WorldWideScience

Sample records for premarket applications pmas

  1. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-10-04

    ... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...

  2. 78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

    Science.gov (United States)

    2013-08-28

    ...] The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers... availability of the draft guidance entitled ``The Applicability of Good Laboratory Practice in Premarket Device... applicability of good laboratory practice (GLP) to nonclinical laboratory studies conducted in support of...

  3. Project Management Accountability System (PMAS) - Project Information and Data

    Data.gov (United States)

    Department of Veterans Affairs — The PMAS Dashboard provides a wide range of helpful data and information to assist you in project management and assessment. The drop down menu can be used to search...

  4. The Disk Mass project; science case for a new PMAS IFU module

    NARCIS (Netherlands)

    Verheijen, M. A. W.; Bershady, M. A.; Andersen, D. R.; Swaters, R. A.; Westfall, K.; Kelz, A.; Roth, M. M.

    2004-01-01

    We present our Disk Mass project as the main science case for building a new fiber IFU-module for the PMAS spectrograph, currently mounted at the Cassegrain focus of the 3.5m telescope on Calar Alto. Compared to traditional long-slit observations, the large light collecting power of 2-dimensional

  5. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  6. PMAS: The Potsdam Multi-Aperture Spectrophotometer. II. The Wide Integral Field Unit PPak

    NARCIS (Netherlands)

    Kelz, Andreas; Verheijen, Marc A. W.; Roth, Martin M.; Bauer, Svend M.; Becker, Thomas; Paschke, Jens; Popow, Emil; Sánchez, Sebastian F.; Laux, Uwe

    2006-01-01

    PPak is a new fiber-based integral field unit (IFU) developed at the Astrophysical Institute of Potsdam and implemented as a module into the existing Potsdam Multi-Aperture Spectrophotometer (PMAS) spectrograph. The purpose of PPak is to provide an extended field of view with a large

  7. MoonMars Astronaut and CapCom Protocols: ESTEC and LunAres PMAS Simulations

    Science.gov (United States)

    Authier, L.; Blanc, A.; Foing, B. H.; Lillo, A.; Evellin, P.; Kołodziejczyk, A.; Heinicke, C.; Harasymczuk, M.; Chahla, C.; Tomic, A.; Hettrich, S.; PMAS Astronauts

    2017-10-01

    ILEWG developed since 2008 a Mobile Laboratory Habitat (ExoHab) at ESTEC which was tested during a short simulation in July. It was a foretaste of the PMAS mission on 31 July-14 August in LunAres base at Pila, with mission control in Torun, Poland.

  8. PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

    DEFF Research Database (Denmark)

    Hulstaert, F.; Neyt, M.; Vinck, I.

    2012-01-01

    data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified...... of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. Conclusions: For innovative high-risk devices, new EU legislation should...

  9. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Science.gov (United States)

    2012-06-01

    ...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... received a petition requesting exemption from the premarket notification requirements for powered patient... necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...

  10. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-07-02

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...

  11. 78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-06-12

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

  12. 76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-06-02

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

  13. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-03-21

    ... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

  14. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-08-19

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...

  15. 75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-06-24

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...

  16. Wavelength calibration with PMAS at 3.5 m Calar Alto Telescope using a tunable astro-comb

    Science.gov (United States)

    Chavez Boggio, J. M.; Fremberg, T.; Bodenmüller, D.; Sandin, C.; Zajnulina, M.; Kelz, A.; Giannone, D.; Rutowska, M.; Moralejo, B.; Roth, M. M.; Wysmolek, M.; Sayinc, H.

    2018-05-01

    On-sky tests conducted with an astro-comb using the Potsdam Multi-Aperture Spectrograph (PMAS) at the 3.5 m Calar Alto Telescope are reported. The proposed astro-comb approach is based on cascaded four-wave mixing between two lasers propagating through dispersion optimized nonlinear fibers. This approach allows for a line spacing that can be continuously tuned over a broad range (from tens of GHz to beyond 1 THz) making it suitable for calibration of low- medium- and high-resolution spectrographs. The astro-comb provides 300 calibration lines and his line-spacing is tracked with a wavemeter having 0.3 pm absolute accuracy. First, we assess the accuracy of Neon calibration by measuring the astro-comb lines with (Neon calibrated) PMAS. The results are compared with expected line positions from wavemeter measurement showing an offset of ∼5-20 pm (4%-16% of one resolution element). This might be the footprint of the accuracy limits from actual Neon calibration. Then, the astro-comb performance as a calibrator is assessed through measurements of the Ca triplet from stellar objects HD3765 and HD219538 as well as with the sky line spectrum, showing the advantage of the proposed astro-comb for wavelength calibration at any resolution.

  17. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Withdrawal without prejudice of a premarket... ADDITIVES Premarket Notifications § 170.103 Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). A manufacturer or supplier may withdraw an FCN without prejudice to a...

  18. Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

    Science.gov (United States)

    Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

    2012-07-01

    High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

  19. High Performance Infrared Plasmonic Metamaterial Absorbers and Their Applications to Thin-film Sensing

    KAUST Repository

    Yue, Weisheng

    2016-04-07

    Plasmonic metamaterial absorbers (PMAs) have attracted considerable attention for developing various sensing devices. In this work, we design, fabricate and characterize PMAs of different geometrical shapes operating in mid-infrared frequencies, and explore the applications of the PMAs as sensor for thin films. The PMAs, consisting of metal-insulator-metal stacks with patterned gold nanostructured surfaces (resonators), demonstrated high absorption efficiency (87 to 98 %) of electromagnetic waves in the infrared regime. The position and efficiency of resonance absorption are dependent on the shape of the resonators. Furthermore, the resonance wavelength of PMAs was sensitive to the thin film coated on the surface of the PMAs, which was tested using aluminum oxide (Al2O3) as the film. With increase of the Al2O3 thickness, the position of resonance absorption shifted to longer wavelengths. The dependence of the resonant wavelength on thin film thickness makes PMAs a suitable candidate as a sensor for thin films. Using this sensing strategy, PMAs have potential as a new method for thin film detection and in situ monitoring of surface reactions. © 2016 Springer Science+Business Media New York

  20. High Performance Infrared Plasmonic Metamaterial Absorbers and Their Applications to Thin-film Sensing

    KAUST Repository

    Yue, Weisheng; Wang, Zhihong; Yang, Yang; Han, Jiaguang; Li, Jingqi; Guo, Zaibing; Tan, Hua; Zhang, Xixiang

    2016-01-01

    Plasmonic metamaterial absorbers (PMAs) have attracted considerable attention for developing various sensing devices. In this work, we design, fabricate and characterize PMAs of different geometrical shapes operating in mid-infrared frequencies, and explore the applications of the PMAs as sensor for thin films. The PMAs, consisting of metal-insulator-metal stacks with patterned gold nanostructured surfaces (resonators), demonstrated high absorption efficiency (87 to 98 %) of electromagnetic waves in the infrared regime. The position and efficiency of resonance absorption are dependent on the shape of the resonators. Furthermore, the resonance wavelength of PMAs was sensitive to the thin film coated on the surface of the PMAs, which was tested using aluminum oxide (Al2O3) as the film. With increase of the Al2O3 thickness, the position of resonance absorption shifted to longer wavelengths. The dependence of the resonant wavelength on thin film thickness makes PMAs a suitable candidate as a sensor for thin films. Using this sensing strategy, PMAs have potential as a new method for thin film detection and in situ monitoring of surface reactions. © 2016 Springer Science+Business Media New York

  1. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...

  2. Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.

    Science.gov (United States)

    2016-01-05

    The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.

  3. 78 FR 44128 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Science.gov (United States)

    2013-07-23

    ... marketing a particular medical device. A class III device that fails to meet PMA requirements is considered... commercial distribution before May 28, 1976, are not required to submit a PMA until 30 months after the... information that is labor-intensive to compile and complete; the remaining PMAs require minimal information...

  4. Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

    Science.gov (United States)

    2013-03-04

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

  5. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Science.gov (United States)

    2012-06-01

    ...] Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator AGENCY: Food and Drug... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... behalf of Bruno Independent Living Aids, Inc., for wheelchair elevator devices (commonly known as...

  6. PISCO: The PMAS/PPak Integral-field Supernova Hosts Compilation

    Science.gov (United States)

    Galbany, L.; Anderson, J. P.; Sánchez, S. F.; Kuncarayakti, H.; Pedraz, S.; González-Gaitán, S.; Stanishev, V.; Domínguez, I.; Moreno-Raya, M. E.; Wood-Vasey, W. M.; Mourão, A. M.; Ponder, K. A.; Badenes, C.; Mollá, M.; López-Sánchez, A. R.; Rosales-Ortega, F. F.; Vílchez, J. M.; García-Benito, R.; Marino, R. A.

    2018-03-01

    We present the PMAS/PPak Integral-field Supernova hosts COmpilation (PISCO), which comprises integral field spectroscopy (IFS) of 232 supernova (SN) host galaxies that hosted 272 SNe, observed over several semesters with the 3.5 m telescope at the Calar Alto Observatory (CAHA). PISCO is the largest collection of SN host galaxies observed with wide-field IFS, totaling 466,347 individual spectra covering a typical spatial resolution of ∼380 pc. Focused studies regarding specific SN Ia-related topics will be published elsewhere; this paper aims to present the properties of the SN environments, using stellar population (SP) synthesis, and the gas-phase interstellar medium, providing additional results separating stripped-envelope SNe into their subtypes. With 11,270 H II regions detected in all galaxies, we present for the first time a statistical analysis of H II regions, which puts H II regions that have hosted SNe in context with all other star-forming clumps within their galaxies. SNe Ic are associated with environments that are more metal-rich and have higher EW(Hα) and higher star formation rate within their host galaxies than the mean of all H II regions detected within each host. This in contrast to SNe IIb, which occur in environments that are very different compared to other core-collapse SNe types. We find two clear components of young and old SPs at SNe IIn locations. We find that SNe II fast decliners tend to explode at locations where the ΣSFR is more intense. Finally, we outline how a future dedicated IFS survey of galaxies in parallel to an untargeted SN search would overcome the biases in current environmental studies.

  7. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

  8. Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

    Science.gov (United States)

    2003-04-22

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

  9. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

    2016-01-01

    Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

  10. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Science.gov (United States)

    2013-03-04

    ... Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug... requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform... wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption...

  11. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  12. Electrical stimulation promotes nerve cell differentiation on polypyrrole/poly (2-methoxy-5 aniline sulfonic acid) composites.

    Science.gov (United States)

    Liu, Xiao; Gilmore, Kerry J; Moulton, Simon E; Wallace, Gordon G

    2009-12-01

    The purpose of this work was to investigate for the first time the potential biomedical applications of novel polypyrrole (PPy) composites incorporating a large polyelectrolyte dopant, poly (2-methoxy-5 aniline sulfonic acid) (PMAS). The physical and electrochemical properties were characterized. The PPy/PMAS composites were found to be smooth and hydrophilic and have low electrical impedance. We demonstrate that PPy/PMAS supports nerve cell (PC12) differentiation, and that clinically relevant 250 Hz biphasic current pulses delivered via PPy/PMAS films significantly promote nerve cell differentiation in the presence of nerve growth factor (NGF). The capacity of PPy/PMAS composites to support and enhance nerve cell differentiation via electrical stimulation renders them valuable for medical implants for neurological applications.

  13. 78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

    Science.gov (United States)

    2013-03-25

    ... requiring this device to meet the statute's premarket approval requirements and the benefits to the public... requiring the device to have an approved PMA or a declared completed PDP and the benefit to the public from... consider exercising enforcement discretion for devices lawfully distributed before the requirement to have...

  14. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

  15. Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Kazuo Iijima

    Full Text Available Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention. However, to our knowledge, no studies have compared the effectiveness and the safety between the pre- and postmarketing settings. In this study, we aimed to investigate the importance of the postmarketing data analysis using clinical data.Studies on capsule endoscopy with rich clinical data in both pre- and postmarketing settings were selected for the analysis. For effectiveness, clinical studies published before October 10, 2015 comparing capsule endoscopy and conventional flexible endoscopy measuring the detection ratio of obscure gastrointestinal bleeding were selected (premarketing: 4 studies and postmarketing: 8 studies from PubMed (MEDLINE, Cochrane Library, EMBASE and Web of Science. Among the 12 studies, 5 were blinded and 7 were non-blinded. A time series meta-analysis was conducted. Effectiveness (odds ratio decreased in the postmarketing setting (premarketing: 5.19 [95% confidence interval: 3.07-8.76] vs. postmarketing: 1.48 [0.81-2.69]. The change in odds ratio was caused by the increase in the detection ratio with flexible endoscopy as the control group. The efficacy of capsule endoscopy did not change between pre- and postmarketing settings. Heterogeneity (I2 increased in the postmarketing setting because of one study. For safety, in terms of endoscope retention in the body, data from the approval summary and adverse event reports were analyzed. The incidence of retention decreased in the postmarketing setting (premarketing: 0.75% vs postmarketing: 0.095%. The introduction of the new patency capsule for checking the patency of the digestive tract might contribute to the decrease.Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be useful to continuously monitor the

  16. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Science.gov (United States)

    2013-03-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0205 (Formerly 2007D-0252)] Pulse Oximeters--Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  17. 21 CFR 814.104 - Original applications.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Original applications. 814.104 Section 814.104...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.104 Original... applicant. (d) Address for submissions and correspondence. Copies of all original HDEs amendments and...

  18. Connecting pre-marketing clinical research and medical practice : opinion-based study of core issues and possible changes in drug regulation

    NARCIS (Netherlands)

    Wieringa, N.F; Peschar, J.L.; Denig, P; de Graeff, P.A.; Vos, R

    2003-01-01

    Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap. Methods: Interviews with 47 physicians and pharmacists who

  19. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

  20. The practice of pre-marketing safety assessment in drug development.

    Science.gov (United States)

    Chuang-Stein, Christy; Xia, H Amy

    2013-01-01

    The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

  1. Differential invariants of generic parabolic Monge–Ampère equations

    International Nuclear Information System (INIS)

    Ferraioli, D Catalano; Vinogradov, A M

    2012-01-01

    Some new results on the geometry of classical parabolic Monge–Ampère equations (PMAs) are presented. PMAs are either integrable, or non-integrable according to the integrability of its characteristic distribution. All integrable PMAs are locally equivalent to the equation u xx = 0. We study non-integrable PMAs by associating with each of them a one-dimensional distribution on the corresponding first-order jet manifold, called the directing distribution. According to some property of this distribution, non-integrable PMAs are subdivided into three classes, one generic and two special. Generic PMAs are completely characterized by their directing distributions, and we study canonical models of the latter, projective curve bundles (PCB). A PCB is a one-dimensional sub-bundle of the projectivized cotangent bundle of a four-dimensional manifold. Differential invariants of projective curves composing such a bundle are used to construct a series of contact differential invariants for corresponding PMAs. These give a solution of the equivalence problem for generic PMAs with respect to contact transformations. The introduced invariants measure the nonlinearity of PMAs in an exact manner. (paper)

  2. Haptic control of a pneumatic muscle actuator to provide resistance for simulated isokinetic exercise: Part I--dynamic test station and human quadriceps dynamic simulator.

    Science.gov (United States)

    Hall, Kara L; Phillips, Chandler A; Reynolds, David B; Mohler, Stanley R; Rogers, Dana B; Neidhard-Doll, Amy T

    2014-01-01

    Pneumatic muscle actuators (PMAs) have a high power to weight ratio and possess unique characteristics which make them ideal actuators for applications involving human interaction. PMAs are difficult to control due to nonlinear dynamics, presenting challenges in system implementation. Despite these challenges, PMAs have great potential as a source of resistance for strength training and rehabilitation. The objective of this work was to control a PMA for use in isokinetic exercise, potentially benefiting anyone in need of optimal strength training through a joint's range of motion. A human quadriceps dynamic simulator (HQDS) was developed so that control effectiveness and accommodation could be tested prior to human implementation. The experimental set-up and HQDS are discussed in Part I of this work. The development of a PMA haptic controller and its interaction with the HQDS are discussed in Part II.

  3. A survey on pneumatic muscle actuators modeling

    OpenAIRE

    Kelasidi, Eleni; Andrikopoulos, Georgios; Nikolakopoulos, George; Manesis, Stamatis

    2012-01-01

    The aim of this article is to provide a survey on the most popular modeling approaches for Pneumatic Muscle Actuators (PMAs). PMAs are highly non-linear pneumatic actuators where their elongation is proportional to the interval pressure. During the last decade, there has been an increase in the industrial and scientific utilization of PMAs, due to their advantages such as high strength and small weight, while various types of PMAs with different technical characteristics have been appeared in...

  4. A computational simulated control system for a high-force pneumatic muscle actuator: system definition and application as an augmented orthosis.

    Science.gov (United States)

    Gerschutz, Maria J; Phillips, Chandler A; Reynolds, David B; Repperger, Daniel W

    2009-04-01

    High-force pneumatic muscle actuators (PMAs) are used for force assistance with minimal displacement applications. However, poor control due to dynamic nonlinearities has limited PMA applications. A simulated control system is developed consisting of: (1) a controller relating an input position angle to an output proportional pressure regulator voltage, (2) a phenomenological model of the PMA with an internal dynamic force loop (system time constant information), (3) a physical model of a human sit-to-stand task and (4) an external position angle feed-back loop. The results indicate that PMA assistance regarding the human sit-to-stand task is feasible within a specified PMA operational pressure range.

  5. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest.

    Science.gov (United States)

    Rothman, David J; McDonald, Walter J; Berkowitz, Carol D; Chimonas, Susan C; DeAngelis, Catherine D; Hale, Ralph W; Nissen, Steven E; Osborn, June E; Scully, James H; Thomson, Gerald E; Wofsy, David

    2009-04-01

    Professional medical associations (PMAs) play an essential role in defining and advancing health care standards. Their conferences, continuing medical education courses, practice guidelines, definitions of ethical norms, and public advocacy positions carry great weight with physicians and the public. Because many PMAs receive extensive funding from pharmaceutical and device companies, it is crucial that their guidelines manage both real and perceived conflict of interests. Any threat to the integrity of PMAs must be thoroughly and effectively resolved. Current PMA policies, however, are not uniform and often lack stringency. To address this situation, the authors first identified and analyzed conflicts of interest that may affect the activities, leadership, and members of PMAs. The authors then went on to formulate guidelines, both short-term and long-term, to prevent the appearance or reality of undue industry influence. The recommendations are rigorous and would require many PMAs to transform their mode of operation and perhaps, to forgo valuable activities. To maintain integrity, sacrifice may be required. Nevertheless, these changes are in the best interest of the PMAs, the profession, their members, and the larger society.

  6. Haptic control of a pneumatic muscle actuator to provide resistance for simulated isokinetic exercise; part II: control development and testing.

    Science.gov (United States)

    Hall, Kara L; Phillips, Chandler A; Reynolds, David B; Mohler, Stanley R; Rogers, Dana B; Neidhard-Doll, Amy T

    2015-01-01

    Pneumatic muscle actuators (PMAs) have a high power to weight ratio and possess unique characteristics which make them ideal actuators for applications involving human interaction. PMAs are difficult to control due to nonlinear dynamics, presenting challenges in system implementation. Despite these challenges, PMAs have great potential as a source of resistance for strength training and rehabilitation. The objective of this work was to control a PMA for use in isokinetic exercise, potentially benefiting anyone in need of optimal strength training through a joint's range of motion. The controller, based on an inverse three-element phenomenological model and adaptive nonlinear control, allows the system to operate as a type of haptic device. A human quadriceps dynamic simulator was developed (as described in Part I of this work) so that control effectiveness and accommodation could be tested prior to human implementation. Tracking error results indicate that the control system is effective at producing PMA displacement and resistance necessary for a scaled, simulated neuromuscular actuator to maintain low-velocity isokinetic movement during simulated concentric and eccentric knee extension.

  7. Imaging characteristics of pilomyxoid astrocytomas in comparison with pilocytic astrocytomas

    International Nuclear Information System (INIS)

    Lee, In Ho; Kim, Ji Hye; Suh, Yeon-Lim; Eo, Hong; Shin, Hyung Jin; Yoo, So-Young; Lee, Kyung Soo

    2011-01-01

    Purpose: Pilomyxoid astrocytoma (PMA) is a recently described astrocytic tumor that has been previously diagnosed as pilocytic astrocytoma (PA). The purpose of this study was to describe the imaging features of PMAs in comparison with PAs. Materials and methods: We retrospectively reviewed CT/MR images and medical records of 10 patients with PMA and 38 patients with PA. The mean ages of patients with PMA and PA were 10 and 15 years, respectively. Imaging features including location, composition, enhancement pattern, presence of calcification, hemorrhage, and leptomeningeal dissemination were compared in patients with two tumor types. Results: Six PMAs (60%) occurred at the suprasellar area and the cerebellum was the most common (45%) site of PA. Solid component was dominant in eight PMAs (80%) and in 19 PAs (50%). All of the PMAs containing solid mass (n = 8) included non-enhancing portion while 12/37 (32%) PAs included non-enhancing solid portion (p < 0.05). Leptomeningeal dissemination was noted in five PMAs (50%) and one PA (3%) (p < 0.05). Other imaging findings were not significantly different. Conclusion: A younger age, more frequent occurrence at the suprasellar area, mainly solid mass containing non-enhancing portion, and more frequent leptomeningeal dissemination are helpful differential features of PMAs as compared to PAs.

  8. Synthesis of sFlt-1 by platelet-monocyte aggregates contributes to the pathogenesis of preeclampsia

    Science.gov (United States)

    Major, Heather D.; Cambell, Robert A.; Silver, Robert M.; Branch, D. Ware; Weyrich, Andrew S.

    2014-01-01

    Objective Soluble fms-like tyrosine kinase (sFlt-1) is an important mediator in the pathogenesis of preeclampsia. We sought to determine if platelet-monocyte aggregates (PMAs) produced sFlt-1 and if PMAs contributed to sFlt-1 production in preeclampsia. Study Design Case-control study of sFlt-1 release from PMAs using blood samples from women with preeclampsia matched by gestational age to pregnant controls. A third group of nonpregnant, reproductive-age women comprised an additional control group. Experiments were also performed using blood from non-pregnant women to elucidate if inducing PMAs could stimulate sFlt-1 production, and if so, to determine the necessary receptors and pathways. Results Women with preeclampsia had increased total Flt-1 concentrations in platelets and monocytes at baseline compared to pregnant controls (25 vs. 10 pg/ml, p=0.0003). sFlt-1 production was elicited from monocytes incubated with thrombin-activated platelets from non-pregnant women. sFlt-1 production was regulated at the transcriptional level by p38 and NF-κB dependent pathways. Conclusion Activated platelets in preeclampsia bind monocytes to generate sFlt-1. PMAs are a previously unrecognized source of sFlt-1 that may contribute to endothelial dysfunction and systemic inflammation commonly observed in preeclampsia. PMID:24440566

  9. 78 FR 65339 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-10-31

    ... the applicant for marketing a particular medical device. A class III device that fails to meet PMA..., devices that were in commercial distribution before May 28, 1976, are not required to submit a PMA until... is labor-intensive to compile and complete; the remaining PMAs require minimal information. Based on...

  10. Tissue engineered constructs: perspectives on clinical translation.

    Science.gov (United States)

    Lu, Lichun; Arbit, Harvey M; Herrick, James L; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J

    2015-03-01

    In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the U.S. Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or new drug application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented.

  11. The medical-industrial complex, professional medical associations, and continuing medical education.

    Science.gov (United States)

    Schofferman, Jerome

    2011-12-01

    Financial relationships among the biomedical industries, physicians, and professional medical associations (PMAs) can be professional, ethical, mutually beneficial, and, most importantly, can lead to improved medical care. However, such relationships, by their very nature, present conflicts of interest (COIs). One of the greatest concerns regarding COI is continuing medical education (CME), especially because currently industry funds 40-60% of CME. COIs have the potential to bias physicians in practice, educators, and those in leadership positions of PMAs and well as the staff of a PMA. These conflicts lead to the potential to bias the content and type of CME presentations and thereby influence physicians' practice patterns and patient care. Physicians are generally aware of the potential for bias when industry contributes funding for CME, but they are most often unable to detect the bias. This may because it is very subtle and/or the educators themselves may not realize that they have been influenced by their relationships with industry. Following Accreditation Council for Continuing Medical Education guidelines and mandating disclosure that is transparent and complete have become the fallback positions to manage COIs, but such disclosure does not really mitigate the conflict. The eventual and best solutions to ensure evidence-based education are complete divestment by educators and leaders of PMAs, minimal and highly controlled industry funding of PMAs, blind pooling of any industry contributions to PMAs and CME, strict verification of disclosures, clear separation of marketing from education at CME events, and strict oversight of presentations for the presence of bias. Wiley Periodicals, Inc.

  12. Compendium of GAO’s Views on the Cost Saving Proposals of the Grace Commission. Volume 1. Summary of Findings.

    Science.gov (United States)

    1985-02-19

    effort to develop a govern- ment-wide integrated financial management structure. Such an effort must have a solid base of fundamental concepts to guide ...initiatives address many PPSSCC debt collection concerns The PPSSCC recommendations basically parallel our prior *- recommendations and ongoing OMB...PPSSCC recommended either selling the PMAs’ facilities or adjusting the PMAs’ user fees, ratemaking process, and pricina structure. In total, the PPSSCC

  13. Prediction of multiple resonance characteristics by an extended resistor-inductor-capacitor circuit model for plasmonic metamaterials absorbers in infrared.

    Science.gov (United States)

    Xu, Xiaolun; Li, Yongqian; Wang, Binbin; Zhou, Zili

    2015-10-01

    The resonance characteristics of plasmonic metamaterials absorbers (PMAs) are strongly dependent on geometric parameters. A resistor-inductor-capacitor (RLC) circuit model has been extended to predict the resonance wavelengths and the bandwidths of multiple magnetic polaritons modes in PMAs. For a typical metallic-dielectric-metallic structure absorber working in the infrared region, the developed model describes the correlation between the resonance characteristics and the dimensional sizes. In particular, the RLC model is suitable for not only the fundamental resonance mode, but also for the second- and third-order resonance modes. The prediction of the resonance characteristics agrees fairly well with those calculated by the finite-difference time-domain simulation and the experimental results. The developed RLC model enables the facilitation of designing multi-band PMAs for infrared radiation detectors and thermal emitters.

  14. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Science.gov (United States)

    2011-12-06

    ... feedback received from this workshop and the continued communication with investigators in this field has... included in IDE and PMA applications, focusing on critical elements of safety and effectiveness for... represent the Agency's current thinking on developing investigations of and premarket applications for...

  15. Continuing medical education and pharmaceutical industry involvement: An evaluation of policies adopted by Canadian professional medical associations.

    Science.gov (United States)

    Shnier, Adrienne; Lexchin, Joel

    2017-01-01

    Professional medical associations (PMAs) play a crucial role in providing accredited continuing medical education (CME) to physicians. Funding from the pharmaceutical industry may lead to biases in CME. This study examines publicly available policies on CME, adopted by Canadian PMAs as of December 2015. Policies were evaluated using an original scoring tool comprising 21 items, two questions about PMAs' general and CME funding from industry, and three enforcement measures. We assessed 236 policies adopted by Canadian PMAs (range, 0 to 32). Medical associations received summative scores that ranged from 0% to 49.2% of the total possible points (maximum score = 63). Twenty-seven associations received an overall score of 0%. The highest mean scores were achieved in the areas of industry involvement in planning CME activities (mean: 1.1/3), presence of a review process for topics of CME activities (mean: 1.1/3), content review for balanced information (mean: 1.1/3), and responsibility of distribution of funds (mean: 1.0/3). The lowest mean scores were achieved in the areas of awards (mean: 0.0/3), industry personnel, representatives, and employees (mean: 0.1/3), distribution of industry-funded educational materials at CME activities (mean: 0.1/3), and distinction between marketing and educational materials (mean: 0.1/3). These results suggest that Canadian PMAs' publicly available policies on industry involvement in CME are generally weak or non-existent; therefore, the accredited CME that is provided to Canadian physicians may be viewed as open to bias. We encourage all Canadian medical associations to strengthen their policies to avoid the potential for industry influence in CME.

  16. 75 FR 4407 - The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-27

    ... enough to provide timely notice. Therefore, you should always check the agency's Web site and call the... premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic...

  17. Comparing parents' and overweight adolescents' reports on parent mealtime actions.

    Science.gov (United States)

    Volpe, Carolina Bertagnoli; Petty, Maria Luiza Blanques; de Souza, Altay Alves Lino; Escrivão, Maria Arlete Meil Schimith

    2018-01-01

    This study aimed to compare answers given by parents and their adolescent children to the Portuguese version of the Parent Mealtime Action Scale (PMAS) and to assess associations among the reported behaviors. To compare these answers, a cross-sectional study was conducted in a sample of 72 patients of the Obesity Clinic of the Division of Nutrology of the Pediatrics Department at the Federal University of São Paulo (Unifesp), Brazil. These patients were aged from 10 years to 19 years and 11 months, and their parents or legal guardians also participated. First, parents were interviewed and instructed to answer how often they perform each behavior measured by the PMAS (never, sometimes or always). Next, the same questions were answered by the adolescents. The general linear model (GLM) showed the effects of the interviewees and of the interaction between interviewees and sex. We also observed a triple interaction effect (sex x interviewees x categorized age). The internal reliability of the PMAS was higher for parental answers than for those given by the children. This finding is probably observed because the scale has been developed and validated to evaluate the pattern of parental responses concerning their eating practices during their children's meals. In addition, although parents believe they are engaging in certain behaviors, the effectiveness of these strategies may not be recognized by their children. Very low intraclass correlation coefficients were observed between parents' and children's answers to the original domains of the PMAS (ICC: 0.130-0.578), suggesting that the factorial structure of the PMAS may only be used to assess parental behavior, as it is not sufficiently accurate to assess the children's understanding of parent mealtime actions. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Draft revision of human factors guideline HF-010

    International Nuclear Information System (INIS)

    Lee, Hyun Chul; Lee, Yong Hee; Oh, In Seok; Lee, Jung Woon; Cha, Woo Chang; Lee, Dhong Ha

    2003-05-01

    The Application of Human Factors to the design of Man-Machine Interfaces System(MMIS) in the nuclear power plant is essential to the safety and productivity of the nuclear power plants, human factors standards and guidelines as well as human factors analysis methods and experiments are weightily used to the design application. A Korean engineering company has developed a human factors engineering guideline, so-call HF-010, and has used it for human factors design, however the revision of HF-010 is necessary owing to lack of the contents related to the advanced MMI(Man-Machine Interfaces). As the results of the reviews of HF-010, it is found out that the revision of Section 9. Computer Displays of HF-010 is urgent, thus the revision was drafted on the basis of integrated human factors design guidelines for VDT, human factors design guidelines for PMAS SPADES display, human factors design guidelines for PMAS alarm display, and human factors design guidelines for electronic displays developed by the surveillance and operation support project of KOICS. The draft revision of HF-010 Section 9 proposed in this report can be utilized for the human factors design of the advanced MMI, and the high practical usability of the draft can be kept up through the continuous revision according to the advancement of digital technology

  19. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  20. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  1. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Science.gov (United States)

    2013-03-18

    ... the applicable hazards will need to be re-evaluated at multiple stages of the development process. In... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0194... Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k...

  2. 21 CFR 814.3 - Definitions.

    Science.gov (United States)

    2010-04-01

    ... detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device. (e) PMA means any premarket approval application...) Reasonable probability means that it is more likely than not that an event will occur. (l) Serious, adverse...

  3. A potência instituinte no projeto "Exercendo Cidadania"

    Directory of Open Access Journals (Sweden)

    Fabiana Davel Canal

    2012-12-01

    Full Text Available As Penas e Medidas Alternativas (PMAs são cada vez mais utilizadas pelo sistema jurídico brasileiro. Diante desse contexto, a Vara de Execuções de Penas e Medidas Alternativas do Espírito Santo estabeleceu um convênio com Prefeitura Municipal de Vitória que oferece um curso de formação em Direitos Humanos, intitulado "Exercendo Cidadania" como forma de cumprimento das PMAs. Este artigo é resultado da análise preliminar de uma pesquisa que tem como objetivo analisar a execução das PMAs no município de Vitória-ES, com atenção especial para o curso em questão. O diário de campo foi o principal instrumento metodológico, confeccionado pelas vivências no curso de outubro a novembro de 2010. Ficamos atentos aos movimentos que nos indicavam como o apenado entende/vive/pensa a PMA,observando as formas rígidas, instituídas de efetivação das mesmas, mas também - e isso que tentamos dar visibilidade - a potência instituinte do curso.

  4. 75 FR 36102 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-06-24

    ... will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the... characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays...

  5. PMGA and its application in area and power optimization for ternary FPRM circuit

    International Nuclear Information System (INIS)

    Wang Pengjun; Li Kangping; Zhang Huihong

    2016-01-01

    Based on the research of population migration algorithms (PMAs), a population migration genetic algorithm (PMGA) is proposed, combining a PMA with a genetic algorithm. A scheme of area and power optimization for a ternary FPRM circuit is proposed by using the PMGA. Firstly, according to the ternary FPRM logic function expression, area and power estimation models are established. Secondly, the PMGA is used to search for the best area and power polarity. Finally, 10 MCNC Benchmark circuits are used to verify the effectiveness of the proposed method. The results show that the ternary FPRM circuits optimized by the PMGA saved 13.33% area and 20.00% power on average than the corresponding FPRM circuits optimized by a whole annealing genetic algorithm. (paper)

  6. What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

    Science.gov (United States)

    Kondo, Hideyuki; Saint-Raymond, Agnès; Yasuda, Naoyuki

    2018-03-01

    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.

  7. 21 CFR 807.93 - Content and format of a 510(k) statement.

    Science.gov (United States)

    2010-04-01

    ... certify that, in my capacity as (the position held in company by person required to submit the premarket... notification submission, including any adverse safety and effectiveness information, but excluding all patient..., whose name will be published by FDA on the list of premarket notification submissions for which...

  8. 77 FR 66601 - Electronic Tariff Filings; Notice of Change to eTariff Type of Filing Codes

    Science.gov (United States)

    2012-11-06

    ... for the Federal Power Marketing Administrations (PMAs): TOFC 1220: ``Rate Extensions''. This code will... Peter Radway, Office of Energy Market Regulation at (202) 502-8782 or send an email to [email protected

  9. Dominance in the prototyping phase. The case of hydrogen passenger cars

    NARCIS (Netherlands)

    Bakker, S.; Meeus, M.T.H.; van Lente, H.

    2012-01-01

    The notion of dominant designs refers to dominance in the market, hence the literature on dominant designs ignores the selection process that already takes place in pre-market R&D stages of technological innovation. In this paper we address the question to what extent pre-market selection takes

  10. ISSN 2073-9990 East Cent. Afr. J. surg

    African Journals Online (AJOL)

    Hp 630 Dual Core

    Key words: -Pilocytic astrocytoma • pilomyxoid astrocytoma • diagnosis • cerebellar ... of cerebellar Pilocytic astrocytoma, he was operated on 07/05/2015 midline .... initial therapy in the treatment of PMAs.16Whereas the literature is replete ...

  11. Impact of polymer modification on mechanical and viscoelastic properties.

    Science.gov (United States)

    2015-10-01

    This study was initiated with the aim of evaluating the relative impact of different cross-linking agents : on the rheological and morphological properties of polymer modified asphalt binders (PMAs). To : complete this objective, two cross-linking ag...

  12. A potência instituinte no projeto "Exercendo Cidadania" La potencia instituyente en el proyecto "Ejerciendo la Ciudadanía" The instituting power in the project "Exercising Citizenship"

    Directory of Open Access Journals (Sweden)

    Fabiana Davel Canal

    2012-12-01

    Full Text Available As Penas e Medidas Alternativas (PMAs são cada vez mais utilizadas pelo sistema jurídico brasileiro. Diante desse contexto, a Vara de Execuções de Penas e Medidas Alternativas do Espírito Santo estabeleceu um convênio com Prefeitura Municipal de Vitória que oferece um curso de formação em Direitos Humanos, intitulado "Exercendo Cidadania" como forma de cumprimento das PMAs. Este artigo é resultado da análise preliminar de uma pesquisa que tem como objetivo analisar a execução das PMAs no município de Vitória-ES, com atenção especial para o curso em questão. O diário de campo foi o principal instrumento metodológico, confeccionado pelas vivências no curso de outubro a novembro de 2010. Ficamos atentos aos movimentos que nos indicavam como o apenado entende/vive/pensa a PMA,observando as formas rígidas, instituídas de efetivação das mesmas, mas também - e isso que tentamos dar visibilidade - a potência instituinte do curso.Las Penas y Medidas Alternativas (PMAs son cada vez más utilizadas por el sistema jurídico brasileño. En este contexto, el Tribunal de Ejecución de Penas y Medidas Alternativas del Espírito Santo ha establecido un acuerdo con el Ayuntamiento de la ciudad de Vitória, que ofrece un curso de capacitación sobre Derechos Humanos titulado "Ejerciendo la Ciudadanía" como una manera de cumplir con las PMAs. Este artículo es el resultado de un análisis preliminar de una investigación que tiene como objetivo analizar el desempeño de las PMAs en la ciudad de Vitória, con especial atención al curso en cuestión. El diario de campo fue la principal herramienta metodológica, hecho a partir de experiencias en el curso de octubre a noviembre de 2010. Nos pusimos atentos a los movimientos que nos indicaban cómo el apenado entiende/vive/piensa la PMA, observando las formas rígidas, instituidas de realización de las mismas, pero también - y fue a eso que tratamos de dar visibilidad - la potencia

  13. Germination of Themeda triandra (Kangaroo grass) as affected by ...

    African Journals Online (AJOL)

    STORAGESEVER

    2009-09-01

    Sep 1, 2009 ... Full Length Research Paper ... 3Department of Entomology, PMAS-Arid Agriculture University Rawalpindi, Pakistan. .... July, 2005 and for second year during mid July, 2006. .... by 20 cm broadcast, respectively, whereas for the last 20 .... on the Management of Grassy Ecosystem, Victoria University of ...

  14. Morphologies and stellar populations of galaxies in the core of Abell 2218

    NARCIS (Netherlands)

    Sánchez, S. F.; Cardiel, N.; Verheijen, M. A. W.; Pedraz, S.; Covone, G.

    2007-01-01

    We present a study of the stellar populations and morphologies of galaxies in the core of the galaxy cluster Abell 2218. Integral field spectroscopy (IFS) observations were performed using PMAS in the PPAK mode covering a field of view of similar to 74 x 64 arcsec(2) centred on the core of the

  15. Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

    2015-07-01

    Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

  16. Effect of nozzle geometry for swirl type twin-fluid water mist nozzle on the spray characteristic

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Soon Hyun; Kim, Do Yeon; Kim, Dong Keon [Pusan National University, Busan (Korea, Republic of); Kim, Bong Hwan [Jinju National University, Jinju (Korea, Republic of)

    2011-07-15

    Experimental investigations on the atomization characteristics of twin-fluid water mist nozzle were conducted using particle image velocimetry (PIV) system and particle motion analysis system (PMAS). The twin-fluid water mist nozzles with swirlers designed two types of swirl angles such as 0 .deg. , 90 .deg. and three different size nozzle hole diameters such as 0.5mm, 1mm, 1.5mm were employed. The experiments were carried out by the injection pressure of water and air divided into 1bar, 2bar respectively. The droplet size of the spray was measured using PMAS. The velocity and turbulence intensity were measured using PIV. The velocity, turbulence intensity and SMD distributions of the sprays were measured along the centerline and radial direction. As the experimental results, swirl angle controlled to droplet sizes. It was found that SMD distribution decreases with the increase of swirl angle. The developed twin-fluid water mist nozzle was satisfied to the criteria of NFPA 750, Class 1. It was proven that the developed nozzle under low pressures could be applied to fire protection system.

  17. VizieR Online Data Catalog: Spectroscopy of NGC3310 HII regions (Miralles-Caballero+, 2014)

    Science.gov (United States)

    Miralles-Caballero, D.; Diaz, A. I.; Rosales-Ortega, F. F.; Perez-Montero, E.; Sanchez, S. F.

    2015-01-01

    NGC 3310 observations were carried out with the 3.5m telescope of the Calar Alto Observatory using the Postdam Multi-Aperture Spectrograph (PMAS) in the PMAS fibre package mode (PPAK). This was part of the PINGS (Rosales-Ortega et al., 2010MNRAS.405..735R). We retrieved publicly available broad-band imaging of this galaxy in order to perform an absolute flux re-calibration. Specifically, we used the Sloan Digital Sky Survey (SDSS, http://www.sdss.org/) broad-band g- and r-filter images (with a spatial resolution of about 1-arcsec) and an HST (http://www.stsci.edu/hst/) image taken with the Wide Field Planetary Camera 2 (WFPC2, with a spatial resolution of about 0.05-arcsec) using the F439W filter (similar to B Johnson). We also obtained UV images of the galaxy. In particular, taken with the UVW2 and UVM2 filters (with effective wavelengths of 2087 and 2297Å, respectively), mounted on the OM camera on board the XMM-Newton satellite. (3 data files).

  18. Effect of nozzle geometry for swirl type twin-fluid water mist nozzle on the spray characteristic

    International Nuclear Information System (INIS)

    Yoon, Soon Hyun; Kim, Do Yeon; Kim, Dong Keon; Kim, Bong Hwan

    2011-01-01

    Experimental investigations on the atomization characteristics of twin-fluid water mist nozzle were conducted using particle image velocimetry (PIV) system and particle motion analysis system (PMAS). The twin-fluid water mist nozzles with swirlers designed two types of swirl angles such as 0 .deg. , 90 .deg. and three different size nozzle hole diameters such as 0.5mm, 1mm, 1.5mm were employed. The experiments were carried out by the injection pressure of water and air divided into 1bar, 2bar respectively. The droplet size of the spray was measured using PMAS. The velocity and turbulence intensity were measured using PIV. The velocity, turbulence intensity and SMD distributions of the sprays were measured along the centerline and radial direction. As the experimental results, swirl angle controlled to droplet sizes. It was found that SMD distribution decreases with the increase of swirl angle. The developed twin-fluid water mist nozzle was satisfied to the criteria of NFPA 750, Class 1. It was proven that the developed nozzle under low pressures could be applied to fire protection system

  19. ESnet authentication services and trust federations

    Energy Technology Data Exchange (ETDEWEB)

    Muruganantham, Dhivakaran; Helm, Mike; Genovese, Tony [ESnet, Energy Sciences Network, 1 Cyclotron Road, MS 50A-3111 Berkeley, California 94720 (United States)

    2005-01-01

    ESnet provides authentication services and trust federation support for SciDAC projects, collaboratories, and other distributed computing applications. The ESnet ATF team operates the DOEGrids Certificate Authority, available to all DOE Office of Science programs, plus several custom CAs, including one for the National Fusion Collaboratory and one for NERSC. The secure hardware and software environment developed to support CAs is suitable for supporting additional custom authentication and authorization applications that your program might require. Seamless, secure interoperation across organizational and international boundaries is vital to collaborative science. We are fostering the development of international PKI federations by founding the TAGPMA, the American regional PMA, and the worldwide IGTF Policy Management Authority (PMA), as well as participating in European and Asian regional PMAs. We are investigating and prototyping distributed authentication technology that will allow us to support the 'roaming scientist' (distributed wireless via eduroam), as well as more secure authentication methods (one-time password tokens)

  20. ESnet authentication services and trust federations

    International Nuclear Information System (INIS)

    Muruganantham, Dhivakaran; Helm, Mike; Genovese, Tony

    2005-01-01

    ESnet provides authentication services and trust federation support for SciDAC projects, collaboratories, and other distributed computing applications. The ESnet ATF team operates the DOEGrids Certificate Authority, available to all DOE Office of Science programs, plus several custom CAs, including one for the National Fusion Collaboratory and one for NERSC. The secure hardware and software environment developed to support CAs is suitable for supporting additional custom authentication and authorization applications that your program might require. Seamless, secure interoperation across organizational and international boundaries is vital to collaborative science. We are fostering the development of international PKI federations by founding the TAGPMA, the American regional PMA, and the worldwide IGTF Policy Management Authority (PMA), as well as participating in European and Asian regional PMAs. We are investigating and prototyping distributed authentication technology that will allow us to support the 'roaming scientist' (distributed wireless via eduroam), as well as more secure authentication methods (one-time password tokens)

  1. The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

    Science.gov (United States)

    Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

    2018-04-20

    A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

  2. Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.

    Science.gov (United States)

    Freckmann, Guido; Schmid, Christina; Baumstark, Annette; Rutschmann, Malte; Haug, Cornelia; Heinemann, Lutz

    2015-07-01

    In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems. © 2015 Diabetes Technology Society.

  3. Post-Stroke Longitudinal Alterations of Inter-Hemispheric Correlation and Hemispheric Dominance in Mouse Pre-Motor Cortex.

    Science.gov (United States)

    Vallone, Fabio; Lai, Stefano; Spalletti, Cristina; Panarese, Alessandro; Alia, Claudia; Micera, Silvestro; Caleo, Matteo; Di Garbo, Angelo

    2016-01-01

    Limited restoration of function is known to occur spontaneously after an ischemic injury to the primary motor cortex. Evidence suggests that Pre-Motor Areas (PMAs) may "take over" control of the disrupted functions. However, little is known about functional reorganizations in PMAs. Forelimb movements in mice can be driven by two cortical regions, Caudal and Rostral Forelimb Areas (CFA and RFA), generally accepted as primary motor and pre-motor cortex, respectively. Here, we examined longitudinal changes in functional coupling between the two RFAs following unilateral photothrombotic stroke in CFA (mm from Bregma: +0.5 anterior, +1.25 lateral). Local field potentials (LFPs) were recorded from the RFAs of both hemispheres in freely moving injured and naïve mice. Neural signals were acquired at 9, 16 and 23 days after surgery (sub-acute period in stroke animals) through one bipolar electrode per hemisphere placed in the center of RFA, with a ground screw over the occipital bone. LFPs were pre-processed through an efficient method of artifact removal and analysed through: spectral,cross-correlation, mutual information and Granger causality analysis. Spectral analysis demonstrated an early decrease (day 9) in the alpha band power in both the RFAs. In the late sub-acute period (days 16 and 23), inter-hemispheric functional coupling was reduced in ischemic animals, as shown by a decrease in the cross-correlation and mutual information measures. Within the gamma and delta bands, correlation measures were already reduced at day 9. Granger analysis, used as a measure of the symmetry of the inter-hemispheric causal connectivity, showed a less balanced activity in the two RFAs after stroke, with more frequent oscillations of hemispheric dominance. These results indicate robust electrophysiological changes in PMAs after stroke. Specifically, we found alterations in transcallosal connectivity, with reduced inter-hemispheric functional coupling and a fluctuating dominance

  4. Post-Stroke Longitudinal Alterations of Inter-Hemispheric Correlation and Hemispheric Dominance in Mouse Pre-Motor Cortex.

    Directory of Open Access Journals (Sweden)

    Fabio Vallone

    Full Text Available Limited restoration of function is known to occur spontaneously after an ischemic injury to the primary motor cortex. Evidence suggests that Pre-Motor Areas (PMAs may "take over" control of the disrupted functions. However, little is known about functional reorganizations in PMAs. Forelimb movements in mice can be driven by two cortical regions, Caudal and Rostral Forelimb Areas (CFA and RFA, generally accepted as primary motor and pre-motor cortex, respectively. Here, we examined longitudinal changes in functional coupling between the two RFAs following unilateral photothrombotic stroke in CFA (mm from Bregma: +0.5 anterior, +1.25 lateral.Local field potentials (LFPs were recorded from the RFAs of both hemispheres in freely moving injured and naïve mice. Neural signals were acquired at 9, 16 and 23 days after surgery (sub-acute period in stroke animals through one bipolar electrode per hemisphere placed in the center of RFA, with a ground screw over the occipital bone. LFPs were pre-processed through an efficient method of artifact removal and analysed through: spectral,cross-correlation, mutual information and Granger causality analysis.Spectral analysis demonstrated an early decrease (day 9 in the alpha band power in both the RFAs. In the late sub-acute period (days 16 and 23, inter-hemispheric functional coupling was reduced in ischemic animals, as shown by a decrease in the cross-correlation and mutual information measures. Within the gamma and delta bands, correlation measures were already reduced at day 9. Granger analysis, used as a measure of the symmetry of the inter-hemispheric causal connectivity, showed a less balanced activity in the two RFAs after stroke, with more frequent oscillations of hemispheric dominance.These results indicate robust electrophysiological changes in PMAs after stroke. Specifically, we found alterations in transcallosal connectivity, with reduced inter-hemispheric functional coupling and a fluctuating

  5. The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

    Science.gov (United States)

    Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

    2018-05-04

    Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional

  6. Creation of an iOS and Android Mobile Application for Inferior Vena Cava (IVC) Filters: A Powerful Tool to Optimize Care of Patients with IVC Filters.

    Science.gov (United States)

    Deso, Steven E; Idakoji, Ibrahim A; Muelly, Michael C; Kuo, William T

    2016-06-01

    Owing to a myriad of inferior vena cava (IVC) filter types and their potential complications, rapid and correct identification may be challenging when encountered on routine imaging. The authors aimed to develop an interactive mobile application that allows recognition of all IVC filters and related complications, to optimize the care of patients with indwelling IVC filters. The FDA Premarket Notification Database was queried from 1980 to 2014 to identify all IVC filter types in the United States. An electronic search was then performed on MEDLINE and the FDA MAUDE database to identify all reported complications associated with each device. High-resolution photos were taken of each filter type and corresponding computed tomographic and fluoroscopic images were obtained from an institutional review board-approved IVC filter registry. A wireframe and storyboard were created, and software was developed using HTML5/CSS compliant code. The software was deployed using PhoneGap (Adobe, San Jose, CA), and the prototype was tested and refined. Twenty-three IVC filter types were identified for inclusion. Safety data from FDA MAUDE and 72 relevant peer-reviewed studies were acquired, and complication rates for each filter type were highlighted in the application. Digital photos, fluoroscopic images, and CT DICOM files were seamlessly incorporated. All data were succinctly organized electronically, and the software was successfully deployed into Android (Google, Mountain View, CA) and iOS (Apple, Cupertino, CA) platforms. A powerful electronic mobile application was successfully created to allow rapid identification of all IVC filter types and related complications. This application may be used to optimize the care of patients with IVC filters.

  7. Establishing a system with Drosophila melanogaster (Diptera: Drosophilidae) to assess the non-target effects of gut-active insecticidal compounds.

    Science.gov (United States)

    Haller, Simone; Meissle, Michael; Romeis, Jörg

    2016-12-01

    Potentially adverse effects on ecosystem functioning by the planting of insect-resistant, genetically engineered plants or by the direct application of insecticidal compounds are carefully evaluated in pre-market risk assessments. To date, few studies have assessed the potential risks of genetically engineered crops or insecticidal compounds on the survival and fitness of dipteran species, despite their important contribution to ecosystem services such as decomposition in agricultural systems. Therefore, we propose that Drosophila melanogaster Meigen (Drosophilidae) be used as a surrogate species for the order Diptera and for the functional guild of soil arthropod decomposers in pre-market risk assessments. We developed two assays to assess the toxicity of gut-active insecticidal compounds to D. melanogaster. One assay uses groups of fly larvae, and the other uses individuals. Cryolite, a mineral pesticide, proved to be an adequate positive control. The effects of cryolite on D. melanogaster larvae were comparable between the two assays. Statistical power analyses were used to define the number of replications required to identify different effect sizes between control and treatment groups. Finally, avidin, E-64, GNA, and SBTI were used as test compounds to validate the individual-based assay; only avidin adversely affected D. melanogaster. These results indicate that both D. melanogaster assays will be useful for early tier risk assessment concerning the effects of orally active compounds on non-target dipterans.

  8. Characterisation of a pneumatic muscle test station with two dynamic plants in cascade.

    Science.gov (United States)

    Serres, J L; Reynolds, D B; Phillips, C A; Rogers, D B; Repperger, D W

    2010-02-01

    Pneumatic muscle actuators (PMAs) offer significant advantages over more traditional actuators, which make them prime candidates in rehabilitation devices. A dynamic test station (DTS) is modified to demonstrate the use of a PMA for this application. The DTS includes two dynamic systems: a PMA and a DC servomotor. An overall transfer function was developed utilising characterisation data for the PMA and DC servomotor. A Tustin (bilinear) transform was performed on the overall transfer function to obtain a discrete time system. Model parameters were optimised and used to generate input voltage profiles that achieve isokinetic (constant velocity) task specifications. Percent root mean square error values (PRMSE) between the actual and ideal profiles were used to evaluate the accuracy of this method in achieving isokinetic displacement. For PMA pressures (in kPa) of 150, 350 and 550 PRMSE were 7.80, 5.40 and 2.76, respectively.

  9. Estimating the Effects of Climate Change on Federal Hydropower and Power Marketing

    Energy Technology Data Exchange (ETDEWEB)

    Sale, Michael J [ORNL; Kao, Shih-Chieh [ORNL; Uria Martinez, Rocio [ORNL; Wei, Yaxing [ORNL

    2011-01-01

    The U.S. Department of Energy is currently preparing an assessment of the effects of climate change on federal hydropower, as directed by Congress in Section 9505 of the Secure Water Act of 2009 (P.L. 111-11). This paper describes the assessment approach being used in a Report to Congress currently being prepared by Oak Ridge National Laboratory. The 9505 assessment will examine climate change effects on water available for hydropower operations and the future power supplies marketed from federal hydropower projects. It will also include recommendations from the Power Marketing Administrations (PMAs) on potential changes in operation or contracting practices that could address these effects and risks of climate change. Potential adaption and mitigation strategies will also be identified. Federal hydropower comprises approximately half of the U.S. hydropower portfolio. The results from the 9505 assessment will promote better understanding among federal dam owners/operators of the sensitivity of their facilities to water availability, and it will provide a basis for planning future actions that will enable adaptation to climate variability and change. The end-users of information are Congressional members, their staff, the PMAs and their customers, federal dam owners/operators, and the DOE Water Power Program.

  10. Hierarchical Compliance Control of a Soft Ankle Rehabilitation Robot Actuated by Pneumatic Muscles.

    Science.gov (United States)

    Liu, Quan; Liu, Aiming; Meng, Wei; Ai, Qingsong; Xie, Sheng Q

    2017-01-01

    Traditional compliance control of a rehabilitation robot is implemented in task space by using impedance or admittance control algorithms. The soft robot actuated by pneumatic muscle actuators (PMAs) is becoming prominent for patients as it enables the compliance being adjusted in each active link, which, however, has not been reported in the literature. This paper proposes a new compliance control method of a soft ankle rehabilitation robot that is driven by four PMAs configured in parallel to enable three degrees of freedom movement of the ankle joint. A new hierarchical compliance control structure, including a low-level compliance adjustment controller in joint space and a high-level admittance controller in task space, is designed. An adaptive compliance control paradigm is further developed by taking into account patient's active contribution and movement ability during a previous period of time, in order to provide robot assistance only when it is necessarily required. Experiments on healthy and impaired human subjects were conducted to verify the adaptive hierarchical compliance control scheme. The results show that the robot hierarchical compliance can be online adjusted according to the participant's assessment. The robot reduces its assistance output when participants contribute more and vice versa , thus providing a potentially feasible solution to the patient-in-loop cooperative training strategy.

  11. CALIFA, the Calar alto legacy integral field area survey

    DEFF Research Database (Denmark)

    Husemann, B.; Jahnke, K.; Sánchez, S. F.

    2013-01-01

    We present the first public data release (DR1) of the Calar Alto Legacy Integral Field Area (CALIFA) survey. It consists of science-grade optical datacubes for the first 100 of eventually 600 nearby (0.005 < z < 0.03) galaxies, obtained with the integral-field spectrograph PMAS/PPak mounted on th...... the available interfaces and tools that allow easy access to this first publicCALIFA data at http://califa.caha.es/DR1....

  12. 77 FR 39924 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Science.gov (United States)

    2012-07-06

    ... application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular... CONTACT: Melissa Burns, Center for Devices and Radiological Health, Food and Drug Administration, 10903... manufacturers, patients and insurance providers. For a new product (i.e., a cardiovascular permanent pacemaker...

  13. Metrological Reliability of Medical Devices

    Science.gov (United States)

    Costa Monteiro, E.; Leon, L. F.

    2015-02-01

    The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

  14. 21 CFR 884.5425 - Scented or scented deodorized menstrual pad.

    Science.gov (United States)

    2010-04-01

    ...) added for aesthetic purposes (scented menstrual pad) or for deodorizing purposes (scented deodorized...) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  15. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Science.gov (United States)

    2011-09-28

    ... Tobacco Control Act amends the FD&C Act and grants FDA authority to regulate the manufacture, marketing... product may be introduced into interstate commerce when the tobacco product is new or modified in any way... (PMTA) under section 910(b) of the FD&C Act and receive a marketing authorization order under section...

  16. 21 CFR 862.1500 - Malic dehydrogenase test system.

    Science.gov (United States)

    2010-04-01

    ... plasma. Malic dehydrogenase measurements are used in the diagnosis and treatment of muscle and liver... marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket...

  17. Total Product Life Cycle (TPLC)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases...

  18. A Statistical Analysis of Black-White Performance Differentials of U.S. Military Personnel

    National Research Council Canada - National Science Library

    Roick, James

    1998-01-01

    .... The research also suggests that much of this gap is a result of differences in premarket acquired cognitive skills, rather than innate ability, labor market discrimination, or quantity of education...

  19. 21 CFR 862.1370 - Human growth hormone test system.

    Science.gov (United States)

    2010-04-01

    ... measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland. (b) Classification. Class I (general controls). The device is exempt from the premarket...

  20. 21 CFR 878.3750 - External prosthesis adhesive.

    Science.gov (United States)

    2010-04-01

    ... used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  1. TU-AB-204-01: Device Approval Process

    International Nuclear Information System (INIS)

    Delfino, J.

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  2. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    International Nuclear Information System (INIS)

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  3. TU-AB-204-02: Device Adverse Events and Compliance

    International Nuclear Information System (INIS)

    Gonzales, S.

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  4. TU-AB-204-03: Research Activities in Medical Physics

    International Nuclear Information System (INIS)

    Badano, A.

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  5. TU-AB-204-04: Partnerships

    International Nuclear Information System (INIS)

    Ochs, R.

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  6. TU-AB-204-02: Device Adverse Events and Compliance

    Energy Technology Data Exchange (ETDEWEB)

    Gonzales, S. [Food & Drug Administration (United States)

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  7. TU-AB-204-04: Partnerships

    Energy Technology Data Exchange (ETDEWEB)

    Ochs, R. [Food & Drug Administration Center for Devices and Radiological Health (United States)

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  8. TU-AB-204-03: Research Activities in Medical Physics

    Energy Technology Data Exchange (ETDEWEB)

    Badano, A. [Food & Drug Administration (United States)

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  9. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  10. TU-AB-204-01: Device Approval Process

    Energy Technology Data Exchange (ETDEWEB)

    Delfino, J. [Food & Drug Administration (United States)

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  11. 21 CFR 862.1130 - Blood volume test system.

    Science.gov (United States)

    2010-04-01

    ... shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte... the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. [52...

  12. Development of NPP Monitoring and Operation Support Technology

    International Nuclear Information System (INIS)

    Lee, Jung Woon; Park, Jae Chang; Lee, Yong Hee

    2008-04-01

    During the first stage (2001.7.1-2004.6.30), we developed general human factors design guidelines VDU-based workstations, PMAS alarm display design guidelines, PMAS SPADES display design guidelines, and the revision of KHNP HFE guidelines (HF-010), which have been applied to domestic NPP designs. We also supported other KNICS projects by performing RPS COM design reviews, development of RPS COM Style Guide, and a review of CEDMCS cabinet operator module display design. We developed the ADIOS prototype, NPP performance analysis systems for YGN No.1, 2 plants and Kori No. 2 plant, alarm cause tracking systems for Kori No. 2 plant and OPR1000, and signal fault detection and diagnosis methods for deaerators and steam generators. During the second stage(2004.7.1-2008.4.30), we supported other KNICS projects by reviewing RPS COM display designs three times, developing ESF-CCS COM style guides and reviewing ESF-CCS COM display design, reviewing CRCS LOM and PCS MTP display designs, and developing requirements for DCS GUI components. We also developed integrated style guide for I and C cabinet operator module display designs. In cooperative research with KOPEC-AE, we developed basic technologies for advanced HSI design including task analysis methods, an information and control requirements database, display design criteria, a HSI prototype with its evaluation, and methods for human factors engineering verification and validation

  13. Development of NPP Monitoring and Operation Support Technology

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Park, Jae Chang; Lee, Yong Hee [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)] (and others)

    2008-04-15

    During the first stage (2001.7.1-2004.6.30), we developed general human factors design guidelines VDU-based workstations, PMAS alarm display design guidelines, PMAS SPADES display design guidelines, and the revision of KHNP HFE guidelines (HF-010), which have been applied to domestic NPP designs. We also supported other KNICS projects by performing RPS COM design reviews, development of RPS COM Style Guide, and a review of CEDMCS cabinet operator module display design. We developed the ADIOS prototype, NPP performance analysis systems for YGN No.1, 2 plants and Kori No. 2 plant, alarm cause tracking systems for Kori No. 2 plant and OPR1000, and signal fault detection and diagnosis methods for deaerators and steam generators. During the second stage(2004.7.1-2008.4.30), we supported other KNICS projects by reviewing RPS COM display designs three times, developing ESF-CCS COM style guides and reviewing ESF-CCS COM display design, reviewing CRCS LOM and PCS MTP display designs, and developing requirements for DCS GUI components. We also developed integrated style guide for I and C cabinet operator module display designs. In cooperative research with KOPEC-AE, we developed basic technologies for advanced HSI design including task analysis methods, an information and control requirements database, display design criteria, a HSI prototype with its evaluation, and methods for human factors engineering verification and validation.

  14. Effects of Power Tracking Algorithms on Lifetime of Power Electronic Devices Used in Solar Systems

    Directory of Open Access Journals (Sweden)

    Canras Batunlu

    2016-10-01

    Full Text Available In photovoltaic solar energy systems, power management algorithms (PMAs, usually called maximum power point tracking (MPPT algorithms, are widely used for extracting maximum available power at every point in time. However, tracking the maximum power has negative effects on the availability of solar energy systems. This is due, mainly, to the created disturbances and thermal stresses on the associated power electronic converters (PECs. This work investigates the effects of PMA on the lifetime consumption, thermal stresses and failures on DC-DC converters used in solar systems. Firstly theoretical analysis and modelling of photovoltaic solar systems including converter’s electro thermal characteristics were developed. Subsequently, experiments on photovoltaic solar systems were carried out using two different PMAs, namely, perturb and observe (P&O and incremental conductance (IC. Real-time data was collected, under different operating conditions, including thermal behavior using thermal imaging camera and dSPACE. Converters’ thermal cycling was found to be approximately 3 °C higher with the IC algorithm. The steady state temperature was 52.7 °C, for the IC while it was 42.6 °C for P&O. Although IC algorithm offers more accurate power management tool, it causes more severe thermal stresses which, in this study, has led to approximately 1.4 times greater life consumption compared to P&O.

  15. Hierarchical Compliance Control of a Soft Ankle Rehabilitation Robot Actuated by Pneumatic Muscles

    Directory of Open Access Journals (Sweden)

    Quan Liu

    2017-12-01

    Full Text Available Traditional compliance control of a rehabilitation robot is implemented in task space by using impedance or admittance control algorithms. The soft robot actuated by pneumatic muscle actuators (PMAs is becoming prominent for patients as it enables the compliance being adjusted in each active link, which, however, has not been reported in the literature. This paper proposes a new compliance control method of a soft ankle rehabilitation robot that is driven by four PMAs configured in parallel to enable three degrees of freedom movement of the ankle joint. A new hierarchical compliance control structure, including a low-level compliance adjustment controller in joint space and a high-level admittance controller in task space, is designed. An adaptive compliance control paradigm is further developed by taking into account patient’s active contribution and movement ability during a previous period of time, in order to provide robot assistance only when it is necessarily required. Experiments on healthy and impaired human subjects were conducted to verify the adaptive hierarchical compliance control scheme. The results show that the robot hierarchical compliance can be online adjusted according to the participant’s assessment. The robot reduces its assistance output when participants contribute more and vice versa, thus providing a potentially feasible solution to the patient-in-loop cooperative training strategy.

  16. Is it all worth it? The experiences of new PhDs on the job market, 2007–10

    Science.gov (United States)

    McFall, Brooke Helppie; Murray-Close, Marta; Willis, Robert J; Chen, Uniko

    2016-01-01

    This paper describes the job market experiences of new PhD economists, 2007-10. Using information from PhD programs' job candidate websites and original surveys, the authors present information about job candidates' characteristics, preferences and expectations; how job candidates fared at each stage of the market; and predictors of outcomes at each stage. Some information presented in this paper updates findings of prior studies. However, design features of the data used in this paper may result in more generalizable findings. This paper is unique in comparing pre-market expectations and preferences with post-market outcomes on the new PhD job market. It shows that outcomes tend to align with pre-market preferences, and candidates' expectations are somewhat predictive of their outcomes. Several analyses also shed light on sub-group differences. PMID:27616783

  17. Effects of Climate Change on Federal Hydropower. Report to Congress

    Energy Technology Data Exchange (ETDEWEB)

    None

    2013-08-01

    This is a formal Department of Energy report to Congress. It outlines the findings of an assessment directed by Congress in Section 9505 of the SECURE Water Act of 2009 (Public Law 111-11), the US Department of Energy (DOE), in consultation with the federal Power Marketing Administrations (PMAs) and other federal agencies, including federal dam owners, has prepared a comprehensive assessment examining the effects of climate change on water available for hydropower at federal facilities and on the marketing of power from these federal facilities.

  18. Socio-cognitive evolution and co-evolution in competing technical trajectories : biogas development in Denmark (1970-2002)

    NARCIS (Netherlands)

    Geels, F.W.; Raven, R.P.J.M.

    2007-01-01

    This article makes two fundamental contributions to evolutionary theories of technological changes. First, a socio-cognitive evolutionary perspective is developed that conceptualises the emergence of new technologies in the pre-market phase. This topic is underdeveloped in evolutionary economics,

  19. 78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

    Science.gov (United States)

    2013-01-08

    .... FDA-2012-N-1173] Cardiovascular Devices; Reclassification of External Cardiac Compressor AGENCY: Food... external cardiac compressors as class III requiring premarket approval. The Cardiovascular Device... on CPR and emergency cardiovascular care (Ref. 1) conclude that ``real-time CPR prompting and...

  20. Minimum Risk Pesticide: Definition and Product Confirmation

    Science.gov (United States)

    Minimum risk pesticides pose little to no risk to human health or the environment and therefore are not subject to regulation under FIFRA. EPA does not do any pre-market review for such products or labels, but violative products are subject to enforcement.

  1. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  2. Safety assessment of foods derived from genetically modified crops

    NARCIS (Netherlands)

    Kleter, G.A.; Kuiper, H.A.

    2003-01-01

    The pre-market safety assessment of foods derived from genetically modified crops is carried out according to the consensus approach of "substantial equivalence", in other words: the comparative safety assessment. Currently, the safety assessment of genetically modified foods is harmonized at the

  3. 76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

    Science.gov (United States)

    2011-04-15

    ... type of device must submit to FDA a premarket notification, prior to marketing the device, which... directs agencies to assess all costs and benefits of available regulatory alternatives and, when... economic, environmental, public health and safety, and other advantages; distributive impacts; and equity...

  4. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Science.gov (United States)

    2011-07-20

    ... type of device must submit to FDA a premarket notification, prior to marketing the device, which... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive...

  5. 76 FR 44489 - Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic...

    Science.gov (United States)

    2011-07-26

    ... is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient... premarket notification, prior to marketing the device, which contains information about the rTMS system they... significant effect on the human environment. Thus, neither an environmental assessment nor an environmental...

  6. 78 FR 52933 - Strengthening the Operating Framework and Furthering the Objectives of Coalition for Accelerating...

    Science.gov (United States)

    2013-08-27

    ... late-emerging issues. Standardized data will allow reviewers to increase review consistency and perform... functions and ongoing business operations, including premarket review, post-market safety, oversight of drug... trials, such as age and gender, have been established through Clinical Data Interchange Standards...

  7. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External aesthetic restoration prosthesis. 878... External aesthetic restoration prosthesis. (a) Identification. An external aesthetic restoration prosthesis... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  8. 77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

    Science.gov (United States)

    2012-02-14

    ... premarket notification, prior to marketing the device, which contains information about the endovascular...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...

  9. Assessing environmental impacts of genetically modified plants on non-target organisms

    NARCIS (Netherlands)

    Arpaia, Salvatore; Birch, A.N.E.; Kiss, Jozsef; Loon, van Joop J.A.; Messéan, Antoine; Nuti, Marco; Perry, Joe N.; Sweet, Jeremy B.; Tebbe, Christoph C.

    2017-01-01

    In legal frameworks worldwide, genetically modified plants (GMPs) are subjected to pre-market environmental risk assessment (ERA) with the aim of identifying potential effects on the environment. In the European Union, the EFSA Guidance Document introduces the rationale that GMPs, as well as their

  10. 21 CFR 862.1265 - Estriol test system.

    Science.gov (United States)

    2010-04-01

    ... estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  11. 75 FR 17093 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

    Science.gov (United States)

    2010-04-05

    ... preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of... premarket approval, unless FDA initiates the following procedures: (1) FDA reclassifies the device into...)), the transcutaneous electrical stimulator for aesthetic purposes (Sec. 882.5890(e)), and the...

  12. 21 CFR 814.100 - Purpose and scope.

    Science.gov (United States)

    2010-04-01

    ... public health and safety and with ethical standards, to encourage the discovery and use of devices... for obtaining: (1) HUD designation of a medical device; and (2) Marketing approval for the HUD... a premarket notification as required under part 807 of this chapter. (c) Obtaining marketing...

  13. CEOs and CFOs on IPOs: The Process and Success of Going Public

    NARCIS (Netherlands)

    van den Assem, M.J.; Van der Sar, N.L.; Versijp, P.

    2017-01-01

    We conducted 46 interviews with CEOs and CFOs who were closely involved in an initial public offering (IPO) in the Netherlands. Among other things, we find that pre-existing relationships are a primary consideration in the selection of the lead manager and other syndicate members. Pre-marketing

  14. Innovation success over time of alliances with different strategic and cooperation objectives

    NARCIS (Netherlands)

    Manuhutu, Ari; von Raesfeld Meijer, Ariane; Geurts, Peter; Ebrahimi, Maryam

    2018-01-01

    In response to uncertainty of prospective technologies and how they might fit market demand, firms tend to establish R&D alliances. In this chapter the effect over time of continuation of underperforming R&D alliances on innovation performance during the pre-market stage is investigated. This stage

  15. Patient safety and efficacy as measured by clinical trials and regulatory policy.

    Science.gov (United States)

    Harvey, B E; Alpert, S

    1997-01-01

    Virtual Reality and other technological innovations in medicine provide new challenges to the regulatory framework of the premarket review process for medical devices. By reinventing the government-academia-industry partnership, clinical trial data necessary for a medical device to enter the market can be more efficiently obtained.

  16. 77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

    Science.gov (United States)

    2012-02-10

    ... late in the development of a drug for marketing approval or after approval based on what is already... investigational drugs to support marketing approval (premarket) and trials conducted after approval (postmarket... assessment without compromising the integrity of the trial results. DATES: Although you can comment on any...

  17. 78 FR 76838 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products...

    Science.gov (United States)

    2013-12-19

    ...) by adding a chapter granting FDA important authority to regulate the manufacture, marketing, and... introduced or delivered for introduction into interstate commerce, a manufacturer must submit a premarket... for introduction into interstate commerce (section 910 of the FD&C Act (21 U.S.C. 387j)). An order...

  18. 21 CFR 177.1585 - Polyestercarbonate resins.

    Science.gov (United States)

    2010-04-01

    .... Polyestercarbonate resins may be safely used as articles or components of articles intended for use in producing.... Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition... examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100...

  19. 21 CFR 880.2920 - Clinical mercury thermometer.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  20. Safety assessment of genetically modified foods

    NARCIS (Netherlands)

    Kleter, G.A.; Noordam, M.Y.

    2016-01-01

    The cultivation of genetically modified (GM) crops has steadily increased since their introduction to the market in the mid-1990s. Before these crops can be grown and sold they have to obtain regulatory approval in many countries, the process of which includes a pre-market safety assessment. The

  1. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

  2. 21 CFR Appendix A to Subpart B of... - Relevant Legislation, Regulations, and Procedures.

    Science.gov (United States)

    2010-04-01

    ... REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices Pt. 26... particular, Parts 800 to 1299. d. Medical Devices; Third Party Review of Selected Premarket Notifications... Program, 63 FR 28392 (May 22, 1998). f. Draft Guidance for Staff, Industry and Third Parties, Third Party...

  3. 21 CFR 866.2420 - Oxidase screening test for gonorrhea.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oxidase screening test for gonorrhea. 866.2420... screening test for gonorrhea. (a) Identification. An oxidase screening test for gonorrhea is an in vitro... of gonorrhea. (b) Classification. Class III (premarket approval) (transitional device). (c) Date PMA...

  4. 21 CFR 872.6570 - Impression tube.

    Science.gov (United States)

    2010-04-01

    ... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  5. 21 CFR 880.6150 - Ultrasonic cleaner for medical instruments.

    Science.gov (United States)

    2010-04-01

    ... instruments by the emission of high frequency soundwaves. (b) Classification. Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  6. 21 CFR 862.1435 - Ketones (nonquantitative) test system.

    Science.gov (United States)

    2010-04-01

    ...) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  7. 21 CFR 878.5350 - Needle-type epilator.

    Science.gov (United States)

    2010-04-01

    ... shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  8. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Science.gov (United States)

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...

  9. An artificial flexible robot arm based on pneumatic muscle actuators

    Directory of Open Access Journals (Sweden)

    Renn Jyh-Chyang

    2017-01-01

    Full Text Available The purpose of this paper is to develop a novel human-friendly artificial flexible robot arm using four parallel-connected pneumatic muscle actuators (PMAs. The PMA is a flexible silicone rubber actuator which has some behaviors nearest to the real biological muscle including translational and rotational motions. An inverse kinematic model for the motion control is also developed. Finally, from experiment results, it is proved that not only the axial contraction control of a single PMA but also the attitude control of the whole pneumatic flexible robot arm using PID controller are satisfactory.

  10. Assessment of the Effects of Climate Change on Federal Hydropower

    Energy Technology Data Exchange (ETDEWEB)

    Sale, Michael J. [M.J. Sale and Associates, Hanson, MA (United States); Shih-Chieh, Kao [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Ashfaq, Moetasim [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Kaiser, Dale P. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Martinez, Rocio [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Webb, Cindy [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wei, Yaxing [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2012-10-01

    As directed by Congress in Section 9505 of the SECURE Water Act of 2009 (Public Law 111-11), the US Department of Energy (DOE), in consultation with the federal Power Marketing Administrations (PMAs) and other federal agencies, including federal dam owners, has prepared a comprehensive assessment examining the effects of climate change on water available for hydropower at federal facilities and on the marketing of power from these federal facilities. This Oak Ridge National Laboratory report, referred to as the “9505 Assessment,” describes the technical basis for the report to Congress that was called for in the SECURE Water Act.

  11. 16 CFR 1119.4 - Factors considered in determining civil penalties.

    Science.gov (United States)

    2010-01-01

    ... relevant premarket and production testing of the product(s) at issue. (2) History of noncompliance: The Commission may consider if the violator has a history of noncompliance with the CPSC and whether a higher... regulatory requirements. (4) Failure of the violator to respond in a timely and complete fashion to the...

  12. 21 CFR 888.3070 - Pedicle screw spinal system.

    Science.gov (United States)

    2010-04-01

    ... immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the... injury to the patient.” (2) Class III (premarket approval), when intended to provide immobilization and...-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's...

  13. 21 CFR 892.1760 - Diagnostic x-ray tube housing assembly.

    Science.gov (United States)

    2010-04-01

    ... may include high voltage and filament transformers or other appropriate components. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. [53 FR 1567, Jan. 20, 1988, as...

  14. 21 CFR 886.4300 - Intraocular lens guide.

    Science.gov (United States)

    2010-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct... lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  15. 21 CFR 177.1637 - Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.

    Science.gov (United States)

    2010-04-01

    ... as articles or components of articles intended for use in contact with food in accordance with the... article shall have a minimum inherent viscosity of 0.55 deciliter per gram in a solution of 0.1 gram of... Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration...

  16. 75 FR 45641 - Medical Device User Fee Rates for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ... fees.) If you prefer to send a check by a courier (such as Federal Express (FEDEX), DHL, United Parcel... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0363... under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262)) Premarket report (submitted...

  17. LMOs/GMOs, the environment and the people: A critical exposition

    African Journals Online (AJOL)

    GREGORY

    2011-12-16

    Dec 16, 2011 ... trade in LMOs/GMOs is concerned, it is the duty of the exporting as well as importing countries to perform universally ... Mexico, South Africa and Brazil, China and India are notable, but they ... about pre-marketing authorization; and Regulation (EC) ..... aspects suggested by the Appellate Body in the US -.

  18. 77 FR 6831 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-02-09

    ... correlation observed by NASDAQ between levels of liquidity provided during pre-market hours and levels... extra rebate with respect to all displayed liquidity provided through a designated MPID that executes at... Execution Ratio'' for the month is less than 10. The PMI Execution Ratio is defined as the ratio of (A) the...

  19. 77 FR 8936 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-02-15

    ... defined as ``the ratio of (A) the total number of liquidity-providing orders entered by a member through... trading sessions. (3) The ratio between shares of liquidity provided through the MPID and total shares..., or pre-market and/or post- market hours; and to maintain a high ratio of liquidity provision to order...

  20. The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration

    NARCIS (Netherlands)

    Slot, M.M.; Wiel, van de C.C.M.; Kleter, G.A.; Visser, R.G.F.; Kok, E.J.

    2018-01-01

    Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as

  1. Thermo-mechanical properties improvement of asphalt binder by using methylmethacrylate/ethylene glycol dimethacrylate

    Directory of Open Access Journals (Sweden)

    A.A. Ragab

    2016-09-01

    Full Text Available Various polymer-modified asphalt compositions for paving and roofing applications are known since several years ago. The degree to which a polymer improves the asphalt’s properties depends on the compatibility of the polymer and the asphalt. Highly compatible polymers are more effective in providing property improvements. In this research, the influence of in situ polymerization of methylmethacrylate monomer with asphalt in presence of ethylene glycol dimethacrylate (EGDM as a crosslinker on the rheological and thermal properties of asphalt binder of type penetration grade 60/70 was studied. To achieve this aim, MMA/EGDM(MC in different ratios as 5, 10 and 15% (w/w were used to modify the thermo-mechanical properties of asphalt via forming chemical bond, and the changing in mechanical and thermal properties, of the mixes as well as the storage stability were studied. Also, the morphology (SEM, thermal characterization (TGA, dynamic mechanical analysis (DMA, bending and rheological tests were detected. The obtained experimental results revealed that the addition of MC causes both the rheological and thermal properties of the binder to improve and the prepared PMAs has high temperature susceptibility and low curing time. The improvement in the properties of the virgin asphalt will be effective in using this soft type in coating applications instead of highly expensive oxidized one.

  2. 21 CFR 814.1 - Scope.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Scope. 814.1 Section 814.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET... paragraph (a), effective Aug. 16, 2010. For the convenience of the user, the revised text is set forth as...

  3. 21 CFR 814.2 - Purpose.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Purpose. 814.2 Section 814.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET..., Apr. 1, 2010, § 814.2 was revised, effective Aug. 16, 2010. For the convenience of the user, the...

  4. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 880.9 Section 880.9 Food and Drugs FOOD AND DRUG... Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification...

  5. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 878.9 Section 878.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510...

  6. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 884.9 Section 884.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510...

  7. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 876.9 Section 876.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510...

  8. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 862.9 Section 862.9 Food and Drugs FOOD AND DRUG... Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket...

  9. New reproductive genetics: political issues.

    Science.gov (United States)

    Hanft, R S

    1993-09-01

    For the last 12 years, the reproductive policies of the executive branch of US government have been dominated by the anti-abortion, right-to-life position. Since coming to office, the Clinton administration has lifted the gag rule on abortion advice, removed the barrier to fetal tissue research, encouraged application for premarket approval of RU-486, and approved the female condom. The new administration's future policy and action taken on abortion, new drugs (e.g., RU-486), fetal tissue research, and payments for prenatal diagnosis, prenatal therapy, and abortion are outlined. President Clinton clearly has enunciated a pro-choice stance on abortion, and rescinded current regulations restricting abortion. The gag rule was lifted on January 22, 1993. The French manufacturer of RU-486 has not applied to the Food and Drug Administration for premarket approval out of concern for the reaction of both the federal executive and a potential boycott of other products by right-to-life, anti-abortion groups. New factors may encourage the manufacturer to apply for approval. The US Public Health Service can be expected to expand information and prevention activities to slow the spread of AIDS and to increase efforts for family planning to reduce teenage pregnancy. Fetal tissue research has contributed to such breakthroughs as prenatal diagnosis, in vitro surgery, and transplantation. The ban on the research was lifted early in the new administration. Aside from the issue of financial coverage under insurance plans to pay for prenatal diagnosis, prenatal therapy, and abortion, prenatal therapy raises a potential new conflict between the mother and her fetus. It raises issues related to equality for the disabled, particularly after life outside the womb is possible. In 2 years there could be a reversal of power in the Congress, again raising the specter of efforts to restrict developments in the field of reproductive biology.

  10. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the...

  11. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 870.9 Section 870.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the...

  12. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the...

  13. 21 CFR 190.6 - Requirement for premarket notification.

    Science.gov (United States)

    2010-04-01

    ... that has not been present in the food supply as an article used for food in a form in which the food... (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, information including any citation to published articles that is...

  14. Premarketing surveillance of ibuprofen suppositories in febrile children.

    Science.gov (United States)

    Hadas, Dan; Youngster, Ilan; Cohen, Avner; Leibovitch, Eugene; Shavit, Itai; Erez, Ilan; Uziel, Yosef; Berkovitch, Matitiahu

    2011-03-01

    In many countries, ibuprofen is available only in oral formulations. The authors aimed to investigate parental satisfaction and possible adverse reactions among children receiving newly marketed ibuprofen suppositories, prior to their arrival at the pharmaceutical points of distribution. Children needing antipyretic medication were recruited from 11 pediatric wards and clinics in Israel. Each patient received ibuprofen suppositories (5-10 mg/kg/dose) after completing a data collection form. After 3 to 7 days of treatment, information regarding parent satisfaction, possible adverse reactions, and concomitant use of drugs was obtained. Overall, 490 children completed the study. Parents' satisfaction was high (4.5 ± 0.47 on a scale of 1-5), and 92.2% reported that they would use the medication in the future. Adverse reactions were reported in 8 patients (1.63%, 95% confidence interval = 1.77-3.25), the most common being diarrhea. Rectal administration of ibuprofen suppositories is well tolerated and overall satisfaction and the repeated expected use were high.

  15. Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

    Science.gov (United States)

    Ma, Handong; Weng, Chunhua

    2016-04-01

    To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long

  16. Optical, physical and chemical properties of aerosols transported to a coastal site in the western Mediterranean: a focus on primary marine aerosols

    Directory of Open Access Journals (Sweden)

    M. Claeys

    2017-06-01

    Full Text Available As part of the ChArMEx-ADRIMED campaign (summer 2013, ground-based in situ observations were conducted at the Ersa site (northern tip of Corsica; 533 m a.s.l. to characterise the optical, physical and chemical properties of aerosols. During the observation period, a major influence of primary marine aerosols was detected (22–26 June, with a mass concentration reaching up to 6.5 µg m−3 and representing more than 40 % of the total PM10 mass concentration. Its relatively low ratio of chloride to sodium (average of 0.57 indicates a fairly aged sea salt aerosol at Ersa. In this work, an original data set, obtained from online real-time instruments (ATOFMS, PILS-IC has been used to characterise the ageing of primary marine aerosols (PMAs. During this PMA period, the mixing of fresh and aged PMAs was found to originate from both local and regional (Gulf of Lion emissions, according to local wind measurements and FLEXPART back trajectories. Two different aerosol regimes have been identified: a dust outbreak (dust originating from Algeria/Tunisia, and a pollution period with aerosols originating from eastern Europe, which includes anthropogenic and biomass burning sources (BBP. The optical, physical and chemical properties of the observed aerosols, as well as their local shortwave (SW direct radiative effect (DRE in clear-sky conditions, are compared for these three periods in order to assess the importance of the direct radiative impact of PMAs compared to other sources above the western Mediterranean Basin. As expected, AERONET retrievals indicate a relatively low local SW DRF during the PMA period with mean values of −11 ± 4 at the surface and −8 ± 3 W m−2 at the top of the atmosphere (TOA. In comparison, our results indicate that the dust outbreak observed at our site during the campaign, although of moderate intensity (AOD of 0.3–0.4 at 440 nm and column-integrated SSA of 0.90–0.95, induced a local

  17. State of Academic Knowledge on Toxicity and Biological Fate of Quantum Dots

    Science.gov (United States)

    Pelley, Jennifer L.; Daar, Abdallah S.; Saner, Marc A.

    2009-01-01

    Quantum dots (QDs), an important class of emerging nanomaterial, are widely anticipated to find application in many consumer and clinical products in the near future. Premarket regulatory scrutiny is, thus, an issue gaining considerable attention. Previous review papers have focused primarily on the toxicity of QDs. From the point of view of product regulation, however, parameters that determine exposure (e.g., dosage, transformation, transportation, and persistence) are just as important as inherent toxicity. We have structured our review paper according to regulatory risk assessment practices, in order to improve the utility of existing knowledge in a regulatory context. Herein, we summarize the state of academic knowledge on QDs pertaining not only to toxicity, but also their physicochemical properties, and their biological and environmental fate. We conclude this review with recommendations on how to tailor future research efforts to address the specific needs of regulators. PMID:19684286

  18. New Methodology For Use in Rotating Field Nuclear MagneticResonance

    Energy Technology Data Exchange (ETDEWEB)

    Jachmann, Rebecca C. [Univ. of California, Berkeley, CA (United States)

    2007-01-01

    High-resolution NMR spectra of samples with anisotropicbroadening are simplified to their isotropic spectra by fast rotation ofthe sample at the magic angle 54.7 circ. This dissertation concerns thedevelopment of novel Nuclear Magnetic Resonance (NMR) methodologies basedwhich would rotate the magnetic field instead of the sample, rotatingfield NMR. It provides an over of the NMR concepts, procedures, andexperiments needed to understand the methodologies that will be used forrotating field NMR. A simple two-dimensional shimming method based onharmonic corrector rings which can provide arbitrary multiple ordershimming corrections were developed for rotating field systems, but couldbe used in shimming other systems as well. Those results demonstrate, forexample, that quadrupolar order shimming improves the linewidth by up toan order of magnitude. An additional order of magnitude reduction is inprinciple achievable by utilizing this shimming method for z-gradientcorrection and higher order xy gradients. A specialized pulse sequencefor the rotating field NMR experiment is under development. The pulsesequence allows for spinning away from the magic angle and spinningslower than the anisotropic broadening. This pulse sequence is acombination of the projected magic angle spinning (p-MAS) and magic angleturning (MAT) pulse sequences. This will be useful to rotating field NMRbecause there are limits on how fast a field can be spun and spin at themagic angle is difficult. One of the goals of this project is forrotating field NMR to be used on biological systems. The p-MAS pulsesequence was successfully tested on bovine tissue samples which suggeststhat it will be a viable methodology to use in a rotating field set up. Aside experiment on steering magnetic particle by MRI gradients was alsocarried out. Some movement was seen in these experiment, but for totalcontrol over steering further experiments would need to bedone.

  19. New Methodology For Use in Rotating Field Nuclear MagneticResonance

    Energy Technology Data Exchange (ETDEWEB)

    Jachmann, Rebecca C. [Univ. of California, Berkeley, CA (United States)

    2007-05-18

    High-resolution NMR spectra of samples with anisotropicbroadening are simplified to their isotropic spectra by fast rotation ofthe sample at the magic angle 54.7 circ. This dissertation concerns thedevelopment of novel Nuclear Magnetic Resonance (NMR) methodologies basedwhich would rotate the magnetic field instead of the sample, rotatingfield NMR. It provides an over of the NMR concepts, procedures, andexperiments needed to understand the methodologies that will be used forrotating field NMR. A simple two-dimensional shimming method based onharmonic corrector rings which can provide arbitrary multiple ordershimming corrections were developed for rotating field systems, but couldbe used in shimming other systems as well. Those results demonstrate, forexample, that quadrupolar order shimming improves the linewidth by up toan order of magnitude. An additional order of magnitude reduction is inprinciple achievable by utilizing this shimming method for z-gradientcorrection and higher order xy gradients. A specialized pulse sequencefor the rotating field NMR experiment is under development. The pulsesequence allows for spinning away from the magic angle and spinningslower than the anisotropic broadening. This pulse sequence is acombination of the projected magic angle spinning (p-MAS) and magic angleturning (MAT) pulse sequences. This will be useful to rotating field NMRbecause there are limits on how fast a field can be spun and spin at themagic angle is difficult. One of the goals of this project is forrotating field NMR to be used on biological systems. The p-MAS pulsesequence was successfully tested on bovine tissue samples which suggeststhat it will be a viable methodology to use in a rotating field set up. Aside experiment on steering magnetic particle by MRI gradients was alsocarried out. Some movement was seen in these experiment, but for totalcontrol over steering further experiments would need to bedone.

  20. Development and Physical Control Research on Prototype Artificial Leg

    Directory of Open Access Journals (Sweden)

    Fei Li

    2016-03-01

    Full Text Available To provide an ideal platform for research on intelligent bionic leg (IBL, this paper proposes a model of a biped robot with heterogeneous legs (BRHL. A prototype of an artificial leg is developed based on biological structure and motion principle analysis of human lower extremities. With regard to the driving sources, servomotors are chosen for the hip joint and ankle joint, while pneumatic muscle actuators (PMAs are chosen for the knee joint. The control system of the bionic artificial leg is designed and a physical experimental platform is established. The physical control experiments are done based on proportional-integral-derivative (PID control strategy. The experimental results show that such a system can realize the expected goals.

  1. Regulation of natural health products in Canada.

    Science.gov (United States)

    Smith, Alysyn; Jogalekar, Sumedha; Gibson, Adam

    2014-12-02

    In Canada, all natural health products (NHPs) are regulated by Health Canada (HC) under the Food and Drugs Act and the Natural Health Product Regulations. All authorized products undergo pre-market assessment for safety, efficacy and quality and the degree of pre-market oversight varies depending on the risk of the product. In Canada, over 70,000 products have been authorized for sale and over 2000 sites have been licensed to produce NHPs. In the management of NHPs on the Canadian market, HC employs a number of active and collaborative methods to address the most common issues such as contamination, adulteration and deceptive or misleading advertising practices. HC is currently evolving its approaches to NHPs to recognize them as part of the larger group of health products available without a prescription. As such, the regulatory responsibility for all over-the-counter (OTC) drugs, including non-prescription drugs and NHPs, has been transferred to a single federal division. As a result of this transition a number of benefits are being realized with respect to government efficiency, clarity for industry, support for new innovations and consolidated government interactions with the Canadian market. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. A risk-based classification scheme for genetically modified foods. I: Conceptual development.

    Science.gov (United States)

    Chao, Eunice; Krewski, Daniel

    2008-12-01

    The predominant paradigm for the premarket assessment of genetically modified (GM) foods reflects heightened public concern by focusing on foods modified by recombinant deoxyribonucleic acid (rDNA) techniques, while foods modified by other methods of genetic modification are generally not assessed for safety. To determine whether a GM product requires less or more regulatory oversight and testing, we developed and evaluated a risk-based classification scheme (RBCS) for crop-derived GM foods. The results of this research are presented in three papers. This paper describes the conceptual development of the proposed RBCS that focuses on two categories of adverse health effects: (1) toxic and antinutritional effects, and (2) allergenic effects. The factors that may affect the level of potential health risks of GM foods are identified. For each factor identified, criteria for differentiating health risk potential are developed. The extent to which a GM food satisfies applicable criteria for each factor is rated separately. A concern level for each category of health effects is then determined by aggregating the ratings for the factors using predetermined aggregation rules. An overview of the proposed scheme is presented, as well as the application of the scheme to a hypothetical GM food.

  3. Biomaterials Evaluation: Conceptual Refinements and Practical Reforms.

    Science.gov (United States)

    Masaeli, Reza; Zandsalimi, Kavosh; Tayebi, Lobat

    2018-01-01

    Regarding the widespread and ever-increasing applications of biomaterials in different medical fields, their accurate assessment is of great importance. Hence the safety and efficacy of biomaterials is confirmed only through the evaluation process, the way it is done has direct effects on public health. Although every biomaterial undergoes rigorous premarket evaluation, the regulatory agencies receive a considerable number of complications and adverse event reports annually. The main factors that challenge the process of biomaterials evaluation are dissimilar regulations, asynchrony of biomaterials evaluation and biomaterials development, inherent biases of postmarketing data, and cost and timing issues. Several pieces of evidence indicate that current medical device regulations need to be improved so that they can be used more effectively in the evaluation of biomaterials. This article provides suggested conceptual refinements and practical reforms to increase the efficiency and effectiveness of the existing regulations. The main focus of the article is on strategies for evaluating biomaterials in US, and then in EU.

  4. IPO Allocations: Discriminatory or Discretionary?

    OpenAIRE

    William Wilhelm; Alexander Ljungqvist

    2001-01-01

    We estimate the structural links between IPO allocations, pre-market information production, and initial underpricing returns, within the context of theories of bookbuilding. Using a sample of both US and international IPOs we find evidence of the following: ? IPO allocation policies favour institutional investors, both in the US and worldwide. ? Increasing institutional allocations results in offer prices that deviate more from the indicative price range established prior to bankers’ efforts...

  5. Medical device registration, agreements on mutual recognition - a step forward to global harmonization?

    International Nuclear Information System (INIS)

    Eidenberger, R.Reiner

    2000-01-01

    The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal - a safe product - but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force. (author)

  6. A Mixture Model of Consumers' Intended Purchase Decisions for Genetically Modified Foods

    OpenAIRE

    Kristine M. Grimsrud; Robert P. Berrens; Ron C. Mittelhammer

    2006-01-01

    A finite probability mixture model is used to analyze the existence of multiple market segments for a pre-market good. The approach has at least two principal benefits. First, the model is capable of identifying likely market segments and their differentiating characteristics. Second, the model can be used to estimate the discount different consumer groups require to purchase the good. The model is illustrated using stated preference survey data collected on consumer responses to the potentia...

  7. Tracking Control of a 2-DOF Arm Actuated by Pneumatic Muscle Actuators Using Adaptive Fuzzy Sliding Mode Control

    Science.gov (United States)

    Chang, Ming-Kun; Wu, Jui-Chi

    Pneumatic muscle actuators (PMAs) have the highest power/weight ratio and power/volume ratio of any actuator. Therefore, they can be used not only in the rehabilitation engineering, but also as an actuator in robots, including industrial robots and therapy robots. It is difficult to achieve excellent tracking performance using classical control methods because the compressibility of gas and the nonlinear elasticity of bladder container causes parameter variations. An adaptive fuzzy sliding mode control is developed in this study. The fuzzy sliding surface can be used to reduce fuzzy rule numbers, and the adaptive control law is used to modify fuzzy rules on-line. A model matching technique is then adopted to adjust scaling factors. The experimental results show that this control strategy can attain excellent tracking performance.

  8. The regulation of herbal medicines in Australia

    International Nuclear Information System (INIS)

    Briggs, David R.

    2002-01-01

    Complementary medicines, including herbal medicines in Australia are regulated under therapeutics goods legislation. Based on risk, Australia has developed a two tiered approach to the regulation of therapeutic goods. Listed medicines are considered to be of lower risk than Registered medicines. Most, but not all, complementary medicines are Listed medicines. Managing the risk associated with therapeutic goods, including complementary medicines, is exerted through the processes of licensing of manufacturers; pre-market assessment of products; and post-market regulatory activity. Herbal medicines may be associated with low or high risk depending on the toxicity of ingredients, proposed dosage, appropriateness of the indications and claims for self-diagnosis and management and the potential for adverse reactions. Registered medicines are individually evaluated for safety, quality and efficacy before they are released onto the market. Listed medicines are individually assessed by the Therapeutic Goods Administration for compliance with legislation, they are not evaluated before release. They may only be formulated from ingredients that have undergone pre-market evaluation for safety and quality and are considered low risk. Listed complementary medicines may only carry indications and claims for the symptomatic relief of non-serious conditions, health maintenance, health enhancement and risk reduction. An important feature of risk management in Australia is that early market access for low risk complementary medicines is supported by appropriate post-market regulatory activity

  9. Premarket safety and efficacy studies for ADHD medications in children.

    Directory of Open Access Journals (Sweden)

    Florence T Bourgeois

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

  10. Results from a Nationwide Cohort Temporary Utilization Authorization (ATU) Survey of Patients in France Treated with Pheburane® (Sodium Phenylbutyrate) Taste-Masked Granules

    OpenAIRE

    Kibleur, Yves; Dobbelaere, Dries; Barth, Magalie; Brassier, Anaïs; Guffon, Nathalie

    2014-01-01

    Objectives The aim of this study was to describe a nationwide system for pre-marketing follow-up (cohort temporary utilization authorization [ATU] protocol; i.e., ‘therapeutic utilization’) of a new taste-masked formulation of sodium phenylbutyrate (NaPB) granules (Pheburane®) in France and to analyze safety and efficacy in this treated cohort of patients with urea cycle disease (UCD). Methods In October 2012, a cohort ATU was established in France to monitor the use of Pheburane® on a named-...

  11. The pharmacist and adverse drug reaction reporting.

    Science.gov (United States)

    Pearson, K

    1982-08-01

    During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.

  12. STS-88 Crew Interview: Jerry Ross

    Science.gov (United States)

    1998-01-01

    Jerry Ross discusses the seven-day mission that will be highlighted by the mating of the U.S.-built Node 1 station element to the Functional Energy Block (FGB) which will already be in orbit, and two spacewalks to connect power and data transmission cables between the Node and the FGB. Node 1 will be the first Space Station hardware delivered by the Space Shuttle. He also disscusses the assembly sequence. The crew will conduct a series of rendezvous maneuvers similar to those conducted on other Shuttle missions to reach the orbiting FGB. Once the two elements are docked, Ross and Newman will conduct two scheduled spacewalks to connect power and data cables between the Node, PMAs and the FGB. The day following the spacewalks, Endeavour will undock from the two components, completing the first Space Station assembly mission.

  13. Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

    Data.gov (United States)

    U.S. Department of Health & Human Services — A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved...

  14. 21 CFR 807.87 - Information required in a premarket notification submission.

    Science.gov (United States)

    2010-04-01

    ... § 807.93. (i) A financial certification or disclosure statement or both, as required by part 54 of this... class III under section 513(b) of the act: (1) Which was introduced or delivered for introduction into.... (Information collection requirements in this section were approved by the Office of Management and Budget (OMB...

  15. 21 CFR 807.81 - When a premarket notification submission is required.

    Science.gov (United States)

    2010-04-01

    ... equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II. (2..., chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the...

  16. Modeling the Static Force of a Festo Pneumatic Muscle Actuator: A New Approach and a Comparison to Existing Models

    Directory of Open Access Journals (Sweden)

    Mirco Martens

    2017-11-01

    Full Text Available In this paper, a new approach for modeling the static force characteristic of Festo pneumatic muscle actuators (PMAs will be presented. The model is physically motivated and therefore gives a deeper understanding of the Festo PMA. After introducing the new model, it will be validated through a comparison to a measured force map of a Festo DMSP-10-250 and a DMSP-20-300, respectively. It will be shown that the error between the new model and the measured data is below 4.4% for the DMSP-10-250 and below 2.35% for the DMSP-20-300. In addition, the quality of the presented model will be compared to the quality of existing models by comparing the maximum error. It can be seen that the newly introduced model is closer to the measured force characteristic of a Festo PMA than any existing model.

  17. Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework.

    Science.gov (United States)

    Abdel-Tawab, Mona

    2018-04-01

    Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission. Georg Thieme Verlag KG Stuttgart · New York.

  18. Current status of herbal product: Regulatory overview

    Science.gov (United States)

    Sharma, Sanjay

    2015-01-01

    A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

  19. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

    International Nuclear Information System (INIS)

    1988-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  20. FDA (Food and Drug Administration) compliance program guidance manual and updates (FY 86). Section 4. Medical and radiological devices. Irregular report

    International Nuclear Information System (INIS)

    1986-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  1. Lightning protection: challenges, solutions and questionable steps in the 21st century

    International Nuclear Information System (INIS)

    BERTA, Istvan

    2011-01-01

    Besides the special primary lightning protection of extremely high towers, huge office and governmental buildings, large industrial plants and resident parks most of the challenges were connected to the secondary lightning protection of sensitive devices in Information and Communication Technology. The 70 year history of Budapest School of Lightning Protection plays an important role in the research and education of lightning and development of lightning protection. Among results and solutions the Rolling Sphere designing method (RS) and the Probability Modulated Attraction Space (PMAS) theory are detailed. As a new field Preventive Lightning Protection (PLP) has been introduced. The PLP method means the use of special preventive actions only for the duration of the thunderstorm. Recently several non-conventional lightning protection techniques have appeared as competitors of the air termination systems formed of conventional Franklin rods. The questionable steps, non-conventional lightning protection systems reported in the literature are the radioactive lightning rods, Early Streamer Emission (ESE) rods and Dissipation Arrays (sometimes called Charge Transfer Systems).

  2. Lightning protection: challenges, solutions and questionable steps in the 21st century

    Science.gov (United States)

    Berta, István

    2011-06-01

    Besides the special primary lightning protection of extremely high towers, huge office and governmental buildings, large industrial plants and resident parks most of the challenges were connected to the secondary lightning protection of sensitive devices in Information and Communication Technology. The 70 year history of Budapest School of Lightning Protection plays an important role in the research and education of lightning and development of lightning protection. Among results and solutions the Rolling Sphere designing method (RS) and the Probability Modulated Attraction Space (PMAS) theory are detailed. As a new field Preventive Lightning Protection (PLP) has been introduced. The PLP method means the use of special preventive actions only for the duration of the thunderstorm. Recently several non-conventional lightning protection techniques have appeared as competitors of the air termination systems formed of conventional Franklin rods. The questionable steps, non-conventional lightning protection systems reported in the literature are the radioactive lightning rods, Early Streamer Emission (ESE) rods and Dissipation Arrays (sometimes called Charge Transfer Systems).

  3. Pneumatic muscle actuator (PMA) task-specific resistance for potential use in microgravity exercise.

    Science.gov (United States)

    Hall, Kara L; Phillips, Chandler A; Reynolds, David B; Mohler, Stanley R; Neidhard-Doll, Amy T

    2012-07-01

    A pneumatic muscle actuator (PMA) is a device that mimics the behavior of skeletal muscle by contracting and generating force when activated. This type of actuator has a high power to weight ratio and unique characteristics which make it ideal for human interaction. PMAs, however, are difficult to control due to nonlinear dynamics. Our objective was to control a PMA as a source of task-specific resistance in simulated isokinetic strength training. Task-specific resistance will benefit those in need of strength training through a joint's range of motion, including astronauts who need to counteract muscle atrophy during prolonged spaceflight. The lightweight, clean, and compact PMA driven by pressurized air is able to produce resistance in microgravity. An open-loop control method based on a three-element phenomenological inverse model was developed to control the PMA. A motor was simultaneously controlled to act as simulated human quadriceps working against the PMA-produced resistance. For ankle weight replacement resistance profiles, the PMA control method produced resistance and PMA displacement tracking errors (RMSE) of 0.36-1.61 Nm and 0.55-1.59 mm, respectively. Motor position (simulated joint angle) tracking errors ranged from 0.47 to 2.82 degrees. Results indicate that the inverse model based control system produces task-specific PMA resistance and displacement. Closed-loop motor control was able to simulate isokinetic movement successfully. More complicated resistance profiles reveal the need for closed-loop control. Future work focuses on advancing both the PMA control strategies and the capabilities of the human simulator so that actual human operator applications can be realized.

  4. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

    Science.gov (United States)

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

    Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  5. Retrospective analysis of RF heating measurements of passive medical implants.

    Science.gov (United States)

    Song, Ting; Xu, Zhiheng; Iacono, Maria Ida; Angelone, Leonardo M; Rajan, Sunder

    2018-05-09

    The test reports for the RF-induced heating of metallic devices of hundreds of medical implants have been provided to the U.S. Food and Drug Administration as a part of premarket submissions. The main purpose of this study is to perform a retrospective analysis of the RF-induced heating data provided in the reports to analyze the trends and correlate them with implant geometric characteristics. The ASTM-based RF heating test reports from 86 premarket U.S. Food and Drug Administration submissions were reviewed by three U.S. Food and Drug Administration reviewers. From each test report, the dimensions and RF-induced heating values for a given whole-body (WB) specific absorption rate (SAR) and local background (LB) SAR were extracted and analyzed. The data from 56 stents were analyzed as a subset to further understand heating trends and length dependence. For a given WB SAR, the LB/WB SAR ratio varied significantly across the test labs, from 2.3 to 11.3. There was an increasing trend on the temperature change per LB SAR with device length. The maximum heating for stents occurred at lengths of approximately 100 mm at 3 T, and beyond 150 mm at 1.5 T. Differences in the LB/WB SAR ratios across testing labs and various MRI scanners could lead to inconsistent WB SAR labeling. Magnetic resonance (MR) conditional labeling based on WB SAR should be derived from a conservative estimate of global LB/WB ratios. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

  6. 3-D bioprinting law regulation perspectives.

    Science.gov (United States)

    Pashkov, Vitalii; Harkusha, Andrii

    Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. General debate of last few years comes down to an attempt to resolve hesitation between legal attempts for regulation of 3-D biobrinting and concept of complete prohibition of such activities. An adequate response to the mentioned challenge is a reasonable position between some aspects of prohibition and self-regulation, resulting in a moderate number of regulations and standards for developing and marketing. Such regulations may concern an intellectual property (IP) rights, regulation of distribution, premarket restrictions, control mechanism etc. Scientific approach and regulatory settlement of 3-D bioprinting sphere must unite to achieve a fair balance between the interests of humanity and of individuals - on the one hand, and development of science and business benefits for stakeholders - on the other. The main instruments for this must be balanced regulation of intellectual property (IP) rights, regulation of access and distribution, premarket restrictions, control mechanism etc.

  7. Technology assessment and the Food and Drug Administration

    Science.gov (United States)

    Kaplan, A. H.; Becker, R. H.

    1972-01-01

    The statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.

  8. Predicting and detecting adverse drug reactions in old age: challenges and opportunities.

    Science.gov (United States)

    Mangoni, Arduino A

    2012-05-01

    Increased, often inappropriate, drug exposure, pharmacokinetic and pharmacodynamic changes, reduced homeostatic reserve and frailty increase the risk of adverse drug reactions (ADRs) in the older population, thereby imposing a significant public health burden. Predicting and diagnosing ADRs in old age presents significant challenges for the clinician, even when specific risk scoring systems are available. The picture is further compounded by the potential adverse impact of several drugs on more 'global' health indicators, for example, physical function and independence, and the fragmentation of care (e.g., increased number of treating doctors and care transitions) experienced by older patients during their clinical journey. The current knowledge of drug safety in old age is also curtailed by the lack of efficacy and safety data from pre-marketing studies. Moreover, little consideration is given to individual patients' experiences and reporting of specific ADRs, particularly in the presence of cognitive impairment. Pending additional data on these issues, the close review and monitoring of individual patients' drug prescribing, clinical status and biochemical parameters remain essential to predict and detect ADRs in old age. Recently developed strategies, for example, medication reconciliation and trigger tool methodology, have the potential for ADRs risk mitigation in this population. However, more information is required on their efficacy and applicability in different healthcare settings.

  9. Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

    Science.gov (United States)

    Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

    The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

  10. Manufacturing of cells and stacks for SOFC development, test and demonstration projects and SOFC hotbox design development

    Energy Technology Data Exchange (ETDEWEB)

    2008-09-15

    The purpose of this project is to support the continued SOFC development through manufacturing process optimization and manufacturing of SOFC cells and stacks. These cells and stacks will serve as a necessary base for the development activities and for the establishment of a number of test and demonstration activities. The manufacture will also help provide operating experience and reduce manufacturing cost. Another main focus of the manufacturing is to assure technical improvements and reliability. It is imperative to the eventual success of the technology that test and demonstration is carried out in the pre-market conditions that will exist for the next years in the three market segments targeted by TOFC (Distributed generation, micro CHP and APU incl. marine APU). Finally, the project also includes development activities focusing on the stack-system interface (hotbox design development) and on dealing with transients and start up and shut down times, which is of particular importance for APU and micro CHP applications. Three topics are addressed:1) Cell manufacture, including production development, capacity lift and manuf. of cells for test and demonstration; 2) Stack manufacture and test, including a test facility, stack manuf. and test of stacks in a system at HCV; 3) Hotbox design development, including design, prototype construction and testing. The progress of this project is documented. Major achievements are successful manufacture of adequate amounts of cells and stacks according to the application. Furthermore significant over-performance in design, construction and test of a methanol based hotbox prototype as well as publication of this. (au)

  11. Complications of transvaginal silicone-coated polyester synthetic mesh sling.

    Science.gov (United States)

    Govier, F E; Kobashi, K C; Kuznetsov, D D; Comiter, C; Jones, P; Dakil, S E; James, R

    2005-10-01

    To report a premarket multicenter trial to test the feasibility of a transvaginal silicone-coated polyester synthetic mesh sling in women with anatomic incontinence. Fifty-one patients in four centers underwent transvaginal placement of a silicone-coated polyester synthetic mesh sling (American Medical Systems) during an 8-month period. Of the 51 patients, 31 were part of a prospective institutional review board-approved feasibility trial in three centers funded by American Medical Systems (group 1) and 20 underwent implantation by a single surgeon and their data were retrospectively reviewed (group 2). The studies were done concomitantly, and all slings were fixed transvaginally with bone anchors. All patients in group 1 were followed up at 4 weeks, 6 months, and 1 year (as applicable) with repeat questionnaires, physical examinations, and pad tests. In group 1, 20 patients completed 6 months of follow-up. Ten patients (32%) required a second surgical procedure at an average of 183 days (range 68 to 343) postoperatively. Eight patients (26%) had vaginal extrusion of the mesh, one (3%) required sling lysis, and one (3%) required sling removal because of infection. In group 2, 8 patients (40%) underwent sling removal for vaginal extrusion at a mean of 160 days (range 83 to 214). Transvaginally placed silicone-coated mesh slings used for the treatment of urinary incontinence demonstrated an unacceptably high vaginal extrusion rate in this study. Once identified, this study was immediately terminated, and this product was not marketed for this application in the United States.

  12. Surveillance of Salmonella enteritidis in layer houses: a retrospective comparison of the Food and Drug Administration's egg safety rule (2010-2011) and the California Egg Quality Assurance Program (2007-2011).

    Science.gov (United States)

    Pitesky, Maurice; Charlton, Bruce; Bland, Mark; Rolfe, Dan

    2013-03-01

    Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs.

  13. Fillers in the skin of color population.

    Science.gov (United States)

    Heath, Candrice R; Taylor, Susan C

    2011-05-01

    The skin of color population in the United States is rapidly growing and the cosmetic industry is responding to the demand for skin of color targeted treatments. The aging face in skin of color patients has a unique pattern that can be successfully augmented by dermal fillers. Though many subjects with skin of color were not included in the pre-market dermal filler clinical trials, some post-market studies have examined the safety and risks of adverse events in this population. The safety data from a selection of these studies was examined. Though pigmentary changes occurred, there have been no reports of keloid development. Developing a patient-specific care plan and instituting close follow up is emphasized.

  14. Dielectric heating. Industrial applications; Chauffage dielectrique. Applications industrielles

    Energy Technology Data Exchange (ETDEWEB)

    Roussy, G. [Nancy-1 Univ. Henri Poincare, Dir. de Recherche 54 (France); Rochas, J.F. [Societe Sairem, 75 - Paris (France); Oberlin, C. [Electricite de France (EDF), Div. de Recherche, 75 - Paris (France)

    2003-11-01

    The heating of insulating or badly power conducting products using high frequency (HF) electromagnetic waves and microwaves (MW) is used in several industrial applications. This article presents some examples of conventional or recent applications of dielectric heating in the industry: 1 - selection criteria between HF and MW heating systems; 2 - HF applications: traditional applications (wood forming and sticking, welding of thermoplastic materials, drying of textile materials, correction of the humidity profile in the paper industry, end-baking of biscuits in the food industry), recent applications (over-moulding of automotive glazing materials, gluing and moulding of plastic parts in the automotive industry, drying of the coating of textile ropes), innovative applications; 3 - microwave applications: traditional applications (moderating of frozen meat by 915 MHz microwaves, drying of coatings on polystyrene or sand core models for foundry, pre-vulcanization of rubber sections, 2450 MHz pasteurization of pumpable products with morsels), examples of recent applications (continuous dehydration in vacuum, MW assisted granulator-dryers in the pharmaceutical industry, decontamination of hospital wastes), examples of innovative applications in the chemical sector, applications in progress; 4 - conclusion. (J.S.)

  15. Applicant Perspectives on the Otolaryngology Residency Application Process

    Science.gov (United States)

    2017-09-09

    ndorsing, Suggestion No.(%) (n=98) Establish a hard cap on the number of applications 43 (43.8) altov:ed per applicant Increase information and...Applicants are overall amenable to a hard cap on applicationsApplicants are interested in being part of the solution to the problem References...better the chances of match·ng. Alch Otoo1yngo/ Head~:< Surg_ 2008: 4 34(10)·1038. 3. Christophel JJ. Levine PA Too much of .a good thing . lAMA

  16. Review of the regulation and safety assessment of food substances in various countries and jurisdictions

    Science.gov (United States)

    Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

    2013-01-01

    This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843

  17. Applicant Perspectives on the Otolaryngology Residency Application Process.

    Science.gov (United States)

    Ward, Matthew; Pingree, Christian; Laury, Adrienne M; Bowe, Sarah N

    2017-08-01

    It has been nearly 25 years since medical students were queried regarding their perspectives on otolaryngology-head and neck surgery (OHNS) residency selection. Understanding this viewpoint is critical to improving the current application process. To evaluate the perceptions of 2016 OHNS residency applicants regarding the application process and offer suggestions for reform. In this cross-sectional study of anonymous online survey data, a 14-question survey was designed based on resources obtained from a computerized PubMed, Ovid, and GoogleScholar database search of the English language from January 1, 1990, through December 31, 2015, was conducted using the following search terms: (medical student OR applicant) AND (application OR match) AND otolaryngology. The survey was administered to 2016 OHNS residency applicants to examine 4 primary areas: current attitudes toward the match, effect of the new Otolaryngology Program Directors Organization personal statement mandate, sources of advice and information, and suggestions for improvement. In January 2016, an email was sent to 100 program directors asking them to distribute the survey to current OHNS applicants at their institution. One follow-up reminder email was sent in February 2016. A link to the survey was posted on the Otomatch.com homepage on January 28, 2016, with the last response received on March 28, 2016. Survey responses regarding the residency application process. A total of 150 of 370 residency applicants (40.5%) responded to the survey. Of these, 125 respondents (90.6%) noted applying to programs in which they had no specific interest simply to improve their chances of matching. Applicants intended to apply to more programs than they actually did (63.6 vs 60.8; r = 0.19; 95% CI, -0.03 to 0.40). Program directors advised fewer applications than other sources; however, 58 respondents (38.7%) did not receive advice from a program director. A total of 121 respondents (80.7%) found online program

  18. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-01-07

    ..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability.... Glucose Monitoring System (TGMS). P000008/S017, FDA-2012-M-1013.. Allergan, Inc..... LAP-BAND \\TM\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc...

  19. 76 FR 48058 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Science.gov (United States)

    2011-08-08

    ... embolism, muscle/nerve stimulation, stenosis, and erosion/extrusion may occur as a result of the clinical... advises that to ensure timely filing of any such petition, any request should be submitted to the Division... timely request for a change in the classification of this device is submitted, the Agency will, within 60...

  20. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-08-04

    ... placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.......... Chestnut Medical Pipeline embolization device.... April 6, 2011. Technologies, Inc. P100034 FDA-2011-M-0295... Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire...

  1. 76 FR 48062 - Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator

    Science.gov (United States)

    2011-08-08

    ... performance standard for CES because the characteristics of the electrical current necessary for potential... literature are beset with weaknesses, such as small sample size, incomplete statistical reporting, and..., costing approximately $1 million each. FDA believes that there are approximately 13 such products, so...

  2. 76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Science.gov (United States)

    2011-08-30

    ... Pacemaker Electrode; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction... preamendments device: Cardiovascular permanent pacemaker electrode. The document was published with an incorrect...

  3. 77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Science.gov (United States)

    2012-06-22

    ... 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 directs Agencies to assess all costs and..., and other advantages; distributive impacts; and equity). The Agency believes that this final rule is... fallen into disuse and FDA has concluded that there is little or no interest in marketing these devices...

  4. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-06-14

    ... Paclitaxel- February 22, 2012. Corp. Eluting Coronary Stent System (Monorail and Over- The-Wire Delivery...] February 22, 2012. Corp. Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery.... Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems). P110023, FDA-2012-M...

  5. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-03-16

    ...-2011-M-0746 Pluromed, Inc........ LEGOO September 28, 2011. P090024, FDA-2011-M-0737 Siemens Healthcare...). P110022, FDA-2011-M-0786 Roche Diagnostics ELECSYS anti-HBC IGM October 26, 2011. Corp. immunoassay and....... November 14, 2011. H090002, FDA-2011-M-0848 BSD Medical Corp..... BSD-2000 November 18, 2011. hyperthermia...

  6. 76 FR 47085 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Science.gov (United States)

    2011-08-04

    ... manufacturers take action to prevent the further use of devices for which no PMA or PDP has been filed and may... completion of a product development protocol (PDP) for the class III preamendments device pacemaker... injury designed to be eliminated or reduced by requiring this device to meet the statute's approval...

  7. Application architecture for .NET designing applications and services

    CERN Document Server

    Microsoft. Redmond

    2003-01-01

    Get expert architectural and design-level guidance for building distributed solutions with the Microsoft® .NET Framework-learning how to synthesize your knowledge of application development, servers, and infrastructure and business requirements. This guide assumes you are familiar with .NET component development and the basic principles of a layered distributed application design. It examines architectural issues and solution design for a range of project stakeholders-whether you build and design applications and services, recommend appropriate technologies and products for applications and s

  8. Comparing Web Applications with Desktop Applications: An Empirical Study

    DEFF Research Database (Denmark)

    Pop, Paul

    2002-01-01

    In recent years, many desktop applications have been ported to the world wide web in order to reduce (multiplatform) development, distribution and maintenance costs. However, there is little data concerning the usability of web applications, and the impact of their usability on the total cost...... of developing and using such applications. In this paper we present a comparison of web and desktop applications from the usability point of view. The comparison is based on an empirical study that investigates the performance of a group of users on two calendaring applications: Yahoo!Calendar and Microsoft...... Calendar. The study shows that in the case of web applications the performance of the users is significantly reduced, mainly because of the restricted interaction mechanisms provided by current web browsers....

  9. Language Modelling for Collaborative Filtering: Application to Job Applicant Matching

    OpenAIRE

    Schmitt , Thomas; Gonard , François; Caillou , Philippe; Sebag , Michèle

    2017-01-01

    International audience; This paper addresses a collaborative retrieval problem , the recommendation of job ads to applicants. Specifically, two proprietary databases are considered. The first one focuses on the context of unskilled low-paid jobs/applicants; the second one focuses on highly qualified jobs/applicants. Each database includes the job ads and applicant resumes together with the collaborative filtering data recording the applicant clicks on job ads. The proposed approach, called LA...

  10. Monitoring and radioecological characteristics of radiocesium in Japanese beef after the Fukushima nuclear accident

    International Nuclear Information System (INIS)

    Steinhauser, Georg

    2017-01-01

    After the Fukushima nuclear accident, beef proved to be a problematic food item with several exceedances entering the market. The reason was contaminated rice straw that was fed to cattle. Japanese authorities responded quickly to the exceedances and made beef one of the most-monitored food items after the Fukushima accident with more than a million samples within 5 years. Activity levels dropped quickly and are now considerably below the regulatory limit. No exceedance of the regulatory limit was observed after October 2012. The monitoring campaign focuses on the pre-market to catch any exceedances before they reach the consumer. The analysis also showed that some late beef samples exhibited an unusually high "1"3"4Cs/"1"3"7Cs activity ratio. The reason for this is unknown. (author)

  11. Human Factors and Medical Devices

    International Nuclear Information System (INIS)

    Dick Sawyer

    1998-01-01

    Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright

  12. THE DIFFERENCE BETWEEN DEVELOPING SINGLE PAGE APPLICATION AND TRADITIONAL WEB APPLICATION BASED ON MECHATRONICS ROBOT LABORATORY ONAFT APPLICATION

    Directory of Open Access Journals (Sweden)

    V. Solovei

    2018-04-01

    Full Text Available Today most of desktop and mobile applications have analogues in the form of web-based applications.  With evolution of development technologies and web technologies web application increased in functionality to desktop applications. The Web application consists of two parts of the client part and the server part. The client part is responsible for providing the user with visual information through the browser. The server part is responsible for processing and storing data.MPA appeared simultaneously with the Internet. Multiple-page applications work in a "traditional" way. Every change eg. display the data or submit data back to the server. With the advent of AJAX, MPA learned to load not the whole page, but only a part of it, which eventually led to the appearance of the SPA. SPA is the principle of development when only one page is transferred to the client part, and the content is downloaded only to a certain part of the page, without rebooting it, which allows to speed up the application and simplify the user experience of using the application to the level of desktop applications.Based on the SPA, the Mechatronics Robot Laboratory ONAFT application was designed to automate the management process. The application implements the client-server architecture. The server part consists of a RESTful API, which allows you to get unified access to the application functionality, and a database for storing information. Since the client part is a spa, this allows you to reduce the load on the connection to the server and improve the user experience

  13. 29 CFR 2704.202 - Contents of application-where the applicant has prevailed.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Contents of application-where the applicant has prevailed... Information Required From Applicants § 2704.202 Contents of application—where the applicant has prevailed. (a) An application for an award under § 2704.105(a) shall show that the applicant has prevailed in a...

  14. Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

    Science.gov (United States)

    Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

    2016-05-01

    Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

  15. Java Application Shell: A Framework for Piecing Together Java Applications

    Science.gov (United States)

    Miller, Philip; Powers, Edward I. (Technical Monitor)

    2001-01-01

    This session describes the architecture of Java Application Shell (JAS), a Swing-based framework for developing interactive Java applications. Java Application Shell is being developed by Commerce One, Inc. for NASA Goddard Space Flight Center Code 588. The purpose of JAS is to provide a framework for the development of Java applications, providing features that enable the development process to be more efficient, consistent and flexible. Fundamentally, JAS is based upon an architecture where an application is considered a collection of 'plugins'. In turn, a plug-in is a collection of Swing actions defined using XML and packaged in a jar file. Plug-ins may be local to the host platform or remotely-accessible through HTTP. Local and remote plugins are automatically discovered by JAS upon application startup; plugins may also be loaded dynamically without having to re-start the application. Using Extensible Markup Language (XML) to define actions, as opposed to hardcoding them in application logic, allows easier customization of application-specific operations by separating application logic from presentation. Through XML, a developer defines an action that may appear on any number of menus, toolbars, and buttons. Actions maintain and propagate enable/disable states and specify icons, tool-tips, titles, etc. Furthermore, JAS allows actions to be implemented using various scripting languages through the use of IBM's Bean Scripting Framework. Scripted action implementation is seamless to the end-user. In addition to action implementation, scripts may be used for application and unit-level testing. In the case of application-level testing, JAS has hooks to assist a script in simulating end-user input. JAS also provides property and user preference management, JavaHelp, Undo/Redo, Multi-Document Interface, Single-Document Interface, printing, and logging. Finally, Jini technology has also been included into the framework by means of a Jini services browser and the

  16. Creation of web applications by Rich Internet Application Adobe Flex

    OpenAIRE

    PEKA, Karel

    2011-01-01

    Bachelor work focuses on explaining the functions and development of interactive applications in Adobe Flex RIA also compared to similar web technologies such as AJAX, Microsoft Silverlight or Adobe Flash. Explain the difference between "ordinary" sites and Rich Internet Application (RIA) and the difference shows a series of demonstration examples were processed in Adobe Flash Builder (environment for building Flex applications). Also will be created large-scale application for comprehensive ...

  17. Engineering applications using CAD based application programming interface

    Directory of Open Access Journals (Sweden)

    Tzotzis Anastasios

    2017-01-01

    Full Text Available Automating the design process of a product or a system can provide engineers and designers with many benefits. As such, repeatable tasks that are time consuming can be handled automatically and with minimal human attention. This is achieved by using the API (Application Programmable Interface of CAD systems in order to create macros or even develop software applications. The present paper deals with an application that has been developed with the API of a general purposes CAD system. This application automates the design process of a standard pneumatic double acting cylinder based on the appropriate inserted parameters (ISO 15552.The design process begins with the creation of a series of components developed as solids, and extends to the extraction of basic attributes and properties from the complete mechanical assembly. Finally, the assembled models and the extracted data can be used to further study the design of the pneumatic double acting cylinder. It is expected in the future to expand the features of the presented application in order to automate the design process of other related mechanical systems.

  18. PSA applications

    International Nuclear Information System (INIS)

    Dubreuil Chambardel, A.

    1996-01-01

    The IAEA now defines three types of PSA applications: Validation of design and of operation procedures; optimization of plant operation; and regulatory applications. The applications of PSA are manifold: only a few are dealt with here (precursor analysis is dealt with in session 3, topic 4). For each of them, we will do the utmost to demonstrate the main difficulties encountered, EDF's viewpoint on the matter, and the points remaining to be solved. In what follows, unless explicitly stated otherwise, we have made every effort to represent the different applications as they are practiced by all concerned in the international community, and to describe the inherent difficulties the international community has encountered with these applications with all objectivity. It goes without saying that the comments below are simply those of the ESF department, and are submitted here for discussion by the experts. 13 refs

  19. PSA applications

    Energy Technology Data Exchange (ETDEWEB)

    Dubreuil Chambardel, A

    1997-12-31

    The IAEA now defines three types of PSA applications: Validation of design and of operation procedures; optimization of plant operation; and regulatory applications. The applications of PSA are manifold: only a few are dealt with here (precursor analysis is dealt with in session 3, topic 4). For each of them, we will do the utmost to demonstrate the main difficulties encountered, EDF`s viewpoint on the matter, and the points remaining to be solved. In what follows, unless explicitly stated otherwise, we have made every effort to represent the different applications as they are practiced by all concerned in the international community, and to describe the inherent difficulties the international community has encountered with these applications with all objectivity. It goes without saying that the comments below are simply those of the ESF department, and are submitted here for discussion by the experts. 13 refs.

  20. 37 CFR 2.27 - Pending trademark application index; access to applications.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Pending trademark application... Registration § 2.27 Pending trademark application index; access to applications. (a) An index of pending... particular pending application will be permitted prior to publication under § 2.80 upon written request. (c...

  1. LCA Applications

    DEFF Research Database (Denmark)

    Owsianiak, Mikołaj; Bjørn, Anders; Laurent, Alexis

    2018-01-01

    The chapter gives examples of applications of LCA by the central societal actors in government, industry and citizens, and discusses major motivations and challenges for the use of LCA to support science-based decision-making from their respective perspectives. We highlight applications of LCA...... environmental impacts of products and systems and support decisions around production and consumption and highlights factors that prevent its even more widespread application....

  2. Increased Productivity for Emerging Grid Applications the Application Support System

    CERN Document Server

    Maier, Andrew; Mendez Lorenzo, Patricia; Moscicki, Jakub; Lamanna, Massimo; Muraru, Adrian

    2008-01-01

    Recently a growing number of various applications have been quickly and successfully enabled on the Grid by the CERN Grid application support team. This allowed the applications to achieve and publish large-scale results in a short time which otherwise would not be possible. We present the general infrastructure, support procedures and tools that have been developed. We discuss the general patterns observed in supporting new applications and porting them to the EGEE environment. The CERN Grid application support team has been working with the following real-life applications: medical and particle physics simulation (Geant4, Garfield), satellite imaging and geographic information for humanitarian relief operations (UNOSAT), telecommunications (ITU), theoretical physics (Lattice QCD, Feynman-loop evaluation), Bio-informatics (Avian Flu Data Challenge), commercial imaging processing and classification (Imense Ltd.) and physics experiments (ATLAS, LHCb, HARP). Using the EGEE Grid we created a standard infrastruct...

  3. Medical Applications

    OpenAIRE

    Biscari, C.; Falbo, L.

    2016-01-01

    The use of accelerators for medical applications has evolved from initial experimentation to turn-key devices commonly operating in hospitals. New applications are continuously being developed around the world, and the hadrontherapy facilities of the newest generation are placed at the frontier between industrial production and advanced R&D. An introduction to the different medical application accelerators is followed by a description of the hadrontherapy facilities, with special emphasis on ...

  4. ADAM (Affordable Desktop Application Manager): a Unix desktop application manager

    International Nuclear Information System (INIS)

    Liebana, M.; Marquina, M.; Ramos, R.

    1996-01-01

    ADAM stands for Affordable Desktop Application Manager. It is a GUI developed at CERN with the aim to ease access to applications. The motivation to develop ADAM came from the unavailability of environments like COSE/CDE and their heavy resource consumption. ADAM has proven to be user friendly: new users are able to customize it to their needs in few minutes. Groups of users may share through ADAM a common application environment. ADAM also integrates the Unix and the PC world. PC users can excess Unix applications in the same way as their usual Windows applications. This paper describes all the ADAM features, how they are used at CERN Public Services, and the future plans for ADAM. (author)

  5. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

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

  6. 78 FR 5816 - Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical...

    Science.gov (United States)

    2013-01-28

    .... The guidance provides recommendations on when and how genomic principles should be considered and... recommendations on when and how genomic principles should be considered and applied in early-phase clinical... the larger, later adequate, and well-controlled trials (phase 3) that are needed to support marketing...

  7. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Science.gov (United States)

    2013-03-04

    ... CFR part 807) require persons who propose to begin the introduction or delivery for introduction into... the Canadian Standards Association (CSA)/ASME standard ``CSA B44.1/ASME A17.5 Elevator and Escalator Electrical Equipment'' for elevator and escalator equipment. FDA has assessed the need for 510(k) clearance...

  8. Applications of radionuclides in industry; Applications des radioelements a l'industrie

    Energy Technology Data Exchange (ETDEWEB)

    Leveque, P [Commissariat a l' Energie Atomique, Paris (France). Centre d' Etudes Nucleaires

    1955-07-01

    After a brief recall of a few concepts (mass number, charge and beams properties) and the description of used detectors (ionization chamber, Geiger-Mueller counter, scintillation counters), some radionuclides applications are described. In a first part, the well-developed applications are presented in three distinct groups: continuous applications such as {beta} and {gamma} gauges (determination hydrogen content of an hydrocarbon and content of an emulsion; discharge of static electricity), discontinuous applications such as radiography and autoradiography, wear or manufacture problems (distribution of a fungicide on tobacco) and finally, applications in research laboratories such as diffusion, exchange and solubility. It also describes the applications which are still in development such as the action of beams on matter (reticulation and degradation of polymers, monomers polymerisation, cold sterilization). In conclusion, few advices on the opportunity of such applications and the choice of the radionuclides are given. (M.P.)

  9. Pulse polarography - special application; Polarographie a impulsions - applications particulieres

    Energy Technology Data Exchange (ETDEWEB)

    Chapron, Y [Commissariat a l' Energie Atomique, Fontenay-aux-Roses (France). Centre d' Etudes Nucleaires

    1967-07-01

    The calculation of the current on a plane electrode in particular conditions is presented briefly, the first part of the report then consists of a theoretical and methodological presentation of pulse polarography. The calculation of the current in pulse polarography is given for different modes of measurement and for redox systems of variable reversibility. Various extensions are proposed with a view to extending the field of application of the method. The second part presents two particular applications. One application is to analytical chemistry: organometallic complexes applied to the pulse polarographic analysis; the other application is to electrochemical kinetics using integral pulse polarography. This research has enabled us to determine, in the first case, elements present in minute traces, and in the second case the kinetic parameters of an electrochemical reaction which is too fast to be analyzed by conventional polarography. (author) [French] Apres un rappel sur le calcul du courant sur electrode plane dans des conditions precises, la premiere partie du memoire est consacree a l'expose theorique et methodologique de la polarographie a impulsions. Le calcul du courant en polarographie a impulsions est donne pour divers modes de mesures et pour des systemes redox de reversibilites variees. Diverses extensions sont proposees de facon a elargir le domaine d'application de la methode. La deuxieme partie introduit deux applications particulieres. Une application a la chimie analytique: les complexes organometalliques appliques a l'analyse pulsopolarographique et une application a la cinetique electrochimique par polarographie a impulsions integrale. Ces recherches nous ont permis de determiner dans le premier cas, des elements a l'etat de traces infimes, dans le deuxieme cas, les parametres cinetiques d'une reaction electrochimique trop rapide pour etre analysee par polarographie classique. (auteur)

  10. Web Application Vulnerabilities

    OpenAIRE

    Yadav, Bhanu

    2014-01-01

    Web application security has been a major issue in information technology since the evolvement of dynamic web application. The main objective of this project was to carry out a detailed study on the top three web application vulnerabilities such as injection, cross site scripting, broken authentication and session management, present the situation where an application can be vulnerable to these web threats and finally provide preventative measures against them. ...

  11. Application and interview features used to assess applicant qualifications for residency training.

    Science.gov (United States)

    Butts, Allison R; Smith, Kelly M

    2015-02-01

    To determine what factors residency program directors (RPDs) consider and what methods they use to assess applicants. Respondents ranked the importance of 27 applicant features within domains: academics/credentials, application features/program fit, involvement, professional experience, research/ teaching experience, and postgraduate year 1 (PGY-1) residency experience. Rank was assigned in an ordinal fashion (1 = most important feature). The domains were characterized by their importance (mean % ± SD) in selecting candidates for interviews. Participants characterized their screening process according to 8 application and 6 interview features and the corresponding applicant dimensions evaluated. RPDs rated the importance of 14 methods applicants used to communicate with the program and 3 methods by which references were obtained. A Likert scale was used for rating (4 = crucial features). The approaches the program used to evaluate 12 application features or interpersonal interactions were reported. The most important application domain was application features/program fit (26.28 ± 19.11). The highest ranked application feature was program fit (2.04 ± 1.17). The applicant's cover letter, recommendation letters, curriculum vitae, and interview meal were commonly used to assess communication and interpersonal skills, knowledge base, and experience. The most important communication venue was the on-site interview (3.95 ± 0.23). Recommendations solicited by RPDs (3.42 ± 0.69) were most important. Programs formally evaluated the interview (89%) and recommendation letters (84%). Understanding the importance that RPDs place on application and interview features, as well as the process used to assess communication skills and interpersonal interactions, should allow residency candidates to become more competitive residency prospects.

  12. Applications for cyber security - System and application monitoring

    International Nuclear Information System (INIS)

    Marron, J. E.

    2006-01-01

    Standard network security measures are adequate for defense against external attacks. However, many experts agree that the greater threat is from internal sources. Insiders with malicious intentions can change controller instructions, change alarm thresholds, and issue commands to equipment which can damage equipment and compromise control system integrity. In addition to strict physical security the state of the system must be continually monitored. System and application monitoring goes beyond the capabilities of network security appliances. It will include active processes, operating system services, files, network adapters and IP addresses. The generation of alarms is a crucial feature of system and application monitoring. The alarms should be integrated to avoid the burden on operators of checking multiple locations for security violations. Tools for system and application monitoring include commercial software, free software, and ad-hoc tools that can be easily created. System and application monitoring is part of a 'defense-in-depth' approach to a control network security plan. Layered security measures prevent an individual security measure failure from being exploited into a successful security breach. Alarming of individual failures is essential for rapid isolation and correction of single failures. System and application monitoring is the innermost layer of this defense strategy. (authors)

  13. Knowledge creation about ADRs-turning the perspective from the rear mirror to the projector?

    DEFF Research Database (Denmark)

    Aagaard, Lise; Soendergaard, Birthe; Stenver, Doris I

    2008-01-01

    What is already known about this subject? Serious and unexpected adverse drug reactions (ADRs) have been reported shortly after marketing of a number of drugs. Review of ADR cases by the regulatory authorities has resulted in suspension of drugs or restrictions in product information. What...... this study adds? Information about serious and unexpected ADRs of three drugs with reported serious ADRs was already present in the registration files. Observations of these ADRs were not investigated further before marketing. A more active utilization of the ADR information in premarketing studies could...... probably prevent the appearance of unexpected and serious ADR cases after marketing. AIMS: Spontaneous reports of adverse drug reactions (ADRs) are often the only documentation used to justify the recall of drugs from the market. The purpose of this study was to investigate whether it would have been...

  14. Children's vulnerability to toxic chemicals: a challenge and opportunity to strengthen health and environmental policy.

    Science.gov (United States)

    Landrigan, Philip J; Goldman, Lynn R

    2011-05-01

    A key policy breakthrough occurred nearly twenty years ago with the discovery that children are far more sensitive than adults to toxic chemicals in the environment. This finding led to the recognition that chemical exposures early in life are significant and preventable causes of disease in children and adults. We review this knowledge and recommend a new policy to regulate industrial and consumer chemicals that will protect the health of children and all Americans, prevent disease, and reduce health care costs. The linchpins of a new US chemical policy will be: first, a legally mandated requirement to test the toxicity of chemicals already in commerce, prioritizing chemicals in the widest use, and incorporating new assessment technologies; second, a tiered approach to premarket evaluation of new chemicals; and third, epidemiologic monitoring and focused health studies of exposed populations.

  15. An evaluation of Admedus' tissue engineering process-treated (ADAPT) bovine pericardium patch (CardioCel) for the repair of cardiac and vascular defects.

    Science.gov (United States)

    Strange, Geoff; Brizard, Christian; Karl, Tom R; Neethling, Leon

    2015-03-01

    Tissue engineers have been seeking the 'Holy Grail' solution to calcification and cytotoxicity of implanted tissue for decades. Tissues with all of the desired qualities for surgical repair of congenital heart disease (CHD) are lacking. An anti-calcification tissue engineering process (ADAPT TEP) has been developed and applied to bovine pericardium (BP) tissue (CardioCel, AdmedusRegen Pty Ltd, Perth, WA, Australia) to eliminate cytotoxicity, improve resistance to acute and chronic inflammation, reduce calcification and facilitate controlled tissue remodeling. Clinical data in pediatric patients, and additional pre-market authorized prescriber data demonstrate that CardioCel performs extremely well in the short term and is safe and effective for a range of congenital heart deformations. These data are supported by animal studies which have shown no more than normal physiologic levels of calcification, with good durability, biocompatibility and controlled healing.

  16. Advancing pharmaceuticals and patient safety in Saudi Arabia: A 2030 vision initiative

    Directory of Open Access Journals (Sweden)

    Tariq M. Alhawassi

    2018-01-01

    Full Text Available Low-quality medicines deliver sub-optimal clinical outcomes and waste precious health resources. It is important to ensure that public funds are spent on healthcare technologies that meet national regulatory bodies such as the Saudi Food and Drug Authority (SFDA, quality standards for safety, efficacy, and quality. Medicines quality is a complicated combination of pre-market regulatory specifications, appropriate sourcing of ingredients (active pharmaceutical ingredient (API, excipients, etc., manufacturing processes, healthcare ecosystem communications, and regular and robust pharmacovigilance practices. A recent conference in Riyadh, sponsored by King Saud University, sought to discuss these issues and develop specific policy recommendations for the Saudi 2030 Vision plan. This and other efforts will require more and more creative educational programs for physicians, pharmacists, hospitals, and patients, and, most importantly evolving regulations on quality standards and oversight by Saudi health authorities.

  17. Next-generation robotic surgery--from the aspect of surgical robots developed by industry.

    Science.gov (United States)

    Nakadate, Ryu; Arata, Jumpei; Hashizume, Makoto

    2015-02-01

    At present, much of the research conducted worldwide focuses on extending the ability of surgical robots. One approach is to extend robotic dexterity. For instance, accessibility and dexterity of the surgical instruments remains the largest issue for reduced port surgery such as single port surgery or natural orifice surgery. To solve this problem, a great deal of research is currently conducted in the field of robotics. Enhancing the surgeon's perception is an approach that uses advanced sensor technology. The real-time data acquired through the robotic system combined with the data stored in the robot (such as the robot's location) provide a major advantage. This paper aims at introducing state-of-the-art products and pre-market products in this technological advancement, namely the robotic challenge in extending dexterity and hopefully providing the path to robotic surgery in the near future.

  18. Connected vehicle applications : environment.

    Science.gov (United States)

    2016-01-01

    The U.S. Department of Transportation has developed a number of connected vehicle environmental applications, including the Applications for the Environment Real-Time Information Synthesis (AERIS) research program applications and road weather applic...

  19. IMS Application Developer's Handbook Creating and Deploying Innovative IMS Applications

    CERN Document Server

    Noldus, Rogier; Mulligan, Catherine; Fikouras, Ioannis; Ryde, Anders; Stille, Mats

    2011-01-01

    IMS Application Developer Handbook will give a hands-on view of exactly what needs to be done by IMS application developers to write an application and take it "live" on an operator's network. It will offer practical guidance on building innovative applications using the features and capabilities of the IMS network, show how the rapidly changing development environment is impacting on the business models employed in the industry and how existing network solutions can be moved towards IMS. The book will also elaborate on how IMS applies basic VoIP principles and techniques to realise a true mul

  20. Medical Applications

    CERN Document Server

    Biscari, C.

    2014-12-19

    The use of accelerators for medical applications has evolved from initial experimentation to turn-key devices commonly operating in hospitals. New applications are continuously being developed around the world, and the hadrontherapy facilities of the newest generation are placed at the frontier between industrial production and advanced R&D. An introduction to the different medical application accelerators is followed by a description of the hadrontherapy facilities, with special emphasis on CNAO, and the report closes with a brief outlook on the future of this field.

  1. Medical Applications

    International Nuclear Information System (INIS)

    Biscari, C; Falbo, L

    2014-01-01

    The use of accelerators for medical applications has evolved from initial experimentation to turn-key devices commonly operating in hospitals. New applications are continuously being developed around the world, and the hadrontherapy facilities of the newest generation are placed at the frontier between industrial production and advanced R&D. An introduction to the different medical application accelerators is followed by a description of the hadrontherapy facilities, with special emphasis on CNAO, and the report closes with a brief outlook on the future of this field

  2. Electrical applications 2

    CERN Document Server

    Tyler, David W

    1998-01-01

    Electrical Applications 2 covers the BTEC NII level objectives in Electrical Applications U86/330. To understand the applications, a knowledge of the underlying principles is needed and these are covered briefly in the text. Key topics discussed are: the transmission and distribution of electrical energy; safety and regulations; tariffs and power factor correction; materials and their applications in the electrical industry; transformers; DC machines; illumination; and fuse protection. Included in each chapter are worked examples which should be carefully worked through before progressing to t

  3. Predicting biomaterial property-dendritic cell phenotype relationships from the multivariate analysis of responses to polymethacrylates

    Science.gov (United States)

    Kou, Peng Meng; Pallassana, Narayanan; Bowden, Rebeca; Cunningham, Barry; Joy, Abraham; Kohn, Joachim; Babensee, Julia E.

    2011-01-01

    Dendritic cells (DCs) play a critical role in orchestrating the host responses to a wide variety of foreign antigens and are essential in maintaining immune tolerance. Distinct biomaterials have been shown to differentially affect the phenotype of DCs, which suggested that biomaterials may be used to modulate immune response towards the biologic component in combination products. The elucidation of biomaterial property-DC phenotype relationships is expected to inform rational design of immuno-modulatory biomaterials. In this study, DC response to a set of 12 polymethacrylates (pMAs) was assessed in terms of surface marker expression and cytokine profile. Principal component analysis (PCA) determined that surface carbon correlated with enhanced DC maturation, while surface oxygen was associated with an immature DC phenotype. Partial square linear regression, a multivariate modeling approach, was implemented and successfully predicted biomaterial-induced DC phenotype in terms of surface marker expression from biomaterial properties with R2prediction = 0.76. Furthermore, prediction of DC phenotype was effective based on only theoretical chemical composition of the bulk polymers with R2prediction = 0.80. These results demonstrated that immune cell response can be predicted from biomaterial properties, and computational models will expedite future biomaterial design and selection. PMID:22136715

  4. Improving maternal and child health systems in Fiji through a perinatal mortality audit.

    Science.gov (United States)

    Raman, Shanti; Iljadica, Alexandra; Gyaneshwar, Rajat; Taito, Rigamoto; Fong, James

    2015-05-01

    To develop a standardized process of perinatal mortality audit (PMA) and improve the capacity of health workers to identify and correct factors underlying preventable deaths in Fiji. In a pilot study, clinicians and healthcare managers in obstetrics and pediatrics were trained to investigate stillbirths and neonatal deaths according to current guidelines. A pre-existing PMA datasheet was refined for use in Fiji and trialed in three divisional hospitals in 2011-12. Key informant interviews identified factors influencing PMA uptake. Overall, 141 stillbirths and neonatal deaths were analyzed (57 from hospital A and 84 from hospital B; forms from hospital C excluded because incomplete/illegible). Between-site variations in mortality were recorded on the basis of the level of tertiary care available; 28 (49%) stillbirths were recorded in hospital A compared with 53 (63%) in hospital B. Substantial health system factors contributing to preventable deaths were identified, and included inadequate staffing, problems with medical equipment, and lack of clinical skills. Leadership, teamwork, communication, and having a standardized process were associated with uptake of PMA. The use of PMAs by health workers in Fiji and other Pacific island countries could potentially rectify gaps in maternal and neonatal service delivery. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  5. Design and Evaluation of the AIRGAIT Exoskeleton: Leg Orthosis Control for Assistive Gait Rehabilitation

    Directory of Open Access Journals (Sweden)

    Mohd Azuwan Mat Dzahir

    2013-01-01

    Full Text Available This paper introduces the body weight support gait training system known as the AIRGAIT exoskeleton and delves into the design and evaluation of its leg orthosis control algorithm. The implementation of the mono- and biarticular pneumatic muscle actuators (PMAs as the actuation system was initiated to generate more power and precisely control the leg orthosis. This research proposes a simple paradigm for controlling the mono- and bi-articular actuator movements cocontractively by introducing a cocontraction model. Three tests were performed. The first test involved control of the orthosis with monoarticular actuators alone without a subject (WO/S; the second involved control of the orthosis with mono- and bi-articular actuators tested WO/S; and the third test involved control of the orthosis with mono- and bi-articular actuators tested with a subject (W/S. Full body weight support (BWS was implemented in this study during the test W/S as the load supported by the orthosis was at its maximum capacity. This assessment will optimize the control system strategy so that the system operates to its full capacity. The results revealed that the proposed control strategy was able to co-contractively actuate the mono- and bi-articular actuators simultaneously and increase stiffness at both hip and knee joints.

  6. Are Wolf-Rayet Stars Able to Pollute the Interstellar Medium of Galaxies? Results from Integral Field Spectroscopy

    Directory of Open Access Journals (Sweden)

    Enrique Pérez-Montero

    2013-01-01

    Full Text Available We investigate the spatial distribution of chemical abundances in a sample of low metallicity Wolf-Rayet (WR galaxies selected from the SDSS. We used the integral field spectroscopy technique in the optical spectral range (3700 Å–6850 Å with PMAS attached to the CAHA 3.5 m telescope. Our statistical analysis of the spatial distributions of O/H and N/O, as derived using the direct method or strong-line parameters consistent with it, indicates that metallicity is homogeneous in five out of the six analysed objects in scales of the order of several kpc. Only in the object WR404 is a gradient of metallicity found in the direction of the low surface brightness tail. In contrast, we found an overabundance of N/O in spatial scales of the order of hundreds of pc associated with or close to the positions of the WR stars in 4 out of the 6 galaxies. We exclude possible hydrodynamical causes, such as the metal-poor gas inflow, for this local pollution by means of the analysis of the mass-metallicity relation (MZR and mass-nitrogen-to-oxygen relation (MNOR for the WR galaxies catalogued in the SDSS.

  7. Hardening Azure applications

    CERN Document Server

    Gaurav, Suraj

    2015-01-01

    Learn what it takes to build large scale, mission critical applications -hardened applications- on the Azure cloud platform. This 208 page book covers the techniques and engineering principles that every architect and developer needs to know to harden their Azure/.NET applications to ensure maximum reliability and high availability when deployed at scale. While the techniques are implemented in .NET and optimized for Azure, the principles here will also be valuable for users of other cloud-based development platforms. Applications come in a variety of forms, from simple apps that can be bui

  8. Criteria for Social Applications

    DEFF Research Database (Denmark)

    Atzenbeck, Claus; Tzagarakis, Manolis

    2007-01-01

    Social networks are becoming increasingly important for a wide number of applications. This is in particular true in the context of the Web 2.0 movement where a number of Web-based applications emerged - termed social networking applications or services - that allow the articulation of social...... relationships between individuals thus creating social networks. Although Web 2.0 applications are a popular and characteristic class of such applications they are not the only representatives that permit such functionality. Applications in the Personal Information Management domain exhibit similar...... characteristics but have never been mentioned in the context of social networking. The increasing number and diversity of such applications makes their study, analysis and evaluation from a systems point of view critical and important as their study may help identify relationships that are useful when attempting...

  9. User Types in Online Applications

    Directory of Open Access Journals (Sweden)

    Ion IVAN

    2011-08-01

    Full Text Available Online applications are presented in the context of information society. Online applications characteristics are analyzed. Quality characteristics are presented in relation to online applications users. Types of users for AVIO application are presented. Use cases for AVIO application are identified. The limitations of AVIO application are defined. Types of users in online applications are identified. The threedimensional matrix of access to the online application resources is built. The user type-oriented database is structured. Access management of the fields related to the database tables is analyzed. The classification of online applications users is done.

  10. Microwave power engineering applications

    CERN Document Server

    Okress, Ernest C

    2013-01-01

    Microwave Power Engineering, Volume 2: Applications introduces the electronics technology of microwave power and its applications. This technology emphasizes microwave electronics for direct power utilization and transmission purposes. This volume presents the accomplishments with respect to components, systems, and applications and their prevailing limitations in the light of knowledge of the microwave power technology. The applications discussed include the microwave heating and other processes of materials, which utilize the magnetron predominantly. Other applications include microwave ioni

  11. Wapice News Mobile Application

    OpenAIRE

    Söylemez, Ilke

    2017-01-01

    Since the mobile phones started to have an increasingly significant role in daily life, the mobile application development also started to be an important area in the software industry. The problem for mobile application developers is to develop a mobile application which supports all the devices and platforms on the market. This issue created a need for cross platform mobile applications. The cross platform mobile development refers to the development of mobile applications that could be use...

  12. Sight Application Analysis Tool

    Energy Technology Data Exchange (ETDEWEB)

    Bronevetsky, G. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2014-09-17

    The scale and complexity of scientific applications makes it very difficult to optimize, debug and extend them to support new capabilities. We have developed a tool that supports developers’ efforts to understand the logical flow of their applications and interactions between application components and hardware in a way that scales with application complexity and parallelism.

  13. SIMS applications workshop. Proceedings

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-04-01

    The first ANSTO/AINSE SIMS Workshop drew together a mixture of Surface Analysis experts and Surface Analysis users with the concept that SIMS analysis has to be enfolded within the spectrum of surface analysis techniques and that the user should select the technique most applicable to the problem. With this concept in mind the program was structured as sessions on SIMS Facilities; Applications to Mineral Surfaces; Applications to Biological Systems, Applications to Surfaces as Semi- conductors, Catalysts and Surface Coatings; and Applications to Ceramics

  14. Development and Application of Microfabricated Chemical Gas Sensors For Aerospace Applications

    Science.gov (United States)

    Hunter, G. W.; Neudeck, P. G.; Fralick, G.; Thomas, V.; Liu, C. C.; Wu, Q. H.; Sawayda, M. S.; Jin, A.; Hammond, J.; Makel, D.; hide

    1990-01-01

    Aerospace applications require the development of chemical sensors with capabilities beyond those of commercially available sensors. In particular, factors such as minimal sensor size, weight, and power consumption are particularly important. Development areas which have potential aerospace applications include launch vehicle leak detection, engine health monitoring and control, and fire detection. Sensor development for these applications is based on progress in three types of technology: 1) Micromachining and microfabrication (Microsystem) technology to fabricate miniaturized sensors. 2) The use of nanocrystalline materials to develop sensors with improved stability combined with higher sensitivity. 3) The development of high temperature semiconductors, especially silicon carbide. Sensor development for each application involves its own challenges in the fields of materials science and fabrication technology. This paper discusses the needs of space applications and the point-contact sensor technology being developed to address these needs. Sensors to measure hydrogen, hydrocarbons, nitrogen oxides (Nox, carbon monoxide, oxygen, and carbon dioxide are being developed. A description is given of each sensor type and its present stage of development. Demonstration and application these sensor technologies will be described. The demonstrations range from use of a microsystem based hydrogen sensor on the Shuttle to engine demonstration of a nanocrystalline based sensor for NO, detection. It is concluded that microfabricated sensor technology has significant potential for use in a range of aerospace applications.

  15. Application Portable Parallel Library

    Science.gov (United States)

    Cole, Gary L.; Blech, Richard A.; Quealy, Angela; Townsend, Scott

    1995-01-01

    Application Portable Parallel Library (APPL) computer program is subroutine-based message-passing software library intended to provide consistent interface to variety of multiprocessor computers on market today. Minimizes effort needed to move application program from one computer to another. User develops application program once and then easily moves application program from parallel computer on which created to another parallel computer. ("Parallel computer" also include heterogeneous collection of networked computers). Written in C language with one FORTRAN 77 subroutine for UNIX-based computers and callable from application programs written in C language or FORTRAN 77.

  16. A novel system for commissioning brachytherapy applicators: example of a ring applicator

    Science.gov (United States)

    Fonseca, Gabriel P.; Van den Bosch, Michiel R.; Voncken, Robert; Podesta, Mark; Verhaegen, Frank

    2017-11-01

    A novel system was developed to improve commissioning and quality assurance of brachytherapy applicators used in high dose rate (HDR). It employs an imaging panel to create reference images and to measure dwell times and dwell positions. As an example: two ring applicators of the same model were evaluated. An applicator was placed on the surface of an imaging panel and a HDR 192Ir source was positioned in an imaging channel above the panel to generate an image of the applicator, using the gamma photons of the brachytherapy source. The applicator projection image was overlaid with the images acquired by capturing the gamma photons emitted by the source dwelling inside the applicator. We verified 0.1, 0.2, 0.5 and 1.0 cm interdwell distances for different offsets, applicator inclinations and transfer tube curvatures. The data analysis was performed using in-house developed software capable of processing the data in real time, defining catheters and creating movies recording the irradiation procedure. One applicator showed up to 0.3 cm difference from the expected position for a specific dwell position. The problem appeared intermittently. The standard deviations of the remaining dwell positions (40 measurements) were less than 0.05 cm. The second ring applicator had a similar reproducibility with absolute coordinate differences from expected values ranging from  -0.10 up to 0.18 cm. The curvature of the transfer tube can lead to differences larger than 0.1 cm whilst the inclination of the applicator showed a negligible effect. The proposed method allows the verification of all steps of the irradiation, providing accurate information about dwell positions and dwell times. It allows the verification of small interdwell positions (⩽0.1 cm) and reduces measurement time. In addition, no additional radiation source is necessary since the HDR 192Ir source is used to generate an image of the applicator.

  17. Learning Android application testing

    CERN Document Server

    Blundell, Paul

    2015-01-01

    If you are an Android developer looking to test your applications or optimize your application development process, then this book is for you. No previous experience in application testing is required.

  18. Role of Pharmacovigilance in India: An overview.

    Science.gov (United States)

    Suke, Sanvidhan G; Kosta, Prabhat; Negi, Harsh

    2015-01-01

    Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV

  19. E-recruitment: a study into applicant perceptions of an online application system

    NARCIS (Netherlands)

    Sylva, H.; Mol, S.T.

    2009-01-01

    Little is known about applicant reactions to web-based recruitment and selection procedures. This study examines applicant perceptions of web-based procedures, based on a field study among 1360 applicants to a multinational financial services organization applying for jobs in the United Kingdom, the

  20. 77 FR 26507 - Application(s) for Duty-Free Entry of Scientific Instruments

    Science.gov (United States)

    2012-05-04

    ... States. Application accepted by Commissioner of Customs: March 29, 2012. Docket Number: 12-018. Applicant... general category manufactured in the United States. Application accepted by Commissioner of Customs: March...: The instrument will be used to investigate the genes and proteins that underlie normal and pathologic...

  1. MO-F-16A-08: Have An Impact On More Patients From Your Ideas And Inventions

    Energy Technology Data Exchange (ETDEWEB)

    Morton, R [Quality and Regulatory Services, Inc., Lincoln, CA (United States)

    2014-06-15

    Purpose: To inform physicists how to obtain an FDA 510(k) clearance for the innovations they use in their facility and to make those ideas widely available to patients throughout the U.S. Methods: Give advice from 20 years experience of assisting in well over 100 successful 510(k) clearances. Results: Learn how to develop a 510(k) submission. Conclusion: Many physicists, physicians and radiation therapists have developed innovations that that are helpful to the patients in their institution. But, many of these innovations deserve to be made available to patients throughout the United States. The author, a Certified Radiological Physicist and former FDA employee, has consulted for over twenty years for inventors, start-ups and established medical device manufacturers to bring new devices to market in the U.S. and to assist them to established FDA compliant quality systems for manufacturing. In this presentation the audience will learn the important points for deciding to go forward with obtaining a Premarket Notification clearance [also known as a 510(k) clearance] to legally market a medical device in the United States. The FDA has published guidelines for submitting a 510(k) application. However, the methods used to efficiently develop the documentation for submission and to obtain clearance in the shortest possible time comes from the author's experience in assisting well over one hundred successful 510(k) clearances.Whether you want to start your own company or to market your idea to an established medical device manufacturer, the value of your innovation increases with a documented 510(k) clearance from FDA.

  2. The Case for Requiring Graphic Warning Labels on Smokeless Tobacco Product Packages.

    Science.gov (United States)

    Pakhale, Smita; Samet, Jonathan; Folan, Patricia; Leone, Frank; White, Alexander

    2016-03-01

    On November 10, 2015, the U.S. Food and Drug Administration approved, for the first time, the sale of smokeless tobacco products authorized under the new premarket tobacco application pathway. This Food and Drug Administration regulatory decision draws attention to the growing worldwide use of smokeless tobacco products in general. Use of these tobacco products is particularly popular in low- and middle-income countries of Asia. Due to aggressive and strategic marketing to children, young adults, and current smokers, rates of smokeless tobacco use in men of all ages are on the rise in United States and elsewhere. The tobacco industry also continues to market these products to current cigarette smokers for use in the growing number of "smoke-free environments." Smokeless tobacco products are associated with cancers of the upper aerodigestive tract, particularly the oral cavity, esophagus, and pancreas; cardiovascular diseases; small-for-gestational-age infants; premature births; increased risk of apnea; and stillbirth. There is no convincing evidence regarding the efficacy of smokeless tobacco, including snus, to promote smoking cessation. Rather, studies from Europe and the United States demonstrate that smokeless tobacco use may facilitate regular cigarette smoking by acting as a gateway drug, especially for children. Caution is warranted before proposing smokeless tobacco as a harm-reduction strategy, in part because of the potential for further promoting smokeless tobacco in low- and middle-income countries where use is already widespread. Continued vigilance through comprehensive surveillance is warranted. We strongly recommend the use of graphic warning labels as a "no regrets" strategy for all smokeless tobacco products marketed globally.

  3. MO-F-16A-08: Have An Impact On More Patients From Your Ideas And Inventions

    International Nuclear Information System (INIS)

    Morton, R

    2014-01-01

    Purpose: To inform physicists how to obtain an FDA 510(k) clearance for the innovations they use in their facility and to make those ideas widely available to patients throughout the U.S. Methods: Give advice from 20 years experience of assisting in well over 100 successful 510(k) clearances. Results: Learn how to develop a 510(k) submission. Conclusion: Many physicists, physicians and radiation therapists have developed innovations that that are helpful to the patients in their institution. But, many of these innovations deserve to be made available to patients throughout the United States. The author, a Certified Radiological Physicist and former FDA employee, has consulted for over twenty years for inventors, start-ups and established medical device manufacturers to bring new devices to market in the U.S. and to assist them to established FDA compliant quality systems for manufacturing. In this presentation the audience will learn the important points for deciding to go forward with obtaining a Premarket Notification clearance [also known as a 510(k) clearance] to legally market a medical device in the United States. The FDA has published guidelines for submitting a 510(k) application. However, the methods used to efficiently develop the documentation for submission and to obtain clearance in the shortest possible time comes from the author's experience in assisting well over one hundred successful 510(k) clearances.Whether you want to start your own company or to market your idea to an established medical device manufacturer, the value of your innovation increases with a documented 510(k) clearance from FDA

  4. Guide to preemption of state-law claims against Class III PMA medical devices.

    Science.gov (United States)

    Whitney, Daniel W

    2010-01-01

    There is a perception that the express preemption holding of the Supreme Court in Riegel v. Medtronic, 552 U.S. 312(2008), immunizes medical device manufacturers from common law personal injury actions involving Class III devices that received FDA clearance under a premarket approval application (PMA). In the aftermath of Riegel, many lawsuits involving Class III PMA devices have been dismissed by district courts applying the new heightened pleading standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Other lawsuits involving Class III PMA devices premised on fraud-on-FDA have been dismissed based on the implied preemption holding of the Supreme Court in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). When these decisions are carefully analyzed together with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which found no preemption regarding a Class III device receiving FDA clearance through the 510(k) mechanism, it is apparent that the preemption defense does not apply universally to Class III PMA devices. The overall methodology for framing a non-preempted claim is to first identify conduct which violated the PMA or other specific requirements related to safety or efficacy. If such conduct can also be stated in terms of a breach of a parallel common law duty (e.g, failure to warn under strict liability or negligence, manufacturing defect or breach of warranty), then it would appear the claim is not preempted. Alternatively, regardless of a specific violation, common law remedies are not preempted by general CGMP requirements.

  5. Galileo Timing Applications

    Science.gov (United States)

    2007-11-01

    public bodies like university and research institutes. The user community analysis also includes a market analysis performed by a specialized company to... companies and public institutions (e.g., universities, research laboratories) that work in several different application domains in order to virtually...Summary of application domains for the use of time in cryptography. B2G B2B B2C Applications Military waypoints, judicial reports, construction

  6. Promise Zones for Applicants

    Data.gov (United States)

    Department of Housing and Urban Development — This tool assists applicants to HUD's Promise Zone initiative prepare data to submit with their application by allowing applicants to draw the exact location of the...

  7. Developing iPhone application

    OpenAIRE

    Nebo, Charles

    2015-01-01

    IPhone application popularity and demand are continuously on the increase since 2008 when Apple launched iPhone. Consequently, many applications are built targeting different user needs. But developing iPhone applications do have challenges. This research study explores current development study for developing iPhone application where the development environment and technologies are problematic. This paper intends to review some software development methodologies, methods, and techniques for ...

  8. 49 CFR 365.503 - Application.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Application. 365.503 Section 365.503... APPLICATIONS FOR OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers § 365.503 Application. (a) Each applicant applying under this subpart must submit an application that consists of: (1) Form...

  9. Android Applications Security

    OpenAIRE

    Paul POCATILU

    2011-01-01

    The use of smartphones worldwide is growing very fast and also the malicious attacks have increased. The mobile security applications development keeps the pace with this trend. The paper presents the vulnerabilities of mobile applications. The Android applications and devices are analyzed through the security perspective. The usage of restricted API is also presented. The paper also focuses on how users can prevent these malicious attacks and propose some prevention measures, including the a...

  10. Application Layer Multicast

    Science.gov (United States)

    Allani, Mouna; Garbinato, Benoît; Pedone, Fernando

    An increasing number of Peer-to-Peer (P2P) Internet applications rely today on data dissemination as their cornerstone, e.g., audio or video streaming, multi-party games. These applications typically depend on some support for multicast communication, where peers interested in a given data stream can join a corresponding multicast group. As a consequence, the efficiency, scalability, and reliability guarantees of these applications are tightly coupled with that of the underlying multicast mechanism.

  11. Quality attributes for mobile applications

    OpenAIRE

    Fernandes, João M.; Ferreira, André Leite

    2016-01-01

    A mobile application is a type of software application developed to run on a mobile device. The chapter discusses the main characteristics of mobile devices, since they have a great impact on mobile applications. It also presents the classification of mobile applications according to two main types: native and web-based applications. Finally, this chapter identifies the most relevant types of quality attributes for mobile applications. It shows that the relevant quality attributes for mobile ...

  12. The discovery of drug-induced illness.

    Science.gov (United States)

    Jick, H

    1977-03-03

    The increased use of drugs (and the concurrent increased risks of drug-induced illness) require definition of relevant research areas and strategy. For established marketed drugs, research needs depend on the magnitudes of risk of an illness from a drug and the base-line risk. With the drug risk high and the base-line risk low, the problem surfaces in premarketing studies or through the epidemic that develops after marketing. If the drug adds slightly to a high base-line risk, the effect is undetectable. When both risks are low, adverse effects can be discovered by chance, but systematic case-referent studies can speed discovery. If both risks are high, clinical trials and nonexperimental studies may be used. With both risks intermediate, systematic evaluations, especially case-referent studies are needed. Newly marketed drugs should be routinely evaluated through compulsory registration and follow-up study of the earliest users.

  13. New drugs and patient-centred end-points in old age: setting the wheels in motion.

    Science.gov (United States)

    Mangoni, Arduino A; Pilotto, Alberto

    2016-01-01

    Older patients with various degrees of frailty and disability, a key population target of pharmacological interventions in acute and chronic disease states, are virtually neglected in pre-marketing studies assessing the efficacy and safety of investigational drugs. Moreover, aggressively pursuing established therapeutic targets in old age, e.g. blood pressure, serum glucose or cholesterol concentrations, is not necessarily associated with the beneficial effects, and the acceptable safety, reported in younger patient cohorts. Measures of self-reported health and functional status might represent additional, more meaningful, therapeutic end-points in the older population, particularly in patients with significant frailty and relatively short life expectancy, e.g. in the presence of cancer and/or neurodegenerative disease conditions. Strategies enhancing early knowledge about key pharmacological characteristics of investigational drugs targeting older adults are discussed, together with the rationale for incorporating non-traditional, patient-centred, end-points in this ever-increasing group.

  14. OCT for industrial applications

    Science.gov (United States)

    Song, Guiju; Harding, Kevin

    2012-11-01

    Optical coherence tomography (OCT), as an interferometric method, has been studied as a distance ranger. As a technology capable of producing high-resolution, depth-resolved images of biological tissue, OCT had been widely used for the application of ophthalmology and has been commercialized in the market today. Enlightened by the emerging research interest in biomedical domain, the applications of OCT in industrial inspection were rejuvenated by a few groups to explore its potential for characterizing new materials, imaging or inspecting industrial parts as a service solution[3]. Benefiting from novel photonics components and devices, the industrial application of the older concepts in OCT can be re-visited with respect to the unique performance and availability. Commercial OCT developers such as Michelson Diagnostics (MDL; Orpington, U.K.) and Thorlabs (Newton, NJ) are actively exploring the application of OCT to industrial applications and they have outlined meaningful path toward the metrology application in emerging industry[3]. In this chapter, we will introduce the fundamental concepts of OCT and discuss its current and potential industrial applications.

  15. The fusion applications study - FAME

    International Nuclear Information System (INIS)

    Schultz, K.R.; Engholm, B.A.; Bourque, R.F.; Cheng, E.T.; Schaffer, M.J.; Wong, C.P.C.

    1986-01-01

    The Fusion Applications and Market Evaluation (''FAME'') study, being conducted by GA Technologies for Lawrence Livermore National Laboratory (LLNL) and US Department of Energy, Office of Fusion Energy, (US DOE) is described. This two-year program has a FY86 objective of Evaluating Alternative Applications of Fusion, and a FY87 goal of Exploring Innovative Applications. Applications are being reviewed and categorized into Baseline, Nuclear, Chemical, Electromagnetic, and Thermal application categories. The ''traditional'' applications of electricity generation, fissile fuel and tritium production, and hydrogen production continue to look attractive. Particularly promising new applications to date, with potential for near-term markets, are isotope production and radiation processing, especially when allied with the traditional application of electricity production. The economics of separate applications as well as coproduction are discussed. The combination of electricity and /sup 60/Co production appears to be one of the most attractive

  16. 78 FR 4094 - Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

    Science.gov (United States)

    2013-01-18

    ... devices. On August 8, 2001, the Orthopaedic and Rehabilitation Devices Panel (the Panel) recommended five... function due to excessive wear, fracture, deformation of the device components, or loosening of the device... excessive wear, fracture, deformation of the device components, or loosening of the device in the surgical...

  17. 78 FR 20268 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices...

    Science.gov (United States)

    2013-04-04

    ... PMA beyond 180 days unless the Agency finds that ``the continued availability of the device is... device that consists of an extracorporeal blood system and a container filled with adsorbent material... population, which typically exhibit severe underlying disease, comorbidities, and high mortality there is no...

  18. 75 FR 52294 - Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices

    Science.gov (United States)

    2010-08-25

    .... Electrical leakage can also cause electrical shock to the physician during placement or use of the device and... other causes, an intrusion of fluid into the pacemaker connection, an improper electrical connection to.... 3. Risks to Health a. Pregnancy--Leakage, breakage, dislodgement, or displacement of the device...

  19. 76 FR 44872 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Science.gov (United States)

    2011-07-27

    ... this device are inadequate, tissue damage can occur. 6. Unintended Stimulation Pacing pulses may... advises that to ensure timely filing of any such petition, any request should be submitted to the Division... timely request for a change in the classification of these devices is submitted, the Agency will, within...

  20. 75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

    Science.gov (United States)

    2010-03-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0143... confer any rights for or on any person and does not operate to bind FDA or the public. An alternative... is to discuss the most current information and thinking about clinical and basic aspects of the still...

  1. 77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Science.gov (United States)

    2012-06-22

    ... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive... of disuse, and FDA has concluded that there is little or no interest in marketing these devices in...

  2. 76 FR 50663 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

    Science.gov (United States)

    2011-08-16

    ... 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits..., and other advantages; distributive impacts; and equity). The Agency believes that this final rule is... is little or no interest in marketing these devices in the future. Therefore, the Agency certifies...

  3. 14 CFR 431.73 - Continuing accuracy of license application; application for modification of license.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Continuing accuracy of license application; application for modification of license. 431.73 Section 431.73 Aeronautics and Space COMMERCIAL SPACE... Conditions § 431.73 Continuing accuracy of license application; application for modification of license. (a...

  4. Fundamentals and applications of neutron imaging. Application part 9. Application of neutron imaging to biological research

    International Nuclear Information System (INIS)

    Kawabata, Yuji

    2007-01-01

    For radiography, the use of neutrons as a complement to X-rays is especially suitable for biological research such as plant, wood, and medical application due to the enhanced sensitivity to light elements such as hydrogen, carbon, and nitrogen. The present paper introduces applications of neutron CT to the humidity (water) distribution and its variation in the flowering plant as cut carnation, observation of water movement in refrigerated chrysanthemum leaves using very cold neutron and in cut leaves using deuterium oxide and ordinary water, measurement of water movement in sprouting cone and soy bean and growing ginseng in the soil, and other applications as to archaeological wood immersed in a restoration solution and to medical purposes. (S. Ohno)

  5. Applicant Satisfaction Survey

    Data.gov (United States)

    Office of Personnel Management — The Chief Human Capital Officers developed 3 surveys that asks applicants to assess their satisfaction with the application process on a 1-10 point scale, with 10...

  6. E-commerce Smartphone Application

    OpenAIRE

    Abdullah Saleh Alqahtani; Robert Goodwin

    2012-01-01

    Mobile and e-commerce applications are tools for accessing the Internet and for buying products and services. These applications are constantly evolving due to the high rate of technological advances being made. This paper provides a new perspective on the types of applications that can be used. It describes and analyses device requirements, provides a literature review of important aspects of mobile devices that can use such applications and the requirements of websites designed for m-commer...

  7. Technical applications of aerogels

    International Nuclear Information System (INIS)

    Hrubesh, L.W.

    1997-01-01

    Aerogel materials posses such a wide variety of exceptional properties that a striking number of applications have developed for them. Many of the commercial applications of aerogels such as catalysts, thermal insulation, windows, and particle detectors are still under development and new application as have been publicized since the ISA4 Conference in 1994: e.g.; supercapacitors, insulation for heat storage in automobiles, electrodes for capacitive deionization, etc. More applications are evolving as the scientific and engineering community becomes familiar with the unusual and exceptional physical properties of aerogels, there are also scientific and technical application, as well. This paper discusses a variety of applications under development at Lawrence Livermore National Laboratory for which several types of aerogels are formed in custom sizes and shapes. Particular discussions will focus on the uses of aerogels for physics experiments which rely on the exceptional, sometimes unique, properties of aerogels

  8. Web application for monitoring mainframe computer, Linux operating systems and application servers

    OpenAIRE

    Dimnik, Tomaž

    2016-01-01

    This work presents the idea and the realization of web application for monitoring the operation of the mainframe computer, servers with Linux operating system and application servers. Web application is intended for administrators of these systems, as an aid to better understand the current state, load and operation of the individual components of the server systems.

  9. Photovoltaic applications

    International Nuclear Information System (INIS)

    Sidrach, M.

    1992-01-01

    The most common terrestrial applications of photovoltaic plants are reviewed. Classification of applications can be done considering end-use sectors and load profiles (consumption demand). For those systems with direct coupling the working point is determined by the intersection of the load line with the I-V curve Design guidelines are provided for photovoltaic systems. This lecture focusses on the distribution system and safeguards

  10. Stirling engine application study

    Science.gov (United States)

    Teagan, W. P.; Cunningham, D.

    1983-01-01

    A range of potential applications for Stirling engines in the power range from 0.5 to 5000 hp is surveyed. Over one hundred such engine applications are grouped into a small number of classes (10), with the application in each class having a high degree of commonality in technical performance and cost requirements. A review of conventional engines (usually spark ignition or Diesel) was then undertaken to determine the degree to which commercial engine practice now serves the needs of the application classes and to detemine the nature of the competition faced by a new engine system. In each application class the Stirling engine was compared to the conventional engines, assuming that objectives of ongoing Stirling engine development programs are met. This ranking process indicated that Stirling engines showed potential for use in all application classes except very light duty applications (lawn mowers, etc.). However, this potential is contingent on demonstrating much greater operating life and reliability than has been demonstrated to date by developmental Stirling engine systems. This implies that future program initiatives in developing Stirling engine systems should give more emphasis to life and reliability issues than has been the case in ongoing programs.

  11. Mobile food ordering application

    OpenAIRE

    Yang, Fan

    2014-01-01

    The purpose of this thesis was to build a food ordering client server application for Tom Yum Thai Oy, which is a Thai restaurant in Vaasa. For the customer, this application provides a view of current food information (category, name, image,price, description etc.) on the website and Android application. The customer can order food from these two platforms. For the administrator in restaurant, this application offers a series of operations to add, update, delete and query the information of ...

  12. Industrial Application of Accelerators

    CERN Multimedia

    CERN. Geneva

    2017-01-01

    At CERN, we are very familiar with large, high energy particle accelerators. However, in the world outside CERN, there are more than 35000 accelerators which are used for applications ranging from treating cancer, through making better electronics to removing harmful micro-organisms from food and water. These are responsible for around $0.5T of commerce each year. Almost all are less than 20 MeV and most use accelerator types that are somewhat different from what is at CERN. These lectures will describe some of the most common applications, some of the newer applications in development and the accelerator technology used for them. It will also show examples of where technology developed for particle physics is now being studied for these applications. Rob Edgecock is a Professor of Accelerator Science, with a particular interest in the medical applications of accelerators. He works jointly for the STFC Rutherford Appleton Laboratory and the International Institute for Accelerator Applications at the Univer...

  13. Industrial Application of Accelerators

    CERN Multimedia

    CERN. Geneva

    2017-01-01

    At CERN, we are very familiar with large, high energy particle accelerators. However, in the world outside CERN, there are more than 35000 accelerators which are used for applications ranging from treating cancer, through making better electronics to removing harmful micro-organisms from food and water. These are responsible for around $0.5T of commerce each year. Almost all are less than 20 MeV and most use accelerator types that are somewhat different from what is at CERN. These lectures will describe some of the most common applications, some of the newer applications in development and the accelerator technology used for them. It will also show examples of where technology developed for particle physics is now being studied for these applications. Rob Edgecock is a Professor of Accelerator Science, with a particular interest in the medical applications of accelerators. He works jointly for the STFC Rutherford Appleton Laboratory and the International Institute for Accelerator Applications at the Uni...

  14. Applications of Photocatalytic Disinfection

    Directory of Open Access Journals (Sweden)

    Joanne Gamage

    2010-01-01

    Full Text Available Due to the superior ability of photocatalysis to inactivate a wide range of harmful microorganisms, it is being examined as a viable alternative to traditional disinfection methods such as chlorination, which can produce harmful byproducts. Photocatalysis is a versatile and effective process that can be adapted for use in many applications for disinfection in both air and water matrices. Additionally, photocatalytic surfaces are being developed and tested for use in the context of “self-disinfecting” materials. Studies on the photocatalytic technique for disinfection demonstrate this process to have potential for widespread applications in indoor air and environmental health, biological, and medical applications, laboratory and hospital applications, pharmaceutical and food industry, plant protection applications, wastewater and effluents treatment, and drinking water disinfection. Studies on photocatalytic disinfection using a variety of techniques and test organisms are reviewed, with an emphasis on the end-use application of developed technologies and methods.

  15. Android Applications Security

    Directory of Open Access Journals (Sweden)

    Paul POCATILU

    2011-01-01

    Full Text Available The use of smartphones worldwide is growing very fast and also the malicious attacks have increased. The mobile security applications development keeps the pace with this trend. The paper presents the vulnerabilities of mobile applications. The Android applications and devices are analyzed through the security perspective. The usage of restricted API is also presented. The paper also focuses on how users can prevent these malicious attacks and propose some prevention measures, including the architecture of a mobile security system for Android devices.

  16. 14 CFR 414.11 - Application.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Application. 414.11 Section 414.11 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...

  17. 32 CFR 724.113 - Application.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Application. 724.113 Section 724.113 National... Definitions § 724.113 Application. In the context of this Manual, a written application to the NDRB for the... must be used for the application. ...

  18. 45 CFR 2400.10 - Application.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Application. 2400.10 Section 2400.10 Public Welfare Regulations Relating to Public Welfare (Continued) JAMES MADISON MEMORIAL FELLOWSHIP FOUNDATION FELLOWSHIP PROGRAM REQUIREMENTS Application § 2400.10 Application. Eligible applicants for fellowships must...

  19. PSO-Ensemble Demo Application

    DEFF Research Database (Denmark)

    2004-01-01

    Within the framework of the PSO-Ensemble project (FU2101) a demo application has been created. The application use ECMWF ensemble forecasts. Two instances of the application are running; one for Nysted Offshore and one for the total production (except Horns Rev) in the Eltra area. The output...

  20. Applications of ionizing radiations

    International Nuclear Information System (INIS)

    2014-01-01

    Developments in standard applications and brand new nuclear technologies, with high impact on the future of the agriculture, medicine, industry and the environmental preservation. The Radiation Technology Center (CTR) mission is to apply the radiation and radioisotope technologies in Industry, Health, Agriculture, and Environmental Protection, expanding the scientific knowledge, improving human power resources, transferring technology, generating products and offering services for the Brazilian society. The CTR main R and D activities are in consonance with the IPEN Director Plan (2011-2013) and the Applications of Ionizing Radiation Program, with four subprograms: Irradiation of Food and Agricultural Products; Radiation and Radioisotopes Applications in Industry and Environment; Radioactive Sources and Radiation Applications in Human Health; and Radioactive Facilities and Equipment for the Applications of Nuclear Techniques

  1. GPU computing and applications

    CERN Document Server

    See, Simon

    2015-01-01

    This book presents a collection of state of the art research on GPU Computing and Application. The major part of this book is selected from the work presented at the 2013 Symposium on GPU Computing and Applications held in Nanyang Technological University, Singapore (Oct 9, 2013). Three major domains of GPU application are covered in the book including (1) Engineering design and simulation; (2) Biomedical Sciences; and (3) Interactive & Digital Media. The book also addresses the fundamental issues in GPU computing with a focus on big data processing. Researchers and developers in GPU Computing and Applications will benefit from this book. Training professionals and educators can also benefit from this book to learn the possible application of GPU technology in various areas.

  2. Applications of ionizing radiations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2014-07-01

    Developments in standard applications and brand new nuclear technologies, with high impact on the future of the agriculture, medicine, industry and the environmental preservation. The Radiation Technology Center (CTR) mission is to apply the radiation and radioisotope technologies in Industry, Health, Agriculture, and Environmental Protection, expanding the scientific knowledge, improving human power resources, transferring technology, generating products and offering services for the Brazilian society. The CTR main R and D activities are in consonance with the IPEN Director Plan (2011-2013) and the Applications of Ionizing Radiation Program, with four subprograms: Irradiation of Food and Agricultural Products; Radiation and Radioisotopes Applications in Industry and Environment; Radioactive Sources and Radiation Applications in Human Health; and Radioactive Facilities and Equipment for the Applications of Nuclear Techniques.

  3. 14 CFR 413.7 - Application.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Application. 413.7 Section 413.7 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LICENSE APPLICATION PROCEDURES § 413.7 Application. (a) Form. An application must be in...

  4. 24 CFR 941.301 - Application.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Application. 941.301 Section 941... PUBLIC HOUSING DEVELOPMENT Application and Proposal § 941.301 Application. If funding is made available for public housing development, HUD will provide information about fund allocation, application...

  5. SAMP: Application Messaging for Desktop and Web Applications

    Science.gov (United States)

    Taylor, M. B.; Boch, T.; Fay, J.; Fitzpatrick, M.; Paioro, L.

    2012-09-01

    SAMP, the Simple Application Messaging Protocol, is a technology which allows tools to communicate. It is deployed in a number of desktop astronomy applications including ds9, Aladin, TOPCAT, World Wide Telescope and numerous others, and makes it straightforward for a user to treat a selection of these tools as a loosely-integrated suite, combining the most powerful features of each. It has been widely used within Virtual Observatory contexts, but is equally suitable for non-VO use. Enabling SAMP communication from web-based content has long been desirable. An obvious use case is arranging for a click on a web page link to deliver an image, table or spectrum to a desktop viewer, but more sophisticated two-way interaction with rich internet applications would also be possible. Use from the web however presents some problems related to browser sandboxing. We explain how the SAMP Web Profile, introduced in version 1.3 of the SAMP protocol, addresses these issues, and discuss the resulting security implications.

  6. Application of fibre reinforced plastic sandwich structures for automotive crashworthiness applications

    NARCIS (Netherlands)

    Lukaszewicz, D.; Blok, L.G.; Kratz, J.; Ward, C.; Kassapoglou, C.; Elmarakbi, A.; Araújo, A.L.

    2016-01-01

    In this work the application of fibre reinforced plastic (FRP) sandwich
    structures, with particular focus on aramid fibre tufted sandwiches is being studied for
    automotive crashworthiness applications using impact testing and numerical simulation.

  7. Current status of postnatal depression smartphone applications available on application stores: an information quality analysis.

    Science.gov (United States)

    Zhang, Melvyn Wb; Ho, Roger Cm; Loh, Alvona; Wing, Tracey; Wynne, Olivia; Chan, Sally Wai Chi; Car, Josip; Fung, Daniel Shuen Sheng

    2017-11-14

    It is the aim of the current research to identify some common functionalities of postnatal application, and to determine the quality of the information content of postnatal depression application using validated scales that have been applied for applications in other specialties. To determine the information quality of the postnatal depression smartphone applications, the two most widely used smartphone application stores, namely Apple iTunes as well as Google Android Play store, were searched between 20May and 31 May. No participants were involved. The inclusion criteria for the application were that it must have been searchable using the keywords 'postnatal', 'pregnancy', 'perinatal', 'postpartum' and 'depression', and must be in English language. The Silberg Scale was used in the assessment of the information quality of the smartphone applications. The information quality score was the primary outcome measure. Our current results highlighted that while there is currently a myriad of applications, only 14 applications are specifically focused on postnatal depression. In addition, the majority of the currently available applications on the store have only disclosed their last date of modification as well as ownership. There remain very limited disclosures about the information of the authors, as well as the references for the information included in the application itself. The average score for the Silberg Scale for the postnatal applications we have analysed is 3.0. There remains a need for healthcare professionals and developers to jointly conceptualise new applications with better information quality and evidence base. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Excimer laser applications

    International Nuclear Information System (INIS)

    Fantoni, R.

    1988-01-01

    This lecture deals with laser induced material photoprocessing, especially concerning those processes which are initiated by u.v. lasers (mostly excimer laser). Advantages of using the u.v. radiation emitted by excimer lasers, both in photophysical and photochemical processes of different materials, are discussed in detail. Applications concerning microelectronics are stressed with respect to other applications in different fields (organic chemistry, medicine). As further applications of excimer lasers, main spectroscopic techniques for ''on line'' diagnostics which employ excimer pumped dye lasers, emitting tunable radiation in the visible and near u.v. are reviewed

  9. 14 CFR 372.30 - Application.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Application. 372.30 Section 372.30... REGULATIONS OVERSEAS MILITARY PERSONNEL CHARTERS Operating Authorization § 372.30 Application. (a) Application... Authorities Division, for filing instructions. The application shall be certified by a responsible official of...

  10. 23 CFR 625.3 - Application.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Application. 625.3 Section 625.3 Highways FEDERAL... FOR HIGHWAYS § 625.3 Application. (a) Applicable Standards. (1) Design and construction standards for..., policy, or standard specification will govern. (c) Application of FHWA regulations, although cited in...

  11. Mongoose for application development

    CERN Document Server

    Holmes, Simon

    2013-01-01

    This book is a mini tutorial full of code examples and strategies to give you plenty of options when building your own applications with MongoDB.This book is ideal for people who want to develop applications on the Node.js stack quickly and efficiently. Prior knowledge of the stack is not essential as the book briefly covers the installation of the core components and builds all aspects of the example application. The focus of the book is on what Mongoose adds to you applications, so experienced Node.js developers will also benefit.

  12. JavaScript Web Applications

    CERN Document Server

    MacCaw, Alex

    2011-01-01

    Building rich JavaScript applications that bring a desktop experience to the Web requires moving state from the server to the client side-not a simple task. This hands-on book takes proficient JavaScript developers through all the steps necessary to create state-of-the-art applications, including structure, templating, frameworks, communicating with the server, and many other issues. Throughout the book, you'll work with real-world example applications to help you grasp the concepts involved. Learn how to create JavaScript applications that offer a more responsive and improved experience. U

  13. Progressive Web applications

    CERN Multimedia

    CERN. Geneva

    2017-01-01

    Progressive Web Applications are native-like applications running inside of a browser context. In my presentation I would like describe their characteristics, benchmarks and building process using a quick and simple case study example with focus on Service Workers api.

  14. 49 CFR 385.603 - Application.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Application. 385.603 Section 385.603... Special Rules for New Entrant Non-North America-Domiciled Carriers § 385.603 Application. (a) Each applicant applying under this subpart must submit an application that consists of: (1) Form OP-1(NNA...

  15. 14 CFR 211.31 - Application.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Application. 211.31 Section 211.31... REGULATIONS APPLICATIONS FOR PERMITS TO FOREIGN AIR CARRIERS Freely Associated State Air Carriers § 211.31 Application. The application shall include, in addition to other requirements of this part, documentation...

  16. 25 CFR 67.6 - Application forms.

    Science.gov (United States)

    2010-04-01

    ... application form is filed by a sponsor, the name and address of the sponsor and the sponsor's relationship to... the applicant's mailing address on the application form. Thereafter, the applicant or sponsor shall... applicant. Otherwise, the mailing address as stated on the application form shall be accepted as the address...

  17. Radioisotopes production and applications

    International Nuclear Information System (INIS)

    Dash, Ashutosh

    2015-01-01

    Application of radioisotopes for both medical and industrial applications constitutes one of the most important peaceful uses of atomic energy. The striking diffusion and the exciting perspective of radioisotope for a plethora of medical and industrial applications are mainly attributable to the penetrating and ionization properties of radiation emanating from radioisotopes. The revolutionary medical applications of radioisotopes for the diagnosis and treatment of a multitude of diseases are causing a rapid expansion of the nuclear medicine field. While the industrial uses of radioisotopes are not expanding as quickly, also require large amounts of radioisotopes. Production of radioisotopes is not only the first step, but also the most crucial for the success as well as sustainable growth of radioisotope applications. With the rapid growth and expanding areas of applications, the demands for isotopes have increased several folds. A number of radioisotopes of different physical half-life, energy of the particle or gamma emission, specific activity and chemistry are now regularly produced both at commercial centers as well as at selected nuclear science research institutes utilizing reactors and cyclotrons to meet the ever growing need

  18. 21 CFR 812.20 - Application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Application. 812.20 Section 812.20 Food and Drugs... INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.20 Application. (a) Submission. (1) A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk device...

  19. 46 CFR 8.520 - Application.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Application. 8.520 Section 8.520 Shipping COAST GUARD... Streamlined Inspection Program § 8.520 Application. To apply for SIP enrollment, a company will submit an application, in writing, to the cognizant OCMI. The application must contain the following: (a) A statement...

  20. Direct application of geothermal energy

    Energy Technology Data Exchange (ETDEWEB)

    Reistad, G.M.

    1980-01-01

    An overall treatment of direct geothermal applications is presented with an emphasis on the above-ground engineering. The types of geothermal resources and their general extent in the US are described. The potential market that may be served with geothermal energy is considered briefly. The evaluation considerations, special design aspects, and application approaches for geothermal energy use in each of the applications are considered. The present applications in the US are summarized and a bibliography of recent studies and applications is provided. (MHR)

  1. Nanomaterials for Defense Applications

    Science.gov (United States)

    Turaga, Uday; Singh, Vinitkumar; Lalagiri, Muralidhar; Kiekens, Paul; Ramkumar, Seshadri S.

    Nanotechnology has found a number of applications in electronics and healthcare. Within the textile field, applications of nanotechnology have been limited to filters, protective liners for chemical and biological clothing and nanocoatings. This chapter presents an overview of the applications of nanomaterials such as nanofibers and nanoparticles that are of use to military and industrial sectors. An effort has been made to categorize nanofibers based on the method of production. This chapter particularly focuses on a few latest developments that have taken place with regard to the application of nanomaterials such as metal oxides in the defense arena.

  2. Enabling network-aware applications

    Energy Technology Data Exchange (ETDEWEB)

    Tierney, Brian L.; Gunter, Dan; Lee, Jason; Stouffer, Martin

    2001-08-01

    Many high performance distributed applications use only a small fraction of their available bandwidth. A common cause of this problem is not a flaw in the application design, but rather improperly tuned network settings. Proper tuning techniques, such as setting the correct TCP buffers and using parallel streams, are well known in the networking community, but outside the networking community they are infrequently applied. In this paper, we describe a service that makes the task of network tuning trivial for application developers and users. Widespread use of this service should virtually eliminate a common stumbling block for high performance distributed applications.

  3. Engineering Adaptive Applications

    DEFF Research Database (Denmark)

    Dolog, Peter

    for a domain.In this book, we propose a new domain engineering framework which extends a development process of Web applications with techniques required when designing such adaptive customizable Web applications. The framework is provided with design abstractions which deal separately with information served...

  4. Underground engineering applications

    International Nuclear Information System (INIS)

    Nordyke, M.D.

    1969-01-01

    Developments of any underground engineering application utilizing nuclear explosives involve answering the same questions one encounters in any new area of technology: What are the characteristics of the new tool? How is it applicable to the job to be done? Is it safe to use? and, most importantly, is its use economically acceptable? The many facets of the answers to these questions will be explored. The general types of application presently under consideration will also be reviewed, with particular emphasis on those specific projects actively being worked on by commercial interests and by the U.S. Atomic Energy Commission. (author)

  5. Underground engineering applications

    Energy Technology Data Exchange (ETDEWEB)

    Nordyke, M D [Lawrence Radiation Laboratory, Livermore, CA (United States)

    1969-07-01

    Developments of any underground engineering application utilizing nuclear explosives involve answering the same questions one encounters in any new area of technology: What are the characteristics of the new tool? How is it applicable to the job to be done? Is it safe to use? and, most importantly, is its use economically acceptable? The many facets of the answers to these questions will be explored. The general types of application presently under consideration will also be reviewed, with particular emphasis on those specific projects actively being worked on by commercial interests and by the U.S. Atomic Energy Commission. (author)

  6. Geometry and its applications

    CERN Document Server

    Meyer, Walter J

    2006-01-01

    Meyer''s Geometry and Its Applications, Second Edition, combines traditional geometry with current ideas to present a modern approach that is grounded in real-world applications. It balances the deductive approach with discovery learning, and introduces axiomatic, Euclidean geometry, non-Euclidean geometry, and transformational geometry. The text integrates applications and examples throughout and includes historical notes in many chapters. The Second Edition of Geometry and Its Applications is a significant text for any college or university that focuses on geometry''s usefulness in other disciplines. It is especially appropriate for engineering and science majors, as well as future mathematics teachers.* Realistic applications integrated throughout the text, including (but not limited to): - Symmetries of artistic patterns- Physics- Robotics- Computer vision- Computer graphics- Stability of architectural structures- Molecular biology- Medicine- Pattern recognition* Historical notes included in many chapters...

  7. 47 CFR 22.939 - Site availability requirements for applications competing with cellular renewal applications.

    Science.gov (United States)

    2010-10-01

    ... competing with cellular renewal applications. 22.939 Section 22.939 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES PUBLIC MOBILE SERVICES Cellular Radiotelephone Service § 22.939 Site availability requirements for applications competing with cellular renewal applications. In...

  8. PRIBIC Application

    International Nuclear Information System (INIS)

    Pascual Alonso, J.L.; Barcala Riveira, J.M.

    2002-01-01

    PRIBIC plant (Pollutants Reduction In small Biomass Combustion systems) at CEDER is a facility specifically designed to do biomass combustion tests. In these tests is necessary to know the values of different sensors in real time. With this information the PRIBIC plant is regulated to its optimum point of work and its possible to follow the operation criteria and get test objectives. Different electronic instruments record information about the plant operation. A software application was developed to let a centralised motorization of that information. The application communicates with the instrumentation, recovers data, lets operators see data in real time and saves the information in files. An important part of this document describes that application, and some considerations to generalise this kind of developments to other Experimental Plants, including cost estimations. Descriptions of plant, analysis of the problem, result evaluations, and conclusions can also be found in the document. (Author) 13 refs

  9. Applications of radionuclides in industry

    International Nuclear Information System (INIS)

    Leveque, P.

    1955-01-01

    After a brief recall of a few concepts (mass number, charge and beams properties) and the description of used detectors (ionization chamber, Geiger-Mueller counter, scintillation counters), some radionuclides applications are described. In a first part, the well-developed applications are presented in three distinct groups: continuous applications such as β and γ gauges (determination hydrogen content of an hydrocarbon and content of an emulsion; discharge of static electricity), discontinuous applications such as radiography and autoradiography, wear or manufacture problems (distribution of a fungicide on tobacco) and finally, applications in research laboratories such as diffusion, exchange and solubility. It also describes the applications which are still in development such as the action of beams on matter (reticulation and degradation of polymers, monomers polymerisation, cold sterilization). In conclusion, few advices on the opportunity of such applications and the choice of the radionuclides are given. (M.P.)

  10. Terahertz Sensing, Imaging and Applications

    Energy Technology Data Exchange (ETDEWEB)

    Otani, C.; Hoshing, H.; Sasaki, Y.; Maki, K.; Hayashi, A. [RIKEN Advanced Science Institute, Sendai (Japan)

    2008-11-15

    Diagnosis using terahertz (THz) wave holds a great potential for various applications in various fields because of its transmittance to many soft materials with the good spatial resolution. In addition, the presence of specific spectral absorption features of crystalline materials is also important for many applications. Such features are different from material to material to material and is applicable for identifying materials inside packages that are opaque to visible light. One of the most impressive examples of such applications is the detection of illicit drugs inside envelopes. In this talk, we will present our recent topics of THz sensing, imaging and applications including this example. We will also present the cancer diagnosis, an application of the photonic crystal to high sensitivity detection, and gas spectroscopy if we have enough time. We also would like to briefly review the recent topics related to THz applications.

  11. Terahertz Sensing, Imaging and Applications

    International Nuclear Information System (INIS)

    Otani, C.; Hoshing, H.; Sasaki, Y.; Maki, K.; Hayashi, A.

    2008-01-01

    Diagnosis using terahertz (THz) wave holds a great potential for various applications in various fields because of its transmittance to many soft materials with the good spatial resolution. In addition, the presence of specific spectral absorption features of crystalline materials is also important for many applications. Such features are different from material to material to material and is applicable for identifying materials inside packages that are opaque to visible light. One of the most impressive examples of such applications is the detection of illicit drugs inside envelopes. In this talk, we will present our recent topics of THz sensing, imaging and applications including this example. We will also present the cancer diagnosis, an application of the photonic crystal to high sensitivity detection, and gas spectroscopy if we have enough time. We also would like to briefly review the recent topics related to THz applications

  12. Electronic Submissions of Pesticide Applications

    Science.gov (United States)

    Applications for pesticide registration can be submitted electronically, including forms, studies, and draft product labeling. Applicants need not submit multiple electronic copies of any pieces of their applications.

  13. Oracle Application Express 4 Recipes

    CERN Document Server

    Zehoo, Edmund

    2011-01-01

    Oracle Application Express 4 Recipes provides an example-based approach to learning Application Express - the ground-breaking, rapid application development platform included with every Oracle Database license. The recipes format is ideal for the quick-study who just wants a good example or two to kick start their thinking and get pointed in the right direction. The recipes cover the gamut of Application Express development. Author and Application Express expert Edmund Zehoo shows how to create data entry screens, visualize data in the form of reports and charts, implement validation and back-

  14. LCS Content Document Application

    Science.gov (United States)

    Hochstadt, Jake

    2011-01-01

    My project at KSC during my spring 2011 internship was to develop a Ruby on Rails application to manage Content Documents..A Content Document is a collection of documents and information that describes what software is installed on a Launch Control System Computer. It's important for us to make sure the tools we use everyday are secure, up-to-date, and properly licensed. Previously, keeping track of the information was done by Excel and Word files between different personnel. The goal of the new application is to be able to manage and access the Content Documents through a single database backed web application. Our LCS team will benefit greatly with this app. Admin's will be able to login securely to keep track and update the software installed on each computer in a timely manner. We also included exportability such as attaching additional documents that can be downloaded from the web application. The finished application will ease the process of managing Content Documents while streamlining the procedure. Ruby on Rails is a very powerful programming language and I am grateful to have the opportunity to build this application.

  15. Database Application Schema Forensics

    Directory of Open Access Journals (Sweden)

    Hector Quintus Beyers

    2014-12-01

    Full Text Available The application schema layer of a Database Management System (DBMS can be modified to deliver results that may warrant a forensic investigation. Table structures can be corrupted by changing the metadata of a database or operators of the database can be altered to deliver incorrect results when used in queries. This paper will discuss categories of possibilities that exist to alter the application schema with some practical examples. Two forensic environments are introduced where a forensic investigation can take place in. Arguments are provided why these environments are important. Methods are presented how these environments can be achieved for the application schema layer of a DBMS. A process is proposed on how forensic evidence should be extracted from the application schema layer of a DBMS. The application schema forensic evidence identification process can be applied to a wide range of forensic settings.

  16. Application Security Automation

    Science.gov (United States)

    Malaika, Majid A.

    2011-01-01

    With today's high demand for online applications and services running on the Internet, software has become a vital component in our lives. With every revolutionary technology comes challenges unique to its characteristics; for online applications, security is one huge concern and challenge. Currently, there are several schemes that address…

  17. Comparing Android Applications to Find Copying

    Directory of Open Access Journals (Sweden)

    Larry Melling

    2012-03-01

    Full Text Available The Android smartphone operating system includes a Java mobile development platform that provides for rapid development and deployment of a wide variety of applications. The open nature of the platform means that reverse engineering of applications is relatively easy, and many developers are concerned as applications similar to their own show up in the Android marketplace and want to know if these applications are pirated. Fortunately, the same characteristics that make an Android application easy to reverse engineer and copy also provide opportunities for Android developers to compare downloaded applications to their own. This paper describes the process for comparing a developer’s application with a downloaded application and defines an identifiability metric to quantify the degree to which an application can be identified by its bytecode.

  18. Applications of high power microwaves

    International Nuclear Information System (INIS)

    Benford, J.; Swegle, J.

    1993-01-01

    The authors address a number of applications for HPM technology. There is a strong symbiotic relationship between a developing technology and its emerging applications. New technologies can generate new applications. Conversely, applications can demand development of new technological capability. High-power microwave generating systems come with size and weight penalties and problems associated with the x-radiation and collection of the electron beam. Acceptance of these difficulties requires the identification of a set of applications for which high-power operation is either demanded or results in significant improvements in peRFormance. The authors identify the following applications, and discuss their requirements and operational issues: (1) High-energy RF acceleration; (2) Atmospheric modification (both to produce artificial ionospheric mirrors for radio waves and to save the ozone layer); (3) Radar; (4) Electronic warfare; and (5) Laser pumping. In addition, they discuss several applications requiring high average power than border on HPM, power beaming and plasma heating

  19. 25 CFR 61.6 - Application forms.

    Science.gov (United States)

    2010-04-01

    ... is claimed. (2) If the application form is filed by a sponsor, the name and address of sponsor and... furnish the applicant's mailing address on the application form. Thereafter, the applicant or sponsor... identification of the application, otherwise the mailing address as stated on the form shall be acceptable as the...

  20. Publication misrepresentation among anesthesiology residency applicants.

    Science.gov (United States)

    Neuman, Stephanie A; Long, Timothy R; Rose, Steven H

    2011-03-01

    Publication misrepresentation has been documented among applicants for residency positions in several specialties. However, these data are not available for anesthesiology applicants. Our purpose in this study was to document the prevalence of publication misrepresentation among applicants to a single anesthesiology residency, to compare anesthesiology publication misrepresentation data with similar data in other specialties, and to determine how often publication misrepresentation leads to an unfair competitive advantage in the application process. Applications to the Mayo School of Graduate Medical Education anesthesiology core residency in Rochester, Minnesota, were reviewed for publication misrepresentations using Medline and PubMed databases, Mayo Clinic library databases, and/or review by a qualified medical librarian. Misrepresented publications underwent further review to identify fraudulent publications and/or citation errors that provide an unfair competitive advantage. The authors found that 2.4% of the applications (13 of 532) included fraudulent publications, 6.6% of the applications with at least 1 publication (13 of 197) included ≥1 that was fraudulent, and 2.9% of all cited publications (15 of 522) were fraudulent. In addition, 0.9% of the applications (5 of 532) contained a citation error that, although not grossly fraudulent, could have favorably affected the applicant's competitiveness for a residency position. Misrepresented publications were fairly common among anesthesiology residency applicants. However, only a small percentage of applicants listed misrepresented publications that were clearly fraudulent or contained a citation error that conferred a competitive advantage. Identification of fraudulent publications on Electronic Residency Application Service applications is important to maintain the integrity of the application process.

  1. Deaf mobile application accessibility requirements

    Science.gov (United States)

    Nathan, Shelena Soosay; Hussain, Azham; Hashim, Nor Laily

    2016-08-01

    Requirement for deaf mobile applications need to be analysed to ensure the disabilities need are instilled into the mobile applications developed for them. Universal design is understandable to comply every user needs, however specific disability is argued by the authors to have different need and requirements. These differences are among the reasons for these applications being developed to target for a specific group of people, however they are less usable and later abandoned. This study focuses on deriving requirements that are needed by the deaf in their mobile applications that are meant specifically for them. Studies on previous literature was conducted it can be concluded that graphic, text, multimedia and sign language interpreter are among mostly required features to be included in their mobile application to ensure the applications are usable for this community.

  2. Drug safety: withdrawn medications are only part of the picture.

    Science.gov (United States)

    Rawson, Nigel S B

    2016-02-13

    In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2.

  3. Gender Wage Disparities among the Highly Educated.

    Science.gov (United States)

    Black, Dan A; Haviland, Amelia; Sanders, Seth G; Taylor, Lowell J

    2008-01-01

    In the U.S. college-educated women earn approximately 30 percent less than their non-Hispanic white male counterparts. We conduct an empirical examination of this wage disparity for four groups of women-non-Hispanic white, black, Hispanic, and Asian-using the National Survey of College Graduates, a large data set that provides unusually detailed information on higher-level education. Nonparametric matching analysis indicates that among men and women who speak English at home, between 44 and 73 percent of the gender wage gaps are accounted for by such pre-market factors as highest degree and major. When we restrict attention further to women who have "high labor force attachment" (i.e., work experience that is similar to male comparables) we account for 54 to 99 percent of gender wage gaps. Our nonparametric approach differs from familiar regression-based decompositions, so for the sake of comparison we conduct parametric analyses as well. Inferences drawn from these latter decompositions can be quite misleading.

  4. Gender Wage Disparities among the Highly Educated

    Science.gov (United States)

    Black, Dan A.; Haviland, Amelia; Sanders, Seth G.; Taylor, Lowell J.

    2015-01-01

    In the U.S. college-educated women earn approximately 30 percent less than their non-Hispanic white male counterparts. We conduct an empirical examination of this wage disparity for four groups of women—non-Hispanic white, black, Hispanic, and Asian—using the National Survey of College Graduates, a large data set that provides unusually detailed information on higher-level education. Nonparametric matching analysis indicates that among men and women who speak English at home, between 44 and 73 percent of the gender wage gaps are accounted for by such pre-market factors as highest degree and major. When we restrict attention further to women who have “high labor force attachment” (i.e., work experience that is similar to male comparables) we account for 54 to 99 percent of gender wage gaps. Our nonparametric approach differs from familiar regression-based decompositions, so for the sake of comparison we conduct parametric analyses as well. Inferences drawn from these latter decompositions can be quite misleading. PMID:26097255

  5. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

    Science.gov (United States)

    Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

    2010-04-01

    Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

  6. Support vector machines applications

    CERN Document Server

    Guo, Guodong

    2014-01-01

    Support vector machines (SVM) have both a solid mathematical background and good performance in practical applications. This book focuses on the recent advances and applications of the SVM in different areas, such as image processing, medical practice, computer vision, pattern recognition, machine learning, applied statistics, business intelligence, and artificial intelligence. The aim of this book is to create a comprehensive source on support vector machine applications, especially some recent advances.

  7. Computer algebra applications

    International Nuclear Information System (INIS)

    Calmet, J.

    1982-01-01

    A survey of applications based either on fundamental algorithms in computer algebra or on the use of a computer algebra system is presented. Recent work in biology, chemistry, physics, mathematics and computer science is discussed. In particular, applications in high energy physics (quantum electrodynamics), celestial mechanics and general relativity are reviewed. (Auth.)

  8. Quality Analysis of Mobile Applications

    Directory of Open Access Journals (Sweden)

    Ion IVAN

    2011-01-01

    Full Text Available Mobile applications are defined and different types of mobile applications are identified. Characteristics of quality are defined and their indicators are constructed to measure levels. Take into account 11 parameters analysis for mobile applications, which are arranged using weights and do a detailed analysis of the system of weights. For SMSEncrypt application performance measurement is done using an aggregate indicator based on the obtained weights system.

  9. Thermal Cameras and Applications

    DEFF Research Database (Denmark)

    Gade, Rikke; Moeslund, Thomas B.

    2014-01-01

    Thermal cameras are passive sensors that capture the infrared radiation emitted by all objects with a temperature above absolute zero. This type of camera was originally developed as a surveillance and night vision tool for the military, but recently the price has dropped, significantly opening up...... a broader field of applications. Deploying this type of sensor in vision systems eliminates the illumination problems of normal greyscale and RGB cameras. This survey provides an overview of the current applications of thermal cameras. Applications include animals, agriculture, buildings, gas detection......, industrial, and military applications, as well as detection, tracking, and recognition of humans. Moreover, this survey describes the nature of thermal radiation and the technology of thermal cameras....

  10. Characterisation of a phenomenological model for commercial pneumatic muscle actuators.

    Science.gov (United States)

    Serres, J L; Reynolds, D B; Phillips, C A; Gerschutz, M J; Repperger, D W

    2009-08-01

    This study focuses on the parameter characterisation of a three-element phenomenological model for commercially available pneumatic muscle actuators (PMAs). This model consists of a spring, damping and contractile element arranged in parallel. Data collected from static loading, contraction and relaxation experiments were fitted to theoretical solutions of the governing equation for the three-element model resulting in prediction profiles for the spring, damping and contractile force coefficient. For the spring coefficient, K N/mm, the following relationships were found: K = 32.7 - 0.0321P for 150 < or = P < or = 314 kPa and K = 17 + 0.0179P for 314 < or = P < or = 550 kPa. For the damping coefficient, B Ns/mm, the following relationship was found during contraction: B = 2.90 for 150 < or = P < or = 550 kPa. During relaxation, B = 1.57 for 150 < or = P < or = 372 kPa and B = 0.311 + 0.00338P for 372 < or = P < or = 550. The following relationship for the contractile force coefficient, F(ce) N, was also determined: F(ce) = 2.91P+44.6 for 150 < or = P < or = 550 kPa. The model was then validated by reasonably predicting the response of the PMA to a triangular wave input in pressure under a constant load on a dynamic test station.

  11. The smart Peano fluidic muscle: a low profile flexible orthosis actuator that feels pain

    Science.gov (United States)

    Veale, Allan J.; Anderson, Iain A.; Xie, Shane Q.

    2015-03-01

    Robotic orthoses have the potential to provide effective rehabilitation while overcoming the availability and cost constraints of therapists. These orthoses must be characterized by the naturally safe, reliable, and controlled motion of a human therapist's muscles. Such characteristics are only possible in the natural kingdom through the pain sensing realized by the interaction of an intelligent nervous system and muscles' embedded sensing organs. McKibben fluidic muscles or pneumatic muscle actuators (PMAs) are a popular orthosis actuator because of their inherent compliance, high force, and muscle-like load-displacement characteristics. However, the circular cross-section of PMA increases their profile. PMA are also notoriously unreliable and difficult to control, lacking the intelligent pain sensing systems of their biological muscle counterparts. Here the Peano fluidic muscle, a new low profile yet high-force soft actuator is introduced. This muscle is smart, featuring bioinspired embedded pressure and soft capacitive strain sensors. Given this pressure and strain feedback, experimental validation shows that a lumped parameter model based on the muscle geometry and material parameters can be used to predict its force for quasistatic motion with an average error of 10 - 15N. Combining this with a force threshold pain sensing algorithm sets a precedent for flexible orthosis actuation that uses embedded sensors to prevent damage to the actuator and its environment.

  12. Origin of interfacial perpendicular magnetic anisotropy in MgO/CoFe/metallic capping layer structures.

    Science.gov (United States)

    Peng, Shouzhong; Wang, Mengxing; Yang, Hongxin; Zeng, Lang; Nan, Jiang; Zhou, Jiaqi; Zhang, Youguang; Hallal, Ali; Chshiev, Mairbek; Wang, Kang L; Zhang, Qianfan; Zhao, Weisheng

    2015-12-11

    Spin-transfer-torque magnetic random access memory (STT-MRAM) attracts extensive attentions due to its non-volatility, high density and low power consumption. The core device in STT-MRAM is CoFeB/MgO-based magnetic tunnel junction (MTJ), which possesses a high tunnel magnetoresistance ratio as well as a large value of perpendicular magnetic anisotropy (PMA). It has been experimentally proven that a capping layer coating on CoFeB layer is essential to obtain a strong PMA. However, the physical mechanism of such effect remains unclear. In this paper, we investigate the origin of the PMA in MgO/CoFe/metallic capping layer structures by using a first-principles computation scheme. The trend of PMA variation with different capping materials agrees well with experimental results. We find that interfacial PMA in the three-layer structures comes from both the MgO/CoFe and CoFe/capping layer interfaces, which can be analyzed separately. Furthermore, the PMAs in the CoFe/capping layer interfaces are analyzed through resolving the magnetic anisotropy energy by layer and orbital. The variation of PMA with different capping materials is attributed to the different hybridizations of both d and p orbitals via spin-orbit coupling. This work can significantly benefit the research and development of nanoscale STT-MRAM.

  13. Cloud Application Architectures Building Applications and Infrastructure in the Cloud

    CERN Document Server

    Reese, George

    2009-01-01

    If you're involved in planning IT infrastructure as a network or system architect, system administrator, or developer, this book will help you adapt your skills to work with these highly scalable, highly redundant infrastructure services. Cloud Application Architectures will help you determine whether and how to put your applications into these virtualized services, with critical guidance on issues of cost, availability, performance, scaling, privacy, and security.

  14. 47 CFR 76.502 - Time limits applicable to franchise authority consideration of transfer applications.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Time limits applicable to franchise authority... Cable Systems § 76.502 Time limits applicable to franchise authority consideration of transfer applications. (a) A franchise authority shall have 120 days from the date of submission of a completed FCC Form...

  15. Reconstruction of a ring applicator using CT imaging: impact of the reconstruction method and applicator orientation

    International Nuclear Information System (INIS)

    Hellebust, Taran Paulsen; Tanderup, Kari; Bergstrand, Eva Stabell; Knutsen, Bjoern Helge; Roeislien, Jo; Olsen, Dag Rune

    2007-01-01

    The purpose of this study is to investigate whether the method of applicator reconstruction and/or the applicator orientation influence the dose calculation to points around the applicator for brachytherapy of cervical cancer with CT-based treatment planning. A phantom, containing a fixed ring applicator set and six lead pellets representing dose points, was used. The phantom was CT scanned with the ring applicator at four different angles related to the image plane. In each scan the applicator was reconstructed by three methods: (1) direct reconstruction in each image (DR) (2) reconstruction in multiplanar reconstructed images (MPR) and (3) library plans, using pre-defined applicator geometry (LIB). The doses to the lead pellets were calculated. The relative standard deviation (SD) for all reconstruction methods was less than 3.7% in the dose points. The relative SD for the LIB method was significantly lower (p < 0.05) than for the DR and MPR methods for all but two points. All applicator orientations had similar dose calculation reproducibility. Using library plans for applicator reconstruction gives the most reproducible dose calculation. However, with restrictive guidelines for applicator reconstruction the uncertainties for all methods are low compared to other factors influencing the accuracy of brachytherapy

  16. Computer Applications in Educational Audiology.

    Science.gov (United States)

    Mendel, Lisa Lucks; And Others

    1995-01-01

    This article provides an overview of how computer technologies can be used by educational audiologists. Computer technologies are classified into three categories: (1) information systems applications; (2) screening and diagnostic applications; and (3) intervention applications. (Author/DB)

  17. MedlinePlus Connect: Web Application

    Science.gov (United States)

    ... MedlinePlus Connect → Web Application URL of this page: https://medlineplus.gov/connect/application.html MedlinePlus Connect: Web ... will change.) Old URLs New URLs Web Application https://apps.nlm.nih.gov/medlineplus/services/mpconnect.cfm? ...

  18. Credential Application Awaiting Information

    Data.gov (United States)

    Department of Homeland Security — When a Credential application or required documentation is incomplete, an Awaiting Information letter is issued. The application process cannot continue until all...

  19. Application analysis tools for ASIP design: application profiling and instruction-set customization

    National Research Council Canada - National Science Library

    Karuri, Kingshuk; Leupers, Ranier

    2011-01-01

    ... of the operating system they are targeting and execute them on the main application processor in the SmartPhone. However these are not the only applications that need to run on the SmartPhone. There are many underlying applications, or lets better call them algorithms, that have very demanding performance and power consumption targets, yet need to be flexible. Here is where the custom processor comes into play for the implementation of algorithms that will have certain variability but are covering a narrow enough design sp...

  20. Plagiarism in residency application essays.

    Science.gov (United States)

    Segal, Scott; Gelfand, Brian J; Hurwitz, Shelley; Berkowitz, Lori; Ashley, Stanley W; Nadel, Eric S; Katz, Joel T

    2010-07-20

    Anecdotal reports suggest that some residency application essays contain plagiarized content. To determine the prevalence of plagiarism in a large cohort of residency application essays. Retrospective cohort study. 4975 application essays submitted to residency programs at a single large academic medical center between 1 September 2005 and 22 March 2007. Specialized software was used to compare residency application essays with a database of Internet pages, published works, and previously submitted essays and the percentage of the submission matching another source was calculated. A match of more than 10% to an existing work was defined as evidence of plagiarism. Evidence of plagiarism was found in 5.2% (95% CI, 4.6% to 5.9%) of essays. The essays of non-U.S. citizens were more likely to demonstrate evidence of plagiarism. Other characteristics associated with the prevalence of plagiarism included medical school location outside the United States and Canada; previous residency or fellowship; lack of research experience, volunteer experience, or publications; a low United States Medical Licensing Examination Step 1 score; and non-membership in the Alpha Omega Alpha Honor Medical Society. The software database is probably incomplete, the 10%-match threshold for defining plagiarism has not been statistically validated, and the study was confined to applicants to 1 institution. Evidence of matching content in an essay cannot be used to infer the applicant's intent and is not sensitive to variations in the cultural context of copying in some societies. Evidence of plagiarism in residency application essays is more common in international applicants but was found in those by applicants to all specialty programs, from all medical school types, and even among applicants with significant academic honors. No external funding.

  1. Large-scale multimedia modeling applications

    International Nuclear Information System (INIS)

    Droppo, J.G. Jr.; Buck, J.W.; Whelan, G.; Strenge, D.L.; Castleton, K.J.; Gelston, G.M.

    1995-08-01

    Over the past decade, the US Department of Energy (DOE) and other agencies have faced increasing scrutiny for a wide range of environmental issues related to past and current practices. A number of large-scale applications have been undertaken that required analysis of large numbers of potential environmental issues over a wide range of environmental conditions and contaminants. Several of these applications, referred to here as large-scale applications, have addressed long-term public health risks using a holistic approach for assessing impacts from potential waterborne and airborne transport pathways. Multimedia models such as the Multimedia Environmental Pollutant Assessment System (MEPAS) were designed for use in such applications. MEPAS integrates radioactive and hazardous contaminants impact computations for major exposure routes via air, surface water, ground water, and overland flow transport. A number of large-scale applications of MEPAS have been conducted to assess various endpoints for environmental and human health impacts. These applications are described in terms of lessons learned in the development of an effective approach for large-scale applications

  2. Stable Structures for Distributed Applications

    Directory of Open Access Journals (Sweden)

    Eugen DUMITRASCU

    2008-01-01

    Full Text Available For distributed applications, we define the linear, tree and graph structure types with different variants and modalities to aggregate them. The distributed applications have assigned structures that through their characteristics influence the costs of stages for developing cycle and the costs for exploitation, transferred to each user. We also present the quality characteristics of a structure for a stable application, which is focused on stability characteristic. For that characteristic we define the estimated measure indicators for a level. The influence of the factors of stability and the ways for increasing it are thus identified, and at the same time the costs of development stages, the costs of usage and the costs of maintenance to be keep on between limits that assure the global efficiency of application. It is presented the base aspects for distributed applications: definition, peculiarities and importance. The aspects for the development cycle of distributed application are detailed. In this article, we alongside give the mechanisms for building the defined structures and analyze the complexity of the defined structures for a distributed application of a virtual store.

  3. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

    Science.gov (United States)

    2008-07-10

    The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

  4. Irregular Applications: Architectures & Algorithms

    Energy Technology Data Exchange (ETDEWEB)

    Feo, John T.; Villa, Oreste; Tumeo, Antonino; Secchi, Simone

    2012-02-06

    Irregular applications are characterized by irregular data structures, control and communication patterns. Novel irregular high performance applications which deal with large data sets and require have recently appeared. Unfortunately, current high performance systems and software infrastructures executes irregular algorithms poorly. Only coordinated efforts by end user, area specialists and computer scientists that consider both the architecture and the software stack may be able to provide solutions to the challenges of modern irregular applications.

  5. High resolution applications of laser-induced breakdown spectroscopy for environmental and forensic applications

    International Nuclear Information System (INIS)

    Martin, Madhavi Z.; Labbe, Nicole; Andre, Nicolas; Harris, Ronny; Ebinger, Michael; Wullschleger, Stan D.; Vass, Arpad A.

    2007-01-01

    Laser-induced breakdown spectroscopy (LIBS) has been used in the elemental analysis for a variety of environmental samples and as a proof of concept for a host of forensic applications. In the first application, LIBS was used for the rapid detection of carbon from a number of different soil types. In this application, a major breakthrough was achieved by using a multivariate analytical approach that has brought us closer towards a 'universal calibration curve'. In a second application, it has been demonstrated that LIBS in combination with multivariate analysis can be employed to analyze the chemical composition of annual tree growth rings and correlate them to external parameters such as changes in climate, forest fires, and disturbances involving human activity. The objectives of using this technology in fire scar determinations are: 1) To determine the characteristic spectra of wood exposed to forest fires and 2) To examine the viability of this technique for detecting fire occurrences in stems that did not develop fire scars. These examples demonstrate that LIBS-based techniques are inherently well suited for diverse environmental applications. LIBS was also applied to a variety of proof of concept forensic applications such as the analysis of cremains (human cremation remains) and elemental composition analysis of prosthetic implants

  6. Development Application - Terra Nova Development - Development Application Summary

    International Nuclear Information System (INIS)

    1996-01-01

    This summary is part of the application for approval of the development of the Terra Nova Field off the coast of Newfoundland, prepared and submitted by Petro-Canada, on behalf of, and with the cooperation of its co-proponents. The full application consists of five parts, comprising the development plan itself, the Canada-Newfoundland benefits plan detailing commitments with regards to contracts and employment, the environmental impact statement concerning the impact of development on the physical and biological environment, and a statement of socio-economic impacts, characterizing existing and projected impacts of the development on the fisheries, industry, employment, demography, social and public infrastructures and facilities, and socio-cultural issues

  7. Neutron sources and applications

    Energy Technology Data Exchange (ETDEWEB)

    Price, D.L. [ed.] [Argonne National Lab., IL (United States); Rush, J.J. [ed.] [National Inst. of Standards and Technology, Gaithersburg, MD (United States)

    1994-01-01

    Review of Neutron Sources and Applications was held at Oak Brook, Illinois, during September 8--10, 1992. This review involved some 70 national and international experts in different areas of neutron research, sources, and applications. Separate working groups were asked to (1) review the current status of advanced research reactors and spallation sources; and (2) provide an update on scientific, technological, and medical applications, including neutron scattering research in a number of disciplines, isotope production, materials irradiation, and other important uses of neutron sources such as materials analysis and fundamental neutron physics. This report summarizes the findings and conclusions of the different working groups involved in the review, and contains some of the best current expertise on neutron sources and applications.

  8. Neutron sources and applications

    International Nuclear Information System (INIS)

    Price, D.L.; Rush, J.J.

    1994-01-01

    Review of Neutron Sources and Applications was held at Oak Brook, Illinois, during September 8--10, 1992. This review involved some 70 national and international experts in different areas of neutron research, sources, and applications. Separate working groups were asked to (1) review the current status of advanced research reactors and spallation sources; and (2) provide an update on scientific, technological, and medical applications, including neutron scattering research in a number of disciplines, isotope production, materials irradiation, and other important uses of neutron sources such as materials analysis and fundamental neutron physics. This report summarizes the findings and conclusions of the different working groups involved in the review, and contains some of the best current expertise on neutron sources and applications

  9. 49 CFR 1018.1 - Application.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Application. 1018.1 Section 1018.1 Transportation Other Regulations Relating to Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION GENERAL RULES AND REGULATIONS DEBT COLLECTION Application and Coverage § 1018.1 Application. (a...

  10. Finite mathematics models and applications

    CERN Document Server

    Morris, Carla C

    2015-01-01

    Features step-by-step examples based on actual data and connects fundamental mathematical modeling skills and decision making concepts to everyday applicability Featuring key linear programming, matrix, and probability concepts, Finite Mathematics: Models and Applications emphasizes cross-disciplinary applications that relate mathematics to everyday life. The book provides a unique combination of practical mathematical applications to illustrate the wide use of mathematics in fields ranging from business, economics, finance, management, operations research, and the life and social sciences.

  11. Microprocessors principles and applications

    CERN Document Server

    Debenham, Michael J

    1979-01-01

    Microprocessors: Principles and Applications deals with the principles and applications of microprocessors and covers topics ranging from computer architecture and programmed machines to microprocessor programming, support systems and software, and system design. A number of microprocessor applications are considered, including data processing, process control, and telephone switching. This book is comprised of 10 chapters and begins with a historical overview of computers and computing, followed by a discussion on computer architecture and programmed machines, paying particular attention to t

  12. Microcomputer interfacing and applications

    CERN Document Server

    Mustafa, M A

    1990-01-01

    This is the applications guide to interfacing microcomputers. It offers practical non-mathematical solutions to interfacing problems in many applications including data acquisition and control. Emphasis is given to the definition of the objectives of the interface, then comparing possible solutions and producing the best interface for every situation. Dr Mustafa A Mustafa is a senior designer of control equipment and has written many technical articles and papers on the subject of computers and their application to control engineering.

  13. Applications of combinatorial optimization

    CERN Document Server

    Paschos, Vangelis Th

    2013-01-01

    Combinatorial optimization is a multidisciplinary scientific area, lying in the interface of three major scientific domains: mathematics, theoretical computer science and management. The three volumes of the Combinatorial Optimization series aims to cover a wide range of topics in this area. These topics also deal with fundamental notions and approaches as with several classical applications of combinatorial optimization. "Applications of Combinatorial Optimization" is presenting a certain number among the most common and well-known applications of Combinatorial Optimization.

  14. REST based mobile applications

    Science.gov (United States)

    Rambow, Mark; Preuss, Thomas; Berdux, Jörg; Conrad, Marc

    2008-02-01

    Simplicity is the major advantage of REST based webservices. Whereas SOAP is widespread in complex, security sensitive business-to-business aplications, REST is widely used for mashups and end-user centric applicatons. In that context we give an overview of REST and compare it to SOAP. Furthermore we apply the GeoDrawing application as an example for REST based mobile applications and emphasize on pros and cons for the use of REST in mobile application scenarios.

  15. Connected vehicle applications : safety.

    Science.gov (United States)

    2016-01-01

    Connected vehicle safety applications are designed to increase situational awareness : and reduce or eliminate crashes through vehicle-to-infrastructure, vehicle-to-vehicle, : and vehicle-to-pedestrian data transmissions. Applications support advisor...

  16. Adaptive Reactive Rich Internet Applications

    Science.gov (United States)

    Schmidt, Kay-Uwe; Stühmer, Roland; Dörflinger, Jörg; Rahmani, Tirdad; Thomas, Susan; Stojanovic, Ljiljana

    Rich Internet Applications significantly raise the user experience compared with legacy page-based Web applications because of their highly responsive user interfaces. Although this is a tremendous advance, it does not solve the problem of the one-size-fits-all approach1 of current Web applications. So although Rich Internet Applications put the user in a position to interact seamlessly with the Web application, they do not adapt to the context in which the user is currently working. In this paper we address the on-the-fly personalization of Rich Internet Applications. We introduce the concept of ARRIAs: Adaptive Reactive Rich Internet Applications and elaborate on how they are able to adapt to the current working context the user is engaged in. An architecture for the ad hoc adaptation of Rich Internet Applications is presented as well as a holistic framework and tools for the realization of our on-the-fly personalization approach. We divided both the architecture and the framework into two levels: offline/design-time and online/run-time. For design-time we explain how to use ontologies in order to annotate Rich Internet Applications and how to use these annotations for conceptual Web usage mining. Furthermore, we describe how to create client-side executable rules from the semantic data mining results. We present our declarative lightweight rule language tailored to the needs of being executed directly on the client. Because of the event-driven nature of the user interfaces of Rich Internet Applications, we designed a lightweight rule language based on the event-condition-action paradigm.2 At run-time the interactions of a user are tracked directly on the client and in real-time a user model is built up. The user model then acts as input to and is evaluated by our client-side complex event processing and rule engine.

  17. Technology and applications of broad-beam ion sources used in sputtering. Part II. Applications

    International Nuclear Information System (INIS)

    Harper, J.M.E.; Cuomo, J.J.; Kaufman, H.R.

    1982-01-01

    The developments in broad-beam ion source technology described in the companion paper (Part I) have stimulated a rapid expansion in applications to materials processing. These applications are reviewed here, beginning with a summary of sputtering mechanisms. Next, etching applications are described, including microfabrication and reactive ion beam etching. The developing area of surface layer applications is summarized, and related to the existing fields of oxidation and implantation. Next, deposition applications are reviewed, including ion-beam sputter deposition and the emerging technique of ion-assisted vapor deposition. Many of these applications have been stimulated by the development of high current ion sources operating in the energy range of tens of hundreds of eV. It is in this energy range that ion-activated chemical etching is efficient, self-limiting compound layers can be grown, and the physical properties of vapor-deposited films can be modified. In each of these areas, broad ion beam technology provides a link between other large area plasma processes and surface analytical techniques using ion beams

  18. Secure Java For Web Application Development

    CERN Document Server

    Bhargav, Abhay

    2010-01-01

    As the Internet has evolved, so have the various vulnerabilities, which largely stem from the fact that developers are unaware of the importance of a robust application security program. This book aims to educate readers on application security and building secure web applications using the new Java Platform. The text details a secure web application development process from the risk assessment phase to the proof of concept phase. The authors detail such concepts as application risk assessment, secure SDLC, security compliance requirements, web application vulnerabilities and threats, security

  19. Molecular imaging. Fundamentals and applications

    International Nuclear Information System (INIS)

    Tian, Jie

    2013-01-01

    Covers a wide range of new theory, new techniques and new applications. Contributed by many experts in China. The editor has obtained the National Science and Technology Progress Award twice. ''Molecular Imaging: Fundamentals and Applications'' is a comprehensive monograph which describes not only the theory of the underlying algorithms and key technologies but also introduces a prototype system and its applications, bringing together theory, technology and applications. By explaining the basic concepts and principles of molecular imaging, imaging techniques, as well as research and applications in detail, the book provides both detailed theoretical background information and technical methods for researchers working in medical imaging and the life sciences. Clinical doctors and graduate students will also benefit from this book.

  20. 48 CFR 1615.370 - Applicability.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Applicability. 1615.370 Section 1615.370 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES... Source Selection 1615.370 Applicability. FAR subpart 15.3 has no practical application to the FEHBP...

  1. SU-F-T-25: Design and Implementation of a Multi-Purpose Applicator for Pelvic Brachytherapy Applications

    Energy Technology Data Exchange (ETDEWEB)

    Bogue, J; Parsai, E [University of Toledo Medical Center, Toledo, OH (United States)

    2016-06-15

    Purpose: The current generation of inflatable multichannel brachytherapy applicators, such as the Varian Capri, have limited implementation to only vaginal and rectal cancers. While there are similar designs utilizing rigid, non-inflatable applicators, these alternatives could cause increased dose to surrounding tissue due to air gaps. Modification of the Capri could allow for easier treatment planning by reducing the number of channels and increased versatility by modifying the applicator to include an attachable single tandem for cervical or multiple tandems for endometrial applications. Methods: A Varian Capri applicator was simulated in water to replicate a patient. Multiple plans were optimized to deliver a prescribed dose of 100 cGy at 5mm away from the exterior of the applicator using six to thirteen existing channels. The current model was expanded upon to include a detachable tandem or multiple tandoms to increase its functionality to both cervical and endometrial cancers. Models were constructed in both threedimensional rendering software and Monte Carlo to allow prototyping and simulations. Results: Treatment plans utilizing six to thirteen channels produced limited dosimetric differences between channel arrangements, with a seven channel plan very closely approximating the thirteen channels. It was concluded that only seven channels would be necessary in future simulations to give an accurate representation of the applicator. Tandem attachments were prototyped for the applicator to demonstrate the ease of which they could be included. Future simulation in treatment planning software and Monte Carlo results will be presented to further define the ideal applicator geometry Conclusion: The current Capri applicator design could be easily modified to increase applicability to include cervical and endometrial treatments in addition to vaginal and rectal cancers. This new design helps in a more versatile single use applicator that can easily be inserted and to

  2. Applications of nonlinear fiber optics

    CERN Document Server

    Agrawal, Govind

    2008-01-01

    * The only book describing applications of nonlinear fiber optics * Two new chapters on the latest developments: highly nonlinear fibers and quantum applications* Coverage of biomedical applications* Problems provided at the end of each chapterThe development of new highly nonlinear fibers - referred to as microstructured fibers, holey fibers and photonic crystal fibers - is the next generation technology for all-optical signal processing and biomedical applications. This new edition has been thoroughly updated to incorporate these key technology developments.The bo

  3. Applications of photovoltaics

    International Nuclear Information System (INIS)

    Pearsall, N.

    1999-01-01

    The author points out that although photovoltaics can be used for generating electricity for the same applications as many other means of generation, they really come into their own where disadvantages associated with an intermittent unpredictable supply are not severe. The paper discusses the advantages and disadvantages to be taken into account when considering a photovoltaic power system. Five main applications, based on the system features, are listed and explained. They are: consumer, professional, rural electrification, building-integrated, centralised grid connected and space power. A brief history of the applications of photovoltaics is presented with statistical data on the growth of installed capacity since 1992. The developing market for photovoltaics is discussed together with how environmental issues have become a driver for development of building-integrated photovoltaics

  4. Improving Knowledge and Process for International Emergency Medicine Fellowship Applicants: A Call for a Uniform Application

    Directory of Open Access Journals (Sweden)

    Gabrielle A. Jacquet

    2013-01-01

    Full Text Available Background. There are currently 34 International Emergency Medicine (IEM fellowship programs. Applicants and programs are increasing in number and diversity. Without a standardized application, applicants have a difficulty approaching programs in an informed and an organized method; a streamlined application system is necessary. Objectives. To measure fellows’ knowledge of their programs’ curricula prior to starting fellowship and to determine what percent of fellows and program directors would support a universal application system. Methods. A focus group of program directors, recent, and current fellows convened to determine the most important features of an IEM fellowship application process. A survey was administered electronically to a convenience sample of 78 participants from 34 programs. Respondents included fellowship directors, fellows, and recent graduates. Results. Most fellows (70% did not know their program’s curriculum prior to starting fellowship. The majority of program directors and fellows support a uniform application service (81% and 67%, resp. and deadline (85% for both. A minority of program directors (35% and fellows (30% support a formal match. Conclusions. Program directors and fellows support a uniform application service and deadline, but not a formalized match. Forums for disseminating IEM fellowship information and for administering a uniform application service and deadline are currently in development to improve the process.

  5. 28 CFR 42.302 - Application.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Application. 42.302 Section 42.302... PROCEDURES Equal Employment Opportunity Program Guidelines § 42.302 Application. (a) Recipient means any... after either the promulgation of these amended guidelines, or the initial application for assistance is...

  6. 28 CFR 36.102 - Application.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Application. 36.102 Section 36.102... ACCOMMODATIONS AND IN COMMERCIAL FACILITIES General § 36.102 Application. (a) General. This part applies to any... courses related to applications, licensing, certification, or credentialing for secondary or postsecondary...

  7. 34 CFR 691.12 - Application.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Application. 691.12 Section 691.12 Education..., DEPARTMENT OF EDUCATION ACADEMIC COMPETITIVENESS GRANT (ACG) AND NATIONAL SCIENCE AND MATHEMATICS ACCESS TO RETAIN TALENT GRANT (NATIONAL SMART GRANT) PROGRAMS Application Procedures § 691.12 Application. (a) As...

  8. Exploiting chaos for applications.

    Science.gov (United States)

    Ditto, William L; Sinha, Sudeshna

    2015-09-01

    We discuss how understanding the nature of chaotic dynamics allows us to control these systems. A controlled chaotic system can then serve as a versatile pattern generator that can be used for a range of application. Specifically, we will discuss the application of controlled chaos to the design of novel computational paradigms. Thus, we present an illustrative research arc, starting with ideas of control, based on the general understanding of chaos, moving over to applications that influence the course of building better devices.

  9. Exploiting chaos for applications

    Energy Technology Data Exchange (ETDEWEB)

    Ditto, William L., E-mail: wditto@hawaii.edu [Department of Physics and Astronomy, University of Hawaii at Mānoa, Honolulu, Hawaii 96822 (United States); Sinha, Sudeshna, E-mail: sudeshna@iisermohali.ac.in [Indian Institute of Science Education and Research (IISER), Mohali, Knowledge City, Sector 81, SAS Nagar, PO Manauli 140306, Punjab (India)

    2015-09-15

    We discuss how understanding the nature of chaotic dynamics allows us to control these systems. A controlled chaotic system can then serve as a versatile pattern generator that can be used for a range of application. Specifically, we will discuss the application of controlled chaos to the design of novel computational paradigms. Thus, we present an illustrative research arc, starting with ideas of control, based on the general understanding of chaos, moving over to applications that influence the course of building better devices.

  10. Refrigeration systems and applications

    CERN Document Server

    Dincer, Ibrahim

    2010-01-01

    Refrigeration Systems and Applications, 2nd edition offers a comprehensive treatise that addresses real-life technical and operational problems, enabling the reader to gain an understanding of the fundamental principles and the practical applications of refrigeration technology. New and unique analysis techniques (including exergy as a potential tool), models, correlations, procedures and applications are covered, and recent developments in the field are included - many of which are taken from the author's own research activities in this area. The book also includes so

  11. Mobile applications and Virtual Observatory

    Science.gov (United States)

    Schaaff, A.; Jagade, S.

    2015-06-01

    Within a few years, smartphones and Internet tablets have become the devices to access Web or standalone applications from everywhere, with a rapid development of the bandwidth of the mobile networks (e.g. 4G). Internet tablets are used to take notes during meetings or conferences, to read scientific papers in public transportation, etc. A smartphone is for example a way to have your data in the pocket or to control, from everywhere, the progress of a heavy workflow process. These mobile devices have enough powerful hardware to run more and more complex applications for many use cases. In the field of astronomy it is possible to use these tools to access data via a simple browser, but also to develop native applications reusing libraries (written in Java for Android or Objective-C/Swift for iOS) developed for desktops/laptops. We describe the experiments conducted in this domain, at CDS and IUCAA, considering a mobile application as a native application as well as a Web application.

  12. Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel.

    Science.gov (United States)

    Stevens, W Grant; Harrington, Jennifer; Alizadeh, Kaveh; Berger, Lewis; Broadway, David; Hester, T Roderick; Kress, Donald; dʼIncelli, Rosalyn; Kuhne, JoAnn; Beckstrand, Maggi

    2012-11-01

    In March of 2012, the U.S. Food and Drug Administration approved Sientra's application for premarket approval for its Silimed brand silicone gel implants, based on data from the largest silicone gel breast implant study to date. This was the first approval for shaped silicone gel breast implants. This article presents the results of Sientra's study through 5 years. Sientra's study is an ongoing, 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's implants in patients undergoing augmentation and reconstruction. A total of 1788 subjects were implanted with 3506 implants, including 1116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction subjects. Physical evaluations and complications were recorded at each visit. Effectiveness was measured by postimplantation bra cup size and assessment of subject satisfaction and quality of life. Of the 1788 subjects, 571 underwent magnetic resonance imaging to assess silent rupture. Safety endpoints were analyzed using the Kaplan-Meier method. Across all cohorts, the risk of rupture was 1.8 percent (95 percent CI, 1.2 to 2.6 percent), the risk of capsular contracture (Baker grade III/IV) was 9.0 percent (95 percent CI, 7.6 to 10.6 percent), and the risk of reoperation was 23.8 percent (95 percent CI, 21.8 to 26.0 percent). Over 99 percent of surgeons reported satisfaction with the postoperative results, and subject satisfaction remained high 5 years after implantation. The 5-year results of Sientra's study continue to provide a comprehensive safety and effectiveness profile of Sientra's portfolio of Silimed brand shaped and round implants. Therapeutic, IV.

  13. Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.

    Science.gov (United States)

    Brooks, Steven S

    2017-06-01

    Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients. Copyright © 2017. Published by Elsevier Inc.

  14. Report of promotion expert commission for radiation application on 'Promotion of accelerator application study'

    International Nuclear Information System (INIS)

    1997-01-01

    This is a report published on June, 1996, by promotion expert commission for radiation application of the Atomic Energy Commission. Japanese research and development in the fields of forming and application techniques of radiation beams using accelerator is at comparatively high level in the world, and it seems to be important for Japan not only to maintain these research and development level but also to contribute to creation of worldwide intelligent welfare due to scientific technology. In this report, some investigations are conducted on present state and future view of the radiation application study using accelerator, accelerator facility necessary to promote such application study and a procedure to execute its smooth application. However, objects of the study are not limited only for physical study on elementary particle and atomic nucleus, but expanded to photon, electron, positron, muon, proton, neutron, various inonic beams and RI beams for radiations, which are widely applied to industries such as materials science, material engineering, bio-and life-science, medical science, technical engineering, and so forth, and which will be expected for large contribution to development of these industries. The following items are discussed here; 1) present state and future view of radiation application study using accelerator, 2) Accelerator to be prepared and its executing method, and 3) Promotion method of the accelerator application study. (G.K.)

  15. Veterinary School Applicants: Financial Literacy and Behaviors.

    Science.gov (United States)

    Carr, McKensie M; Greenhill, Lisa M

    2015-01-01

    Each year the Association of American Veterinary Medical Colleges (AAVMC) conducts a survey after the close of the Veterinary Medical College Application Service (VMCAS) application. The survey provides a glimpse into applicant behavior surrounding the veterinary school application process. Additional survey questions probe into applicant financial behaviors, use of financial products and services, and pet ownership. This article examines the 2013 survey data from applicants who successfully completed the application, with a focus on applicant financial literacy and behaviors. Data from the study revealed a disconnect between applicants' perception of their ability to deal with day-to-day finances and their actual financial behaviors, particularly for first-generation college student applicants and applicants who are racially/ethnically underrepresented in veterinary medicine (URVM). Many applicants were not able to accurately report the average veterinary school graduate's student debt level, which suggests the potential need for better education about the costs associated with attending veterinary school.

  16. Nanobiomaterials development and applications

    CERN Document Server

    Papaefthymiou-Davis, Georgia C

    2013-01-01

    Nanomaterials in Nanobiotechnologies: Preparation, Characterization, and ApplicationsBio-Inspired Magnetic NanoparticlesGeorgia C. Papaefthymiou and Eamonn DevlinNanoparticles for BioimagingHye Sun Park and Yong Taik LimBiomedical Applications of Dendrimer Porphyrin or PhthalocyanineWoo-Dong Jang and Won-Gun KohPolymeric Nanoparticles in Cancer TherapyHeebeom Koo, Ji Young Yhee, Ick Chan Kwon, Kwangmeyung Kim, and Ramesh SubbiahCarbon Nanotube BioconjugatesMonica Samal, Dong Kee Yi, and Shashadhar SamalBiocatalytic NanosystemsJaehong Lim and Su Seong LeeMagnetically Induced Hyperthermia for Biomedical ApplicationsMichael Fardis, Ioannis Rabias, Georgios Diamantopoulos, Eleni Karakosta, Danai Tsitrouli, Vassilios Tzitzios, and Georgios PapavassiliouSoft Block Nanobuilding: New Preparation Routes of Soft Nanomaterials Using BiomoleculesEngineered Biomolecules as NanomaterialsYun Jung Lee and Ki Tae NamNanomaterials and Bio-MEMS: Nano- and Microscale Hybridization of Materials and ApplicationsMicrofluidic-Based ...

  17. 77 FR 39953 - Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

    Science.gov (United States)

    2012-07-06

    ... bands to treat medical conditions other than malignancies through means other than heat. The devices are... body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and is intended for the treatment of medical conditions by means other than the generation of deep heat within...

  18. PRA insights applicable to the design of a broad applications test reactor

    International Nuclear Information System (INIS)

    Khericha, S.T.; Reilly, H.J.

    1993-01-01

    Design insights applicable to the design of a new Broad Applications Test Reactor (BATR), studied during Fiscal Years 1992 an d1993 at Idaho National Engineering Laboratory (INEL), are summarized. Sources of design insights include past probabilistic risk assessments (PRAs) and related studies for Department of Energy (DOE)-owned Class A reactors and for commercial reactors. The report includes preliminary risk allocations for the BATR. The survey addressed those design insights that would affect the reactor core damage frequency (CDF). The design insights, while selected specifically for BATR, should be applicable to any new advanced test reactor

  19. 8 CFR 245.2 - Application.

    Science.gov (United States)

    2010-01-01

    ... ADMITTED FOR PERMANENT RESIDENCE § 245.2 Application. (a) General—(1) Jurisdiction. USCIS has jurisdiction... on Form I-485, Application for Permanent Residence. The application must be accompanied by the..., deportation, or removal proceeding and who is in lawful V status shall not be deemed an abandonment of the...

  20. 18 CFR 284.501 - Applicability.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Applicability. 284.501 Section 284.501 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT... Applications for Market-Based Rates for Storage § 284.501 Applicability. Any pipeline or storage service...

  1. 23 CFR 1200.10 - Application.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Application. 1200.10 Section 1200.10 Highways NATIONAL... PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS Application, Approval, and Funding of the Highway Safety Program § 1200.10 Application. Each fiscal year, a State's...

  2. 48 CFR 225.502 - Application.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Application. 225.502....502 Application. (b) Use the following procedures instead of the procedures in FAR 25.502(b) for... of Payments Program, then only qualifying country end products are exempt from application of the Buy...

  3. Application coordination in pervasive systems

    CERN Document Server

    Majuntke, Verena Elisabeth

    2013-01-01

    Pervasive applications are designed to support users in their daily life. For this purpose, applications interact with their environment, i.e. their context. They are able to adapt themselves to context changes or to explicitly change the context via actuators. If multiple applications are executed in the same context, interferences are likely to occur. To manage interferences, a coordination framework is presented in this thesis. Interferences are detected using a context model and information about applications' interaction with the context. The resolution of interference is achieved through

  4. Designing and Programming CICS Applications

    CERN Document Server

    Horswill, John

    2011-01-01

    CICS is an application server that delivers industrial-strength, online transaction management for critical enterprise applications. Proven in the market for over 30 years with many of the world's leading businesses, CICS enables today's customers to modernize and extend their applications to take advantage of the opportunities provided by e-business while maximizing the benefits of their existing investments. Designing and Programming CICS Applications will benefit a diverse audience. It introduces new users of IBM's mainframe (OS/390) to CICS features. It shows experienced users how t

  5. Basics and application of PSpice

    International Nuclear Information System (INIS)

    Choi, Pyeong; Cho, Yong Beom; Mok, Hyeong Su; Baek, Dong CHeol

    2006-03-01

    This book is comprised of nineteenth chapters, which introduces basics and application of PSpice. The contents of this book are PSpice?, PSpice introduction, PSpice simulation, DC analysis, parametric analysis, Transient analysis, parametric analysis and measurements, Monte Carlo analysis, changing of device characteristic, ABM application. The elementary laws of circuit, R.L.C. basic circuit, Diode basic cc circuit, Transistor and EET basic circuit, OP-Amp basic circuit, Digital basic circuit, Analog, digital circuit practice, digital circuit application and practice and ABM circuit application and practice.

  6. Track formation. Principles and applications

    International Nuclear Information System (INIS)

    Monnin, M.

    1978-01-01

    The principles and technical aspects of track formation in insulating solids are first described. The characteristics of dialectic track detection are discussed from the technical point of view: the nature of the detectors, the chemical treatment, the sensitivity and the environmental conditions of use. The applications are reviewed. The principle of each type of applied research is described and then the applications are listed. When used as a detector, nuclear tracks can provide valuable information in a number of fields: element content determination and wrapping, imaging, radiation dosimetry, environmental studies, technological uses and miscellaneous other applications. The track-formation process can also be used for making well-defined holes; this method allows other applications which are also described. Finally, some possible future applications are mentioned. (author)

  7. 30 CFR 7.83 - Application requirements.

    Science.gov (United States)

    2010-07-01

    ...) Injector nozzle; (9) Injection fuel pump; (10) Governor; (11) Turbocharger, if applicable; (12) Aftercooler... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.83 Application requirements. (a) An application for approval of a diesel engine...

  8. Express web application development

    CERN Document Server

    Yaapa, Hage

    2013-01-01

    Express Web Application Development is a practical introduction to learning about Express. Each chapter introduces you to a different area of Express, using screenshots and examples to get you up and running as quickly as possible.If you are looking to use Express to build your next web application, ""Express Web Application Development"" will help you get started and take you right through to Express' advanced features. You will need to have an intermediate knowledge of JavaScript to get the most out of this book.

  9. Mobile Application Recommender System

    OpenAIRE

    Davidsson, Christoffer

    2010-01-01

    With the amount of mobile applications available increasing rapidly, users have to put a lot of effort into finding applications of interest. The purpose of this thesis is to investigate how to aid users in the process of discovering new mobile applications by providing them with recommendations. A prototype system is then built as a proof-of-concept. The work of the thesis is divided into three phases where the aim of the first phase is to study related work and related systems to identify p...

  10. Sensors Applications, Volume 4, Sensors for Automotive Applications

    Science.gov (United States)

    Marek, Jiri; Trah, Hans-Peter; Suzuki, Yasutoshi; Yokomori, Iwao

    2003-07-01

    An international team of experts from the leading companies in this field gives a detailed picture of existing as well as future applications. They discuss in detail current technologies, design and construction concepts, market considerations and commercial developments. Topics covered include vehicle safety, fuel consumption, air conditioning, emergency control, traffic control systems, and electronic guidance using radar and video. Meeting the growing need for comprehensive information on the capabilities, potentials and limitations of modern sensor systems, Sensors Applications is a book series covering the use of sophisticated technologies and materials for the creation of advanced sensors and their implementation in the key areas process monitoring, building control, health care, automobiles, aerospace, environmental technology and household appliances.

  11. 76 FR 50997 - Application(s) for Duty-Free Entry of Scientific Instruments

    Science.gov (United States)

    2011-08-17

    ... DEPARTMENT OF COMMERCE International Trade Administration Application(s) for Duty-Free Entry of..., School of Earth Sciences, 275 Mendenhall Laboratory, 125 South Oval Mall, Columbus, OH 43210. Instrument... and high-contrast images, a stage that is easy to move, a focus that does not change with changing...

  12. 28 CFR 18.2 - Application.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Application. 18.2 Section 18.2 Judicial Administration DEPARTMENT OF JUSTICE OFFICE OF JUSTICE PROGRAMS HEARING AND APPEAL PROCEDURES § 18.2 Application. (a) These procedures apply to all appeals and hearings of State formula or block grant applicants or...

  13. 76 FR 78628 - Copper Valley Electric Association, Inc.; Notice of Application and Applicant-Prepared EA...

    Science.gov (United States)

    2011-12-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13124-003] Copper Valley... Application: Major License. b. Project No.: P-13124-003. c. Date filed: August 30, 2011. d. Applicant: Copper.... 791 (a)-825(r). h. Applicant Contact: Robert A. Wilkinson, CEO, Copper Valley Electric Association...

  14. Magnesium motorcycle applications

    International Nuclear Information System (INIS)

    Jianyong Cao; Zonghe Zhang; Dongxia Xiang; Jun Wang

    2005-01-01

    Magnesium, the lightest engineering structural metal, has been comprehensively used in castings of aviation and aerospace, communication and transportation, and IT components. This paper introduced the history, advantages and difficulties of magnesium castings for motorcycle application as well as its application state in China. It also indicated the production situation of magnesium motorcycle components in CQMST and difficulties need to overcome for further development. (orig.)

  15. Technological laser application

    International Nuclear Information System (INIS)

    Shia, D.O.; Kollen, R.; Rods, U.

    1980-01-01

    Problems of the technological applications of lasers are stated in the popular form. Main requirements to a technological laser as well as problems arising in designing any system using lasers have been considered. Areas of the laser applications are described generally: laser treatment of materials, thermal treatment, welding, broach and drilling of holes, scribing, microtreatment and adjustment of resistors, material cutting, investigations into controlled thermonuclear fussion

  16. Instrumentation for Applied Physics and Industrial Applications: Applications of Detectors in Technology, Medicine and Other Fields

    CERN Document Server

    Hillemanns, H

    2011-01-01

    Instrumentation for Applied Physics and Industrial Applications in 'Applications of Detectors in Technology, Medicine and Other Fields', part of 'Landolt-Börnstein - Group I Elementary Particles, Nuclei and Atoms: Numerical Data and Functional Relationships in Science and Technology, Volume 21B2: Detectors for Particles and Radiation. Part 2: Systems and Applications'. This document is part of Part 2 'Principles and Methods' of Subvolume B 'Detectors for Particles and Radiation' of Volume 21 'Elementary Particles' of Landolt-Börnstein - Group I 'Elementary Particles, Nuclei and Atoms'. It contains the Section '7.3 Instrumentation for Applied Physics and Industrial Applications' of Chapter '7 Applications of Detectors in Technology; Medicine and Other Fields' with the content: 7.3 Instrumentation for Applied Physics and Industrial Applications 7.3.1 Applications of HEP Detectors 7.3.2 Fast Micro- and Nanoelectronics for Particle Detector Readout 7.3.2.1 Fast Counting Mode Front End Electronics 7.3.2.2 NINO,...

  17. 7 CFR 764.51 - Loan application.

    Science.gov (United States)

    2010-01-01

    ... to make a determination on the loan application. (e) The applicant need not submit any information... ordering a credit report on the applicant; (12) Verification of all debts; (13) Any additional information...-Doc OL request, the applicant must: (1) Be current on all payments to all creditors including the...

  18. Applications of Nano-optics.

    Science.gov (United States)

    Zhou, Changhe; Fainman, Yeshaiahu; Sheng, Yunlong

    2011-11-01

    As nanoscale fabrication techniques advance, nano-optics continues to offer enabling solutions to numerous practical applications for information optics. This Applied Optics feature issue focuses on the Application of Nano-optics. © 2011 Optical Society of America

  19. Active and passive beam application design guide for global application

    CERN Document Server

    Rimmer, Julian

    2015-01-01

    The Active and Passive Beam Application Design Guide is the result of collaboration by worldwide experts to give system designers a current, authoritative guide on successfully applying active and passive beam technology. Active and Passive Beam Application Design Guide provide energy-efficient methods of cooling, heating, and ventilating indoor areas, especially spaces that require individual zone control and where internal moisture loads are moderate. The systems are simple to operate, with low maintenance requirements. This book is an essential resource for consulting engineers, architects, owners, and contractors who are involved in the design, operation, and installation of these systems. Building on REHVA’s Chilled Beam Application Guidebook, this new guide provides up-to-date tools and advice for designing, commissioning, and operating chilled-beam systems to achieve a determined indoor climate, and includes examples of active and passive beam calculations and selections. Dual units (SI and I-P) are...

  20. Designing scientific applications on GPUs

    CERN Document Server

    Couturier, Raphael

    2013-01-01

    Many of today's complex scientific applications now require a vast amount of computational power. General purpose graphics processing units (GPGPUs) enable researchers in a variety of fields to benefit from the computational power of all the cores available inside graphics cards.Understand the Benefits of Using GPUs for Many Scientific ApplicationsDesigning Scientific Applications on GPUs shows you how to use GPUs for applications in diverse scientific fields, from physics and mathematics to computer science. The book explains the methods necessary for designing or porting your scientific appl

  1. The mobile application hacker's handbook

    CERN Document Server

    Chell, Dominic; Colley, Shaun; Whitehouse, Ollie

    2015-01-01

    See your app through a hacker's eyes to find the real sources of vulnerability The Mobile Application Hacker's Handbook is a comprehensive guide to securing all mobile applications by approaching the issue from a hacker's point of view. Heavily practical, this book provides expert guidance toward discovering and exploiting flaws in mobile applications on the iOS, Android, Blackberry, and Windows Phone platforms. You will learn a proven methodology for approaching mobile application assessments, and the techniques used to prevent, disrupt, and remediate the various types of attacks. Coverage i

  2. NASA technology applications team: Applications of aerospace technology

    Science.gov (United States)

    1993-01-01

    This report covers the activities of the Research Triangle Institute (RTI) Technology Applications Team for the period 1 October 1992 through 30 September 1993. The work reported herein was supported by the National Aeronautics and Space Administration (NASA), Contract No. NASW-4367. Highlights of the RTI Applications Team activities over the past year are presented in Section 1.0. The Team's progress in fulfilling the requirements of the contract is summarized in Section 2.0. In addition to our market-driven approach to applications project development, RTI has placed increased effort on activities to commercialize technologies developed at NASA Centers. These Technology Commercialization efforts are summarized in Section 3.0. New problem statements prepared by the Team in the reporting period are presented in Section 4.0. The Team's transfer activities for ongoing projects with the NASA Centers are presented in Section 5.0. Section 6.0 summarizes the status of four add-on tasks. Travel for the reporting period is described in Section 7.0. The RTI Team staff and consultants and their project responsibilities are listed in Appendix A. Appendix B includes Technology Opportunity Announcements and Spinoff! Sheets prepared by the Team while Appendix C contains a series of technology transfer articles prepared by the Team.

  3. 7 CFR 1610.4 - Loan applications.

    Science.gov (United States)

    2010-01-01

    ... Regulations of the Department of Agriculture (Continued) RURAL TELEPHONE BANK, DEPARTMENT OF AGRICULTURE LOAN POLICIES § 1610.4 Loan applications. No application for a loan will be considered for approval by the Bank... of the applicant for a Bank loan and the amount thereof. Loan application forms are available from...

  4. 50 CFR 85.21 - Application procedures.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Application procedures. 85.21 Section 85... Application for Grants § 85.21 Application procedures. (a) Eligible applicants will submit their proposals to..., Missouri, Ohio, and Wisconsin Division of Federal Aid, U.S. Fish and Wildlife Service, Bishop Henry Whipple...

  5. 8 CFR 1245.2 - Application.

    Science.gov (United States)

    2010-01-01

    ... ADJUSTMENT OF STATUS TO THAT OF PERSON ADMITTED FOR PERMANENT RESIDENCE § 1245.2 Application. (a) General—(1... Residence. The application must be accompanied by the appropriate fee as explained in the instructions to... in lawful V status shall not be deemed an abandonment of the application if, upon returning to this...

  6. 43 CFR 3.5 - Application.

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Application. 3.5 Section 3.5 Public Lands: Interior Office of the Secretary of the Interior PRESERVATION OF AMERICAN ANTIQUITIES § 3.5 Application. Each application for a permit should be filed with the Secretary having jurisdiction, and must be...

  7. 14 CFR 298.50 - Application.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Application. 298.50 Section 298.50... § 298.50 Application. (a) Any person desiring to provide air transportation as a commuter air carrier... Department— (1) An application in accordance with the requirements of parts 201 and 302 of this chapter; (2...

  8. Engineering Web Applications

    DEFF Research Database (Denmark)

    Casteleyn, Sven; Daniel, Florian; Dolog, Peter

    Nowadays, Web applications are almost omnipresent. The Web has become a platform not only for information delivery, but also for eCommerce systems, social networks, mobile services, and distributed learning environments. Engineering Web applications involves many intrinsic challenges due...... to their distributed nature, content orientation, and the requirement to make them available to a wide spectrum of users who are unknown in advance. The authors discuss these challenges in the context of well-established engineering processes, covering the whole product lifecycle from requirements engineering through...... design and implementation to deployment and maintenance. They stress the importance of models in Web application development, and they compare well-known Web-specific development processes like WebML, WSDM and OOHDM to traditional software development approaches like the waterfall model and the spiral...

  9. Connected vehicle application : safety.

    Science.gov (United States)

    2015-01-01

    Connected vehicle safety applications are designed to increase situational awareness : and reduce or eliminate crashes through vehicle-to-infrastructure (V2I), vehicle-to-vehicle (V2V), and vehicle-to-pedestrian (V2P) data transmissions. Applications...

  10. Evolution of Mobile Applications

    Directory of Open Access Journals (Sweden)

    Phongtraychack Anachack

    2018-01-01

    Full Text Available Currently, we can see the rapid evolution of mobile technology, which involves mobile communication, mobile hardware, and mobile software. Features of mobile phones largely depend on software. In contemporary information and communication age [1–4], mobile application is one of the most concerned and rapidly developing areas. At the same time, the development of mobile application undergoes great changes with the introduction of new software, service platforms and software development kits (SDK. These changes lead to appearance of many new service platforms such as Google with Android and Apple with iOS. This article presents the information about the evolution of mobile application, gives some statistical data on the past and present situation, demonstrates how individual users of mobile devices can benefit, and shows how mobile applications affect society from the ethical perspective.

  11. Designing Adaptive Web Applications

    DEFF Research Database (Denmark)

    Dolog, Peter

    2008-01-01

    Learning system to study a discipline. In business to business interaction, different requirements and parameters of exchanged business requests might be served by different services from third parties. Such applications require certain intelligence and a slightly different approach to design. Adpative web......The unique characteristic of web applications is that they are supposed to be used by much bigger and diverse set of users and stakeholders. An example application area is e-Learning or business to business interaction. In eLearning environment, various users with different background use the e......-based applications aim to leave some of their features at the design stage in the form of variables which are dependent on several criteria. The resolution of the variables is called adaptation and can be seen from two perspectives: adaptation by humans to the changed requirements of stakeholders and dynamic system...

  12. Engineering Adaptive Web Applications

    DEFF Research Database (Denmark)

    Dolog, Peter

    2007-01-01

    suit the user profile the most. This paper summarizes the domain engineering framework for such adaptive web applications. The framework provides guidelines to develop adaptive web applications as members of a family. It suggests how to utilize the design artifacts as knowledge which can be used......Information and services on the web are accessible for everyone. Users of the web differ in their background, culture, political and social environment, interests and so on. Ambient intelligence was envisioned as a concept for systems which are able to adapt to user actions and needs....... With the growing amount of information and services, the web applications become natural candidates to adopt the concepts of ambient intelligence. Such applications can deal with divers user intentions and actions based on the user profile and can suggest the combination of information content and services which...

  13. Food Applications and Regulation

    Science.gov (United States)

    Gálvez, Antonio; Abriouel, Hikmate; Omar, Nabil Ben; Lucas, Rosario

    This chapter deals with food applications of bacteriocins. Regulatory issues on the different possibilities for incorporating bacteriocins as bioprotectants are discussed. Specific applications of bacteriocins or bacteriocin-producing strains are described for main food categories, including milk and dairy products, raw meats, ready-to-eat meat and poultry products, fermented meats, fish and fish products or fermented fish. The last section of the chapter deals with applications in foods and beverages derived from plant materials, such as raw vegetable foods, fruits and fruit juices, cooked food products, fermented vegetable foods and ­fermented beverages. Results obtained for application of bacteriocins in combination with other hurdles are also discussed for each specific case, with a special emphasis on novel food packaging and food-processing technologies, such as irradiation, pulsed electric field treatments or high hydrostatic pressure treatment.

  14. Printing Technologies for Medical Applications.

    Science.gov (United States)

    Shafiee, Ashkan; Atala, Anthony

    2016-03-01

    Over the past 15 years, printers have been increasingly utilized for biomedical applications in various areas of medicine and tissue engineering. This review discusses the current and future applications of 3D bioprinting. Several 3D printing tools with broad applications from surgical planning to 3D models are being created, such as liver replicas and intermediate splints. Numerous researchers are exploring this technique to pattern cells or fabricate several different tissues and organs, such as blood vessels or cardiac patches. Current investigations in bioprinting applications are yielding further advances. As one of the fastest areas of industry expansion, 3D additive manufacturing will change techniques across biomedical applications, from research and testing models to surgical planning, device manufacturing, and tissue or organ replacement. Copyright © 2016. Published by Elsevier Ltd.

  15. Studies on deaf mobile application

    Science.gov (United States)

    Nathan, Shelena Soosay; Hussain, Azham; Hashim, Nor Laily

    2016-08-01

    The deaf normally considered to be disabled that do not need any mobile technology due to the inabilities of hearing and talking. However, many deaf are using mobile phone in their daily life for various purposes such as communication and learning. Many studies have attempted to identify the need of deaf people in mobile application and level of usage of the applications. This study aims in studying the recent research conducted on deaf mobile application to understand the level of importance of mobile technology for this disabled community. This paper enable identification of studies conducted are limited and the need of more research done of this disabled people to ensure their privilege of using mobile technology and its application, which leads to the identification of deaf user requirement for mobile application as future study.

  16. From initial application to routine operation: Reviewing the Applications for Power Uprates

    International Nuclear Information System (INIS)

    Garis, Ninos; Skaanberg, Lars

    2007-01-01

    Current plans for power uprates in Swedish nuclear power plants will lead to significant increases in seven units and a lesser increase in one unit. To date SKI has received six applications, and two more are due in 2007. A power uprate process is initiated by the application to the Government by a licensee for approval to increase the thermal output of a reactor unit. This request is addressed to the Government and is forwarded to SKI for a preliminary safety review. The result of the review is then provided by SKI as a basis for a governmental decision. Six applications have been taken through the first stage of the process; of these, three have received governmental approval and three are currently awaiting a decision. If the licensee's application is approved by the Government, deeper analyses and studies are required in order to modify the plant and update the safety analysis report and the associated technical specifications. SKI reviews this material on a continuous basis prior to test and routine operation at the increased power level. There are four stages that require attention and review by SKI; 1. Review of the application to the Government for approval to operate at increased power levels, and preparation of a suitable answer. 2. Review and approval of the preliminary safety analysis report (PSAR) 3. Review and approval of the application for testing at the higher power level 4. Review and approval of routine operation at the higher power level. A thorough description of the handling of a power uprate process can be found in the SKI PM (SKI-PM 04:11) that is available on the SKI website (in Swedish)

  17. Biomedical applications of polymers

    CERN Document Server

    Gebelein, C G

    1991-01-01

    The biomedical applications of polymers span an extremely wide spectrum of uses, including artificial organs, skin and soft tissue replacements, orthopaedic applications, dental applications, and controlled release of medications. No single, short review can possibly cover all these items in detail, and dozens of books andhundreds of reviews exist on biomedical polymers. Only a few relatively recent examples will be cited here;additional reviews are listed under most of the major topics in this book. We will consider each of the majorclassifications of biomedical polymers to some extent, inclu

  18. Professional Cocoa Application Security

    CERN Document Server

    Lee, Graham J

    2010-01-01

    The first comprehensive security resource for Mac and iPhone developers. The Mac platform is legendary for security, but consequently, Apple developers have little appropriate security information available to help them assure that their applications are equally secure. This Wrox guide provides the first comprehensive go-to resource for Apple developers on the available frameworks and features that support secure application development.: While Macs are noted for security, developers still need to design applications for the Mac and the iPhone with security in mind; this guide offers the first

  19. Superconductivity and its application

    International Nuclear Information System (INIS)

    Spadoni, M.

    1988-01-01

    This paper, after a short introduction to superconductivity and to multifilamentary superconducting composites is aiming to review the state of the art and the future perspective of some of the applications of the superconducting materials. The main interest is focussed to large scale applications like, for istance, magnets for accelerators or fusion reactors, superconducting system for NMR thomography, etc. A short paragraph is dedicated to applications for high sensitivity instrumentation. The paper is then concluded by some considerations about the potentialities of the newly discovered high critical temperature materials

  20. Professional Tizen application development

    CERN Document Server

    Jaygarl, HoJun; Kim, YoonSoo; Choi, Eunyoung; Bradwick, Kevin; Lansdell

    2014-01-01

    Create powerful, marketable applications with Tizen for the smartphone and beyond  Tizen is the only platform designed for multiple device categories that is HTML5-centric and entirely open source. Written by experts in the field, this comprehensive guide includes chapters on both web and native application development, covering subjects such as location and social features, advanced UIs, animations, sensors and multimedia. This book is a comprehensive resource for learning how to develop Tizen web and native applications that are polished, bug-free and ready to sell on a range of smart dev

  1. Developing Large Web Applications

    CERN Document Server

    Loudon, Kyle

    2010-01-01

    How do you create a mission-critical site that provides exceptional performance while remaining flexible, adaptable, and reliable 24/7? Written by the manager of a UI group at Yahoo!, Developing Large Web Applications offers practical steps for building rock-solid applications that remain effective even as you add features, functions, and users. You'll learn how to develop large web applications with the extreme precision required for other types of software. Avoid common coding and maintenance headaches as small websites add more pages, more code, and more programmersGet comprehensive soluti

  2. Professional mobile application development

    CERN Document Server

    McWherter, Jeff

    2012-01-01

    Create applications for all major smartphone platforms Creating applications for the myriad versions and varieties of mobile phone platforms on the market can be daunting to even the most seasoned developer. This authoritative guide is written in such as way that it takes your existing skills and experience and uses that background as a solid foundation for developing applications that cross over between platforms, thereby freeing you from having to learn a new platform from scratch each time. Concise explanations walk you through the tools and patterns for developing for all the mobile platfo

  3. 25 CFR 75.9 - Application form.

    Science.gov (United States)

    2010-04-01

    ... applicant. If the application is filed on behalf of a minor, the name and address of the person filing the application and his relationship to the minor. (b) The name, relationship, tribe and roll number of the ancestor or ancestors through whom enrollment rights are claimed, and whether applicant is enrolled with...

  4. Applications of artificial intelligence to rotorcraft

    Science.gov (United States)

    Abbott, Kathy H.

    1987-01-01

    The application of AI technology may have significant potential payoff for rotorcraft. In the near term, the status of the technology will limit its applicability to decision aids rather than total automation. The specific application areas are categorized into onboard and nonflight aids. The onboard applications include: fault monitoring, diagnosis, and reconfiguration; mission and tactics planning; situation assessment; navigation aids, especially in nap-of-the-earth flight; and adaptive man-machine interfaces. The nonflight applications include training and maintenance diagnostics.

  5. Retrieval operators of remote sensing applications

    International Nuclear Information System (INIS)

    Ahmad, T.; Shah, A.

    2014-01-01

    A set of operators of remote sensing applications have been proposed to fulfill most of the Functional Requirements (FR). These operators capture the functions of the applications, which can be considered as the services provided by the applications. In general, a good application meets maximum FR from user. In this paper, we have defined a remote sensing application by a set, having all images created at dissimilar time instances, and each image is categorized into set of different layers. (author)

  6. Dosimetry of Sr-90 ophthalmic applicators

    International Nuclear Information System (INIS)

    Reft, C.S.; Kuchnir, F.T.; Rosenberg, I.; Myrianthopoulos, L.C.

    1990-01-01

    Sr-90 ophthalmic applicators are commonly used for the treatment of superficial eye disorders. Although a variety of dosimetric devices such as film, thermoluminescent dosimeters (TLD's), ion chambers, and radiochromic foils have been used to measure the peak dose at the applicator surface, there is no internationally agreed upon calibration procedure. Recently, large discrepancies among calibrations of the same applicator at three institutions have been reported. Here we describe a technique to obtain the peak dose rate at the applicator surface using LiF TLD's. The technique can be used for the calibration of flat as well as curved surface applicators. Results for two flat and three concave applicators are presented. Our measurement of the surface dose rate for one of the flat applicators is compared with those obtained by four other institutions, each using different dosimetric devices

  7. 15 CFR 315.3 - Application.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Application. 315.3 Section 315.3...-VEHICLE MANUFACTURER § 315.3 Application. Any person in the United States desiring to be determined a bona... in accordance with the instructions set forth on the form and this part. Application forms may be...

  8. 21 CFR 808.20 - Application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Application. 808.20 Section 808.20 Food and Drugs....20 Application. (a) Any State or political subdivision may apply to the Food and Drug Administration... effect of law. However, an application for exemption may be submitted before the effective date of the...

  9. Energy applications of superconductivity

    International Nuclear Information System (INIS)

    Schneider, T.R.; Dale, S.J.; Wolf, S.M.

    1991-01-01

    Recent progress in developing high-temperature superconductors has enhanced the economic viability of energy applications such as power systems, motors, material processing and handling, refrigeration, transportation, and power electronics. This paper discusses the technical and economic issues associated with these applications

  10. Accounting Applications---Introduction

    OpenAIRE

    Joshua Ronen

    1980-01-01

    Introduction to special issue on accounting applications. By publishing these papers together in one issue of Management Science we wish to accomplish the dual purpose of exposing management scientists to the application of their discipline to important accounting problems and of allowing management scientists and accountants to interact in areas of research and problem-solving, thus stimulating the interest of readers who are concerned with the problems of accounting.

  11. Opal web services for biomedical applications.

    Science.gov (United States)

    Ren, Jingyuan; Williams, Nadya; Clementi, Luca; Krishnan, Sriram; Li, Wilfred W

    2010-07-01

    Biomedical applications have become increasingly complex, and they often require large-scale high-performance computing resources with a large number of processors and memory. The complexity of application deployment and the advances in cluster, grid and cloud computing require new modes of support for biomedical research. Scientific Software as a Service (sSaaS) enables scalable and transparent access to biomedical applications through simple standards-based Web interfaces. Towards this end, we built a production web server (http://ws.nbcr.net) in August 2007 to support the bioinformatics application called MEME. The server has grown since to include docking analysis with AutoDock and AutoDock Vina, electrostatic calculations using PDB2PQR and APBS, and off-target analysis using SMAP. All the applications on the servers are powered by Opal, a toolkit that allows users to wrap scientific applications easily as web services without any modification to the scientific codes, by writing simple XML configuration files. Opal allows both web forms-based access and programmatic access of all our applications. The Opal toolkit currently supports SOAP-based Web service access to a number of popular applications from the National Biomedical Computation Resource (NBCR) and affiliated collaborative and service projects. In addition, Opal's programmatic access capability allows our applications to be accessed through many workflow tools, including Vision, Kepler, Nimrod/K and VisTrails. From mid-August 2007 to the end of 2009, we have successfully executed 239,814 jobs. The number of successfully executed jobs more than doubled from 205 to 411 per day between 2008 and 2009. The Opal-enabled service model is useful for a wide range of applications. It provides for interoperation with other applications with Web Service interfaces, and allows application developers to focus on the scientific tool and workflow development. Web server availability: http://ws.nbcr.net.

  12. Automated Inadvertent Intruder Application

    International Nuclear Information System (INIS)

    Koffman, Larry D.; Lee, Patricia L.; Cook, James R.; Wilhite, Elmer L.

    2008-01-01

    The Environmental Analysis and Performance Modeling group of Savannah River National Laboratory (SRNL) conducts performance assessments of the Savannah River Site (SRS) low-level waste facilities to meet the requirements of DOE Order 435.1. These performance assessments, which result in limits on the amounts of radiological substances that can be placed in the waste disposal facilities, consider numerous potential exposure pathways that could occur in the future. One set of exposure scenarios, known as inadvertent intruder analysis, considers the impact on hypothetical individuals who are assumed to inadvertently intrude onto the waste disposal site. Inadvertent intruder analysis considers three distinct scenarios for exposure referred to as the agriculture scenario, the resident scenario, and the post-drilling scenario. Each of these scenarios has specific exposure pathways that contribute to the overall dose for the scenario. For the inadvertent intruder analysis, the calculation of dose for the exposure pathways is a relatively straightforward algebraic calculation that utilizes dose conversion factors. Prior to 2004, these calculations were performed using an Excel spreadsheet. However, design checks of the spreadsheet calculations revealed that errors could be introduced inadvertently when copying spreadsheet formulas cell by cell and finding these errors was tedious and time consuming. This weakness led to the specification of functional requirements to create a software application that would automate the calculations for inadvertent intruder analysis using a controlled source of input parameters. This software application, named the Automated Inadvertent Intruder Application, has undergone rigorous testing of the internal calculations and meets software QA requirements. The Automated Inadvertent Intruder Application was intended to replace the previous spreadsheet analyses with an automated application that was verified to produce the same calculations and

  13. Dosimetric differences between electrons beams with rio applicators of GMV and conventional Elekta applicators

    International Nuclear Information System (INIS)

    Sendon del Rio, J. R.; Ayala Lazaro, R.; Jimenez Rojas, M. R.; Gomez Cores, S.; Gonzalez Ruiz, C.; Garcia Hernandez, M. J.; Lopez Bote, M. A.

    2013-01-01

    Intraoperative radiotherapy (River) is a form of cancer treatment that consists of a session of radiation ionizing on macroscopic tumor or tumor bed surgically exposed. In our institution, is administered with beams of electrons in a Linear Accelerator for use general and adapted through specific (applicators RIVER). In this work we studied the dosimetry differences between modified by applicators electron beams conventional and they changed by applicators River. (Author)

  14. BEAM applications to polymer materials

    International Nuclear Information System (INIS)

    Tagawa, Seiichi

    1994-01-01

    Recently papers about beam applications to polymers have been increasing rapidly both in the fundamental and applied fields. Fairly large number of papers have been published in the fundamental aspects of radiation effects of beam applications to polymers such as pulse radiolysis and high density electronic excitation effects. A number of papers have been published in the more applied aspects of beam applications to polymers such as radiation processing and curing. The present paper describes recent beam applications to polymers. 1. Radiation Effects on Polymers; Radiation effects on polymers have been studied for more than 40 years. Most of work on radiation effects on polymers has been carried out by using high energy photon (gamma-ray) and electron beams, since polymers are sensitive to any kinds of ionizing radiation. Even non-ionizing radiation such as ultraviolet and visible light excites electronic excited states of polymers and then photo-chemical reactions of polymers are induced from the electronic excited states. Studies on radiation effects of other ionizing radiation on polymers have not been so popular for a long time. Recently application of new radiation such as ion beams to polymers have been worthy of remark in fields of advanced science and technology, since new radiation beams induce different radiation effects from those induced by high energy gamma-rays and electrons. 2. Beam Applications of Polymers; Recent progress in beam applications to polymers such as radiation processing and curing, x-ray and electron beam microlithography, and applications of new beams such as ion beams to polymers has been reviewed. (author)

  15. Smartphone Applications for Mental Health

    Science.gov (United States)

    Vona, Pamela L.; Santostefano, Antonella M.; Ciaravino, Samantha; Miller, Elizabeth; Stein, Bradley D.

    2016-01-01

    Abstract Many adolescents and adults do not seek treatment for mental health symptoms. Smartphone applications (apps) may assist individuals with mental health concerns in alleviating symptoms or increasing understanding. This study seeks to characterize apps readily available to smartphone users seeking mental health information and/or support. Ten key terms were searched in the Apple iTunes and Google Play stores: mental health, depression, anxiety, schizophrenia, bipolar, trauma, trauma in schools, post traumatic stress disorder (PTSD), child trauma, and bullying. A content analysis of the first 20 application descriptions retrieved per category was conducted. Out of 300 nonduplicate applications, 208 (70%) were relevant to search topic, mental health or stress. The most common purported purpose for the apps was symptom relief (41%; n = 85) and general mental health education (18%; n = 37). The most frequently mentioned approaches to improving mental health were those that may benefit only milder symptoms such as relaxation (21%; n = 43). Most app descriptions did not include information to substantiate stated effectiveness of the application (59%; n = 123) and had no mention of privacy or security (89%; n = 185). Due to uncertainty of the helpfulness of readily available mental health applications, clinicians working with mental health patients should inquire about and provide guidance on application use, and patients should have access to ways to assess the potential utility of these applications. Strategic policy and research developments are likely needed to equip patients with applications for mental health, which are patient centered and evidence based. PMID:27428034

  16. Peaceful applications of nuclear explosions

    International Nuclear Information System (INIS)

    Wallin, L.B.

    1975-12-01

    The intension of this report is to give a survey of the field of peaceful applications of nuclear explosions. As an introduction some examples of possibilities of application are given together with a simple description of nuclear explosions under ground. After a summary of what has been done and will be done in this field nationally and internationally, a short discussion of advantages and problems with peaceful application of nuclear explosions follows. The risks of spreading nuclear weapons due to this applications are also touched before the report is finished with an attempt to judge the future development in this field. (M.S.)

  17. iPhone Applications Tune-Up

    CERN Document Server

    Moses, Loyal

    2011-01-01

    Written to be read straight through as well as to be used as a technical reference, each chapter of this book focuses on an individual aspect of application performance and how it relates to the overall development and tune-up process. The reader will be introduced to the fundamentals of iOS performance bottlenecks and how poor application performance can and does affect a user's experience, adoption, and ultimately success This book is for iOS application developers who are interested in resolving application performance bottlenecks in both new and existing Xcode projects. Readers should be f

  18. Modelling Foundations and Applications

    DEFF Research Database (Denmark)

    This book constitutes the refereed proceedings of the 8th European Conference on Modelling Foundations and Applications, held in Kgs. Lyngby, Denmark, in July 2012. The 20 revised full foundations track papers and 10 revised full applications track papers presented were carefully reviewed...

  19. Medical application of EPR

    International Nuclear Information System (INIS)

    Eichhoff, Uwe; Hoefer, Peter

    2015-01-01

    Selected applications of continuous-wave EPR in medicine are reviewed. This includes detection of reactive oxygen and nitrogen species, pH measurements and oxymetry. Applications of EPR imaging are demonstrated on selected examples and future developments to faster imaging methods are discussed

  20. Nanomaterials in biomedical applications

    DEFF Research Database (Denmark)

    Christiansen, Jesper de Claville; Potarniche, Catalina-Gabriela; Vuluga, Z.

    2011-01-01

    Advances in nano materials have lead to applications in many areas from automotive to electronics and medicine. Nano composites are a popular group of nano materials. Nanocomposites in medical applications provide novel solutions to common problems. Materials for implants, biosensors and drug del...

  1. Applications of Evolutionary Computation

    NARCIS (Netherlands)

    Mora, Antonio M.; Squillero, Giovanni; Di Chio, C; Agapitos, Alexandros; Cagnoni, Stefano; Cotta, Carlos; Fernández De Vega, F; Di Caro, G A; Drechsler, R.; Ekárt, A; Esparcia-Alcázar, Anna I.; Farooq, M; Langdon, W B; Merelo-Guervós, J.J.; Preuss, M; Richter, O.-M.H.; Silva, Sara; Sim$\\$~oes, A; Squillero, Giovanni; Tarantino, Ernesto; Tettamanzi, Andrea G B; Togelius, J; Urquhart, Neil; Uyar, A S; Yannakakis, G N; Smith, Stephen L; Caserta, Marco; Ramirez, Adriana; Voß, Stefan; Squillero, Giovanni; Burelli, Paolo; Mora, Antonio M.; Squillero, Giovanni; Jan, Mathieu; Matthias, M; Di Chio, C; Agapitos, Alexandros; Cagnoni, Stefano; Cotta, Carlos; Fernández De Vega, F; Di Caro, G A; Drechsler, R.; Ekárt, A; Esparcia-Alcázar, Anna I.; Farooq, M; Langdon, W B; Merelo-Guervós, J.J.; Preuss, M; Richter, O.-M.H.; Silva, Sara; Sim$\\$~oes, A; Squillero, Giovanni; Tarantino, Ernesto; Tettamanzi, Andrea G B; Togelius, J; Urquhart, Neil; Uyar, A S; Yannakakis, G N; Caserta, Marco; Ramirez, Adriana; Voß, Stefan; Squillero, Giovanni; Burelli, Paolo; Esparcia-Alcazar, Anna I; Silva, Sara; Agapitos, Alexandros; Cotta, Carlos; De Falco, Ivanoe; Cioppa, Antonio Della; Diwold, Konrad; Ekart, Aniko; Tarantino, Ernesto; Vega, Francisco Fernandez De; Burelli, Paolo; Sim, Kevin; Cagnoni, Stefano; Simoes, Anabela; Merelo, J.J.; Urquhart, Neil; Haasdijk, Evert; Zhang, Mengjie; Squillero, Giovanni; Eiben, A E; Tettamanzi, Andrea G B; Glette, Kyrre; Rohlfshagen, Philipp; Schaefer, Robert; Caserta, Marco; Ramirez, Adriana; Voß, Stefan

    2015-01-01

    The application of genetic and evolutionary computation to problems in medicine has increased rapidly over the past five years, but there are specific issues and challenges that distinguish it from other real-world applications. Obtaining reliable and coherent patient data, establishing the clinical

  2. 47 CFR 76.41 - Franchise application process.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Franchise application process. 76.41 Section 76... MULTICHANNEL VIDEO AND CABLE TELEVISION SERVICE Cable Franchise Applications § 76.41 Franchise application process. (a) Definition. Competitive franchise applicant. For the purpose of this section, an applicant...

  3. Microtron for radiation applications

    International Nuclear Information System (INIS)

    Soni, H.C.; Ramamurthi, S.S.

    1993-01-01

    The electron accelerator called microtron is a powerful tool for research, medical and industrial applications which need electron beam in energy range of few tens of MeV. Either electron beam from microtron is directly used for radiation applications or electron beam is utilized to produce x-rays or neutrons which are eventually used for radiation applications. After considering the vast potential, lower cost, simpler construction and excellent quality of electron beam from microtron, it was decided to develop this machine at Centre for Advanced Technology (CAT). The microtrons in two standard models have been developed which will cover all the above mentioned applications except free electron lasers. The microtron of model 1 provides electron beam of 20 MeV, 15/30 mA and that of model 2 provides electron beam of 8/12 MeV, 50/30 mA. (author). 2 figs., 1 tab

  4. IOS SAFETY APPLICATION FOR UITM

    Directory of Open Access Journals (Sweden)

    MOHAMAD FAHMI HUSSIN

    2016-04-01

    Full Text Available This paper presents an iOS application, which is developed, to ensure that every task related to safety and health such as inspection, deviation analysis and accident reporting becomes more simple and easier. Normally, these three (3 tasks are done separately and the data are saved in different ways. These situations make the tasks become complicated and consume a lot of time. Therefore, this application is developed to overcome all the problems that occurred. The main objective of this application is to allow the user to handle inspection checklist, deviation analysis and accident reporting efficiently by using iOS devices such as iPhone and iPad. Hence, using iOS device, instead of using a lot of paper, can do all the tasks. Using Xcode SDK, which is the software that is used to develop iOS application, developed this application. Xcode use Objective-C as the programming language, which is quite similar with other programming languages such as C and C++. The final result of this project is that this application can handle all the three (3 tasks and the form or the findings can be emailed to the Safety and Health Officer (SHO. This application will reduce time consume to conduct safety inspection, deviation and reporting tasks as well as avoid delay that might happen while using the traditional method.

  5. Graphene energy storage and conversion applications

    CERN Document Server

    Liu, Zhaoping

    2014-01-01

    Series PrefacePrefaceAuthorsGraphene Overview; Xufeng Zhou, Wei Wang, and Zhaoping LiuSynthesis of Graphene; Wei Wang, Hailiang Cao, Xufeng Zhou, and Zhaoping LiuApplications of Graphene in Lithium Ion Batteries; Xufeng Zhou and Zhaoping LiuApplications of Graphene in New-Concept Batteries; Xufeng Zhou and Zhaoping LiuApplications of Graphene in Supercapacitors; Chao Zheng, Xufeng Zhou, Hailiang Cao, and Zhaoping LiuApplications of Graphene in Solar Cells; Fuqiang Huang, Dongyun Wan, Hui Bi, and Tianquan LinApplications of Graphene in Fuel Cells; Xuejun Zhou, Jinli Qiao, and Yuyu LiuIndex.

  6. The Management of the Citizen Oriented Applications

    Directory of Open Access Journals (Sweden)

    Ion IVAN

    2010-04-01

    Full Text Available The context of the knowledge based society is presented. The new user requirements in the context of the new society are analyzed. Basic concepts regarding the citizen oriented applications are presented. Issues specific to the citizen oriented applications are presented. The development cycle of the citizen oriented applications is analyzed. The particular elements for developing citizen oriented applications are described. The quality concept for the citizen oriented applications is defined. Quality characteristics and the costs of quality are defined and analyzed. A system of indicators for the quantification of the quality of the citizen oriented applications is developed. Ways of increasing the quality of the applications are analyzed. Issues as improving the users’ training level, implementing new development techniques, advanced testing techniques and the requirement of audit are approached. The concept of optimization is defined. Optimum criteria are defined and analyzed. Ways of optimizing applications are described. Security requirements are enumerated and described. The particularities of the security requirements for the citizen oriented applications are analyzed. Measures for ensuring the security of the citizen oriented applications are described. A citizen oriented application for the analysis of the structured entities is developed. The application collects data regarding the behavior of the users. The collected data are used for verifying the hypotheses regarding the quality characteristics if the citizen oriented informatics applications.

  7. iPhone Open Application Development Write Native Applications Using the Open Source Tool Chain

    CERN Document Server

    Zdziarski, Jonathan

    2008-01-01

    Developers everywhere are eager to create applications for the iPhone, and many of them prefer the open source, community-developed tool chain to Apple's own toolkit. This new edition of iPhone Open Application Development covers the latest version of the open toolkit -- now updated for Apple's iPhone 2.x software and iPhone 3G -- and explains in clear language how to create applications using Objective-C and the iPhone API.

  8. Other applications of ion microbeams

    International Nuclear Information System (INIS)

    Cookson, J.A.

    1987-01-01

    The paper concerns the analytical and non-analytical applications of ion microbeams. The analytical applications considered include:-fusion research, environmental studies, ion implantations and criminology, and each is briefly discussed. Non-analytical applications in which nuclear microprobes have been used include:-thickness and uniformity measurements, energy loss radiography, channelling contrast, tomography, topography, ion implantation, and detector testing, and these are also discussed. (UK)

  9. Pervasive Application Rights Management Architecture

    OpenAIRE

    Dusparic, Ivana

    2005-01-01

    This dissertation describes an application rights management architecture that combines license management with digital rights management to provide an integrated platform for the specification, generation, delivery and management of application usage rights for pervasive computing environments. A new rights expression language is developed, extended from the existing language, ODRL, which allows the expression of mobile application usage rights and supports fine-grained usage ...

  10. The application of RFQs

    International Nuclear Information System (INIS)

    Schempp, A.

    1992-01-01

    The Radio Frequency Quadrupole Accelerator (RFQ) has found wide application, not only as the preinjector linac for new high energy light ion accelerators but also in a variety of other projects. Progress in development has made ion linacs practical for medical and industrial applications including radiation therapy, isotope and neutron production, material modification and ion beam diagnostic. The paper discusses various projects together with applications in science where RFQs serve as stand-alone tools, for example for the calibration of detectors, as decelerators or as small compact beam sources for atomic physics and materials research. (Author) 7 figs., 40 refs

  11. Lift application development cookbook

    CERN Document Server

    Garcia, Gilberto T

    2013-01-01

    Lift Application Development Cookbook contains practical recipes on everything you will need to create secure web applications using this amazing framework.The book first teaches you basic topics such as starting a new application and gradually moves on to teach you advanced topics to achieve a certain task. Then, it explains every step in detail so that you can build your knowledge about how things work.This book is for developers who have at least some basic knowledge about Scala and who are looking for a functional, secure, and modern web framework. Prior experience with HTML and JavaScript

  12. Building Social Web Applications

    CERN Document Server

    Bell, Gavin

    2009-01-01

    Building a web application that attracts and retains regular visitors is tricky enough, but creating a social application that encourages visitors to interact with one another requires careful planning. This book provides practical solutions to the tough questions you'll face when building an effective community site -- one that makes visitors feel like they've found a new home on the Web. If your company is ready to take part in the social web, this book will help you get started. Whether you're creating a new site from scratch or reworking an existing site, Building Social Web Applications

  13. Technology Applications Team: Applications of aerospace technology

    Science.gov (United States)

    1993-01-01

    Highlights of the Research Triangle Institute (RTI) Applications Team activities over the past quarter are presented in Section 1.0. The Team's progress in fulfilling the requirements of the contract is summarized in Section 2.0. In addition to our market-driven approach to applications project development, RTI has placed increased effort on activities to commercialize technologies developed at NASA Centers. These Technology Commercialization efforts are summarized in Section 3.0. New problem statements prepared by the Team in the reporting period are presented in Section 4.0. The Team's transfer activities for ongoing projects with the NASA Centers are presented in Section 5.0. Section 6.0 summarizes the status of four add-on tasks. Travel for the reporting period is described in Section 7.0. The RTI Team staff and consultants and their project responsibilities are listed in Appendix A. The authors gratefully acknowledge the contributions of many individuals to the RTI Technology Applications Team program. The time and effort contributed by managers, engineers, and scientists throughout NASA were essential to program success. Most important to the program has been a productive working relationship with the NASA Field Center Technology Utilization (TU) Offices. The RTI Team continues to strive for improved effectiveness as a resource to these offices. Industry managers, technical staff, medical researchers, and clinicians have been cooperative and open in their participation. The RTI Team looks forward to continuing expansion of its interaction with U.S. industry to facilitate the transfer of aerospace technology to the private sector.

  14. WAPTT - Web Application Penetration Testing Tool

    Directory of Open Access Journals (Sweden)

    DURIC, Z.

    2014-02-01

    Full Text Available Web applications vulnerabilities allow attackers to perform malicious actions that range from gaining unauthorized account access to obtaining sensitive data. The number of reported web application vulnerabilities in last decade is increasing dramatically. The most of vulnerabilities result from improper input validation and sanitization. The most important of these vulnerabilities based on improper input validation and sanitization are: SQL injection (SQLI, Cross-Site Scripting (XSS and Buffer Overflow (BOF. In order to address these vulnerabilities we designed and developed the WAPTT (Web Application Penetration Testing Tool tool - web application penetration testing tool. Unlike other web application penetration testing tools, this tool is modular, and can be easily extended by end-user. In order to improve efficiency of SQLI vulnerability detection, WAPTT uses an efficient algorithm for page similarity detection. The proposed tool showed promising results as compared to six well-known web application scanners in detecting various web application vulnerabilities.

  15. Sharing Vital Signs between mobile phone applications.

    Science.gov (United States)

    Karlen, Walter; Dumont, Guy A; Scheffer, Cornie

    2014-01-01

    We propose a communication library, ShareVitalSigns, for the standardized exchange of vital sign information between health applications running on mobile platforms. The library allows an application to request one or multiple vital signs from independent measurement applications on the Android OS. Compatible measurement applications are automatically detected and can be launched from within the requesting application, simplifying the work flow for the user and reducing typing errors. Data is shared between applications using intents, a passive data structure available on Android OS. The library is accompanied by a test application which serves as a demonstrator. The secure exchange of vital sign information using a standardized library like ShareVitalSigns will facilitate the integration of measurement applications into diagnostic and other high level health monitoring applications and reduce errors due to manual entry of information.

  16. SAMP, the Simple Application Messaging Protocol: Letting applications talk to each other

    Science.gov (United States)

    Taylor, M. B.; Boch, T.; Taylor, J.

    2015-06-01

    SAMP, the Simple Application Messaging Protocol, is a hub-based communication standard for the exchange of data and control between participating client applications. It has been developed within the context of the Virtual Observatory with the aim of enabling specialised data analysis tools to cooperate as a loosely integrated suite, and is now in use by many and varied desktop and web-based applications dealing with astronomical data. This paper reviews the requirements and design principles that led to SAMP's specification, provides a high-level description of the protocol, and discusses some of its common and possible future usage patterns, with particular attention to those factors that have aided its success in practice.

  17. Functionalized carbon nanotubes: biomedical applications

    Science.gov (United States)

    Vardharajula, Sandhya; Ali, Sk Z; Tiwari, Pooja M; Eroğlu, Erdal; Vig, Komal; Dennis, Vida A; Singh, Shree R

    2012-01-01

    Carbon nanotubes (CNTs) are emerging as novel nanomaterials for various biomedical applications. CNTs can be used to deliver a variety of therapeutic agents, including biomolecules, to the target disease sites. In addition, their unparalleled optical and electrical properties make them excellent candidates for bioimaging and other biomedical applications. However, the high cytotoxicity of CNTs limits their use in humans and many biological systems. The biocompatibility and low cytotoxicity of CNTs are attributed to size, dose, duration, testing systems, and surface functionalization. The functionalization of CNTs improves their solubility and biocompatibility and alters their cellular interaction pathways, resulting in much-reduced cytotoxic effects. Functionalized CNTs are promising novel materials for a variety of biomedical applications. These potential applications are particularly enhanced by their ability to penetrate biological membranes with relatively low cytotoxicity. This review is directed towards the overview of CNTs and their functionalization for biomedical applications with minimal cytotoxicity. PMID:23091380

  18. Application-Defined Decentralized Access Control

    Science.gov (United States)

    Xu, Yuanzhong; Dunn, Alan M.; Hofmann, Owen S.; Lee, Michael Z.; Mehdi, Syed Akbar; Witchel, Emmett

    2014-01-01

    DCAC is a practical OS-level access control system that supports application-defined principals. It allows normal users to perform administrative operations within their privilege, enabling isolation and privilege separation for applications. It does not require centralized policy specification or management, giving applications freedom to manage their principals while the policies are still enforced by the OS. DCAC uses hierarchically-named attributes as a generic framework for user-defined policies such as groups defined by normal users. For both local and networked file systems, its execution time overhead is between 0%–9% on file system microbenchmarks, and under 1% on applications. This paper shows the design and implementation of DCAC, as well as several real-world use cases, including sandboxing applications, enforcing server applications’ security policies, supporting NFS, and authenticating user-defined sub-principals in SSH, all with minimal code changes. PMID:25426493

  19. Arithmetic circuits for DSP applications

    CERN Document Server

    Stouraitis, Thanos

    2017-01-01

    Arithmetic Circuits for DSP Applications is a complete resource on arithmetic circuits for digital signal processing (DSP). It covers the key concepts, designs and developments of different types of arithmetic circuits, which can be used for improving the efficiency of implementation of a multitude of DSP applications. Each chapter includes various applications of the respective class of arithmetic circuits along with information on the future scope of research. Written for students, engineers, and researchers in electrical and computer engineering, this comprehensive text offers a clear understanding of different types of arithmetic circuits used for digital signal processing applications. The text includes contributions from noted researchers on a wide range of topics, including a review o circuits used in implementing basic operations like additions and multiplications; distributed arithmetic as a technique for the multiplier-less implementation of inner products for DSP applications; discussions on look ...

  20. Industrial accelerators and their applications

    CERN Document Server

    Hamm, Marianne E

    2012-01-01

    This unique new book is a comprehensive review of the many current industrial applications of particle accelerators, written by experts in each of these fields. Readers will gain a broad understanding of the principles of these applications, the extent to which they are employed, and the accelerator technology utilized. The book also serves as a thorough introduction to these fields for non-experts and laymen. Due to the increased interest in industrial applications, there is a growing interest among accelerator physicists and many other scientists worldwide in understanding how accelerators are used in various applications. The government agencies that fund scientific research with accelerators are also seeking more information on the many commercial applications that have been or can be developed with the technology developments they are funding. Many industries are also doing more research on how they can improve their products or processes using particle beams.