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

    PubMed

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

    2015-07-01

    There is no prospective evidence on inhibitor recurrence among haemophilia A patients with low titre inhibitors or history of inhibitors, and whether or how therapeutic choices affect the risk of recurrence. The aims of this study were to synthesise safety data in patients with moderate-severe haemophilia A and with low titre inhibitors or inhibitor history enrolled in the rAHF PFM (ADVATE) - Post-Authorization Safety Studies (ADVATE-PASS) international programme. The study was conducted in clinics participating to the ADVATE PASS programme. The patient population consisted of patients entering the studies with low titre (??5 BU) inhibitors or a positive personal history of inhibitors. Patients on Immune Tolerance Induction at study entry were excluded. Primary outcome was new or recurrent inhibitor titre >?5 BU. Secondary outcomes were any increase of inhibitor titre not reaching 5 BU; any unexplained change in treatment regimen. Primary analysis was done by two-stage random effects meta-analysis. Secondary analysis was done by a hierarchical Bayesian random effects logistic model. A total of 219 patients from seven studies were included. Of these 214 (97.7?%) patients had been previously treated for more than 50 exposure days. Two hundred ten patients had positive history for inhibitors, nine a baseline measurable titre. No patient presented a primary outcome event (95?% confidence interval [CI] 0-1.6?%). Six patients with previous history developed a low titre recurrence (overall rate 2.2, 95?%CI 0-4.8?%). When any increase of inhibitor titre or any treatment change was accounted for, overall 3.7?% (95?% CI 0?%-8.0?%) of patients experienced the outcome. In conclusion, the observed rate of events does not support the definition of this population as at high risk for inhibitor development. PMID:26017627

  3. 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)…

  4. [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

  5. 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 390.209 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MOTOR CARRIER SAFETY REGULATIONS; GENERAL Unified Registration System 390.209 Pre-authorization safety... 385.607(c) of this subchapter as a condition for receiving registration under this part....

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  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. 49 CFR 218.61 - Authority to deactivate safety devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Authority to deactivate safety devices. 218.61 Section 218.61 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD OPERATING PRACTICES Prohibition Against Tampering With Safety Devices 218.61 Authority...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  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, 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...

  20. 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...

  1. 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...

  2. 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...

  3. NASA's post-Challenger safety program - Themes and thrusts

    NASA Technical Reports Server (NTRS)

    Rodney, G. A.

    1988-01-01

    The range of managerial, technical, and procedural initiatives implemented by NASA's post-Challenger safety program is reviewed. The recommendations made by the Rogers Commission, the NASA post-Challenger review of Shuttle design, the Congressional investigation of the accident, the National Research Council, the Aerospace Safety Advisory Panel, and NASA internal advisory panels and studies are summarized. NASA safety initiatives regarding improved organizational accountability for safety, upgraded analytical techniques and methodologies for risk assessment and management, procedural initiatives in problem reporting and corrective-action tracking, ground processing, maintenance documentation, and improved technologies are discussed. Safety issues relevant to the planned Space Station are examined.

  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. Post Closure Safety of the Morsleben Repository

    SciTech Connect

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

    2002-02-26

    After the completion of detailed studies of the suitability the twin-mine Bartensleben-Marie, situated in the Federal State of Saxony-Anhalt (Germany), was chosen in 1970 for the disposal of low and medium level radioactive waste. The waste emplacement started in 1978 in rock cavities at the mine's fourth level, some 500 m below the surface. Until the end of the operational phase in 1998 in total about 36,800 m{sup 3} of radioactive waste was disposed of. The Morsleben LLW/ILW repository (ERAM) is now under licensing for closure. After completing the licensing procedure the repository will be sealed and backfilled to exclude any undue future impact onto man or the environment. The main safety objective is to protect the biosphere from the harmful effects of the disposed radionuclides. Furthermore, classical or conventional requirements call for ruling out or minimizing other unfavorable environmental effects. The ERAM is an abandoned rock salt and potash mine. As a consequence it has a big void volume, however small parts of the cavities are backfilled with crushed salt rocks. Other goals of the closure concept are therefore a long-term stabilization of the cavities to prevent a dipping or buckling of the ground surface. In addition, groundwater protection shall be assured. For the sealing of the repository a closure concept was developed to ensure compliance with the safety protection objectives. The concept anticipates the backfilling of the cavities with hydraulically setting backfill materials (salt concretes). The reduction of the remaining void volume in the mine causes in the case of brine intrusions a limitation of the leaching processes of the exposed potash seams. However, during the setting process the hydration heat of the concrete will lead to an increase of the temperature and hence to thermally induced stresses of the concrete and the surrounding rocks. Therefore, the influence of these stresses and deformations on the stability of the salt body and the integrity of the geological barrier was examined by 2D and 3D thermo-mechanical computations. The compliance of the safety objectives are proved on the basis of safety evidence criteria. It can be concluded that the closure concept is able to serve all conventional and radiological safety objectives.

  7. 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.

  8. 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 20102011. 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.

  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. Safety studies of post-surgical buprenorphine therapy for mice.

    PubMed

    Traul, Karl A; Romero, Jennell B; Brayton, Cory; DeTolla, Louis; Forbes-McBean, Nadine; Halquist, Matthew S; Karnes, H Thomas; Sarabia-Estrada, Rachel; Tomlinson, Michael J; Tyler, Betty M; Ye, Xiaobu; Zadnik, Patricia; Guarnieri, Michael

    2015-04-01

    The use of appropriate analgesia in laboratory mice may be suboptimal because of concerns about adverse events (AE). Target Animal Safety trials were conducted to determine the safety of an extended-release suspension of buprenorphine. Drug or control suspensions were injected subcutaneously in surgically-treated BALB/c mice anesthetized with ketamine-xylazine to mimic post-operative conditions in which the compound might commonly be administered. Single and repeat five-fold (5) excesses of the 3.25 mg/kg intended dose were used to provoke potential AE. Trials included prospective measurements of weight changes, blood chemistry, hematology, and histopathology. Clinical and histopathology findings were similar in drug-treated and control mice in a four-day trial using a single 16.25 mg/kg, 5 overdose of the drug. In a 12-day trial, which used a total buprenorphine dose of 48.75 mg/kg, clinical and histopathology values were also similar in control and drug-treated female mice. In the male arm of the repeat-overdose trial, two of eight mice died on the morning of day 12, three days following the third 16.25 mg/kg overdose administration. Histopathology did not reveal a cause of death. In a 14-month trial using a single 3.25 mg/kg dose of the drug, no significant findings identified potential AE. These findings indicate a high tolerance to an extended-release buprenorphine suspension administered post-operatively in mice with appropriate husbandry. PMID:25305141

  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. 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

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

    SciTech Connect

    Booker, Paul M.; Brown, Lisa M.

    2005-07-01

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

  15. 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...

  16. 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.

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

    PubMed

    Viscusi, Eugene R

    2015-12-01

    The need for better post-surgical pain management continues to be unmet, despite clinicians' awareness and concern for many years. Opioids remain the standard of care because of their analgesic efficacy; however, opioid use is often associated with adverse effects and poor patient outcomes. Multimodal analgesic regimens have recently been endorsed as a way to provide adequate post-surgical pain control while reducing opioid consumption. Liposome bupivacaine is a liposomal formulation of bupivacaine indicated for a single administration into the surgical site. Based on the available clinical trial data compiled to date, as well as the author's review of publicly available post-marketing safety information, liposome bupivacaine may be a viable addition to currently available therapeutic options for post-surgical analgesia while reducing potential risks associated with use of opioid analgesics, and may represent a useful addition to the multimodal analgesic modalities currently used for post-operative pain management. The potential for its use in other areas is also being investigated. The purpose of this review is to examine the currently available post-marketing safety information on liposome bupivacaine. PMID:26436689

  18. A pre-marketing ALT signal predicts post-marketing liver safety.

    PubMed

    Moylan, Cynthia A; Suzuki, Ayako; Papay, Julie I; Yuen, Nancy A; Ames, Michael; Hunt, Christine M

    2012-08-01

    Drug induced liver injury during drug development is evidenced by a higher incidence of serum alanine aminotransferase (ALT) elevations in treated versus placebo populations and termed an "ALT signal". We sought to quantify whether an ALT signal in pre-marketing clinical trials predicted post-marketing hepatotoxicity. Incidence of ALT elevations (ALT ? 3 times upper limits normal [ ULN]) for drug and placebo of new chemical entities and approved drugs associated with hepatotoxicity was calculated using the Food and Drug Administration (FDA) website. Post-marketing liver safety events were identified using the FDA Adverse Event Reporting System (AERS). The association of FDA AERS signal score (EB05 ? 2) and excess risk of pre-marketing ALT elevation (difference in incidence of ALT ? 3 ULN in treated versus placebo) was examined. An ALT signal of ? 1.2% was significantly associated with a post-marketing liver safety signal (p ? 0.013) and a 71.4% positive predictive value. An absent ALT signal was associated with a high likelihood of post-marketing liver safety; negative predictive value of 89.7%. Daily drug dose information improved the prediction of post-marketing liver safety. A cut-off of 1.2% increase in ALT ? 3 ULN in treated versus placebo groups provides an easily calculated method for predicting post-marketing liver safety. PMID:22668747

  19. 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

  20. 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…

  1. 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

  2. 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

  3. 7 CFR 735.10 - Posting of certificates of licensing, certificates of authorization or other USWA documents.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Agriculture (Continued) FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE REGULATIONS FOR WAREHOUSES REGULATIONS FOR THE UNITED STATES WAREHOUSE ACT General Provisions 735.10 Posting of certificates of licensing, certificates of authorization or other USWA documents. (a) The warehouse operator must post, in a...

  4. 7 CFR 735.10 - Posting of certificates of licensing, certificates of authorization or other USWA documents.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Agriculture (Continued) FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE REGULATIONS FOR WAREHOUSES REGULATIONS FOR THE UNITED STATES WAREHOUSE ACT General Provisions 735.10 Posting of certificates of licensing, certificates of authorization or other USWA documents. (a) The warehouse operator must post, in a...

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

    ERIC Educational Resources Information Center

    Borrows, Peter; Vincent, Ray; Cochrane, Allen

    1998-01-01

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

  6. 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...

  7. Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

    PubMed

    Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

    2012-08-01

    Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.440.70 mg/kg of feed and 7.542.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans. PMID:22802203

  8. 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.

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

    PubMed

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

    2015-08-01

    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

  10. 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; Nub, 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

  11. Status of High Flux Isotope Reactor (HFIR) post-restart safety analysis and documentation upgrades

    SciTech Connect

    Cook, D.H.; Radcliff, T.D.; Rothrock, R.B.; Schreiber, R.E.

    1990-01-01

    The High Flux Isotope Reactor (HFIR), an experimental reactor located at the Oak Ridge National Laboratory (ORNL) and operated for the US Department of Energy by Martin Marietta Energy Systems, was shut down in November, 1986 after the discovery of unexpected neutron embrittlement of the reactor vessel. The reactor was restarted in April, 1989, following an extensive review by DOE and ORNL of the HFIR design, safety, operation, maintenance and management, and the implementation of several upgrades to HFIR safety-related hardware, analyses, documents and procedures. This included establishing new operating conditions to provide added margin against pressure vessel failure, as well as the addition, or upgrading, of specific safety-related hardware. This paper summarizes the status of some of the follow-on (post-restart) activities which are currently in progress, and which will result in a comprehensive set of safety analyses and documentation for the HFIR, comparable with current practice in commercial nuclear power plants. 8 refs.

  12. The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.

    PubMed

    Nguyen, Michael; Ball, Robert; Midthun, Karen; Lieu, Tracy A

    2012-01-01

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. PRISM has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, PRISM monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, PRISM links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support PRISM are updated quarterly, and PRISM can conduct medical record review for validation of computerized data. The FDA has structured PRISM as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from PRISM's large cohort size. The PRISM program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among PRISM and other surveillance systems, offering potential synergies. FDA and PRISM will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise. PMID:22262619

  13. [The management of post donation information: a fundamental element of blood safety].

    PubMed

    Herv, I; Simonet, M; Rebibo, D; Leconte des Floris, M-F; Taouqi-Le Cann, M; Jbilou, S; Brunet, A

    2010-12-01

    Post donation information management is a fundamental axis of haemovigilance in terms of blood safety. It requires an organization ensuring a permanent reactivity, a good sensitization of French National Blood Service professionals and needs also a strong awareness of blood donors. Previous identification of stakeholders to warn during these kinds of alerts is essential to avoid the use of any blood product presenting a potential risk. The recent implementation of a consensual internal document aims to target the reinforcement of a homogeneous decision-making process, combining blood product self-sufficiency and above all recipient safety. PMID:21051261

  14. [Post-operative surveillance and intensive care after orthopedic procedures of the vertebral column (author's transl)].

    PubMed

    Bauer, R; Kroesen, G; Geir, W

    1977-12-01

    113 corrective procedures of the vertebral column by ventral and/or dorsal approach have been analysed. The post-operative findings have been reported, including blood-gas analysis, hemoglobin and hematocrit, electrolytes, and fluid balance. A correlative-statistical analysis of the scoliosis group was carried out according to number of involved segments, degree of curvature, age, length of operative time and total blood loss. The post-operative complications were related to preexisting risk factors. PMID:603439

  15. 7 CFR 735.10 - Posting of certificates of licensing, certificates of authorization or other USWA documents.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 7 2010-01-01 2010-01-01 false Posting of certificates of licensing, certificates of authorization or other USWA documents. 735.10 Section 735.10 Agriculture Regulations of the Department of Agriculture (Continued) FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE REGULATIONS FOR WAREHOUSES REGULATIONS FOR THE UNITED STATES...

  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. 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

  18. 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

  19. 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…

  20. 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

  1. 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…

  2. 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

  3. 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 material that should try to protect from patenting and commercialisation. Finally, we should be aware of the requirements of movement of GMOs within borders, i.e. GMOs grown or used in other countries but which are not intended to cross into Greece, since Greece is very close to countries that are non-EU. This is where the development of a new, integrated, trustworthy and transparent food quality control system will help to satisfy the societal demands for safe and quality products. On the other hand, Greece should not be isolated from any recent scientific technological development and should assess the possible advantages for some cultivation using a case by case approach. Finally, the safety assessment of GM foods and feed has been discussed according to the risk assessment methodology applied by EFSA. PMID:17275157

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

    TOXLINE Toxicology Bibliographic Information

    Varzakas TH; 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 material that should try to protect from patenting and commercialisation. Finally, we should be aware of the requirements of movement of GMOs within borders, i.e. GMOs grown or used in other countries but which are not intended to cross into Greece, since Greece is very close to countries that are non-EU. This is where the development of a new, integrated, trustworthy and transparent food quality control system will help to satisfy the societal demands for safe and quality products. On the other hand, Greece should not be isolated from any recent scientific technological development and should assess the possible advantages for some cultivation using a case by case approach. Finally, the safety assessment of GM foods and feed has been discussed according to the risk assessment methodology applied by EFSA.

  5. 41 CFR 302-9.173 - How many replacement POV's may my agency authorize me to transport to my post of duty at...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 41 Public Contracts and Property Management 4 2014-07-01 2014-07-01 false How many replacement POV's may my agency authorize me to transport to my post of duty at Government expense? 302-9.173... Assignment 302-9.173 How many replacement POV's may my agency authorize me to transport to my post of...

  6. 41 CFR 302-9.173 - How many replacement POV's may my agency authorize me to transport to my post of duty at...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 false How many replacement POV's may my agency authorize me to transport to my post of duty at Government expense? 302-9.173... Assignment 302-9.173 How many replacement POV's may my agency authorize me to transport to my post of...

  7. 41 CFR 302-9.173 - How many replacement POV's may my agency authorize me to transport to my post of duty at...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 4 2013-07-01 2012-07-01 true How many replacement POV's may my agency authorize me to transport to my post of duty at Government expense? 302-9.173... Assignment 302-9.173 How many replacement POV's may my agency authorize me to transport to my post of...

  8. 41 CFR 302-9.173 - How many replacement POV's may my agency authorize me to transport to my post of duty at...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 41 Public Contracts and Property Management 4 2011-07-01 2011-07-01 false How many replacement POV's may my agency authorize me to transport to my post of duty at Government expense? 302-9.173... How many replacement POV's may my agency authorize me to transport to my post of duty at...

  9. 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

    ... product design. A copy of the petition, as well as any written communications concerning the petition, is... Product Safety Plan In accordance with Part 236 of Title 49 Code of Federal Regulations (CFR) and 49 U.S.C... a Product Safety Plan (PSP). FRA assigned the petition Docket Number FRA-2012-0075. PATH...

  10. 76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

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

  11. Safety analysis of Epzicom® (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan†

    PubMed Central

    Kurita, Tomoko; Kitaichi, Tomomi; Nagao, Takako; Miura, Toshiyuki; Kitazono, Yoshifumi

    2014-01-01

    Purpose To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600 mg/lamivudine 300 mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010. Methods A joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of HIV infection in Japan. Safety and effectiveness data from total 624 cases (1107.3 person-years) registered to the HRD surveys and received Epzicom were obtained. Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be ‘ruled out’. Results It was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis. In addition, the frequently reported ADR included hyperlipidaemia (59 cases), hypertriglyceridaemia (21 cases), blood bilirubin increased (19 cases), gamma-glutamyltransferase increase (14 cases), blood triglyceride increase (14 cases) and rash (14 cases). Serious AEs were seen in 19 patients (30 events), including one death (no evident association with Epzicom). There were four cases (0.6%) of survey-defined ‘hypersensitivity’, and the incidence was 0.9% (4/445) among abacavir naïve patients; none of which was reported as serious. No case of myocardial infarction was reported. One pregnant case who delivered a normal baby by caesarean section was reported to have experienced aggravation of anaemia and nausea. Conclusions The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population. PMID:24590575

  12. Analysis of Sawtooth Post-Cursor Oscillations in Low Safety Factor DIII-D Plasmas

    NASA Astrophysics Data System (ADS)

    Cabrera, J. D.; Paz-Soldan, C.; Strait, E. J.; Shiraki, D.

    2014-10-01

    Large sawtooth oscillations are a commonly observed phenomenon in very low safety factor (q95 ~ 2) plasmas. Following the sawtooth crash phase, low frequency (~200 Hz) post-cursor oscillations in the magnetic field, with amplitudes ~2 G decaying in time, are excited. These post-cursor oscillations do not exhibit the usual m = odd poloidal structures of sawtooth oscillation, but instead are found to be m = even in structure, suggesting the excitation of global kink modes. A novel means of modeling such post-cursor oscillations is presented via computational analysis of data obtained from high-resolution magnetic sensors installed at the DIII-D tokamak facility. Nonlinear regression analysis is used to obtain modeling parameters such as rates of decay and rotation. Trends in parameters over many oscillations are then compared with equilibrium plasma parameters. The impact of measured parameters on global instability onset and disruption prediction is considered. Supported by the National Undergraduate Fellowship Program in Plasma Physics and Fusion Energy Sciences and the US DOE under DE-FC02-04ER54698.

  13. [Utilization of Genomic Biomarkers for Post-marketing Safety of Drugs].

    PubMed

    Kaniwa, Nahoko

    2015-01-01

    To prevent adverse drug reactions in the post-marketing phase, therapeutic drug monitoring and various laboratory tests have been used for decades. Recently, data on associations between drug adverse reactions and biomarkers based on "omics" technologies/studies have been increasing. Using genomic biomarkers, patients at high risk for developing side effects can be distinguished before initiating medical treatment, allowing the choice of an appropriate drug/initial dosage regimen. Biomarkers based on proteomics or metabolomics can detect the onset of adverse reactions at an earlier stage than can be accomplished with classical laboratory tests. However, the clinical use of drug safety-related biomarkers is still limited compared with biomarkers that predict drug efficacy of, for example, molecular-targeted drugs. In this symposium, genomic biomarkers associated with the safety of anticancer drugs and idiosyncratic adverse reactions are introduced and compared between Japan and other countries. Prospective studies evaluating the application of screening tests to prevent adverse drug reactions are also shown, and steps necessary to accelerate the use of drug safety-related biomarkers are discussed. PMID:25948300

  14. 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 facility will be limited in quantity, type and form in accordance with the BMBL requirements and approval by the Institutional Biosafety Committee (IBC). The proposed facility will have the unique capability within DOE/NNSA to perform aerosol studies to include challenges to rodents using infectious agents or biologically derived toxins (biotoxins). These types of aerosol studies will be strictly confined in a Class II Type B biosafety cabinet.

  15. Safety of post-operative epidural analgesia in the paediatric population: A retrospective analysis

    PubMed Central

    Kasanavesi, Ramakrishna Chaitanya; Gazula, Suhasini; Pula, Ravikanth; Thakur, Nagarjuna

    2015-01-01

    Background and Aims: Epidural infusion analgesia (EIA) is among the common procedures performed in children to provide analgesia. However, the administration of epidural is not without complications. Limited studies are available regarding the safety of EIA in children with no studies from the Indian subcontinent. The aim of this study was to analyse all the complications that occured during administration and maintenance of EIA in paediatric patients. Methods: All children undergoing elective or emergency surgeries under general anaesthesia and given concomitant epidural analgesia for post-operative pain management were included. Data were collected by reviewing patient medical records, anaesthesia registers and post-operative intensive care unit charts. Statistical averages were drawn to assess the complication rates. Results: Seventy children received epidural analgesia during the span of study, of them five were neonates and fifteen were infants. No major complications that were life-threatening or leading to permanent disability were documented. Two children (2.85%) had blood tap during procedure. Eleven children (15%) had peri-catheter leaks and 14 children (20%) had catheter dislodgements. Conclusion: EIA seems to be a relatively safe method of providing analgesia. It is associated with the occurrence of complications which are at best temporary. PMID:26644609

  16. 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.

  17. Safety and acceptability of post-abortal IUD insertion and the importance of counseling.

    PubMed

    El-Tagy, Ahmed; Sakr, Ezzat; Sokal, David C; Issa, Adel Hakim

    2003-03-01

    This nonrandomized observational clinical study evaluated the safety and acceptability of intrauterine device insertion either immediately or 2 weeks after abortion, according to the patient's preference. Participants were 300 women with first-trimester abortions who agreed to immediate or delayed insertion. End points were bleeding patterns, pregnancy, expulsion, perforation, infection and device removal at 2, 6 and 10 weeks after insertion, and acceptance rates before and after counseling procedures were improved. The overall initial acceptance rate was 35.8%, and the actual acceptance rate was 31.7%. After counseling procedures were improved, the initial and actual acceptance rates increased substantially (17.7% vs. 44.3% and 10.2% vs. 42.0%, respectively). Bleeding, expulsion rates and pain did not differ significantly between the immediate and delayed insertion groups after IUD insertion. No pregnancies, perforations or cases of pelvic inflammatory disease were recorded in either group. Immediate post-abortal insertion offers the advantage of being a painless procedure. The quality of counseling is critical to improving acceptance of post-abortion contraception. PMID:12618259

  18. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... medical services/injury surveillance, roadway and vehicle record keeping systems, and driver license data... limited to the standards for financial management systems required under 49 CFR 18.20; (8) Ensure that all..., driver and other data sources to identify safety problems within the State; (2) Establish highway...

  19. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... medical services/injury surveillance, roadway and vehicle record keeping systems, and driver license data... limited to the standards for financial management systems required under 49 CFR 18.20; (8) Ensure that all..., driver and other data sources to identify safety problems within the State; (2) Establish highway...

  20. 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.

  1. 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

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false When I am authorized to transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to that post of duty, may I have the manufacturer or the manufacturer's agent transport a new POV from...

  2. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false If circumstances warrant an authorization to transport a POV to my post of duty after my assignment to the post of duty, must I sign a new service agreement? 302-9.171 Section 302-9.171 Public Contracts and Property...

  3. 41 CFR 302-9.209 - Under what conditions may my agency authorize me to transport from my post of duty a replacement...

    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 conditions may my agency authorize me to transport from my post of duty a replacement POV purchased at that post of duty? 302-9.209 Section 302-9.209 Public Contracts and Property Management Federal...

  4. [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

  5. Authorizing Authority.

    ERIC Educational Resources Information Center

    Deutelbaum, Wendy

    In contrast to a teacher-dominated literature classroom where authority rests with the one who has the power to grade, a classroom dedicated to cultivating the creative process breaks down the traditional hierarchies (such as theory and practice, text and reader, and organization and improvisation) and concentrates on the needs of the individual

  6. Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs.

    PubMed

    Lu, Zhengwu

    2010-01-01

    To identify key challenges and propose technical considerations in designing electronic case report form (eCRF) for post-marketing studies, the author undertakes a comprehensive literature review of peer reviewed and grey literature to assess the key aspects, processes, standards, recommendations, and best practices in designing eCRFs based on industry experience in designing and supporting electronic data capture (EDC) studies. Literature search using strings on MEDLINE and PUBMED returned few papers directly related to CRF design. Health informatics and general practice journals were searched and results reviewed. Many conference, government commission, health professional and special interests group websites provide relevant information from practical experience - summarization of this information is presented. Further, we presented a list of concrete technical considerations in dealing with EDC technology/system limitations based on literature assessment and industry implementation experience. It is recognized that cross-functional teams be involved in eCRF design process and decision making. To summarize the keys in designing eCRFs to address post-market study safety and pharmacovigilance needs, the first is to identify required data elements from the study protocol supporting data analyses and reporting requirements. Secondly, accepted best practices, CDASH & CDISC guidelines, and company internal or therapeutic unit standard should be considered and applied. Coding (MedDRA & WHODD) mapping should be managed and implemented as well when possible. Finally, we need to be on top of the EDC technologies, challenge the technologies, drive EDC improvement via working with vendors, and utilize the technologies to drive clinical effectiveness. PMID:19900576

  7. 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

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false What is the âauthorized point of originâ when I transport my POV from my post of duty? 302-9.204 Section 302-9.204 Public...” when I transport my POV from my post of duty? The “authorized point of origin” when you transport...

  8. 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 point of originâ when I transport a POV to my post of duty? 302-9.141 Section 302-9.141 Public Contracts... I transport a POV to my post of duty? Your “authorized point of origin” is as follows: If you are...

  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 similar to its comparators indicating no increase in the overall risk for any of the investigated safety end points. PMID:26316734

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

    SciTech Connect

    Cottrell, W.B.; Passiakos, M.

    1982-06-01

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

  11. 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. [Safety and health aspects in urbanised areas of different density (author's transl)].

    PubMed

    Boeddinghaus, G

    1978-08-01

    Germans like to live in one-family houses. This way of living prevails more and more during recent years. However, the increase of one-family housing implies a high state of car dependence. Especially for children, youths, aged and disadvantaged people living in a car oriented city becomes difficult. Also a higher use of cars implies more air pollution and waste of energy. And additionaly, the increasing travel distances cause higher rates of traffic accidents. To avoid these disadvantages the alternative must be the high density development comprising both, high density-low-rise buildings and especially high rise buildings. By abandoning all one-family homes and using only tall buildings for dwelling and other purposes (stores, offices, schools etc.) the area of a city could be reduced to about one tenth of that what is urbanized today. Because of the short distances in such a city most of the trips could be made by walking or by using lifts. Accordingly traffic accidents could be reduced to one tenth of today's figures too. Despite of the many advantages the high density city has with respect to safety and health of its population such a city will be rarely realized because it does not meet the ideas and imaginations of many people. Nevertheless it seems to be advisable to promote high density residential areas for all those people who are willing to accept it or who prefer this way of living. This minority, however, should not be irritated by unqualified generalizing negative reports in the media. PMID:716696

  13. 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.

  14. 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

  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. 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.

  18. 41 CFR 302-9.203 - Is there any circumstance under which I may be authorized to transport my POV from a 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 Is there any circumstance under which I may be authorized to transport my POV from a post of duty before completing my service agreement? 302-9.203 Section 302-9.203 Public Contracts and Property Management Federal...

  19. 41 CFR 302-9.173 - How many replacement POV's may my agency authorize me to transport to my post of duty at...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false How many replacement POV's may my agency authorize me to transport to my post of duty at Government expense? 302-9.173 Section 302-9.173 Public Contracts and Property Management Federal Travel Regulation System...

  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

    ... 41 Public Contracts and Property Management 4 2011-07-01 2011-07-01 false When I am authorized to... factory or other shipping point directly to my post of duty? 302-9.175 Section 302-9.175 Public Contracts and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION...

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

    PubMed

    Islam, Md Tazul; El-Basyouny, Karim

    2015-07-01

    Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads. PMID:25846231

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

    PubMed

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

    2015-01-01

    Consistent with evidence of a strong correlation between interferon gamma (IFN?) production and rabies virus (RABV) clearance from the CNS, we recently demonstrated that engineering a pathogenic RABV to express IFN? highly attenuates the virus. Reasoning that IFN? expression by RABV vaccines would enhance their safety and efficacy, we reverse-engineered two proven vaccine vectors, GAS and GASGAS, to express murine IFN?. Mortality and morbidity were monitored during suckling mice infection, immunize/challenge experiments and mixed intracranial infections. We demonstrate that GAS? and GAS?GAS are significantly attenuated in suckling mice compared to the GASGAS vaccine. GAS? better protects mice from lethal DRV4 RABV infection in both pre- and post-exposure experiments compared to GASGAS. Finally, GAS?GAS reduces post-infection neurological sequelae, compared to control, during mixed intracranial infection with DRV4. These data show IFN? expression by a vaccine vector can enhance its safety while increasing its efficacy as pre- and post-exposure treatment. PMID:25463615

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... to when DHS could reasonably complete evaluations of offerors' applications for SAFETY...

  5. 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

  6. 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…

  7. 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

  8. [Skin test: guide of post-marketed re-evaluation of clinical safety in traditional Chinese medicine injection].

    PubMed

    Wei, Xu; Xie, Yanming; Wang, Yongyan

    2011-10-01

    Anaphylaxis is the most common adverse reaction caused by traditional Chinese medicine (TCM) injection, the most serious of which is type I, so post-marketed safety re-evaluation is necessary. Skin test can be used to screen type I allergy reaction, which is of great significance for TCM injection safe use. Skin test is not only able to find the population sensitization situation of TCM injection, but also is a way of understanding the mechanism of allergy reaction. TCM injection varieties that often occur type I anaphylaxis are applicable to skin test, and study population include healthy volunteers and patients whose disease is listed in the drug specification, intracutaneous test and prick test are the alternative method. The concentration of skin-test solution may influence the positive rate of skin test, penicillin skin-test solution preparation method can be used as the reference in TCM injection. Different doses of TCM injection skin-test solution,glucose injection and normal saline, histamine hydrochloride are comprised in comparison. Given the characteristics of type I allergy reaction,we should be pay close attention to skin test reaction in half an hour, and observation index need be designed based on post-marketed re-evaluation of clinical safety. PMID:22292390

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

    PubMed

    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

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

    PubMed

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

    2011-01-01

    One of the most important scientific discoveries of the last century was that persistent infection by some types of HPV is a precondition for the development of cervical cancer. The oncogenic types of HPV are also associated with other tumours (vaginal, vulvar and anal carcinomas, tumours of the head and neck, urethra and penis). Two preventive vaccines are currently available (Cervarix and Gardasil). Both have shown very good efficacy, safety and tolerability profiles. Nonetheless, extensive vaccination requires long-term monitoring of safety and tolerability. The aim of our study was to evaluate the safety and tolerability of the bivalent vaccine Cervarix in Italy. Every participant in the study completed a questionnaire after each dose of vaccine received, with a view to recording adverse events during the first 7 days after vaccination. We registered local (pain, redness, swelling) and systemic symptoms (fever, headache, myalgia, fatigue, arthralgia, itching, gastrointestinal disorders, rash and urticaria). A total of 4,643 subjects were recruited. In all, 7,107 questionnaires were collected: 3,064 after the first dose, 2,367 after the second and 1,676 after the third. No serious adverse events were observed. The most frequent local symptom was pain at the injection site, while fatigue, headache and myalgia were the most common systemic reactions. Pain was reported more frequently after the first dose than after the others, while all the other local and general symptoms were reported most frequently after the third dose. Almost all of the local and general reactions proved to be of negligible intensity and duration and required no medical intervention. Our results show better tolerability of the vaccine in comparison with the data from some controlled clinical studies and from other surveillance programmes conducted internationally. That tolerability proved to be better than in clinical studies could be explained by the absence of the typical apprehension felt by subjects involved in clinical experimentation. PMID:21266842

  11. Safety and Efficacy of Eltrombopag in Post-hematopoietic Stem Cell Transplantation (HSCT) Thrombocytopenia.

    PubMed

    Raut, Shreeniwas S; Shah, Sandip A; Sharanangat, Vijay V; Shah, Kamlesh M; Patel, Kinnari A; Anand, Asha S; Talati, Shailesh S; Panchal, Harsha P; Patel, Apurva A; Parikh, Sonia K; Shukla, Shilin N

    2015-12-01

    Twelve adult patients (median age 29.5years) were started on Eltrombopag 25-50mg/day for post-hematopoietic stem cell transplantation (HSCT) thrombocytopenia. All patients were having primary thrombocytopenia after HSCT. No patient had other secondary cause for thrombocytopenia. Two patients were allogenic subsets (1 acute myeloid leukemia i.e., AML and 1 aplastic anemia), and 10 were autologous transplants (3 multiple myeloma, 6 lymphoma and 1 AML). Nine patients were males, three were females. The median time of starting Eltrombopag was 21days post-stem cell infusion (range day +17 to +60) at a median platelet count of 9,000/cmm (range 3,000-11,000/cmm). The median duration for treatment was 29days. Median total dose of 812.5mg was received by patients and they had a median platelet increment of 36,000/cmm. We observed that there were no adverse effects in these patients and there was a gradual increase in platelet count so that none of the patients had any complication due to thrombocytopenia. The cost of treatment was less than the cost of extended hospitalization and irradiated single donor platelet transfusion. PMID:26306064

  12. 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

  13. Safety evaluation of phytosterol-esters. Part 9: Results of a European post-launch monitoring programme.

    PubMed

    Lea, L J; Hepburn, P A

    2006-08-01

    Phytosterol-esters were developed by Unilever as a cholesterol lowering novel food ingredient for use initially in vegetable oil spreads. In addition to an extensive package of safety studies and clinical studies a programme of post-launch monitoring (PLM) was developed. PLM was used to address the following questions: (a) Is the product use as predicted/recommended? (b) Are the known effects as predicted? (c) Does the product cause unexpected health effects? The overall conclusions from the PLM programme were: the product is being bought by the target population but intakes are less than the original assumptions made in the risk assessment; long-term use of phytosterol-ester enriched spreads results in a reduction in the serum levels of the most lipophilic carotenoids but at current levels of intake this is unlikely to result in reductions in carotenoids that are of biological significance; evaluation of health related consumer complaints have not indicated any unexpected health effects associated with the use of the product in the marketplace. As part of the European approval under Regulation (EC) No. 258/97 on Novel Foods and Food Ingredients the results of the PLM programme had to be submitted to the European Commission (EC) and reviewed by the Scientific Committee on Food (SCF). They concluded that the study provided valuable information, which complemented the pre-market safety evaluation studies, and that the EC mandatory requirement had been met. PMID:16542769

  14. 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

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

    SciTech Connect

    Altenbach, T; Nguyen, S

    2005-01-04

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

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

    PubMed

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

    2015-12-01

    Data from randomized, controlled trials suggest that post-induction phase (IP) treatment with bevacizumab may benefit patients with advanced non-small-cell lung cancer (NSCLC). Real-world clinical practice, however, can involve variable use and patterns of treatment in broader patient populations. To assess the effect of bevacizumab on post-IP overall survival (OS) following IP chemotherapy + bevacizumab, analyses were conducted in patients enrolled in the Avastin Registry-Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) who received post-IP bevacizumab. ARIES was a large, prospective OCS of patients who received chemotherapy in combination with bevacizumab for the first-line treatment of NSCLC. This unplanned, post hoc analysis included patients who received chemotherapy and bevacizumab and who did not have progressive disease through the completion of IP treatment. A dichotomous analysis compared outcomes in patients who did and did not receive bevacizumab before a landmark date of day 30 post IP. A cumulative exposure analysis used a time-dependent Cox regression model to assess the effect of cumulative post-IP bevacizumab exposure on post-IP OS. In the dichotomous analysis, the duration of post-IP OS was significantly longer in patients who received post-IP bevacizumab; median post-IP OS was 15.6 vs. 11.3months, respectively (hazard ratio [HR]?=?0.80; 95% confidence interval 0.71-0.91; P?post-IP OS by 2.7%, on average. In conclusion, post-IP bevacizumab exposure was associated with improved post-IP OS in patients with advanced NSCLC who were enrolled in the ARIES OCS. PMID:25559289

  17. 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)

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

    PubMed

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

    2013-09-01

    Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM. PMID:24471316

  19. Comprehensive property retrieval and measurement of concrete spalling using machine vision for post-earthquake safety assessments

    NASA Astrophysics Data System (ADS)

    German, Stephanie; Brilakis, Ioannis; DesRoches, Reginald

    2012-04-01

    Current procedures in post-earthquake safety and structural assessment are performed by a skilled triage team of structural engineers/certified inspectors. These procedures, in particular the physical measurement of the damage properties, are time-consuming and qualitative in nature. Spalling has been accepted as an important indicator of significant damage to structural elements during an earthquake, and thus provides a sound springboard for a model in machine vision automated assessment procedures as is proposed in this research. Thus, a novel method that automatically detects regions of spalling on reinforced concrete columns and measures their properties in image data is the specific focus of this work. According to this method, the region of spalling is first isolated by way of a local entropy-based thresholding algorithm. Following this, the properties of the spalled region are depicted by way of classification of the extent of spalling on the column. The region of spalling is sorted into one of three categories by way of a novel global entropy-based adaptive thresholding algorithm in conjunction with well-established image processing methods in template matching and morphological operations. These three categories are specified as the following: (1) No spalling; (2) Spalling of cover concrete; and (3) Spalling of the core concrete (exposing reinforcement). In addition, the extent of the spalling along the length of the column is quantified. The method was tested on a database of damaged RC column images collected after the 2010 Haiti Earthquake, and comparison of the results with manual measurements indicate the validity of the method.

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

    PubMed

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

    2007-06-01

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

  1. 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

  2. Safety and efficacy of micafungin for prophylaxis against invasive fungal infections in Japanese patients undergoing hematopoietic stem cell transplantation: Results of a post-marketing surveillance study.

    PubMed

    Kobayashi, Chie; Hanadate, Tomoko; Niwa, Toshiro; Hirano, Yasuno; Yoshiyasu, Takashi; So, Masahiro; Matsui, Keita

    2015-06-01

    Invasive fungal infections are a major cause of morbidity and mortality in patients with hematopoietic stem cell transplantation. A prospective multicenter post-marketing observational surveillance study was conducted from July 2007 to June 2010 to assess the safety and efficacy of micafungin, an echinocandin antifungal, for prophylaxis against invasive fungal infections in Japanese patients undergoing hematopoietic stem cell transplantation. Among 241 patients evaluated for safety, 143 adverse drug reactions were reported in 86 patients (35.7%), with hepatobiliary disorders the most frequently reported adverse drug reactions. The success rate for prophylaxis at the end of observation was 72.8% (131/180 patients), and the incidence of breakthrough infections was only 4.4% (8/180 patients). In conclusion, micafungin had sufficient safety and efficacy for prophylaxis against invasive fungal infections in Japanese patients with various backgrounds undergoing hematopoietic stem cell transplantation. PMID:25749360

  3. Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis

    PubMed Central

    De Hert, Marc; Eramo, Anna; Landsberg, Wally; Kostic, Dusan; Tsai, Lan-Feng; Baker, Ross A

    2015-01-01

    Purpose To assess the efficacy and safety of aripiprazole once-monthly 400 mg (AOM 400), an extended-release injectable suspension of aripiprazole, in obese and nonobese patients. Patients and methods This post hoc analysis of a 38-week randomized, double-blind, active-controlled, noninferiority study (NCT00706654) compared the clinical profile of AOM 400 in obese (body mass index [BMI] ≥30 kg/m2) and nonobese (BMI <30 kg/m2) patients with schizophrenia for ≥3 years. Patients were randomized 2:2:1 to AOM 400, oral aripiprazole 10–30 mg/d, or aripiprazole once-monthly 50 mg (AOM 50 mg) (subtherapeutic dose). Within obese and nonobese patient subgroups, treatment-group differences in Kaplan–Meier estimated relapse rates at week 26 (z-test) and in observed rates of impending relapse through week 38 (chi-square test) were analyzed. Treatment-emergent adverse events (TEAEs) (>10% in any treatment group) were summarized. Results At baseline of the randomized phase, obesity rates were similar among patients randomized to AOM 400 (n=95/265, 36%), oral aripiprazole (n=95/266, 36%), and AOM 50 mg (n=43/131, 33%). In both obese and nonobese patients, relapse rates through week 38 for patients randomized to AOM 400 (obese, 7.4%; nonobese, 8.8%) were similar to those in patients on oral aripiprazole (obese, 8.4%; nonobese, 7.6%), whereas relapse rates were significantly lower with AOM 400 versus AOM 50 mg (obese, 27.9% [P=0.0012]; nonobese, 19.3% [P=0.0153]). The most common TEAEs with AOM 400 in obese and nonobese patients were insomnia (12.6% and 11.2%), headache (12.6% and 8.2%), injection site pain (11.6% and 5.3%), akathisia (10.5% and 10.6%), upper respiratory tract infection (10.5% and 4.7%), weight increase (10.5% and 8.2%), and weight decrease (6.3% and 11.8%). Within the AOM 400 group, 7.6% of patients who were nonobese at baseline became obese, and 17.9% of obese patients became nonobese during randomized treatment. Conclusion The clinical profile of AOM 400 was similar in obese and nonobese patients. PMID:26064048

  4. 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

    Chacn, 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 17.919.0] 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 was only influenced by severity of diarrhea episode, as well as being considered an effective and well tolerated treatment by physicians and patients. PMID:20668711

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

    PubMed

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

    2014-01-01

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

  6. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial.

    PubMed

    Nam, Hyung Seok; Park, Yoon Ghil; Paik, Nam-Jong; Oh, Byung-Mo; Chun, Min Ho; Yang, Hea-Eun; Kim, Dae Hyun; Yi, Youbin; Seo, Han Gil; Kim, Kwang Dong; Chang, Min Cheol; Ryu, Jae Hak; Lee, Shi-Uk

    2015-10-15

    Botulinum toxin A is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. Efficacy and safety of a new botulinum toxin type A, NABOTA (DWP450) in post-stroke upper limb spasticity was evaluated in comparison with Botox (onabotulinum toxin A). A total of 197 patients with post-stroke upper limb spasticity were included in this study and randomly assigned to NABOTA group (n=99) or Botox group (n=98). Wrist flexors with modified Ashworth Scale (MAS) grade 2 or greater, and elbow flexors, thumb flexors and finger flexors with MAS 1 or greater were injected with either drug. The primary outcome was the change of wrist flexor MAS between baseline and 4weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12weeks. The change of MAS for wrist flexor between baseline and 4weeks post-injection was -1.440.72 in the NABOTA group and -1.460.77 in the Botox group. The difference of change between both groups was 0.0129 (95% confidence interval -0.2062-0.2319), within the non-inferiority margin of 0.45. Both groups showed significant improvements regarding MAS of all injected muscles, DAS, and Caregiver Burden Scale at all follow-up periods. There were no significant differences in all secondary outcome measures between the two groups. NABOTA demonstrated non-inferior efficacy and safety for improving upper limb spasticity in stroke patients compared to Botox. PMID:26233808

  7. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... I sign a new service agreement? 302-9.171 Section 302-9.171 Public Contracts and Property Management... 41 Public Contracts and Property Management 4 2011-07-01 2011-07-01 false If circumstances warrant... transport a POV to my post of duty after my assignment to the post of duty, must I sign a new...

  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 14) in the tibiofemoral 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 their required doses, and delay potential future surgical intervention. PMID:25897212

  9. [Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments)].

    PubMed

    Xie, Yan-Ming; Liao, Xing; Zhao, Yu-Bin; Li, Ming-Quan; Zhang, Yun-Ling; Ma, Rong; Xian, Shao-Xiang; Liu, Jian; Li, Su-Yun; Wen, Ze-Huai; Yang, Zhong-Qi; Zou, Jian-Dong; Sun, Hong-Sheng; He, Yan; Li, Xue-Lin; Jiang, Jun-Jie; Wang, Zhi-Fei; Li, Yuan-Yuan; Wang, Lian-Xin; Chang, Yan-Peng; Yang, Wei; Zhang, Wen

    2013-09-01

    It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs. PMID:24471304

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

    PubMed

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

    2006-04-01

    Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines. PMID:16481089

  11. 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...

  12. Safety and Efficacy of Facial Rejuvenation with Small Gel Particle Hyaluronic Acid with Lidocaine and AbobotulinumtoxinA in Post-Chemotherapy Patients

    PubMed Central

    2014-01-01

    Background: Due to advances in detection and treatment, approximately 70 percent of cancer patients are living more than five years after diagnosis. Research indicates that appearance worries are of great concern to cancer survivors impacting their quality of life. This is the first Phase IV investigator-initiated study to investigate the safety and efficacy of facial rejuvenation with small gel particle hyaluronic acid with lidocaine and abobotulinumtoxinA in post-chemotherapy patients. Methods: The safety and efficacy of facial rejuvenation with small gel particle hyaluronic acid with lidocaine and abobotulinumtoxinA was assessed in nine post-chemotherapy patients. Efficacy of small gel particle hyaluronic acid with lidocaine and abobotulinumtoxinA was measured at baseline, Week 2, and Week 8, using a wrinkle severity assessment score. Safety and tolerability of both products were assessed throughout the study by monitoring the occurrence of adverse events. Results: Patients received a mean total of 2.4mL of small gel particle hyaluronic acid with lidocaine in the nasolabial folds and 57.8 Units of abobotulinumtoxinA to glabellar lines at baseline. Additionally, at Week 2, a mean total l.OmL of small gel particle hyaluronic acid with lidocaine was administered to four patients. The mean investigators wrinkle severity assessment score at baseline was 2.22, indicating mild-to-moderate severity. At each of Weeks 2 and 8, there were significant improvements from baseline in wrinkle severity (p=0.004). Overall, small gel particle hyaluronic acid with lidocaine was well tolerated. Adverse events (i.e., bruising, redness, swelling, pain, tenderness, itching or other adverse events) were localized, self-limiting, and resolved within 1 to 2 days. The only adverse event attributed to abobotulinumtoxinA was soreness and slight tenderness at an injection site reported in one patient. Conclusion: Both study products were well tolerated in post-chemotherapy patients with no significant adverse events. There was a clinically meaningful and statistically significant improvement in wrinkle severity at Week 2 post-administration as compared to baseline. This improvement was maintained in all patients at Week 8. PMID:24563694

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

    PubMed

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

    2015-12-01

    The European Food Safety Authority (EFSA) has concluded from a limited review of the literature that although docosahexaenoic acid (DHA) is required for infant formula, arachidonic acid is not required "even in the presence of DHA" (EFSA Journal, 12 (2014) 3760). This flawed opinion is grounded in human trials which tested functionality of DHA in neural outcomes and included arachidonic acid ostensibly to support growth. The EFSA report mistakes a nutrient ubiquitous in the diets of newborn infants, through breast milk and with wide-ranging health and neurodevelopmental effects, for an optional drug targeted to a particular outcome that is properly excluded when no benefit is found for that particular outcome. Arachidonic acid has very different biological functions compared to DHA, for example, arachidonic acid has unique functions in the vasculature and in specific aspects of immunity. Indeed, the overwhelming majority of trials include both DHA and arachidonic acid, and test development specific to DHA such as neural and visual development. DHA suppresses membrane arachidonic acid concentrations and its function. An infant formula with DHA and no arachidonic acid runs the risk of cardio and cerebrovascular morbidity and even mortality through suppression of the favorable oxylipin derivatives of arachidonic acid. The EFSA recommendation overruling breast milk composition should be revised forthwith, otherwise being unsafe, ungrounded in most of the evidence, and risking lifelong disability. PMID:26432509

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

    PubMed Central

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

    2015-01-01

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

  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. 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 (2.871.40 for Remifemin and 2.701.26 for Tibolone) and hot flash/sweating scores (0.941.72 for Remifemin and 1.061.78 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

  17. Immunogenicity, safety and tolerability of meningococcal C CRM197 conjugate vaccine administered 3, 5 and 11 months post-natally to pre- and full-term infants.

    PubMed

    Esposito, Susanna; Corbellini, Barbara; Bosis, Samantha; Pugni, Lorenza; Tremolati, Elena; Tagliabue, Claudia; Toneatto, Daniela; Mosca, Fabio; Principi, Nicola

    2007-06-21

    A total of 79 pre-term infants with a gestational age > or =32 weeks and 74 full-term infants were studied in order to evaluate the immunogenicity, safety and tolerability of meningococcal C (MenC)-CRM(197) conjugate vaccine administered 3, 5 and 11 months post-natally. The evoked immune response seemed to be substantially similar in the pre- and full-term infants, and there were only clinically marginal differences in safety and tolerability between the groups. The results support the use of two doses of MenC-CRM(197) vaccine at 3 and 5 months of age for primary immunisation, with a booster dose being given at about 1 year. In addition to reducing costs, this scheme seems to assure global immunogenicity and potential efficacy that is better than that offered by the accelerated scheme of administration with only three doses of vaccine in the first months of life, and similar to that observed with a fourth dose used as booster after the first year. PMID:17513025

  18. 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

  19. 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

  20. [Post-therapeutic evolution of patients presenting an immunological suspicion of trypanosomiasis without parasitological proof in support of it (author's transl)].

    PubMed

    Frezil, J L; Coulm, J; Alary, J C

    1979-01-01

    The authors have recently preconised systematic treatment of every human being who is fluorescent positive. The evolution of antibodies of 26 subjects parasitologically negative and positive only in FAT test is described here after treatment with Arsobal. Statistically the antibodies decrease progressively like antibodies of Sleeping Sickness patients of first period usually did. Therefore it is possible to conclude that immunological suspects who were treated were realy sick and rightly cured. PMID:379493

  1. Safety of besifloxacin ophthalmic suspension 0.6% in refractive surgery: a retrospective chart review of post-LASIK patients

    PubMed Central

    Nielsen, Steven A; McDonald, Marguerite B; Majmudar, Parag A

    2013-01-01

    Background To evaluate the safety of besifloxacin ophthalmic suspension 0.6% when used in laser-assisted in situ keratomileusis (LASIK) prophylactic antibiotic regimens. Methods Retrospective surveillance of LASIK surgery cases where besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% were prescribed as prophylactic medications. Surgeons from nine US surgical centers provided retrospective case information on surgical outcomes from consecutive cases and reported any adverse events related to the antibacterial used. The primary endpoint was the incidence of adverse drug reactions. Results A total of 801 case reports (801 eyes; 534 besifloxacin, 267 moxifloxacin) were obtained. The mean (standard deviation [SD]) age at time of surgery was 36.1 (10.6) years. The mean (SD) duration of antibiotic treatment was 8.6 (2.2) days in the besifloxacin group and 8.0 (2.3) in the moxifloxacin group; daily dosing frequency was higher in the moxifloxacin group preoperatively, on the day of surgery, and postoperatively. There were no reports of adverse drug reactions for the 801 eyes in this surveillance. There were no differences between the besifloxacin and moxifloxacin treatment groups in rates of unexpected corneal findings (2.1% vs 1.5%, P = 0.949). The distribution of final visual acuity for the besifloxacin and moxifloxacin groups were similar (P = 0.793). Most cases had a final visual acuity of 20/20 or better. Conclusion In this retrospective surveillance study, the prophylactic use of besifloxacin ophthalmic suspension 0.6% and moxifloxacin ophthalmic solution 0.5% in patients undergoing LASIK surgery was not associated with any adverse drug reactions. PMID:23355771

  2. 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 trauma is listened to. Support also comes from the ease of hypnosis. The cut-out acts independently of the override. It is linked to low metabolism at the same point in the left precuneus by evidence from all three conditions, hypnosis, PTSD and DID. The concept of dissociation is not required with any of the hypotheses. PMID:23790686

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

    PubMed Central

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

    2014-01-01

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

  4. 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 20mg/40mg) 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 20mg/40mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140mmHg and diastolic BP (DBP) to <90mmHg 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 164mmHg was reduced to 153, 145, 134 and 130mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100mmHg was reduced to 93, 89, 84 and 82mmHg 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 20mg/40mg is effective and well tolerated without any serious adverse events in patients with hypertension. PMID:24973841

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 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...

  7. Intellectual Authority and Institutional Authority.

    ERIC Educational Resources Information Center

    Collier, Charles W.

    1992-01-01

    This essay examines the idea of intellectual authority as reflected in legal and literary theory and reviews empirical studies of effects of institutional authority on acceptance/rejection of papers by juried journals. It refutes ideas of Stanley Fish that an author's background (his/her "institutional authority") are relevant in evaluating the

  8. 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).

  9. A 6-year open-label study of the efficacy and safety of olanzapine long-acting injection in patients with schizophrenia: a post hoc analysis based on the European label recommendation

    PubMed Central

    Anand, Ernie; Berggren, Lovisa; Deix, Claudia; Tth, goston; McDonnell, David P

    2015-01-01

    Purpose To assess the long-term efficacy and safety of olanzapine long-acting injection (LAI) in the treatment of schizophrenia, focusing on clinical trial data consistent with the approved indication and dosing recommendations in the European label and which forms the basis for treatment decisions made by clinicians in daily clinical practice. Patients and methods This was a post hoc analysis of a 6-year open-label study of olanzapine LAI in patients (male or female, 1875 years old) with schizophrenia entering this study following feeder studies of olanzapine LAI. Patients were flexibly dosed (45405 mg, 2- to 4-week intervals), but those receiving oral olanzapine supplementation whose total olanzapine dose was >20 mg/day equivalent were excluded from this post hoc analysis. Results Data from 669 patients were analyzed (44.5% completed). Positive and Negative Syndrome Scale total scores did not change significantly from baseline to endpoint; Clinical Global Impression-Severity scores improved significantly. Mean weight change was +2.19 kg (P<0.001), with 40.8% of patients experiencing ?7% weight gain. There were 24 occurrences of post-injection delirium/sedation syndrome (PDSS). Conclusion Olanzapine LAI appeared to be effective in the long-term maintenance of schizophrenia, and the safety profile was consistent with that of oral olanzapine, except for injection-related events and PDSS events. PMID:26064053

  10. Promoting a Culture of Safety as a Patient Safety Strategy

    PubMed Central

    Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

    2015-01-01

    Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were prepost evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

  11. 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...

  12. 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...

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

    PubMed Central

    Dez-Domingo, Javier; Bald, Jos-Mara; Planelles-Catarino, Maria Victoria; Garcs-Snchez, Mara; Ubeda, Isabel; JubertRosich, Angels; Mars, Josep; Garcia-Corbeira, Pilar; Moris, Philippe; Teko, Maurice; Vanden Abeele, Carline; Gillard, Paul

    2015-01-01

    Background An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6months following the first vaccination in children aged 39years. Methods In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24months post-vaccination in children aged 39years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (19?g or 375?g hemagglutinin antigen) formulated with AS03A or AS03B (1189mg or 593mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). Results The safety population included 405 children. Over 24months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n=1) and autoimmune hepatitis (n=1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4+ T cells with a TH1 profile were observed. Conclusions Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24months following first vaccination. PMID:25652873

  14. 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

  15. Post-test analysis of dryout test 7B' of the W-1 Sodium Loop Safety Facility Experiment with the SABRE-2P code. [LMFBR

    SciTech Connect

    Rose, S.D.; Dearing, J.F.

    1981-01-01

    An understanding of conditions that may cause sodium boiling and boiling propagation that may lead to dryout and fuel failure is crucial in liquid-metal fast-breeder reactor safety. In this study, the SABRE-2P subchannel analysis code has been used to analyze the ultimate transient of the in-core W-1 Sodium Loop Safety Facility experiment. This code has a 3-D simple nondynamic boiling model which is able to predict the flow instability which caused dryout. In other analyses dryout has been predicted for out-of-core test bundles and so this study provides additional confirmation of the model.

  16. 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.

  17. Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir (I): a drug use investigation.

    PubMed

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

    2014-11-01

    Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. We conducted a drug use investigation of peramivir from October 2010 to February 2012 and evaluated its safety and effectiveness under routine clinical settings. We collected data of 1309 patients from 189 facilities across Japan and examined safety in 1174 patients and effectiveness in 1158 patients. In total, 143 adverse events were observed with an incidence rate of 7.33% (86/1174). Of these, 78 events were adverse drug reactions (ADRs) with an incidence rate of 4.34% (51/1174). The most frequently reported ADRs were diarrhea, vomiting, and nausea, with incidence rates of 1.87% (22/1174), 0.85% (10/1174), and 0.68% (8/1174), respectively. Moreover, no ADR was reported as serious. ADR onset was within 3 days after the start of peramivir administration in 91.0% (71 events) of the 78 ADRs, and ADRs were resolved or improved within 7 days after onset in 96.2% (75 events) of the 78 ADRs. Neither patient characteristics nor treatment factors appeared to significantly affect drug safety. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. The present study demonstrates the safety and effectiveness of peramivir under routine clinical settings. PMID:25131292

  18. 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

  19. 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…

  20. Rosuvastatin for primary prevention in patients with European systematic coronary risk evaluation risk ?5% or Framingham risk >20%: post hoc analyses of the JUPITER trial requested by European health authorities

    PubMed Central

    Koenig, Wolfgang; Ridker, Paul M

    2011-01-01

    Aims On the basis of the JUPITER trial, European health authorities recently approved the use of rosuvastatin to reduce first major cardiovascular events among high' global risk primary prevention patients defined either by Framingham risk score >20% or European systematic coronary risk evaluation (SCORE) ?5%. However, as these are post hoc analyses, data describing these subgroups have not previously been available to the clinical community. Methods and results We randomized 17 802 apparently healthy men aged ?50 and women ?60 with low-density lipoprotein cholesterol (LDL-C) <3.4 mmol/L, who were at an increased vascular risk due to elevated levels of C-reactive protein measured with a high-sensitivity (hs) assay to rosuvastatin 20 mg daily or placebo. Patients with high global cardiovascular risk at baseline were identified by 10-year Framingham risk score >20% or SCORE risk ?5%. During 1.8-year median follow-up (maximum 5 years) of patients with Framingham risk >20%, the rate of myocardial infarction/stroke/cardiovascular death was 9.4 and 18.2 per 1000 person-years in rosuvastatin and placebo-allocated patients, respectively [hazard ratio (HR): 0.50, 95% confidence interval (CI): 0.270.93, P = 0.028]. Among patients with SCORE risk ?5%, the corresponding rates were 6.9 and 12.0 using a model extrapolating risk for age ?65 years (HR: 0.57, 95% CI: 0.430.78, P = 0.0003) and rates were 5.9 and 12.7 when risk for age was capped at 65 years (HR: 0.47, 95% CI: 0.320.68, P < 0.0001). Conclusion In primary prevention patients with elevated hs C-reactive protein who have high global cardiovascular risk (10-year Framingham risk score >20% or SCORE risk ?5%), but LDL-C levels not requiring pharmacologic treatment, rosuvastatin 20 mg significantly reduced major cardiovascular events. ClinicalTrial.gov Identifier: NCT00239681 PMID:20971747

  1. 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 1624). Median progression-free survival was 22.4 weeks (95% confidence interval, 21.724.0). The overall survival rate at 24 weeks was 91% (95% confidence interval, 8894). 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 handfoot syndrome (hazard ratio = 0.636; 95% confidence interval, 0.4560.888) and leukopenia (hazard ratio = 0.683; 95% confidence interval, 0.4920.948) 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

  2. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... system remains operational until verification that the launch vehicle does not represent a risk of... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Post-launch and post-flight-attempt hazard... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Ground Safety § 417.415 Post-launch and...

  3. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... system remains operational until verification that the launch vehicle does not represent a risk of... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Post-launch and post-flight-attempt hazard... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Ground Safety § 417.415 Post-launch and...

  4. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... system remains operational until verification that the launch vehicle does not represent a risk of... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Post-launch and post-flight-attempt hazard... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Ground Safety § 417.415 Post-launch and...

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

    PubMed Central

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

    2015-01-01

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

  6. Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir. II: a pediatric drug use investigation.

    PubMed

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

    2015-03-01

    Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. In October 2010, an additional indication for pediatric use was approved. We conducted a pediatric drug use investigation of peramivir from October 2010 to February 2012 and evaluated its real-world safety and effectiveness in pediatric patients. We collected the data of 1254 peramivir-treated pediatric patients from 161 facilities across Japan and examined the safety in 1199 patients and effectiveness in 1188 patients. In total, 245 adverse events were observed with an incidence rate of 14.01% (168/1199). Of these, 115 events were adverse drug reactions (ADRs) with an incidence rate of 7.67% (92/1199). Common ADRs were diarrhea and abnormal behavior, with incidence rates of 2.50% (30/1199) and 2.25% (27/1199), respectively. Fourteen serious ADRs were observed in 12 patients (1.00%), including 5 cases each of abnormal behavior and neutrophil count decreased. While 87.0% (100 events) of ADRs occurred within 3 days after the initiation of peramivir administration, 87.8% (101 events) resolved or improved within 7 days after onset. Multivariate analyses indicated that the presence or absence of underlying diseases/complications was significantly related to ADR incidence. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. Thus, this study confirms the pediatric safety of peramivir without any concerns about effectiveness under routine clinical settings. PMID:25523716

  7. 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.

  8. 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

    Mahendra, B J; Narayana, Dh Ashwath; Agarkhedkar, Sharad; Ravish, H S; Harish, B R; Agarkhedkar, Shalaka; Madhusudana, S N; 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

  9. NIOSH post-hearing comments to DOL on the Mine Safety and Health Administration proposed rule: Ionizing radiation standard for metal and nonmetal mines, February 26, 1988

    SciTech Connect

    Not Available

    1988-02-26

    The testimony addresses many questions and points in the Mine Safety and Health Administration (MSHA) proposed ionizing radiation standards. Specific items addressed in the testimony included the effect of the hard rock mining experience of the United States Public Health Service uranium miners cohort on the results of the analysis; the potential influence of other hard rock mining experience, the documentation of exposure to average radon progeny, how many lung cancer deaths were observed among miners, use of personal protective equipment, keeping of environmental and medical records, risk assessment, risk factors, risk analysis, possible biases in the study, adverse health effects of exposure, and random sampling strategies, relative risk of developing leukemia, pulmonary function testing, lung cancer survival rate, rotation of workers, radiation hormesis, lung cancer risk, healthy worker effect, ALARA, and the NIOSH recommended exposure limit.

  10. The Safety of Concurrent Administration of Opioids via Epidural and Intravenous Routes for Post-operative Pain in Pediatric Oncology Patients

    PubMed Central

    Anghelescu, Doralina L.; Ross, Catherine E.; Oakes, Linda L.; Burgoyne, Laura L.

    2008-01-01

    Supplementation of epidural opioid analgesia with intravenous opioids is usually avoided because of concern about respiratory depression. However, the choice of adjunct analgesic agents for pediatric oncology patients is limited. Antipyretic drugs may mask fever in neutropenic patients, and non-steroidal anti-inflammatory agents may exert anti-platelet effects and interact with chemotherapeutic agents. We examined the safety of concurrent use of epidural and intravenous opioids in a consecutive series of 117 epidural infusions in pediatric patients and compared our findings to those reported by other investigators. We observed a 0.85% rate of clinically significant respiratory complications. The single adverse event was associated with an error in dosage. In our experience, the supplementation of epidural opioid analgesia with intravenous opioids has been a safe method of postoperative pain control for pediatric patients with cancer. PMID:18291619

  11. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting.

    PubMed

    Lim, Fong Seng; Phua, Kong Boo; Lee, Bee Wah; Quak, Seng Hock; Teoh, Yee Leong; Ramakrishnan, Gunasekaran; Han, Htay-Htay; Van Der Meeren, Olivier; Jacquets, Jeanne-Marie; Bock, Hans L

    2011-01-01

    Combination vaccines have been shown to improve the timeliness of vaccination and vaccine coverage. Safety and reactogenicity of combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus and Haemophilus influenzae type b vaccine (DTPa-IPV/Hib, Infanrix IPV+Hib, GlaxoSmithKline Biologicals) was assessed in two clinical studies. In Study A, 2,590 subjects received DTPa-IPV/Hib at 3, 4 and 5 months of age with a booster at 18 months. In Study B, 702 subjects received the same schedule but with DTPa-hepatitis B-IPV/Hib (DTPa-HBV-IPV/Hib, Infanrix hexa, GlaxoSmithKline Biologicals) vaccine administered at 5 months of age. Reactogenicity was assessed for four days after each dose using diary cards. Serious adverse events (SAEs) were assessed until 24 months of age. The vaccines were well tolerated. After primary vaccination, irritability was the most frequently reported grade 3 general symptom (0.8% of doses in both studies). Fever (axillary) > 39 degrees C was infrequent (0.3% of doses in Study A; 0.5% of doses in Study B). After the booster dose, the most frequently reported grade 3 symptom was redness (5%) in Study A and pain (0.5%) in Study B. An axillary temperature > 39 degrees C was reported in 1.1% of subjects. Throughout the study period, 646 SAEs were reported, of which 6 SAEs were considered to be vaccination-related. The reactogenicity and safety profile of the combined DTPa-IPV/Hib vaccine was good when used for primary and booster vaccinations in over 3,000 Singaporean infants. Substitution of DTPa-IPV/Hib with DTPa-HBV-IPV/Hib at Month 5 reduced the number of injections required at this age by one. PMID:21323176

  12. A Systematic Review of the Efficacy and Safety Experience Reported for Sorafenib in Advanced Renal Cell Carcinoma (RCC) in the Post-Approval Setting

    PubMed Central

    Fishman, Mayer N.; Tomshine, Jin; Fulp, William J.; Foreman, Pamela K.

    2015-01-01

    Background Sorafenib was FDA approved in 2005 for treatment of renal cell carcinoma (RCC) based on the results of the pivotal phase 3 clinical trial, TARGET (Treatment Approaches in Renal Cancer Global Evaluation Trial). Since that time, numerous clinical studies have been undertaken that substantially broaden our knowledge of the use of sorafenib for this indication. Methods We systematically reviewed PubMed, Web of Science, Embase, Cochrane Library, and www.clinicaltrials.gov for prospective clinical studies using single agent sorafenib in RCC and published since 2005. Primary endpoints of interest were progression-free survival (PFS) and safety. PROSPERO International prospective register of systematic reviews #CRD42014010765. Results We identified 30 studies in which 2182 patients were treated with sorafenib, including 1575 patients who participated in randomized controlled phase 3 trials. In these trials, sorafenib was administered as first-, second- or third-line treatment. Heterogeneity among trial designs and reporting of data precluded statistical comparisons among trials or with TARGET. The PFS appeared shorter in second- vs. first-line treatment, consistent with the more advanced tumor status in the second-line setting. In some trials, incidences of grade 3/4 hypertension or hand-foot skin reaction (HFSR) were more than double that seen in TARGET (4% and 6%, respectively). These variances may be attributable to increased recognition of HFSR, or potentially differences in dose adjustments, that could be consequences of increased familiarity with sorafenib usage. Several small studies enrolled exclusively Asian patients. These studies reported notably longer PFS than was observed in TARGET. However, no obvious corresponding differences in disease control rate and overall survival were seen. Conclusions Collectively, more recent experiences using sorafenib in RCC are consistent with results reported for TARGET with no marked changes of response endpoints or new safety signals observed. PMID:25830512

  13. Hand Safety

    MedlinePLUS

    ... Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Cómo sacarse un anillo ... Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Cómo sacarse un anillo ...

  14. 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 0.10mm 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

  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. 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

  17. 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.

  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. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 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...

  20. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 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...

  1. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 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...

  2. 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...

  3. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD ACCIDENT/INCIDENT INVESTIGATION PROCEDURES 831.3 Authority of Directors. The Directors, Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and...

  4. Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction

    PubMed Central

    Hamdy, Reggie C; Montpetit, Kathleen; Ruck-Gibis, Joanne; Thorstad, Kelly; Raney, Ellen; Aiona, Michael; Platt, Robert; Finley, Allen; Mackenzie, William; McCarthy, James; Narayanan, Unni

    2007-01-01

    Background Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A), which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis. Methods/Design The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 521 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont). Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group) intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada. Discussion BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX-A is being used under the context of limb lengthening and deformity correction. Trial Registration NCT00412035 PMID:17903262

  5. 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

  6. 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.

  7. 47 CFR 80.407 - Operator authorization.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Operator authorization. 80.407 Section 80.407... MARITIME SERVICES Station Documents 80.407 Operator authorization. This section contains information and rules pertinent to the application for and posting of radio operator authorizations. Rules applicable...

  8. 47 CFR 80.407 - Operator authorization.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Operator authorization. 80.407 Section 80.407... MARITIME SERVICES Station Documents 80.407 Operator authorization. This section contains information and rules pertinent to the application for and posting of radio operator authorizations. Rules applicable...

  9. 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

  10. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... part, the Commission may authorize construction of a geologic repository operations area at the Yucca Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  11. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... part, the Commission may authorize construction of a geologic repository operations area at the Yucca Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  12. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... part, the Commission may authorize construction of a geologic repository operations area at the Yucca Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  13. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Licenses Construction Authorization § 63.31 Construction authorization... part, the Commission may authorize construction of a geologic repository operations area at the Yucca Mountain site if it determines: (a) Safety. (1) That there is reasonable assurance that the types...

  14. 48 CFR 50.202 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., 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...

  15. 48 CFR 50.202 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., 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...

  16. 48 CFR 50.202 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., 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...

  17. 48 CFR 50.202 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., 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...

  18. 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. MedRadio operation is authorized anywhere...

  19. 48 CFR 50.202 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 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 by..., Contracting Authority of Government Agencies in Connection with National Defense Functions. (d) 6 CFR Part 25....

  20. 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

  1. 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)

  2. 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...

  3. 48 CFR 605.502 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 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...

  4. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) 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...

  5. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., 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...

  6. 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)....

  7. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  8. 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)....

  9. 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....

  10. 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)....

  11. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable...

  12. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable...

  13. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable...

  14. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable...

  15. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable...

  16. Safety of Navigation Locks

    SciTech Connect

    Kolosov, M. A.

    2002-03-15

    The author's observations and studies of safety of navigation locks are described. A mathematical model of lock reliability and its graphical interpretation are presented. The possibility of determination of the accident risk level by processing statistical data is discussed.

  17. 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…

  18. 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

  19. 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...

  20. 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)

  1. 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

  2. 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…

  3. Total safety: A new safety culture to integrate nuclear safety and operational safety

    SciTech Connect

    Saji, G.; Murphy, G.A.

    1991-07-01

    The creation of a complete and thorough safety culture is proposed for the purpose of providing additional assurance about nuclear safety and improving the performance of nuclear power plants. The safety philosophy developed a combination of the former hardware-oriented nuclear safety approach and recent operational safety concepts. The improvement of the latter, after TMI-2 and Chernobyl, has been proven very effective in reducing the total risk associated with nuclear power plants. The first part of this article introduces a {open_quotes}total safety{close_quotes} concept. This extends the concept of {open_quotes}nuclear safety{close_quotes} and makes it closer to the public perception of safety. This concept is defined by means of a taxonomy of total safety. The second part of the article shows that total safety can be achieved by integrating it into a modern quality assurance (QA) system since it is tailored to make implementation into a framework of QA easier. The author believes that the outstanding success experienced by various industries as a result of introducing the modern QA system should lead to its application for ensuring the safety and performance of nuclear facilities. 15 refs., 3 figs.

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

    SciTech Connect

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

    1993-06-01

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

  5. 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 RoSPA awards at site and sector level and nomination, at Company level, for the RoSPA George Earle trophy for outstanding performance in Health and Safety (Reactor Sites, 2006). After 'setting the scene' and describing the challenges that the company has had to respond to, the paper explains how these improvements have been delivered. Specifically it explains the process that has been followed and the parts played by sites and suppliers to deliver improved performance. With the experience of already having transitioned several Magnox stations from operations to defueling and then to decommissioning, the paper describes the valuable experience that has been gained in achieving an optimum change process and maintaining momentum. (authors)

  6. 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...

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

    PubMed

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

    2015-11-01

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

  8. 77 FR 8288 - State's Mine Health and Safety Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... Safety and Health Administration State's Mine Health and Safety Grants AGENCY: Mine Safety and Health... United States Department of Labor, Mine Safety and Health Administration (MSHA), has posted its... formula in Section 503(h) of the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 953(h)) and...

  9. 76 FR 1642 - State's Mine Health and Safety Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ... Safety and Health Administration State's Mine Health and Safety Grants AGENCY: Mine Safety and Health... Safety and Health Administration (MSHA), has posted its solicitation for grant applications (SGA) for the... Safety and Health Act of 1977 (30 U.S.C. 953(h)) and MSHA's final Fiscal Year 2011...

  10. 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....

  11. 30 CFR 282.11 - Director's authority.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Director's authority. 282.11 Section 282.11 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE... Responsibilities of Director 282.11 Director's authority. (a)-(c) (d)(1) The Director may approve...

  12. 30 CFR 282.11 - Director's authority.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Director's authority. 282.11 Section 282.11 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE... Responsibilities of Director 282.11 Director's authority. (a)-(c) (d)(1) The Director may approve...

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

    SciTech Connect

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

    1993-06-01

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

  14. Drug Safety

    MedlinePLUS

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

  15. Food Safety

    MedlinePLUS

    ... Waste Food Safety Newsroom Dietary Guidelines Communicator’s Guide Food Safety You are here Home / Audience / Children / Preschoolers Food Safety Print Share Preschoolers' immune systems are still developing. ...

  16. Safety Education.

    ERIC Educational Resources Information Center

    Daniels, James H.; And Others

    1980-01-01

    Five articles in this issue focus on safety education in agricultural laboratories. Topics discussed include teacher liability; elements of a safety instruction program; state and federal safety standards; ground fault current protection; and eye protection requirements and equipment. (SK)

  17. Post-emergence herbicides useful in calendula

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  18. 49 CFR 238.211 - Collision posts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Collision posts. 238.211 Section 238.211 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PASSENGER EQUIPMENT SAFETY STANDARDS Specific Requirements for Tier I Passenger Equipment 238.211 Collision posts....

  19. 49 CFR 238.213 - Corner posts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Corner posts. 238.213 Section 238.213 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PASSENGER EQUIPMENT SAFETY STANDARDS Specific Requirements for Tier I Passenger Equipment 238.213 Corner posts. (a)(1)...

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

    PubMed

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-03-24

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

  1. Vaccine Safety

    MedlinePLUS

    ... Vaccine Safety Smallpox Vaccine Safety Common Concerns Adjuvants Autism CDC Statement: 2004 Pediatrics Paper on MMR and Autism Fainting (Syncope) Febrile Seizures Guillain-Barre Syndrome Multiple ...

  2. Liquefied natural gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1977-01-01

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

  3. 200 Area Deactivation Project Facilities Authorization Envelope Document

    SciTech Connect

    DODD, E.N.

    2000-03-28

    Project facilities as required by HNF-PRO-2701, Authorization Envelope and Authorization Agreement. The Authorization Agreements (AA's) do not identify the specific set of environmental safety and health requirements that are applicable to the facility. Therefore, the facility Authorization Envelopes are defined here to identify the applicable requirements. This document identifies the authorization envelopes for the 200 Area Deactivation.

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

    SciTech Connect

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

    1993-06-01

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

  5. 14 CFR 415.117 - Ground safety.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... system and operation used in launch processing and post-flight operations as required by § 417.109 of... TRANSPORTATION LICENSING LAUNCH LICENSE Safety Review and Approval for Launch of an Expendable Launch Vehicle From a Non-Federal Launch Site § 415.117 Ground safety. (a) General. An applicant's safety...

  6. 14 CFR 415.117 - Ground safety.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... system and operation used in launch processing and post-flight operations as required by § 417.109 of... TRANSPORTATION LICENSING LAUNCH LICENSE Safety Review and Approval for Launch of an Expendable Launch Vehicle From a Non-Federal Launch Site § 415.117 Ground safety. (a) General. An applicant's safety...

  7. 14 CFR 415.117 - Ground safety.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... system and operation used in launch processing and post-flight operations as required by § 417.109 of... TRANSPORTATION LICENSING LAUNCH LICENSE Safety Review and Approval for Launch of an Expendable Launch Vehicle From a Non-Federal Launch Site § 415.117 Ground safety. (a) General. An applicant's safety...

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

    PubMed

    Kochhar, Sonali

    2015-01-01

    Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world. PMID:25859676

  9. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Post hearing briefs. 3.544 Section 3.544 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.544 Post hearing briefs. The ALJ...

  10. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Post hearing briefs. 3.544 Section 3.544 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.544 Post hearing briefs. The ALJ...

  11. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Post hearing briefs. 3.544 Section 3.544 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.544 Post hearing briefs. The ALJ...

  12. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Post hearing briefs. 3.544 Section 3.544 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.544 Post hearing briefs. The ALJ...

  13. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Post hearing briefs. 3.544 Section 3.544 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.544 Post hearing briefs. The ALJ...

  14. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... launch vehicle flown with a flight safety system, identify any flight environment not consistent with the... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report....

  15. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... launch vehicle flown with a flight safety system, identify any flight environment not consistent with the... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report....

  16. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... launch vehicle flown with a flight safety system, identify any flight environment not consistent with the... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report....

  17. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... launch vehicle flown with a flight safety system, identify any flight environment not consistent with the... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report....

  18. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... launch vehicle flown with a flight safety system, identify any flight environment not consistent with the... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report....

  19. 30 CFR 44.9 - Posting of petition.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Posting of petition. 44.9 Section 44.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS RULES OF PRACTICE FOR PETITIONS FOR MODIFICATION OF MANDATORY SAFETY STANDARDS General § 44.9 Posting of petition. An operator of a...

  20. 30 CFR 44.9 - Posting of petition.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Posting of petition. 44.9 Section 44.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS RULES OF PRACTICE FOR PETITIONS FOR MODIFICATION OF MANDATORY SAFETY STANDARDS General § 44.9 Posting of petition. An operator of a...

  1. 30 CFR 44.9 - Posting of petition.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting of petition. 44.9 Section 44.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS RULES OF PRACTICE FOR PETITIONS FOR MODIFICATION OF MANDATORY SAFETY STANDARDS General § 44.9 Posting of petition. An operator of a...

  2. 30 CFR 44.9 - Posting of petition.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Posting of petition. 44.9 Section 44.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS RULES OF PRACTICE FOR PETITIONS FOR MODIFICATION OF MANDATORY SAFETY STANDARDS General § 44.9 Posting of petition. An operator of a...

  3. 30 CFR 44.9 - Posting of petition.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Posting of petition. 44.9 Section 44.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS RULES OF PRACTICE FOR PETITIONS FOR MODIFICATION OF MANDATORY SAFETY STANDARDS General § 44.9 Posting of petition. An operator of a...

  4. Safe Schools Survey: Post-Secondary Survey Results.

    ERIC Educational Resources Information Center

    Mowery, Andrea

    This report provides the results of a survey of safety and security at colleges and universities in Minnesota, along with policy recommendations to improve safety and security at Minnesota post-secondary institutions. It is based on campus security reports voluntarily submitted by 60 of the 110 Minnesota post-secondary institutions, personal

  5. Biological post

    PubMed Central

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

    2015-01-01

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

  6. Authoring and GTE.

    ERIC Educational Resources Information Center

    Johnson, Robin; Sime, Julie-Ann

    1998-01-01

    Examines GTE (Generic Tutoring Environment) from an authoring perspective, describes how GTE may be used to create courseware, and reviews potential difficulties that authors face when using such a tool. Summarizes two studies that investigated how authors used GTE and concludes that GTE designs are difficult for authors to test and evaluate.

  7. Authoring hypermedia training applications

    NASA Astrophysics Data System (ADS)

    Tsalgatidou, Aphrodite; Anastasiou, M.; Plevria, D.; Hatzopoulos, M.

    1998-09-01

    This paper presents an approach for authoring training applications. In this approach we think an author can undertake two roles: the meta-authoring role and the authoring role. A meta-author selects educational material and proposes lessons to be used later by an author in order to build specific educational applications. These two roles are supported by the meta-authoring tool and the authoring tool, which both form the authoring environment. The system also comprises a repository with generic and re-usable data, and a delivery environment. Resulted applications consist of flexible educational sessions, which are adjustable according to the learner's profile and overcome several problems, such as disorientation, usually encountered in hypermedia applications. Thus, authors can easily and effectively build educational applications, trainees' progress is automatically assessed, and reusability is achieved.

  8. Biologic Safety in Psoriasis

    PubMed Central

    Mansouri, Yasaman

    2015-01-01

    The development of targeted biologic agents has revolutionized the treatment of psoriasis. In this review, the authors focus on the published long-term (? one year) safety data for the use of tumor necrosis factor-? antagonists etanercept, infliximab, and adalimumab, as well as the IL-12/IL-23 antagonist ustekinumab, in adult patients with moderate-to-severe psoriasis. The efficacy of these currently available biologic therapies has been demonstrated in several studies, and their safety profiles are also reassuring. PMID:25741401

  9. 42 CFR 3.508 - Authority of the ALJ.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Authority of the ALJ. 3.508 Section 3.508 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.508 Authority of the ALJ. (a) The ALJ...

  10. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.416 Authority to settle. Nothing in...

  11. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.514 Authority to settle. The Secretary...

  12. 42 CFR 3.508 - Authority of the ALJ.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Authority of the ALJ. 3.508 Section 3.508 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.508 Authority of the ALJ. (a) The ALJ...

  13. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.416 Authority to settle. Nothing in...

  14. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.514 Authority to settle. The Secretary...

  15. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.416 Authority to settle. Nothing in...

  16. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.416 Authority to settle. Nothing in...

  17. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.514 Authority to settle. The Secretary...

  18. 42 CFR 3.508 - Authority of the ALJ.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority of the ALJ. 3.508 Section 3.508 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.508 Authority of the ALJ. (a) The ALJ...

  19. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.514 Authority to settle. The Secretary...

  20. 42 CFR 3.508 - Authority of the ALJ.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Authority of the ALJ. 3.508 Section 3.508 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.508 Authority of the ALJ. (a) The ALJ...

  1. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.416 Authority to settle. Nothing in...

  2. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program 3.514 Authority to settle. The Secretary...

  3. 29 CFR 1975.2 - Basis of authority.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 9 2013-07-01 2013-07-01 false Basis of authority. 1975.2 Section 1975.2 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) COVERAGE OF EMPLOYERS UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 1975.2 Basis of authority. The power...

  4. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 5 2010-07-01 2010-07-01 false Authority for inspection. 1903.3 Section 1903.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES § 1903.3 Authority for inspection. (a) Compliance Safety...

  5. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 5 2013-07-01 2013-07-01 false Authority for inspection. 1903.3 Section 1903.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES § 1903.3 Authority for inspection. (a) Compliance Safety...

  6. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 5 2011-07-01 2011-07-01 false Authority for inspection. 1903.3 Section 1903.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES § 1903.3 Authority for inspection. (a) Compliance Safety...

  7. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 5 2014-07-01 2014-07-01 false Authority for inspection. 1903.3 Section 1903.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES § 1903.3 Authority for inspection. (a) Compliance Safety...

  8. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 5 2012-07-01 2012-07-01 false Authority for inspection. 1903.3 Section 1903.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES § 1903.3 Authority for inspection. (a) Compliance Safety...

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

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2005-01-01

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

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

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2004-01-01

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

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

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2004-01-01

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

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

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2005-01-01

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

  13. 30 CFR 57.19094 - Posting signal code.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Posting signal code. 57.19094 Section 57.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 57.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  14. 30 CFR 56.19094 - Posting signal code.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  15. 30 CFR 56.19094 - Posting signal code.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Posting signal code. 56.19094 Section 56.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 56.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  16. 30 CFR 56.19094 - Posting signal code.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Posting signal code. 56.19094 Section 56.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 56.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  17. 30 CFR 56.19094 - Posting signal code.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Posting signal code. 56.19094 Section 56.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 56.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  18. 30 CFR 57.19094 - Posting signal code.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Posting signal code. 57.19094 Section 57.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 57.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  19. 30 CFR 57.19094 - Posting signal code.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Posting signal code. 57.19094 Section 57.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 57.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  20. 30 CFR 57.19094 - Posting signal code.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  1. 30 CFR 56.19094 - Posting signal code.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Posting signal code. 56.19094 Section 56.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 56.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  2. 30 CFR 57.19094 - Posting signal code.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Posting signal code. 57.19094 Section 57.19094 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE... Signaling 57.19094 Posting signal code. A legible signal code shall be posted prominently in the...

  3. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ....1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL... number of men permitted to ride on each hoist or elevator at one time; this limit shall be posted on...

  4. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ....1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL... number of men permitted to ride on each hoist or elevator at one time; this limit shall be posted on...

  5. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ....1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL... number of men permitted to ride on each hoist or elevator at one time; this limit shall be posted on...

  6. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ....1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL... number of men permitted to ride on each hoist or elevator at one time; this limit shall be posted on...

  7. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ....1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL... number of men permitted to ride on each hoist or elevator at one time; this limit shall be posted on...

  8. Auto Safety

    MedlinePLUS

    ... KidsHealth in the Classroom What Other Parents Are Reading Zika & Pregnancy: What to Know Signing Kids Up ... kids by following simple safety measures and by teaching some basic rules. Importance of Child Safety Seats ...

  9. Water Safety

    MedlinePLUS

    ... Caring for Your Child All About Food Allergies Water Safety KidsHealth > For Parents > Water Safety Print A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  10. And Speaking of Authority...

    ERIC Educational Resources Information Center

    Williams, Connie

    2010-01-01

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

  11. Authority in Engineering Education

    ERIC Educational Resources Information Center

    Stephan, Karl D.

    2012-01-01

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

  12. And Speaking of Authority...

    ERIC Educational Resources Information Center

    Williams, Connie

    2010-01-01

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

  13. Authorization basis supporting documentation for plutonium finishing plant

    SciTech Connect

    King, J.P., Fluor Daniel Hanford

    1997-03-05

    The identification and definition of the authorization basis for the Plutonium Finishing Plant (PFP) facility and operations are essential for compliance to DOE Order 5480.21, Unreviewed Safety Questions. The authorization basis, as defined in the Order, consists of those aspects of the facility design basis, i.e., the structures, systems and components (SSCS) and the operational requirements that are considered to be important to the safety of operations and are relied upon by DOE to authorize operation of the facility. These facility design features and their function in various accident scenarios are described in WHC-SD-CP-SAR-021, Plutonium Finishing Plant Final Safety Analysis Report (FSAR), Chapter 9, `Accident Analysis.` Figure 1 depicts the relationship of the Authorization Basis to its components and other information contained in safety documentation supporting the Authorization Basis. The PFP SSCs that are important to safety, collectively referred to as the `Safety Envelope` are discussed in various chapters of the FSAR and in WHC-SD-CP-OSR-010, Plutonium Finishing Plant Operational Safety Requirements. Other documents such as Criticality Safety Evaluation Reports (CSERS) address and support some portions of the Authorization Basis and Safety Envelope.

  14. Safety Handbook.

    ERIC Educational Resources Information Center

    Montgomery County Public Schools, Rockville, MD.

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

  15. System safety 2000: A practical guide for planning, managing, and conducting system safety programs

    SciTech Connect

    Stephenson, J.

    1991-01-01

    This book attempts to provide a backgound for converting system safety into a science. The author addresses the commonality of system safety terms, tools, and techniques in the aerospace and weapons industries. The book is broken into four parts: Introduction to System Safety, System Safety Program Planning and Management, Analytical Aids, and System Safety Analysis Techniques. The book is a useful guide or textbook for boosting future safety systems.

  16. 12 CFR 380.25 - Post-insolvency interest.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  17. 12 CFR 380.25 - Post-insolvency interest.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  18. 12 CFR 380.25 - Post-insolvency interest.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  19. Robotic safety

    SciTech Connect

    Kessel, D.S.

    1984-10-01

    The introduction of industrial robots in the workplace has improved safety by reducing human exposure to some of the traditional hazardous tasks and environments, yet at the same time robots have introduced new hazards in the workplace. There are currently no national consensus standards for robotic safety in the US. This report discusses the hazards associated with industrial robots and provides safety guidelines to protect workers from these hazards. In conclusion, it is the responsibility of manufacturers and users of industrial robots to develop and implement robotic safety guidelines for each application to ensure worker safety. 13 references.

  20. Post-mortem toxicology.

    PubMed

    Drummer, Olaf H

    2007-01-17

    Studies examining post-mortem processes are difficult to conduct since changes will have already occurred when the body arrives at the mortuary. While control of collection site for blood can minimize changes in concentration it is very difficult to conduct experiments in humans aimed at understanding the mechanisms and determining the extent of such changes. The use of appropriate animal models can be useful in this regard providing the species and conditions are carefully chosen. Pharmacokinetic studies in humans are also very useful for understanding the changes in drug concentration with time in blood (and other fluids) and also for improving our understanding of drug effects. Unfortunately, doses of illicit drugs that can be given are relatively low to guarantee safety hence extrapolations are made to real life situations. Individual case studies can be useful to describe an unusual or particularly interesting circumstances but little useful information can be obtained when trying to ascertain the role of competing factors, e.g. role of individual drugs when multiple drugs are present, varying toxicity between route of administration, and the role of age or natural disease when drugs are also present. Epidemiological approaches by reviewing large numbers of related cases are the most powerful tool to obtain this information. All of these studies need to operate under the ethical and legal framework appropriate for a jurisdiction. This paper discusses the relative merits of scientific approaches to research in post-mortem toxicology and provides guidance on the most appropriate techniques for future studies. PMID:16781104

  1. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  2. 20 CFR 801.102 - Review authority.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Review authority. 801.102 Section 801.102 Employees' Benefits BENEFITS REVIEW BOARD, DEPARTMENT OF LABOR ESTABLISHMENT AND OPERATION OF THE BOARD... Safety Act, hereinafter, FCMHSA, of 1969) as amended by the Black Lung Benefits Reform Act of...

  3. 20 CFR 801.102 - Review authority.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 4 2013-04-01 2013-04-01 false Review authority. 801.102 Section 801.102 Employees' Benefits BENEFITS REVIEW BOARD, DEPARTMENT OF LABOR ESTABLISHMENT AND OPERATION OF THE BOARD... Safety Act, hereinafter, FCMHSA, of 1969) as amended by the Black Lung Benefits Reform Act of...

  4. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  5. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested...

  6. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  7. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested...

  8. 48 CFR 23.901 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Authority. 23.901 Section 23.901 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contractor Compliance...

  9. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY,...

  10. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY,...

  11. 47 CFR 97.111 - Authorized transmissions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Station Operation Standards 97.111 Authorized transmissions. (a) An amateur station may transmit... other stations in the amateur service, except those in any country whose administration has notified...

  12. 47 CFR 97.111 - Authorized transmissions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Station Operation Standards 97.111 Authorized transmissions. (a) An amateur station may transmit... other stations in the amateur service, except those in any country whose administration has notified...

  13. 47 CFR 97.111 - Authorized transmissions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Station Operation Standards 97.111 Authorized transmissions. (a) An amateur station may transmit... other stations in the amateur service, except those in any country whose administration has notified...

  14. 47 CFR 97.111 - Authorized transmissions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Station Operation Standards 97.111 Authorized transmissions. (a) An amateur station may transmit... other stations in the amateur service, except those in any country whose administration has notified...

  15. 47 CFR 97.111 - Authorized transmissions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Station Operation Standards 97.111 Authorized transmissions. (a) An amateur station may transmit... other stations in the amateur service, except those in any country whose administration has notified...

  16. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  17. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  18. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  19. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY,...

  20. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  1. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  2. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY,...

  3. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  4. 48 CFR 23.901 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Authority. 23.901 Section 23.901 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contractor Compliance...

  5. Authoring tool evaluation

    SciTech Connect

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

    1994-09-15

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

  6. Akenti Authorization System

    Energy Science and Technology Software Center (ESTSC)

    2000-06-01

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

  7. Teaching Electrical Safety.

    ERIC Educational Resources Information Center

    Ellse, Mark D.

    1989-01-01

    An understanding of the important concepts of electrical safety can be developed without the concept of potential. Stresses the idea of current flow and the hazards involved. Discusses ground-fault circuit breakers. Includes diagrams on safe and faulty circuits which could lead to electrocution. (Author/MVL)

  8. Tank Farms Technical Safety Requirements

    SciTech Connect

    DANNA, M.A.

    2003-10-24

    The TSRs define the acceptable conditions, safe boundaries, bases thereof, and controls to ensure safe operation during authorized activities, for facilities within the scope of the Tank Farms Documented Safety Analysis (DSA), in parallel with the DSA.

  9. Laser Safety in the Laboratory

    ERIC Educational Resources Information Center

    Weichel, H.; And Others

    1974-01-01

    Deals with the subject of laser hazards, laser hazards control, and laser safety practices in the laboratory. Describes four categories of hazards: radiative, electrical, explosive, and toxic, and explains the status of federal regulations that seek to define lazer hazards and control safety standards. (Author/GS)

  10. Vaccine Safety Resources for Nurses

    PubMed Central

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

    2015-01-01

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

  11. Boerhaave: Author and Editor *

    PubMed Central

    Lindeboom, G. A.

    1974-01-01

    The many facets of Herman Boerhaave's life are presented. He was a renowned teacher, physician, author, and editor. Discussed here are his activities as cataloger of the Vossius Collection, author of books on chemistry, botany, and medicine, and as editor of works by Vesalius and early Greek medical writers. Printing and bookselling in Leiden during Boerhaave's era are described. Images PMID:4596962

  12. The Authors Reply

    ERIC Educational Resources Information Center

    File, Kieran A.; Adams, Rebecca

    2010-01-01

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

  13. The Voice of Authority

    ERIC Educational Resources Information Center

    Wetterlund, Kris

    2012-01-01

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

  14. Adopt an Author.

    ERIC Educational Resources Information Center

    Shaw, Pamela Carson

    1994-01-01

    This article recounts a learning experience at the Kansas State School for the Deaf in which students invited an author of children's books about deaf children, Jean Andrews, to visit and participated with the author in developing her next book. Students also wrote their own books, and received feedback on them from Andrews. (DB)

  15. Charter Authorizers Face Challenges

    ERIC Educational Resources Information Center

    Gustafson, Joey

    2013-01-01

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

  16. The Authors Reply

    ERIC Educational Resources Information Center

    Guilloteaux, Marie J.; Dornyei, Zoltan

    2009-01-01

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

  17. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Acquisitions by overseas... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  18. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Acquisitions by overseas... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  19. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Acquisitions by overseas... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  20. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Acquisitions by overseas... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  1. 48 CFR 606.304-70 - Acquisitions by overseas posts.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Acquisitions by overseas... Acquisitions by overseas posts. The Departmental Competition Advocate is the approval authority for the... through the Principal Officer at the overseas post....

  2. Authorization basis requirements comparison report

    SciTech Connect

    Brantley, W.M.

    1997-08-18

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

  3. [The safety of blood donors].

    PubMed

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

    2011-04-01

    For a long time, safety has been patient-centred and taken for granted. Indeed, it needed a dramatic accident and the study of post-donation information for the question to be looked into again. However, under various statutory, organizational aspects and the professionalization of the staffs, safety has always accompanied the donor throughout its course of donation. Self-sufficiency is, certainly, the first mission of the tablissement Franais du Sang: while we have to supply patients with sufficient blood products complying with quality criteria, we must not however forget the essential respect for the safety of the donor. PMID:21440480

  4. Skateboard Safety.

    ERIC Educational Resources Information Center

    Della-Giustina, Daniel

    1979-01-01

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

  5. Questioning the psychoanalyst's authority.

    PubMed

    Tuch, R H

    2001-01-01

    Sources of the trend to question not just the analyst's authority to interpret, but the analyst's use of authority in general, are explored. Out of a wish to circumvent the potentially detrimental effects an analyst's interpretations can have on patients, certain psychoanalysts have modified their analytic techniques with an eye to downplaying the role of their authority. When taken to extremes, this has led analysts to act as if they have little to offer patients in the way of an alternative point of view, and to privilege patients' accounts and interpretations by treating them as if they were objectively true. It is argued that one need not go so far in order to protect patients from the analyst's less than careful use of authority. It is argued further that the judicious use of authority remains an indispensable tool in helping to ready the patient's mind for a consideration of constructs different from those on which the patient has always relied. Finally, becoming comfortable with the aggressive aspect of the use of one's authority may determine the extent to which one is willing to employ one's authority with patients. PMID:11508374

  6. ASAP Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    2004-01-01

    This is the First Quarterly Report for the newly reconstituted Aerospace Safety Advisory Panel (ASAP). The NASA Administrator rechartered the Panel on November 18,2003, to provide an independent, vigilant, and long-term oversight of NASA's safety policies and programs well beyond Return to Flight of the Space Shuttle. The charter was revised to be consistent with the original intent of Congress in enacting the statute establishing ASAP in 1967 to focus on NASA's safety and quality systems, including industrial and systems safety, risk-management and trend analysis, and the management of these activities.The charter also was revised to provide more timely feedback to NASA by requiring quarterly rather than annual reports, and by requiring ASAP to perform special assessments with immediate feedback to NASA. ASAP was positioned to help institutionalize the safety culture of NASA in the post- Stafford-Covey Return to Flight environment.

  7. 49 CFR 659.19 - System safety program plan: contents.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program plan: contents. 659.19... State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall... safety program and describes the authority that establishes the system safety program plan. (b) A...

  8. Authorizing Online Learning. Viewpoint

    ERIC Educational Resources Information Center

    Patrick, Susan; Vander Ark, Tom

    2011-01-01

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

  9. Making Authority Relationships Reciprocal.

    ERIC Educational Resources Information Center

    Boccialetti, Gene

    1996-01-01

    Offers guidelines for a situational and reciprocal approach to authority relationships. Compares the following leadership styles: accommodating (military, helper, diplomat, partisan), autonomous (independent, counselor), and adversarial (gamesperson, rebel, whistleblower). (JOW)

  10. 29 CFR 2700.83 - Authority to sign orders.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Authority to sign orders. 2700.83 Section 2700.83 Labor Regulations Relating to Labor (Continued) FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION PROCEDURAL RULES Miscellaneous § 2700.83 Authority to sign orders. The Chairman or other designated Commissioner is authorized...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  14. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  15. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  16. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Authorized emergency vehicles. 4.3 Section 4.3 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR VEHICLES AND TRAFFIC SAFETY 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to...

  17. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing...

  18. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Authorized emergency vehicles. 4.3 Section 4.3 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR VEHICLES AND TRAFFIC SAFETY 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to...

  19. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 3 2012-07-01 2012-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing...

  20. Editorial: Instructions for Authors

    NASA Astrophysics Data System (ADS)

    Arbutina, B.; Urosevic, D.; Knezevic, Z.

    2011-12-01

    The purpose of this editorial is to assist authors in preparing papers to be submitted to our journal. Papers should be prepared in LaTeX by using Serbian Astronomical Journal style file which has some predefined fields in the preamble and some additional or slightly modified commands for the main text. The authors are welcome to use this document as the sample paper and/or template.

  1. EASy: Expert authorizations system

    SciTech Connect

    Altfeld, J.; Landon, D.F.; Daniels, C.J.

    1996-12-31

    Equifax Check Services provides retail merchants and other businesses with quality decisions concerning the acceptability. risk. or fraudulence of customer checks. The greatest percentage of these decisions are provided automatically through on-line links with point-of-sale terminals. When a transaction is suspect, a referral notice is generated directing the merchant to call one of Equifax Check Services` authorization centers for additional processing. This processing considers a wide variety of information unavailable through online processing, thereby giving consumers the greatest possible benefit of doubt prior to declining checks. These high-risk authorizations had historically been handled using a legacy mainframe system involving a high degree of manual intervention. Authorizations agents would complete a lengthy, rigorous training regimen, and be monitored as to their performance. Pursuit of service excellence caused Equifax, in conjunction with Brightware Corporation, to develop the Expert Authorization System (EASy), a rule-based solution for check authorizations that uses an innovative twist on a standard blackboard architecture. EASy was deployed and is used today by as many as 300 concurrent users. By encapsulating extensive domain knowledge, EASy has effectively eliminated authorization errors, provided consistent and replicable decisions, reduced elapsed time to a decision, and reduced the average agent training time from 4-6 weeks to 3 days.

  2. Safety First

    ERIC Educational Resources Information Center

    Taft, Darryl

    2011-01-01

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

  3. Safety Systems

    ERIC Educational Resources Information Center

    Halligan, Tom

    2009-01-01

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

  4. Safety First

    ERIC Educational Resources Information Center

    Taft, Darryl

    2011-01-01

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

  5. Safety Systems

    ERIC Educational Resources Information Center

    Halligan, Tom

    2009-01-01

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

  6. Safety: Biological defense safety program

    SciTech Connect

    1993-12-31

    This pamphlet establishes the Army safety program for all aspects of the Biological Defense Program. It provides new Department of the Army policy on the management of the Biological Defense Safety Program. This pamphlet implements the Centers for Disease Control - National Institutes of Health Guidelines on Laboratory Biosafety, Department of Defense and Department of the Army policy statements, and other Federal regulations. It prescribes procedures for safety studies and reviews of biological defense research, development, test and evaluation projects, and prescribes safety precautions and procedures applicable to contractor operations.

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

    ERIC Educational Resources Information Center

    Kpachavi, Teresa

    1996-01-01

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

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

    PubMed

    Strz, H; Rosemeyer, B

    1979-04-01

    Following the introduction of skateboards into Germany in 1976 an increasing number of accidents and injuries have been noted, affecting mainly children 10 to 14 years of age. The causes were lack of experience and the careless use of the boards on public streets. More than 30% of injuries were fractures mainly affecting the upper limb. Because of the frequent involvement of the epiphyseal plates the post-accidental growth may be seriously disturbed. Severe and sometimes fatal head or abdominal injuries have been reported, mainly after collision with cars. PMID:107438

  9. 28 CFR 549.80 - Authority to conduct autopsies.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... transplanting, to be performed on the body of a deceased inmate of the facility with the written consent of a... transplanting) authorized to permit the autopsy or post-mortem operation under the law of the State in which...

  10. 28 CFR 549.80 - Authority to conduct autopsies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... transplanting, to be performed on the body of a deceased inmate of the facility with the written consent of a... transplanting) authorized to permit the autopsy or post-mortem operation under the law of the State in which...

  11. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  12. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  13. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  14. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  15. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  16. School Bus Fleet Safety: Planning and Development.

    ERIC Educational Resources Information Center

    Bieber, Robert M.

    1984-01-01

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

  17. [Immunological safety of transfusion].

    PubMed

    Muller, Jean-Yves; Chiaroni, Jacques; Garraud, Olivier

    2015-02-01

    Transfusion safety lies on the strict application of measures aimed: at avoiding the occurrence of acute hazards, as far as they can be prevented by e.g. the ABO compatibility for red blood cell concentrates and therapeutic plasma; at reducing the frequency of other acute accidents such as TRALI or post-transfusion GVH (based on the implementation of measures which prove to be largely efficacious though not completely); and at reducing delayed incidents and hazards. The implementation of such immunological safety measures also aim at favoring the transfusion efficacy, in avoiding the lysis of transfused red cells or platelets. Perfect immunological compatibility (match) is impossible because transfused cells expose several hundreds of molecular variants with antigenic properties. Adaptive immunity is largely based upon antigen/antibody conflicts and it predominates in transfusion immunological hazards, but inflammation (as well as other components of innate immunity) is now acknowledged as a major actor of transfusion immunological linked hazards. PMID:25578545

  18. Software safety

    NASA Technical Reports Server (NTRS)

    Leveson, Nancy

    1987-01-01

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

  19. 20 CFR 725.706 - Authorization to provide medical services.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED CLAIMS FOR BENEFITS UNDER PART C OF..., Branch of Medical Analysis and Services, DCMWC, is authorized to approve a request for hospitalization...

  20. 20 CFR 725.706 - Authorization to provide medical services.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED CLAIMS FOR BENEFITS UNDER PART C OF..., Branch of Medical Analysis and Services, DCMWC, is authorized to approve a request for hospitalization...

  1. 20 CFR 725.706 - Authorization to provide medical services.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED CLAIMS FOR BENEFITS UNDER PART C OF..., Branch of Medical Analysis and Services, DCMWC, is authorized to approve a request for hospitalization...

  2. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  3. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  4. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  5. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  6. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  7. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  8. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  9. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  10. 12 CFR 1253.1 - Purpose and authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  11. What about ex post facto

    SciTech Connect

    McKee, H.C.

    1992-07-01

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

  12. Authoring with Video

    ERIC Educational Resources Information Center

    Strassman, Barbara K.; O'Connell, Trisha

    2007-01-01

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

  13. FFTF Authorization Agreement

    SciTech Connect

    DAUTEL, W.A.

    2000-02-25

    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.

  14. Children as Authors Handbook.

    ERIC Educational Resources Information Center

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

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

  15. Site authorization service (SAZ)

    SciTech Connect

    Dane Skow; Igor Mandrichenko; Vijay Sehkri

    2003-10-01

    In this paper the authors present a methodology to provide an additional level of centralized control for the grid resources. This centralized control is applied to site-wide distribution of various grids and thus provides an upper hand in the maintenance.

  16. Creating Digital Authors

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  17. Author Identification Systems

    ERIC Educational Resources Information Center

    Wagner, A. Ben

    2009-01-01

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

  18. [On "gespr" (author's transl)].

    PubMed

    Wurst, F

    1976-01-01

    The term "Gespr" frequently used by H. ASPERGER is analyzed by the author. Predispositions for perceptual abilities and formal interpretation of expression and behavior, their ontogenetic and phylogenetic background are examined as well as defects (lack of sensitivity for expression), and their consequences for subjects involved. The questions of trainability and differentiation to parapsychological phenomena are also discussed. PMID:1250634

  19. Creating Digital Authors

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  20. Authors on Film.

    ERIC Educational Resources Information Center

    Geduld, Harry M., Ed.

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

  1. Authors on Film.

    ERIC Educational Resources Information Center

    Geduld, Harry M., Ed.

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

  2. Safety Tips.

    ERIC Educational Resources Information Center

    Nagel, Miriam C., Ed.

    1984-01-01

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

  3. Antibiotic Safety

    MedlinePLUS

    ... Copyright © 2005 by The Association for Professionals in Infection Control and Epidemiology (APIC). www.apic.org Antibiotic Safety What are Antibiotics? Antibiotics are powerful medicines that help stop bacterial infections. They are used to kill germs that cause ...

  4. Nuclear Power - Post Fukushima

    NASA Astrophysics Data System (ADS)

    Reyes, Jose, Jr.

    2011-10-01

    The extreme events that led to the prolonged power outage at the Fukushima Daiicchi nuclear plant have highlighted the importance of assuring a means for stable long term cooling of the nuclear fuel and containment following a complete station blackout. Legislative bodies, regulatory agencies and industry are drawing lessons from those events and considering what changes, if any, are needed to nuclear power, post Fukushima. The enhanced safety of a new class of reactor designed by NuScale Power is drawing significant attention in light of the Fukushima events. During normal operation, each NuScale containment is fully immersed in a water-filled stainless steel lined concrete pool that resides underground. The pool, housed in a Seismic Category I building, is large enough to provided 30 days of core and containment cooling without adding water. After 30 days, the decay heat generations coupled with thermal radiation heat transfer is completely adequate to remove core decay heat for an unlimited period of time. These passive power systems can perform their function without requiring an external supply of water of power. An assessment of the NuScale passive systems is being performed through a comprehensive test program that includes the NuScale integral system test facility at Oregon State University

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

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

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

  6. Firearms safety program

    USGS Publications Warehouse

    U.S. Geological Survey

    2005-01-01

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

  7. Safety monitoring in clinical trials.

    PubMed

    Yao, Bin; Zhu, Li; Jiang, Qi; Xia, H Amy

    2013-01-01

    Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. As the industry transitions from passive to active safety surveillance activities, there will be greater demand for more comprehensive and innovative approaches that apply quantitative methods to accumulating data from all sources, ranging from the discovery and preclinical through clinical and post-approval stages. Statistical methods, especially those based on the Bayesian framework, are important tools to help provide objectivity and rigor to the safety monitoring process. PMID:24300399

  8. Safety Monitoring in Clinical Trials

    PubMed Central

    Yao, Bin; Zhu, Li; Jiang, Qi; Xia, H. Amy

    2013-01-01

    Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. As the industry transitions from passive to active safety surveillance activities, there will be greater demand for more comprehensive and innovative approaches that apply quantitative methods to accumulating data from all sources, ranging from the discovery and preclinical through clinical and post-approval stages. Statistical methods, especially those based on the Bayesian framework, are important tools to help provide objectivity and rigor to the safety monitoring process. PMID:24300399

  9. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 8 2014-10-01 2014-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4... for examination by the National Shipping Authority at any time....

  10. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 8 2010-10-01 2010-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4... for examination by the National Shipping Authority at any time....

  11. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 8 2012-10-01 2012-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4... for examination by the National Shipping Authority at any time....

  12. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 8 2013-10-01 2013-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4... for examination by the National Shipping Authority at any time....

  13. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 8 2011-10-01 2011-10-01 false Posting of bond. Sec. 4 Section 4 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION A-NATIONAL SHIPPING AUTHORITY BONDING OF SHIP'S PERSONNEL Sec. 4... for examination by the National Shipping Authority at any time....

  14. 46 CFR 71.75-15 - Posting of Convention certificates.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 3 2013-10-01 2013-10-01 false Posting of Convention certificates. 71.75-15 Section 71.75-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PASSENGER VESSELS INSPECTION AND CERTIFICATION Certificates Under the International Convention for Safety of Life at Sea, 1974 71.75-15 Posting of Convention certificates....

  15. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  16. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  17. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  18. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  19. 30 CFR 40.4 - Posting at mine.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting at mine. 40.4 Section 40.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS REPRESENTATIVE OF MINERS § 40.4 Posting at mine. A copy of the information provided the...

  20. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  1. 30 CFR 7.8 - Post-approval product audit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  2. 30 CFR 7.310 - Post-approval product audit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Post-approval product audit. 7.310 Section 7.310 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies 7.310 Post-approval product audit. Upon request...

  3. 30 CFR 7.310 - Post-approval product audit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 7.310 Section 7.310 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies 7.310 Post-approval product audit. Upon request...

  4. System safety education focused on flight safety

    NASA Technical Reports Server (NTRS)

    Holt, E.

    1971-01-01

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

  5. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 8 2011-07-01 2011-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures §...

  6. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 8 2013-07-01 2013-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures §...

  7. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 8 2012-07-01 2012-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures §...

  8. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 8 2010-07-01 2010-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures §...

  9. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 8 2014-07-01 2014-07-01 false Post-dive procedures. 1926.1083 Section 1926.1083 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures §...

  10. Premarket Safety and Efficacy Studies for ADHD Medications in Children

    PubMed Central

    Bourgeois, Florence T.; Kim, Jeong Min; Mandl, Kenneth D.

    2014-01-01

    Background Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing. Methods We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials. Results A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed. Conclusions Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved. PMID:25007171

  11. Evaluation of autoimmune safety signal in observational vaccine safety studies

    PubMed Central

    Chao, Chun; Jacobsen, Steven

    2012-01-01

    Autoimmune safety evaluation is an important component of post-licensure vaccine safety evaluation. Recently, we published the findings from a large observational safety study of the quadrivalent human papillomavirus vaccine in females. From this study, based on two large managed care organizations, we have obtained some empirical data that may prove useful for the design of future vaccine safety studies within a managed care environment. For autoimmune conditions, a major challenge in vaccine safety study is to determine true incident cases in relation to the timing of vaccination. We found expert case review of medical records an indispensable component for autoimmune safety studies based on electronic health records. Case identification should also be expanded to include the use of laboratory test results or other relevant measures in addition to the disease specific ICD-9 diagnosis codes, when applicable. Furthermore, we recommend the parallel use of both safety signal evaluation that involves pattern evaluation for conditions that are more common, and statistical comparisons for conditions that are rather rare. Finally, we recommend an accompanying vaccine uptake study to understand the potential selection bias and confounding in a given study population that should be addressed with data collection and analytical techniques. PMID:22871958

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

    PubMed Central

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

    2015-01-01

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

  13. First Aid and Safety

    MedlinePLUS

    ... Outdoors A Safe and Spooktacular Halloween All-Terrain Vehicle (ATV) Safety Auto Safety Backpack Safety Booster Seat ... the Whole Family Play It Safe All-Terrain Vehicle (ATV) Safety Bike Safety How to Choose & Use ...

  14. 22 CFR 18.6 - Authority to prohibit appearances.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Authority to prohibit appearances. 18.6 Section 18.6 Foreign Relations DEPARTMENT OF STATE PERSONNEL REGULATIONS CONCERNING POST EMPLOYMENT CONFLICT OF INTEREST Administrative Enforcement Proceedings § 18.6 Authority to prohibit appearances....

  15. 22 CFR 18.6 - Authority to prohibit appearances.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Authority to prohibit appearances. 18.6 Section 18.6 Foreign Relations DEPARTMENT OF STATE PERSONNEL REGULATIONS CONCERNING POST EMPLOYMENT CONFLICT OF INTEREST Administrative Enforcement Proceedings § 18.6 Authority to prohibit appearances....

  16. 22 CFR 18.6 - Authority to prohibit appearances.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Authority to prohibit appearances. 18.6 Section 18.6 Foreign Relations DEPARTMENT OF STATE PERSONNEL REGULATIONS CONCERNING POST EMPLOYMENT CONFLICT OF INTEREST Administrative Enforcement Proceedings § 18.6 Authority to prohibit appearances....

  17. 22 CFR 18.6 - Authority to prohibit appearances.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  18. 22 CFR 18.6 - Authority to prohibit appearances.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Authority to prohibit appearances. 18.6 Section 18.6 Foreign Relations DEPARTMENT OF STATE PERSONNEL REGULATIONS CONCERNING POST EMPLOYMENT CONFLICT OF INTEREST Administrative Enforcement Proceedings § 18.6 Authority to prohibit appearances....

  19. [Acceptance and safety of vaccines].

    PubMed

    Bartz, H; von Knebel-Dberitz, M

    2009-04-01

    As a result of decreasing willingness to be vaccinated some diseases, which seemingly had been eradicated, may reappear. One example for this is the increase of measles cases in the United Kingdom since the 1990s after a decrease of immunization rate in response to a subsequently discredited publication suggesting a link between the triple measles, mumps and rubella vaccine and autism. As the incidence of vaccine preventable diseases decreases, vaccine safety dominates personal risk-benefit analysis. To deal with such concerns this review discusses pre- and post-licensing procedures controlling vaccine safety, taking HPV vaccination as well as vaccination against rotavirus as examples. PMID:19353475

  20. Hanford Generic Interim Safety Basis

    SciTech Connect

    Lavender, J.C.

    1994-09-09

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

  1. Efficacy and safety of post-cesarean section incisional infiltration with lidocaine and epinephrine versus lidocaine alone in reducing postoperative pain: A randomized controlled double-blinded clinical trial

    PubMed Central

    Tharwat, Ahmed A.; Yehia, Amr H.; Wahba, Karim A.; Ali, Abd-Elrhman G.

    2016-01-01

    Objective Aim was to assess the efficacy and safety of incisional infiltration of lidocaine and epinephrine vs. lidocaine only to reduce postcesarean section (C/S) pain. Material and Methods It was a prospective, randomized, controlled, double-blinded clinical trial that was conducted in two tertiary hospitals in Egypt and included 153 women undergoing C/S under general anesthesia. They were randomly divided into the following two groups: Group I (control group, number=78), in which the wound was infiltrated before skin closure with 20 mL of 2% lidocaine, and Group II (study group, number=75), in which the wound was infiltrated before skin closure with 20 mL of 2% lidocaine and epinephrine. The primary outcomes were the time to first analgesic (TFA) request (minutes) and the postoperative pain scores that were measured using a visual analogue scale (VAS). The secondary outcomes included the duration of C/S, onset of mobilization, onset of breastfeeding, duration of hospital stay, local or systemic side effects of lidocaine and epinephrine, postoperative pyrexia, and postoperative wound infection. Results The pain score determined using VAS after 1 and 2 h was significantly decreased in Group II than in Group I. However, at 4.8 and 16 h, these results were significantly reversed in Group II than in Group I. The cumulative postoperative opioid consumption was significantly less in Group II than in Group I (50 vs. 90 mg). The onset of mobilization, onset of breastfeeding, and duration of hospital stay was significantly shorter in Group II than in Group I, whereas the TFA request was significantly longer in Group II. Conclusion Administering epinephrine with 2% lidocaine prolongs the anesthetic effect and reduces the opioid analgesic dose postoperatively required, thereby enhancing patient recovery.

  2. Tasseography: Reading Post-Racial Resistance to Teaching

    ERIC Educational Resources Information Center

    Houston, Akil

    2011-01-01

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

  3. 77 FR 25179 - Patient Safety Organizations: Voluntary Relinquishment From Surgical Safety Institute

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality... of health care delivery. The Patient Safety Rule, 42 CFR part 3, authorizes AHRQ, on behalf of the... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH...

  4. IMS QTI Authoring

    NASA Astrophysics Data System (ADS)

    Miao, Yongwu

    Assessment of students' work is a critically important part of teaching/learning of any subject. According to Biggs (1999), teaching, learning, and assessment interact in new learning, requiring that curriculum objectives, teaching/learning activities, and assessment tasks are aligned. Assessment may be undertaken at the beginning/middle/end of a period of study, as diagnostic assessment, formative assessment, and summative assessment. When developing an online course (e.g., a unit of learning) in Learning Networks, the learning designer may need to align assessment activities with learning/teaching activities. Therefore, an integrated authoring environment is required in Learning Network infrastructure for specifying an integrated learning, teaching, and assessment process as a unit of learning.

  5. A question of authority

    SciTech Connect

    Morgan, Earl W.)

    2003-10-15

    A Question of Authority. This article deals with a certain scenario and several reviewers are to give their opinion. This one is in regards to - Suspending an IACUC approved animal use activity is about the last thing a research institution wants to do. Consider the predicament that the Great Eastern University IACUC faced when Dr. Janet Jenkins, the Attending Veterinarian, suspended all animal use activity on an approved protocol of Dr. Roy Maslo. Jenkins had the IACUCs authority to temporarily suspend a protocol, subject to review by a quorum of the full committee. She alleged that Maslo used mice from his breeding colony, not purchased rats, to begin a new study. Jenkins saw Maslos technicians bringing mouse cages to a procedure room and setting up for a minor survival surgery. She asked them to wait until she clarified things as she felt confident that the protocol called for rats. She called Maslo and asked him if the study had been approved for mice, to which he responded affirmatively. Still not feeling quite assured, she went to her office, reviewed the protocol, and found only rat studies described. She also called the IACUC office to see if there were any approved amendments which she may not have received, and was told that there were none. By the time she returned, one procedure was completed. Understandably upset, she informed the technicians and Maslo that any further activity on the protocol was suspended until the issue was resolved. Jenkins informed the IACUC chairman who in turned called an emergency meeting of the committee.

  6. 47 CFR 87.147 - Authorization of equipment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorization of equipment. 87.147 Section 87.147 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Technical Requirements § 87.147 Authorization of equipment. (a) Certification may be requested by following the procedures in...

  7. 47 CFR 87.147 - Authorization of equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorization of equipment. 87.147 Section 87.147 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES... authorization. The FAA should mail its determination to: Office of Engineering and Technology...

  8. 47 CFR 101.31 - Temporary and conditional authorizations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Temporary and conditional authorizations. 101.31 Section 101.31 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Applications and Licenses General Filing Requirements § 101.31 Temporary and conditional authorizations....

  9. 49 CFR 831.9 - Authority of Board representatives.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Authority of Board representatives. 831.9 Section 831.9 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD ACCIDENT/INCIDENT INVESTIGATION PROCEDURES 831.9 Authority of Board representatives. (a) General. Any employee of the Board,...

  10. 47 CFR 95.101 - What the license authorizes.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false What the license authorizes. 95.101 Section 95.101 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES General Mobile Radio Service (GMRS) 95.101 What the license authorizes. (a)...

  11. 40 CFR 1620.7 - Limitations on authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 33 2011-07-01 2011-07-01 false Limitations on authority. 1620.7 Section 1620.7 Protection of Environment CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD ADMINISTRATIVE CLAIMS ARISING UNDER THE FEDERAL TORT CLAIMS ACT 1620.7 Limitations on authority. (a) An...

  12. 40 CFR 1620.7 - Limitations on authority.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 34 2012-07-01 2012-07-01 false Limitations on authority. 1620.7 Section 1620.7 Protection of Environment CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD ADMINISTRATIVE CLAIMS ARISING UNDER THE FEDERAL TORT CLAIMS ACT 1620.7 Limitations on authority. (a) An...

  13. 40 CFR 1620.7 - Limitations on authority.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Limitations on authority. 1620.7 Section 1620.7 Protection of Environment CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD ADMINISTRATIVE CLAIMS ARISING UNDER THE FEDERAL TORT CLAIMS ACT 1620.7 Limitations on authority. (a) An...

  14. 40 CFR 1620.7 - Limitations on authority.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 34 2013-07-01 2013-07-01 false Limitations on authority. 1620.7 Section 1620.7 Protection of Environment CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD ADMINISTRATIVE CLAIMS ARISING UNDER THE FEDERAL TORT CLAIMS ACT 1620.7 Limitations on authority. (a) An...

  15. 40 CFR 1620.7 - Limitations on authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Limitations on authority. 1620.7 Section 1620.7 Protection of Environment CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD ADMINISTRATIVE CLAIMS ARISING UNDER THE FEDERAL TORT CLAIMS ACT 1620.7 Limitations on authority. (a) An...

  16. 47 CFR 97.301 - Authorized frequency bands.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized frequency bands. 97.301 Section 97.301 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO SERVICE Technical Standards § 97.301 Authorized frequency bands. The following transmitting frequency bands are available to an...

  17. 78 FR 2660 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... National Telecommunications and Information Administration First Responder Network Authority Board Meeting... First Responder Network Authority (FirstNet). DATES: The meeting will be held on February 12, 2013, from... directs FirstNet to establish a nationwide, interoperable public safety broadband network. The...

  18. 77 FR 67342 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... National Telecommunications and Information Administration First Responder Network Authority Board Meeting... (NTIA) will convene open public meetings of the Board of the First Responder Network Authority (FirstNet... a single nationwide, interoperable public safety broadband network. The FirstNet Board...

  19. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  20. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  1. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  2. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  3. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  4. 42 CFR 85.5 - Authority for investigations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Authority for investigations. 85.5 Section 85.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES REQUESTS FOR HEALTH HAZARD EVALUATIONS 85.5 Authority...

  5. 42 CFR 85.5 - Authority for investigations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Authority for investigations. 85.5 Section 85.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES REQUESTS FOR HEALTH HAZARD EVALUATIONS 85.5 Authority...

  6. 42 CFR 85.5 - Authority for investigations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority for investigations. 85.5 Section 85.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES REQUESTS FOR HEALTH HAZARD EVALUATIONS 85.5 Authority...

  7. 42 CFR 85.5 - Authority for investigations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Authority for investigations. 85.5 Section 85.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES REQUESTS FOR HEALTH HAZARD EVALUATIONS 85.5 Authority...

  8. 42 CFR 85.5 - Authority for investigations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Authority for investigations. 85.5 Section 85.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES REQUESTS FOR HEALTH HAZARD EVALUATIONS 85.5 Authority...

  9. 47 CFR 87.147 - Authorization of equipment.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Authorization of equipment. 87.147 Section 87.147 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Technical Requirements 87.147 Authorization of equipment. (a) Certification may be requested by following the procedures in...

  10. School Safety.

    ERIC Educational Resources Information Center

    The Newsletter of the Comprehensive Center-Region VI, 1999

    1999-01-01

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

  11. Art Safety.

    ERIC Educational Resources Information Center

    BCATA Journal for Art Teachers, 1991

    1991-01-01

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

  12. Child Safety

    MedlinePLUS

    ... your children safe: Install the right child safety seat in your car Teach children how to cross the street safely Make sure they wear the right gear and equipment for sports Install and test smoke alarms Store ... your home Don't leave small children unattended

  13. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation

    PubMed Central

    Yamamoto, Takanori; Tsujimoto, Mika; Sowa, Hideaki

    2015-01-01

    Objective Serum procollagen type I N-terminal propeptide (PINP), a representative marker of bone anabolic action, is strongly related to bone mineral density during teriparatide therapy. This post hoc study analyzed data from a Phase III study (ClinicalTrials.gov identifier NCT00433160) to determine if there was an association between serum PINP elevation and serum calcium concentration or calcium metabolism-related disorders. Research design and methods Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects. Main outcome measures Serum PINP levels were measured at baseline, and after 1, 3, 6, 12, 18, and 24 months of treatment. Serum calcium levels were measured at baseline, and after 1, 3, 6, 9, 12, 15, 18, 21, and 24 months of treatment. Results Serum PINP increased from baseline to 1 month of treatment and then remained high through 24 months. Twenty-eight of 195 subjects experienced PINP elevations >200 μg/L during teriparatide treatment. Serum calcium concentration in both the teriparatide and placebo groups remained within the normal range. There was no clinically relevant difference in serum calcium concentration between subjects with PINP >200 μg/L and subjects with PINP ≤200 μg/L. Two subjects experienced hypercalcemia and recovered without altering teriparatide treatment. Adverse events possibly related to calcium metabolism disorders included periarthritis calcarea (one subject) and chondrocalcinosis pyrophosphate (two subjects), but neither was accompanied with a significant increase in PINP or serum calcium concentration. Conclusion Although the moderate size of this study prevented statistical analysis of any potential association between calcium metabolism-related disorders and elevated PINP, this analysis suggests that there was no association between serum PINP elevation during daily teriparatide treatment and serum calcium concentration or calcium metabolism-related disorders in Japanese subjects. PMID:26185429

  14. Safety and Efficacy of At-Home Robotic Locomotion Therapy in Individuals with Chronic Incomplete Spinal Cord Injury: A Prospective, Pre-Post Intervention, Proof-of-Concept Study

    PubMed Central

    Rupp, Rüdiger; Schließmann, Daniel; Plewa, Harry; Schuld, Christian; Gerner, Hans Jürgen; Weidner, Norbert; Hofer, Eberhard P.; Knestel, Markus

    2015-01-01

    Background The compact Motorized orthosis for home rehabilitation of Gait (MoreGait) was developed for continuation of locomotion training at home. MoreGait generates afferent stimuli of walking with the user in a semi-supine position and provides feedback about deviations from the reference walking pattern. Objective Prospective, pre-post intervention, proof-of-concept study to test the feasibility of an unsupervised home-based application of five MoreGait prototypes in subjects with incomplete spinal cord injury (iSCI). Methods Twenty-five (5 tetraplegia, 20 paraplegia) participants with chronic (mean time since injury: 5.8 ± 5.4 (standard deviation, SD) years) sensorimotor iSCI (7 ASIA Impairment Scale (AIS) C, 18 AIS D; Walking Index for Spinal Cord Injury (WISCI II): Interquartile range 9 to 16) completed the training (45 minutes / day, at least 4 days / week, 8 weeks). Baseline status was documented 4 and 2 weeks before and at training onset. Training effects were assessed after 4 and 8 weeks of therapy. Results After therapy, 9 of 25 study participants improved with respect to the dependency on walking aids assessed by the WISCI II. For all individuals, the short-distance walking velocity measured by the 10-Meter Walk Test showed significant improvements compared to baseline (100%) for both self-selected (Mean 139.4% ± 35.5% (SD)) and maximum (Mean 143.1% ± 40.6% (SD)) speed conditions as well as the endurance estimated with the six-minute walk test (Mean 166.6% ± 72.1% (SD)). One device-related adverse event (pressure sore on the big toe) occurred in over 800 training sessions. Conclusions Home-based robotic locomotion training with MoreGait is feasible and safe. The magnitude of functional improvements achieved by MoreGait in individuals with iSCI is well within the range of complex locomotion robots used in hospitals. Thus, unsupervised MoreGait training potentially represents an option to prolong effective training aiming at recovery of locomotor function beyond in-patient rehabilitation. Trial Registration German Clinical Trials Register (DKRS) DRKS00005587 PMID:25803577

  15. Safety and regulation of yeasts used for biocontrol or biopreservation in the food or feed chain.

    PubMed

    Sundh, Ingvar; Melin, Petter

    2011-01-01

    Yeasts have been important components of spontaneous fermentations in food and beverage processing for millennia. More recently, the potential of utilising antagonistic yeasts, e.g. Pichia anomala and Candida spp., for post-harvest biological control of spoilage fungi during storage of plant-derived produce ('biopreservation') has been clearly demonstrated. Although some yeast species are among the safest microorganisms known, several have been reported in opportunistic infections in humans, including P. anomala and bakers' yeast, Saccharomyces cerevisiae. More research is needed about the dominant pathogenicity and virulence factors in opportunistic yeasts, and whether increased utilisation of biopreservative yeasts in general could contribute to an increased prevalence of yeast infections. The regulatory situation for yeasts used in post-harvest biocontrol is complex and the few products that have reached the market are mainly registered as biological pesticides. The qualified presumption of safety (QPS) approach to safety assessments of microorganisms intentionally added to food or feed, recently launched by the European Food Safety Authority, can lead to more efficient evaluations of new products containing microbial species with a sufficient body of knowledge or long-term experience on their safety. P. anomala is one of several yeast species that have been given QPS status, although the status is restricted to use of this yeast for enzyme and metabolite production purposes. With regard to authorisation of new biopreservative yeasts, we recommend that the possibility to regulate microorganisms for food biopreservation as food additives be considered. PMID:21086043

  16. Dam safety program spared; dam safety act extended

    SciTech Connect

    Not Available

    1993-02-01

    Before leaving office, President Bush signed a bill that included funding of $612,000 to continue the Federal Emergency Management Agency's Dam Safety Program for the fiscal year that ends September 30, 1993. This amount includes funding for Association of State Dam Safety Officials programs. Bush signed the bill October 6, despite his administration's earlier attempt to terminate the program. Loss of funding for the 1993 fiscal year could have proven devastating to state dam safety programs, as states take their lead from the federal government. Ninety-five percent of the nation's dams are regulated by state dam safety programs, including 2,500 unsafe, high-hazard dams. Funding for the federal program was included in the Veterans Administration, Housing and Urban Development, and Independent Agencies Appropriations Bill (HR 5679). The appropriation included approximately $250,000 to renew a research grant ASDSO will use to fund its popular public awareness workshop program, regional technical seminars, and annual research projects. In addition to urging Congress to fund FEMA's Dam Safety Program, ASDSO is pursuing a long-term plan to see that new federal dam safety legislation is authorized. The 102nd Congress chose not to revise existing dam safety legislation and instead passed a watered-down version of the Water Resources Development Act of 1992, extending the Dam Safety Act of 1986 from 1992 to 1994.

  17. Scientific and Artistic Authority

    NASA Astrophysics Data System (ADS)

    Eriksson, S. C.

    2012-12-01

    The differences and similarities between science and art are commonly discussed in various disciplines, e.g. collective versus individual, truth versus imagination, fact versus fiction, and more. Both art and science involve communication. Both artists and scientists have responsibilities of integrity in the arena of intellectual property. However, an artist has a primary responsibility to his/her personal artistic vision and craft. A scientist has a very clearly defined responsibility to scientific method as a collective practice, i.e. generally accepted scientific knowledge, norms of data collection and analysis as well as norms of communication. In presenting a work of art to an audience, it is accepted that different people will interpret the art through different lens. In science communication, we hope that the audience's understanding is in line with scientific interpretation. When science and art meet, how do we come to an understanding of what the intended message should be and how it should or must be received. Accuracy in fact is important in science, as is accuracy of the message whether it is a process, model, image or story. How do we mediate this tension in collaborative projects? How do we celebrate the artistic nature of an artwork based on science when there is tension between the artistic merit and the scientific content? Authority of the artist, scientist, and organization must be satisfied.

  18. Authors in Schools: Some Perspectives.

    ERIC Educational Resources Information Center

    Clark, Margaret

    An author's school visits can be, to a degree, part of an author's workplace depending on how many visits an author undertakes during a year. From the perspective of an author, the visits need to be fulfilling in terms of feeling valued and respected. From the school's point of view, it would appear that the visit is deemed a success if the author

  19. Aerospace safety advisory panel

    NASA Technical Reports Server (NTRS)

    1995-01-01

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

  20. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    MedlinePLUS

    ... Information and Adverse Event Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share ... deficiency. Posted 03/22/2016 More What's New FDA Approved Safety Information DailyMed (National Library of Medicine) ...