Science.gov

Sample records for post authorization safety

  1. A pathway to improved prospective observational post-authorization safety studies.

    PubMed

    Kiri, Victor A

    2012-09-01

    Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of drugs but not necessarily so for drug safety where inadequate power to detect either multiple or rare adverse events is a major handicap. Furthermore, the conditions under which drugs are approved for market use are often different from the settings in actual use. Indeed, with their control mechanisms, trials are by design largely inadequate for the identification of potential safety signals, especially of the rare type, hence the value of postmarketing surveillance and risk management plan-based activities. Today, clinical trials constitute only a part of the research that goes into assessing the safety of drugs. Observational studies, where the investigators merely collect data on treatments received by patients and their health status in routine clinical practice are increasing in uptake because they reflect the real-life utility of drugs, despite the absence of random treatment assignment. Although such studies generally provide less compelling evidence than RCTs, they can be far more useful to drug safety assessment activities than generally acknowledged. An increasing number of post-authorization safety studies (PASS) within the European Medicines Agency's jurisdiction are of the observational type - considered perhaps as more appropriate vehicles for exploring and documenting how products perform in the real world. A similar trend is emerging in the US following the FDA Amendments Act of 2007; since early 2010, an increasing number of post-approval commitments mandated by the FDA include observational studies. However, despite this pattern, not much is known about ongoing efforts to address many of the recognized inadequacies associated with existing methodologies and practices currently adopted in observational PASS. This current opinion presents an overview of some of the main challenges we face in prospective observational PASS, mainly from practical experience, and

  2. 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.

  3. Tolerability and safety of Octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials

    PubMed Central

    Frenzel, Wolfgang; Wietek, Stefan; Svae, Tor-Einar; Debes, Anette; Svorc, Daniel

    2016-01-01

    Objective: To evaluate the tolerability and safety of Octagam® 5% and 10% across all indications, ages, and treatment regimens, using data from four non-interventional post-authorization safety studies (PASS); this analysis was performed following changes in the preparation of raw material used to manufacture Octagam. Methods: All four studies included in- and out-patients prescribed Octagam for treatment of their medical condition. Physicians used case report forms to document baseline demographics, Octagam treatment details, and data on the efficacy of Octagam, and recorded all adverse drug reactions (ADRs) and other safety data. Results: Altogether 21,780 infusions of Octagam in 2,397 patients were included in our analysis. The most frequent indication for Octagam was secondary immunodeficiencies (SID; n = 1,368, 11,348 infusions), followed by primary immunodeficiencies (PID; n = 363; 3,923 infusions). During the individual patient observation, 83% of SID and 67% of PID patients were free of any infection. In up to 85% of all investigator assessments, Octagam was rated to have a favorable effect. In autoimmune diseases, investigators assessed Octagam as being beneficial in 70% (immune thrombocytopenia) up to 100% (Guillain-Barré syndrome), depending on the indication. The majority of patients (92%) tolerated Octagam treatment without any ADR. The overall incidence of reported ADRs was 1.0% for all infusions. The majority of ADRs were considered non-serious (93%) and mild or moderate (87%) in severity. No unexpected ADR signal was detected. Conclusions: This analysis demonstrates that the changes in the preparation of raw material used to manufacture Octagam did not affect the safety profile of Octagam® 5% and 10%. PMID:27719744

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

    PubMed Central

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

    2016-01-01

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

  5. How real is intention-to-treat (ITT) analysis in non-interventional post authorization safety studies? We can do better.

    PubMed

    Kiri, Victor A; MacKenzie, Gilbert

    2009-05-01

    Although cohort studies which are based on intention-to-treat (ITT) approach offer a simple design with data which are simpler to analyse and results easier to interpret, such studies also intrinsically assume that any time-varying treatment effect that exits can be adequately estimated by a fixed-effect component. However, such an assumption may not reflect real-life drug use. Reflection of real-life clinical practice is a major strength of epidemiologic safety studies. The failure to properly reflect reality may result in effect under-estimation leading to false and irreproducible conclusions due to exposure misclassification. In effect, the use of nested case-control design is a concesion that ITT in cohort design may not be adequate. But the nested design also has its own sources of bias, including confounding by indication. We present an overview of the counter-matched version of the nested case-control, case-crossover, case-in-time, case series and case-cohort designs as alternatives in prospective post-authorization safety studies.

  6. 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.

  7. 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)…

  8. 49 CFR 390.209 - Pre-authorization safety audit.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  9. 49 CFR 390.209 - Pre-authorization safety audit.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 5 2013-10-01 2013-10-01 false Pre-authorization safety audit. 390.209 Section... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL Unified Registration System § 390.209 Pre-authorization...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    Code of Federal Regulations, 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...

  13. 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...

  14. 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...

  15. 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.

  16. 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.

  17. 76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... Safety Audits AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice; response...-Authorization Safety Audits (PASAs) for two motor carriers that applied to participate in the Agency's...

  18. 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

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

    USGS Publications Warehouse

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

    2013-01-01

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

  20. 80 FR 60952 - Positive Train Control Safety Plan for the Southern California Regional Rail Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2015-10-08

    ... PTCSP describes the SCRRA I-ETMS implementation and the associated I- ETMS safety processes; safety...-2010-0048] Positive Train Control Safety Plan for the Southern California Regional Rail Authority... Positive Train Control Safety Plan (PTCSP) Version 1.7 for approval under the Federal railroad...

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

    PubMed

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

    2014-09-01

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

  2. 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...

  3. 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.

  4. 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.

  5. [Study on method on post-marketing traditonal Chinese medicine safety assessment].

    PubMed

    Kou, Qiuai; Zhao, Suping; Feng, Guoshuang; Xie, Yanming

    2011-10-01

    Traditional Chinese medicine (TCM) safety assessment is an important content of post-marketing Chinese herbal medicine assessment and the primary question. It includes safety monitoring and safety evaluation. China has established the elementary system for the TCM safety monitoring, but did few things on safety evaluation. People have knew that the methods of pharmacoepidemiology have good practicability on drug safety assessment in recent years. This article analyzed three methods of pharmacoepidemiology used in post-marketing Chinese herbal medicine safety assessment. There are three examples that may give some suggestions to fellow doctors working for safety monitoring and evaluation of TCM.

  6. Evolution of safety-critical requirements post-launch

    NASA Technical Reports Server (NTRS)

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

    2001-01-01

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

  7. 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... that an Atomic Safety and Licensing Board (Board) is being established to preside over the following... Radiation. The Board is comprised of the following administrative judges: Alex S. Karlin, Chairman,...

  8. 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.

  9. 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.

  10. 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.

  11. 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…

  12. 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.

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

    PubMed

    Viscusi, Eugene R

    2015-01-01

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

  14. 77 FR 28566 - Notice of Request for a New Information Collection (Food Safety Education Campaign-Post-Wave...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    ... seeking approval of a new information collection to help evaluate the impact of the Food Safety Education... Collection (Food Safety Education Campaign--Post-Wave Tracking Survey) AGENCY: Food Safety and Inspection... tracking survey associated with the Food Safety Education Campaign. The post-wave survey is conducted...

  15. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... effect, the handler employer shall display, in accordance with this section, pesticide safety information... clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and...

  16. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... effect, the handler employer shall display, in accordance with this section, pesticide safety information... clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and...

  17. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... effect, the handler employer shall display, in accordance with this section, pesticide safety information... clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and...

  18. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... effect, the handler employer shall display, in accordance with this section, pesticide safety information... clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and...

  19. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... effect, the handler employer shall display, in accordance with this section, pesticide safety information... clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and...

  20. Power learning or path dependency? Investigating the roots of the European Food Safety Authority.

    PubMed

    Roederer-Rynning, Christilla; Daugbjerg, Carsten

    2010-01-01

    A key motive for establishing the European Food Safety Authority (EFSA) was restoring public confidence in the wake of multiplying food scares and the BSE crisis. Scholars, however, have paid little attention to the actual political and institutional logics that shaped this new organization. This article explores the dynamics underpinning the making of EFSA. We examine the way in which learning and power shaped its organizational architecture. It is demonstrated that the lessons drawn from the past and other models converged on the need to delegate authority to an external agency, but diverged on its mandate, concretely whether or not EFSA should assume risk management responsibilities. In this situation of competitive learning, power and procedural politics conditioned the mandate granted to EFSA. The European Commission, the European Parliament and the European Council shared a common interest in preventing the delegation of regulatory powers to an independent EU agency in food safety policy.

  1. Current status and future directions of post-marketing vaccine safety monitoring with focus on USA and Europe.

    PubMed

    Bonhoeffer, Jan; Black, Steve; Izurieta, Hector; Zuber, Patrick; Sturkenboom, Miriam

    2012-09-01

    Vaccine safety research is a key component of public health programs. Regulatory agencies need to be able to make informed decisions. Public health authorities need to respond to vaccine concerns before they turn into large scale scares reducing vaccine uptake and derailing immunization programs. Several post-licensure vaccine safety monitoring systems have been established in the USA and Europe, and methods such as rapid cycle analysis have been developed for real-time detection and analysis of safety issues. Accurate and reliable vaccine product testing and monitoring requires high quality data of populations of 100 million and above depending on the frequency of the event, vaccine coverage, and the time pressure during which data need to be generated. This requires post-licensure safety studies utilizing large linked population based databases of exposure and outcomes. Harmonized methods for development and linkage of these databases across countries need to be further developed, validated and implemented. Concerted action between the US and Europe could move vaccine safety monitoring to today's level of requirements globally and should be pursued.

  2. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    PubMed

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  3. Authority.

    ERIC Educational Resources Information Center

    Update on Law-Related Education, 1987

    1987-01-01

    Offers a lesson designed to help students recognize a key philosophical principle embodied in the U.S. Constitution: that the consent of the governed is the ultimate source of authority in our political system. (JDH)

  4. 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.

  5. [Siamese twins: anesthesia, pre-per- and post-operative care (author's transl)].

    PubMed

    Delègue, L; Ghnassia, M D; Du Fontenioux, T

    1980-01-01

    The authors relate the anesthetic and pre-, per- and post-operative care problems they had to meet with six pairs of siamese twins separated at the Hôpital des Enfants Malades (Paris), between 1960 and 1978. 77 cases of such anomalies have been reported since the beginning of the XXth century. The authors point out the importance of: 1) a precise pre-operative assessment of the anatomo- and physiopathological status of the conjoined twins, 2) an outstanding technical organization, 3) a medical and nursing team specialized in pediatric anesthesia and intensive care to face with the predictable and unpredictable problems which may occur, specially those which the clinical and paraclinical investigations have not been able to discover before the operation.

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

    NASA Astrophysics Data System (ADS)

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

    2016-08-01

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

  7. 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.

  8. 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

    ... FOR THE UNITED STATES WAREHOUSE ACT General Provisions § 735.10 Posting of certificates of licensing... 7 Agriculture 7 2012-01-01 2012-01-01 false Posting of certificates of licensing, certificates of authorization or other USWA documents. 735.10 Section 735.10 Agriculture Regulations of the Department...

  9. 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

    ... FOR THE UNITED STATES WAREHOUSE ACT General Provisions § 735.10 Posting of certificates of licensing... 7 Agriculture 7 2014-01-01 2014-01-01 false Posting of certificates of licensing, certificates of authorization or other USWA documents. 735.10 Section 735.10 Agriculture Regulations of the Department...

  10. 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…

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

    PubMed

    2015-05-01

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

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

    PubMed

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

    2013-01-01

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

  13. 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.

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

    PubMed

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

    2015-09-01

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

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

    PubMed

    Hervé, 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.

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

    PubMed

    Katan, M B

    2012-06-01

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

  17. 77 FR 28451 - Unsatisfactory Safety Rating; Revocation of Operating Authority Registration; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ... registration of a for-hire motor carrier for failure to comply with safety fitness requirements; if the Agency determines that a motor carrier is ``Unfit'' based on its Safety Fitness Determination procedures, the Agency... failure to comply with safety fitness requirements. See 49 U.S.C. 13905(f)(1)(B) and (3). The...

  18. The DELTA Network Study of Distributed Automated Post-Market Cardiovascular Device Safety Surveillance

    PubMed Central

    Kumar, Amit; Matheny, Michael E.; Ho, Kalon K.L.; Yeh, Robert W.; Piemonte, Thomas C.; Waldman, Howard; Shah, Pinak B.; Cope, Richard; Normand, Sharon-Lise; Donnelly, Sharon; Robbins, Susan; Resnic, Frederic S.

    2016-01-01

    Background Current approaches for post-market medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates. Methods and Results The DELTA (Data Extraction and Longitudinal Trend Analysis) network study was a multicenter prospective observational study designed to evaluate the safety of devices used during percutaneous coronary interventions (PCI). All adult patients undergoing PCI from January 2008 through December 2012 at five participating Massachusetts sites were included. A safety alert was triggered if the cumulative observed adverse event rates for the study device exceeded the upper 95% confidence interval of the event rates of propensity-matched control cohort. Pre-specified sensitivity analyses were developed to validate any identified safety signal. A total of 23,805 consecutive PCI procedures were evaluated. Two out of 24 safety analyses triggered safety alerts. Patients receiving Perclose vascular closure device (VCD) experienced an increased risk of minor vascular complications (relative risk [RR] 4.14; p <0.01) and any vascular complication (RR: 2.06; p = 0.01) as compared with propensity-matched patients receiving alternative VCD; a result primarily driven by relatively high event rates at one participating center. Sensitivity analyses based on alternative risk adjustment methods confirmed the a pattern of increased rate of complications at one of the five participating sites in their use of Perclose VCD. Conclusions The DELTA network study demonstrates that distributed automated prospective safety surveillance has the potential of providing near real-time assessment of safety risks of newly approved medical devices. PMID:25491915

  19. 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

  20. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... information contained in State highway safety data systems, including crash, citation, adjudication, emergency medical services/injury surveillance, roadway and vehicle record keeping systems, and driver license...

  1. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... information contained in State highway safety data systems, including crash, citation, adjudication, emergency medical services/injury surveillance, roadway and vehicle record keeping systems, and driver license...

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

    NASA Astrophysics Data System (ADS)

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

    2016-07-01

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

  3. 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...

  4. Automated surveillance to detect post-procedure safety signals of approved medical devices

    PubMed Central

    Resnic, Frederic S.; Gross, Thomas P.; Marinac-Dabic, Danica; Loyo-Berrios, Nilsa; Donnelly, Sharon; Normand, Sharon-Lise T.; Matheny, Michael E.

    2016-01-01

    Context Assuring the safety of medical devices challenges current surveillance approaches which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the post-market evaluation of medical device safety. Objective To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices. Design Prospective propensity matched cohort analysis of seven newly introduced cardiovascular devices, utilizing data from patients undergoing percutaneous coronary intervention (PCI) in Massachusetts between April 2003 and October 2007. Setting and Patients All adults undergoing PCI in Massachusetts licensed hospitals utilizing clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry. Main Outcome Measure The presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered. Results We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in two implantable devices. Patients receiving Taxus Express2® drug eluting stents (DES) experienced a 1.28 fold (2.87% versus 2.25%, absolute risk increase of 0.62%, CI: 0.25-0.99%) increased risk of post-procedural myocardial infarction and a 1.21 fold increase major adverse cardiac events relative to alternative DES (4.24% vs. 3.50%, absolute increase of 0.74%, CI: 0.29-1.19%). Patients receiving the Angio-Seal STS® vascular closure device (VCD) experienced a 1.51 fold increased risk (1.09% vs. 0.72%, absolute increased risk 0.37%, CI: 0.03-0.71%) increased risk of major vascular complications compared with alternative VCD. Sensitivity analyses confirmed

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

    PubMed

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

    2014-04-01

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

  6. 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

  7. Food Safety Impacts from Post-Harvest Processing Procedures of Molluscan Shellfish.

    PubMed

    Baker, George L

    2016-04-18

    Post-harvest Processing (PHP) methods are viable food processing methods employed to reduce human pathogens in molluscan shellfish that would normally be consumed raw, such as raw oysters on the half-shell. Efficacy of human pathogen reduction associated with PHP varies with respect to time, temperature, salinity, pressure, and process exposure. Regulatory requirements and PHP molluscan shellfish quality implications are major considerations for PHP usage. Food safety impacts associated with PHP of molluscan shellfish vary in their efficacy and may have synergistic outcomes when combined. Further research for many PHP methods are necessary and emerging PHP methods that result in minimal quality loss and effective human pathogen reduction should be explored.

  8. 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.

  9. 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…

  10. 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…

  11. 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…

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

    PubMed

    Silva, I R; Kulldorff, M

    2015-09-01

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

  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.

  14. 41 CFR 302-9.141 - What is the “authorized point of origin” when I transport a POV to my post of duty?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 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... “authorized point of origin” when I transport a POV to my post of duty? Your “authorized point of origin”...

  15. 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.

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

    SciTech Connect

    Cottrell, W B; Passiakos, M

    1980-06-01

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

  17. 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.

  18. [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.

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

    PubMed

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

    2016-05-01

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

  20. Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.

    PubMed

    Wang, Yali; Dong, Duo; Cheng, Gang; Zuo, Shuyan; Liu, Dawei; Du, Xiaoxi

    2014-10-07

    Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied.

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

    PubMed

    Silva, Ivair R

    2016-04-30

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

  2. Food Safety Impacts from Post-Harvest Processing Procedures of Molluscan Shellfish

    PubMed Central

    Baker, George L.

    2016-01-01

    Post-harvest Processing (PHP) methods are viable food processing methods employed to reduce human pathogens in molluscan shellfish that would normally be consumed raw, such as raw oysters on the half-shell. Efficacy of human pathogen reduction associated with PHP varies with respect to time, temperature, salinity, pressure, and process exposure. Regulatory requirements and PHP molluscan shellfish quality implications are major considerations for PHP usage. Food safety impacts associated with PHP of molluscan shellfish vary in their efficacy and may have synergistic outcomes when combined. Further research for many PHP methods are necessary and emerging PHP methods that result in minimal quality loss and effective human pathogen reduction should be explored. PMID:28231124

  3. 75 FR 3946 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... Bellefonte Efficiency and Sustainability Team, and the Southern Alliance for Clean Energy in response to a... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY... following proceeding: Tennessee Valley Authority (Bellefonte Nuclear Plant, Units 1 and 2) This...

  4. 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.

  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. 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, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 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... point of origin” when I transport my POV from my post of duty? The “authorized point of origin” when...

  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, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 4 2013-07-01 2012-07-01 true 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... point of origin” when I transport my POV from my post of duty? The “authorized point of origin” when...

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

    PubMed Central

    Lexchin, Joel

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  10. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  11. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  15. 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, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 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...

  16. [The safety evaluation of fradiomycin-gramicidin S troches "Meiji" (author's transl)].

    PubMed

    Yokota, M; Odaki, M; Koeda, T; Sato, K; Akiyoshi, M

    1976-09-01

    The troches "Meiji" contain fradiomycin (neomycin), an aminoglycoside antibiotic, and gramicidin S, and are effective against gram-negative and -positive bacteria. In this paper the safety evaluation of the troches is reported. In this study male guinea pigs of Hartley strain were used, and fradiomycin (FRM) and gramicidin S (GRMN) were administered orally for 35 days consecutively except Sunday. The PRYER'S reflex test was carried out with frequency range of 10,000 approximately 15,000 Hz before, during and after the administration. After the last administration the animals underwent vital perfusion with physiological saline and then with Wittmack's fixative. Bilateral temporal bones were removed and fixed in the same fixative for several days. Using a conventional method, serial celloidin horinzontal sections were prepared and stained with hematoxyline-eosine to observe histopathological effect of the medicines on the organs of CORTI. The results were as follows: 1) There were no remarkable differences in the treated animals from the initial states. No animal died at all the doses tested. 2) All of the guinea pigs received 10 and 50 mg/kg of FRM and 4 and 20 mg/kg of GRMN for 35 days indicated positive pinna reflex in the extensive frequency range of 10,000 approximately 15,000 Hz. There was no remarkable damage in the organ of CORTI on histopathological examination. 3) It was concluded from these results that the troches are highly safe.

  17. 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.

  18. Post-licensure safety evaluation of dihydroartemisinin piperaquine in the three major ecological zones across Ghana

    PubMed Central

    Oduro, Abraham R.; Owusu-Agyei, Seth; Gyapong, Margaret; Osei, Isaac; Adjei, Alex; Yawson, Abena; Sobe, Edward; Baiden, Rita; Adjuik, Martin; Binka, Fred

    2017-01-01

    Background Uncommon and rare adverse events (AEs), with delayed onset may not be detected before new drugs are licensed and deployed. The present study examined the post licensure safety of dihydroartemisinin-piperaquine (DHP) as an additional treatment for malaria in Ghana. The relationship between the incidence of AEs, treatment completion rate, participant characteristics and concomitant medications are reported. Methods A study conducted from September 2013 to June 2014 in Navrongo, Kintampo and Dodowa health research centres in Ghana is presented. Participants had confirmed malaria and no known allergy to study drug. Patients provided informed consent and had their symptoms and results of their clinical examinations documented. Treatment with Eurartesim® (20/160mg dihydroartemisinin and 40/320mg piperaquine by Sigma-Tau Incorporated) was given, according to the body weight of patients. First treatment doses were under observation but the second and third doses were taken at home except in a sub-study involving a nested cohort. Patients were contacted at Day 5 (± 2 days) either on telephone or by a home visit to document any AEs experienced. Patients were asked to report to the study team any other AEs that occurred within 28 days post-treatment. All patients in the nested cohort had electrocardiogram (ECG). Findings A total of 4563 patients, 52.1% females and 48.2% <6 years completed the study. A total of 444 patients were enrolled into the nested cohort. About 33% had temperature ≥ 37.5°C at enrolment. Approximately 3.4% reported taking prior antimalarials, 19.4% other medications and 86% took at least one concomitant medication. Incidence of AEs was 7.6% including infections (4.6%), gastrointestinal disorders (1.0%) and local reactions at the site of venesection (0.5%). Others were respiratory disorders (0.4%) and nervous system disorders (0.3%). There were nine adverse events of special interest (AESI); itching/pruritus (7), dizziness (1), and skin

  19. 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

    ... 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 A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for...

  20. 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

    ... 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 A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for...

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

    SciTech Connect

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

    2015-01-01

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

  2. 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... fundamentally incompatible mix of technologies in the band. The Commission resolves the interference by reconfiguring the band to spectrally separate incompatible technologies. The Commission delegated authority...

  3. 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.

  4. 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.

  5. Timing, safety, and efficacy of thoracoscopic evacuation of undrained post-traumatic hemothorax.

    PubMed

    Vassiliu, P; Velmahos, G C; Toutouzas, K G

    2001-12-01

    Residual post-traumatic hemothorax (RPTH) occurs in 3 to 8 per cent of patients with tube thoracostomy and may cause serious infectious complications. Surgical evacuation is recommended, and thoracoscopic evacuation (THEVA) tends to replace open thoracotomy for this purpose. The objective of this study is to evaluate the optimal timing, safety, and efficacy of THEVA. Over 5 years patients with tube thoracostomy for trauma who had unresolved opacities on plain chest radiograph were evaluated by CT. If the residual fluid volume was estimated to be more than 500 mL3 on CT the patients were offered THEVA. Unstable patients were excluded. A score ranging from one (easy) to three (difficult) was used to grade the difficulty of the operation according to the attending surgeon's perception. Of 1728 chest trauma patients 143 (8%) were evaluated by CT for persistent opacity on plain film, 31 (1.8%) were found to have RPTH, and 24 (1.4%) were eventually taken for THEVA at 3.5+/-2 days after admission. Low oxygen saturation (less than 94%) was found in 58 per cent of patients before THEVA but in only 25 per cent after THEVA (P = 0.02). The majority of chest tubes (75%) were removed within 4 days of the operation. Two patients required conversion to thoracotomy. THEVA done within 3 days of admission was associated with a lower operative difficulty score, shorter hospital stay, and a trend toward shorter intraoperative time compared with THEVA done after 3 days of admission. All patients had effective resolution of their radiographic opacities after THEVA. Three patients developed a complication (urinary tract infection, pneumonia, and persistent air leak). We conclude that patients with significant RPTH and without major physiologic compromise are appropriate candidates for THEVA. The procedure is safe, evacuates PRTH effectively, and improves the respiratory function of affected patients. Ideally it should be performed within 3 days of admission.

  6. 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

  7. Safety and efficacy of pregabalin in patients with central post-stroke pain.

    PubMed

    Kim, Jong S; Bashford, Guy; Murphy, T Kevin; Martin, Andrew; Dror, Vardit; Cheung, Raymond

    2011-05-01

    Pregabalin has demonstrated efficacy in several forms of neuropathic pain, but its long-term efficacy in central post-stroke pain (CPSP) is unproven. We evaluated the efficacy and safety of pregabalin versus placebo in patients with CPSP. A 13-week, randomized, double-blind, multicenter, placebo-controlled, parallel group study of 150 to 600 mg/day pregabalin was conducted in patients aged ≥18 years with CPSP. The primary efficacy endpoint was the mean pain score on the Daily Pain Rating Scale over the last 7 days on study drug up to week 12 or early termination visit. Secondary endpoints included other pain parameters and patient-reported sleep and health-related quality-of-life measures. A total of 219 patients were treated (pregabalin n=110; placebo n=109). A mean pain score at baseline of 6.5 in the pregabalin group and 6.3 in the placebo group reduced at endpoint to 4.9 in the pregabalin group and 5.0 in the placebo group (LS mean difference=-0.2; 95% CI=-0.7, 0.4; P=0.578). Treatment with pregabalin resulted in significant improvements, compared with placebo, on secondary endpoints including MOS-sleep, HADS-A anxiety, and clinician global impression of change (CGIC) P<0.05. Adverse events were more frequent with pregabalin than with placebo and caused discontinuation in 9 (8.2%) of pregabalin patients versus 4 (3.7%) of placebo patients. Although pain reductions at endpoint did not differ significantly between pregabalin and placebo, improvements in sleep, anxiety, and CGIC suggest some utility of pregabalin in the management of CPSP.

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

    PubMed

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

    2016-07-01

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

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

    PubMed

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

    2015-12-01

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

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

    ERIC Educational Resources Information Center

    Jackson, Natalie Jo

    2009-01-01

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

  11. Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

    PubMed

    Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

    2017-02-21

    Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  13. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  14. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  15. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  16. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  17. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  18. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  19. 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, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 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...

  20. 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.

  1. 77 FR 10666 - Pipeline Safety: Post Accident Drug and Alcohol Testing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... operators and operators of Liquefied Natural Gas (LNG) facilities to conduct post- accident drug and alcohol... Pipelines and Liquefied Natural Gas Facilities. Subject: Post-Accident Drug and Alcohol Testing. Advisory... INFORMATION: I. Background On September 9, 2010, a 30-inch-diameter segment of an intrastate natural...

  2. Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.

    PubMed

    Fox, Bethany

    2012-01-01

    While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.

  3. 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

  4. Risk assessment of pesticides and other stressors in bees: Principles, data gaps and perspectives from the European Food Safety Authority.

    PubMed

    Rortais, Agnès; Arnold, Gérard; Dorne, Jean-Lou; More, Simon J; Sperandio, Giorgio; Streissl, Franz; Szentes, Csaba; Verdonck, Frank

    2017-06-01

    Current approaches to risk assessment in bees do not take into account co-exposures from multiple stressors. The European Food Safety Authority (EFSA) is deploying resources and efforts to move towards a holistic risk assessment approach of multiple stressors in bees. This paper describes the general principles of pesticide risk assessment in bees, including recent developments at EFSA dealing with risk assessment of single and multiple pesticide residues and biological hazards. The EFSA Guidance Document on the risk assessment of plant protection products in bees highlights the need for the inclusion of an uncertainty analysis, other routes of exposures and multiple stressors such as chemical mixtures and biological agents. The EFSA risk assessment on the survival, spread and establishment of the small hive beetle, Aethina tumida, an invasive alien species, is provided with potential insights for other bee pests such as the Asian hornet, Vespa velutina. Furthermore, data gaps are identified at each step of the risk assessment, and recommendations are made for future research that could be supported under the framework of Horizon 2020. Finally, the recent work conducted at EFSA is presented, under the overarching MUST-B project ("EU efforts towards the development of a holistic approach for the risk assessment on MUltiple STressors in Bees") comprising a toolbox for harmonised data collection under field conditions and a mechanistic model to assess effects from pesticides and other stressors such as biological agents and beekeeping management practices, at the colony level and in a spatially complex landscape. Future perspectives at EFSA include the development of a data model to collate high quality data to calibrate and validate the model to be used as a regulatory tool. Finally, the evidence collected within the framework of MUST-B will support EFSA's activities on the development of a holistic approach to the risk assessment of multiple stressors in bees. In

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

    ERIC Educational Resources Information Center

    Akaiso, Darlington

    2013-01-01

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

  6. Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care.

    PubMed

    Kim, C M; Kim, Y S; Sunwoo, S; Cho, B; Rho, M; Yang, Y J; Kim, C H; Shin, H C; Lee, S Y; Kim, D H

    2007-01-01

    To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were 'very satisfied' or 'satisfied' with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.

  7. 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)

  8. 48 CFR 50.205-4 - Authorization of awards made presuming SAFETY Act designation or certification after contract award.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... the class of technology to be acquired under the solicitation....

  9. 48 CFR 50.205-4 - Authorization of awards made presuming SAFETY Act designation or certification after contract award.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... the class of technology to be acquired under the solicitation....

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... the class of technology to be acquired under the solicitation....

  11. 48 CFR 50.205-4 - Authorization of awards made presuming SAFETY Act designation or certification after contract award.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... the class of technology to be acquired under the solicitation....

  12. 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

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... the class of technology to be acquired under the solicitation....

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

    PubMed

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

    2013-06-01

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

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

    PubMed Central

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

    2014-01-01

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

  15. [Cytological study of the post-embryonic development of the digestive gland of Sepia officinalis L. Mollusca : Cephalopoda (author's transl)].

    PubMed

    Yim, M; Boucaud-Camou, E

    1980-01-01

    A histological and ultrastructural study of the development of the digestive gland of Sepia officinalis L. was carried out on young Sepia reared in the laboratory, during the first month of post-embryonic life. The increasing complexity of the histological structure of the gland is related to the successive appearance of several cell types : immature cell, synthetizing cell, mature digestive cell ("cellule à boules"), and resting cell. These types are, in fact, just the evolutive stages of the same cell, the digestive cell. The sequence of appearance of the different cell types and the changes occurring in feeding can be used to define three stages in the post-embryonic development of the Sepia officinalis L. digestive gland : a multiplication stage (from hatching to the 5th day), a maturation stage (5th to 30th day), and adult stage (after the first month of post-embryonic life). These stages are identical to the three periods previously described by Richard and Decleir (1969) in the life of Sepia.

  16. Comparison of Efficacy and Safety of Intramuscular Piroxicam and Tramadol for Post-operative Pain in Patients Undergoing Caesarean Delivery

    PubMed Central

    Thippeswamy, Tejashree; Bengalorkar, Girish M; Mariyappa, Narayanaswamy

    2016-01-01

    Introduction Post-caesarean section pain can be both stressful and unfavourable. Effective and rapid reduction of pain facilitates early ambulation and care of the new born. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and opioids are used for pain relief but they are associated with adverse effects both in the mother and the child. Aim To evaluate efficacy and safety of piroxicam and tramadol in post-caesarean section pain. Materials and Methods Primigravidae who underwent elective caesarean section received either piroxicam 20mg or tramadol 100mg intra-muscularly, following recovery from anaesthesia. Severity of pain was assessed using Visual Analogue Scale (VAS) and side-effects to study drugs were noted. Rescue analgesic butorphanol 2mg was administered if VAS score was more than four. Patient’s satisfaction score was assessed at 12 hours post-operatively. Results Mean age in piroxicam and tramadol groups were 23.32±3.43 and 22.03±2.0 years respectively. Significant reduction in pain was observed at 2, 4, 8, 12 and 24 hours in both groups (p<0.001). Pain relief was significant at 2, 4 and 8 hours in piroxicam group compared to tramadol. Twenty-one and 12 patients in tramadol and piroxicam groups received rescue analgesic respectively. Sedation and nausea was significantly higher in tramadol group (p<0.001), 46.66% of patients graded their satisfaction score as good and 15% as excellent in piroxicam group. Conclusion Intra-muscular piroxicam was effective in reducing post-caesarean section pain for 24 hours with minimal side-effects compared to tramadol. PMID:28050391

  17. 30 CFR 774.11 - Post-permit issuance requirements for regulatory authorities and other actions based on ownership...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... control or have controlled surface coal mining and reclamation operations with a demonstrated pattern of... regulatory authorities and other actions based on ownership, control, and violation information. 774.11... REQUIREMENTS; AND OTHER ACTIONS BASED ON OWNERSHIP, CONTROL, AND VIOLATION INFORMATION § 774.11...

  18. 30 CFR 774.11 - Post-permit issuance requirements for regulatory authorities and other actions based on ownership...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Section 774.11 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER... actions, we, the regulatory authority, must enter into AVS the data shown in the following table— We...

  19. 30 CFR 774.11 - Post-permit issuance requirements for regulatory authorities and other actions based on ownership...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Section 774.11 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER... actions, we, the regulatory authority, must enter into AVS the data shown in the following table— We...

  20. 30 CFR 774.11 - Post-permit issuance requirements for regulatory authorities and other actions based on ownership...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Section 774.11 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER... actions, we, the regulatory authority, must enter into AVS the data shown in the following table— We...

  1. 30 CFR 774.11 - Post-permit issuance requirements for regulatory authorities and other actions based on ownership...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Section 774.11 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER... actions, we, the regulatory authority, must enter into AVS the data shown in the following table— We...

  2. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... technologies before release of any solicitation; and (3) Market research shows that there will be...

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... technologies before release of any solicitation; and (3) Market research shows that there will be...

  4. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... technologies before release of any solicitation; and (3) Market research shows that there will be...

  5. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... technologies before release of any solicitation; and (3) Market research shows that there will be...

  6. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002... technologies before release of any solicitation; and (3) Market research shows that there will be...

  7. An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance.

    PubMed

    Langley, Richard G B; Luger, Thomas A; Cork, Michael J; Schneider, Dirk; Paul, Carle

    2007-01-01

    In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has a favourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2-5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy.

  8. 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.

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

    PubMed

    Woolfson, Charles

    2006-01-01

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

  10. 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.

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

    PubMed

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

    2016-05-01

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

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

    PubMed

    Zhu, Xiao; Kruhlak, Naomi L

    2014-07-03

    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.

  13. Safety of measles-containing vaccines in post-marketing surveillance in Anhui, China.

    PubMed

    Meng, Fan-Ya; Sun, Yong; Shen, Yong-Gang; Pan, Hai-Feng; Tang, Ji-Hai; Wang, Bin-Bing; Wu, Chang-Hao; Ye, Dong-Qing

    2017-01-01

    The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191.4 per million doses), of which, 33 serious AEFIs (3.3 per million vaccine doses) were reported. 59.4% (1124 cases) were male cases, and 85.1% (1611 cases) occurred in persons aged < 1 year. 93.3% (1766 cases) occurred at the first dose of vaccination and 95.9% (1815 cases) were found within 3 days after vaccination. This study presents up-to-date data and suggests that the measles-containing vaccines used in Anhui Province of China are safe.

  14. Safety of measles-containing vaccines in post-marketing surveillance in Anhui, China

    PubMed Central

    Meng, Fan-Ya; Sun, Yong; Shen, Yong-Gang; Pan, Hai-Feng; Tang, Ji-Hai; Wang, Bin-Bing; Wu, Chang-Hao; Ye, Dong-Qing

    2017-01-01

    The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191.4 per million doses), of which, 33 serious AEFIs (3.3 per million vaccine doses) were reported. 59.4% (1124 cases) were male cases, and 85.1% (1611 cases) occurred in persons aged < 1 year. 93.3% (1766 cases) occurred at the first dose of vaccination and 95.9% (1815 cases) were found within 3 days after vaccination. This study presents up-to-date data and suggests that the measles-containing vaccines used in Anhui Province of China are safe. PMID:28192490

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

    PubMed Central

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

    2006-01-01

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

  16. Post-marketing surveillance of the safety of cimetidine: twelve-month morbidity report.

    PubMed

    Colin Jones, D G; Langman, M J; Lawson, D H; Vessey, M P

    1985-03-01

    A total of 9928 patients taking cimetidine and 9351 controls were included in a post-marketing drug surveillance study in Glasgow, Nottingham, Oxford and Portsmouth; 98.8 per cent of the takers and 97.7 per cent of the controls were successfully followed up for at least one year during which hospital visits and deaths were recorded. Methods of identification of subjects and 12-month mortality results have been reported previously. A general analysis of the morbidity experienced by these patients during the study year is presented here. Thirty-nine per cent of takers and 21 per cent of controls were seen at outpatient clinics, and 18 per cent of takers and 8 per cent of controls were admitted to hospital; 15 325 individual diagnoses in takers and 5002 diagnoses in controls were reviewed. An association with cimetidine treatment was found, as expected, for gastrointestinal diseases. Weaker associations were found for haematological disorders, some tumours, infections, disorders of the locomotor system and respiratory diseases. Detailed examination revealed that these were mainly due to confounding from several sources, for example, from the underlying cause of the dyspepsia which resulted in cimetidine use, from the higher level of physician contact in cimetidine takers, and smoking. The scheme successfully detected and quantified some already known adverse effects of cimetidine and did not detect any new effects. It is concluded that this method of collecting information is feasible and useful, but several interpretive pitfalls arise, some of which can be avoided by careful analysis. No evidence of any major unrecognised risk of cimetidine treatment emerged from the study.

  17. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    PubMed

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  18. [Safety and efficacy of docetaxel in prostate cancer patients: based on the post-marketing surveillance in Japan].

    PubMed

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

    The safety and efficacy of docetaxel in prostate cancer were evaluated based on the results of post-marketing surveillance. 149 patients were enrolled between September 2008 and May 2010. The starting dose of docetaxel was 75 mg/m² in 53 patients(36%), 70 mg/m² in 55 (37%), and ≤ 60 mg/m² in 41(28%). The median number of treatment cycles was 8 (range, 1 to 10). There was no age difference observed in the starting doses and the treatment cycles. The most common ≥ grade 3 adverse drug reactions (ADRs) were neutropenia (71%)and leukocytopenia (51%), and they occurred more frequently in patients receiving ≥ 70 mg/m². However, the multi-variate analyses revealed that ≥ grade 3 ADRs did not correlate with the starting doses. Infection-related events (≥ grade 3) and interstitial pneumonia were observed in 15% and 1% of patients, respectively. Prostate-specific-antigen (PSA) flare appeared in 19% of 95 evaluable patients at median period of 26 days from treatment initiation. It continued with median duration of 39. 5 days. PSA response rate as defined ≥ 50% level decline was 37%(95%confidence interval: 27-47) in evaluable patients. It was low in patients receiving ≤ 60 mg/m² (18%). There was no notable difference between patients with initial dose of 75 and 70 mg/m². Further investigation for the longer term is warranted.

  19. [Explore method about post-marketing safety re-evaluation of Chinese patent medicines based on HIS database in real world].

    PubMed

    Yang, Wei; Xie, Yanming; Zhuang, Yan

    2011-10-01

    There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals. Chinese patent medicine's safety problems are the most concerned by patients and physicians. At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China. However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems. HIS database in real world is a good resource with rich information to research medicine safety. This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures. This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database. A clear protocol has been completed as for the first step for the whole study. The protocol is as follows. First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database. Secondly, select some related laboratory tests indexes as the safety evaluating outcomes, such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests. Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines. Finally, judge the relationship between those abnormal changing and Chinese patent medicine. We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.

  20. [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.

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

    PubMed

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

    2016-01-01

    The antimalarial drug piperaquine is associated with delayed ventricular depolarization, causing prolonged QT interval (time taken for ventricular de-polarisation and re-polarisation). There is a lack of safety data regarding dihydroartemisinin/piperaquine (DHA/PPQ) for the treatment of uncomplicated malaria, which has limited its use. We created a platform where electrocardiograms (ECG) were performed in public hospitals for the safety assessment of DHA/PPQ, at baseline before the use of dihydroartemisinin/piperaquine (Eurartesim®), and on day 3 (before and after administration of the final dose) and day 7 post-administration. Laboratory analyses included haematology and clinical chemistry. The main objective of the ECG assessment in this study was to evaluate the effect of administration of DHA/PPQ on QTc intervals and the association of QTc intervals with changes in blood biochemistry, full and differential blood count over time after the DHA/PPQ administration. A total of 1315 patients gave consent and were enrolled of which 1147 (87%) had complete information for analyses. Of the enrolled patients 488 (42%), 323 (28%), 213 (19%) and 123 (11%) were from Ghana, Burkina Faso, Tanzania and Mozambique, respectively. Median (lower-upper quartile) age was 8 (5-14) years and a quarter of the patients were children under five years of age (n = 287). Changes in blood biochemistry, full and differential blood count were temporal which remained within clinical thresholds and did not require any intervention. The mean QTcF values were significantly higher than on day 1 when measured on day 3 before and after administration of the treatment as well as on day 7, four days after completion of treatment (12, 22 and 4 higher, p < 0.001). In all age groups the values of QT, QTcF and QTcB were highest on day 3 after drug intake. The mean extreme QTcF prolongation from baseline was lowest on day 3 before drug intake (33 ms, SD = 19) and highest on day 3 after the last dose (60 ms

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

    PubMed Central

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

    2016-01-01

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

  3. 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.

  4. 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.

  5. 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

    Chacón, Jose

    2010-07-21

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

  6. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study.

    PubMed

    Jost, Wolfgang H; Hefter, Harald; Reissig, Andrea; Kollewe, Katja; Wissel, Joerg

    2014-02-15

    The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale ('no goal achievement', 'goal achievement', 'good goal achievement', 'best goal achievement'). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pre-treatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728 U and an inverse dose-response relationship was observed. Treatment was well tolerated. 500-1000 U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation.

  7. 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

    2006-04-03

    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.

  8. 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 -1.44±0.72 in the NABOTA group and -1.46±0.77 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.

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

    PubMed Central

    Chacón, Jose

    2010-01-01

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

  10. 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.

  11. Including non-dietary sources into an exposure assessment of the European Food Safety Authority: The challenge of multi-sector chemicals such as Bisphenol A.

    PubMed

    von Goetz, N; Pirow, R; Hart, A; Bradley, E; Poças, F; Arcella, D; Lillegard, I T L; Simoneau, C; van Engelen, J; Husoy, T; Theobald, A; Leclercq, C

    2017-04-01

    In the most recent risk assessment for Bisphenol A for the first time a multi-route aggregate exposure assessment was conducted by the European Food Safety Authority. This assessment includes exposure via dietary sources, and also contributions of the most important non-dietary sources. Both average and high aggregate exposure were calculated by source-to-dose modeling (forward calculation) for different age groups and compared with estimates based on urinary biomonitoring data (backward calculation). The aggregate exposure estimates obtained by forward and backward modeling are in the same order of magnitude, with forward modeling yielding higher estimates associated with larger uncertainty. Yet, only forward modeling can indicate the relative contribution of different sources. Dietary exposure, especially via canned food, appears to be the most important exposure source and, based on the central aggregate exposure estimates, contributes around 90% to internal exposure to total (conjugated plus unconjugated) BPA. Dermal exposure via thermal paper and to a lesser extent via cosmetic products may contribute around 10% for some age groups. The uncertainty around these estimates is considerable, but since after dermal absorption a first-pass metabolism of BPA by conjugation is lacking, dermal sources may be of equal or even higher toxicological relevance than dietary sources.

  12. 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.

  13. Impact of a program combining pre-authorization requirement and post-prescription review of carbapenems: an interrupted time-series analysis.

    PubMed

    Delory, T; De Pontfarcy, A; Emirian, A; About, F; Berdougo, B; Brun-Buisson, C; Lesprit, P

    2013-12-01

    The objective of this study was to assess the impact on carbapenems use of a program combining pre-authorization requirement and systematic post-prescription review of carbapenems prescriptions. The program was implemented in a 1,230-bed teaching tertiary hospital. Monthly carbapenems consumption was analyzed using a controlled interrupted time-series method and compared to that of vancomycin before and after implementation of the intervention. Compared to the pre-intervention period (14 monthly points), a significant and sustained decrease of carbapenems consumption [1.66 defined daily doses (DDD)/1,000 patient-days; p = 0.048] was observed during the intervention period (12 monthly points), despite an increasing trend in incidence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) isolates (0.02/1,000 patient-days per month; p = 0.093). As expected, vancomycin consumption was unaffected by the intervention. A total of 337 prescriptions were reviewed in the intervention period; most were microbiologically documented (81.3%; ESBL-PE: 39.2%). Three of four (76.6%) carbapenems prescriptions were modified within a median [interquartile range] of 2 [1; 4] days, either after infectious disease physician (IDP) advice (48.4%) or by ward physicians (28.2%). Most changes included de-escalating (52.2%) or reducing the planned duration (22.2%), which resulted in a median duration of treatment of only 3 [2; 7] days. The median length of stay and mortality rate were not influenced by the intervention. This reasonably practicable antimicrobial stewardship program including controlled delivery and systematic reevaluation of carbapenems prescriptions was able to reduce their use in our hospital, despite a rising ESBL-PE incidence.

  14. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    PubMed

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  15. [The significance of introducing registry study in the post-marketing safety research for Chinese medicine and pharmacy].

    PubMed

    Liao, Xing; Xie, Yan-Ming; Yang, Wei; Chang, Yan-Peng

    2014-03-01

    There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.

  16. [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.

  17. Author! Author! Beverly Cleary

    ERIC Educational Resources Information Center

    Brodie, Carolyn S.

    2005-01-01

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

  18. Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

    PubMed Central

    Nishikawa, Atsushi; Yoshiki, Fumito; Taketsuna, Masanori; Kajimoto, Kenta; Enomoto, Hiroyuki

    2016-01-01

    Teriparatide (recombinant 1–34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 μg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed. PMID:27895472

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

    PubMed

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

    2012-06-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. 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.

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  3. 41 CFR 302-9.141 - What is the “authorized point of origin” when I transport a POV to my post of duty?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

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

    PubMed

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

    2011-01-01

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

  5. Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study

    PubMed Central

    Yan, Ying-Ying; Yang, Yi-Heng; Wang, Wei-Wei; Pan, Yu-Ting; Zhan, Si-Yan; Sun, Ming-Yang; Zhang, Hong; Zhai, Suo-Di

    2017-01-01

    Background Salvia Miltiorrhiza Depside Salt for Infusion (SMDS) is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed. Objective To investigate the safety issues, including adverse events (AEs), adverse events related to SMDS (ADEs), and adverse drug reactions (ADRs) of the SMDS in the real world clinical practice. Methods This is a prospective, multicenter, pharmacist-led, cohort study in the real world setting. Consecutive patients prescribed with SMDS were all included in 36 sites. Pharmacists were well trained to standardized collect the patients information, including demographics, medical history, prescribing patterns of SMDS, combined medications, adverse events, laboratory investigations, outcomes of the treatment when discharge, and interventions by pharmacists. Adverse events and adverse drug reactions were collected in details. Multivariate possion regression analysis was applied to identify risk factors associated with ADEs using the significance level (α) 0.05. ClinicalTrials.gov Identifier: NCT01872520. Results Thirty six hospitals were participated in the study and 30180 consecutive inpatients were included. The median age was 62 (interquartile range [IQR], 50–73) years, and male was 17384 (57.60%) among the 30180 patients. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. There were 9 kinds of new ADEs which were not on the approved label found in the present study. According to the multivariate analysis, male (RR = 1.381, P = 0.009, 95%CI [1.085~1.759]), more concomitant medications (RR = 1.049, P<0.001, 95%CI [1.041~1.057]), longer duration of SMDS therapy (RR = 1.027, P<0.001, 95%CI [1.013~1.041]), higher drug concentration (RR = 1.003, P = 0.014, 95%CI [1.001~1.006]), and resolvent unapproved (RR = 1.900, P = 0.002, 95%CI [1.260~2.866]) were the independent risk

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

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

    PubMed

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

    2000-12-01

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

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

    PubMed

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

    2014-03-26

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

  12. 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

  13. Safety and Tolerability of Nafamostat Mesilate and Heparin as Anticoagulants in Leukocytapheresis for Ulcerative Colitis: Post Hoc Analysis of a Large-Scale, Prospective, Observational Study.

    PubMed

    Sawada, Koji; Ohdo, Maiko; Ino, Tomoko; Nakamura, Takashi; Numata, Toyoko; Shibata, Hiroshi; Sakou, Jun-ichi; Kusada, Masahiro; Hibi, Toshifumi

    2016-04-01

    Nafamostat mesilate is the first anticoagulant of choice for leukocytapheresis (LCAP) with a Cellsorba E column for treating ulcerative colitis (UC). However, because of complications, mainly due to allergy to nafamostat mesilate, heparin may be used as a substitute. To evaluate the safety and tolerability of nafamostat mesilate and heparin as anticoagulants in LCAP for UC, we conducted post hoc analysis of data from a large-scale, prospective, observational study of LCAP, which was conducted at 116 medical facilities in Japan between May 2010 and December 2012. Of 832 patients included in this analysis, nafamostat mesilate and heparin were used in 676 (81.3%) and 113 (13.6%), respectively. There were no significant differences in the incidence of adverse reactions (8.6% vs. 7.1%) and intrafilter pressure increases (12.7% vs. 16.8%) between the nafamostat mesilate and heparin groups. Adverse reactions of hemorrhage or blood pressure decreases associated with heparin use were not observed. There were no significant differences in rates of clinical remission (69.1% vs. 68.1%) and mucosal healing (62.9% vs. 63.6%) between the nafamostat mesilate and heparin groups. Thus, the safety and tolerability were comparable in the nafamostat mesilate and heparin groups, indicating that both nafamostat mesilate and heparin can be well tolerated as anticoagulants in LCAP for UC.

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

    PubMed

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

    2014-04-01

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

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

    PubMed Central

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

    2016-01-01

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

  16. An immunogenicity, safety and post-marketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax) in Indian subjects.

    PubMed

    Sudarshan, M K; Bhardwaj, S; Mahendra, B J; Sharma, H; Sanjay, T V; Ashwathnarayana, D H; Bilagumba, Gangaboraiah

    2008-01-01

    In 1999, Serum Institute of India indigenously developed an adsorbed human diploid cell rabies vaccine (Rabivax). During 2000-04, this new vaccine was subjected to a series of immunogenecity and safety studies. Initially, an experimental batch of Rabivax (adsorbed) was assessed on ten healthy adult volunteers and its response was comparable with that of Merieux inactivated rabies vaccine (MIRV, lyophilized) which was used as a control. Subsequently, Rabivax (adsorbed) was assessed on forty-five suspect rabid dog bite cases with MIRV as control. The vaccine was found to be equally safe and immunogenic as MIRV and showed better rabies virus neutralizing antibody (RVNA) response on day 90 than MIRV. A post-licensing study conducted on 150 cases of suspect rabid animal bites showed it to be safe and immunogenic. To assess its long-term sero-efficacy some of these subjects tested after one year of follow up showed that 84% of them had adequate RVNA titers. In addition, a routine post-marketing surveillance done on 1608 animal bite cases demonstrated that Rabivax (adsorbed) was safe and efficacious. The adverse events to Rabivax (adsorbed) included pain at injection site (3.4%), swelling with induration (2.8%), fever and headache (1.4%). No serious adverse event was reported from the studies. In conclusion, Rabivax (adsorbed) is an immunogenic, safe and efficacious vaccine for rabies prophylaxis in humans.

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

    PubMed

    Ozilgen, Sibel; Bucak, Seyda; Ozilgen, Mustafa

    2013-06-01

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

  18. 49 CFR Appendix to Subpart H of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North America-Domiciled...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... damage as a result of the accident requiring the motor vehicle to be transported away from the scene by a... carrier incurs two or more recordable accidents within the 12 months before the safety audit. An urban... urban carrier (1.5 for all other carriers), the carrier is determined to have inadequate basic...

  19. Safety and Tolerability of Adjunctive Aripiprazole in Major Depressive Disorder: A Pooled Post Hoc Analysis (studies CN138-139 and CN138-163)

    PubMed Central

    Thase, Michael E.; Trivedi, Madhukar H.; Fava, Maurizio; Han, Jian; Van Tran, Quynh; Pikalov, Andrei; Qi, Ying; Carlson, Berit X.; Marcus, Ronald N.; Berman, Robert M.

    2009-01-01

    Objective: To evaluate the safety and tolerability of aripiprazole adjunctive to standard antidepressant therapy (ADT) for patients with major depressive disorder (DSM-IV-TR criteria). Method: Data from 2 identical studies of aripiprazole augmentation (8 weeks of prospective ADT treatment followed by 6 weeks of randomized double-blind adjunctive treatment) were pooled. The incidence of treatment-emergent adverse events (TEAEs) and weight, electrocardiogram (ECG), and laboratory measurements were assessed during the 6-week phase, including time course, severity, resolution, and predictors. The studies were conducted from June 2004 to April 2006 and September 2004 to December 2006. Results: The safety analysis included 737 outpatients (aripiprazole, n = 371; placebo, n = 366). The majority of patients completed the trials (aripiprazole, 86%; placebo, 88%). Common TEAEs (≥ 5% and twice the placebo rate) with aripiprazole were akathisia (25%), restlessness (12%), insomnia (8%), fatigue (8%), blurred vision (6%), and constipation (5%). Most TEAEs were of mild to moderate severity (aripiprazole, 89%; placebo, 95%). TEAE rates in the aripiprazole and placebo groups were not affected by ADT, age, or gender. Discontinuation due to TEAEs was low (aripiprazole, 3%; placebo, 1%). Mean weight change was higher with aripiprazole versus placebo (1.73 kg vs 0.38 kg, P < .001). At endpoint, clinical laboratory parameters, vital signs, and ECG indices (including QTc interval) were similar between groups. Akathisia with aripiprazole generally occurred in the first 3 weeks (76%), was of mild to moderate severity (92%), and led to discontinuation in 3 patients (0.8%). Within the aripiprazole group, age (18–40 years) was the only positive predictor for akathisia. Conclusions: In this short-term post hoc analysis, aripiprazole as augmentation to ADT demonstrated a safety and tolerability profile similar to that in monotherapy studies in other psychiatric populations. Controlled long

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

    PubMed Central

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

    2016-01-01

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

  1. 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

  2. Post-licensure safety surveillance study of routine use of tetanus toxoid, reduced diphtheria toxoid and 5-component acellular pertussis vaccine

    PubMed Central

    Baxter, Roger; Hansen, John; Timbol, Julius; Pool, Vitali; Greenberg, David P.; Johnson, David R.; Decker, Michael D.

    2016-01-01

    ABSTRACT An observational post-licensure (Phase IV) retrospective large-database safety study was conducted at Kaiser Permanente, a US integrated medical care organization, to assess the safety of Tetanus Toxoid, Reduced Diphtheria Toxoid and 5-Component Acellular Pertussis Vaccine (Tdap5) administered as part of routine healthcare among adolescents and adults. We evaluated incidence rates of various clinical events resulting in outpatient clinic, emergency department (ED), and hospital visits during various time intervals (windows) following Tdap5 vaccination using 2 pharmacoepidemiological methods (risk interval and historic cohort) and several screening thresholds. Plausible outcomes of interest with elevated incidence rate ratios (IRRs) were further evaluated by reviewing individual patient records to confirm the diagnosis, timing (temporal relationship), alternative etiology, and other health record details to discern possible relatedness of the health events to vaccination. Overall, 124,139 people received Tdap5 vaccine from September 2005 through mid-October 2006, and 203,154 in the comparison cohort received a tetanus and diphtheria toxoid adsorbed vaccine (and no live virus vaccine) during the year prior to initiation of this study. In the outpatient, ED and hospital databases, respectively, we identified 11/26, 179/700 and 187/700 unique health outcomes with IRRs significantly >1.0. Among the same unique health outcomes in the outpatient, ED, and hospital databases, 9, 146, and 385, respectively, had IRRs significantly <1.0. Further scrutiny of the outcomes with elevated IRRs did not reveal unexpected signals of adverse outcomes related to vaccination. In conclusion, Tdap5 vaccine was found to be safe among this large population of adolescents and adults. PMID:27388557

  3. Efficacy and Safety of Risedronate in Osteoporosis Subjects with Comorbid Diabetes, Hypertension, and/or Dyslipidemia: A Post Hoc Analysis of Phase III Trials Conducted in Japan.

    PubMed

    Inoue, Daisuke; Muraoka, Ryoichi; Okazaki, Ryo; Nishizawa, Yoshiki; Sugimoto, Toshitsugu

    2016-02-01

    Many osteoporotics have comorbid diabetes mellitus (DM), hypertension (HT), and dyslipidemia (DL). However, whether such comorbidities alter response to anti-osteoporotic treatment is unknown. We did post hoc analyses of combined data from three risedronate Japanese phase III trials to determine whether the presence of DM, HT, or DL affects its efficacy and safety. Data from 885 subjects who received 48-week treatment with risedronate were collected and combined from the three phase III trials. They were divided into two groups by the presence or absence of comorbidities: DM (n = 53) versus non-DM (n = 832); HT (n = 278) versus non-HT (n = 607); and DL (n = 292) versus non-DL (n = 593). Bone mineral density (BMD), urinary type 1 collagen N-telopeptide (uNTX), and serum bone-specific alkaline phosphatase (BAP) were measured at baseline and sequentially until 48 weeks. BMD or bone markers were not different between any of the two groups. Overall, BMD was increased by 5.52%, and uNTX and BAP were decreased by 35.4 and 33.8%, respectively. Some bone markers were slightly lower in DM and DL subjects, but the responses to risedronate were not significantly different. Statin users had lower uNTX and BAP, but showed no difference in the treatment response. All the other medications had no apparent effect. Adverse event incidence was marginally higher in DL compared with non-DL (Relative risk 1.06; 95% confidence interval 1.01-1.11), but was not related to increase in any specific events. Risedronate shows consistent safety and efficacy in suppressing bone turnover and increasing BMD in osteoporosis patients with comorbid DM, HT, and/or DL.

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

    PubMed Central

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

    2014-01-01

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

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

    ERIC Educational Resources Information Center

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

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

  6. Hand Safety

    MedlinePlus

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

  7. A risk stratification algorithm using non-invasive respiratory volume monitoring to improve safety when using post-operative opioids in the PACU.

    PubMed

    Voscopoulos, Christopher; Theos, Kimberly; Tillmann Hein, H A; George, Edward

    2017-04-01

    Late detection of respiratory depression in non-intubated patients compromises patient safety. SpO2 is a lagging indicator of respiratory depression and EtCO2 has proven to be unreliable in non-intubated patients. A decline in minute ventilation (MV) is the earliest sign of respiratory depression. A non-invasive respiratory volume monitor (RVM) that provides accurate, continuous MV measurements enables clinicians to predict and quantify respiratory compromise. For this observational study, practitioners were blinded to the RVM measurements and pain management followed the usual routine. Patients were stratified by their MV on PACU admission and classified as "At-Risk" or "Not-At-Risk," with progression to "Low MV" status following opioids assessed for each category. The purpose was to determine if stratifying based on MV on PACU arrival could identify patients at higher risk for respiratory depression. Ability to identify in advance patients at higher risk for respiratory depression following standard opioid dosing would drive changes in pain management and improve patient care. RVM and opioid administration data from 150 PACU patients following elective joint-replacement surgery were collected in an observational study. "Predicted" MV (MVPRED) and "Percent Predicted" (MVMEASURED/MVPRED × 100 %) were calculated for each patient using standard formulas. Prior to opioid administration, patients were classified as either "Not-At-Risk" (MV ≥ 80 % MVPRED) or "At-Risk" (MV < 80 % MVPRED). "Low MV" was defined as MV < 40 % MVPRED. Post-operative apnea (POA) was defined as ≥5 ten-second apneas per hour of PACU stay. We compared the incidences of Low MV following a single opioid dose, POA, and Low MV at discharge for both groups. In the PACU, 74/150 patients received opioids. Within 15 min of opioid administration, 32 % (24/74) developed Low MV. The risk-stratification algorithm identified 22/24 patients (92 % sensitivity). Only 46 % of them had POA

  8. 49 CFR 198.11 - Grant authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Grant authority. 198.11 Section 198.11... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY REGULATIONS FOR GRANTS TO AID STATE PIPELINE SAFETY PROGRAMS Grant Allocation § 198.11 Grant authority. The pipeline safety laws (49...

  9. 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...

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

    PubMed Central

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

    2014-01-01

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

  11. To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL)

    PubMed Central

    Rabi Das, Vidya Nand; Siddiqui, Niyamat Ali; Pal, Biplab; Lal, Chandra Shekhar; Verma, Neena; Kumar, Ashish; Verma, Rakesh Bihari; Kumar, Dhirendra; Das, Pradeep; Pandey, Krishna

    2017-01-01

    Background Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients. Methods In this open label study 50 patients with PKDL, aged between 5–60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year. Results A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups. Conclusion The lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment. PMID:28355259

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

    SciTech Connect

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

    1998-11-01

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

  13. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland Security Bureau, is hereby delegated authority to perform all functions of the Bureau, described in §§...

  14. 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…

  15. Author Indexing.

    ERIC Educational Resources Information Center

    Diodato, Virgil P.

    1981-01-01

    Discusses the effectiveness of using author-supplied indexing to increase subject control in information retrieval, and describes a study which compared author indexing for articles published in "American Mathematical Society" journals to indexing of the same articles by an editor of "Mathematical Reviews." Nine references are…

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

    ERIC Educational Resources Information Center

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

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-09-01

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

  19. 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)...

  20. 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)...

  1. 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)...

  2. 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)...

  3. 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)...

  4. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  5. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  6. Evaluating the Effectiveness of Traditional Training Methods in Non-Traditional Training Programs for Adult Learners through a Pre-Test/Post-Test Comparison of Food Safety Knowledge

    ERIC Educational Resources Information Center

    Dodd, Caleb D.; Burris, Scott; Fraze, Steve; Doerfert, David; McCulloch, Abigail

    2013-01-01

    The incorporation of hot and cold food bars into grocery stores in an effort to capture a portion of the home meal replacement industry is presenting new challenges for retail food establishments. To ensure retail success and customer safety, employees need to be educated in food safety practices. Traditional methods of training are not meeting…

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

    PubMed

    Mansour, Mansour; Skull, Alice; Parker, Michael

    2015-01-01

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

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

    PubMed

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

    2016-07-01

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

  9. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  10. [Oral contraceptives: recent safety studies (author's transl)].

    PubMed

    Edgren, R A

    1983-09-01

    Considerable research evidence now exists to suggest that the risks of oral contraceptive (OC) use were seriously overestimated in earlier work. Because experimentation in medicine is never possible in the rigorous sense in which it is employed in basic sciences, other sources of information must be substituted. Information on the dangers of OC use has come from anecdotal reports, retrospective case control studies, prospective cohort studies, and statistical analyses of deaths, each source being associated with specific problems of interpretation. Recent findings of the Royal College of General Practitioners, the Walnut Creek Study, and the Oxford Study have suggested a lowered incidence of malignant neoplasms in OC than in IUD or diaphragm users; a reduced incidence of breast cancer although the relationship did not consistently achieve statistical significance, and a reduced incidence of ovarian and endometrial cancer. The risks of cervical cancer among OC users appeared slightly higher but disappeared when sexual behavior was controlled. Despite much concern with the possibility of postpill amenorrhea and perhaps sterility among women discontinuing OC use, it now appears that after 2 years there is no difference in the fertility of women who have discontinued use of OCs, IUDs, or diaphragms. Use of OCs as a contraceptive before pregnancy does not appear to be associated with fetal malformations, spontaneous abortion, or perinatal mortality, and the inadvertent use of OCs in early pregnancy is apparently associated with only a very slight risk of anomalies. Recent studies of cardiovascular disease risks indicate that the relative risks of cardiovascular disease among OC users have been greatly exaggerated, especially when smoking is taken into account. Various studies of mortality data have failed to establish a link between OC use and excess mortality from cardiovascular disease.

  11. 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.

  12. 77 FR 35338 - Schedule of Fees Authorized

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... National Highway Traffic Safety Administration 49 CFR Part 594 RIN 2127-AL09 Schedule of Fees Authorized... rulemaking. SUMMARY: This document proposes fees for Fiscal Year 2013 and until further notice, as authorized... not certified as conforming to the Federal motor vehicle safety standards (FMVSS). These fees...

  13. 77 FR 50637 - Schedule of Fees Authorized

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... National Highway Traffic Safety Administration 49 CFR Part 594 RIN 2127-AL09 Schedule of Fees Authorized... document adopts fees for Fiscal Year 2013 and until further notice, as authorized by 49 U.S.C. 30141... to the Federal motor vehicle safety standards (FMVSS). These fees are needed to maintain...

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

    SciTech Connect

    1996-02-01

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

  15. 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.

  16. 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.

  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.

  18. FFTF Authorization Agreement

    SciTech Connect

    DAUTEL, W.A.

    2000-09-25

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

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

    PubMed Central

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

    2015-01-01

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

  20. A global perspective on vaccine safety.

    PubMed

    Duclos, Philippe

    2004-05-07

    "Immunization Safety" (i.e., ensuring and monitoring the safety of all aspects of immunization, including vaccine quality, storage and handling, vaccine administration and the disposal of sharps) remains a major challenge. Any vaccine safety issue, real or perceived, may lead to rumors and undermine confidence in vaccination and, ultimately, have dramatic consequences for immunization coverage and disease incidence. In 1999, WHO's Department of Vaccines and Biologicals launched the Immunization Safety Priority Project to establish a comprehensive system to ensure the safety of all immunizations given in national immunization programmes. The project aims at strengthening each country's capacity. The principal areas of activity of the project include: research and development of safer vaccines and safer and simpler vaccine delivery technologies; assurance of vaccine safety through quality control procedures and quality specifications; implementation of tools to ensure vaccine quality up to vaccine administration; access to safe and efficient vaccine administration technologies and their disposal; and identification and management of risks related to immunization. This report focuses on the latter area and highlights challenges and critical factors in establishing a safety profile for a vaccine and the importance and limits of post market surveillance. It presents some of WHO's supporting activities among which the establishment of a Global Advisory Committee on Vaccine Safety to provide an independent scientific assessment of vaccine safety issues. WHO has a role to play not only because of its technical and normative role but also because of its privileged relation with country authorities and its global vision and mandate and being perceived as neutral and free of conflicts of interest.

  1. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  2. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  3. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  4. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  5. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

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

    ERIC Educational Resources Information Center

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

    2007-01-01

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

  7. Efficacy and safety of growth hormone replacement therapy in Japanese adults with growth hormone deficiency: a post-marketing observational study.

    PubMed

    Shimatsu, Akira; Tai, Shigeru; Imori, Makoto; Ihara, Katsuichiro; Taketsuna, Masanori; Funai, Jumpei; Tanaka, Toshiaki; Teramoto, Akira; Irie, Minoru; Chihara, Kazuo

    2013-01-01

    This large-scale observational study examined the long-term effectiveness and safety of growth hormone (GH) replacement therapy for adult GH deficiency (GHD) in Japanese clinical practice using the Hypopituitary Control and Complications Study database. The study included 402 GHD patients for safety analyses and a subset of 209 patients (149 adult-onset and 60 childhood-onset GHD patients) who had not previously received GH replacement therapy for the efficacy analyses. Data on clinical, metabolic, quality of life (QoL) characteristics, and all adverse events (AEs) were collected at baseline (start of GH treatment), 6 months, 1 year and 2 years. Over the observation period, there were improvements from baseline in insulin-like growth factor-I standard deviation scores (P<0.001), although the changes in metabolic parameters were minimal. QoL (Short Form-36) Z-scores significantly increased from baseline in both onset-type groups for several subscale domains (P<0.05). A total of 145 (36.1%) patients experienced ≥1 AE. Common AEs were hyperlipidaemia (2.7%) and hyperinsulinaemia (2.2%). Some patients experienced recurrent hypothalamic/pituitary tumour (events per 1000 patient-years: 2.78), new benign (0.93), malignant tumour (10.28) or other new tumour (0.93), new diabetes mellitus (7.45), and new stroke (3.71). Seven patients died during the observation period. Our safety findings are inconclusive about the associations between GH replacement and AEs, although the incidence of diabetes mellitus and cardiovascular events are similar to those reported in the Japanese general population. In conclusion, the key beneficial effects of GH replacement therapy for GHD are observed in routine clinical practice in Japan.

  8. 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.

  9. Safety and efficacy of transdermal buprenorphine versus oral tramadol for the treatment of post-operative pain following surgery for fracture neck of femur: A prospective, randomised clinical study

    PubMed Central

    Desai, Sameer N; Badiger, Santhoshi V; Tokur, Shreesha B; Naik, Prashanth A

    2017-01-01

    Background: Transdermal buprenorphine, which is used in chronic pain management, has rarely been studied for use in acute pain management. The aim of this study was to compare the safety and efficacy of transdermal buprenorphine patch to oral tramadol for post-operative analgesia, following proximal femur surgeries. Methodology: Fifty adult patients undergoing surgery for hip fracture under spinal anaesthesia were included in this study. One group (Group TDB) received transdermal buprenorphine 10 mcg/h patch applied a day before the surgery and other group received oral tramadol 50 mg three times a day for analgesia (Group OT). They were allowed to take diclofenac and paracetamol tablets for rescue analgesia. Pain scores at rest, on movement, rescue analgesic requirement and side effects were compared between the groups over 7 days. Chi-square and independent sample t-test were used for categorical and continuous variables, respectively. Results: Resting pain scores and pain on movement were significantly lower in TDB Group on all 7 days starting from 24 h post-operatively. Rescue analgesic requirement was significantly lower in TDB Group compared to OT Group. All the patients needed rescue analgesic in OT Group whereas 68% of the patients needed the same in TDB Group. Incidence of vomiting was less and satisfaction scores were much higher in TDB Group as compared to OT Group (79% vs. 66%, P < 0.001). Conclusion: Transdermal buprenorphine can be safely used for post-operative analgesia and is more efficacious in reducing post-operative pain after 24 hours, with fewer side effects when compared to oral tramadol.

  10. 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

  11. Efficacy and safety of rituximab treatment in patients with progressive transformation of germinal centers after Hodgkin lymphoma in complete remission post-induction chemotherapy and radiotherapy.

    PubMed

    Picardi, Marco; Zeppa, Pio; Ciancia, Giuseppe; Pettinato, Guido; Grimaldi, Francesco; Fabbricini, Rossella; Mainolfi, Ciro; Pane, Fabro

    2011-11-01

    Because the lymphatic tissue of progressive transformation of germinal centers (PTGC) expresses CD20, rituximab treatment may prevent transformation to lymphoma of this rather atypical entity. We prospectively evaluated the efficacy of immunotherapy with rituximab (375 mg/m2 i.v. weekly for 4 consecutive weeks, followed by a single i.v. infusion of 375 mg/m2 every 3 months for 2 consecutive years) in 48 patients with biopsy-proven PTGC after Hodgkin lymphoma in complete remission post-induction therapy (4-6 courses of anthracycline-containing chemotherapy with radiotherapy). The event-free survival (EFS) of this series was compared with that of a historical cohort of 48 patients with PTGC developing after Hodgkin lymphoma in complete remission post-induction therapy, who underwent observation. At a median follow-up of 40 months, histology showed a malignancy in 27% of patients in the observation group (Hodgkin lymphoma, 13 patients) and in 2% of patients in the rituximab-protected group (non-Hodgkin lymphoma, one patient) (p ∼ 0.001). Rituximab was well tolerated in all treated patients. All relapses in the group not protected by immunotherapy involved the PTGC regions and non-contiguous nodal sites, which suggests that PTGC is a reservoir for malignant transformation and dissemination. The number needed to treat with rituximab to avoid one Hodgkin lymphoma relapse was four. Our study shows that prophylaxis with rituximab helps improve EFS in patients with PTGC and a history of Hodgkin lymphoma.

  12. 16 CFR 1101.71 - Delegation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Delegation of authority. 1101.71 Section 1101.71 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Delegation of Authority to Information Group § 1101.71 Delegation...

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

    PubMed Central

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

    2015-01-01

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

  14. Safety and efficacy of citrate anti-coagulation continuous renal replacement therapies in post-cardiac surgery patients with liver dysfunction.

    PubMed

    De Vico, Pasquale; Messino, Valentina; Tartaglione, Alessandra; Beccaris, Camilla; Buonomo, Chiara; Talarico, Daniela; Prati, Paolo; Sabato, Alessandro Fabrizio; Colella, Dionisio Fernando

    2015-06-01

    The study's aim was to examine safety and efficiency of citrate anticoagulated continuous renal replacement therapies (CRRT) in cardiac surgery patients with acute kidney injury and associated liver dysfunction. The study was conducted on critical ICU patients, hospitalized after cardiac surgery, who developed renal and liver acute failures due to low-flow syndrome. CRRT in continuous veno-venous hemodiafiltration with regional citrate anticoagulation (RCA) was prescribed to address renal failure and avoid bleeding-risk. Patient Ca(++) was measured to monitor RCA safety, while thromboelastography (TEG) and circuit Ca(++) were used to verify efficacy. CRRT effectiveness was evaluated through creatinine and urea levels, while liver function was monitored through bilirubin, aspartate aminotransferase, glutamic oxaloacetic transaminase (AST GOT) and gamma glutamyl transferase (GT) levels. The study did not require ethical approval. Hepatic and renal failures were confirmed by baseline levels (total bilirubin=3.1 ± 3.37 mg/dL, AST GOT=153 ± 147 U/L and gamma GT=93.3 ± 86 IU/L, creatinine=1.97 ± 0.88 and blood urea nitrogen [BUN] 98.13 ± 71.34) assessed in 15 patients. During treatment, Ca(++) (patient and circuit) remained stable and within range for the whole therapy thanks to low citrate dose (2.8 ± 0.3 mmol/L of blood), while hepatic markers did not show any significant changes the therapy, although treatment with citrate is contraindicated in patients with hepatic failure. RCA quality was confirmed by TEG values, which showed an anticoagulated circuit with no effects on patients. These results involved a high filter lifespan (49.76 ± 22.10 h) and with an effective creatinine and BUN clearance. No episodes of citrate intoxication were reported (total/ionized calcium ratio remained stable and physiologic). RCA during CRRT with dilute solutions proved both effective and safe, even in patients with acute liver failure.

  15. 32 CFR 643.120 - Post offices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  16. 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

  17. 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

  18. 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…

  19. 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)

  20. 48 CFR 23.901 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contractor Compliance With Environmental Management Systems 23.901 Authority. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation...

  1. 48 CFR 23.901 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contractor Compliance With Environmental Management Systems 23.901 Authority. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation...

  2. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  3. 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)....

  4. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  5. 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)....

  6. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  7. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  8. 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)....

  9. 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)....

  10. 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....

  11. 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.

  12. [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.

  13. 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.

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

    PubMed Central

    Romano, Laura S.; Cook, James L.

    2015-01-01

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

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

    PubMed

    Romano, Laura S; Cook, James L

    2015-09-01

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

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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 5–21 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

  1. 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.

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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 INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator...

  10. 36 CFR 251.53 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... use authorizations for National Forest System land under the authorities cited and for the types of... structures and facilities for recreation, public convenience, or safety; (ii) industrial or commercial... oil or gas products, where no Federal land besides National Forest System lands is required,...

  11. 49 CFR 356.5 - Traversal authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS MOTOR CARRIER ROUTING REGULATIONS § 356.5 Traversal authority. (a) Scope. An irregular route motor carrier may operate between authorized service points over any reasonably direct or logical route unless expressly prohibited....

  12. Real-World Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir/+Dasabuvir±Ribavirin (OBV/PTV/r/+DSV±RBV) Therapy in Recurrent Hepatitis C Virus (HCV) Genotype 1 Infection Post-Liver Transplant: AMBER-CEE Study.

    PubMed

    Tronina, Olga; Durlik, Magdalena; Wawrzynowicz-Syczewska, Marta; Buivydiene, Arida; Katzarov, Krum; Kupcinskas, Limas; Tolmane, Ieva; Karpińska, Ewa; Pisula, Arkadiusz; Karwowska, Kornelia Magdalena; Bolewska, Beata; Jabłkowski, Maciej; Rostkowska, Karolina; Jakutiene, Jolita; Simonova, Marieta; Flisiak, Robert

    2017-04-07

    BACKGROUND The introduction of direct-acting antivirals (DAAs) has considerably improved therapeutic outcomes for patients with chronic hepatitis C virus (HCV) infections. The AMBER-CEE study aimed to assess real-world efficacy and safety of ombitasvir/paritaprevir/ritonavir/+ dasabuvir ±ribavirin (OBV/PTV/r/ +DSV±RBV) in the treatment of post-transplant recurrence of HCV infection. MATERIAL AND METHODS Liver transplant recipients with recurrent HCV genotype 1 infection, scheduled for OBV/PTV/r/+DSV±RBV according to therapeutic guidelines, were eligible. The primary efficacy endpoint was sustained virologic response (SVR) 12 weeks after the end of treatment (FU12). Clinical and laboratory adverse events (AEs) were recorded from baseline to FU12. RESULTS A total of 35 patients were included: 91.4% genotype 1b-infected, 94.3% treatment-experienced, and 77.1% at fibrosis stage ≥F2. SVR12 was achieved by all patients (35/35, 100%) including one patient with genotype 1a, one patient with detectable HCV RNA at the end of treatment, two patients with a history of first-generation DAA therapy, and two patients who prematurely discontinued the regimen. AEs were experienced by 22 patients (62.9%) and were mostly mild. No death, graft loss, or acute graft rejections were reported during the therapy. On-treatment hepatic decompensation occurred in three patients (8.6%). Anemia was observed in 29 patients (83.9%), with 21 (60%) requiring RBV dose reduction or discontinuation. CONCLUSIONS OBV/PTV/r/+DSV±RBV has excellent efficacy in post-transplant recurrence of HCV genotype 1-infection treated under real-world conditions. Excellent virologic outcomes were observed irrespective of prior treatment history or the degree of fibrosis, and AEs were mostly mild and transient.

  13. Authorization for Voluntary Services of Certain Students; Hearing Before the Subcommittee on Manpower and Civil Service of the Committee on Post Office and Civil Service; House of Representatives; Ninety-Fourth Congress; First Session.

    ERIC Educational Resources Information Center

    Congress of the U. S., Washington, DC. House Committee on Post Office and Civil Service.

    The hearing considered two bills, H.R. 2162 introduced by Charles Wilson of California, and H.R. 3522 by C. W. Bill Young of Florida, which authorize any officer or employee of the United States to accept the voluntary services of certain students for the United States. This was advocated by President Ford in his commencement address to the Ohio…

  14. 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.

  15. 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 ...

  16. Vaccine Safety

    MedlinePlus

    ... FAQs about Vaccine Safety Research Publications HDM Reports ISO Scientific Agenda Ensuring Safety History Understanding Side Effects ... Datalink Publications Emergency Preparedness Vaccine Safety Partners About ISO File Formats Help: How do I view different ...

  17. 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.

  18. 48 CFR 923.7001 - Nuclear safety.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  19. Radiation safety systems at the NSLS

    SciTech Connect

    Dickinson, T.

    1987-04-01

    This report describes design principles that were used to establish the radiation safety systems at the National Synchrotron Light Source. The author described existing safety systems and the history of partial system failures. 1 fig. (TEM)

  20. 16 CFR 1101.71 - Delegation of authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Delegation of authority. 1101.71 Section 1101.71 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS... Information Group § 1101.71 Delegation of authority. (a) Delegation. Pursuant to section 27(b)(9) of the...

  1. 78 FR 52457 - Transfers of Operating Authority Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... Federal Motor Carrier Safety Administration 49 CFR Part 365 Transfers of Operating Authority Registration... operating authority registration by non-exempt for-hire motor carriers, property brokers and freight... CONTACT: Mr. Jeff Secrist, Office of Registration and Safety Information, U.S. Department...

  2. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of...

  3. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of...

  4. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of...

  5. 42 CFR 3.508 - Authority of the ALJ.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 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...

  6. 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..., Urgency and Safety Procedures § 80.311 Authority for distress transmission. A mobile station in...

  7. 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..., Urgency and Safety Procedures § 80.311 Authority for distress transmission. A mobile station in...

  8. 47 CFR 80.311 - Authority for distress transmission.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authority for distress transmission. 80.311 Section 80.311 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO..., Urgency and Safety Procedures § 80.311 Authority for distress transmission. A mobile station in...

  9. 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..., Urgency and Safety Procedures § 80.311 Authority for distress transmission. A mobile station in...

  10. 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..., Urgency and Safety Procedures § 80.311 Authority for distress transmission. A mobile station in...

  11. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 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 has exclusive authority to settle any issue or case without the consent of the ALJ....

  12. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 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 has exclusive authority to settle any issue or case without the consent of the ALJ....

  13. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 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 has exclusive authority to settle any issue or case without the consent of the ALJ....

  14. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 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 has exclusive authority to settle any issue or case without the consent of the ALJ....

  15. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 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 has exclusive authority to settle any issue or case without the consent of the ALJ....

  16. 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.

  17. 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.

  18. 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.

  19. 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)

  20. School Security and Safety.

    ERIC Educational Resources Information Center

    Licht, Kenneth F.

    The author contends that safety and accident prevention should be given primary consideration in a school system's risk management program. He argues that accidents and losses are symptoms of defects in the management system. Two classes of loss discussed are (1) accidental -- injury/loss resulting from unintended events; and (2) purposeful --…

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

    ERIC Educational Resources Information Center

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

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

  2. 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.

  3. 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)

  4. 78 FR 41991 - Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by Flooding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-12

    ... Pipeline and Hazardous Materials Safety Administration Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by Flooding AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT... operators should contact the appropriate state pipeline safety authority. A list of state pipeline...

  5. 77 FR 33495 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

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

  6. 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.

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

    SciTech Connect

    Not Available

    1993-05-01

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

  8. Auto Safety

    MedlinePlus

    ... kids by following simple safety measures and by teaching some basic rules. Importance of Child Safety Seats ... your child correctly — a small child in a large seat may not be the best option. Models ...

  9. Water Safety

    MedlinePlus

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety A A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  10. Water Safety

    MedlinePlus

    ... Loss Surgery? A Week of Healthy Breakfasts Shyness Water Safety KidsHealth > For Teens > Water Safety A A ... tied to alcohol use. previous continue At the Water Park OK, so you do more splashing than ...

  11. Food Safety

    MedlinePlus

    ... the safety of fish caught in your local lakes, rivers, and coastal areas. Advisories may recommend that ... Charts Picky Eating Physical Activity Food Safety Resources Kids Students Adults Families Professionals Multiple Languages MyPlate, MyWins ...

  12. Water Safety

    MedlinePlus

    ... Old Feeding Your 1- to 2-Year-Old 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 ...

  13. Water Safety

    MedlinePlus

    ... Loss Surgery? A Week of Healthy Breakfasts Shyness Water Safety KidsHealth > For Teens > Water Safety Print A ... tied to alcohol use. previous continue At the Water Park OK, so you do more splashing than ...

  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. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 29 CFR 2700.83 - Authority to sign orders.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 9 2012-07-01 2012-07-01 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...

  1. 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...

  2. 29 CFR 2700.83 - Authority to sign orders.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 9 2011-07-01 2011-07-01 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...

  3. 29 CFR 2700.83 - Authority to sign orders.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 9 2013-07-01 2013-07-01 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...

  4. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 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,...

  5. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  6. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  7. 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... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or...

  8. 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,...

  9. 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... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or...

  10. 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....

  11. 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....

  12. 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....

  13. 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....

  14. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  15. 49 CFR 172.308 - Authorized abbreviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 2 2014-10-01 2014-10-01 false Authorized abbreviations. 172.308 Section 172.308 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS HAZARDOUS MATERIALS TABLE,...

  16. 49 CFR 172.308 - Authorized abbreviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Authorized abbreviations. 172.308 Section 172.308 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS HAZARDOUS MATERIALS TABLE,...

  17. 49 CFR 172.308 - Authorized abbreviations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 2 2013-10-01 2013-10-01 false Authorized abbreviations. 172.308 Section 172.308 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS HAZARDOUS MATERIALS TABLE,...

  18. 49 CFR 172.308 - Authorized abbreviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 2 2011-10-01 2011-10-01 false Authorized abbreviations. 172.308 Section 172.308 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS HAZARDOUS MATERIALS TABLE,...

  19. 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...

  20. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  1. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  2. 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...

  3. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  4. 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...

  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, 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...

  7. 47 CFR 80.407 - Operator authorization.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... commercial radio operators are contained in part 13 of this chapter. (a) Application. Detailed information... authorizations is contained in the bulletin “Commercial Radio Operator Licenses and Permits.” This bulletin is... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN...

  8. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  9. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  10. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  11. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  12. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  13. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  14. 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…

  15. 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…

  16. 46 CFR 122.515 - Passenger safety bill.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  17. 46 CFR 122.515 - Passenger safety bill.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  18. 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-α 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

  19. 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…

  20. 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…

  1. Medication safety.

    PubMed

    Keohane, Carol A; Bates, David W

    2008-03-01

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

  2. 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),...

  3. 33 CFR 203.31 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... Emergency operations under Public Law 84-99 apply to Flood Response and Post Flood Response activities. Flood Response activities include flood fighting, rescue operations, and protection of Corps-constructed... such agencies have emergency flood fighting authority. Further, Flood Response measures...

  4. 33 CFR 203.31 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... Emergency operations under Public Law 84-99 apply to Flood Response and Post Flood Response activities. Flood Response activities include flood fighting, rescue operations, and protection of Corps-constructed... such agencies have emergency flood fighting authority. Further, Flood Response measures...

  5. 78 FR 25916 - Authorization of Radiofrequency Equipment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-03

    ...This document proposes certain changes to the Commission's equipment authorization processes to ensure that they continue to operate efficiently and effectively. In particular, it addresses the role of TCBs in certifying RF equipment and post-market surveillance, as well as the Commission's role in assessing TCB performance. It also addresses the role of test laboratories in the RF equipment......

  6. Authoring tool evaluation

    SciTech Connect

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

    1994-09-15

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

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

    PubMed Central

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

    2016-01-01

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

  8. Unreviewed safety question determination application guide

    SciTech Connect

    Not Available

    1991-09-01

    The basic purpose of the Unreviewed Safety Question Determination (USQD) process is to ascertain if a change to a facility can be made without a prior safety review and approval by the original approving body. The USQD process judges whether the change could result in the facility being outside its authorization basis. If the change could result in the facility being outside its authorization basis, the change involves an Unreviewed Safety Question (USQ). The authorization basis consists of those aspects of the facility design basis relied upon by the original approving body to authorize operation. The authorization basis would typically include the facility Safety Analysis Report, Technical Safety Requirements (TSRs), Operational Safety Requirements (OSRs), Technical Specifications, DOE-issued Safety Evaluation Reports, Safety Analysis Report Update Program documents, Safety Studies, Safety Assessments, Risk Assessments, Facility Safety Evaluations, and any applicable commitments made to comply with Department of Energy (DOE) orders or policies. Steps in the USQD process include defining the changes being evaluated; evaluating the process by which the change is accomplished; then the potential effects of the change are compared to the authorization basis for the facility to determine if the change could result in the facility being outside is authorization basis. The USQD will provide input to the change control board for facilities placed under configuration management to aid their understanding of the extent of a proposed change and whether or not the change should be authorized. The USQD will also provide input to the categorization of reportable occurrences under DOE Order 5000.3A, Occurrence Reporting and Processing of Operations Information. This report provides an overview of the steps in the USQD process and detailed instructions and examples intended primarily for use by the personnel who perform, review, and approve the USQDs. 3 refs., 3 figs.

  9. Solidifying Safety

    NASA Technical Reports Server (NTRS)

    Covault, Craig

    2003-01-01

    Contents include the following: 1. Solidifying Safety: NASA s new safety organization spools up, as the 1SS program grapples with long-term risk. 2. Earth to Orbit O'Keefe telling skeptical lawmakers Orbital Space Plan (OSP) will cover exploration vision. China's rapid pace.

  10. 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…

  11. Lab Safety.

    ERIC Educational Resources Information Center

    West, Sandra S.

    1991-01-01

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

  12. 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…

  13. Publishers: Save Authors' Time.

    PubMed

    Moustafa, Khaled

    2017-02-02

    Scientific journals ask authors to put their manuscripts, at the submission stage, sometimes in a complex style and a specific pagination format that are time consuming while it is unclear yet that the submitted manuscripts will be accepted. In the case of rejections, authors need to submit to another journal most likely with a different style and formatting that require additional work and time. To save authors' time, publishers should allow authors to submit their manuscripts in any format and to comply with the style required by the targeted journal only in revised versions, but not at the submission step when the manuscripts are not yet approved for publication.

  14. Firearms safety program

    USGS Publications Warehouse

    ,

    2005-01-01

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

  15. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Maximum load; posting. 77.1402-1 Section 77.1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... MINES Personnel Hoisting § 77.1402-1 Maximum load; posting. The operator shall designate the...

  16. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Maximum load; posting. 77.1402-1 Section 77.1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... MINES Personnel Hoisting § 77.1402-1 Maximum load; posting. The operator shall designate the...

  17. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  18. 49 CFR 501.7 - Administrator's reservations of authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... awarding of alcohol incentive grants to the States authorized under 23 U.S.C. 408, and drunk driving... State for violations of the National Maximum Speed Limit, Safety Belt and Motorcycle Helmet...

  19. 49 CFR 501.7 - Administrator's reservations of authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... awarding of alcohol incentive grants to the States authorized under 23 U.S.C. 408, and drunk driving... State for violations of the National Maximum Speed Limit, Safety Belt and Motorcycle Helmet...

  20. 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.

  1. 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.

  2. Evaluating Digital Authoring Tools

    ERIC Educational Resources Information Center

    Wilde, Russ

    2004-01-01

    As the quality of authoring software increases, online course developers become less reliant on proprietary learning management systems, and develop skills in the design of original, in-house materials and the delivery platforms for them. This report examines the capabilities of digital authoring software tools for the development of learning…

  3. Dealing with the authorities.

    PubMed

    Nemes, J

    1991-10-14

    Tax-exempt bond financings, inherently complex transactions, can become even more complicated, cumbersome and costly as hospitals come to terms with restrictive policies imposed by some state financing authorities. Executives also find they sometimes get caught in authorities' political machinations that may have little to do with the business of the municipal bond markets.

  4. Authoring and Hypermedia.

    ERIC Educational Resources Information Center

    Lieberth, Ann K.; Martin, Doug R.

    1995-01-01

    Because of the diversity of clients served by speech-language pathologists and audiologists, available commercial software may not meet all needs. Authoring programs allow the clinician to design software that can be customized for individual clients. This article describes an authoring program called HyperCard and its use in preparing hypermedia…

  5. 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…

  6. Freedom, Coercion, Authority.

    ERIC Educational Resources Information Center

    Bellah, Robert N.

    1999-01-01

    Despite much talk about balancing freedom and responsibility in higher education, a more appropriate pairing is of freedom with authority. The concept of responsibility has become problematic, and educators have lost the ability to speak with authority. Although we have come to identify freedom with the free market, it is the bottom line which has…

  7. 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

  8. 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…

  9. 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.

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

    ERIC Educational Resources Information Center

    Glazener, Everett R.; Comstock, Thomas W.

    1978-01-01

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

  11. 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.

  12. The effects of organizational commitment and structural empowerment on patient safety culture.

    PubMed

    Horwitz, Sujin K; Horwitz, Irwin B

    2017-03-20

    Purpose The purpose of this paper is to investigate the relationship between patient safety culture and two attitudinal constructs: affective organizational commitment and structural empowerment. In doing so, the main and interaction effects of the two constructs on the perception of patient safety culture were assessed using a cohort of physicians. Design/methodology/approach Affective commitment was measured with the Organizational Commitment Questionnaire, whereas structural empowerment was assessed with the Conditions of Work Effectiveness Questionnaire-II. The abbreviated versions of these surveys were administered to a cohort of 71 post-doctoral medical residents. For the data analysis, hierarchical regression analyses were performed for the main and interaction effects of affective commitment and structural empowerment on the perception of patient safety culture. Findings A total of 63 surveys were analyzed. The results revealed that both affective commitment and structural empowerment were positively related to patient safety culture. A potential interaction effect of the two attitudinal constructs on patient safety culture was tested but no such effect was detected. Research limitations/implications This study suggests that there are potential benefits of promoting affective commitment and structural empowerment for patient safety culture in health care organizations. By identifying the positive associations between the two constructs and patient safety culture, this study provides additional empirical support for Kanter's theoretical tenet that structural and organizational support together helps to shape the perceptions of patient safety culture. Originality/value Despite the wide recognition of employee empowerment and commitment in organizational research, there has still been a paucity of empirical studies specifically assessing their effects on patient safety culture in health care organizations. To the authors' knowledge, this study is the first

  13. Safety in the Elementary Science Classroom.

    ERIC Educational Resources Information Center

    Dean, Robert A.; And Others

    This safety guide for elementary school science teachers who plan science activities or laboratories for their students, presents information in the form of a flip chart that can be posted in the classroom and referred to in an emergency. Space is provided for emergency telephone numbers. A safety checklist is given for the teacher. Topics…

  14. 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.

  15. Sun Safety

    MedlinePlus

    ... Links Buttons and Badges Stay Informed Cancer Home Sun Safety Language: English Español (Spanish) Recommend on Facebook Tweet Share Compartir The sun’s ultraviolet (UV) rays can damage your skin in ...

  16. Nuclear Safety Information Center, Its Products and Services

    ERIC Educational Resources Information Center

    Buchanan, J. R.

    1970-01-01

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

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

    SciTech Connect

    CASH, R.J.

    2000-12-28

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

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

    ERIC Educational Resources Information Center

    Roy, Kenneth R.

    2000-01-01

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

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

    NASA Technical Reports Server (NTRS)

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

    2006-01-01

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

  20. 47 CFR 73.1230 - Posting of station license.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... principal control point of the transmitter. (b) Posting of the station license and any other instruments of... station license and any other instrument of station authorization shall be posted in a conspicuous...

  1. 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...

  2. 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...

  3. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post...

  4. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 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. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post...

  5. 14 CFR 136.3 - Letters of Authorization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS COMMERCIAL AIR TOURS AND NATIONAL PARKS AIR TOUR MANAGEMENT National Air Tour Safety Standards § 136.3 Letters of Authorization. Operators subject to this subpart who have Letters of Authorization may use the...

  6. 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...

  7. 47 CFR 101.1311 - Initial EA license authorization.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Initial EA license authorization. 101.1311 Section 101.1311 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... EA license authorization. (a) Winning bidders must file an application (FCC Form 601) for an...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 20 CFR 410.686 - Authority of representative.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Authority of representative. 410.686 Section 410.686 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF..., Administrative Review, Finality of Decisions, and Representation of Parties § 410.686 Authority of...

  14. 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.

  15. Fire safety. Explosion safety - Handbook

    NASA Astrophysics Data System (ADS)

    Baratov, Anatolii Nikolaevich

    The physicochemical principles underlying combustion and explosion processes are examined, and the main fire and explosion safety characteristics of materials are reviewed with particular reference to the ignition limits of combustible mixtures, the minimal oxygen content that constitutes an explosion hazard, and the flash point and ignition temperatures. Fire-fighting and explosion suppression methods and equipment are described. The discussion also covers the efficiency of fire prevention measures and safety engineering in fire fighting.

  16. Ocular Safety of Topical Naltrexone

    DTIC Science & Technology

    2010-05-01

    AD_________________ AWARD NUMBER: W81XWH-09-1-0312 TITLE: Ocular Safety of Topical Naltrexone ...Topical Naltrexone 5b. GRANT NUMBER W81XWH-09-1-0312 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER Joseph W. Sassani, M.D.; Ian...associates have been funded to perform a Phase I Clinical Trial of Naltrexone dissolved in Vigamox® and applied topically as eye drops preliminary to a

  17. Quality of Care is Similar for Safety-Net and Non-Safety-Net Hospitals

    MedlinePlus

    ... the data. Safety-net hospitals tended to be teaching institutions with higher average patient volumes for each ... Grant Application, Review & Award Process Post-Award Grant Management Contracts About About AHRQ Organization & Contacts News Newsroom ...

  18. First Aid and Safety

    MedlinePlus

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

  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. Outer Space Traffic Safety Standards

    NASA Astrophysics Data System (ADS)

    Larsen, Paul B.

    2013-09-01

    Management of traffic in outer space is a major safety problem. Traffic is increasing. Most satellites are navigable but they have to co-exist with space debris which is not navigable. We need minimum safety rules for outer space traffic. We have the possible beginnings of international safety standards in the form of national space object tracking; Global Navigation Satellite Systems (GNSS) standardization through ICAO and the International Committee on GNSS (ICG); the IADC space debris guidelines; and the proposed Code of Conduct. However, safety could be improved by standards for such activities as licensing launches of satellites into outer space; standards for accident investigation and search and rescue: operational safety zones around space objects such as the International Space Station. This paper describes legal authority for minimum safety standards. It considers safety standards established by private agreements among commercial operators. Finally it examines a number of options for an international forum to establish safety standards, including self-regulation, COPUOS, ICAO, ITU, a space code of conduct, and a new space organization.

  1. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  2. 46 CFR Sec. 4 - Posting of bond.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  3. Vaccination in a post earthquake crisis.

    PubMed

    Wiwanitkit, Viroj

    2010-07-01

    Earthquakes are a kind of natural disaster. Several infectious diseases should be considered important emerging diseases in post-disaster situations and adequate prevention measures should be implemented in these circumstances. For prevention, vaccination is an important infection control method. In this brief article, the author will discuss the importance of vaccination in a post-earthquake situation.

  4. 47 CFR 27.52 - RF safety.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... this chapter, as appropriate. Applications for equipment authorization of mobile or portable devices... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES Technical Standards § 27.52 RF safety. Licensees and manufacturers are subject to...

  5. Outdoor Lighting: A Showcase of Safety

    ERIC Educational Resources Information Center

    Modern Schools, 1973

    1973-01-01

    Creative, constructive night lighting can, in addition to deterring vandalism, beautify parking lots, recreation fields, entrances, grassy areas, walkways, and driveways of schools; and provide safety for those using the facilities after dark. (Author)

  6. The Management of Post-Term Pregnancy

    PubMed Central

    Iwanicki, Stanislaw; Akierman, Albert

    1988-01-01

    Although post-term pregnancy is associated with an increased incidence of fetal distress, oligohydramnios, fetal macrosomia, fetal dysmaturity, and perinatal mortality, as many as 80% of post-term fetuses appear completely normal. The authors of this article discuss the three sub-groups of post-term pregnancies, and deal with the diagnosis and antepartum and intrapartum management of the condition. Recommendations and a protocol for management are provided. PMID:21253236

  7. 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…

  8. Author and Agitator.

    ERIC Educational Resources Information Center

    Mark, Jan

    1978-01-01

    Many schools now bring professional writers in to work with or talk to children, often with impressive results. But what do the writers themselves make of these visits? Here a children's books author pens a wry portrait of a typical classroom encounter. (Editor/RK)

  9. 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…

  10. 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…

  11. CAL Authoring Aids.

    ERIC Educational Resources Information Center

    McGinnis, N. P.

    In their eight years of involvement in Computer Assisted Learning, the Division of Education Research Services has assisted many authors in developing their courseware. Whether the courseware has been a short half hour module or a large course involving over a hundred hours of student time, there have been many common problems. A major objective…

  12. Safety Precautions in Fiber Arts.

    ERIC Educational Resources Information Center

    Hamilton, Marcia

    1979-01-01

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

  13. 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…

  14. Home Safety

    MedlinePlus

    ... in Pune (October 2015) Preventing accidental injuries to children in India. Video Changing the News with Neal McDonough: Fire Safety Together, we can change the news by learning simple, effective ways to prevent injuries to children due to fire. Infographic Escuche el Bip Donde ...

  15. Safety Resources.

    ERIC Educational Resources Information Center

    Hoot, James L.; Bartkowiak, Elaine T.

    1994-01-01

    Lists 72 organizations and programs that deal with child safety, grouped by the following categories: (1) general; (2) general violence; (3) gun violence; (4) media violence; (5) drugs and alcohol; (6) child abuse and at-risk children; (7) parenting programs; (8) community service programs; (9) leadership programs; (10) peer counseling; (11)…

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

    PubMed Central

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

    2015-01-01

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

  17. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

    PubMed Central

    Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

    2016-01-01

    Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design. PMID:27932872

  18. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.

    PubMed

    Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

    2016-01-01

    Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

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

    PubMed

    Han, Sangjin

    2016-01-01

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

  20. Vaccine safety.

    PubMed

    Jacobson, Robert M

    2003-11-01

    Rates of reported adverse events are remarkably low. VAERS identifies an adverse event rate approximating 11.4 reports per 100,000 vaccine doses. Approximately 15% of these reports represent SAEs, but less than 2% involve death; in most cases, reviews have shown no causal relation between the events and the vaccine. Across the spectrum of vaccines in use (including those directed against influenza and hepatitis B virus), many claims of adverse events regarding vaccines represent typical reactions to vaccinations. These reactions can be thought of as foreign-body reactions and predominate among the inactivated vaccines. In controlled studies, the adverse event rates that occur with vaccination resemble those that occur with placebo injections. Typical reactions associated with live viral and bacterial vaccines, such as MMR and varicella vaccines, may resemble attenuated forms of the disease for which the vaccine is directed. Other claims against vaccines represent chance-coincidence or misunderstood data; further studies of claims have vindicated the overall safety of the vaccines in most cases. Two documented safety concerns with vaccines, however, have demonstrated that vaccines (like other biologics and pharmacologic) can result in harm (eg, rotavirus and OPV vaccines). The denouement with these vaccines indicates the broad postmarketing data collection and evaluation that extends efforts made with prelicensure study to balance the benefits from vaccination with the risk for harm. Overall, measures including prelicensure study and postlicensure surveillance, such as VAERS, the Vaccine Safety Datalink Project, and the Clinical Immunization Safety Assessment Centers, have resulted in an exceptional safety profile for the vaccines in use.

  1. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  2. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  3. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  4. 14 CFR 139.309 - Safety areas.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  5. Good Practices Guide for Bicycle Safety Education.

    ERIC Educational Resources Information Center

    Department of Transportation, Washington, DC.

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

  6. Radiation Safety Committee report

    SciTech Connect

    Almond, P.

    1986-01-01

    There are three groups of people concerned with the radiation safety and health hazards associated with californium. These three groups are the general public, hospital personnel who are involved in californium treatments, and the patients themselves. There is also a subgroup in groups one and two, and possibly group three, although very unlikely, and that is the unborn child or fetus. This subgroup is applicable when the mother is in the very early stages of pregnancy, at which time the mother does not know that she is pregnant. The author discusses the concerns for the three groups in detail.

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

    PubMed

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

    2013-11-01

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

  8. [Post-partum and post-abortal use of IUDs (author's transl)].

    PubMed

    Laufe, L E

    1983-04-01

    The search for an IUD that could be safely inserted in the immediate postpartum period and retained as long as desired led the Population Council to undertake a 13-center study of Lippes loop insertion during the 1st 10 postpartum days. The expulsion rate of 20.5% in the 1st 3 months following insertion was considered too high, despite apparently lower risks of perforation and infection. In 1975 the International Fertility Research Program (IFRP) began a program to modify existing IUDs for immediate postpartum and postabortal insertion. Several approaches were explored using biodegradable materials to avoid expulsion, and a modified Lippes loop with catgut sutures gave good results. A case study undertaken by the IFRP attempted to evaluate too many factors with too little attention to the qualifications of participating physicians, resulting in highly variable experiences in different centers. A program recently initiated in 10 collaborating centers in Turkey promises to yield interesting results; preliminary indications are that success rates vary between institutions and depend partly on the enthusiasm of the program director. 1 Turkish center solved the difficult problem of follow-up by adding a clinic where the newborns received check-ups. In 1 month, with 100% follow-up, over 100 IUDs were inserted and only 1 of the last 50 was expelled. Many IUDs inserted postpartum are expelled because they are not placed sufficiently deeply in the uterine cavity. The IFRP believes that with appropriate training of personnel and a better tool for insertion, a high rate of retention can be achieved. Within 6 months the IFRP expects to begin clinical testing of a 2nd generation postpartum IUD with improved sutures. Despite variable success in the past, development of a satisfactory postpartum IUD would be a valuable addition to many national family planning programs.

  9. The Author's Report

    NASA Astrophysics Data System (ADS)

    Greenslade, Thomas B.

    2011-01-01

    The referee's report is a standard rite of passage for an author of articles in The Physics Teacher. Will the referee (and the editor) agree with the basic premise and the details of your carefully thought-out article? I have faced this moment of truth many times; the majority of them were during the editorship of Cliff Swartz. These reminiscences are as much about the journal as Cliff, for, to many of us, the two seemed inseparable.

  10. Safety harness

    SciTech Connect

    Gunter, L.W.

    1991-04-08

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

  11. Safety harness

    DOEpatents

    Gunter, Larry W.

    1993-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  13. Safety Checklists

    DTIC Science & Technology

    1987-01-01

    all rags, waste, etc., soiled by combustible or flaxmable materials kept In tightly rnosed metal containers for daily disposal? 3. Are fire plans ...To prevent cold weather injuries, does the cowmander ensure that: (TBMad 81, pars, 5) a. Safety is included in planning ? b. Suitable cold weather gear...pages 2-2 thru 2-6) 2. Are prior planning and coordination of sling load operations always accomplished between the ground crews and aviation crews

  14. Safety valve

    DOEpatents

    Bergman, Ulf C.

    1984-01-01

    The safety valve contains a resilient gland to be held between a valve seat and a valve member and is secured to the valve member by a sleeve surrounding the end of the valve member adjacent to the valve seat. The sleeve is movable relative to the valve member through a limited axial distance and a gap exists between said valve member and said sleeve.

  15. Farm Safety

    PubMed Central

    Wilson, G. S.

    1966-01-01

    Accident and safety are related terms; the higher the accident rate in any industry, the greater is the need for safety measures designed to prevent accidents. This article discusses the accident and safety problems in agriculture, which includes horticulture and forestry. There is still a tendency among townspeople to think of the countryside as peaceful and tranquil, a place where nothing happens very quickly and far removed from violent death or crippling injury. This pleasant rustic picture has undergone a striking change in the last 30 years owing to considerable agricultural mechanization and the development of chemical pesticides, which have brought new dangers to those who live and work on the land. Although men have readily adapted themselves to new machines and methods, they have not proved as able to recognize new dangers and learn how to guard against them. In consequence, accidents have increased to such an extent that the whole industry has realized the need for positive preventive measures. In this country, it is generally accepted that an employer of labour has a responsibility to provide safe working conditions for those he employs. Farm safety legislation goes a little further and usually requires an employer to provide necessary safeguards, with the added requirement on a worker to make use of them. It is a feature of accident prevention work that it never reaches a stage when it can be regarded as complete. Even when a reduction in accidents has been achieved, the effort must be sustained or the trend will be quickly reversed. Images PMID:5904095

  16. Solid waste burial grounds interim safety analysis

    SciTech Connect

    Saito, G.H.

    1994-10-01

    This Interim Safety Analysis document supports the authorization basis for the interim operation and restrictions on interim operations for the near-surface land disposal of solid waste in the Solid Waste Burial Grounds. The Solid Waste Burial Grounds Interim Safety Basis supports the upgrade progress for the safety analysis report and the technical safety requirements for the operations in the Solid Waste Burial Grounds. Accident safety analysis scenarios have been analyzed based on the significant events identified in the preliminary hazards analysis. The interim safety analysis provides an evaluation of the operations in the Solid Waste Burial Grounds to determine if the radiological and hazardous material exposures will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, the public, and the environment.

  17. Counterfactual quantum certificate authorization

    NASA Astrophysics Data System (ADS)

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

    2014-05-01

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

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

    PubMed

    Sato, J

    2001-12-01

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

  19. Impact of cycling at low temperatures on the safety behavior of 18650-type lithium ion cells: Combined study of mechanical and thermal abuse testing accompanied by post-mortem analysis

    NASA Astrophysics Data System (ADS)

    Friesen, Alex; Horsthemke, Fabian; Mönnighoff, Xaver; Brunklaus, Gunther; Krafft, Roman; Börner, Markus; Risthaus, Tim; Winter, Martin; Schappacher, Falko M.

    2016-12-01

    The impact of cycling at low temperatures on the thermal and mechanical abuse behavior of commercial 18650-type lithium ion cells was compared to fresh cells. Post-mortem analyses revealed a deposition of high surface area lithium (HSAL) metal on the graphite surface accompanied by severe electrolyte decomposition. Heat wait search (HWS) tests in an accelerating rate calorimeter (ARC) were performed to investigate the thermal abuse behavior of aged and fresh cells under quasi-adiabatic conditions, showing a strong shift of the onset temperature for exothermic reactions. HSAL deposition promotes the reduction of the carbonate based electrolyte due to the high reactivity of lithium metal with high surface area, leading to a thermally induced decomposition of the electrolyte to produce volatile gaseous products. Nail penetration tests showed a change in the thermal runaway (TR) behavior affected by the decomposition reaction. This study indicates a greater thermal hazard for LIB cells at higher SOC and experiencing aging at low temperature.

  20. Bibliography on Liquefied Natural Gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1976-01-01

    Approximately 600 citations concerning safety of liquefied natural gas and liquid methane are presented. Each entry includes the title, author, abstract, source, description of figures, key references, and major descriptors for retrieving the document. An author index is provided as well as an index of descriptors.

  1. [Schistosomiasis epidemiology (author's transl)].

    PubMed

    Picq, J J; Roux, J

    1980-01-01

    Schistosomiasis are, with three hundred million of infested people, the second world endemy, after malaria. For each of the four species, the distribution areas, the life cycle and the main epidemiological features are recalled in the first chapter. In the five following chapters, the authors consider the human or animal reservoirs of virus, the importance of these diseases towards public health, the gasteropod molluscs acting as intermediate hosts, and the problems of immunity in man. The concepts of "schistosomian infection" and "schistosomian disease" are exposed as well as the differences affecting the various strains of schistosomes and snails intermediate hosts. The authors emphasize the value of quantitative parasitological techniques and sero-immunological methods for epidemiological surveys. They underline the difficulties met in the evaluation of the effect of these diseases upon public health. The main causes inducing the duration of the endemy and those responsible for its extension are studied. The value of mathematic patterns is briefly discussed. Quantitative data compiled through epidemiological surveys should improve the use of the various means presently available for controling schistosomiasis.

  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. A Canadian Journey: Post-Secondary Education Since 1945

    ERIC Educational Resources Information Center

    Bruneau, William

    2004-01-01

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

  4. Payload safety requirements

    NASA Technical Reports Server (NTRS)

    Scheller, J.

    1979-01-01

    Space Shuttle payload safety requirements are summarized. Consideration is given to NASA objectives on STS payloads, payload safety documents, STS payload safety management, safety implementation possibilities, the hazard control procedure, and significant technical requirements.

  5. Safety and Liability.

    ERIC Educational Resources Information Center

    Berthelot, Ronald J.; And Others

    1982-01-01

    This series of five articles highlights Pensacola Junior College's occupational safety course, involving simulated emergencies, Florida's standards for teacher liability, electrical safety in the classroom and laboratory, color coding for machine safety, and Florida industrial arts safety instructional materials. (SK)

  6. [Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States].

    PubMed

    Saito, Mitsuo; Hirata-Koizumi, Mutsuko; Miyake, Shinji; Hasegawa, Ryuichi

    2005-01-01

    Cerivastatin, a lipid-lowering agent, was voluntarily withdrawn from the market because of high risk of rhabdomyolysis when used as monotherapy and as comedication with fibrates, especially gemfibrozil. Thereafter, investigators found a five-fold increase in the area under the curve (AUC) when cerivastatin was used as comedication with gemfibrozil and theorized that the increase was associated with inhibition of the hepatic uptake and metabolism. By contrast, a number of pharmacoepidemiological investigations--one of which involved evaluation of the Food and Drug Administration (FDA) database for suspected adverse drug reactions and 11 cohort studies of statin and fibrate users in United States showed the risk of rhabdomyolysis to be greater in cerivastatin than in other statins used in either monotherapy or in comedication with fibrates, especially gemfibrozil. This incident regarding risk of rhabdomyolysis in cerivastatin monotherapy was taken to court in the United States and unpublished company (manufacturer of cerivastatin) documents were opened. The incident was then analyzed and discussed in the Journal of American Medical Association (JAMA) as a concern of the current US post-marketing surveillance system. The company's action and timing were judged and found to be inappropriate (although companies of this sort generally have insurmountable conflicts of interest), and the work of the US regulatory system and funding for post-marketing safety management were found to be insufficient. On the basis of the current situation, the authors and editors recommend further improvement of post-marketing regulations including the establishment of an independent drug safety board to oversee post-marketing surveillance. Among the opened, unpublished data, was the finding that cerivastatin obviously induced myopathy in a dose-dependent manner when administrated as monotherapy. As for other statins, only limited data was available for the relationship between the dosage and

  7. Becoming Co-Authors: Toward Sharing Authority in Religious Education

    ERIC Educational Resources Information Center

    Kim, Hyun-Sook

    2009-01-01

    This article offers an alternative model, the model of shared authority, to the traditional, authoritarian model for authority and obedience for Religious Education. This model moves away from the authoritarian model of a teacher as the authority and the students as obedient listeners in the direction of a shared authority model in which teachers…

  8. 75 FR 3859 - Safety Zone; Baltimore Captain of Port Zone

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Baltimore Captain of Port Zone AGENCY... establishing a temporary safety zone in all navigable waters of the Captain of the Port Baltimore zone. The... authorized by the Captain of the Port Baltimore, or his designated representative. This safety zone...

  9. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following... basic or advanced life support services on an ongoing basis are eligible to hold authorization...

  10. 78 FR 66987 - Railroad Safety Technology Program Grant Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... Federal Railroad Administration Railroad Safety Technology Program Grant Program AGENCY: Federal Railroad... applications. SUMMARY: The Railroad Safety Technology Grant Program was first authorized under the Rail Safety... Mark.Hartong@dot.gov , or Mr. David Blackmore, Program Manager-Advanced Technologies, FRA, at (312)...

  11. 75 FR 15484 - Railroad Safety Technology Program Grant Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... Federal Railroad Administration Railroad Safety Technology Program Grant Program AGENCY: Federal Railroad... Applications. SUMMARY: The Rail Safety Technology Program is a newly authorized program under the Rail Safety... ), or Mr. David Blackmore, FRA, Program Manager- Advanced Technologies (Phone: (312) 835-3903,...

  12. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the...

  13. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the...

  14. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the...

  15. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the...

  16. Highway Safety Program Manual: Volume 10: Traffic Records.

    ERIC Educational Resources Information Center

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

    Volume 10 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on traffic records. The purpose and specific objectives of a traffic records program are discussed. Federal authority in the area of highway safety and policies regarding a traffic records…

  17. Highway Safety Program Manual: Volume 6: Codes and Laws.

    ERIC Educational Resources Information Center

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

    Volume 6 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred safety practices) concentrates on codes and laws. The purpose and specific objectives of the Codes and Laws Program, Federal authority in the area of highway safety, and policies regarding traffic regulation are described.…

  18. Highway Safety Program Manual: Volume 18: Accident Investigation and Reporting.

    ERIC Educational Resources Information Center

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

    Volume 18 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on accident investigation and reporting. The purpose and objectives of an investigation and reporting program are outlined. Federal authority in the area of highway safety and policies…

  19. Highway Safety Program Manual: Volume 15: Police Traffic Services.

    ERIC Educational Resources Information Center

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

    Volume 15 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on police traffic services. The purpose and objectives of a police services program are described. Federal authority in the areas of highway safety and policies regarding a police traffic…

  20. 31 CFR 538.519 - Aircraft and maritime safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft and maritime safety. 538.519..., Authorizations, and Statements of Licensing Policy § 538.519 Aircraft and maritime safety. Specific licenses may... aircraft, and to ensure the safety of ocean-going maritime traffic in international waters....