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. CRITICALITY SAFETY POSTING GUIDELINES

    SciTech Connect

    JENSEN, M.A.

    2001-11-01

    This document provides a set of guidelines in the preparation of criticality safety postings. Guidance is provided in word choice, word arrangement, common human factors considerations. and use of color to highlight limits, cautions, and permissives.

  3. 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

  4. 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. PMID:21829787

  5. Training in Post-authorization Pharmacovigilance

    PubMed Central

    Ahuja, Vivek; Sharma, Varun

    2010-01-01

    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. PMID:21829787

  6. 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)…

  7. 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...

  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, 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...

  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, 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...

  13. 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...

  14. 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...

  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, 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  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. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 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...

  3. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 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...

  4. 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.

  5. [Recommendations for inspections of the French nuclear safety authority].

    PubMed

    Rousse, C; Chauvet, B

    2015-10-01

    The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. PMID:26321685

  6. DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

    SciTech Connect

    D. A. MC CLURE; C. A. NELSON; R. L. BOUDRIE

    2001-04-01

    This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamos National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety.

  7. 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.

  8. [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

  9. 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.

  10. Evolution of safety-critical requirements post-launch

    NASA Technical Reports Server (NTRS)

    Lutz, R. R.; Mikulski, I. C.

    2001-01-01

    This paper reports the results of a small study of requirements changes to the onboard software of three spacecraft subsequent to launch. Only those requirement changes that resulted from post-launch anoma-lies (i.e., during operations) were of interest here, since the goal was to better understand the relation-ship between critical anomalies during operations and how safety-critical requirements evolve. The results of the study were surprising in that anomaly-driven, post-launch requirements changes were rarely due to previous requirements having been incorrect. Instead, changes involved new requirements (1) for the software to handle rare events or (2) for the software to compensate for hardware failures or limitations. The prevalence of new requirements as a result of post-launch anomalies suggests a need for increased requirements-engineering support of maintenance activities in these systems. The results also confirm both the difficulty and the benefits of pursuing requirements completeness, especially in terms of fault tolerance, during development of critical systems.

  11. 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...

  12. 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.

  13. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE...

  14. 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

  15. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... limited to the standards for financial management systems required under 49 CFR 18.20; (8) Ensure that all... highway safety grant funds are conducted; (9) Track and maintain current knowledge of changes in State... 23 Highways 1 2014-04-01 2014-04-01 false State Highway Safety Agency-Authority and...

  16. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... limited to the standards for financial management systems required under 49 CFR 18.20; (8) Ensure that all... highway safety grant funds are conducted; (9) Track and maintain current knowledge of changes in State... 23 Highways 1 2013-04-01 2013-04-01 false State Highway Safety Agency-Authority and...

  17. 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...

  18. 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.

  19. 77 FR 28566 - Notice of Request for a New Information Collection (Food Safety Education Campaign-Post-Wave...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    ... Collection (Food Safety Education Campaign--Post-Wave Tracking Survey) AGENCY: Food Safety and Inspection... tracking survey associated with the Food Safety Education Campaign. The post-wave survey is conducted after.... SUPPLEMENTARY INFORMATION: Title: Food Safety Education Campaign Post-Wave Tracking Survey. Type of Request:...

  20. 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.

  1. [Post-marketing drug safety measures for the attainment of safer and more effective use of drug].

    PubMed

    Kurokawa, Tatsuo

    2011-01-01

    In contrast with the 20th century's dramatic improvements in the direct and/or hazardous toxicity of drugs, indirect toxicity and/or long-term safety concerns such as relation of cancer risk and TNF-alpha receptor blockers have caused significant complexity in post-marketing surveillance (PMS) scenery. The post-marketing phase of drugs and their safety measures now appear to be much more complicated and heavier than decades ago. The spontaneous adverse drug reaction (ADR) reporting system which has been one of the main pillars of PMS measures for almost 50 years may have to be reviewed in terms of its effectiveness, and may need augmentation from medical data bases. Only a pharmaco-epidemiological analysis and integration of the output with a conventional spontaneous reporting approach offers a chance to satisfy the current complex safety issues. Today's tendency toward practical saturation at medical/pharmaceutical frontiers, by regulatory authorities and safety divisions of pharmaceutical companies with ever-increasing day-to-day safety information can also be pointed out. Such phenomena may actually reduce the productivity of safety measures and also jeopardize the maintenance of an acceptable risk/benefit drug ratio. To alleviate these potential negative implications, establishment of a consortium to act as a sentinel that would gather up-to-date and essential safety information, including epidemiological data, from all sources and provide it plus recommendations to all stakeholders can be suggested. Through such activities, we could expect significant improvement of drug safety measures in post-marketing phase which would effectively cover not only new drugs but also generic and bio-simulated drugs. PMID:21628973

  2. Knowledge and practices of a control authority: impact on the environment and food safety.

    PubMed

    Toh, Poh See

    2002-12-01

    This study investigates the practices and knowledge of a Control Authority dealing with the environment and the safety and control of hawker foods. Experience and background education are used as likely determinants of food safety practices and knowledge of the control authority. A total of 60 questionnaires were distributed to the Health Inspectors (HIs) in the Hawkers' and Health Departments, City Hall, Kuala Lumpur. The return rate was 93%. The structured questionnaire contained 14 main food safety practices and knowledge constructs. Significance was found pertaining to knowledge of HIs with different experience backgrounds but experience was not demonstrated to impact on practices of HIs. However, education was noted to have significantly but inconsistently influenced certain Practices and Knowledge scores of HIs. A Pearson bivariate coefficient characterised an association between food safety practices and knowledge of the control authority. The findings: (1) highlight the actual shortcomings in the staff resources relating to environmental health, food safety, foodborne illnesses and their control, and (2) provide information on the control aspect within the hawker micro-industry with the view of protecting the public from health hazards arising from the hawkers' practices and consumption of hawker foods. PMID:12596745

  3. 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…

  4. Capacity for a global vaccine safety system: the perspective of national regulatory authorities.

    PubMed

    Graham, Janice E; Borda-Rodriguez, Alexander; Huzair, Farah; Zinck, Emily

    2012-07-13

    Confidence in vaccine safety is critical to national immunization strategies and to global public health. To meet the Millenium Development Goals, and buoyed by the success of new vaccines produced in developing countries, the World Health Organization has been developing a strategy to establish a global system for effective vaccine pharmacovigilance in all countries. This paper reports the findings of a qualitative survey, conducted for the WHO Global Vaccine Safety Blueprint project, on the perspectives of national regulatory authorities responsible for vaccine safety in manufacturing and procuring countries. Capacity and capabilities of detecting, reporting and responding to adverse events following immunization (AEFI), and expectations of minimum capacity necessary for vaccine pharmacovigilance were explored. Key barriers to establishing a functional national vaccine safety system in developing countries were identified. The lack of infrastructure, information technology for stable communications and data exchange, and human resources affect vaccine safety monitoring in developing countries. A persistent "fear of reporting" in several low and middle income countries due to insufficient training and insecure employment underlies a perceived lack of political will in many governments for vaccine pharmacovigilance. Regulators recommended standardized and internationally harmonized safety reporting forms, improved surveillance mechanisms, and a global network for access and exchange of safety data independent of industry. PMID:22658930

  5. 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.

  6. Rosuvastatin safety: lessons from the FDA review and post-approval surveillance.

    PubMed

    Davidson, Michael H

    2004-11-01

    Rosuvastatin is the first statin approved by the regulatory authorities since the withdrawal of cerivastatin. Although highly efficacious, this new statin has generated considerable controversy regarding its safety. Rosuvastatin was approved for clinical use based on the largest pre-approval database for all statins prior to commercial use. In this database, rosuvastatin had a similar safety profile to other approved statins up to the highest approval dose of 40 mg. As with all statins, there is a marked increase in adverse effects when the dose is titrated from 40 to 80 mg, and rosuvastatin demonstrates a similar dose/toxicity relationship. In the pre-approval data trials on 80 mg, there was a 1.0% (n = 16) incidence of myopathy and 7 patients developed rhabdomyolysis. However the post-marketing surveillance for rosuvastatin, there have been reports of rhabdomyolysis, but the incidence rate, when corrected for prescription utilisation, is similar to other statins following initial approval. PMID:15500414

  7. 41 CFR 302-9.140 - 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 upon my assignment to that post... post of duty upon my assignment to that post of duty? Your agency may authorize transportation of a POV to your post of duty when: (a) It has determined in accordance with § 302-9.503 that it is in...

  8. 41 CFR 302-9.504 - What factors must we consider in deciding whether to authorize transportation of a POV to a post...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... consider in deciding whether to authorize transportation of a POV to a post of duty? 302-9.504 Section 302... whether to authorize transportation of a POV to a post of duty? When deciding whether to authorize transportation of a POV to a post of duty, you must consider if: (a) Local conditions at the employee's post...

  9. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002 50.205-3 Authorization of offers contingent upon SAFETY Act designation or certification before... contingent upon SAFETY Act designation or certification before contract award. 50.205-3 Section...

  10. 48 CFR 50.205-4 - Authorization of awards made presuming SAFETY Act designation or certification after contract award.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002 50.205-4 Authorization of awards made presuming SAFETY Act designation or certification after... made presuming SAFETY Act designation or certification after contract award. 50.205-4 Section...

  11. 41 CFR 302-9.503 - Under what condition may we authorize transportation of a POV to a post of duty?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... employee to have use of a POV at the post of duty. Effective Date Note: By FTR Amdt. 2011-01, 76 FR 18342... we authorize transportation of a POV to a post of duty? 302-9.503 Section 302-9.503 Public Contracts... post of duty? You may authorize transportation of a POV to a post of duty only when you...

  12. 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...

  13. 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.

  14. 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.

  15. High convection volume in online post-dilution haemodiafiltration: relevance, safety and costs

    PubMed Central

    Mostovaya, Ira M.; Grooteman, Muriel P.C.; Basile, Carlo; Davenport, Andrew; de Roij van Zuijdewijn, Camiel L.M.; Wanner, Christoph; Nubé, Menso J.; Blankestijn, Peter J.

    2015-01-01

    Increasing evidence suggests that treatment with online post-dilution haemodiafiltration (HDF) improves clinical outcome in patients with end-stage kidney disease, if compared with haemodialysis (HD). Although the primary analyses of three large randomized controlled trials (RCTs) showed inconclusive results, post hoc analyses of these and previous observational studies comparing online post-dilution HDF with HD showed that the risk of overall and cardiovascular mortality is lowest in patients who are treated with high-volume HDF. As such, the magnitude of the convection volume seems crucial and can be considered as the ‘dose’ of HDF. In this narrative review, the relevance of high convection volume in online post-dilution HDF is discussed. In addition, we briefly touch upon some safety and cost issues. PMID:26251701

  16. Safe Physical Activity Environments--To What Extent Are Local Government Authorities Auditing the Safety of Grassed Sporting Grounds?

    ERIC Educational Resources Information Center

    Otago, Leonie; Swan, Peter; Donaldson, Alex; Payne, Warren; Finch, Caroline

    2009-01-01

    Physical activity (PA) participation is influenced by the safety of the settings in which it is undertaken. This study describes the grounds assessment practices of Local Government Authorities (LGAs) in Victoria, Australia to ensure the safety of grassed sporting grounds. It also makes recommendations for improving these practices to maximise the…

  17. [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

  18. 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. PMID:19603396

  19. 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

  20. GPs' compliance with health and safety legislation and their occupational health needs in one London health authority.

    PubMed Central

    Kennedy, Ioanna; Williams, Siân; Reynolds, Anne; Cockcroft, Anne; Solomon, Jack; Farrow, Stephen

    2002-01-01

    This survey assessed general practitioners' (GPs') knowledge of and compliance with, health and safety legislation and occupational health guidance in one London health authority. The response rate was 85%. Although the majority of practices were aware of the most important piece of legislation--The Management of Health and Safety at Work Regulations, 1992--less than one in ten practices had carried out the required systematic risk assessments. Compliance with other health and safety legislation and related employment issues was also poor. The health of GPs and their staff may be at risk and these general practices may be vulnerable to prosecution by the Health and Safety Executive. PMID:12236278

  1. 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... transportation of a POV to my post of duty subsequent to the time of my assignment to that post? Your agency...

  2. 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. PMID:22683835

  3. 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

  4. 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.

  5. 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

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

    PubMed Central

    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. PMID:24584134

  7. 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. PMID:24584134

  8. 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…

  9. 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…

  10. 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…

  11. [Night sleep patterns in post-operative intensive care patients (author's transl)].

    PubMed

    Landau-Ferey, J; Rebelo, F; Glaser, P; Garma, L

    1977-01-01

    5 patients admitted to intensive care following post-operative complications had EEG recordings on 2 consecutive nights some time after their operations. Study of the different sleep stages showed a marked increase in deep slow wave sleep and waking but asignificant reduction in light slow wave sleep and paradoxical sleep. The appearance of the sleep cycles through the night was unusual with respect to the maximum occurrence of the various stages and their evolution. Finally certain characteristics of paradoxical sleep, the rhythm and duration of the phases and the number and frequency of ocular movements were also modified. Comparison of these findings with those previously reported show that these abnormalities, rather than suggesting sleep deprivation resemble more closely the fidings in shift workers when they resume night sleep after a period of day sleep. The also resemble the changes seen in people whose circadian rhythm has been displaced by 12 hours. PMID:565525

  12. 41 CFR 302-9.204 - What is the “authorized point of origin” when I transport my POV from my post of duty?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Return Transportation of a POV From a Post of Duty § 302-9.204 What is the “authorized point of origin” when I transport my POV from my post of duty? The “authorized point of origin” when you transport your... point of originâ when I transport my POV from my post of duty? 302-9.204 Section 302-9.204...

  13. 41 CFR 302-9.204 - What is the “authorized point of origin” when I transport my POV from my post of duty?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Return Transportation of a POV From a Post of Duty § 302-9.204 What is the “authorized point of origin” when I transport my POV from my post of duty? The “authorized point of origin” when you transport your... point of originâ when I transport my POV from my post of duty? 302-9.204 Section 302-9.204...

  14. 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

  15. 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

  16. Attitudes and beliefs on the establishment of a national food safety authority in Cyprus. A population-based survey.

    PubMed

    Hadjigeorgiou, Andreas; Talias, Michael A; Soteriades, Elpidoforos S; Philalithis, Anastasios; Psaroulaki, Anna; Gikas, Achilleas; Tselentis, Yiannis

    2014-04-01

    Cyprus does not have a National Food Safety Authority (NFSA), but a multi-level, fragmented system with responsibilities divided among different ministries and governmental agencies, frequently impeding efforts to effectively manage food risks by duplication and overlapping of responsibilities. A population-based survey was carried out to determine the beliefs and attitudes of interested parties concerning the establishment of a NFSA in Cyprus. Information was collected using a random stratified sampling design and a structured questionnaire. A total of 868 questionnaires were collected (704 from regular consumers, 154 from food businesses' representatives, and 10 from public services' directors or acting head officers). About 11% of food businesses' representatives and 45% of consumers reported that they did not know which public authorities are responsible for food control. Moreover, 2 out of 10 (17%) of responders from public agencies, 70% from food businesses and 91% from consumers, although not aware of ongoing efforts to establish a food safety authority in Cyprus (currently under consideration), were supportive of the idea [8 out of 10 (83%) of responders from public services, 93% from food businesses, and 89% of consumers]. Finally, 7 out of 10 (67%) from the public agencies and 84% of representatives from food businesses agreed with the separation of risk assessment from risk management activities. Public opinion in Cyprus as well as public agencies and food businesses' representatives support the establishment of a single independent national food safety authority in Cyprus based on the European paradigm including the division of risk activities. PMID:24378621

  17. 77 FR 64374 - Notification of Petition for Approval; Port Authority Trans-Hudson Product Safety Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... a Product Safety Plan (PSP). FRA assigned the petition Docket Number FRA-2012-0075. PATH is... maintenance costs. PATH asserts that the PSP demonstrates that Digicode has been designed in a highly safe... Train Control Systems. The PSP itself provides the detailed description of the Digicode track...

  18. 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. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26561330

  19. 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.

  20. 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.

  1. 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

  2. [Weighing use and safety of therapeutic agents and feed additives (author's transl)].

    PubMed

    van der Wal, P

    1982-02-01

    (1) The pros and cons of using feed additives and therapeutic agents may be successfully weighed in the light of carefully considered consumer requirements. (2) The socio-economic interests of the producer and the welfare of the animal will also determine the response of the production apparatus to consumer requirements. (3) Consumption of the current amounts of products of animal origin and maintenance of price and quality will only be feasible in the event of rational large-scale production in which constituents used in nutrition, prophylaxis and therapeutics are highly important factors. (4) Using these ingredients should be preceded by accurate evaluation of their use and safety. Testing facilities, conduct of studies and reporting should be such as to make the results nationally and internationally acceptable to all those concerned. (5) In deciding whether feed constituents are acceptable in view of the established use and safety, compliance will have to be sought with those standards which are accepted in other fields of society. Measures which result in raising the price of food without actually helping to reduce the risks to the safety of man, animals and environment, are likely to be rejected by any well-informed consumer who is aware of the facts. (6) For accurate weighing of use and safety at a national level, possibilities are hardly adequate in Europe. Decisions reached within the framework of the European Community, also tuned to U.S.A.- conditions are rightly encouraged. A centrally managed professionally staffed and equipped test system in the European Community would appear to be indispensable. PMID:7058519

  3. 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

  4. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... chapter. (b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of... training requirements of Subparts D through H of this part. (2) Physicians, dentists, or podiatrists... H of this part. (3) Physicians, dentists, or podiatrists who used only...

  5. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... chapter. (b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of... training requirements of Subparts D through H of this part. (2) Physicians, dentists, or podiatrists... H of this part. (3) Physicians, dentists, or podiatrists who used only...

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. The new structure and contents of employers' juridical responsibility for workers' health and safety in the post-industrial system.

    PubMed

    Ichino, P

    2006-01-01

    1. The enlargement of the labour law application area in the post-industrial system. 2. The enormous growth of differences in productivity between workers and its consequences on the employer's safety obligation. 3. Depressive disorders as a typical professional risk in the post-industrial system and the employer's prevention responsibility. 4. Harassment in the work-place as a typical pathologic consequence of the de-standardization of jobs. The specific employer's prevention responsibility in this field. 5. A conclusive remark. PMID:17017355

  13. Safety and Efficacy of Zonisamide in Patients with Epilepsy: A Post-Marketing Surveillance Study

    PubMed Central

    Lee, Hye Jin; Son, Jeong Min; Mun, Jihee; Kim, Dong Wook

    2015-01-01

    Background and Purpose: Zonisamide (ZNS) is one of new antiepileptic drug, which is known to inhibit seizure through multiple mechanisms of action. In Korea, ZNS was approved as an antiepileptic drug in 1992 and has been used for epilepsy patients with partial and generalized seizures. The objective of this study was to investigate the efficacy and tolerability of ZNS in patients with epilepsy and to identify the incidence of adverse events in real clinical setting. Methods: This study was carried out in patients who received ZNS for epilepsy. Patients who were observed for at least 12 weeks after treatment with ZNS were included as evaluable subjects. Information regarding the status and type of adverse events occurring during the course of treatment with ZNS was obtained regardless of causal relationship to ZNS and efficacy was assessed by the study physicians and patients at 12 weeks post dose of ZNS. Results: A total of 1,948 patients were included in the study, and ZNS efficacy was evaluated in 1,744 patients. ZNS was used as a monotherapy in 1,095 patients and as an adjunctive drug in 853 patients. Of the total patients, 1,345 (69.1%) patients had partial seizure, 563 patients had generalized seizure, and 40 patients were undetermined. Adverse events were reported in 65 patients (3.34%) including 1 case of Stevens-Johnson syndrome, but no incidence of serious unexpected adverse drug reactions were reported. 755 patients (43.29%) became seizure free with ZNS treatment, and additional 322 patients (18.41%) experienced marked improvement with ZNS treatment. Conclusions: Our study shows the safety and tolerability of ZNS treatment in patients with epilepsy in real clinical setting. In addition, ZNS was found to be an effective option as a monotherapy or in patients with generalized seizure. PMID:26819941

  14. 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

  15. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.

    PubMed

    Roller, Sarah Taylor; Pippins, Raqiyyah R; Ngai, Jennifer W

    2009-01-01

    This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment. PMID:19999646

  16. 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

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL...

  17. [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

  18. 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.

  19. 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

  20. 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…

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

    PubMed

    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. PMID:25463615

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

    PubMed Central

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

    2014-01-01

    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. PMID:25463615

  3. Development of the preliminary procedure for a national nuclear safety authority staff acting during the PWR NPP accident

    SciTech Connect

    Kostadinov, V.

    1997-12-01

    We present the development of the new preliminary procedure for a National Nuclear Safety Authority staff preparedness for action in the case of a Pressurized Water Reactor Nuclear Power Plant accident. The procedures are generic and equally applicable for advanced nuclear plants. The basic goal of the procedure is systematic determination of the responsibilities of the staff expert group(s) members for accident analysis and consequences prediction. Moreover, the procedure describes anticipated practices of an expert group acting during a plant accident. Different sources will define the state(s) of the plant as: the plant form for initial notification of an accident, the particular form for specific plant information, etc. By this procedure we propose three expert groups successively to work up to eight hours each, in the circumstances of an accident. We suppose the expert group to have mostly five members each. The members should have different tasks for resolution, defined by the procedure. The head of the group will coordinate group members work during an accident. Group members have to be qualified and acquainted with all adequate references. In the paper we present a newly devised agenda with presumed duties of each member of the group. Furthermore, we also composed a special form for information exchange between the utility and regulatory staff member during an accident. 8 refs., 1 fig.

  4. Improving Post-Approval Drug Safety Surveillance: Getting Better Information Sooner

    PubMed Central

    Hennessy, Sean; Strom, Brian L.

    2015-01-01

    Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include establishment of government-sponsored networks of population databases, use of data mining approaches, and formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks, allowing earlier identification of risks as well as reassurance about the absence of specific risks. PMID:25292435

  5. 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…

  6. Epidural dexamethasone for post-operative analgesia in patients undergoing abdominal hysterectomy: A dose ranging and safety evaluation study

    PubMed Central

    Hefni, Amira Fathy; Mahmoud, Mohamed Sidky; Al Alim, Azza Atef Abd

    2014-01-01

    Aim: Number of studies revealed that epidural bupivacaine-dexamethasone has the same analgesic potency as bupivacaine-fentanyl with opioid sparing and antiemetic effects. Different doses of dexamethasone were used in different studies. This study was designed to evaluate the optimum dose of epidural dexamethasone for post-operative analgesia. Materials and Methods: In this double-blinded randomized controlled study, we evaluated the efficiency and safety of different doses of epidural dexamethasone for post-operative analgesia in 160 patients aged 45-60 years scheduled for total abdominal hysterectomy. Patient were randomly allocated into four groups to receive a total volume of 10 ml epidural plain bupivacaine 0.25% in the control group (Group D0) with either 4 mg dexamethasone in (Group D4) or 6 mg dexamethasone in (Group D6) or 8 mg dexamethasone in (Group D8). Patients then received general anesthesia. Sedation, satisfaction and visual analog pain scores (VAS) at rest and with effort were measured post-operatively. Meperidine was administered when VAS > or = 4. Intra-operative fentanyl dose, post-operative meperidine consumption and the time to first analgesic requirement were recorded by a blinded observer. Blood glucose was measured pre-operatively and at 4 h and 8 h after study drug administration. Wound healing and infection were assessed after 1 week. Results: Intraoperative fentanyl requirements were comparable among groups. The time to first analgesic requirement was significantly prolonged 5.5 times in D8 Group but only 1.5 times in D6 and D4 Groups more than the analgesic duration in the control Group D0, with a P < 0.01. There was a significant reduction in post-operative meperidine consumption during the first 24 h in the D8 (75%) in comparison with D6 and D4 Groups (50%), respectively, (P < 0.01) and the control Group D0 (0%) (P < 0.01). VAS scores were significantly lower and patient satisfaction score was significantly higher in the D8 and

  7. Safety and Immunogenicity of purified chick embryo cell rabies vaccine (VaxiRab N) administered intradermally as post exposure prophylaxis

    PubMed Central

    Ravish, Hardanahalli S; Vijayashankar, Veena; Madhusudana, Shampur N; Sudarshan, Mysore K; Narayana, Doddabele HA; Andanaiah, Gangaboraiah; Ashwin, Belludi Y; Rachana, Annadani R; Shamanna, Manjula

    2014-01-01

    The affordability to rabies vaccine for intramuscular administration in post exposure prophylaxis is a major constraint. Therefore, in countries, where there are financial constraints, World Health Organization recommends intradermal rabies vaccination that reduces the quantity and cost of vaccination. This study was done to evaluate the safety and immunogenicity of indigenously developed rabies vaccine (VaxiRab N) in comparison to a WHO recommended rabies vaccine (Rabipur) with demonstrated efficacy when administered by intradermal route using updated Thai Red Cross regimen. Eighty-six dog bite cases were randomly given either VaxiRab N (n = 43) or Rabipur (n = 43) as post exposure prophylaxis. The rabies virus neutralizing antibody concentrations on days 14, 28, 90, and 180 were tested by modified rapid fluorescent focus inhibition test. The geometric mean RVNA concentration of both the groups were compared using t- test and was found that, P value > 0.05 on all days, thus showing no significant difference between the 2 groups. The adverse drug events were also compared using Z-test and was found to be not statistically significant (Z = 1.476, P = 0.139). In conclusion, VaxiRab N was found to be safe and effective in post exposure prophylaxis by intradermal route and was similar to the WHO recommended rabies vaccine (Rabipur) of demonstrated efficacy. PMID:25424951

  8. 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

  9. 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. PMID:25171757

  10. Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators, Clinicians, and Patients.

    PubMed

    Baksh, Sheriza N; Gellad, Walid F; Alexander, G Caleb

    2016-05-01

    In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi(®)) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the unmet need of women with this disorder, extensive advocacy and politicization surrounding the product's relevance to women and sexual health, the potential for widespread off-label use, and the product's tenuous risk/benefit profile. Despite that, attention now shifts to maximizing the safe use of the product, including the optimal means to avoid numerous drug-drug interactions as well as the concomitant use of alcohol, both of which potentiate the risks of dizziness, hypotension, and syncope. Although the FDA has implemented a comprehensive Risk Evaluation and Mitigation Strategies program to maximize the product's safe use, patients, clinicians, and regulators must exhibit heightened vigilance early in the product's post-market life. PMID:26798050

  11. 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. PMID:16943136

  12. 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

  13. Efficacy and Safety of Paromomycin in Treatment of Post-Kala-Azar Dermal Leishmaniasis

    PubMed Central

    Sundar, Shyam; Singh, Anup; Tiwari, Anurag; Shukla, Saurabh; Chakravarty, Jaya; Rai, Madhukar

    2014-01-01

    Background. Post-kala-azar dermal leishmaniasis (PKDL) plays an important role in maintaining endemicity of visceral leishmaniasis and its transmission. Treatment regimens for PKDL are toxic and require 3-4 months of hospitalization. These long and arduous regimens result in extensive noncompliance. There is an urgent need to develop a safe, effective, and acceptable regimen for the treatment of PKDL. Paromomycin (PM) has been recently approved in India for treatment of visceral leishmaniasis (VL); hence we tested its efficacy in patients with PKDL. Methods. In this exploratory study, 31 patients with PKDL aged 10 years and above were administered PM 11 mg/kg daily intramuscularly for 45  days and followed up for one year. Results. Out of 31 patients, 7 patients were lost to followup at 1  year and 9 (37.5%) got cured with complete disappearance of lesion, while 15 (62.5%) showed no improvement by per protocol analysis. Conclusion. Cure rate with 45 intramuscular injections of PM was unacceptably low though there was no serious side effect of the drug. Whether paromomycin can be used in multidrug therapy to shorten the duration of treatment should be the next logical step for investigation.

  14. 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)

  15. Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

    PubMed Central

    Chambers, Christina D; Tutuncu, Zuhre N; Johnson, Diana; Jones, Kenneth L

    2006-01-01

    For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described. PMID:16774693

  16. [The control of radiation protection in the field of radiotherapy by the French Nuclear Safety Authority (ASN)].

    PubMed

    Godet, J-L

    2007-11-01

    During the last months, several incidents at radiotherapy services occurred in France; one of these accidents led to the death of several patients or required further heavy surgical acts. In this context, ASN (Autorité de sûreté nucléaire) issued an experimental guide for the notification of radiation protection events and achieved, in dialogue with professional organisations, a new scale intended to facilitate public information on radiotherapy incidents. ASN is also fully involved in the preparation of the action plan managed by the Health ministry in order to improve the safety of treatment in radiotherapy. PMID:17962062

  17. [Involvement of veterinary medicine in, and its responsibility for, the microbiological safety of foods of animal origin (author's transl)].

    PubMed

    Mossel, D A

    1977-02-01

    Epidemiological data indicate that, in the majority of outbreaks, the aetiology of diseases of microbial origin transmitted by foods is the "dual failure": poor sanitary handling in addition to storage of perishable items at temperatures allowing of microbial proliferation. For statistical reasons, sampling and examination of final products is completely ineffective as a means to obtain safe foods and meals. Dependable assurance of microbiological safety of foods should rather be attained by the application of Good Manufacturing Practices. The shared responsibility for reliable, uninterrupted preventive safeguarding of the food chain calls for cooperation between line workers of various disciplines. Microbiological examination of final product samples is still meaningful in order to monitor Good Manufacturing Practices. Reference values ("standards" with which data obtained can be compared are essential for this purpose. Theri establishment, based on product sample surveys of factories previously examined for reliable operation of approved procedures, is outlined. PMID:319560

  18. 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

  19. 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

    ... factory or other shipping point directly to my post of duty? 302-9.175 Section 302-9.175 Public Contracts... factory or other shipping point directly to my post of duty? Yes, you may have the manufacture or manufacture's agent transport a new POV from the factory or other shipping point to your post of duty...

  20. 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

    ... factory or other shipping point directly to my post of duty? 302-9.175 Section 302-9.175 Public Contracts... factory or other shipping point directly to my post of duty? Yes, you may have the manufacture or manufacture's agent transport a new POV from the factory or other shipping point to your post of duty...

  1. 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. PMID:17660718

  2. 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

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

    PubMed Central

    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

  4. 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

    ... factory or other shipping point directly to my post of duty? 302-9.175 Section 302-9.175 Public Contracts... transport a new POV from the factory or other shipping point directly to my post of duty? Yes, you may have the manufacture or manufacture's agent transport a new POV from the factory or other shipping point...

  5. 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

    ... factory or other shipping point directly to my post of duty? 302-9.175 Section 302-9.175 Public Contracts... transport a new POV from the factory or other shipping point directly to my post of duty? Yes, you may have the manufacture or manufacture's agent transport a new POV from the factory or other shipping point...

  6. 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

    ... factory or other shipping point directly to my post of duty? 302-9.175 Section 302-9.175 Public Contracts... transport a new POV from the factory or other shipping point directly to my post of duty? Yes, you may have the manufacture or manufacture's agent transport a new POV from the factory or other shipping point...

  7. 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

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false Under what specific... assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... Government, or assigned if you were a new appointee or student trainee, to your post of duty; and (f)...

  8. 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

  9. 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

    ... Evaluation Criteria for Non-North America-Domiciled Motor Carriers Appendix to Subpart H of Part 385... America-Domiciled Motor Carriers I. General (a) FMCSA will perform a safety audit of each non-North...-North America-domiciled carrier's basic safety management controls. (b) The safety audit is a review...

  10. 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...

  11. 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…

  12. "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…

  13. A Literature Review on the Efficacy and Safety of Botulinum Toxin: An Injection in Post-Stroke Spasticity

    PubMed Central

    Ghasemi, Majid; Salari, Mehri; Khorvash, Fariborz; Shaygannejad, Vahid

    2013-01-01

    Background: A variety of techniques for the management of spasticity have been suggested, including positioning, cryotherapy, splinting and casting, biofeedback, electrical stimulation, and medical management by pharmacological agents, Botulinum toxin A (BTA) is now the pharmacological treatment of choice in focal spasticity. BTA by blocking acetylcholine release at neuromuscular junctions accounts for its therapeutic action to relieve spasticity. Methods: A computerized search of Pub Med was carried out to find the latest result about efficacy of BTA in management of post stroke spasticity. Result: Among 84 articles were found, frothy of them included in this review and divided to lower and upper extremity. Conclusions: BTA is a treatment choice in reducing tone and managing post stroke spasticity . PMID:23776717

  14. 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

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false What is the âauthorized... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... student trainee Place of actual residence....

  15. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety.

    PubMed

    Liao, Xing; Robinson, Nicola

    2013-07-01

    Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, postmarketing surveillance (PMS) has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions (ADRs). Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines. PMID:23818200

  16. 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

  17. 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. PMID:11140712

  18. Safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use in post-exposure prophylaxis.

    PubMed

    Wang, Ling-yun; Sun, Mei-ping; Zhang, Xue-chun; Suo, Luo-dan; Xu, Ruo-hui; Zou, Yan-jie; Zuo, Li-bo; Qi, Hua

    2011-03-24

    To provide basis for human rabies vaccination in China, the safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use were assessed. A total of 250 volunteers were enrolled and divided into two groups: volunteers in Group A (n=200) were vaccinated five doses of Speeda Vero cell rabies vaccine manufactured by Liaoning Chengda Biotechnology Co. Ltd. on day 0, 3, 7, 14, 28 after exposure. Volunteers in Group B (n=50) were treated with Verorab Vero cell rabies vaccine manufactured by Sanofi Pasteur on the same schedule. The local and systematic adverse reactions were observed. Serum neutralizing antibody levels of 80 individuals in Group A and 50 individuals in Group B were tested with RFFIT on day 7, 14, 45, 180, 360 after the first dose. The seroconversion rates in Groups A and B were 40.3% and 37.0% on day 7 after the first dose, 95.5% and 97.7% on day 14, 100% and 100% on day 45, 100% and 100% on day 180, 89.1% and 89.5% on day 360 respectively, indicating no significant differences between the two groups. And no significant differences were found between the neutralizing antibody geometric mean titers (GMTs) of the two groups on day 7, 14, 45, 180 and 360 after the first dose, with the GMTs of day 14, 45, 180 and 360 all higher than 0.5IU/ml. Antibody levels of the two groups peaked around 2 weeks after the full vaccination program, followed by a 55% decrease up to day 180 and another 76% decrease up to day 360. Both groups experienced occasions of transient fever, rash, edema, and scleroma after vaccination. Neither group had any severe adverse reactions. It was concluded that both vaccines showed satisfactory safety and immunogenicity. Booster vaccination is recommended following another exposure after six months since the full vaccination program. PMID:21296694

  19. 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...

  20. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    PubMed Central

    Okada, Kenya; Sudo, Yohei; Itoh, Hiromichi; Yoshida, Hisao; Kuroda, Tatsuhiko

    2014-01-01

    Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7%) of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%). No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy. PMID:26770729

  1. 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

  2. Improvement of the safety of the red pepper spice with FMEA and post processing EWMA quality control charts.

    PubMed

    Ozilgen, Sibel; Bucak, Seyda; Ozilgen, Mustafa

    2013-06-01

    Although there are numerous decades-old studies drawing attention to the presence of aflatoxins in spices, and particularly in red pepper spice, the problem has not been eradicated. In the present study, information presented in the literature, about production method of red pepper spice, its contamination with aflatoxin, and the uncertainty about the data are assessed to find out the points where improvement may be achieved. Failure Mode and Effect Analysis (FMEA) are performed to assess the risk. The highest total risk attributable to chemical plus physical plus biological causes is associated with the washing stage (RPN=363), which is followed by the receiving (RPN=342) and the storage (RPN=342) stages. The highest risk attributable to biological causes (RPN=180) is associated with microbial growth and aflatoxin production due to insufficient control of drying conditions. The highest chemical risk (RPN=144) is found for the presence of unintentional food additives, such as pesticides, herbicides, hormones, and heavy metals in fresh red pepper fruits. EWMA (exponentially weighted average) charts are employed to monitor aflatoxin production during storage. They successfully distinguished between the batches, which turned to be unsafe. Risk associated with unintentional additives may be reduced by using certified additives only. Better drying control will definitely reduce the risk associated with the drying process. Codex Alimentarius plan has worldwide acceptance for assessing safety of the nuts. Risk of accepting the batches contaminated with aflatoxin may be eliminated by applying the Codex Alimentarius sampling plan before putting the dry pulverized red pepper into the storage facility. PMID:24425941

  3. 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

  4. Is it possible to "achieve a balance" and meet the "safety net"? Paediatric Advisory Subcommittee to the North West Thames Regional Health Authority.

    PubMed

    Jones, S A; Kovar, I; Williams, M; Bentley, D

    1989-09-30

    The government's document Hospital Medical Staffing--Achieving a Balance--Plan for Action introduced the concept of a "safety net"--that is, a minimum safe level of staffing--of junior doctors in the acute specialties. The North West Thames Paediatric Advisory Group has therefore reviewed the implications and consequences of implementing the safety net in respect of children's services. The group found that if a reasonable safety net was to be provided that enabled the services to stay within the projected junior staffing levels, maintain a balance, meet training needs, and reduce junior doctors' hours of work, then changes in the organisation of the services would be required. Examining the options available showed that to achieve a safety net within the projected numbers of junior staff at least six paediatric units in the region would have to close. It is doubtful if there is the political will to support the very radical changes that would be needed in the distribution of services if the government's recommendations in Achieving a Balance were to be implemented. The profession, the Department of Health, and the public must be made aware that the proposed changes in medical staffing will cause a fundamental change in the traditional pattern of delivery of health care. PMID:2510851

  5. Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative

    PubMed Central

    2015-01-01

    OBJECTIVE: To perform a quality assurance and performance improvement project through review of our single center data on the safety and patient acceptability of the stellate ganglion blockade (SGB) procedure for the relief of symptoms related to chronic post-traumatic stress disorder. BACKGROUND: Our interventional pain management service has been offering trials of SGB therapy to assist with the management of the sympathetically mediated anxiety and hyperarousal symptoms of severe and treatment-refractory combat-related PTSD. There have been multiple case series in the literature describing the potential impact of this procedure for PTSD symptom management as well as the safety of image-guided procedures. We wished to ensure that we were performing this procedure safely and that patients were tolerating and accepting of this adjunctive treatment option. METHODS: We conducted a review of our quality assurance and performance improvement data over the past 18 months during which we performed 250 stellate ganglion blocks for the management of PTSD symptoms to detect any potential complications or unanticipated side effects.  We also analyzed responses from an anonymous patient de-identified survey collected regarding the comfort and satisfaction associated with the procedure. RESULTS: We did not identify any immediate post-procedural complications or delayed complications from any of the 250 procedures performed from November 2013 to April 2015. Of the 110 surveys that were returned and tabulated, 100% of the patients surveyed were overall satisfied with our process and with the procedure, 100% said they would recommend the procedure to a friend, and 95% stated that they would be willing to undergo as many repeat procedures as necessary based on little discomfort and tolerable side effects. CONCLUSION: Our quality assurance assessment suggests that in our center the SGB procedure for PTSD is a safe, well-tolerated, and acceptable

  6. 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

  7. 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

    ... months. Recordable accident, as defined in 49 CFR 390.5, means an accident involving a commercial motor... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix...

  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. 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

  10. 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).

  11. Authoring Tools

    NASA Astrophysics Data System (ADS)

    Treviranus, Jutta

    Authoring tools that are accessible and that enable authors to produce accessible Web content play a critical role in web accessibility. Widespread use of authoring tools that comply to the W3C Authoring Tool Accessibility Guidelines (ATAG) would ensure that even authors who are neither knowledgeable about nor particularly motivated to produce accessible content do so by default. The principles and techniques of ATAG are discussed. Some examples of accessible authoring tools are described including authoring tool content management components such as TinyMCE. Considerations for creating an accessible collaborative environment are also covered. As part of providing accessible content, the debate between system-based personal optimization and one universally accessible site configuration is presented. The issues and potential solutions to address the accessibility crisis presented by the advent of rich internet applications are outlined. This challenge must be met to ensure that a large segment of the population is able to participate in the move toward the web as a two-way communication mechanism.

  12. 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…

  13. 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. PMID:26428349

  14. 49 CFR 198.11 - Grant authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 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. 23 CFR 1251.3 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 23 Highways 1 2011-04-01 2011-04-01 false Authority. 1251.3 Section 1251.3 Highways NATIONAL 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...

  16. 49 CFR 198.11 - Grant authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 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...

  17. 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...

  18. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    PubMed

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma. PMID:26704926

  19. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 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...

  20. Safety: An Attitude

    ERIC Educational Resources Information Center

    Smith, Harry T.

    1978-01-01

    Describes eight safety concepts developed by the author to teach safety and accident prevention in industrial arts shops and to promote more positive student attitudes toward shop safety. Stressing several general safety concepts instead of requiring dozens of rules has been found to work. (MF)

  1. 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…

  2. 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 ...

  3. 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 ...

  4. 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.

  5. Safety after cardiac catheterization.

    PubMed

    Huber, Charlotte

    2009-08-01

    The Pennsylvania Patient Safety Authority's reporting system is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, and birthing centers, as well as some abortion facilities, must file information on medical errors. Safety Monitor is a column from the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu. PMID:19641415

  6. 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…

  7. 48 CFR 23.105 - Exemption authority.

    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 23.105 Exemption authority. (a) The head of...

  8. Post and Lintel Architecture

    ERIC Educational Resources Information Center

    Daniel, Robert A.

    1973-01-01

    Author finds that children understand architectural concepts more readily when he refers to familiar non-architectural examples of them such as goal posts, chairs, tables, and playground equipment. (GB)

  9. 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…

  10. 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 ...

  11. 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...

  12. 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...

  13. 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

  14. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, Tennessee Valley Authority. Supplement number 20

    SciTech Connect

    1996-02-01

    This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), Supplement No. 14 (December 1994), Supplement No. 15 (June 1995), Supplement No. 16 (September 1995), Supplement No. 17 (October 1995), Supplement No. 18 (October 1995), and Supplement No. 19 (November 1995) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the issues identified in the SER.

  15. 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

  16. 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

  17. [Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS].

    PubMed

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Xu, Wen-fu

    2015-12-01

    This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety. PMID:27245015

  18. [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

  19. 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.

  20. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and... 10 Energy 2 2010-01-01 2010-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review...

  1. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types...

  2. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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…

  9. TWRS safety management plan

    SciTech Connect

    Popielarczyk, R.S., Westinghouse Hanford

    1996-08-01

    The Tank Waste Remediation System (TWRS) Safety Management Program Plan for development, implementation and maintenance of the tank farm authorization basis is described. The plan includes activities and procedures for: (a) Updating the current Interim Safety Basis, (b) Development,implementation and maintenance of a Basis for Interim Operations, (c) Development, implementation and maintenance of the Final Safety Analyses Report, (d) Development and implementation of a TWRS information Management System for monitoring the authorization basis.

  10. 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.

  11. Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen)

    PubMed Central

    Mahendra, BJ; Narayana, DH Ashwath; Agarkhedkar, Sharad; Ravish, HS; Harish, BR; Agarkhedkar, Shalaka; Madhusudana, SN; Belludi, Ashwin; Ahmed, Khaleel; Jonnalagedda, Rekha; Vakil, Hoshang; Bhusal, Chiranjiwi; Arora, Ashwani Kumar

    2015-01-01

    Despite availability of effective rabies vaccines, India has the highest global mortality rate for rabies. Low socio-economic communities are most affected due to lack of awareness of the disease and poor compliance to post-exposure prophylactic regimens. Currently, the only approved intramuscular regimen for post-exposure prophylaxis (PEP) against rabies in India is the Essen regimen, which consists of 5 injections administered over 5 separate days in a period of one month. The high number of doses and clinical visits, however, are major reasons for non-compliance, and thus a shorter regimen would be beneficial. In a simulated PEP trial in healthy, adult subjects, this study evaluated whether purified chick embryo cell vaccine (PCECV), administered according to the WHO-recommended 4-dose/3 visit Zagreb vaccination regimen is of equal immunogenicity and safety as the standard Essen regimen in Indian subjects. Two hundred and 50 healthy adults were enrolled and randomized into a Zagreb or Essen group, each receiving PCECV according to their respective regimen. Blood samples were collected on Days 0, 7, 14 and 42 and analyzed using the rapid fluorescent focus inhibition test (RFFIT). By Day 14, all subjects across both groups attained rabies virus neutralizing antibody (RVNA) concentrations of ≥ 0.5IU/ml. The Zagreb regimen was then demonstrated to be immunologically non-inferior to the Essen regimen by Day 14, which was the primary endpoint of the study. No safety issues were noted and the occurrence of adverse events was similar in both groups (17% and 15%, respectively). NCT01365494. CTRI No.: CTRI/2011/07/001857 PMID:25692792

  12. 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.

  13. A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India

    PubMed Central

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    Aim A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. Objectives Primary objective: 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). Secondary objective: 1. Clinical and procedural success. Materials and methods This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. Results MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Conclusion Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. PMID:25634405

  14. A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: results of over 3200 consecutive cases in post-marketing all-patient surveillance

    PubMed Central

    Akaza, Hideyuki; Oya, Mototsugu; Iijima, Masafumi; Hyodo, Ichinosuke; Gemma, Akihiko; Itoh, Hiroshi; Adachi, Masatoshi; Okayama, Yutaka; Sunaya, Toshiyuki; Inuyama, Lyo

    2015-01-01

    Objective Real-life safety and efficacy of sorafenib in advanced renal cell carcinoma in a nationwide patient population were evaluated by post-marketing all-patient surveillance. Methods All patients with unresectable or metastatic renal cell carcinoma in Japan who started sorafenib therapy from February 2008 to September 2009 were registered and followed for up to 12 months. Baseline characteristics, treatment status, tumor response, survival and safety data were recorded by the prescribing physicians. Results Safety and efficacy were evaluated in 3255 and 3171 patients, respectively. The initial daily dose was 800 mg in 78.2% of patients. Median duration of treatment was 6.7 months and the mean relative dose intensity was 68.4%. Overall, 2227 patients (68.4%) discontinued the treatment by 12 months, half of which (52.0% of discontinued patients) were due to adverse events. The most common adverse drug reactions were hand–foot skin reaction (59%), hypertension (36%), rash (25%) and increase in lipase/amylase (23%). The median progression-free survival was 7.3 months (95% confidence intervals: 6.7–8.1), and the overall survival rate at 1 year was 75.4% (73.5–77.1). Prognostic factors for overall survival were mostly consistent with those in previous clinical trials in the univariate analysis and largely similar to those for progression-free survival and duration of treatment in the multivariate analysis. Conclusions Sorafenib for the treatment of advanced renal cell carcinoma under the labeled dose was feasible in daily medical practice, for its acceptable toxicity profile and favorable clinical benefit that were consistent with those in clinical trials. PMID:26206897

  15. 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

  16. 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…

  17. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 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 being performed must be...

  18. 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...

  19. 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

  20. Post clamp

    NASA Technical Reports Server (NTRS)

    Ramsey, John K. (Inventor); Meyn, Erwin H. (Inventor)

    1990-01-01

    A pair of spaced collars are mounted at right angles on a clamp body by retaining rings which enable the collars to rotate with respect to the clamp body. Mounting posts extend through aligned holes in the collars and clamp body. Each collar can be clamped onto the inserted post while the clamp body remains free to rotate about the post and collar. The clamp body is selectively clamped onto each post.

  1. 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

  2. 48 CFR 50.202 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., Contracting Authority of Government Agencies in Connection with National Defense Functions. (d) 6 CFR Part 25. ... EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002 50.202 Authorities. The following authorities apply: (a) Support Anti-terrorism...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 48 CFR 50.101-1 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Authority. 50.101-1... EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Extraordinary Contractual Actions 50.101-1 Authority. (a... following agencies to exercise the authority conferred by Pub. L. 85-804 and to delegate it to...

  8. 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...

  9. 16 CFR 1500.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1500.2 Section 1500.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS § 1500.2 Authority. Authority under...

  10. 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...

  11. 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...

  12. 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...

  13. 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

  14. Clinical Efficacy and Safety of Pamidronate Therapy on Bone Mass Density in Early Post-Renal Transplant Period: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wang, Zijie; Han, Zhijian; Tao, Jun; Lu, Pei; Liu, Xuzhong; Wang, Jun; Wu, Bian; Huang, Zhengkai; Yin, Changjun; Tan, Ruoyun; Gu, Min

    2014-01-01

    Introduction The overall effect of pamidronate on bone mass density (BMD) in the early renal transplant period varies considerably among studies. The effects of pamidronate on graft function have not been determined. Materials and Methods A comprehensive search was conducted in PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL) and Embase independently by two authors. Randomized controlled trials of pamidronate evaluating bone loss in the first year of renal transplantation were included. Methods reported in the “Cochrane Handbook for Systematic Reviews of Interventions 5.0.2” were used to evaluate changes of lumbar spine and femoral neck BMD, and serum creatinine, calcium and intact parathyroid hormone (iPTH) levels. Fixed or random effect models were used as appropriate. Results Six randomized trials evaluating 281 patients were identified. One hundred forty-four were treated with pamidronate and 137 were control patients. Administration of pamidronate was associated with significant reduction of bone loss in the lumbar spine, compared to the control group (standardized mean difference (SMD)  = 24.62 [16.25, 32.99]). There was no difference between the pamidronate treated and control femoral neck BMD (SMD  = 3.53 [−1.84, 8.90]). A significant increase in the serum creatinine level of the intervention group was seen, compared to the control group. The serum calcium and iPTH of the pamidronate and control groups were not different after 1 year (serum creatinine: SMD  = −3.101 [−5.33, −0.89]; serum calcium: SMD  = 2.18 [−0.8, 5.16]; serum iPTH: SMD  = 0.06 [−0.19, 0.31]). Heterogeneity was low for serum calcium and iPTH and high for serum creatinine. Conclusions This meta-analysis demonstrated the beneficial clinical efficacy of pamidronate on BMD with no association with any alteration in graft function during the first year of renal transplantation. Significant heterogeneity precludes the conclusion of the

  15. 48 CFR 605.502 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PLANNING PUBLICIZING CONTRACT ACTIONS Paid Advertisements 605.502 Authority. (a) For paid advertisements in... the purposes of FAR 5.502(a). For acquisitions by overseas posts necessitating paid advertisements...

  16. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) regulations, Protection of Stratospheric Ozone (40 CFR Part 82). ... 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...

  17. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) regulations, Protection of Stratospheric Ozone (40 CFR Part 82). ... 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...

  18. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) regulations, Protection of Stratospheric Ozone (40 CFR Part 82). ... 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...

  19. 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)....

  20. 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)....

  1. 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)....

  2. 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....

  3. 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....

  4. Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis.

    PubMed

    Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko; Ishiguro, Naoki; Ryu, Junnosuke; Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Fujii, Koichi; Yoshinaga, Takunari; Freundlich, Bruce; Suzukawa, Michio

    2012-06-01

    The aim is to investigate the relationship of duration of rheumatoid arthritis (RA) with safety and effectiveness of etanercept (ETN) in Japan. Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. Baseline characteristics, treatment effectiveness, incidence of adverse events (AEs), and serious AEs (SAEs) in relation to duration of RA were studied. At baseline, patients with RA for longer duration were older, weighed less, had more comorbidities, allergies, and corticosteroid use, but smoked less and had less morning stiffness. By 2-5 years with RA, more than half of the patients had advanced to Steinbrocker radiographic stage III or IV. Methotrexate (MTX) was the most commonly used pre-treatment disease-modifying antirheumatic drug; however, concomitant MTX use and its dose were lower among patients with longer duration of RA. Remission rates (26.6%) were greatest among patients having RA for <2 years. Less AEs and SAEs were observed among patients with shorter duration of RA. These results suggest that RA treatment in Japan in the era pre-biologics may not have been adequate to control disease activity and prevent joint destruction. Patients with shorter duration of RA may have better physical status which allows the opportunity to treat more intensively putting a higher percentage of patients in remission and possibly decreasing exposure to SAEs. PMID:21327436

  5. 75 FR 55352 - Delegation of Authorities and Assignment of Responsibilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... section 18C are delegated and assigned to the Assistant Secretary for Occupational Safety and Health... to safety and health delegated to the Assistant Secretary for Occupational Safety and Health or the... Secretary for Occupational Safety and Health. The authority of the Administrator, WHD includes...

  6. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements for Ship Stations § 80.1103...

  7. Introduction to Safety

    ERIC Educational Resources Information Center

    Church, Ellen Booth

    2005-01-01

    This article discusses summertime safety activities for children. As children participate in the summer safety activities, they learn how to identify problems and communicate their ideas and feelings about potentially dangerous situations. They learn how to think through the problem and create solutions. The author presents a few ideas to go with…

  8. Schooling in a Post-Industrial Society

    ERIC Educational Resources Information Center

    Doll, William, E. Jr.

    1978-01-01

    Explores the coming post-industrial society for its possible effects on the education-schooling syndrome we now have. Emphasizes the sociological writings of the "father" of post-industrialism, Daniel Bell. (Author/RK)

  9. 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…

  10. 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)

  11. 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. PMID:26979136

  12. 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....

  13. 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....

  14. 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....

  15. 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....

  16. 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....

  17. 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...

  18. [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

  19. 77 FR 5577 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... 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... Occupational Safety and Health, authorized the preparation of this notice under the authority granted...

  20. 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...

  1. 49 CFR 374.503 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Authority. 374.503 Section 374.503 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Incidental Charter Rights § 374.503 Authority. Motor carriers transporting passengers, in interstate...

  2. 49 CFR 374.503 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Authority. 374.503 Section 374.503 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Incidental Charter Rights § 374.503 Authority. Motor carriers transporting passengers, in interstate...

  3. 47 CFR 95.1203 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1203 Section 95.1203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Medical Device Radiocommunication Service (MedRadio) § 95.1203 Authorized locations....

  4. 47 CFR 95.1203 - Authorized locations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized locations. 95.1203 Section 95.1203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Medical Device Radiocommunication Service (MedRadio) § 95.1203 Authorized locations....

  5. 47 CFR 95.1505 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1505 Section 95.1505 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... locations. Operation of DSRCS On-Board Units is authorized anywhere CB station operation is permitted...

  6. 47 CFR 95.1505 - Authorized locations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Authorized locations. 95.1505 Section 95.1505 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... locations. Operation of DSRCS On-Board Units is authorized anywhere CB station operation is permitted...

  7. 47 CFR 95.1505 - Authorized locations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Authorized locations. 95.1505 Section 95.1505 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... locations. Operation of DSRCS On-Board Units is authorized anywhere CB station operation is permitted...

  8. 47 CFR 95.1505 - Authorized locations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized locations. 95.1505 Section 95.1505 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... locations. Operation of DSRCS On-Board Units is authorized anywhere CB station operation is permitted...

  9. 47 CFR 95.1505 - Authorized locations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Authorized locations. 95.1505 Section 95.1505 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... locations. Operation of DSRCS On-Board Units is authorized anywhere CB station operation is permitted...

  10. Delivering safety

    SciTech Connect

    Baldwin, N.D.; Spooner, K.G.; Walkden, P.

    2007-07-01

    In the United Kingdom there have been significant recent changes to the management of civil nuclear liabilities. With the formation in April 2005 of the Nuclear Decommissioning Authority (NDA), ownership of the civil nuclear licensed sites in the UK, including the Magnox Reactor Stations, passed to this new organisation. The NDAs mission is to seek acceleration of the nuclear clean up programme and deliver increased value for money and, consequently, are driving their contractors to seek more innovative ways of performing work. British Nuclear Group manages the UK Magnox stations under contract to the NDA. This paper summarises the approach being taken within its Reactor Sites business to work with suppliers to enhance working arrangements at sites, improve the delivery of decommissioning programmes and deliver improvements in safety and environmental performance. The UK Magnox stations are 1. generation gas-graphite reactors, constructed in the 1950's and 1960's. Two stations are currently still operating, three are shut-down undergoing defueling and the other five are being decommissioned. Despite the distractions of industry restructuring, an uncompromising policy of demanding improved performance in conjunction with improved safety and environmental standards has been adopted. Over the past 5 years, this policy has resulted in step-changes in performance at Reactor Sites, with increased electrical output and accelerated defueling and decommissioning. The improvements in performance have been mirrored by improvements in safety (DACR of 0 at 5 sites); environmental standards (reductions in energy and water consumption, increased waste recycling) and the overall health of the workforce (20% reduction in sickness absence). These achievements have, in turn, been recognised by external bodies, resulting in several awards, including: the world's first ISRS and IERS level 10 awards (Sizewell, 2006), the NUMEX plant maintenance award (Bradwell, 2006), numerous Ro