...

  12. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Banks and Banking FEDERAL HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS... implementing the prior approval authority for enterprise products, in accordance with section 1321 of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act) (12...

  13. Authorizing Online Learning. Viewpoint

    ERIC Educational Resources Information Center

    Patrick, Susan; Vander Ark, Tom

    2011-01-01

    processing to personalized learning. There will also be a slow enrollment shift from traditional district-operated schools to schools and programs operated by organizations authorized under contracts or…

  14. Firearms safety program

    USGS Publications Warehouse

    ,

    2005-01-01

    The USGS provides appropriate firearms safety training for any employee or USGS volunteer who uses, handles, carries, or stores a firearm as part of his or her official duties. An employee or volunteer can be authorized to carry a firearm while on official duty once he or she has completed specified training requirements and a certificate of need and qualification inquiry. Knowledge of details for firearms storage, security, and transport is also necessary.

  15. Safety in Riding Programs: A Director's Guide.

    ERIC Educational Resources Information Center

    Kpachavi, Teresa

    1996-01-01

    Camp riding programs should be examined regularly for liability and risk management issues. Elements of a basic safety assessment include requiring proper safety apparel, removing obstructions from riding rings, ensuring doors and gates are closed, requiring use of lead ropes, securing equine medications, banning smoking, posting written…

  16. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 8 2010-10-01 2010-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4 Posting of bond. The General Agent shall retain an executed copy of each such bond in its principal...

  17. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 8 2012-10-01 2012-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4 Posting of bond. The General Agent shall retain an executed copy of each such bond in its principal...

  18. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 8 2014-10-01 2014-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4 Posting of bond. The General Agent shall retain an executed copy of each such bond in its principal...

  19. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 8 2011-10-01 2011-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4 Posting of bond. The General Agent shall retain an executed copy of each such bond in its principal...

  20. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 8 2013-10-01 2013-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4 Posting of bond. The General Agent shall retain an executed copy of each such bond in its principal...

  1. Software safety

    NASA Technical Reports Server (NTRS)

    Leveson, Nancy

    1987-01-01

    Software safety and its relationship to other qualities are discussed. It is shown that standard reliability and fault tolerance techniques will not solve the safety problem for the present. A new attitude requires: looking at what you do NOT want software to do along with what you want it to do; and assuming things will go wrong. New procedures and changes to entire software development process are necessary: special software safety analysis techniques are needed; and design techniques, especially eliminating complexity, can be very helpful.

  2. Design and development of safety evaluation system of buildings on a seismic field based on the network platform

    NASA Astrophysics Data System (ADS)

    Sun, Baitao; Zhang, Lei; Chen, Xiangzhao; Zhang, Xinghua

    2015-03-01

    This paper describes a set of on-site earthquake safety evaluation systems for buildings, which were developed based on a network platform. The system embedded into the quantitative research results which were completed in accordance with the provisions from Post-earthquake Field Works, Part 2: Safety Assessment of Buildings, GB18208.2 -2001, and was further developed into an easy-to-use software platform. The system is aimed at allowing engineering professionals, civil engineeing technicists or earthquake-affected victims on site to assess damaged buildings through a network after earthquakes. The authors studied the function structure, process design of the safety evaluation module, and hierarchical analysis algorithm module of the system in depth, and developed the general architecture design, development technology and database design of the system. Technologies such as hierarchical architecture design and Java EE were used in the system development, and MySQL5 was adopted in the database development. The result is a complete evaluation process of information collection, safety evaluation, and output of damage and safety degrees, as well as query and statistical analysis of identified buildings. The system can play a positive role in sharing expert post-earthquake experience and promoting safety evaluation of buildings on a seismic field.

  3. Hanford site post NPH building inspection plan

    SciTech Connect

    Wagenblast, G.R., Westinghouse Hanford

    1996-09-12

    This plan establishes consistent post-NPH building inspection procedures and defines a procedure for prioritization of buildings for inspection to ensure the safety of facilities prior to reentry. Qualification of systems for restart of operation is not included. This plan takes advantage, where possible, of existing national procedures for post-NPH inspection of buildings, of existing structural design and evaluation documentation of Hanford facilities, and current and proposed seismic instrumentation located throughout the Hanford site. A list of buildings, prioritized according to current building safety function and building vulnerability (without regard for or information about a damaging natural forces event) is provided.

  4. Safety Tips.

    ERIC Educational Resources Information Center

    Nagel, Miriam C., Ed.

    1984-01-01

    Outlines a cooperative effort in Iowa to eliminate dangerous or unwanted chemicals from school science storerooms. Also reviews the Council of State Science Supervisor's safety program and discusses how to prevent cuts and punctures from jagged glass tubing. (JN)

  5. Incorrect author affiliation.

    PubMed

    2015-05-01

    Incorrect Author Affiliation: In the article titled “Effect of Human Papillomavirus on Patterns of Distant Metastatic Failure in Oropharyngeal Squamous Cell Carcinoma Treated With Chemoradiotherapy,”published online March 5, 2015, and also in this issue of JAMA Otolaryngology–Head & Neck Surgery (doi:10.1001/jamaoto.2015 .136), the Author Affiliations were incorrect. That section should have been given as follows: "Author Affiliations: Head and Neck Institute, Cleveland Clinic Foundation, Cleveland, Ohio (Trosman, Lamarre, Scharpf, Khan, Lorenz, Burkey); Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio (Koyfman,Ward, Greskovich); Department of Otolaryngology–Head and Neck Surgery, Rush University, Chicago, Illinois (Al-Khudari); Department of Hematology and Medical Oncology,Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio (Nwizu, Adelstein)." This article was corrected online and in print.

  6. Adolescent attitudes to authority.

    PubMed

    Coleman, J; Coleman, E Z

    1984-06-01

    This study is concerned with adolescent attitudes to authority. In particular the investigation focuses on notions of the ideal authority figure, attitudes to the sorts of conflicts experienced at home and in school, and on the types of resolutions to conflicts preferred by young people. Subjects were 43 adolescents from working class areas in outer London boroughs, all of whom were given a semistructured interview. Results indicated important differences in the amount of control required at home and in the school, and showed adolescents of 14 and 15 to have relatively little need for autonomy but a very considerable need for support from parents and teachers.

  7. Hanford Generic Interim Safety Basis

    SciTech Connect

    Lavender, J.C.

    1994-09-09

    The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports.

  8. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations...

  9. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations...

  10. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations...

  11. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations...

  12. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations...

  13. Safety Education--An Essential Element of Technical Training

    ERIC Educational Resources Information Center

    Glazener, Everett R.; Comstock, Thomas W.

    1978-01-01

    After tracing the background of the safety movement, provisions of recent safety legislation, and the ecological and environmental impact of industrial processes, the author stresses the need for safety education in technical education programs to prepare future employees for industrial safety requirements. (MF)

  14. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination

    PubMed Central

    Díez-Domingo, Javier; Baldó, José-María; Planelles-Catarino, Maria Victoria; Garcés-Sánchez, María; Ubeda, Isabel; Jubert–Rosich, Angels; Marès, Josep; Garcia-Corbeira, Pilar; Moris, Philippe; Teko, Maurice; Vanden Abeele, Carline; Gillard, Paul

    2015-01-01

    Background An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years. Methods In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3–9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03A or AS03B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). Results The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4+ T cells with a TH1 profile were observed. Conclusions Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination. PMID:25652873

  15. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    PubMed

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  16. Another Approach to Enhance Airline Safety: Using Management Safety Tools

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

    2006-01-01

    The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

  17. Authors on Film.

    ERIC Educational Resources Information Center

    Geduld, Harry M., Ed.

    Different authors' attitudes toward film are revealed through five different sections of this book: (1) articles, essays, and reviews pertaining to the silent cinema and the transition to sound; (2) general statements on the film medium or filmmakers and their messages; (3) essays dealing with the problems, involvements, and reflections of the…

  18. Authoring with Video

    ERIC Educational Resources Information Center

    Strassman, Barbara K.; O'Connell, Trisha

    2007-01-01

    Teachers are hungry for strategies that will motivate their students to engage in reading and writing. One promising method is the Authoring With Video (AWV) approach, which encourages teachers to use captioning software and digital video in writing assignments. AWV builds on students' fascination with television and video but removes the audio…

  19. Children as Authors Handbook.

    ERIC Educational Resources Information Center

    Hawaii State Dept. of Education, Honolulu. Office of Instructional Services.

    Intended for teachers, librarians, and administrators, this handbook explores the possibilities of implementing a "Children as Authors" project by using collaborative and integrative teaching strategies to motivate elementary school children to write. After describing the project and explaining its benefits, the handbook explores ways teachers and…

  20. Today's Authors, Tomorrow's Scientists

    ERIC Educational Resources Information Center

    Porter, Diana

    2009-01-01

    Although not all teachers can invite scientists into classrooms on a regular basis, they can invite them into their students' worlds through literature. Here the author shares how she used the nonfiction selection, "Science to the Rescue" (Markle 1994), as an opportunity for students to investigate socially significant problems and empower them to…

  1. Students as Textbook Authors

    ERIC Educational Resources Information Center

    Chou, Hsiao-Yi; Lau, Sok-Han; Yang, Huei-Chia; Murphey, Tim

    2007-01-01

    The authors describe their experience using a learner-centered approach to turn learner writing into booklets. When students write about their own lives, they can focus on the language they need to express their ideas. Interaction increases because interest is high. Near beginners can create fact sheets about themselves, and more advanced students…

  2. Author Identification Systems

    ERIC Educational Resources Information Center

    Wagner, A. Ben

    2009-01-01

    Many efforts are currently underway to disambiguate author names and assign unique identification numbers so that publications by a given scholar can be reliably grouped together. This paper reviews a number of operational and in-development services. Some systems like ResearcherId.Com depend on self-registration and self-identification of a…

  3. Creating Digital Authors

    ERIC Educational Resources Information Center

    Zoch, Melody; Langston-DeMott, Brooke; Adams-Budde, Melissa

    2014-01-01

    Elementary students find themselves engaged and learning at a digital writing camp. The authors find that such elementary students usually have limited access to technology at home and school, and posit that teachers should do all they can to give them more access to and experience in digital composing. Students were motivated and learned to use…

  4. The Authors Respond.

    ERIC Educational Resources Information Center

    Zigler, Edward F.; And Others

    1996-01-01

    The authors of proposals for a child care allowance for poor families, a parental leave program to ensure infant care, and a linkage of child care and public education systems respond to comments by three reviewers. The commentaries illustrate the diversity of perspectives on child care and the public sector. (SLD)

  5. 77 FR 67342 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... (NTIA) will convene open public meetings of the Board of the First Responder Network Authority (FirstNet... (2012), created FirstNet as an independent authority within NTIA. The Act directs FirstNet to establish a single nationwide, interoperable public safety broadband network. The FirstNet Board...

  6. 47 CFR 87.147 - Authorization of equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorization of equipment. 87.147 Section 87.147 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Technical Requirements § 87.147 Authorization of equipment. (a) Certification may be requested by following the procedures in...

  7. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 7 2014-10-01 2014-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of...

  8. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of...

  9. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of...

  10. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 7 2013-10-01 2013-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of...

  11. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of...

  12. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Authority of Directors. 831.3 Section 831.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD ACCIDENT/INCIDENT INVESTIGATION PROCEDURES § 831.3 Authority of Directors. The Directors, Office...

  13. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Authority of Directors. 831.3 Section 831.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD ACCIDENT/INCIDENT INVESTIGATION PROCEDURES § 831.3 Authority of Directors. The Directors, Office...

  14. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Authority of Directors. 831.3 Section 831.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD ACCIDENT/INCIDENT INVESTIGATION PROCEDURES § 831.3 Authority of Directors. The Directors, Office...

  15. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 7 2014-10-01 2014-10-01 false Authority of Directors. 831.3 Section 831.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD ACCIDENT/INCIDENT INVESTIGATION PROCEDURES § 831.3 Authority of Directors. The Directors, Office...

  16. 49 CFR 450.11 - Application for delegation of authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Application for delegation of authority. 450.11 Section 450.11 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for Delegation to Approval Authorities § 450.11 Application...

  17. [Skateboard injuries (author's transl)].

    PubMed

    Stürz, H; Rosemeyer, B

    1979-04-01

    Following the introduction of skateboards into Germany in 1976 an increasing number of accidents and injuries have been noted, affecting mainly children 10 to 14 years of age. The causes were lack of experience and the careless use of the boards on public streets. More than 30% of injuries were fractures mainly affecting the upper limb. Because of the frequent involvement of the epiphyseal plates the post-accidental growth may be seriously disturbed. Severe and sometimes fatal head or abdominal injuries have been reported, mainly after collision with cars.

  18. System safety education focused on flight safety

    NASA Technical Reports Server (NTRS)

    Holt, E.

    1971-01-01

    The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

  19. 22 CFR 18.6 - Authority to prohibit appearances.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Authority to prohibit appearances. 18.6 Section 18.6 Foreign Relations DEPARTMENT OF STATE PERSONNEL REGULATIONS CONCERNING POST EMPLOYMENT CONFLICT OF INTEREST Administrative Enforcement Proceedings § 18.6 Authority to prohibit appearances....

  20. A Prospective, Open-label Study to Compare the Efficacy and the Safety of Topical Loteprednol Etabonate and Topical Flurbiprofen Sodium in Patients with Post-Operative Inflammation after Cataract Extraction

    PubMed Central

    Bannale, Sheshidhar G.; Pundarikaksha, H.P.; Sowbhagya, H.N.

    2012-01-01

    Purpose To study the effect of the topical Non-Steroidal Anti Inflammatory Drug (NSAID), Flurbiprofen 0.03%, as an alternative to the topical steroids for the postoperative control of inflammation in cataract surgeries. Methods The effect of the topical NSAID, flurbiprofen sodium 0.03%, was studied and compared with that of the topical steroid – Loteprednol etabonate 0.5% suspension (as eye drops) in a prospective, open labelled study. Both the groups (20 patients each) were similar in the baseline parameters. The postoperative inflammatory response following the standard, small incision, extra capsular cataract extraction was assessed in both the groups for 28 post-operative days. The parameters which were considered for the study were conjunctival hyperaemia, ciliary congestion, corneal oedema, cells in the anterior chamber, aqueous flare and ocular pain. The severity of the postoperative inflammatory responses for both the drugs was graded on the post-operative days 1, 7, 14, 21 and 28 and it was statistically analyzed. Results The 2 groups did not differ statistically in the effect of the treatment for any of the variables, which included aqueous cells, flare, ciliary congestion and conjunctival congestion (p< 0.001). Both the drugs were well tolerated and no severe adverse Drug Reactions (ADRs) were caused by the topical NSAID and the topical steroid. Conclusion The topical NSAID, Flurbiprofen, is as effective as the topical corticosteroid, Loteprednol and it can be used as an alternative in the routine postoperative treatment following uncomplicated cataract surgeries. PMID:23285440

  1. Tank Farms Technical Safety Requirements [VOL 1 and 2

    SciTech Connect

    CASH, R.J.

    2000-12-28

    The Technical Safety Requirements (TSRs) define the acceptable conditions, safe boundaries, basis thereof, and controls to ensure safe operation during authorized activities, for facilities within the scope of the Tank Waste Remediation System (TWRS) Final Safety Analysis Report (FSAR).

  2. Pupil Transportation Safety Audits in New York State.

    ERIC Educational Resources Information Center

    Goodrich, Watson I.

    1980-01-01

    Safety audits were conducted in each of New York State's 750 school districts to help school administrators understand and comply with laws and regulations relating to the safety aspects of pupil transportation. (Author/MLF)

  3. OSHA Laboratory Standard: Driving Force for Laboratory Safety!

    ERIC Educational Resources Information Center

    Roy, Kenneth R.

    2000-01-01

    Discusses the Occupational Safety and Health Administration's (OSHA's) Laboratory Safety Standards as the major driving force in establishing and maintaining a safe working environment for teachers and students. (Author)

  4. Nuclear Safety Information Center, Its Products and Services

    ERIC Educational Resources Information Center

    Buchanan, J. R.

    1970-01-01

    The Nuclear Safety Information Center (NSIC) serves as a focal point for the collection, analysis and dissemination of information related to safety problems encountered in the design, analysis, and operation of nuclear facilities. (Author/AB)

  5. First Aid and Safety

    MedlinePlus

    ... First-Aid Kit Food Safety for Your Family Gun Safety Halloween Candy Hints Household Safety Checklists Household ... Climbing, and Grabbing Household Safety: Preventing Injuries From Firearms Household Safety: Preventing Injuries in the Crib Household ...

  6. What about ex post facto

    SciTech Connect

    McKee, H.C.

    1992-07-01

    This note presents a legal question in an attempt to find an answer. The author hopes that some legal scholar can explain the principle of ex post facto in the US Constitution as it applies to some of the environmental laws. One of the major advantages of the Association is that it provides a forum for communication among members with different backgrounds and experience. An ex post facto law is one that is applied retroactively. Under such a law, a person could be punished for some act that violated a law passed after the act was committed, even though the act was legal when committed. The US Constitution prohibits such laws, as will be discussed later. States are also prohibited from enacting ex post facto laws.

  7. 78 FR 76191 - Operational Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Train Speeds and Other Speed Restrictions AGENCY: Federal Railroad Administration (FRA), Department of... maximum authorized train speeds and other speed restrictions. SUMMARY: FRA is issuing Safety Advisory 2013... and applicable railroad operating rules regarding maximum authorized train speed limits and...

  8. Aerospace safety advisory panel

    NASA Technical Reports Server (NTRS)

    1995-01-01

    The Aerospace Safety Advisory Panel (ASAP) monitored NASA's activities and provided feedback to the NASA Administrator, other NASA officials and Congress throughout the year. Particular attention was paid to the Space Shuttle, its launch processing and planned and potential safety improvements. The Panel monitored Space Shuttle processing at the Kennedy Space Center (KSC) and will continue to follow it as personnel reductions are implemented. There is particular concern that upgrades in hardware, software, and operations with the potential for significant risk reduction not be overlooked due to the extraordinary budget pressures facing the agency. The authorization of all of the Space Shuttle Main Engine (SSME) Block II components portends future Space Shuttle operations at lower risk levels and with greater margins for handling unplanned ascent events. Throughout the year, the Panel attempted to monitor the safety activities related to the Russian involvement in both space and aeronautics programs. This proved difficult as the working relationships between NASA and the Russians were still being defined as the year unfolded. NASA's concern for the unique safety problems inherent in a multi-national endeavor appears appropriate. Actions are underway or contemplated which should be capable of identifying and rectifying problem areas. The balance of this report presents 'Findings and Recommendations' (Section 2), 'Information in Support of Findings and Recommendations' (Section 3) and Appendices describing Panel membership, the NASA response to the March 1994 ASAP report, and a chronology of the panel's activities during the reporting period (Section 4).

  9. 7 CFR 318.13-15 - Parcel post inspection.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 5 2014-01-01 2014-01-01 false Parcel post inspection. 318.13-15 Section 318.13-15... From Hawaii and the Territories § 318.13-15 Parcel post inspection. Inspectors are authorized to inspect, with the cooperation of the U.S. Postal Service, parcel post packages placed in the mails...

  10. 47 CFR 74.564 - Posting of station license.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Posting of station license. 74.564 Section 74... Auxiliary Stations § 74.564 Posting of station license. (a) The station license and any other instrument of... position. (b) Posting of the station license and any other instruments of authorization shall be done...

  11. Tasseography: Reading Post-Racial Resistance to Teaching

    ERIC Educational Resources Information Center

    Houston, Akil

    2011-01-01

    This article focuses on developing a progressive philosophy of praxis that challenges, what the author argues is, a post-racial resistance to teaching about racial injustice. Post-racial resistance to teaching can lead to forms of enlightened racism and sexism in the classroom. In this essay, the author develops and extends the use of the metaphor…

  12. A Canadian Journey: Post-Secondary Education Since 1945

    ERIC Educational Resources Information Center

    Bruneau, William

    2004-01-01

    In this article, the author traces the history of Canadian post-secondary education. The author observes how the development of the country's post-secondary education reflects the changes of its socioeconomic priorities. Two relatively calm beginnings characterized by the construction of the first universities, the period of expansion of the…

  13. Online Safety.

    ERIC Educational Resources Information Center

    Levine, Elliott

    2001-01-01

    Describes provisions of Children's Internet Protection Act, which school districts are required to implement on or before October 31, 2001, involving the development and public dissemination of federally mandated Internet-safety policy to prevent minors from accessing inappropriate and harmful material. Provides suggestions to protect children…

  14. Playground Safety.

    ERIC Educational Resources Information Center

    Sipes, James L.

    2000-01-01

    Discusses the issues of risk, liability, and fun when landscaping playgrounds with safety in mind. The importance of playground surfaces and several preventive measures landscapers can use to reduce the risk of injury are discussed. Concluding comments address playground design features and liability. (GR)

  15. School Safety.

    ERIC Educational Resources Information Center

    The Newsletter of the Comprehensive Center-Region VI, 1999

    1999-01-01

    The articles in this issue dealing with school safety discusses what rural and small urban settings are doing to prevent violence and to educate young people about prosocial alternatives to violence. The research is quite clear that female, minority, and gay students are the targets of a disproportionate amount of harassment and violence, both in…

  16. Art Safety.

    ERIC Educational Resources Information Center

    BCATA Journal for Art Teachers, 1991

    1991-01-01

    Advocating that Canadian art programs should use and model environmentally safe practices, the articles in this journal focus on issues of safe practices in art education. Articles are: (1) "What is WHMIS?"; (2) "Safety Precautions for Specific Art Processes"; (3) "Toxic Substances"; (4) "Using Clay, Glazes, and Kilns Safely in the Classroom"…

  17. Counterfactual quantum certificate authorization

    NASA Astrophysics Data System (ADS)

    Shenoy H., Akshata; Srikanth, R.; Srinivas, T.

    2014-05-01

    We present a multipartite protocol in a counterfactual paradigm. In counterfactual quantum cryptography, secure information is transmitted between two spatially separated parties even when there is no physical travel of particles transferring the information between them. We propose here a tripartite counterfactual quantum protocol for the task of certificate authorization. Here a trusted third party, Alice, authenticates an entity Bob (e.g., a bank) that a client Charlie wishes to securely transact with. The protocol is counterfactual with respect to either Bob or Charlie. We prove its security against a general incoherent attack, where Eve attacks single particles.

  18. [The problem of post-marketing surveillance planning on drugs for infectious disease].

    PubMed

    Sato, J

    2001-12-01

    In principle, a new drug is approved via the assessments of safety and efficacy by the Ministry of Health, Labor and Welfare (MHLW). After approval, conduct of post-marketing surveillance is requested by law in order to assess the safety and efficacy of the drug in a large number of patients. Before initiating a surveillance, submission to MHLW of a document on the plan of survey is necessary in the purpose of inspection if it includes any ethical or regulatory problem or not. Through the inspections of the plans submitted during the period of April 1998 and March 2000, many problems have been pointed out. In this report, the author introduces some of the concrete problems noted in the plans on drugs for infectious diseases and shows some of the guidance made by the authority how to improve them. It is expected that such practical analyses of cases may be useful for future planning of post-marketing surveillance on drugs for infectious diseases.

  19. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination.

    PubMed

    Naud, Paulo S; Roteli-Martins, Cecilia M; De Carvalho, Newton S; Teixeira, Julio C; de Borba, Paola C; Sanchez, Nervo; Zahaf, Toufik; Catteau, Gregory; Geeraerts, Brecht; Descamps, Dominique

    2014-01-01

    HPV-023 (NCT00518336; ClinicalTrial.gov) is a long-term follow-up of an initial double-blind, randomized (1:1), placebo-controlled study (HPV-001, NCT00689741) evaluating the efficacy against human papillomavirus (HPV)-16/18 infection and associated cyto-histopathological abnormalities, persistence of immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine. Among the women, aged 15-25 years, enrolled in HPV-001 and who participated in the follow-up study HPV-007 (NCT00120848), a subset of 437 women from five Brazilian centers participated in this 36-month long-term follow-up (HPV-023) for a total of 113 months (9.4 years). During HPV-023, anti-HPV-16/18 antibodies were measured annually by enzyme-linked immunosorbent assay (ELISA) and pseudovirion-based neutralisation assay (PBNA). Cervical samples were tested for HPV DNA every 6 months, and cyto-pathological examinations were performed annually. During HPV-023, no new HPV-16/18-associated infections and cyto-histopathological abnormalities occurred in the vaccine group. Vaccine efficacy (VE) against HPV-16/18 incident infection was 100% (95%CI: 66.1, 100). Over the 113 months (9.4 years), VE was 95.6% (86.2, 99.1; 3/50 cases in vaccine and placebo groups, respectively) against incident infection, 100% (84·1, 100; 0/21) against 6-month persistent infection (PI); 100% (61·4, 100; 0/10) against 12-month PI; 97·1% (82.5, 99.9; 1/30) against ≥ ASC-US; 95·0% (68.0, 99.9; 1/18) against ≥ LSIL; 100% (45.2, 100; 0/8) against CIN1+; and 100% (-128.1, 100; 0/3) against CIN2+ associated with HPV-16/18. All vaccinees remained seropositive to HPV-16/18, with antibody titers remaining several folds above natural infection levels, as measured by ELISA and PBNA. There were no safety concerns. To date, these data represent the longest follow-up reported for a licensed HPV vaccine. PMID:25424918

  20. Efficacy and safety of Postoperative Intravenous Parecoxib sodium Followed by ORal CElecoxib (PIPFORCE) post-total knee arthroplasty in patients with osteoarthritis: a study protocol for a multicentre, double-blind, parallel-group trial

    PubMed Central

    Zhuang, Qianyu; Bian, Yanyan; Wang, Wei; Jiang, Jingmei; Feng, Bin; Sun, Tiezheng; Lin, Jianhao; Zhang, Miaofeng; Yan, Shigui; Shen, Bin; Pei, Fuxing; Weng, Xisheng

    2016-01-01

    Introduction Total knee arthroplasty (TKA) has been regarded as a most painful orthopaedic surgery. Although many surgeons sequentially use parecoxib and celecoxib as a routine strategy for postoperative pain control after TKA, high quality evidence is still lacking to prove the effect of this sequential regimen, especially at the medium-term follow-up. The purpose of this study, therefore, is to evaluate efficacy and safety of postoperative intravenous parecoxib sodium followed by oral celecoxib in patients with osteoarthritis (OA) undergoing TKA. The hypothesis is that compared to placebo with opioids as rescue treatment, sequential use of parecoxib and celecoxib can achieve less morphine consumption over the postoperative 2 weeks, as well as better pain control, quicker functional recovery in the postoperative 6 weeks and less opioid-related adverse events during the 12-week recovery phase. Methods and analysis This study is designed as a multicentre, randomised, double-blind, parallel-group and placebo-controlled trial. The target sample size is 246. All participants who meet the study inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either the parecoxib/celecoxib group or placebo group. The randomisation and allocation will be study site based. The study will consist of three phases: an initial screening phase; a 6-week double-blind treatment phase; and a 6-week follow-up phase. The primary end point is cumulative opioid consumption during 2 weeks postoperation. Secondary end points consist of the postoperative visual analogue scale score, knee joint function, quality of life, local skin temperature, erythrocyte sedimentation rate, C reactive protein, cytokines and blood coagulation parameters. Safety end points will be monitored too. Ethics and dissemination Ethics approval for this study has been obtained from the Ethics Committee, Peking Union Medical College Hospital, China (Protocol number: S-572) Study results will be

  1. Safety Awareness in High Tech Operations.

    ERIC Educational Resources Information Center

    Stewart, Gordon L.

    1987-01-01

    The author introduces a simple three-step formula for teaching safety awareness in technology education classes and in industry. The steps are (1) understand the hazard, (2) recognize the defense, and (3) act in time. (CH)

  2. Safety Precautions in Fiber Arts.

    ERIC Educational Resources Information Center

    Hamilton, Marcia

    1979-01-01

    The author discusses the potential hazards of working with fibers, dyes, and wax in textile art projects: bacteria, dust, poisons, allergies, and fumes. Safety precautions for working with dyes are listed. This article is one of seven in this issue on fiber arts. (SJL)

  3. Physicians Experience with and Expectations of the Safety and Tolerability of WHO-Step III Opioids for Chronic (Low) Back Pain: Post Hoc Analysis of Data from a German Cross-Sectional Physician Survey

    PubMed Central

    Ueberall, Michael A.; Eberhardt, Alice; Mueller-Schwefe, Gerhard H. H.

    2015-01-01

    Objective. To describe physicians' daily life experience with WHO-step III opioids in the treatment of chronic (low) back pain (CLBP). Methods. Post hoc analysis of data from a cross-sectional online survey with 4.283 Germany physicians. Results. With a reported median use in 17% of affected patients, WHO-step III opioids play a minor role in treatment of CLBP in daily practice associated with a broad spectrum of positive and negative effects. If prescribed, potent opioids were reported to show clinically relevant effects (such as ≥50% pain relief) in approximately 3 of 4 patients (median 72%). Analgesic effects reported are frequently related with adverse events (AEs). Only 20% of patients were reported to remain free of any AE. Most frequently reported AE was constipation (50%), also graded highest for AE-related daily life restrictions (median 46%). Specific AE countermeasures were reported to be necessary in approximately half of patients (median 45%); nevertheless AE-related premature discontinuation rates reported were high (median 22%). Fentanyl/morphine were the most/least prevalently prescribed potent opioids mentioned (median 20 versus 8%). Conclusion. Overall, use of WHO-step III opioids for CLBP is low. AEs, especially constipation, are commonly reported and interfere significantly with analgesic effects in daily practice. Nevertheless, beneficial effects outweigh related AEs in most patients with CLBP. PMID:26568890

  4. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    PubMed

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

  5. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    PubMed

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management. PMID:25374273

  6. Safety harness

    DOEpatents

    Gunter, Larry W.

    1993-01-01

    A safety harness to be worn by a worker, especially a worker wearing a plastic suit thereunder for protection in a radioactive or chemically hostile environment, which safety harness comprises a torso surrounding portion with at least one horizontal strap for adjustably securing the harness about the torso, two vertical shoulder straps with rings just forward of the of the peak of the shoulders for attaching a life-line and a pair of adjustable leg supporting straps releasibly attachable to the torso surrounding portion. In the event of a fall, the weight of the worker, when his fall is broken and he is suspended from the rings with his body angled slightly back and chest up, will be borne by the portion of the leg straps behind his buttocks rather than between his legs. Furthermore, the supporting straps do not restrict the air supplied through hoses into his suit when so suspended.

  7. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Safety areas. 139.309 Section 139.309... Operations § 139.309 Safety areas. (a) In a manner authorized by the Administrator, each certificate holder must provide and maintain, for each runway and taxiway that is available for air carrier use, a...

  8. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Safety areas. 139.309 Section 139.309... Operations § 139.309 Safety areas. (a) In a manner authorized by the Administrator, each certificate holder must provide and maintain, for each runway and taxiway that is available for air carrier use, a...

  9. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Safety areas. 139.309 Section 139.309... Operations § 139.309 Safety areas. (a) In a manner authorized by the Administrator, each certificate holder must provide and maintain, for each runway and taxiway that is available for air carrier use, a...

  10. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Safety areas. 139.309 Section 139.309... Operations § 139.309 Safety areas. (a) In a manner authorized by the Administrator, each certificate holder must provide and maintain, for each runway and taxiway that is available for air carrier use, a...

  11. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Safety areas. 139.309 Section 139.309... Operations § 139.309 Safety areas. (a) In a manner authorized by the Administrator, each certificate holder... area of at least the dimensions that— (1) Existed on December 31, 1987, if the runway or taxiway had...

  12. Good Practices Guide for Bicycle Safety Education.

    ERIC Educational Resources Information Center

    Department of Transportation, Washington, DC.

    The purpose of this guide is to serve as an informational resource for educators and other interested professionals in planning and developing bicycle safety education programs. The guide examines 15 existing bicycle safety education programs in the United States and one from Canada. (Author)

  13. Defining Intellectual Safety in the College Classroom

    ERIC Educational Resources Information Center

    Call, Carolyne M.

    2007-01-01

    The author investigated college students' perceptions of intellectual safety by posing research questions designed to elicit a definition of intellectual safety and the elements needed to create an intellectually safe environment. Participants included undergraduate and graduate students drawn from three institutions. All students filled out a…

  14. 30 CFR 7.310 - Post-approval product audit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Post-approval product audit. 7.310 Section 7.310 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION... Post-approval product audit. Upon request by MSHA but not more than once a year, except for cause,...

  15. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 8 2011-07-01 2011-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Post-dive procedures. Note: The requirements applicable to construction work under this section...

  16. 30 CFR 7.410 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 7.410 Section 7.410 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION..., and Cable Splice Kits § 7.410 Post-approval product audit. Upon request by MSHA, but no more than...

  17. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 8 2010-07-01 2010-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Post-dive procedures. Note: The requirements applicable to construction work under this section...

  18. 30 CFR 7.310 - Post-approval product audit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 7.310 Section 7.310 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION... Post-approval product audit. Upon request by MSHA but not more than once a year, except for cause,...

  19. 30 CFR 7.410 - Post-approval product audit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Post-approval product audit. 7.410 Section 7.410 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION..., and Cable Splice Kits § 7.410 Post-approval product audit. Upon request by MSHA, but no more than...

  20. 30 CFR 7.310 - Post-approval product audit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Post-approval product audit. 7.310 Section 7.310 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION... Post-approval product audit. Upon request by MSHA but not more than once a year, except for cause,...

  1. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 8 2014-07-01 2014-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Post-dive procedures. Note: The requirements applicable to construction work under this section...

  2. 30 CFR 7.30 - Post-approval product audit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Post-approval product audit. 7.30 Section 7.30 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND....30 Post-approval product audit. Upon request by MSHA but no more than once a year except for...

  3. 30 CFR 7.30 - Post-approval product audit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Post-approval product audit. 7.30 Section 7.30 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND....30 Post-approval product audit. Upon request by MSHA but no more than once a year except for...

  4. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Post-approval product audit. 7.8 Section 7.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.8 Post-approval product...

  5. 30 CFR 7.410 - Post-approval product audit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Post-approval product audit. 7.410 Section 7.410 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION..., and Cable Splice Kits § 7.410 Post-approval product audit. Upon request by MSHA, but no more than...

  6. 30 CFR 7.30 - Post-approval product audit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Post-approval product audit. 7.30 Section 7.30 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND....30 Post-approval product audit. Upon request by MSHA but no more than once a year except for...

  7. 30 CFR 7.310 - Post-approval product audit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Post-approval product audit. 7.310 Section 7.310 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION... Post-approval product audit. Upon request by MSHA but not more than once a year, except for cause,...

  8. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 7.8 Section 7.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.8 Post-approval product...

  9. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Post-approval product audit. 7.8 Section 7.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.8 Post-approval product...

  10. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Post-approval product audit. 7.8 Section 7.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.8 Post-approval product...

  11. 30 CFR 7.310 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 7.310 Section 7.310 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION... Post-approval product audit. Upon request by MSHA but not more than once a year, except for cause,...

  12. 29 CFR 1910.423 - Post-dive procedures.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 5 2014-07-01 2014-07-01 false Post-dive procedures. 1910.423 Section 1910.423 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Post-dive procedures. (a) General. The employer shall comply with the following requirements which...

  13. 30 CFR 7.410 - Post-approval product audit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 7.410 Section 7.410 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION..., and Cable Splice Kits § 7.410 Post-approval product audit. Upon request by MSHA, but no more than...

  14. 30 CFR 7.410 - Post-approval product audit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Post-approval product audit. 7.410 Section 7.410 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION..., and Cable Splice Kits § 7.410 Post-approval product audit. Upon request by MSHA, but no more than...

  15. 30 CFR 7.30 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 7.30 Section 7.30 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND....30 Post-approval product audit. Upon request by MSHA but no more than once a year except for...

  16. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 7.8 Section 7.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.8 Post-approval product...

  17. 30 CFR 7.30 - Post-approval product audit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 7.30 Section 7.30 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND....30 Post-approval product audit. Upon request by MSHA but no more than once a year except for...

  18. 29 CFR 1910.423 - Post-dive procedures.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 5 2012-07-01 2012-07-01 false Post-dive procedures. 1910.423 Section 1910.423 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Post-dive procedures. (a) General. The employer shall comply with the following requirements which...

  19. 47 CFR 87.103 - Posting station license.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Posting station license. 87.103 Section 87.103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Operating Requirements and Procedures Operating Procedures § 87.103 Posting station license. (a) Stations...

  20. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  1. 47 CFR 90.437 - Posting station licenses.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Posting station licenses. 90.437 Section 90.437 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Operating Requirements § 90.437 Posting station licenses. (a) The current...

  2. 30 CFR 57.5045 - Posting of inactive workings.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting of inactive workings. 57.5045 Section 57.5045 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Posting of inactive workings. Inactive workings in which radon daughter concentrations are above 1.0...

  3. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  4. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  5. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  6. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  7. Safety valve

    DOEpatents

    Bergman, Ulf C.

    1984-01-01

    The safety valve contains a resilient gland to be held between a valve seat and a valve member and is secured to the valve member by a sleeve surrounding the end of the valve member adjacent to the valve seat. The sleeve is movable relative to the valve member through a limited axial distance and a gap exists between said valve member and said sleeve.

  8. Becoming Co-Authors: Toward Sharing Authority in Religious Education

    ERIC Educational Resources Information Center

    Kim, Hyun-Sook

    2009-01-01

    This article offers an alternative model, the model of shared authority, to the traditional, authoritarian model for authority and obedience for Religious Education. This model moves away from the authoritarian model of a teacher as the authority and the students as obedient listeners in the direction of a shared authority model in which teachers…

  9. 16 CFR 1105.8 - Costs must be authorized and incurred.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Costs must be authorized and incurred. 1105.8 Section 1105.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CONTRIBUTIONS TO COSTS OF PARTICIPANTS IN DEVELOPMENT OF CONSUMER PRODUCT SAFETY STANDARDS §...

  10. The Next Generation of Post-placement and Post-adoption Services: A Complementary Contract Approach.

    ERIC Educational Resources Information Center

    Burnell, Alan; Briggs, Adrian

    1995-01-01

    Discusses postplacement adoption service contracts between East Sussex Social Services and the Post-Adoption Centre (PAC). Describes how PAC originally provided subscription services to local authorities, but when limitations of the subscription service were recognized, a collaborative service with more local authority was developed. (AJH)

  11. 22 CFR 211.8 - Disposition of commodities unfit for authorized use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... discharge port or point of entry overseas, USAID or the Diplomatic Post shall immediately arrange for... Diplomatic Post from the sales proceeds, from CCC Account No. 20FT401 or from the special title II, Public... approved by USAID or the Diplomatic Post. If no competent local authority is available, USAID or...

  12. Solid waste burial grounds interim safety analysis

    SciTech Connect

    Saito, G.H.

    1994-10-01

    This Interim Safety Analysis document supports the authorization basis for the interim operation and restrictions on interim operations for the near-surface land disposal of solid waste in the Solid Waste Burial Grounds. The Solid Waste Burial Grounds Interim Safety Basis supports the upgrade progress for the safety analysis report and the technical safety requirements for the operations in the Solid Waste Burial Grounds. Accident safety analysis scenarios have been analyzed based on the significant events identified in the preliminary hazards analysis. The interim safety analysis provides an evaluation of the operations in the Solid Waste Burial Grounds to determine if the radiological and hazardous material exposures will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, the public, and the environment.

  13. Safety and Efficacy of At-Home Robotic Locomotion Therapy in Individuals with Chronic Incomplete Spinal Cord Injury: A Prospective, Pre-Post Intervention, Proof-of-Concept Study

    PubMed Central

    Rupp, Rüdiger; Schließmann, Daniel; Plewa, Harry; Schuld, Christian; Gerner, Hans Jürgen; Weidner, Norbert; Hofer, Eberhard P.; Knestel, Markus

    2015-01-01

    Background The compact Motorized orthosis for home rehabilitation of Gait (MoreGait) was developed for continuation of locomotion training at home. MoreGait generates afferent stimuli of walking with the user in a semi-supine position and provides feedback about deviations from the reference walking pattern. Objective Prospective, pre-post intervention, proof-of-concept study to test the feasibility of an unsupervised home-based application of five MoreGait prototypes in subjects with incomplete spinal cord injury (iSCI). Methods Twenty-five (5 tetraplegia, 20 paraplegia) participants with chronic (mean time since injury: 5.8 ± 5.4 (standard deviation, SD) years) sensorimotor iSCI (7 ASIA Impairment Scale (AIS) C, 18 AIS D; Walking Index for Spinal Cord Injury (WISCI II): Interquartile range 9 to 16) completed the training (45 minutes / day, at least 4 days / week, 8 weeks). Baseline status was documented 4 and 2 weeks before and at training onset. Training effects were assessed after 4 and 8 weeks of therapy. Results After therapy, 9 of 25 study participants improved with respect to the dependency on walking aids assessed by the WISCI II. For all individuals, the short-distance walking velocity measured by the 10-Meter Walk Test showed significant improvements compared to baseline (100%) for both self-selected (Mean 139.4% ± 35.5% (SD)) and maximum (Mean 143.1% ± 40.6% (SD)) speed conditions as well as the endurance estimated with the six-minute walk test (Mean 166.6% ± 72.1% (SD)). One device-related adverse event (pressure sore on the big toe) occurred in over 800 training sessions. Conclusions Home-based robotic locomotion training with MoreGait is feasible and safe. The magnitude of functional improvements achieved by MoreGait in individuals with iSCI is well within the range of complex locomotion robots used in hospitals. Thus, unsupervised MoreGait training potentially represents an option to prolong effective training aiming at recovery of locomotor

  14. Scientific and Artistic Authority

    NASA Astrophysics Data System (ADS)

    Eriksson, S. C.

    2012-12-01

    The differences and similarities between science and art are commonly discussed in various disciplines, e.g. collective versus individual, truth versus imagination, fact versus fiction, and more. Both art and science involve communication. Both artists and scientists have responsibilities of integrity in the arena of intellectual property. However, an artist has a primary responsibility to his/her personal artistic vision and craft. A scientist has a very clearly defined responsibility to scientific method as a collective practice, i.e. generally accepted scientific knowledge, norms of data collection and analysis as well as norms of communication. In presenting a work of art to an audience, it is accepted that different people will interpret the art through different lens. In science communication, we hope that the audience's understanding is in line with scientific interpretation. When science and art meet, how do we come to an understanding of what the intended message should be and how it should or must be received. Accuracy in fact is important in science, as is accuracy of the message whether it is a process, model, image or story. How do we mediate this tension in collaborative projects? How do we celebrate the artistic nature of an artwork based on science when there is tension between the artistic merit and the scientific content? Authority of the artist, scientist, and organization must be satisfied.

  15. Safety and Liability.

    ERIC Educational Resources Information Center

    Berthelot, Ronald J.; And Others

    1982-01-01

    This series of five articles highlights Pensacola Junior College's occupational safety course, involving simulated emergencies, Florida's standards for teacher liability, electrical safety in the classroom and laboratory, color coding for machine safety, and Florida industrial arts safety instructional materials. (SK)

  16. A Product Safety Primer

    ERIC Educational Resources Information Center

    Brown, Mary Anne Symons

    1975-01-01

    The article offers an overview of the product safety issue and offers ideas for helping students develop product safety awareness. The role of the Consumer Product Safety Commission and safety legislation are discussed. (MW)

  17. 75 FR 38603 - State Responsibility for the Timely Reporting and Posting of Certain Convictions and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... Federal Motor Carrier Safety Administration State Responsibility for the Timely Reporting and Posting of... and posting of convictions for traffic offenses. This action is in response to the Department of... to ensuring highway safety. On July 31, 2002, FMCSA published a final rule (67 FR 49761)...

  18. AFR-100 safety analyses

    SciTech Connect

    Sumner, T.; Moisseytsev, A.; Wei, T. Y. C.

    2012-07-01

    The Advanced Fast Reactor-100 (AFR-100) is Argonne National Laboratory's 250 MWth metal-fueled modular sodium-cooled pool-type fast reactor concept. [1] A series of accident sequences that focused on the AFR-100's ability to provide protection against reactor damage during low probability accident sequences resulting from multiple equipment failures were examined. Protected and Unprotected Loss of Flow (PLOF and ULOF) and Unprotected Transient Over-Power (UTOP) accidents were simulated using the SAS4A/SASSYS-1 safety analysis code. The large heat capacity of the sodium in the pool-type reactor allows the AFR-100 to absorb large amounts of energy during a PLOF with relatively small temperature increases throughout the system. During a ULOF with a 25-second flow halving time, coolant and cladding temperatures peak around 720 deg. C within the first minute before reactivity feedback effects decrease power to match the flow. Core radial expansion and fuel Doppler provide the necessary feedback during the UTOP to bring the system back to critical before system temperatures exceed allowable limits. Simulation results indicate that adequate ULOF safety margins exist for the AFR-100 design with flow halving times of twenty-five seconds. Significant safety margins are maintained for PLOF accidents as well as UTOP accidents if a rod stop is used. (authors)

  19. Microbiological safety of water.

    PubMed

    Dawson, D J; Sartory, D P

    2000-01-01

    Significant advances in water treatment over the last century have resulted in massive improvements in the microbiological safety of public drinking water supplies in the UK and the developed countries. Incidences of illness due to poor treatment or post-treatment contamination are rare, but when they occur tend to attract considerable media attention. A well managed water treatment works and supply system can provide high quality drinking water wherever in the world it is located. As a rule, throughout the world, private supplies tend to be of a poorer quality than public supplies, but poorly managed public supplies have the potential to make a large number of people ill and continued effort is needed to maintain and improve drinking water quality world-wide.

  20. Safety Grooving

    NASA Technical Reports Server (NTRS)

    1985-01-01

    Safety grooving, the cutting of grooves in concrete to increase traction and prevent injury, was first developed to reduce aircraft accidents on wet runways. Represented by the International Grooving and Grinding Association (IG&GA), the industry expanded into highway and pedestrian applications. The technique originated at Langley, which assisted in testing the grooving at airports and on highways. Skidding was reduced, stopping distance decreased, and a vehicle's cornering ability on curves was increased. The process has been extended to animal holding pens, steps, parking lots and other potentially slippery surfaces.