Science.gov

Sample records for premarket applications pmas

  1. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... Review of New Tobacco Products; Availability; Agency Information Collection Activities; Proposed... ``Applications for Premarket Review of New Tobacco Products.'' The draft guidance is intended to assist persons submitting applications for new tobacco products under the Federal Food, Drug, and Cosmetic Act (the FD&C...

  2. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Confidentiality of data and information in a... General § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file. (a) A “PMA file” includes all data and information submitted with or incorporated by reference in...

  3. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES... the safety and effectiveness of the device that is the subject of the PMA and that is the basis for... under § 20.61; and (ii) Any personnel, medical, and similar information disclosure of which...

  4. 78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... nonclinical laboratory studies conducted in support of research and marketing applications for medical devices... clarification on GLP terminology, the types of medical device research or marketing applications that are... Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food...

  5. 78 FR 19714 - User Fees and Refunds for Premarket Approval Applications and Device Biologics License...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute...

  6. Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System.

    PubMed

    McInerney, Stephen

    2015-01-01

    Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if FDA has the statutory. authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, FDA published guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as "mobile medical applications." For the guidance to be effective, FDA must continue to work directly with all actors--including innovators, doctors, and patients--as the market for mobile health applications continues to develop. This Article argues that FDA should adopt a two-step plan--a pre-market notification program and a mobile medical application database--to aid in the successful implementation of its 2013 guidance. By doing so, FDA will ensure that this burgeoning market can reach its fullest potential.

  7. Structural precaution: the application of premarket approval schemes in EU food legislation.

    PubMed

    van der Meulen, Bernd M J; Bremmers, Harry J; Wijnands, Jo H M; Poppe, Krijn J

    2012-01-01

    Structural precaution refers to legal requirements by which food products (whether as ingredients, additives, genetically modified or innovative in some other form) are only admitted to the market after authorization by public authorities and till then are presumed unsafe. In the EU such authorization is granted after provision of conclusive scientific evidence of the product's safety by the applicant. The objective of this article is to critically evaluate structural precaution in the EU against the general principles of European and international law. Moreover, it addresses the positive and negative side-effects of structural precaution for food businesses. The methods which are applied are legal-systematic and empirical. Legal-systematic research shows that the European system of structural precaution may come into conflict with the principles of free trade. Empirical research on the effects of structural precaution shows that the barriers to market access impede food innovations, negatively impact competitiveness, and induce opportunistic strategic responses by food businesses. Among the opportunistic strategic responses that were identified are window-dressing, trespassing and circumventing. These may have adverse effects on food safety. This is remarkable since food safety is the key driving force behind the application of structural precaution. The article advocates an overhaul of the present European risk prevention framework. It argues that the newly proposed European legal framework for innovative foods only partly addresses the identified problems with which the food industry is confronted. Supplementary to legal-systematic overhaul, authorities should invest in accessibility and transparency of the legal framework and provide compliance assistance to reduce regulatory burdens.

  8. The regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts?

    PubMed

    Kerouac, James D

    2002-01-01

    This article discusses the Food and Drug Administration (FDA) authority to regulate home use diagnostics for genetic disorders based on the social effects of the devices in the premarket approval process (PMA). It begins with a discussion of the potential social impacts of home use genetic diagnostics, focusing particularly on the psychological effects of the devices. The article then discusses the FDA's past experience in regulating home use diagnostics for HIV and for drugs of abuse testing under its PMA authority. In approving PMA applications for home tests for HIV and drugs of abuse, the FDA has considered various social effects of the devices and tailored its approval to these considerations. However, the agency did not deny approval because of social considerations. The author argues that the FDA's past experience in approving PMA applications indicates both a willingness to consider social considerations in the PMA process and that the agency may deny a PMA application based on social considerations in appropriate circumstances. The author also argues that the FDA may deny application if the social impacts and other health risks of the device greatly outweigh the therapeutic benefits of the device. For example, in applications involving late onset genetic disorders for which no therapeutic options currently exist, the social risks of the device may be found to outweigh the benefits to health and therefore the FDA may deny a PMA application in these situations.

  9. 78 FR 44128 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... into class III by FDA are subject to premarket approval requirements. Premarket approval (PMA) is the.... An approved PMA is, in effect, a private license granted to the applicant for marketing a particular medical device. A class III device that fails to meet PMA requirements is considered to be...

  10. 75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317, FDA-2009-M-0369, FDA-2009-M... Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket...

  11. FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

    PubMed

    Jenson, Desmond; Lester, Joelle; Berman, Micah L

    2016-05-01

    Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process. PMID:27068243

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

    PubMed

    O'Neill, R T

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

  13. Lights out on federal power: A plan to privatize the PMAs

    SciTech Connect

    Block, M.K.; Shadegg, J.

    1997-11-01

    Privatizing the power marketing administrations makes sense. Unless these federal administrations are sold, taxpayers will continue to subsidize power to the rich, and the PMAs will distort and hinder competition in the electric energy market. Employ this plan today and it will be possible to achieve benefits for all stakeholders. If there were a book entitled Privatization in The United States, it would be very thin indeed. It would be so partly because America did not participate as extensively as most countries in this century`s destructive experiment where governments produced goods that would be more efficiently produced by the private sector. Unfortunately, the book also would be thin because Americans have been less aggressive and imaginative than countries from Great Britain to Bolivia in withdrawing their national government from activities better suited to the private sector. One obvious target for immediate privatization is the federal electric power resources. This article proposes a politically viable plan to expand privatization in America by selling three of the federal government`s power marketing administrations. The PMAs, as they are known to the cognoscenti, market power generated by federally owned dams. Currently, the federal government is the nation`s largest producer and transmitter of electricity. While the government`s involvement in the electricity industry was once justified, these reasons no longer exist.

  14. 21 CFR 884.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such... regulation classifying the device unless the manufacturer has an approval under section 515 of the act... of the act consists of FDA's issuance of an order approving an application for premarket...

  15. 21 CFR 880.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such... regulation classifying the device unless the manufacturer has an approval under section 515 of the act... of the act consists of FDA's issuance of an order approving an application for premarket...

  16. 77 FR 39924 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... permanent pacemaker electrode industry to obtain an approved PMA or establish a PDP before marketing new... be distributed among device manufacturers, patients and insurance providers. For a new product (i.e... filing of a premarket approval application (PMA) or a notice of completion of a product...

  17. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... use, and the directions for its use. Where applicable, photographs or engineering drawings should...

  18. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... HUMAN SERVICES Food and Drug Administration Content of Premarket Submissions for Management of... Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket... draft guidance document entitled ``Content of Premarket Submissions for Management of Cybersecurity...

  19. Mapping the starburst in blue compact dwarf galaxies. PMAS integral field spectroscopy of Mrk 1418

    NASA Astrophysics Data System (ADS)

    Cairós, L. M.; Caon, N.; Zurita, C.; Kehrig, C.; Weilbacher, P.; Roth, M.

    2009-12-01

    Aims: By means of optical integral field spectroscopy observations, we aim to differentiate and characterize the starburst component in the blue compact dwarf (BCD) galaxy Mrk 1418. In particular we propose to study the stellar and ionized gas morphology, to investigate the ionization mechanism(s) acting in the interstellar medium, and to derive the physical parameters and abundances of the ionized gas. Methods: Integral field spectroscopy observations of Mrk 1418 were carried out with the Potsdam multi-aperture spectrophotometer (PMAS) at the 3.5 m telescope at Calar Alto Observatory. The central 16 arcsec×16 arcsec (1.14 × 1.14 kpc2 at the distance of Mrk 1418) were mapped with a spatial sampling of 1 arcsec; we took data in the 3590-6996 Å spectral range, with a linear dispersion of 3.2 Å per pixel. The seeing was about 1farcs5. From these data we built maps of the most prominent emission lines, namely [O ii], Hβ, [O iii], Hα, [N ii], and [S ii], as well as of several continuum bands, plus maps of the main line ratios: [O iii]/Hβ, [N ii]/Hα, [S ii]/Hα, and Hα/Hβ, and derived the physical parameters and gaseous metal abundances of the different star-forming regions detected in the field of view. Results: Mrk 1418 shows a distorted morphology both in the continuum and in the ionized gas maps; the current star- formation episode is taking place in five knots, distributed around the nucleus of the galaxy. The interstellar medium surrounding these knots is photo-ionized by stars, with no clear evidence for other excitation mechanisms. The galaxy displays an inhomogeneous dust distribution, with the high Hα/Hβ ratio in the central areas indicating a large amount of dust. The oxygen abundances derived for the individual star-forming knots are very similar, suggesting that the ionized interstellar medium is chemically homogeneous in O/H over spatial scales of hundreds of parsecs. This abundance (Z ≈ 0.4 Z⊙ from the empirical calibrations) places Mrk

  20. Effective date of requirement for premarket approval for automated external defibrillator systems. Final rule.

    PubMed

    2015-01-29

    The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). PMID:25730922

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

    PubMed

    2016-01-01

    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. PMID:26742183

  2. PMAS optical integral field spectroscopy of luminous infrared galaxies. II. Spatially resolved stellar populations and excitation conditions

    NASA Astrophysics Data System (ADS)

    Alonso-Herrero, A.; García-Marín, M.; Rodríguez Zaurín, J.; Monreal-Ibero, A.; Colina, L.; Arribas, S.

    2010-11-01

    Context. The general properties (e.g., activity class, star formation rates, metallicities, extinctions, average ages, etc.) of luminous (LIRGs) and ultraluminous infrared galaxies (ULIRGs) in the local universe are well known because large samples of these objects have been the subject of numerous spectroscopic works over the past three decades. There are, however, relatively few studies of the spatially-resolved spectroscopic properties of large samples of LIRGs and ULIRGs using integral field spectroscopy (IFS). Aims: We are carrying out an IFS survey of local (z<0.26) samples of LIRGs and ULIRGs to characterize their two-dimensional spectroscopic properties. The main goal of this paper is to study the spatially resolved properties of the stellar populations and the excitation conditions in a sample of LIRGs. Methods: We analyze optical (3800-7200 Å) IFS data taken with the Potsdam Multi-Aperture Spectrophotometer (PMAS) of the central few kiloparsecs of eleven LIRGs. To study these stellar populations, we fit the optical stellar continuum and the hydrogen recombination lines of selected regions in the galaxies. We analyzed the excitation conditions of the gas using the spatially resolved properties of the brightest optical emission lines. We complemented the PMAS observations with existing HST/NICMOS near-infrared continuum and Paα imaging. Results: The optical continua of selected regions in our LIRGs are well fitted with a combination of an evolved (~0.7-10 Gyr) stellar population with an ionizing stellar population (1-20 Myr). The latter population is more obscured than the evolved population, and has visual extinctions in good agreement with those obtained from the Balmer decrement. Except for NGC 7771, we find no clear that there is an important contribution to the optical light from an intermediate-aged stellar population (~100-500 Myr). Even after correcting for the presence of stellar absorption, a large number of spaxels with low observed equivalent

  3. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification § 190.6 Requirement for premarket... dietary supplement that contains a new dietary ingredient that has not been present in the food supply as... manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office...

  4. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.104 Action on a.... (d) If FDA and a manufacturer or supplier agree that the notifier may submit a food additive petition... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Action on a premarket notification for a...

  5. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.101...

  6. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... guidance published in the Federal Register on July 12, 2011 (76 FR 40921), and the comment period closed on...; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology... for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.''...

  7. 77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... subject to the requirements of premarket approval. In the Federal Register of May 6, 1994 (59 FR 23731... premarket approval. ] In the Federal Register of July 27, 2011 (76 FR 44872) (the July 27, 2011, proposed... submitted in response to the 515(i) Order, (April 9, 2009 (74 FR 16214)), and any additional...

  8. New Light in Star-Forming Dwarf Galaxies: The PMAS Integral Field View of the Blue Compact Dwarf Galaxy Mrk 409

    NASA Astrophysics Data System (ADS)

    Cairós, Luz M.; Caon, Nicola; Papaderos, Polychronis; Kehrig, Carolina; Weilbacher, Peter; Roth, Martin M.; Zurita, Cristina

    2009-12-01

    We present an integral field spectroscopic study of the central 2 × 2 kpc2 of the blue compact dwarf galaxy Mrk 409, observed with the Potsdam MultiAperture Spectrophotometer (PMAS). This study focuses on the morphology, two-dimensional chemical abundance pattern, excitation properties, and kinematics of the ionized interstellar medium in the starburst component. We also investigate the nature of the extended ring of ionized gas emission surrounding the bright nuclear starburst region of Mrk 409. PMAS spectra of selected regions along the ring, interpreted with evolutionary and population synthesis models, indicate that their ionized emission is mainly due to a young stellar population with a total mass of ~1.5 × 106 M sun, which started forming almost coevally ~10 Myr ago. This stellar component is likely confined to the collisional interface of a spherically expanding, starburst-driven super-bubble with denser, swept-up ambient gas, ~600 pc away from the central starburst nucleus. The spectroscopic properties of the latter imply a large extinction (CHβ>0.9), and the presence of an additional non-thermal ionization source, most likely a low-luminosity active galactic nucleus. Mrk 409 shows a relatively large oxygen abundance (12 + log(O/H) ~ 8.4) and no chemical abundance gradients out to R ~ 600 pc. The ionized gas kinematics displays an overall regular rotation on a northwest-southeast axis, with a maximum velocity of 60 km s-1 the total mass inside the star-forming ring is about 1.4 × 109 M sun. Based on observations obtained at the German-Spanish Astronomical Center, Calar Alto, operated by the Max-Planck-Institut für Astronomie Heidelberg jointly with the Spanish National Commission for Astronomy.

  9. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical...

  10. FDA use of international standards in the premarket review process.

    PubMed

    Rechen, E; Barth, D J; Marlowe, D; Kroger, L

    1998-01-01

    "This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European

  11. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  12. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  13. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  14. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  15. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  16. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  17. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2012-04-01 2012-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  18. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2013-04-01 2013-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  19. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications §...

  20. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications §...

  1. Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. PMID:11010655

  2. Cardiovascular devices; reclassification of nonroller-type cardiopulmonary bypass blood pumps for cardiopulmonary and circulatory bypass; effective date of requirement for premarket approval for nonroller-type cardiopulmonary bypass blood pumps for temporary ventricular support. Final order.

    PubMed

    2015-06-01

    The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order. PMID:26054096

  3. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  4. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    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...

  5. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  6. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  7. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ...-2011-M-0917] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval..., FDA-2011-M-0791 Medtronic Ireland.... ASSURANT COBALT October 26, 2011. iliac balloon- expandable... November 2, 2011. LLC. transcatheter heart valve and RETROFLEX 3 delivery system, RETROFLEX...

  8. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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... or on the last day of the 30th full calendar month after the regulation that classifies the...

  9. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or on the last day of the 30th full calendar month after the regulation that classifies the...

  10. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... 30th full calendar month after the regulation that classifies the device into class III is...

  11. 21 CFR 872.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 872.3 Section 872.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... day of the 30th full calendar month after the regulation that classifies the device into class III...

  12. 21 CFR 876.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or on the last day of the 30th full calendar month after the regulation that classifies the...

  13. 21 CFR 886.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 886.3 Section 886.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... day of the 30th full calendar month after the regulation that classifies the device into class III...

  14. 21 CFR 882.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 882.3 Section 882.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... 30th full calendar month after the regulation that classifies the device into class III is...

  15. 21 CFR 870.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 870.3 Section 870.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... 30th full calendar month after the regulation that classifies the device into class III is...

  16. 21 CFR 890.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 890.3 Section 890.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... 30th full calendar month after the regulation that classifies the device into class III is...

  17. 21 CFR 880.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 880.3 Section 880.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or on the last day of the 30th full calendar month after the regulation that classifies the...

  18. 21 CFR 884.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 884.3 Section 884.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or on the last day of the 30th full calendar month after the regulation that classifies the...

  19. 21 CFR 888.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 888.3 Section 888.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... day of the 30th full calendar month after the regulation that classifies the device into class III...

  20. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  1. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  2. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  3. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  4. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  5. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  6. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  7. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  8. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  9. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  10. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  11. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Action on a premarket notification for a...

  12. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Action on a premarket notification for a...

  13. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  14. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  15. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  16. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Action on a premarket notification for a...

  17. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Action on a premarket notification for a...

  18. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  19. 21 CFR 888.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  20. 21 CFR 886.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  1. 21 CFR 888.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  2. 21 CFR 870.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  3. 21 CFR 882.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  4. 21 CFR 872.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  5. 21 CFR 872.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  6. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  7. 21 CFR 886.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as... approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section... (premarket approval) shall not be commercially distributed after the date shown in the regulation...

  8. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  9. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  10. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  11. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  12. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  13. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  14. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  15. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  16. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  17. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  18. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  19. 76 FR 50663 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... House Report on the 1976 amendments states that ``* * * he thirty month `grace period' afforded after... premarket approval. In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6, 1994, notice), FDA... August 25, 2010 (75 FR 52294) (the August 25, 2010, proposed rule), FDA published a proposed rule...

  20. 77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... that ``* * * he thirty month `grace period' afforded after classification of a device into class III... May 6, 1994 (59 FR 23731), FDA issued a notice of availability of a preamendments class III devices... premarket approval. In the Federal Register of August 4, 2011 (76 FR 47085), FDA published a proposed...

  1. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  2. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  3. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  4. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for...

  5. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for...

  6. 21 CFR 876.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions § 876.3...

  7. 21 CFR 876.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions § 876.3...

  8. 21 CFR 876.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions § 876.3...

  9. 21 CFR 876.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions § 876.3...

  10. 21 CFR 807.81 - When a premarket notification submission is required.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false When a premarket notification submission is required. 807.81 Section 807.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the Food and Drug Administration at least 90 days before he proposes to begin the introduction...

  11. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... that has undergone a significant change or modification that could significantly affect the safety...

  12. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... Federal Register of July 19, 2007 (72 FR 39631), FDA announced the availability of the draft guidance... developed this guidance document to assist industry in preparing a Premarket Notification (510(k)) for...

  13. Cardiovascular devices; reclassification of external counter-pulsating devices for treatment of chronic stable angina; effective date of requirement for premarket approval for external counter-pulsating devices for other specified intended uses. Final order.

    PubMed

    2013-12-30

    The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order. PMID:24383148

  14. Effective date of requirement for premarket approval for transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances; reclassification of SHS and devices for the treatment of poisoning and drug overdose. Final order.

    PubMed

    2014-01-17

    The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) for the transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances and to reclassify SHS devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls). PMID:24443766

  15. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED)...

  16. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED)...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED)...

  18. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED)...

  19. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED)...

  20. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED)...

  1. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG... food contact substance (FCN). (a) During the 120-day period of the Food and Drug Administration...

  2. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG... food contact substance (FCN). (a) During the 120-day period of the Food and Drug Administration...

  3. Patients' rights a case for a Charter of Participant Rights in Pre-Market Drug Trials: the next evolution.

    PubMed

    Sheldon, C Tess; Ferris, Lorraine E

    2010-06-01

    Since the first publication of Medicine and Law thirty years ago, there have been significant international advances in patient rights and participant protections in clinical trials. Despite such advances, there are still alarming reports of actual or perceived breaches in ethical standards by Institutions, Investigators and Sponsors of pre-market drug clinical trials. This is particularly disturbing as these trials involve participants in the testing of an investigational drug before its full safety, effectiveness, and clinical outcomes are understood. Moreover, the study design may randomize participants (recruited because they have specific diseases or conditions) into a group receiving a placebo or comparator drug versus a group receiving the investigational drug. The proposed Charter of Participant Rights in Pre-Market Drug Trials reflects the growing trend towards a participant-centred approach to the implementation and enforcement of participant rights. The development and adoption of the Charter is the next natural step towards the guarantee of rights in pre-market clinical drug trials.

  4. Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.

    PubMed

    Goldman, Stephen A

    2016-10-01

    Since 1993, how to assess the causality of serious adverse events in premarketing drug clinical trials has undergone sustained regulatory evolution in the USA. In that year, an investigational drug study for chronic hepatitis B virus infection was emergently stopped after a patient suddenly exhibited hepatic failure and lactic acidosis, which later developed, along with pancreatitis and peripheral neuropathy, in several others after drug discontinuation. Five patients eventually died, including three despite emergency liver transplantation. The drug's multisystem toxicity was not predicted by preclinical animal studies, with grave injury to human mitochondria subsequently implicated. A concerned US Food and Drug Administration (FDA) created a task force whose findings would have a lasting impact on the agency's thinking. In 1994, the FDA proposed to amend its investigational new drug reporting requirements largely based on task force recommendations for ways to enhance the likelihood that sponsors and investigators would consider investigational agents as a possible cause of serious adverse events mimicking the underlying disease or concomitant drug toxicity. Then, in its 1997 final rule for expedited safety reporting requirements for drugs and biologics, the FDA advised sponsors that such reporting of serious, unexpected clinical trial cases would be expected when "there is a reasonable suspected causal relationship between the investigational product and the adverse event (i.e., the causal relationship cannot be ruled out)." This last clause was codified into the suspected adverse drug reaction definition in the FDA's 2003 safety reporting requirements for drugs and biologics proposed rule. The negatively received suspected adverse drug reaction and proposed causality standard were not adopted in the FDA's 2010 finalized investigational new drug safety reporting regulations, the agency stating that "'reasonable possibility' means there is evidence to suggest a

  5. Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.

    PubMed

    Goldman, Stephen A

    2016-10-01

    Since 1993, how to assess the causality of serious adverse events in premarketing drug clinical trials has undergone sustained regulatory evolution in the USA. In that year, an investigational drug study for chronic hepatitis B virus infection was emergently stopped after a patient suddenly exhibited hepatic failure and lactic acidosis, which later developed, along with pancreatitis and peripheral neuropathy, in several others after drug discontinuation. Five patients eventually died, including three despite emergency liver transplantation. The drug's multisystem toxicity was not predicted by preclinical animal studies, with grave injury to human mitochondria subsequently implicated. A concerned US Food and Drug Administration (FDA) created a task force whose findings would have a lasting impact on the agency's thinking. In 1994, the FDA proposed to amend its investigational new drug reporting requirements largely based on task force recommendations for ways to enhance the likelihood that sponsors and investigators would consider investigational agents as a possible cause of serious adverse events mimicking the underlying disease or concomitant drug toxicity. Then, in its 1997 final rule for expedited safety reporting requirements for drugs and biologics, the FDA advised sponsors that such reporting of serious, unexpected clinical trial cases would be expected when "there is a reasonable suspected causal relationship between the investigational product and the adverse event (i.e., the causal relationship cannot be ruled out)." This last clause was codified into the suspected adverse drug reaction definition in the FDA's 2003 safety reporting requirements for drugs and biologics proposed rule. The negatively received suspected adverse drug reaction and proposed causality standard were not adopted in the FDA's 2010 finalized investigational new drug safety reporting regulations, the agency stating that "'reasonable possibility' means there is evidence to suggest a

  6. A comparative analysis of insertional effects in genetically engineered plants: considerations for pre-market assessments.

    PubMed

    Schnell, Jaimie; Steele, Marina; Bean, Jordan; Neuspiel, Margaret; Girard, Cécile; Dormann, Nataliya; Pearson, Cindy; Savoie, Annie; Bourbonnière, Luc; Macdonald, Philip

    2015-02-01

    During genetic engineering, DNA is inserted into a plant's genome, and such insertions are often accompanied by the insertion of additional DNA, deletions and/or rearrangements. These genetic changes are collectively known as insertional effects, and they have the potential to give rise to unintended traits in plants. In addition, there are many other genetic changes that occur in plants both spontaneously and as a result of conventional breeding practices. Genetic changes similar to insertional effects occur in plants, namely as a result of the movement of transposable elements, the repair of double-strand breaks by non-homologous end-joining, and the intracellular transfer of organelle DNA. Based on this similarity, insertional effects should present a similar level of risk as these other genetic changes in plants, and it is within the context of these genetic changes that insertional effects must be considered. Increased familiarity with genetic engineering techniques and advances in molecular analysis techniques have provided us with a greater understanding of the nature and impact of genetic changes in plants, and this can be used to refine pre-market assessments of genetically engineered plants and food and feeds derived from genetically engineered plants.

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

    PubMed

    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.

  8. An evaluation of conventional culture, invA PCR, and the real-time PCR iQ-Check kit as detection tools for Salmonella in naturally contaminated premarket and retail turkey.

    PubMed

    Nde, Chantal W; Fakhr, Mohamed K; Doetkott, Curt; Logue, Catherine M

    2008-02-01

    This study was aimed at comparing the ability of conventional culture, the iQ-Check real-time PCR kit, and invA PCR to detect Salmonella in naturally contaminated premarket and retail turkey parts. Premarket (n = 120) turkey parts collected from a commercial turkey processing plant, and retail turkey parts (n = 138) were examined. Both PCR methods detected a significantly greater (P < 0.05) number of positive samples when compared with the conventional culture method for the premarket turkey parts. The indices of total agreement between the conventional culture method and the iQ-Check kit for the premarket and retail parts were 79.2% (95% CI: 70.8, 86) and 90.6% (95% CI: 84.4, 94.9), respectively. When the conventional culture method was compared with invA PCR for Salmonella detection in the premarket and retail parts, the indices of total agreement were 75.8% (95% CI: 67.2, 83.2) and 84.1% (95% CI: 76.9, 89.7), respectively. The rates of false positives (premarket: 31.9%, retail: 9.7%) and false negatives (premarket: 5.9%, retail: 9.7%) were determined between the culture method and the iQ-Check kit. When invA PCR was compared with the culture method, the rates of false positives (premarket: 37.7%, retail: 11.1%) and false negatives (premarket: 5.9%, retail: 18.3%) were obtained. The higher total agreement and the lower rates of both false positives and false negatives for the iQ-Check kit compared with invA PCR for both premarket and retail turkey parts corroborates the use of the iQ-Check kit as a screening tool for Salmonella in poultry meat.

  9. An evaluation of conventional culture, invA PCR, and the real-time PCR iQ-Check kit as detection tools for Salmonella in naturally contaminated premarket and retail turkey.

    PubMed

    Nde, Chantal W; Fakhr, Mohamed K; Doetkott, Curt; Logue, Catherine M

    2008-02-01

    This study was aimed at comparing the ability of conventional culture, the iQ-Check real-time PCR kit, and invA PCR to detect Salmonella in naturally contaminated premarket and retail turkey parts. Premarket (n = 120) turkey parts collected from a commercial turkey processing plant, and retail turkey parts (n = 138) were examined. Both PCR methods detected a significantly greater (P < 0.05) number of positive samples when compared with the conventional culture method for the premarket turkey parts. The indices of total agreement between the conventional culture method and the iQ-Check kit for the premarket and retail parts were 79.2% (95% CI: 70.8, 86) and 90.6% (95% CI: 84.4, 94.9), respectively. When the conventional culture method was compared with invA PCR for Salmonella detection in the premarket and retail parts, the indices of total agreement were 75.8% (95% CI: 67.2, 83.2) and 84.1% (95% CI: 76.9, 89.7), respectively. The rates of false positives (premarket: 31.9%, retail: 9.7%) and false negatives (premarket: 5.9%, retail: 9.7%) were determined between the culture method and the iQ-Check kit. When invA PCR was compared with the culture method, the rates of false positives (premarket: 37.7%, retail: 11.1%) and false negatives (premarket: 5.9%, retail: 18.3%) were obtained. The higher total agreement and the lower rates of both false positives and false negatives for the iQ-Check kit compared with invA PCR for both premarket and retail turkey parts corroborates the use of the iQ-Check kit as a screening tool for Salmonella in poultry meat. PMID:18326192

  10. Information Regarding the OraQuick In-Home HIV Test

    MedlinePlus

    ... test? Information on the OraQuick In-Home HIV Test can be found on FDA’s website . Additionally, information can be obtained from the manufacturer, OraSure Technologies. back to top More in Premarket Approvals (PMAs) ...

  11. Cardiovascular devices; reclassification of intra-aortic balloon and control systems for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure; effective date of requirement for premarket approval for intra-aortic balloon and control systems for septic shock or pulsatile flow generation. Final order.

    PubMed

    2013-12-30

    The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for IABPs when indicated for septic shock or pulsatile flow generation. PMID:24383147

  12. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD...

  13. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  14. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  15. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  16. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  17. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

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

    PubMed Central

    Iijima, Kazuo; Umezu, Mitsuo; Iwasaki, Kiyotaka

    2016-01-01

    Background 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. Methods and Findings 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. Conclusions Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be

  19. How pre-marketing data can be used for predicting the weight of drug interactions in clinical practice.

    PubMed

    Caccia, Silvio; Pasina, Luca; Nobili, Alessandro

    2013-04-01

    Unexpected drug interactions have led to the withdrawal of many drugs, raising concern about the gap between what is known at the time of approval and the risk of serious effects in the longer term, particularly in high-risk populations generally excluded from drug development. This is because the majority of drug interaction studies are done using in vitro methods, or in healthy young volunteers who may not reflect the complexity of patients, and the settings in which the drug will be used in clinical practice. Pre-marketing interaction studies should therefore be designed to make information easily accessible and clinically transferable. They should be adequate in terms of sample size, population, comorbidity, phenotyping and/or genotyping, end-points and outcome measures, and conducted in conditions of dose, route and timing of co-administration that reproduce the proposed therapeutic indications of the new drug. Although young volunteers have the advantage of minimizing some confounding effects introduced by diseases or polypharmacy, patients drawn from populations for whom the drug is intended would be more relevant and accurate, providing the studies are feasible and safe.

  20. The application of post-market monitoring to novel foods.

    PubMed

    Hepburn, P; Howlett, J; Boeing, H; Cockburn, A; Constable, A; Davi, A; de Jong, N; Moseley, B; Oberdörfer, R; Robertson, C; Wal, J M; Samuels, F

    2008-01-01

    The role of post-market monitoring (PMM) in the safety assessment of novel foods is critically discussed in order to derive guidelines as to in which situations the application of PMM might be warranted. Available data sources on food consumption and health status, and the methodologies for generating such data are reviewed. The paper suggests improvements to make them more applicable for PMM purposes. It is concluded that any PMM programme must be a hypothesis-driven scientific exercise. PMM can have a role as a complement to, but not as a replacement for, a comprehensive pre-market safety assessment. Its use may be appropriate to confirm that product use is as predicted in the pre-market assessment; to provide reassurance that effects observed in the pre-market assessment occur with no greater frequency or intensity in the post-market phase than anticipated; and to investigate the significance of any adverse effects reported by consumers after market-launch. However PMM is insufficiently powerful to test the hypothesis that any effects seen in the pre-market assessment are absent in the post-market phase. Current methodologies place limitations on what PMM can achieve. PMM should only be used when triggered by or when the focus is on specific evidence-based questions.

  1. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... substantially equivalent to a legally marketed predicate device; (2) Issue an order declaring the device to be not substantially equivalent to any legally marketed predicate device; (3) Request additional.... Until the applicant receives an order declaring a device substantially equivalent, the applicant may...

  2. Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format. Final order.

    PubMed

    2016-10-01

    The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as "copper reduction tablet test"). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

  3. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.

    PubMed

    Walter, Jessica R; Hayman, Emily; Tsai, Shelun; Ghobadi, Comeron W; Xu, Shuai

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices. PMID:27159747

  4. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... a color additive petition submitted as part of a PMA is governed by § 71.15. (b) The existence of a... secret or confidential commercial or financial information under § 20.61. (3) Any adverse reaction report...: (i) Any information that constitutes trade secret or confidential commercial or financial...

  5. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... defined in § 20.81. (5) An assay method or other analytical method, unless it does not serve any... confidential commercial or financial information as defined in § 20.61: (1) Manufacturing methods or processes... available for public disclosure. (3) Quantitative or semiquantitative formulas....

  6. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... defined in § 20.81. (5) An assay method or other analytical method, unless it does not serve any... confidential commercial or financial information as defined in § 20.61: (1) Manufacturing methods or processes... available for public disclosure. (3) Quantitative or semiquantitative formulas....

  7. The benefits of the 3T3 NRU test in the safety assessment of cosmetics: long-term experience from pre-marketing testing in the Czech Republic.

    PubMed

    Jírová, D; Kejlová, K; Brabec, M; Bendová, H; Kolárová, H

    2003-01-01

    We have introduced the 3T3 NRU cytotoxicity test for methodological, economical and ethical reasons as a regular part of tier pre-marketing testing to assess local tolerance of raw materials for cosmetics, household chemicals and final cosmetic products. Using the 3T3 cell line according to the standard INVITTOX protocol No.64 (NRU Assay) the borderline concentration, relevant to the highest tolerated dose, is determined for each material. The toxic effect is reached at different concentration levels specific for individual cosmetics categories, depending on their chemical characteristics. Typical ranges of cytotoxicity for specific categories of cosmetics were established after testing of hundreds of materials. The range lies between 1 microg/ml (anti-dandruff shampoos), up to 2000 microg/ml (toothpastes and mouthwashes). The 3T3 NRU cytotoxicity test is a sensitive tool able to identify more aggressive products, that are also more likely to evoke irritation in human skin. It was even possible to detect protective effects of one natural herbal ingredient. The comparative study of cytotoxicity test results and human patch test results from a group of essential oils is presented. Cytotoxicity tests represent a highly ethical approach for estimation of irritancy. On the basis of in vitro test results suggesting low risk we can proceed to confirmatory tests in human volunteers.

  8. High-density power management architecture for portable applications

    NASA Astrophysics Data System (ADS)

    Ahsanuzzaman, S. M.

    This thesis introduces a power management architecture (PMA) and its on-chip implementation, designed for battery-powered portable applications. Compared to conventional two-stage PMA architectures, consisting of a front-end inductive converter followed by a set of point-of-load (PoL) buck converters, the presented PMA has improved power density. The new architecture, named MSC-DB, is based on a hybrid converter topology that combines a fixed ratio multi-output switched capacitor converter (MSC) and a set of differential-input buck (DB) converters, to achieve low volume and high power processing efficiency. The front-end switched capacitor stage has a higher power density than the conventionally used inductive converters. The downstream differential-input buck converters enable tight output voltage regulation, and allow for a drastic reduction of output filter inductors without the need for increasing switching frequency, hence limiting switching losses and improving the efficiency of the system. Furthermore, the new PMA provides battery cells balancing feature, not existing in conventional systems. The PMA architecture is implemented both as a discrete prototype and as an application-specific integrated circuit (IC) module. The on-chip implemented architecture is fabricated in a standard 0.13microm CMOS process and operates at 9.3 MHz switching frequency. Experimental comparisons with a conventional two-cell battery input architecture, providing 15 W of total power in three different voltage outputs, demonstrate up to a 50% reduction in the inductances of the downstream converter stages and up to a 53% reduction in losses, equivalent to the improvement of the power processing efficiency of a 12%. Moreover, the fabricated IC module is co-packaged with low-profile thin-film inductors, to demonstrate the effectiveness of the introduced architecture in reducing the volume of PMAs for portable applications and possibly providing complete on-chip implementation of PMAs

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

    NASA Astrophysics Data System (ADS)

    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.

  10. Generic approvals of irradiated foods: Application of the chemiclearance principle

    SciTech Connect

    Taub, I.A.

    1996-10-01

    The use of irradiation for food preservation requires premarket approval primarily by the Food and Drug Administration (FDA), based on data establishing the safety of the process. Several approvals have already been granted on the strength of extensive microbiological, genotoxicity, nutritional, and animal feeding studies. Extending approval to other foods that are pasteurized or are sterilized by treatment to high doses, and consequently storable of ambient temperatures, does not necessarily have to involve comprehensive research on each and every food item. Generic approvals of classes of food is possible, because of the commonality in the response of similar foods to treatment by ionizing irradiation. This commonality is the basis for the chemiclearance principle, by which it can be shown that compositionally similar conditions are toxicologically equivalent. The use of different chemical investigations into radiolytic effects in both low and high dose irradiated muscle foods will be discussed to illustrate the application of this approach for obtaining approvals, nationally and internationally.

  11. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814... to amend a PMA or PMA supplement with any information regarding the device that is necessary for...

  12. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814... to amend a PMA or PMA supplement with any information regarding the device that is necessary for...

  13. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low... document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA)...

  14. Guidance for Industry: Preparation of Premarket Submissions ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... 确定这些数据的方法。如果难以取得分子量,申请人应提供聚合体的其他属性; 这些属性应为分子量的应变量,例如固有粘度或相对粘度、或熔体流动指数 ...

  15. Applications

    NASA Astrophysics Data System (ADS)

    Stern, Arthur M.

    1986-07-01

    Economic incentives have spurred numerous applications of genetically engineered organisms in manufacture of pharmaceuticals and industrial chemicals. These successes, involving a variety of methods of genetic manipulation, have dispelled early fears that genetic engineering could not be handled safely, even in the laboratory. Consequently, the potential for applications in the wider environment without physical containment is being considered for agriculture, mining, pollution control, and pest control. These proposed applications range from modest extensions of current plant breeding techniques for new disease-resistant species to radical combinations of organisms (for example, nitrogen-fixing corn plants). These applications raise concerns about potential ecological impacts (see chapter 5), largely because of adverse experiences with both deliberate and inadvertent introductions of nonindigenous species.

  16. 21 CFR 12.28 - Denial of hearing in whole or in part.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... application, new animal drug application, device premarket approval application or product development... established in the statutory provision governing the matter involved constitutes a waiver of the right...

  17. Comparison between small radiation therapy electron beams collimated by Cerrobend and tubular applicators.

    PubMed

    Di Venanzio, Cristina; Marinelli, Marco; Tonnetti, Alessia; Verona-Rinati, Gianluca; Bagalà, Paolo; Falco, Maria Daniela; Guerra, Antonio Stefano; Pimpinella, Maria

    2015-01-01

    The purpose of this study was to compare the dosimetric properties of small field electron beams shaped by circular Cerrobend blocks and stainless steel tubular applicators. Percentage depth dose curves, beam profiles, and output factors of small-size circular fields from 2 to 5 cm diameter, obtained either by tubular applicators and Cerrobend blocks, were measured for 6, 10, and 15 MeV electron beam energies. All measurements were performed using a PTW microDiamond 60019 premarket prototype. An overall similar behavior between the two collimating systems can be observed in terms of PDD and beam profiles. However, Cerrobend collimators produce a higher bremsstrahlung background under irradiation with high-energy electrons. In such irradiation condition, larger output factors are observed for tubular applicators. Similar dosimetric properties are observed using circular Cerrobend blocks and stainless steel tubular applicators at lower beam energies. However, Cerrobend collimators allow the delivery of specific beam shapes, conformed to the target area. On the other hand, in high-energy irradiation conditions, tubular applicators produce a lower bremsstrahlung contribution, leading to lower doses outside the target volume. In addition, the higher output factors observed at high energies for tubular applicators lead to reduced treatment times. PMID:25679175

  18. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814... information regarding the device that is necessary for FDA or the appropriate advisory committee to complete... applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary...

  19. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814... information regarding the device that is necessary for FDA or the appropriate advisory committee to complete... applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary...

  20. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false PMA amendments and resubmitted PMA's. 814.37... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.37 PMA amendments and resubmitted PMA's. (a) An applicant may amend a pending PMA or PMA...

  1. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary...

  2. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary...

  3. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary...

  4. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary...

  5. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other...

  6. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other...

  7. Premarketing surveillance of ibuprofen suppositories in febrile children.

    PubMed

    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.

  8. Premarketing surveillance of ibuprofen suppositories in febrile children.

    PubMed

    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. PMID:21224250

  9. 21 CFR 3.2 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... does not have a biological product or device mode of action. (l) Premarket review includes the... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.2 Definitions. For the purpose...

  10. 78 FR 50064 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Submission for... Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION:...

  11. 21 CFR 814.15 - Research conducted outside the United States.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.15 Research... foreign data are applicable to the U.S. population and U.S. medical practice; (2) The studies have...

  12. 21 CFR 814.15 - Research conducted outside the United States.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.15 Research... foreign data are applicable to the U.S. population and U.S. medical practice; (2) The studies have...

  13. 75 FR 12758 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice... submitted the following proposed collection of information to OMB for review and clearance....

  14. 21 CFR 3.5 - Procedures for identifying the designated agency component.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications... and Research have entered into agreements clarifying product jurisdictional issues. These guidance... responsibility for categories of products or specific products. These intercenter agreements, and any...

  15. 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.

    PubMed

    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.

  16. 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.

    PubMed

    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. PMID:27247483

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

    NASA Astrophysics Data System (ADS)

    Pengjun, Wang; Kangping, Li; Huihong, Zhang

    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. Project supported by the Natural Science Foundation of Zhejiang Province (No. LY13F040003), the National Natural Science Foundation of China (Nos. 61234002, 61306041), and the K. C. Wong Magna Fund in Ningbo University.

  18. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... quantitate the anti-seizure drugs lamotrigine and zonisamide in serum. The Therapeutic Drug Monitoring (TDM... TDM Roundtable recommendations. Some of the general concepts in this guidance may also be helpful...

  19. 77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-13

    ... date P100031, FDA-2011-M-0502...... Roche Diagnostics ELECSYS ANTI-HBC IMMUNOASSAY & June 22, 2011. Corp.. ELECSYS PRECICONTROL ANTI-HBC. P100032, FDA-2011-M-0503...... Roche Diagnostics ELECSYS ANTI-HBC IMMUNOASSAY, June 27, 2011. Corp.. ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010...

  20. 21 CFR 890.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.3 Effective dates... new, not substantially equivalent, device introduced into commercial distribution on or after May 28... distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a...

  1. 21 CFR 890.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.3 Effective dates... new, not substantially equivalent, device introduced into commercial distribution on or after May 28... distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a...

  2. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., where necessary. (c) Be submitted in duplicate on standard size paper, including the original and two.... (2) For devices regulated by the Center for Biologics Evaluation and Research, be addressed to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and...

  3. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., where necessary. (c) Be submitted in duplicate on standard size paper, including the original and two.... (2) For devices regulated by the Center for Biologics Evaluation and Research, be addressed to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and...

  4. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., where necessary. (c) Be submitted in duplicate on standard size paper, including the original and two.... (2) For devices regulated by the Center for Biologics Evaluation and Research, be addressed to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and...

  5. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., where necessary. (c) Be submitted in duplicate on standard size paper, including the original and two.... (2) For devices regulated by the Center for Biologics Evaluation and Research, be addressed to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and...

  6. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ...-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability of Safety and Effectiveness... Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc LINX \\TM\\ Reflux March 22, 2012...-M-0734....... Abbott Medical Healon July 2, 2012. Optics, Inc. EndoCoat OpViscosurgical...

  7. 76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... December 23, 2010. SYSTEM. FDA-2011-M-0035 P100028 Cook Medical, Inc.. FORMULA BALLOON- January 14, 2011...-0132, FDA-2011-M-0170, FDA-2011-M-0175, and FDA-2011-M-0198] Medical Devices; Availability of Safety.... Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that...

  8. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... Medical, Prometra February 7, 2012. Inc. (approved under Programmable Medasys, Inc.). Infusion Pump System...-0177 Medtronic Vascular... Resolute MicroTrac/ February 17, 2012. Resolute Integrity...

  9. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ...-1048, FDA- 2012-M-1049, FDA-2012-M-1066, FDA-2012-M-1084, FDA-2012-M-1085, FDA- 2012-M-1088, FDA-2012-M...-2012-M-1085 Paradigm Spine, LLC.. coflex October 17, 2012. Interlaminar Technology. P110039,...

  10. 76 FR 32214 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... notice solicits comments on the procedure by which a manufacturer or distributor of dietary supplements... that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe... commerce of a dietary supplement that contains a new dietary ingredient, a manufacturer or distributor...

  11. 78 FR 52773 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... invites comments on the procedure by which a manufacturer or distributor of dietary supplements or of a... dietary supplement containing a new dietary ingredient will reasonably be expected to be safe. DATES... a dietary supplement that contains a new dietary ingredient, a manufacturer or distributor...

  12. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    .... 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 when... sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. ] 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a...

  13. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21... LEFT VENTRICULAR ASSIST 20, 2010 SYSTEM (LVAS) H080002 Medtronic, MEDTRONIC MELODY January...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... to be used or delivered by the device, and a description of the operational principles of the device... § 807.93. (i) A financial certification or disclosure statement or both, as required by part 54 of this... III device and other similar legally marketed devices has been conducted (class III certification),...

  15. 75 FR 54154 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ..., 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to.... The 30-day period for requesting reconsideration of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b... April 8, 2010 FDA-2010-M-0220 Therapies, LLC P090022 Lenstec, Inc. SOFTEC HD POSTERIOR CHAMBER April...

  16. 78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of... (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching...) submissions for nucleic acid-based HLA test kits used for matching of donors and recipients in transfusion...

  17. 78 FR 4094 - Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-18

    ... the following two class III preamendments devices: Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented.... Hip Joint Metal/Metal Semi-Constrained, With a Cemented Acetabular Component, Prosthesis (21 CFR...

  18. 78 FR 5816 - Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-28

    ... effects in specific subgroups (i.e., use in study enrichment strategies). On February 18, 2011 (76 FR 9583... how variations in the human genome, specifically DNA sequence variants, could affect a drug's..., specifically DNA sequence variants, could affect a drug's pharmacokinetics, pharmacodynamics, efficacy,...

  19. 76 FR 17136 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... October 20, 2010. P980018 (S010) FDA-2010-M-0557...... Dako Denmark A/S..... HercepTest kit Approved.... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA...

  20. 78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... Approval for Automated External Defibrillator System. AGENCY: Food and Drug Administration, HHS. ACTION... the following class III preamendments devices: Automated external defibrillators systems (AEDs), which... Innovation Act (FDASIA) (Pub. L. 112-144) establish a comprehensive system for the regulation of...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... device along with information submitted in response to the 515(i) Order, (74 FR 16214, April 9, 2009... published in the Federal Register on these dates: November 28, 1974 (43 FR 55716), September 4, 1979 (44 FR 51770), January 6, 1989 (54 FR 550), August 31, 1993 (58 FR 45865), August 24, 1995 (60 FR...

  2. 21 CFR 807.81 - When a premarket notification submission is required.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the... exception or alternative under § 801.128 or § 809.11 of this chapter satisfies the requirement in...

  3. 78 FR 44130 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Sec. 807.87(h), each 510(k) submitter must include in the 510(k) either a summary of the information in the 510(k) as required by Sec. 807.92 (510(k) summary) or a statement certifying that the.... 807.93 (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the...

  4. 78 FR 20268 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... transilluminator for breast evaluation (76 FR 48062, August 8, 2011; 77 FR 9610, February 17, 2012; 77 FR 39953, July 6, 2012; 75 FR 52294, August 25, 2010). FDA is issuing this proposed administrative order to... 5, 2013 (77 FR 71195, November 29, 2012). Because of the level of interest in the classification...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ..., 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that, 1 day after date of publication of...: Wheelchair Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... notification requirements for wheelchair elevator devices commonly known as inclined platform lifts...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... states that:`` he thirty month grace period afforded after classification of a device into class III... 515(i) Order (74 FR 16214, April 9, 2009), and any additional information that FDA has encountered... found in the following proposed and final rules and notices published in the Federal Register: 44...

  7. 76 FR 48058 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... required to be filed. The House Report on the 1976 amendments states that: `` he thirty month grace period... classification of this device along with information submitted in response to the 515(i) order (74 FR 16214... proposed and final rules and notices published in the Federal Register on these dates: (45 FR 7907 at...

  8. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ..., 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a device from..., p. 3.) In the Federal Register of June 1, 2012 (77 FR 32642), FDA published a notice announcing that... against the criteria laid out in the Class II 510(k) Exemption Guidance and in 63 FR 3142, and agrees...

  9. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ..., 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a device from....) In the Federal Register of June 1, 2012 (77 FR 32644), FDA published a notice announcing that this... criteria laid out in the Class II 510(k) Exemption Guidance and in 63 FR 3142, and agrees they weigh...

  10. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    .... FDA published that list in the Federal Register of January 21, 1998 (63 FR 3142). Section 510(m)(2) of.... These devices are used to assist transfers of a mobility impaired person up and down flights of...

  11. 75 FR 32476 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... required for all device changes that affect safety and effectiveness of a device unless such changes are modifications to manufacturing procedures or method of manufacture. This type of manufacturing change now... PMA process more efficient, in the past several years FDA has done the following: (1) Made changes...

  12. 76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... a proposed rule that appeared in the Federal Register of August 8, 2011 (76 FR 48058). The document..., Silver Spring, MD 20993-0002, 301-796-6216. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-19959, appearing... Approval for Cardiovascular Permanent Pacemaker Electrode; Correction AGENCY: Food and Drug...

  13. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final.... P070015 (S54) FDA-2011-M-0431. Abbott Vascular....... Xience nano everolimus-eluting May 24,...

  14. 75 FR 52294 - Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... other physical trauma--Depending on the design of the device, use of the female condom may cause... response to the 515(i) order (74 FR 16214, April 9, 2009) and any additional information that FDA has... dates: Cardiovascular devices, 21 CFR part 870 (44 FR 13284, March 9, 1979; 45 FR 7904, February 5,...

  15. 75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21............ Abbott Molecular, Inc... ABBOTT REALTIME HBV August 13, 2010. ASSAY. II. Electronic Access Persons...

  16. 78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ...-2013-M-0282 Lombard Medical...... Aorfix AAA Flexible February 14, 2013. Stent Graft System. P040046... February 22, 2013. Inc. Zotarolimus-Eluting Coronary Stent System. P100030, FDA-2013-M-0281 Tenaxis...

  17. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ... (with the adjunctive Zenith Alignment Stent). P110029, FDA-2012-M-0372 Abbot Laboratories... ARCHITECT... Stent on RX System. P110035, FDA-2012-M-0373 Boston Scientific Epic\\TM\\ Vascular Self- April 13, 2012. Corp. Expanding Stent System. P090015, FDA-2012-M-0390 Leica Biosystems..... BOND\\TM\\ ORACLE\\TM\\...

  18. 76 FR 44872 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ... the 515(i) Order that published in the Federal Register of April 9, 2009 (74 FR 16214), and any... published in the Federal Register on the following dates: March 9, 1979 (44 FR 13373); February 5, 1980 (45 FR 7907); and May 11, 1987 (52 FR 17736). IV. Device Subject to This Proposal--Implantable...

  19. 21 CFR 807.81 - When a premarket notification submission is required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. (ii) A major change or modification in...

  20. Commercial applications

    NASA Technical Reports Server (NTRS)

    Togai, Masaki

    1990-01-01

    Viewgraphs on commercial applications of fuzzy logic in Japan are presented. Topics covered include: suitable application area of fuzzy theory; characteristics of fuzzy control; fuzzy closed-loop controller; Mitsubishi heavy air conditioner; predictive fuzzy control; the Sendai subway system; automatic transmission; fuzzy logic-based command system for antilock braking system; fuzzy feed-forward controller; and fuzzy auto-tuning system.

  1. Land Application.

    ERIC Educational Resources Information Center

    Reynolds, James H.

    1978-01-01

    Presents a literature review of wastewater land application, covering publications of 1976-77. This review covers areas such as the history, development, philosophy, design, models, and case studies of land application. A list of 41 references is also presented. (HM)

  2. Plasma Applications

    NASA Astrophysics Data System (ADS)

    Kristiansen, M.; Guenther, A. H.

    Plasmas have numerous applications for civilian as well as defense purposes. However, technical development is still in its infancy. Many new important applications depend only upon the imagination of engineers and scientists. In contrast to other develping technologies, applications from the fields of plasma science and engineering can only evolve through a multidisciplinary synergism. Research in plasma chemistry and physics together with gaseous electronics, fluid dynamics and thermodynamics, particularly mass and heat transfer, must be coupled with electro-chemistry and material science research particularly those aspects dealing with surfaces. In this paper we attempt to evaluate the importance of plasma applications. Obviously, it is impossible to do justice to all the important areas. The selection of topics is, therefore, influenced by the authors' interests and background. We will outline most of the applications rather briefly and concentrate in some detail on those areas in which we are interested.

  3. 21 CFR 16.1 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application. Section 515(e)(3) of the act relating to the temporary suspension of approval of a premarket approval application. Section 515(f)(6) of the act relating to a proposed order revoking a device product... application from an investigational device exemption (see §§ 812.19(c), 812.30(c), 813.30(d), and 813.35(c)...

  4. 21 CFR 16.1 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... application. Section 515(e)(3) of the act relating to the temporary suspension of approval of a premarket approval application. Section 515(f)(6) of the act relating to a proposed order revoking a device product... application from an investigational device exemption (see §§ 812.19(c), 812.30(c), 813.30(d), and 813.35(c)...

  5. Rejected applications

    PubMed Central

    2014-01-01

    Objective: To review membership application materials (especially rejected applications) to the American Academy of Neurology (AAN) during its formative years (1947–1953). Methods: Detailed study of materials in the AAN Historical Collection. Results: The author identified 73 rejected applications. Rejected applicants (71 male, 2 female) lived in 25 states. The largest number was for the Associate membership category (49). These were individuals “in related fields who have made and are making contributions to the field of neurology.” By contrast, few applicants to Active membership or Fellowship status were rejected. The largest numbers of rejectees were neuropsychiatrists (19), neurosurgeons (16), and psychiatrists (14). Conclusion: The AAN, established in the late 1940s, was a small and politically vulnerable organization. A defining feature of the fledgling society was its inclusiveness; its membership was less restrictive than that of the older American Neurological Association. At the same time, the society needed to preserve its core as a neurologic society rather than one of psychiatry or neurosurgery. Hence, the balance between inclusiveness and exclusive identity was a difficult one to maintain. The Associate membership category, more than any other, was at the heart of this issue of self-definition. Associate members were largely practitioners of psychiatry or neurosurgery. Their membership was a source of consternation and was to be carefully been held in check during these critical formative years. PMID:24944256

  6. ASCI applications

    SciTech Connect

    Nowak, D.A.; Christensen, R.C.

    1997-11-11

    ASCI applications codes are key elements of the Department of Energy`s Stockpile Stewardship and Management Program (SSMP). They will provide the simulation capabilities needed to predict the performance, safety, reliability, and manufacturability of the U.S. nuclear deterrent.

  7. 21 CFR 812.38 - Confidentiality of data and information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Confidentiality of data and information. (a) Existence of IDE. FDA will not disclose the existence of an IDE... application for premarket approval of the device subject to the IDE; or a notice of completion of a product... an application for an IDE for a banned device. The summary shall include information on any...

  8. Application note :

    SciTech Connect

    Russo, Thomas V.

    2013-08-01

    The development of the XyceTM Parallel Electronic Simulator has focused entirely on the creation of a fast, scalable simulation tool, and has not included any schematic capture or data visualization tools. This application note will describe how to use the open source schematic capture tool gschem and its associated netlist creation tool gnetlist to create basic circuit designs for Xyce, and how to access advanced features of Xyce that are not directly supported by either gschem or gnetlist.

  9. Photography applications

    USGS Publications Warehouse

    Cochran, Susan A.; Goodman, James A.; Purkis, Samuel J.; Phinn, Stuart R.

    2013-01-01

    Photographic imaging is the oldest form of remote sensing used in coral reef studies. This chapter briefly explores the history of photography from the 1850s to the present, and delves into its application for coral reef research. The investigation focuses on both photographs collected from low-altitude fixed-wing and rotary aircraft, and those collected from space by astronauts. Different types of classification and analysis techniques are discussed, and several case studies are presented as examples of the broad use of photographs as a tool in coral reef research.

  10. Medical Applications

    NASA Astrophysics Data System (ADS)

    Boccara, A. Claude; Mordon, Serge

    2015-10-01

    In re-listening to the lectures of Charles Townes shortly after the invention of the laser (e.g., in the Boston Science Museum), one can already have a realistic vision of the potentialities of this new tool in the field of medical therapy, as evidenced by the use of the laser in ophthalmology to cure retinal detachment in the 1960's. Since then, applications have flourished in the domain of therapy. We will thus illustrate here only some of the main fields of application of medical lasers. On the opposite, the use of lasers in medical imaging is, with one exception in ophthalmology, still at the development level. It is becoming a diagnostic tool in addition to high performance imaging facilities that are often very expensive (such as CT scan, Magnetic Resonance Imaging (MRI) and nuclear imaging). Even if progress is sometimes slow, one can now image with light inside the human body, in spite of the strong scattering of light by tissues, in the same way as a pathologist sees surgical specimens.

  11. 21 CFR 3.9 - Effect of letter of designation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Effect of letter of designation. 3.9 Section 3.9... JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.9 Effect of letter of... designated agency component with the written consent of the sponsor, or without its consent to protect...

  12. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration 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 Food and Drug Administration (FDA) is announcing...

  13. 21 CFR 814.110 - New indications for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false New indications for use. 814.110 Section 814.110...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.110 New indications for use. (a) An applicant seeking a new indication for use of a HUD approved under this subpart...

  14. 21 CFR 814.110 - New indications for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false New indications for use. 814.110 Section 814.110...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.110 New indications for use. (a) An applicant seeking a new indication for use of a HUD approved under this subpart...

  15. 21 CFR 14.1 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Committee (TEPRSSC); (ii) Section 14.140 on review of the safety of color additives; (iii) Section 14.160 on... the act on review of device premarket approval applications and product development protocols; and (ix... Research Involving Human Subjects Committee (RIHSC). (c) This part applies only when a committee...

  16. 21 CFR 814.126 - Postapproval requirements and reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.126... of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the... known or reasonably should be known to the applicant, medical device reports made under part 803 of...

  17. 21 CFR 814.126 - Postapproval requirements and reports.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.126... of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the... known or reasonably should be known to the applicant, medical device reports made under part 803 of...

  18. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... guidance practices regulation. FDA withdrew the 1994 draft on January 5, 2005 (70 FR 824) and is now... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart...

  19. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for... document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational...

  20. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    .... On June 22, 2011 (76 FR 36542), FDA announced the availability of the draft guidance document...) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft guidance...; The Content of Investigational Device Exemption and Premarket Approval Applications for...

  1. 21 CFR 3.9 - Effect of letter of designation.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.9 Effect of letter of... as provided in paragraph (b) of this section. (b) The product jurisdiction officer may change...

  2. 21 CFR 3.3 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.3 Scope. This section applies to: (a) Any combination product, or (b) Any product where the agency component with primary jurisdiction is unclear or...

  3. 21 CFR 3.6 - Product jurisdiction officer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Product jurisdiction officer. 3.6 Section 3.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.6 Product...

  4. 78 FR 64220 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-28

    ... substantially equivalent to a legally marketed device, it must have an approved premarket approval application..., components, method of manufacturer, or the intended use that could affect the safety and effectiveness of the... effectiveness. This information will be provided to any person within 30 days of a request if the...

  5. 75 FR 63489 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  6. 21 CFR 876.5870 - Sorbent hemoperfusion system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... metabolic disturbances. (b) Classification. (1) Class II (special controls) when the device is intended for... the treatment of hepatic coma and metabolic disturbances. (c) Date premarket approval application (PMA... indicated for treatment of hepatic coma or metabolic disturbances that was in commercial distribution...

  7. 21 CFR 814.45 - Denial of approval of a PMA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the... information before the agency, FDA determines that any of the grounds for denying approval of a PMA...

  8. 21 CFR 814.45 - Denial of approval of a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the... information before the agency, FDA determines that any of the grounds for denying approval of a PMA...

  9. 21 CFR 814.45 - Denial of approval of a PMA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the... information before the agency, FDA determines that any of the grounds for denying approval of a PMA...

  10. 78 FR 24426 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of... information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum...

  11. 21 CFR 814.126 - Postapproval requirements and reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the... known or reasonably should be known to the applicant, medical device reports made under part 803 of this... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices §...

  12. 21 CFR 814.40 - Time frames for reviewing a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Time frames for reviewing a PMA. 814.40 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames for reviewing a PMA. Within 180 days after receipt of an application that is accepted for filing and to...

  13. 21 CFR 814.40 - Time frames for reviewing a PMA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Time frames for reviewing a PMA. 814.40 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames for reviewing a PMA. Within 180 days after receipt of an application that is accepted for filing and to...

  14. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug..., 1976 shall have an approved PMA or declared completed PDP in effect before beginning...

  15. 78 FR 30312 - Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... notification (510(k)) or premarket approval application (PMA). In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is... 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $52 per hour...

  16. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug..., 1976 shall have an approved PMA or declared completed PDP in effect before beginning...

  17. 77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class III devices. On July 18, 1995 (60 FR 36639), FDA published a Final Rule that misbranded breast... to a premarket approval application for the Automated Breast Ultrasound (ABUS) scanning...

  18. 77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS)...

  19. 77 FR 39953 - Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... response to the 515(i) Order (74 FR 16214, April 9, 2009), and any additional information that FDA has... Register: 44 FR 50512 (August 28, 1979), 48 FR 53032 (November 23, 1983), and 52 FR 17732 (May 11, 1987... rule issued August 28, 1979 (44 FR 50512), based on recommendations made by the Physical...

  20. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  1. 75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    .... It discussed methods of detecting DILI by periodic tests of serum enzyme activities and bilirubin concentration elevations, and how those laboratory tests might change over time, along with symptoms...

  2. Premarket evaluations of the IMDx C. difficile for Abbott m2000 Assay and the BD Max Cdiff Assay.

    PubMed

    Stellrecht, K A; Espino, A A; Maceira, V P; Nattanmai, S M; Butt, S A; Wroblewski, D; Hannett, G E; Musser, K A

    2014-05-01

    Clostridium difficile-associated diarrhea is a well-recognized complication of antibiotic use. Historically, diagnosing C. difficile has been difficult, as antigen assays are insensitive and culture-based methods require several days to yield results. Nucleic acid amplification tests (NAATs) are quickly becoming the standard of care. We compared the performance of two automated investigational/research use only (IUO/RUO) NAATs for the detection of C. difficile toxin genes, the IMDx C. difficile for Abbott m2000 Assay (IMDx) and the BD Max Cdiff Assay (Max). A prospective analysis of 111 stool specimens received in the laboratory for C. difficile testing by the laboratory's test of record (TOR), the BD GeneOhm Cdiff Assay, and a retrospective analysis of 88 specimens previously determined to be positive for C. difficile were included in the study. One prospective specimen was excluded due to loss to follow-up discrepancy analysis. Of the remaining 198 specimens, 90 were positive by all three methods, 9 were positive by TOR and Max, and 3 were positive by TOR only. One negative specimen was initially inhibitory by Max. The remaining 95 specimens were negative by all methods. Toxigenic C. difficile culture was performed on the 12 discrepant samples. True C. difficile-positive status was defined as either positive by all three amplification assays or positive by toxigenic culture. Based on this definition, the sensitivity and specificity were 96.9% and 95% for Max and 92.8% and 100% for IMDx. In summary, both highly automated systems demonstrated excellent performance, and each has individual benefits, which will ensure that they will both have a niche in clinical laboratories.

  3. Aerospace Applications of Microprocessors

    NASA Technical Reports Server (NTRS)

    1980-01-01

    An assessment of the state of microprocessor applications is presented. Current and future requirements and associated technological advances which allow effective exploitation in aerospace applications are discussed.

  4. Sight Application Analysis Tool

    SciTech Connect

    Bronevetsky, G.

    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.

  5. Ruby on Rails Applications

    NASA Technical Reports Server (NTRS)

    Hochstadt, Jake

    2011-01-01

    Ruby on Rails is an open source web application framework for the Ruby programming language. The first application I built was a web application to manage and authenticate other applications. One of the main requirements for this application was a single sign-on service. This allowed authentication to be built in one location and be implemented in many different applications. For example, users would be able to login using their existing credentials, and be able to access other NASA applications without authenticating again. The second application I worked on was an internal qualification plan app. Previously, the viewing of employee qualifications was managed through Excel spread sheets. I built a database driven application to streamline the process of managing qualifications. Employees would be able to login securely to view, edit and update their personal qualifications.

  6. CYBER 200 Applications Seminar

    NASA Technical Reports Server (NTRS)

    Gary, J. P. (Compiler)

    1984-01-01

    Applications suited for the CYBER 200 digital computer are discussed. Various areas of application including meteorology, algorithms, fluid dynamics, monte carlo methods, petroleum, electronic circuit simulation, biochemistry, lattice gauge theory, economics and ray tracing are discussed.

  7. Industrial storage applications overview

    NASA Technical Reports Server (NTRS)

    Duscha, R. A.

    1980-01-01

    The implementation of a technology demonstration for the food processing industry, development and technology demonstrations for selected near-term, in-plant applications and advanced industrial applications of thermal energy storage are overviewed.

  8. Entomopathogenic nematode application technology

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Biocontrol success when using entomopathogenic nematodes (EPNs) in the genera Heterorhabditis and Steinernema relies on a variety of factors including components of the application event itself. Successful application encompasses both abiotic and biotic influences. For example, adverse array of equi...

  9. AFRL POSS Applications Research

    NASA Astrophysics Data System (ADS)

    Phillips, Shawn

    2002-09-01

    The Air Force is heavily invested in POSS Applications Research and Development. Currently one application is being 'flight-tested' for a technology transition. New applications are being investigated (e.g. batteries, capacitors, radomes). The technology transfer to Hybrid Plastics is a success story with significant volume increase and price reduction. POSS Nanotechnology Offers Versatility.

  10. Teaching Computer Applications.

    ERIC Educational Resources Information Center

    Lundgren, Carol A.; And Others

    This document, which is designed to provide classroom teachers at all levels with practical ideas for a computer applications course, examines curricular considerations, teaching strategies, delivery techniques, and assessment methods applicable to a course focusing on applications of computers in business. The guide is divided into three…

  11. Parts application handbook study

    NASA Technical Reports Server (NTRS)

    1978-01-01

    The requirements for a NASA application handbook for standard electronic parts are determined and defined. This study concentrated on identifying in detail the type of information that designers and parts engineers need and expect in a parts application handbook for the effective application of standard parts on NASA projects.

  12. Engineering electrochemical capacitor applications

    NASA Astrophysics Data System (ADS)

    Miller, John R.

    2016-09-01

    Electrochemical capacitor (EC) applications have broadened tremendously since EC energy storage devices were introduced in 1978. Then typical applications operated below 10 V at power levels below 1 W. Today many EC applications operate at voltages approaching 1000 V at power levels above 100 kW. This paper briefly reviews EC energy storage technology, shows representative applications using EC storage, and describes engineering approaches to design EC storage systems. Comparisons are made among storage systems designed to meet the same application power requirement but using different commercial electrochemical capacitor products.

  13. Biopharmaceutical applications of nanogold.

    PubMed

    Alanazi, Fars K; Radwan, Awwad A; Alsarra, Ibrahim A

    2010-10-01

    The application of nanogold in biopharmaceutical field is reviewed in this work. The properties of nanogold including nanogold surface Plasmon absorption and nanogold surface Plasmon light scattering are illustrated. The physical, chemical, biosynthesis methods of nanogold preparation are presented. Catalytic properties as well as biomedical applications are highlighted as one of the most important applications of nanogold. Biosensing, and diagnostic and therapeutic applications of gold nanoparticles are evaluated. Moreover, gold nanoparticles in drugs, biomolecules and proteins' delivery are analyzed. Gold nanoparticles for the site-directed photothermal applications are reviewed as the most fruitful research area in the future.

  14. ERIP application instructions

    SciTech Connect

    Watt, D.M.

    1992-01-02

    This report provides background information and instructions to assist applicants in writing Energy-Related Inventions Program (ERIP) applications. Initial feedback fro usage for the new instructions shows that the best instructions would not be read and followed by all applicants. Applications from more than thirty applicants who have received the new instructions indicated that few had read the instructions. Based on this feedback, the instructions have been further revised to include a title page and table of contents. A warning was also added to advise applicants of the potential penalty of delayed review if these instructions are not followed. This revision was intended to address the possibility that some applicants did not see or bother to follow the instructions which followed the background information about ERIP. Included are two examples of ERIP applications which have been prepared for handout at workshops or mailing to applicants. Writing of example applications was time consuming and more difficult than expected for several reasons: (1) Full disclosures can be lengthy, very detailed, and technical. This contrasts with the desire to prepare examples which are comparatively short and easy for the non-technical person to read. (2) Disclosures contain confidential information which should not be published. (3) It is difficult to imagine that applicants will study examples when they do not bother to read the basic instructions.

  15. International Space Station Environmental Control and Life Support System: Verification for the Pressurized Mating Adapters

    NASA Technical Reports Server (NTRS)

    Williams, David E.

    2007-01-01

    The International Space Station (ISS) Pressurized Mating Adapters (PMAs) Environmental Control and Life Support (ECLS) System is comprised of three subsystems: Atmosphere Control and Supply (ACS), Temperature and Humidity Control (THC), and Water Recovery and Management (WRM). PMA 1 and PMA 2 flew to ISS on Flight 2A and PMA 3 flew to ISS on Flight 3A. This paper provides a summary of the PMAs ECLS design and the detailed Element Verification methodologies utilized during the Qualification phase for the PMAs.

  16. Technical applications of aerogels

    SciTech Connect

    Hrubesh, L.W.

    1997-08-18

    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.

  17. Applications of MST radars: Meteorological applications

    NASA Technical Reports Server (NTRS)

    Larsen, M. F.

    1989-01-01

    Applications of mesosphere stratosphere troposphere radar to mesoscale meteorology are discussed. The applications include using the radar either as a research tool to improve our understanding of certain dynamical systems or as part of a network used to provide input data for weather forecasting. The workhorse of the operational observing network is the radiosonde balloon which provides measurements of pressure, temperature, humidity, and winds up to heights of 16 to 20 km. Horizontal and vertical measurement capabilities, reflectivity data, derivable quantities and parameters, and special operational requirements are surveyed.

  18. Application Layer Multicast

    NASA Astrophysics Data System (ADS)

    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.

  19. Exploiting chaos for applications

    SciTech Connect

    Ditto, William L.; Sinha, Sudeshna

    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.

  20. LANL application communication patterns

    SciTech Connect

    Pakiin, Scott

    2011-01-10

    This brief presentation describes the communication patterns used by a set of unclassified applications developed at Los Alamos National Laboratory: XNobel/XRAGE/RAGE/SAGE, Krak, Sweep3D, and Partisn. It mentions which processes communicate with which other processes, whether the application is typically run in a strong-scaling mode or a weak-scaling mode, what message sizes are commonly used, and how the application's performance changes at scale.

  1. International Space Station Environmental Control and Life Support System Acceptance Testing for the Pressurized Mating Adapters

    NASA Technical Reports Server (NTRS)

    Williams, David E.

    2008-01-01

    The International Space Station (ISS) Pressurized Mating Adapters (PMAs) Environmental Control and Life Support (ECLS) System is comprised of three subsystems: Atmosphere Control and Supply (ACS), Temperature and Humidity Control (THC), and Water Recovery and Management (WRM). PMAs 1 and 2 flew to ISS on Flight 2A and Pressurized Mating Adapter (PMA) 3 flew to ISS on Flight 3A. This paper provides a summary of the PMAs ECLS design and a detailed discussion of the ISS ECLS Acceptance Testing methodologies utilized for the PMAs.

  2. Applications and Experiences

    NASA Astrophysics Data System (ADS)

    Sacco, Giovanni Maria; Ferré, Sébastien

    This chapter discusses a number of real-world applications of dynamic taxonomies. Most current applications are object-seeking or knowledge-seeking exploratory tasks, and address important areas such as e-commerce, multimedia infobases, diagnostic systems, digital libraries and news systems, e-government, file systems, and geographical information systems. Applications in these areas are discussed in detail in the following, and applications in cultural heritage, art and architecture, e-recruitment, e-hrm, e-matchmaking, e-health, and e-learning are briefly reviewed.

  3. Application Power Signature Analysis

    SciTech Connect

    Hsu, Chung-Hsing; Combs, Jacob; Nazor, Jolie; Santiago, Fabian; Thysell, Rachelle; Rivoire, Suzanne; Poole, Stephen W

    2014-01-01

    The high-performance computing (HPC) community has been greatly concerned about energy efficiency. To address this concern, it is essential to understand and characterize the electrical loads of HPC applications. In this work, we study whether HPC applications can be distinguished by their power-consumption patterns using quantitative measures in an automatic manner. Using a collection of 88 power traces from 4 different systems, we find that basic statistical measures do a surprisingly good job of summarizing applications' distinctive power behavior. Moreover, this study opens up a new area of research in power-aware HPC that has a multitude of potential applications.

  4. Nanomaterials for Defense Applications

    NASA Astrophysics Data System (ADS)

    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.

  5. Flat conductor cable applications

    NASA Technical Reports Server (NTRS)

    Angele, W.

    1972-01-01

    Some of the numerous applications of flat conductor cable (FCC) systems are briefly described. Both government and commercial uses were considered, with applications designated as either aerospace, military, or commercial. The number and variety of ways in which FCC is being applied and considered for future designs are illustrated.

  6. Automatic multiple applicator electrophoresis

    NASA Technical Reports Server (NTRS)

    Grunbaum, B. W.

    1977-01-01

    Easy-to-use, economical device permits electrophoresis on all known supporting media. System includes automatic multiple-sample applicator, sample holder, and electrophoresis apparatus. System has potential applicability to fields of taxonomy, immunology, and genetics. Apparatus is also used for electrofocusing.

  7. Application Statistics 1987.

    ERIC Educational Resources Information Center

    Council of Ontario Universities, Toronto.

    Summary statistics on application and registration patterns of applicants wishing to pursue full-time study in first-year places in Ontario universities (for the fall of 1987) are given. Data on registrations were received indirectly from the universities as part of their annual submission of USIS/UAR enrollment data to Statistics Canada and MCU.…

  8. Microcomputer Applications in Agriculture.

    ERIC Educational Resources Information Center

    Hilgenberg, Gene; And Others

    This curriculum guide is intended to assist persons teaching a course in microcomputer applications in agriculture. (These applications are designed to be used on Apple IIe or TRS-80 microcomputers.) Addressed in the individual units of instruction are the following topics: microcomputer operating procedures; procedures for evaluating and…

  9. Application Security Automation

    ERIC Educational Resources Information Center

    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…

  10. Applications of Solubility Data

    ERIC Educational Resources Information Center

    Tomkins, Reginald P. T.

    2008-01-01

    This article describes several applications of the use of solubility data. It is not meant to be exhaustive but rather to show that knowledge of solubility data is required in a variety of technical applications that assist in the design of chemical processes. (Contains 3 figures and 1 table.)

  11. Applications of Carbon Nanotubes

    NASA Astrophysics Data System (ADS)

    Ajayan, Pulickel M.; Zhou, Otto Z.

    Carbon nanotubes have attracted the fancy of many scientists worldwide. The small dimensions, strength and the remarkable physical properties of these structures make them a very unique material with a whole range of promising applications. In this review we describe some of the important materials science applications of carbon nanotubes. Specifically we discuss the electronic and electrochemical applications of nanotubes, nanotubes as mechanical reinforcements in high performance composites, nanotube-based field emitters, and their use as nanoprobes in metrology and biological and chemical investigations, and as templates for the creation of other nanostructures. Electronic properties and device applications of nanotubes are treated elsewhere in the book. The challenges that ensue in realizing some of these applications are also discussed from the point of view of manufacturing, processing, and cost considerations.

  12. Stirling engine application study

    NASA Technical Reports Server (NTRS)

    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.

  13. Wind energy applications guide

    SciTech Connect

    anon.

    2001-01-01

    The brochure is an introduction to various wind power applications for locations with underdeveloped transmission systems, from remote water pumping to village electrification. It includes an introductory section on wind energy, including wind power basics and system components and then provides examples of applications, including water pumping, stand-alone systems for home and business, systems for community centers, schools, and health clinics, and examples in the industrial area. There is also a page of contacts, plus two specific example applications for a wind-diesel system for a remote station in Antarctica and one on wind-diesel village electrification in Russia.

  14. Application trends for photovoltaics

    NASA Astrophysics Data System (ADS)

    Macomber, H. L.

    This paper presents the results of studies by MONEGON to develop forecasts of PV system application markets. These forecasts consider economic factors such as conventional energy costs now and in the future, the relationship between world economic conditions, as represented by each country's Gross National Product, and energy demand; the cost potential for PV systems technologies; and the application trends in the past and future. The application sectors analyzed are: remote, stand-alone systems; residential systems; service/commercial/industrial/institutional; and central utility systems. An overall market forecast is developed and this forecast is segmented into the four market sectors.

  15. Biomaterials and therapeutic applications

    NASA Astrophysics Data System (ADS)

    Ferraro, Angelo

    2016-03-01

    A number of organic and inorganic, synthetic or natural derived materials have been classified as not harmful for the human body and are appropriate for medical applications. These materials are usually named biomaterials since they are suitable for introduction into living human tissues of prosthesis, as well as for drug delivery, diagnosis, therapies, tissue regeneration and many other clinical applications. Recently, nanomaterials and bioabsorbable polymers have greatly enlarged the fields of application of biomaterials attracting much more the attention of the biomedical community. In this review paper I am going to discuss the most recent advances in the use of magnetic nanoparticles and biodegradable materials as new biomedical tools.

  16. Industrial applications of nanoparticles.

    PubMed

    Stark, W J; Stoessel, P R; Wohlleben, W; Hafner, A

    2015-08-21

    Research efforts in the past two decades have resulted in thousands of potential application areas for nanoparticles - which materials have become industrially relevant? Where are sustainable applications of nanoparticles replacing traditional processing and materials? This tutorial review starts with a brief analysis on what makes nanoparticles attractive to chemical product design. The article highlights established industrial applications of nanoparticles and then moves to rapidly emerging applications in the chemical industry and discusses future research directions. Contributions from large companies, academia and high-tech start-ups are used to elucidate where academic nanoparticle research has revolutionized industry practice. A nanomaterial-focused analysis discusses new trends, such as particles with an identity, and the influence of modern instrument advances in the development of novel industrial products.

  17. Neutron sources and applications

    SciTech Connect

    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.

  18. Food Applications and Regulation

    NASA Astrophysics Data System (ADS)

    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.

  19. Applications of decelerated ions

    SciTech Connect

    Johnson, B.M.

    1985-03-01

    Many facilities whose sole purpose had been to accelerate ion beams are now becoming decelerators as well. The development and current status of accel-decel operations is reviewed here. Applications of decelerated ions in atomic physics experiments are discussed.

  20. Space applications of superconductivity

    NASA Technical Reports Server (NTRS)

    Sullivan, D. B.; Vorreiter, J. W.

    1979-01-01

    Some potential applications of superconductivity in space are summarized, e.g., the use of high field magnets for cosmic ray analysis or energy storage and generation, space applications of digital superconducting devices, such as the Josephson switch and, in the future, a superconducting computer. Other superconducting instrumentation which could be used in space includes: low frequency superconducting sensors, microwave and infrared detectors, instruments for gravitational studies, and high-Q cavities for use as stabilizing elements in clocks and oscillators.

  1. Photovoltaic systems and applications

    SciTech Connect

    Not Available

    1982-01-01

    Abstracts are given of presentations given at a project review meeting held at Albuquerque, NM. The proceedings cover the past accomplishments and current activities of the Photovoltaic Systems Research, Balance-of-System Technology Development and System Application Experiments Projects at Sandia National Laboratories. The status of intermediate system application experiments and residential system analysis is emphasized. Some discussion of the future of the Photovoltaic Program in general, and the Sandia projects in particular is also presented.

  2. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard

    1998-01-01

    This column will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter's column will include some announcements and some recent radiation test results and evaluations of interest. Specifically, the following topics will be covered: the Military and Aerospace Applications of Programmable Devices and Technologies Conference to be held at GSFC in September, 1998, proton test results, heavy ion test results, and some total dose results.

  3. Tissue engineered constructs: perspectives on clinical translation.

    PubMed

    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. PMID:25711151

  4. Tissue Engineered Constructs: Perspectives on Clinical Translation

    PubMed Central

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

    2015-01-01

    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 US 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. PMID:25711151

  5. Applications of cavity optomechanics

    SciTech Connect

    Metcalfe, Michael

    2014-09-15

    “Cavity-optomechanics” aims to study the quantum properties of mechanical systems. A common strategy implemented in order to achieve this goal couples a high finesse photonic cavity to a high quality factor mechanical resonator. Then, using feedback forces such as radiation pressure, one can cool the mechanical mode of interest into the quantum ground state and create non-classical states of mechanical motion. On the path towards achieving these goals, many near-term applications of this field have emerged. After briefly introducing optomechanical systems and describing the current state-of-the-art experimental results, this article summarizes some of the more exciting practical applications such as ultra-sensitive, high bandwidth accelerometers and force sensors, low phase noise x-band integrated microwave oscillators and optical signal processing such as optical delay-lines, wavelength converters, and tunable optical filters. In this rapidly evolving field, new applications are emerging at a fast pace, but this article concentrates on the aforementioned lab-based applications as these are the most promising avenues for near-term real-world applications. New basic science applications are also becoming apparent such as the generation of squeezed light, testing gravitational theories and for providing a link between disparate quantum systems.

  6. LCS Content Document Application

    NASA Technical Reports Server (NTRS)

    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.

  7. Computer Applications in Educational Audiology.

    ERIC Educational Resources Information Center

    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)

  8. Technology Applications Team: Applications of aerospace technology

    NASA Technical Reports Server (NTRS)

    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.

  9. 45 CFR Appendix A to Part 13 - Appendix A to Part 13

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... device premarket approval applications 21 U.S.C. 306e(e), (g) 21 CFR part 12. Office for Civil Rights 1...); 1395bbb(c)(1); 1396b(m)(5)(B); 1396r(b)(3)(B)(ii), (g)(2)(A)(i); 1396t(i)(3); 11131(c); 11137(b)(2) 42 CFR part 1003; 42 CFR part 1005. 2. Appeals of exclusions from Medicare and State health care programs...

  10. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  11. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  12. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  13. Nonlinear Optics and Applications

    NASA Technical Reports Server (NTRS)

    Abdeldayem, Hossin A. (Editor); Frazier, Donald O. (Editor)

    2007-01-01

    Nonlinear optics is the result of laser beam interaction with materials and started with the advent of lasers in the early 1960s. The field is growing daily and plays a major role in emerging photonic technology. Nonlinear optics play a major role in many of the optical applications such as optical signal processing, optical computers, ultrafast switches, ultra-short pulsed lasers, sensors, laser amplifiers, and many others. This special review volume on Nonlinear Optics and Applications is intended for those who want to be aware of the most recent technology. This book presents a survey of the recent advances of nonlinear optical applications. Emphasis will be on novel devices and materials, switching technology, optical computing, and important experimental results. Recent developments in topics which are of historical interest to researchers, and in the same time of potential use in the fields of all-optical communication and computing technologies, are also included. Additionally, a few new related topics which might provoke discussion are presented. The book includes chapters on nonlinear optics and applications; the nonlinear Schrodinger and associated equations that model spatio-temporal propagation; the supercontinuum light source; wideband ultrashort pulse fiber laser sources; lattice fabrication as well as their linear and nonlinear light guiding properties; the second-order EO effect (Pockels), the third-order (Kerr) and thermo-optical effects in optical waveguides and their applications in optical communication; and, the effect of magnetic field and its role in nonlinear optics, among other chapters.

  14. Multiphysics Application Coupling Toolkit

    SciTech Connect

    Campbell, Michael T.

    2013-12-02

    This particular consortium implementation of the software integration infrastructure will, in large part, refactor portions of the Rocstar multiphysics infrastructure. Development of this infrastructure originated at the University of Illinois DOE ASCI Center for Simulation of Advanced Rockets (CSAR) to support the center's massively parallel multiphysics simulation application, Rocstar, and has continued at IllinoisRocstar, a small company formed near the end of the University-based program. IllinoisRocstar is now licensing these new developments as free, open source, in hopes to help improve their own and others' access to infrastructure which can be readily utilized in developing coupled or composite software systems; with particular attention to more rapid production and utilization of multiphysics applications in the HPC environment. There are two major pieces to the consortium implementation, the Application Component Toolkit (ACT), and the Multiphysics Application Coupling Toolkit (MPACT). The current development focus is the ACT, which is (will be) the substrate for MPACT. The ACT itself is built up from the components described in the technical approach. In particular, the ACT has the following major components: 1.The Component Object Manager (COM): The COM package provides encapsulation of user applications, and their data. COM also provides the inter-component function call mechanism. 2.The System Integration Manager (SIM): The SIM package provides constructs and mechanisms for orchestrating composite systems of multiply integrated pieces.

  15. Multiphysics Application Coupling Toolkit

    2013-12-02

    This particular consortium implementation of the software integration infrastructure will, in large part, refactor portions of the Rocstar multiphysics infrastructure. Development of this infrastructure originated at the University of Illinois DOE ASCI Center for Simulation of Advanced Rockets (CSAR) to support the center's massively parallel multiphysics simulation application, Rocstar, and has continued at IllinoisRocstar, a small company formed near the end of the University-based program. IllinoisRocstar is now licensing these new developments as free, openmore » source, in hopes to help improve their own and others' access to infrastructure which can be readily utilized in developing coupled or composite software systems; with particular attention to more rapid production and utilization of multiphysics applications in the HPC environment. There are two major pieces to the consortium implementation, the Application Component Toolkit (ACT), and the Multiphysics Application Coupling Toolkit (MPACT). The current development focus is the ACT, which is (will be) the substrate for MPACT. The ACT itself is built up from the components described in the technical approach. In particular, the ACT has the following major components: 1.The Component Object Manager (COM): The COM package provides encapsulation of user applications, and their data. COM also provides the inter-component function call mechanism. 2.The System Integration Manager (SIM): The SIM package provides constructs and mechanisms for orchestrating composite systems of multiply integrated pieces.« less

  16. APTASENSORS FOR BIOSECURITY APPLICATIONS

    SciTech Connect

    Fischer, N; Tarasow, T; Tok, J

    2007-01-03

    Nucleic acid aptamers have found steadily increased utility and application steadily over the last decade. In particular, aptamers have been touted as a valuable complement to and in some cases replacement for antibodies due to their structural and functional robustness as well as their ease in generation and synthesis. They are thus attractive for biosecurity applications, e.g. pathogen detection, and are especially well suited since their in vitro generation process does not require infection of any host systems. Herein we provide a brief overview of the aptamers generated against biopathogens over the last few years. In addition, a few recently described detection platforms using aptamers (aptasensors) and potentially suitable for biosecurity applications will be discussed.

  17. Data management applications

    NASA Technical Reports Server (NTRS)

    1983-01-01

    Kennedy Space Center's primary institutional computer is a 4 megabyte IBM 4341 with 3.175 billion characters of IBM 3350 disc storage. This system utilizes the Software AG product known as ADABAS with the on line user oriented features of NATURAL and COMPLETE as a Data Base Management System (DBMS). It is operational under the OS/VSI and is currently supporting batch/on line applications such as Personnel, Training, Physical Space Management, Procurement, Office Equipment Maintenance, and Equipment Visibility. A third and by far the largest DBMS application is known as the Shuttle Inventory Management System (SIMS) which is operational on a Honeywell 6660 (dedicated) computer system utilizing Honeywell Integrated Data Storage I (IDSI) as the DBMS. The SIMS application is designed to provide central supply system acquisition, inventory control, receipt, storage, and issue of spares, supplies, and materials.

  18. Infrared in automotive applications

    NASA Astrophysics Data System (ADS)

    Predmesky, Ronald L.; Zaluzec, Matthew J.

    1997-04-01

    As the automotive industry continues to develop advanced materials and manufacturing processes, infrared imaging has the potential to become a major tool in process monitoring and closed loop process control. This paper reviews five novel applications of infrared imaging in applications such as product testing, component manufacture, and vehicle assembly. Infrared was found to be effective as a diagnostics tool for characterizing disc brake systems and electronic engine control sensors. The effectiveness of infrared to qualify fuel nozzle backspray was used to optimize hardware design for fuel systems. Finally, infrared was found to be useful in vehicle assembly operations in the installation of windshield glass and instrument panel hardware where visual inspection was impractical. The speed of image capture and the availability of image processing software for real time image processing and closed loop process control will no doubt find more applications as infrared imaging finds its niche in the automotive industry.

  19. Applications of aerospace technology

    NASA Technical Reports Server (NTRS)

    Rouse, Doris J.

    1984-01-01

    The objective of the Research Triangle Institute Technology Transfer Team is to assist NASA in achieving widespread utilization of aerospace technology in terrestrial applications. Widespread utilization implies that the application of NASA technology is to benefit a significant sector of the economy and population of the Nation. This objective is best attained by stimulating the introduction of new or improved commercially available devices incorporating aerospace technology. A methodology is presented for the team's activities as an active transfer agent linking NASA Field Centers, industry associations, user groups, and the medical community. This methodology is designed to: (1) identify priority technology requirements in industry and medicine, (2) identify applicable NASA technology that represents an opportunity for a successful solution and commercial product, (3) obtain the early participation of industry in the transfer process, and (4) successfully develop a new product based on NASA technology.

  20. Location Based Application Availability

    NASA Astrophysics Data System (ADS)

    Naeem Akram, Raja; Markantonakis, Konstantinos; Mayes, Keith

    Smart cards are being integrated into a diverse range of industries: ranging from banking, telecom, transport, home/office access control to health and E-passport. Traditionally, cardholders are required to carry a smart card for each application. However, recent developments in the Near Field Communication (NFC) have renewed the interest in multiple applications for different services on a single device. This paper builds onto the NFC initiative and avoids the smart card ownership issues that hinder the adoption of such devices. The proposal integrates the Global Positioning System with the NFC in mobile phones to provide a ubiquitously and flexible service access model.

  1. Science Application Teams

    NASA Technical Reports Server (NTRS)

    2000-01-01

    This paper discusses the science application team activities. Science Application team are: (1) Represent the diversity of NASA onboard computing of the future. (2) Drive architecture and system software requirements. (3) Demonstrate the benefit of highly capable computing onboard. (4) Study the birth of the first galaxies. (5) Study formation of stars. (6) Discusses the next generation space telescope hardware/software requirement: image processing and on-board optical calibration. Also discusses gamma ray large area space telescope; orbital thermal imaging spectrometer; solar terrestrial probe program; autonomous Mars rover;fault tolerance and errors.

  2. National information infrastructure applications

    SciTech Connect

    Forslund, D.; George, J.; Greenfield, J.

    1996-07-01

    This is the final report of a two-year, Laboratory-Directed Research and Development (LDRD) project at the Los Alamos National Laboratory (LANL). This project sought to develop a telemedical application in which medical records are electronically searched and digital signatures of real CT scan data are indexed and used to characterize a range of diseases and are used to compare on-line medical data with archived clinical data rapidly. This system includes multimedia data management, interactive collaboration, data compression and transmission, remote data storage and retrieval, and automated data analysis integrated in a distributed application between Los Alamos and the National Jewish Hospital.

  3. Microgravity Science and Applications

    NASA Technical Reports Server (NTRS)

    1986-01-01

    The report presents fifteen papers from a workshop on microgravity science and applications held at the Jet Propulsion Laboratory in Pasadena, California, on December 3 to 4, 1984. The workshop and panel were formed by the Solid State Sciences Committee of the Board on Physics and Astronomy of the National Research Council in response to a request from the Office of Science and Technology Policy. The goal was to review the microgravity science and applications (MSA) program of NASA and to evaluate the quality of the program. The topics for the papers are metals and alloys, electronic materials, ceramics and glasses, biotechnology, combustion science, and fluid dynamics.

  4. Future communications satellite applications

    NASA Technical Reports Server (NTRS)

    Bagwell, James W.

    1992-01-01

    The point of view of the research is made through the use of viewgraphs. It is suggested that future communications satellite applications will be made through switched point to point narrowband communications. Some characteristics of which are as follows: small/low cost terminals; single hop communications; voice compatible; full mesh networking; ISDN compatible; and possible limited use of full motion video. Some target applications are as follows: voice/data networks between plants and offices in a corporation; data base networking for commercial and science users; and cellular radio internodal voice/data networking.

  5. Applications of Ion Laser Systems

    NASA Astrophysics Data System (ADS)

    Fletcher, Peter W.

    1987-04-01

    This paper provides an introduction to the more common applications of ion laser systems. Applications discussed include photocoagulation, flow cytometry, laser disk mastering, laser doppler velocimetry, Raman spectroscopy, holography, laser light shows, large screen projection, fingerprint detection, and applications in printing such as color separation and scanning. All these applications are currently in widespread use. At the end of the paper a short review is provided of developing applications such as cardiovascular surgery and semiconductor processing.

  6. Business Applications of WAP.

    ERIC Educational Resources Information Center

    van Steenderen, Margaret

    2002-01-01

    Explains the development of WAP (wireless application protocol), how it works, and what the major advantages and disadvantages are, especially when applied to the use of information. Topics include standardization; mobile communications; the effect of WAP on business tools, electronic commerce, and information services; consumers; corporate users;…

  7. Applications of Superconductivity

    ERIC Educational Resources Information Center

    Goodkind, John M.

    1971-01-01

    Presents a general review of current practical applications of the properties of superconducters. The devices are classified into groups according to the property that is of primary importance. The article is inteded as a first introduction for students and professionals. (Author/DS)

  8. Biomedical applications engineering tasks

    NASA Technical Reports Server (NTRS)

    Laenger, C. J., Sr.

    1976-01-01

    The engineering tasks performed in response to needs articulated by clinicians are described. Initial contacts were made with these clinician-technology requestors by the Southwest Research Institute NASA Biomedical Applications Team. The basic purpose of the program was to effectively transfer aerospace technology into functional hardware to solve real biomedical problems.

  9. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation. Donald K. Balmer (H), Mark Bushnell (O), Charles J . Garcia (SS), Enzo Mantovani (S), Vicky Pease (T), James E. Quick (V), Gerard Schuster (S), Endre Skaar, Michael Underwood (T), J o hn J . Whipple (H).

  10. Arizona's Application Service Provider.

    ERIC Educational Resources Information Center

    Jordan, Darla

    2002-01-01

    Describes the U.S.'s first statewide K-12 application service provider (ASP). The ASP, implemented by the Arizona School Facilities Board, provides access to productivity, communications, and education software programs from any Internet-enabled device, whether in the classroom or home. (EV)

  11. TIGER Arc Modification Application

    SciTech Connect

    Armstrong, Hillary

    1995-03-06

    The application enables the geometric correction of TIGER arcs to a more accurate spatial data set. This is done in a structured automated environment according to Census Bureau guidelines and New Mexico state GIS standards. Arcs may be deleted, added, combined, split, and moved relative to a coverage or image displayed in the background.

  12. Clinical Application of Electrocardiography.

    ERIC Educational Resources Information Center

    Brammell, H. L.; Orr, William

    The scalar electrocardiogram (ECG) is one of the most important and commonly used clinical tools in medicine. A detailed description of the recordings of cardiac electrical activity made by the ECG is presented, and the vast numbers of uses made with the data provided by this diagnostic tool are cited. Clinical applications of the ECG are listed.…

  13. Overview 1993: Computational applications

    NASA Technical Reports Server (NTRS)

    Benek, John A.

    1993-01-01

    Computational applications include projects that apply or develop computationally intensive computer programs. Such programs typically require supercomputers to obtain solutions in a timely fashion. This report describes two CSTAR projects involving Computational Fluid Dynamics (CFD) technology. The first, the Parallel Processing Initiative, is a joint development effort and the second, the Chimera Technology Development, is a transfer of government developed technology to American industry.

  14. Transducer applications, a compilation

    NASA Technical Reports Server (NTRS)

    1972-01-01

    The characteristics and applications of transducers are discussed. Subjects presented are: (1) thermal measurements, (2) liquid level and fluid flow measurements, (3) pressure transducers, (4) stress-strain measurements, (5) acceleration and velocity measurements, (6) displacement and angular rotation, and (7) transducer test and calibration methods.

  15. NASA lithium cell applications

    NASA Technical Reports Server (NTRS)

    Juvinall, G. L.

    1978-01-01

    The advantages of lithium systems are described and a general summary of their application in present and future NASA programs is presented. Benefits of the lithium systems include an increased payload weight and an increased cost effectiveness to the customer. This also allows for more flexibility in the design of future space transportation systems.

  16. Optical Scanning Applications.

    ERIC Educational Resources Information Center

    Wagner, Hans

    The successful use of optical scanning at the University of the Pacific (UOP) indicates that such techniques can simplify a number of administrative data processing tasks. Optical scanning is regularly used at UOP to assist with data processing in the areas of admissions, registration and grade reporting and also has applications for other tasks…

  17. Computer Applications for Children.

    ERIC Educational Resources Information Center

    Dulsky, Dwight; And Others

    1993-01-01

    Four articles discuss computer-assisted instruction, including (1) a middle school art and computer departments project that used LOGO to create rose window designs; (2) student journals; (3) the application of Piaget constructivism and Vygotskin social interaction to LOGO learning; and (4) computer lab writing workshops for elementary school…

  18. Mobile Agents Applications.

    ERIC Educational Resources Information Center

    Martins, Rosane Maria; Chaves, Magali Ribeiro; Pirmez, Luci; Rust da Costa Carmo, Luiz Fernando

    2001-01-01

    Discussion of the need to filter and retrieval relevant information from the Internet focuses on the use of mobile agents, specific software components which are based on distributed artificial intelligence and integrated systems. Surveys agent technology and discusses the agent building package used to develop two applications using IBM's Aglet…

  19. Applications Using AIRS Data

    NASA Astrophysics Data System (ADS)

    Ray, S. E.; Pagano, T. S.; Fetzer, E. J.; Lambrigtsen, B.; Olsen, E. T.; Teixeira, J.; Licata, S. J.; Hall, J. R.; Thompson, C. K.

    2015-12-01

    The Atmospheric Infrared Sounder (AIRS) on NASA's Aqua spacecraft has been returning daily global observations of Earth's atmospheric constituents and properties since 2002. With a 12-year data record and daily, global observations in near real-time, AIRS data can play a role in applications that fall under many of the NASA Applied Sciences focus areas. For vector-borne disease, research is underway using AIRS near surface retrievals to assess outbreak risk, mosquito incubation periods and epidemic potential for dengue fever, malaria, and West Nile virus. For drought applications, AIRS temperature and humidity data are being used in the development of new drought indicators and improvement in the understanding of drought development. For volcanic hazards, new algorithms using AIRS data are in development to improve the reporting of sulfur dioxide concentration, the burden and height of volcanic ash and dust, all of which pose a safety threat to aircraft. In addition, anomaly maps of many of AIRS standard products are being produced to help highlight "hot spots" and illustrate trends. To distribute it's applications imagery, AIRS is leveraging existing NASA data frameworks and organizations to facilitate archiving, distribution and participation in the BEDI. This poster will communicate the status of the applications effort for the AIRS Project and provide examples of new maps designed to best communicate the AIRS data.

  20. VCSEL Applications and Simulation

    NASA Technical Reports Server (NTRS)

    Cheung, Samson; Goorjian, Peter; Ning, Cun-Zheng; Li, Jian-Zhong

    2000-01-01

    This viewgraph presentation gives an overview of Vertical Cavity Surface Emitting Laser (VCSEL) simulation and its applications. Details are given on the optical interconnection in information technology of VCSEL, the formulation of the simulation, its numeric algorithm, and the computational results.

  1. Medical applications of holography

    NASA Astrophysics Data System (ADS)

    von Bally, Gert

    1991-11-01

    From the various capabilities of holography for image processing and measuring purposes, holographic interferometric techniques have found more extended application in biological and medical research. Due to their special properties the different methods of holographic interferometry are applied to characteristic fields of biomedical investigations where--similar to nondestructive testing--vibration and deformation analysis is of interest. Features of holographic interferometry, such as the possibility of noncontactive, three-dimensional investigations with a large field-of-depth, are used with advantage. The main applications can be found in basic research e.g., in audiology, dentistry, opthalmology, and experimental orthopedics. Because of the great number of investigations and the variety of medical domains in which these investigations were performed this survey is confined to some characteristic examples. As in all fields of optics and laser metrology, a review on biomedical applications of holography would be incomplete if military developments and utilization were not mentioned. As demonstrated by selected examples, the increasing interlacing of science with the military does not stop at domains that traditionally are regarded as exclusively oriented to human welfare--like biomedical research. The term ''Star Wars Medicine'', which becomes an increasingly popular expression for laser applications (including holography) in medicine, characterizes the consequences of this development.

  2. Core Design Applications

    1995-07-12

    CORD-2 is intended for core desigh applications of pressurized water reactors. The main objective was to assemble a core design system which could be used for simple calculations (such as frequently required for fuel management) as well as for accurate calculations (for example, core design after refueling).

  3. Microcomputer Applications Specialist.

    ERIC Educational Resources Information Center

    Ohio State Univ., Columbus. Center on Education and Training for Employment.

    This publication contains 16 subjects appropriate for use in a competency list for the occupation of microcomputer applications specialist, 1 of 12 occupations within the business/computer technologies cluster. Each unit consists of a number of competencies; a list of competency builders is provided for each competency. Titles of the 16 units are…

  4. Adaptive Sampling Proxy Application

    2012-10-22

    ASPA is an implementation of an adaptive sampling algorithm [1-3], which is used to reduce the computational expense of computer simulations that couple disparate physical scales. The purpose of ASPA is to encapsulate the algorithms required for adaptive sampling independently from any specific application, so that alternative algorithms and programming models for exascale computers can be investigated more easily.

  5. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard; Day, John H. (Technical Monitor)

    2001-01-01

    This report will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter will continue a series of notes concentrating on analysis techniques with this issue's section discussing the use of Root-Sum-Square calculations for digital delays.

  6. Permit application modifications

    SciTech Connect

    1995-11-01

    This document contains the Permit Application Modifications for the Y-12 Industrial Landfill V site on the Oak Ridge Reservation. These modifications include the assessment of stability of the proposed Landfill V under static and loading conditions. Analyses performed include the general slope stability, veneer stability of the bottom liner and cover system, and a liquefaction potential assessment of the foundation soils.

  7. Forensic Applications of LIBS

    NASA Astrophysics Data System (ADS)

    Hark, Richard R.; East, Lucille J.

    Forensic science is broadly defined as the application of science to matters of the law. Practitioners typically use multidisciplinary scientific techniques for the analysis of physical evidence in an attempt to establish or exclude an association between a suspect and the scene of a crime.

  8. Novel Applications of Peroxidase

    NASA Astrophysics Data System (ADS)

    Rob, Abdul; Ball, Andrew S.; Tuncer, Munir; Wilson, Michael T.

    1997-02-01

    The article entitled "Novel Biocatalysts Will Work Even Better for Industry" published recently in this Journal (1) was informative and interesting. However it touched only briefly on the application of peroxidase as catalyst. Here, we would like to mention in more detail the novel applications of peroxidase in agricultural, paper pulp, water treatment, pharmaceutical, and medical situations. Firstly, the peroxidase isolated from Phanerochaete chyrosporium has been shown to detoxify herbicides such as atrazine to less toxic compounds and would certainly find potential application in agriculture (2). Secondly, the peroxidase produced by Streptomyces thermoviolaceus may find application in the paper pulp industry as a delignifying agent (3). Thirdly, it has been shown that extracellular peroxidase produced by Streptomyces avermitilis can remove the intense color from paper-mill effluent obtained after semichemical alkaline pulping of wheat straw (4), and thus this enzyme might find application as a catalyst in water treatment plants. Fourthly, the heme-containing horseradish peroxidase enzyme has been exploited in several diagnostic applications in pharmaceutics and medicine, such as the detection of human immunodeficiency virus and cystic fibrosis (5-10). Finally, recent work from our laboratory has suggested that thermophilic nonheme peroxidase produced by Thermomonospora fusca BD25 may find medical use in the diagnosis of myocardial infarction (11, 12). Literature Cited 1. Wiseman, A. J. Chem. Educ. 1996, 73, 55-58. 2. Mougin, C. Appl. Environ. Microbiol. 1994, 60, 705-708. 3. McCarthy A. J.; Peace, W.; Broda, P. Appl. Microbiol. Technol. 1985, 23, 238-244. 4. Hernandez, M; Rodriguez J; Soliveri, J; Copa, J. L; Perez, M. I; Arias, M. E. Appl. Environ. Microbiol. 1994, 60, 3909-3913. 5. Hopfer, S. M.; Aslanzadeh, J. Ann. Clin. Lab. Sci. 1995, 25, 475-480. 6. Suzuki, K; Iman, M. J. Virol. Methods 1995, 55, 347-356. 7. Nielsen, K. J. Immunoassay 1995, 16, 183-197. 8

  9. Glyconanomaterials for biosensing applications.

    PubMed

    Hao, Nanjing; Neranon, Kitjanit; Ramström, Olof; Yan, Mingdi

    2016-02-15

    Nanomaterials constitute a class of structures that have unique physiochemical properties and are excellent scaffolds for presenting carbohydrates, important biomolecules that mediate a wide variety of important biological events. The fabrication of carbohydrate-presenting nanomaterials, glyconanomaterials, is of high interest and utility, combining the features of nanoscale objects with biomolecular recognition. The structures can also produce strong multivalent effects, where the nanomaterial scaffold greatly enhances the relatively weak affinities of single carbohydrate ligands to the corresponding receptors, and effectively amplifies the carbohydrate-mediated interactions. Glyconanomaterials are thus an appealing platform for biosensing applications. In this review, we discuss the chemistry for conjugation of carbohydrates to nanomaterials, summarize strategies, and tabulate examples of applying glyconanomaterials in in vitro and in vivo sensing applications of proteins, microbes, and cells. The limitations and future perspectives of these emerging glyconanomaterials sensing systems are furthermore discussed. PMID:26212205

  10. Triclosan: applications and safety.

    PubMed

    Bhargava, H N; Leonard, P A

    1996-06-01

    Triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether) is a nonionic, broad spectrum, antimicrobial agent that, because of its favorable safety profile, has been incorporated into a variety of many personal care products, including deodorant soaps, underarm deodorants, shower gels, and health care personnel handwashes. Triclosan exhibits a moderate degree of substantivity to the skin, and, in many products, it imparts a remnant antimicrobial effect. Although direct contact with the material under exaggerated exposure conditions causes dermal irritation in laboratory animals, it has only rarely been associated with skin irritation or sensitization in human being in formulated products. Acute, subacute/subchronic, and chronic toxicity profiles have been established to determine that triclosan is neither an acute oral toxicant nor that it acts as a carcinogen, mutagen, or teratogen. A new application for triclosan is in oral dentifrices for plaque control. Currently under investigation in the United States, it is approved for oral care application in Canada and many European countries.

  11. Ceramics for fusion applications

    SciTech Connect

    Clinard, F.W. Jr.

    1986-01-01

    Ceramics are required for a variety of uses in both near-term fusion devices and in commercial powerplants. These materials must retain adequate structural and electrical properties under conditions of neutron, particle, and ionizing irradiation; thermal and applied stresses; and physical and chemical sputtering. Ceramics such as Al/sub 2/O/sub 3/, MgAl/sub 2/O/sub 4/, BeO, Si/sub 3/N/sub 4/ and SiC are currently under study for fusion applications, and results to date show widely-varying response to the fusion environment. Materials can be identified today which will meet initial operating requirements, but improvements in physical properties are needed to achieve satisfactory lifetimes for critical applications.

  12. RAIS PDA Application

    2004-10-06

    The Regulatory Authority Information System (RAIS) is a management tool for information related to the regulatory control of radioactive sealed sources developed for the International Atomic Energy Agency (IAEA). The RAIS PDA Application extends the functionality of the RAIS database by allowinig users to download radioactive sealed source data from the RAIS database to a portable PDA equipped with a barcode scanner. This allows users to verify radioactive sealed source data, gather radioactive sealed sourcemore » audit information, and upload audit data to the RAIS database in the field. The application was developed for a tested on the Symbol Model SPT 1800 PDA with PalmOS version 4.1 and a built-in barcode scanner.« less

  13. NASA: Biomedical applications team

    NASA Technical Reports Server (NTRS)

    1981-01-01

    The status of projects involving the adaptation of NASA technologies for medical purposes is reviewed. Devices for the measurement of joint deformation of arthritic hands, the development of an artificial pancreas, provision of an auditory signal to avert epileptic seizures, are described along with the control of medication levels, a compressed air tank to supply power for field dentistry, and an electroencephalogram monitor. The use of the Lixiscope as a portable fluoroscope, thermal laminates for hand and foot warmers for patients with Raynaud's syndrome, and the use of absorptive coatings for instruments for controlling medication levels are described. The applicability of occupation health and safety practices to industry, computerized patient scheduling, impregnation of the common facial tissue with an agent for killing respiratory viruses, commercial applications of anthropometric data, and multispectral image analysis of the skin as a diagnostic tool are reviewed.

  14. Nattokinase: production and application.

    PubMed

    Dabbagh, Fatemeh; Negahdaripour, Manica; Berenjian, Aydin; Behfar, Abdolazim; Mohammadi, Fatemeh; Zamani, Mozhdeh; Irajie, Cambyz; Ghasemi, Younes

    2014-11-01

    Nattokinase (NK, also known as subtilisin NAT) (EC 3.4.21.62) is one of the most considerable extracellular enzymes produced by Bacillus subtilis natto. The main interest about this enzyme is due to its direct fibrinolytic activity. Being stable enough in the gastrointestinal tract makes this enzyme a useful agent for the oral thrombolytic therapy. Thus, NK is regarded as a valuable dietary supplement or nutraceutical. Proven safety and ease of mass production are other advantages of this enzyme. In addition to these valuable advantages, there are other applications attributed to NK including treatment of hypertension, Alzheimer's disease, and vitreoretinal disorders. This review tends to bring a brief description about this valuable enzyme and summarizes the various biotechnological approaches used in its production, recovery, and purification. Some of the most important applications of NK, as well as its future prospects, are also discussed.

  15. Clinical applications for estetrol.

    PubMed

    Visser, Monique; Coelingh Bennink, Herjan J T

    2009-03-01

    In this paper the potential clinical applications for the human fetal estrogen estetrol (E(4)) are presented based on recently obtained data in preclinical and clinical studies. In the past E(4) has been classified as a weak estrogen due to its rather low estrogen receptor affinity. However, recent research has demonstrated that due to its favorable pharmacokinetic properties, especially the slow elimination and long half-life, E(4) is an effective orally bioavailable estrogen agonist with estrogen antagonistic effects on the breast in the presence of estradiol. Based on the pharmacokinetic properties, the pharmacological profile and the safety and efficacy results in human studies, E(4) seems potentially suitable as a drug for human use in applications such as hormone replacement therapy (vaginal atrophy and vasomotor symptoms), contraception, osteoporosis and breast cancer. PMID:19167495

  16. RAIS PDA Application

    SciTech Connect

    2004-10-06

    The Regulatory Authority Information System (RAIS) is a management tool for information related to the regulatory control of radioactive sealed sources developed for the International Atomic Energy Agency (IAEA). The RAIS PDA Application extends the functionality of the RAIS database by allowinig users to download radioactive sealed source data from the RAIS database to a portable PDA equipped with a barcode scanner. This allows users to verify radioactive sealed source data, gather radioactive sealed source audit information, and upload audit data to the RAIS database in the field. The application was developed for a tested on the Symbol Model SPT 1800 PDA with PalmOS version 4.1 and a built-in barcode scanner.

  17. ESnet authentication services and trust federations

    NASA Astrophysics Data System (ADS)

    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).

  18. Baltimore applications project

    NASA Technical Reports Server (NTRS)

    Golden, T. S.; Yaffee, P.

    1978-01-01

    The Baltimore Applications Project (BAP) was originally designed as an experimental effort to assist the government of the City of Baltimore in applying technology to the solution of municipal problems. Recent modifications in the structuring and operation of the program are discussed. A tabular update on the individual tasks undertaken and their treatment is provided. Details of energy and nonenergy related tasks are presented in appendices.

  19. Newton polyhedron and applications

    SciTech Connect

    Bruno, A.D.

    1994-12-31

    We give a simple presentation of an algorithm of selecting asymptotical first approximations of equations (algebraic and ordinary differential and partial differential). Here the first approximation of a solution of the initial equation is a solution of the corresponding first approximation of the equation. The algorithm is based on the geometry of power exponents including the Newton polyhedron. We give also a survey of applications of the algorithm in problems of Celestial Mechanics and Hydrodynamics.

  20. ARM for Platform Application

    NASA Astrophysics Data System (ADS)

    Patte, Mathieu; Poupat, Jean-Luc; Le Meur, Patrick

    2015-09-01

    The activities described in this paper are part of the CNES R&T “Study of a Cortex-R ARM based architecture” performed by Airbus DS Space System & Electronics in 2014. With the support of CNES, Airbus DS has performed the porting of a representative space application software on an ARM based demonstration platform. This paper presents the platform itself, the activities performed at software level and the first results on this evaluation study.

  1. Biomedical applications of photochemistry.

    PubMed

    Chan, Barbara Pui

    2010-10-01

    Photochemistry is the study of photochemical reactions between light and molecules. Recently, there have been increasing interests in using photochemical reactions in the fields of biomaterials and tissue engineering. This work revisits the components and mechanisms of photochemistry and reviews biomedical applications of photochemistry in various disciplines, including oncology, molecular biology, and biosurgery, with particular emphasis on tissue engineering. Finally, potential toxicities and research opportunities in this field are discussed.

  2. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation.Aubrey L. Anderson (O), Lennart A. Anderson (V), Kathleen W. Baird (V), William R. Bergmann (A), E. N. Bernard (O), Joyce R. Blueford (O), Wayne M. Brewer (T), Nancy Ann Brewster (O), Philip S. Callahan (O), Jack G. Calvert (A), Drew A. Carey (O), Benjamin Chen (O), J. W. Cole (V), George Courtney (T), Charles G. Crawford (H).

  3. Applications of ionic liquids.

    PubMed

    Patel, Divia Dinesh; Lee, Jong-Min

    2012-06-01

    Ionic liquids have recently gained popularity in the scientific community owing to their special properties and characteristics. One of the reasons why ionic liquids have been termed "green solvents" is due to their negligible vapour pressure. Their use in electrochemical, biological and metal extraction applications is discussed. Wide research has been carried out for their use in batteries, solar panels, fuel cells, drug deliveries and biomass pretreatments. This work aims to consolidate the various findings from previous works in these areas.

  4. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation.Raffi Aroian (P), David Baker (P), D. Craig Barilotti (O), Stephen J. Barnes (V), Thomas O. Barnwell (H), Robert P. Bessette (G), Brian Bicknell (H), William Blumberg (A), Michele A. Boccadoro (G), Richard Boylan (T), Robert C. Bucknam (T), Roman J. Budzianowski (H), Bruce M. Crowe (V), Charles G. Cunningham (V).

  5. Laser applications in criminalistics

    NASA Astrophysics Data System (ADS)

    Menzel, E. R.

    1990-10-01

    Lasers find application in numerous areas of criminalistics such as fiber analysis document examination and serology. Their widest use however is in detection of latent finger prints. Several routine procedures for obtaining laserexcited fingerprint fluorescence on a range of surfaces have been devel oped. However many surfaces fluoresce so strongly themselves that they are not amenable to these procedures. Timeresolved luminescence imaging is being investigated to permit detection of fingerprints on such surfaces.

  6. Applications of ionic liquids.

    PubMed

    Patel, Divia Dinesh; Lee, Jong-Min

    2012-06-01

    Ionic liquids have recently gained popularity in the scientific community owing to their special properties and characteristics. One of the reasons why ionic liquids have been termed "green solvents" is due to their negligible vapour pressure. Their use in electrochemical, biological and metal extraction applications is discussed. Wide research has been carried out for their use in batteries, solar panels, fuel cells, drug deliveries and biomass pretreatments. This work aims to consolidate the various findings from previous works in these areas. PMID:22711528

  7. Advanced Welding Applications

    NASA Technical Reports Server (NTRS)

    Ding, Robert J.

    2010-01-01

    Some of the applications of advanced welding techniques are shown in this poster presentation. Included are brief explanations of the use on the Ares I and Ares V launch vehicle and on the Space Shuttle Launch vehicle. Also included are microstructural views from four advanced welding techniques: Variable Polarity Plasma Arc (VPPA) weld (fusion), self-reacting friction stir welding (SR-FSW), conventional FSW, and Tube Socket Weld (TSW) on aluminum.

  8. Agricultural application of SWECS

    NASA Astrophysics Data System (ADS)

    Nelson, V.

    Principal applications of wind energy for agriculture are (1) farmstead power, mainly electrical, (2) building heating, (3) irrigation pumping, (4) product storage and processing, (5) hot water for residences and dairies, and (6) associated industries of agribusiness such as feedlots, fertilizer elevators, greenhouses, etc. Field experiments show that wind energy is a viable alternative, however, reliability and maintenance are still major problems. Test results of the various experiments are described.

  9. Performance Application Programming Interface

    2005-10-31

    PAPI is a programming interface designed to provide the tool designer and application engineer with a consistent interface and methodology for use of the performance counter hardware found in most major microprocessors. PAPI enables software engineers to see, in near real time, the relation between software performance and processor events. This release covers the hardware dependent implementation of PAPI version 3 for the IBM BlueGene/L (BG/L) system.

  10. Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.

    PubMed

    Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E

    2013-01-01

    While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence.

  11. Immunogenetically controlled autoimmune reactions induced by mercury, gold and D-penicillamine in laboratory animals: a review from the vantage point of premarketing safety studies.

    PubMed

    Balazs, T

    1987-09-01

    Mercury and gold salts as well as d-penicillamine can cause glomerulonephritis by an autoimmune mechanism in man. The susceptibility to this effect of these chemicals is controlled by the genes of the major histocompatibility complex (MHC). The presence of certain alleles confers sensitivity. The role of MHC-linked genes has been demonstrated also in the rat and mouse in the development of autoimmunity induced by these chemicals. While Brown Norway rats and ASW mice were sensitive, several other strains were resistant. Also an interaction of MHC with background genes has been shown in determination of the response to HgCl2. In conventional toxicity studies, use of a single inbred strain of laboratory animals obviously handicaps the detection of a reaction of this nature.

  12. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... toxicity), this level is equal to or greater than 200 parts per billion in the daily diet (0.6 milligram... per million in the daily diet (3 mg/person/day); or (2) There exists a bioassay on the food...

  13. IMS applications analysis

    SciTech Connect

    RODACY,PHILIP J.; REBER,STEPHEN D.; SIMONSON,ROBERT J.; HANCE,BRADLEY G.

    2000-03-01

    This report examines the market potential of a miniature, hand-held Ion Mobility Spectrometer. Military and civilian markets are discussed, as well as applications in a variety of diverse fields. The strengths and weaknesses of competing technologies are discussed. An extensive Ion Mobility Spectrometry (IMS) bibliography is included. The conclusions drawn from this study are: (1) There are a number of competing technologies that are capable of detecting explosives, drugs, biological, or chemical agents. The IMS system currently represents the best available compromise regarding sensitivity, specificity, and portability. (2) The military market is not as large as the commercial market, but the military services are more likely to invest R and D funds in the system. (3) Military applications should be addressed before commercial applications are addressed. (4) There is potentially a large commercial market for rugged, hand-held Ion Mobility Spectrometer systems. Commercial users typically do not invest R and D funds in this type of equipment rather, they wait for off-the-shelf availability.

  14. Load Balancing Scientific Applications

    SciTech Connect

    Pearce, Olga Tkachyshyn

    2014-12-01

    The largest supercomputers have millions of independent processors, and concurrency levels are rapidly increasing. For ideal efficiency, developers of the simulations that run on these machines must ensure that computational work is evenly balanced among processors. Assigning work evenly is challenging because many large modern parallel codes simulate behavior of physical systems that evolve over time, and their workloads change over time. Furthermore, the cost of imbalanced load increases with scale because most large-scale scientific simulations today use a Single Program Multiple Data (SPMD) parallel programming model, and an increasing number of processors will wait for the slowest one at the synchronization points. To address load imbalance, many large-scale parallel applications use dynamic load balance algorithms to redistribute work evenly. The research objective of this dissertation is to develop methods to decide when and how to load balance the application, and to balance it effectively and affordably. We measure and evaluate the computational load of the application, and develop strategies to decide when and how to correct the imbalance. Depending on the simulation, a fast, local load balance algorithm may be suitable, or a more sophisticated and expensive algorithm may be required. We developed a model for comparison of load balance algorithms for a specific state of the simulation that enables the selection of a balancing algorithm that will minimize overall runtime.

  15. Biomedical applications of nisin.

    PubMed

    Shin, J M; Gwak, J W; Kamarajan, P; Fenno, J C; Rickard, A H; Kapila, Y L

    2016-06-01

    Nisin is a bacteriocin produced by a group of Gram-positive bacteria that belongs to Lactococcus and Streptococcus species. Nisin is classified as a Type A (I) lantibiotic that is synthesized from mRNA and the translated peptide contains several unusual amino acids due to post-translational modifications. Over the past few decades, nisin has been used widely as a food biopreservative. Since then, many natural and genetically modified variants of nisin have been identified and studied for their unique antimicrobial properties. Nisin is FDA approved and generally regarded as a safe peptide with recognized potential for clinical use. Over the past two decades the application of nisin has been extended to biomedical fields. Studies have reported that nisin can prevent the growth of drug-resistant bacterial strains, such as methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae, Enterococci and Clostridium difficile. Nisin has now been shown to have antimicrobial activity against both Gram-positive and Gram-negative disease-associated pathogens. Nisin has been reported to have anti-biofilm properties and can work synergistically in combination with conventional therapeutic drugs. In addition, like host-defence peptides, nisin may activate the adaptive immune response and have an immunomodulatory role. Increasing evidence indicates that nisin can influence the growth of tumours and exhibit selective cytotoxicity towards cancer cells. Collectively, the application of nisin has advanced beyond its role as a food biopreservative. Thus, this review will describe and compare studies on nisin and provide insight into its future biomedical applications.

  16. Transactional Network Platform: Applications

    SciTech Connect

    Katipamula, Srinivas; Lutes, Robert G.; Ngo, Hung; Underhill, Ronald M.

    2013-10-31

    In FY13, Pacific Northwest National Laboratory (PNNL) with funding from the Department of Energy’s (DOE’s) Building Technologies Office (BTO) designed, prototyped and tested a transactional network platform to support energy, operational and financial transactions between any networked entities (equipment, organizations, buildings, grid, etc.). Initially, in FY13, the concept demonstrated transactions between packaged rooftop air conditioners and heat pump units (RTUs) and the electric grid using applications or "agents" that reside on the platform, on the equipment, on a local building controller or in the Cloud. The transactional network project is a multi-lab effort with Oakridge National Laboratory (ORNL) and Lawrence Berkeley National Laboratory (LBNL) also contributing to the effort. PNNL coordinated the project and also was responsible for the development of the transactional network (TN) platform and three different applications associated with RTUs. This document describes two applications or "agents" in details, and also summarizes the platform. The TN platform details are described in another companion document.

  17. Commercial applications for COIL

    NASA Astrophysics Data System (ADS)

    Solomon, Wayne C.; Carroll, David L.; King, D. M.; Fockler, L. A.; Stromberg, D. S.; Sexauer, M.; Milmoe, A.; Sentman, Lee H.

    2000-01-01

    The chemical oxygen-iodine laser (COIL) is a high power, fiber deliverable tool, which can be used for a number of different industrial applications. COIL is of particular interest because of its short fiber deliverable wavelength, high scaleable continuous wave power, and excellent material interaction properties. In past research the University of Illinois at Urbana-Champaign identified and decommissioning and decontamination (DD) of nuclear facilities as a primary focus for COIL technology. DD will be a major challenge in the coming decades. The use of a robotically driven fiber delivered cutting/ablation tool in contaminated areas promises to lower risks to workers for the DD mission. Further, the high cutting speed of COIL will significantly reduce the time required to cut contaminated equipment, reducing costs. The high power of COIL will permit the dismantling of thick stacks of piping and equipment as well as reactor vessels. COIL is very promising for the removal of material from contaminated surfaces, perhaps to depths thicker than an inch. Laser cutting and ablation minimizes dust and fumes, which reduces the required number of high efficiency particulate accumulator filters, thus reducing costly waste disposal. Other potential industrial applications for COIL are shipbuilding, automotive manufacturing, heavy machinery manufacturing, tasks requiring underwater cutting or welding, and there appear to be very promising applications for high powers lasers in the oil industry.

  18. FPA Depot - Web Application

    NASA Technical Reports Server (NTRS)

    Avila, Edwin M. Martinez; Muniz, Ricardo; Szafran, Jamie; Dalton, Adam

    2011-01-01

    Lines of code (LOC) analysis is one of the methods used to measure programmer productivity and estimate schedules of programming projects. The Launch Control System (LCS) had previously used this method to estimate the amount of work and to plan development efforts. The disadvantage of using LOC as a measure of effort is that one can only measure 30% to 35% of the total effort of software projects involves coding [8]. In the application, instead of using the LOC we are using function point for a better estimation of hours in each software to develop. Because of these disadvantages, Jamie Szafran of the System Software Branch of Control And Data Systems (NE-C3) at Kennedy Space Canter developed a web application called Function Point Analysis (FPA) Depot. The objective of this web application is that the LCS software architecture team can use the data to more accurately estimate the effort required to implement customer requirements. This paper describes the evolution of the domain model used for function point analysis as project managers continually strive to generate more accurate estimates.

  19. Next generation EFB applications

    NASA Astrophysics Data System (ADS)

    Pschierer, C.; Sindlinger, A.; Barraci, N.; Wiesemann, T.; Gaertner, M.; Schiefele, J.

    2011-06-01

    Today pilots have to obtain required information from a number of different sources like airport/SID/STAR/approach or enroute charts (respectively their electronic representations), printouts like the flight plan or a weather briefing, and updates via voice communications. The flight crew is required to mentally combine all this information. This situation will become even more difficult to cope with in the SESAR/NextGen world with dynamic changes of the trajectory (flight plan), and more frequent updates of weather, NOTAMs and other information requiring a higher degree of automation and better information presentation. To address these issues, lower the pilot's workload, and increase his situational awareness, a concept is presented where all required information is provided through one application. Depending on the phase of flight (taxi-in/taxi-out, departure, enroute, arrival, approach) the application will select the currently required information and provide a seamless representation for the crew. The challenge is to provide the right information at the right time to the crew (e.g. significant weather moving into the direction of the flight plan). The focus of this paper will be on the components of the new application related to ground operations. This includes an enhanced, AMM-like view with integrated taxi-routing support, graphical and textual display of chart notes (e.g. wingspan restrictions, taxiway closures etc.), and updates of such information by automatic inclusion of digital NOTAMs.

  20. [The applicability of results].

    PubMed

    Marín-León, I

    2015-11-01

    The ultimate aim of the critical reading of medical literature is to use the scientific advances in clinical practice or for innovation. This requires an evaluation of the applicability of the results of the studies that have been published, which begins with a clear understanding of these results. When the studies do not provide sufficient guarantees of rigor in design and analysis, the conditions necessary for the applicability of the results are not met; however, the fact that the results are reliable is not enough to make it worth trying to use their conclusions. This article explains how carrying out studies in experimental or artificial conditions often moves them away from the real conditions in which they claim to apply their conclusions. To evaluate this applicability, the article proposes evaluating a set of items that will enable the reader to determine the likelihood that the benefits and risks reported in the studies will yield the least uncertainty in the clinical arena where they aim to be applied.

  1. Hyperspectral image projector applications

    NASA Astrophysics Data System (ADS)

    Rice, Joseph P.; Brown, Steven W.; Allen, David W.; Yoon, Howard W.; Litorja, Maritoni; Hwang, Jeeseong C.

    2012-03-01

    For the past several years NIST has been developing, along with several collaborators, a Hyperspectral Image Projector (HIP). This scene projector produces high-resolution programmable spectra and projects them into dynamic two-dimensional images. The current digital micromirror device (DMD) based HIP prototype has a spatial resolution of 1024 x 768 pixels and a spectral range of 450 nm to 2400 nm, with spectral resolution from 2 nm in the visible to 5 nm in the short-wave infrared. It disperses light from a supercontinuum fiber source across two DMDs to produce the programmable spectra, which then globally-illuminate a third DMD to form the spatial images. The HIP can simulate top-of-the atmosphere spectral radiance over a 10 mm x 14 mm, f/3 image, and this can be collimated to stimulate remote sensing instruments. Also, the spectral radiance of the projected scenes can be measured with a NIST-calibrated spectroradiometer, such that the spectral radiance projected into each pixel can be accurately known. The HIP was originally developed for applications in multi-spectral and hyperspectral imager testing, calibration, and performance validation, and examples of this application will be reviewed. Conceivable applications for the HIP in photovoltaic device characterization and optical medical imaging will also be discussed.

  2. 40 CFR 194.15 - certification application(s).

    Code of Federal Regulations, 2011 CFR

    1996-07-01

    ... ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Compliance Certification and Re-certification Applications Sec. 194.15 Content of compliance re-certification application(s... Sec. 194.15 Content of compliance re PROTECTION OF ENVIRONMENT ENVIRONMENTAL PROTECTION...

  3. Application Program Interface for Engineering and Scientific Applications

    2001-10-18

    An Application Program Interface (API) for engineering and scientific applications. This system allows application developers to write to a single uniform interface, obtaining access to all solvers in the Trilinos framwork. This includes linear solvers, eigensolvers, non-linear solvers, and time-dependent solvers.

  4. LAVA Applications to Open Rotors

    NASA Technical Reports Server (NTRS)

    Kiris, Cetin C.; Housman, Jeff; Barad, Mike; Brehm, Christoph

    2015-01-01

    Outline: LAVA (Launch Ascent Vehicle Aerodynamics); Introduction; Acoustics Related Applications; LAVA Applications to Open Rotor; Structured Overset Grids; Cartesian Grid with Immersed Boundary; High Speed Case; High Speed Case with Plate Low Speed Case.

  5. Sample Cancer Epidemiology Grant Applications

    Cancer.gov

    The National Cancer Institute frequently receives questions from investigators for examples of successfully funded grant applications. Several investigators agreed to let the Epidemiology and Genomics Research Program post excerpts of their grant applications online.

  6. Applications of lobster eye optics

    NASA Astrophysics Data System (ADS)

    Hudec, R.; Pina, L.; Inneman, A.; Tichy, V.

    2015-05-01

    Applications of wide field Lobster Eye X ray telescopes are presented and discussed. The wide field X ray optics was originally proposed for use in X-ray astronomy, but there are numerous other application areas as well.

  7. Capacitor Technologies, Applications and Reliability

    NASA Technical Reports Server (NTRS)

    1981-01-01

    Various aspects of capacitor technologies and applications are discussed. Major emphasis is placed on: the causes of failures; accelerated testing; screening tests; destructive physical analysis; applications techniques; and improvements in capacitor capabilities.

  8. Applicant Analysis: 2001 Entering Class.

    ERIC Educational Resources Information Center

    Weaver, Richard G.; Haden, N. Karl; Ramanna, Satyan; Valachovic, Richard W.

    2003-01-01

    Presents findings of the annual analysis of dental school applicant numbers and characteristics conducted by the American Dental Education Association. There were 7,412 applicants to dental schools in 2001, and 57.6% were enrolled in 2001. Provides other data about applicants and admissions. (SLD)

  9. Liquid lubrication for space applications

    NASA Technical Reports Server (NTRS)

    Fusaro, Robert L.; Khonsari, Michael M.

    1992-01-01

    Reviewed here is the state of the art of liquid lubrication for space applications. The areas discussed are types of liquid lubrication mechanisms, space environmental effects on lubrication, classification of lubricants, liquid lubricant additives, grease lubrication, mechanism materials, bearing anomalies and failures, lubricant supply techniques, and application types and lubricant needs for those applications.

  10. CERES Search and Subset Application

    Atmospheric Science Data Center

    2016-02-18

    CERES Search and Subset Application Thursday, February 18, 2016 ... Science Team is pleased to announce the release of the CERES Search and Subset Application. Features of the application provide a single, ... data granules using a high resolution spatial metadata database and directly accessing the archived data granules for the following ...

  11. Factsheets Web Application

    SciTech Connect

    VIGIL,FRANK; REEDER,ROXANA G.

    2000-10-30

    The Factsheets web application was conceived out of the requirement to create, update, publish, and maintain a web site with dynamic research and development (R and D) content. Before creating the site, a requirements discovery process was done in order to accurately capture the purpose and functionality of the site. One of the high priority requirements for the site would be that no specialized training in web page authoring would be necessary. All functions of uploading, creation, and editing of factsheets needed to be accomplished by entering data directly into web form screens generated by the application. Another important requirement of the site was to allow for access to the factsheet web pages and data via the internal Sandia Restricted Network and Sandia Open Network based on the status of the input data. Important to the owners of the web site would be to allow the published factsheets to be accessible to all personnel within the department whether or not the sheets had completed the formal Review and Approval (R and A) process. Once the factsheets had gone through the formal review and approval process, they could then be published both internally and externally based on their individual publication status. An extended requirement and feature of the site would be to provide a keyword search capability to search through the factsheets. Also, since the site currently resides on both the internal and external networks, it would need to be registered with the Sandia search engines in order to allow access to the content of the site by the search engines. To date, all of the above requirements and features have been created and implemented in the Factsheet web application. These have been accomplished by the use of flat text databases, which are discussed in greater detail later in this paper.

  12. New emerging MEMS applications

    NASA Astrophysics Data System (ADS)

    Mounier, Eric; Eloy, Jean-Christophe

    2007-02-01

    This paper presents the trends for the years to come for the different MEMS markets. Consumer applications have really started to push the MEMS business in 2005. Many different devices are involved, like pressure sensors (altimeters), microphones, accelerometers, gyroscopes . . . One of the most significant consequences is that all the Top 50 semiconductor companies are now looking at these MEMS applications as possible growth areas. Another result of the growth of the MEMS market is the strong growth of the foundries and contract manufacturers. We have seen growth of more than 35% in 2005 compared to 2004 and we expect similar growth in the next 3 years. We will review the next MEMS applications which have currently a high growth: Si microphones, microdisplays (for RPTV, portable projectors or automotive HUDs), gyroscopes and micro-fuel cells. In the longer term, micro-source of energy could also become an important MEMS market. In term of milestones, the following points can be highlighted: -In 2005 market, the MEMS market is 5.1 B worldwide and very fragmented in terms of companies and products. -In 2010, it will be a 9.7 B market worldwide. MEMS foundries and contract manufacturers will account for at least 8 % of the world market with several being public companies. More than 50% of today's systems companies who have integrated fabs will be using external manufacturers. Several large integrated companies will have created independent MEMS spin-offs and IC manufacturers will be deeply involved in MEMS manufacturing. -In 2015, it will be an 18 B$ market worldwide with no longer systems manufacturers with internal fabs. And we forecast that 50% of the total market will be in the hands of semiconductor manufacturers.

  13. Photocathodes in accelerator applications

    SciTech Connect

    Fraser, J.S.; Sheffield, R.L.; Gray, E.R.; Giles, P.M.; Springer, R.W.; Loebs, V.A.

    1987-01-01

    Some electron accelerator applications require bursts of short pulses at high microscopic repetition rates and high peak brightness. A photocathode, illuminated by a mode-locked laser, is well suited to filling this need. The intrinsic brightness of a photoemitter beam is high; experiments are under way at Los Alamos to study the brightness of short bunches with high space charge after acceleration. A laser-illuminated Cs/sub 3/Sb photoemitter is located in the first rf cavity of an injector linac. Diagnostics include a pepper-pot emittance analyzer, a magnetic spectrometer, and a streak camera.

  14. Industrial application experiment series

    NASA Technical Reports Server (NTRS)

    Bluhm, S. A.

    1981-01-01

    Two procurements within the Industrial Application Experiment Series of the Thermal Power Systems Project are discussed. The first procurement, initiated in April 1980, resulted in an award to the Applied Concepts Corporation for the Capital Concrete Experiment: two Fresnel concentrating collectors will be evaluated in single-unit installations at the Jet Propulsion Laboratory Parabolic Dish Test Site and at Capitol Concrete Products, Topeka, Kansas. The second procurement, initiated in March 1981, is titled, "Thermal System Engineering Experiment B." The objective of the procurement is the rapid deployment of developed parabolic dish collectors.

  15. Laser applications in phlebology

    NASA Astrophysics Data System (ADS)

    Longo, Leonardo; Mancini, S.; Postiglione, Marco; Postiglione, M. G.

    2001-06-01

    PURPOSE: review of laser used in phlebology METHOD: critical analysis of scientific data taken from the literature and based on 25 years personal experience. RESULTS: we have three groups of laser applications in phlebology: for the diagnosis, as physical therapy and as surgical therapy. DISCUSSION AND CONCLUSION: the laser-doppler studies the microcirculations, the no-surgical therapy shown positive results in the treatment of venous ulcers and for the wound healing. It could be indicate also as antiphlogistic and anti-edema therapy, in superficial thrombophlebitis. The surgical laser is useful for the surgical cleaning of ulcers, for haemorroids, angiomas and telangiectases.

  16. Mechanics: Ideas, problems, applications

    NASA Astrophysics Data System (ADS)

    Ishlinskii, A. Iu.

    The book contains the published articles and reports by academician Ishlinskii which deal with the concepts and ideas of modern mechanics, its role in providing a general understanding of the natural phenomena, and its applications to various problems in science and engineering. Attention is given to the methodological aspects of mechanics, to the history of the theories of plasticity, friction, gyroscopic and inertial systems, and inertial navigation, and to mathematical methods in mechanics. The book also contains essays on some famous scientists and engineers.

  17. Thermoplastics for prosthetic applications.

    PubMed

    Lawrence, R B; Davies, R M

    1981-10-01

    The rapid and accurate thermoforming of plastics for prosthetic applications has been the subject of considerable research and development by the Bioengineering Centre. This paper outlines the progress in the general concepts that have been effected to date. The original below knee (B/K) socket vacuum forming technique has been extended to above knee (A/K) and supracondylar cases, and there have been developments in rotational casting technology. The work is necessarily based on a sound understanding of the properties of the materials concerned and of the associated manufacturing processes. The contribution of the Bioengineering Centre is outlined together with summaries of collaborative work carried out with other organizations.

  18. NASA RFID Applications

    NASA Technical Reports Server (NTRS)

    Fink, Patrick, Ph.D.; Kennedy, Timothy, Ph.D; Powers, Anne; Haridi, Yasser; Chu, Andrew; Lin, Greg; Yim, Hester; Byerly, Kent, Ph.D.; Barton, Richard, Ph.D.; Khayat, Michael, Ph.D.; Studor, George; Brocato, Robert; Ngo, Phong; Arndt, G. D., Ph.D.; Gross, Julia; Phan, Chau; Ni, David, Ph.D.; Dusl, John; Dekome, Kent

    2007-01-01

    This viewgraph document reviews some potential uses for Radio Frequency Identification in space missions. One of these is inventory management in space, including the methods used in Apollo, the Space Shuttle, and Space Station. The potential RFID uses in a remote human outpost are reviewed. The use of Ultra-Wideband RFID for tracking are examined such as that used in Sapphire DART The advantages of RFID in passive, wireless sensors in NASA applications are shown such as: Micrometeoroid impact detection and Sensor measurements in environmental facilities The potential for E-textiles for wireless and RFID are also examined.

  19. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard

    1999-01-01

    This column will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter the focus is on some experimental data on low voltage drop out regulators to support mixed 5 and 3.3 volt systems. A discussion of the Small Explorer WIRE spacecraft will also be given. Lastly, we show take a first look at robust state machines in Hardware Description Languages (VHDL) and their use in critical systems. If you have information that you would like to submit or an area you would like discussed or researched, please give me a call or e-mail.

  20. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation.Henry D. I. Abarbanel (O), Julia C. Allen (H), Gwendolyn L. Anson (GP), Andrew Bakun (O), C. A. Bengtson (T), Patricia A. Berge (S), Peter R. Betzer (O), Pierre Boivin (V), Michael V. Capobianco (P), Martin C. Chapman (S), Chu-Yung Chen (V), Timothy J. Clarke (S), Steven C. Constable (GP), Michele Dermer (H), G. M. Dow (T), Carl E. Draper (G), Dean A. Dunn (O), I. B. Everingham (S).

  1. Space applications instrumentation systems

    NASA Technical Reports Server (NTRS)

    Minzner, R. A.; Oberholtzer, J. D.

    1972-01-01

    A compendium of resumes of 158 instrument systems or experiments, of particular interest to space applications, is presented. Each resume exists in a standardized format, permitting entries for 26 administrative items and 39 scientific or engineering items. The resumes are organized into forty groups determined by the forty spacecraft with which the instruments are associated. The resumes are followed by six different cross indexes, each organized alphabetically according to one of the following catagories: instrument name, acronym, name of principal investigator, name of organization employing the principal investigator, assigned experiment number, and spacecraft name. The resumes are associated with a computerized instrument resume search and retrieval system.

  2. Direct application of geothermal energy

    SciTech Connect

    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)

  3. Aerospace materials for nonaerospace applications

    NASA Technical Reports Server (NTRS)

    Johnston, R. L.; Dawn, F. S.

    1974-01-01

    Many of the flame-resistant nonmetallic materials that were developed for the Apollo and Skylab programs are discussed for commercial and military applications. Interchanges of information are taking place with the government agencies, industries, and educational institutions, which are interested in applications of fire-safe nonmetallic materials. These materials are particularly applicable to the design of aircraft, mass transit interiors, residential and public building constructions, nursing homes and hospitals, and to other fields of fire safety applications. Figures 22, 23 and 24 show the potential nonaerospace applications of flame-resistant aerospace materials are shown.

  4. Medical devices: US medical device regulation.

    PubMed

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

    Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation.

  5. Applications of Groundwater Helium

    USGS Publications Warehouse

    Kulongoski, Justin T.; Hilton, David R.

    2011-01-01

    Helium abundance and isotope variations have widespread application in groundwater-related studies. This stems from the inert nature of this noble gas and the fact that its two isotopes ? helium-3 and helium-4 ? have distinct origins and vary widely in different terrestrial reservoirs. These attributes allow He concentrations and 3He/4He isotope ratios to be used to recognize and quantify the influence of a number of potential contributors to the total He budget of a groundwater sample. These are atmospheric components, such as air-equilibrated and air-entrained He, as well as terrigenic components, including in situ (aquifer) He, deep crustal and/or mantle He and tritiogenic 3He. Each of these components can be exploited to reveal information on a number of topics, from groundwater chronology, through degassing of the Earth?s crust to the role of faults in the transfer of mantle-derived volatiles to the surface. In this review, we present a guide to how groundwater He is collected from aquifer systems and quantitatively measured in the laboratory. We then illustrate the approach of resolving the measured He characteristics into its component structures using assumptions of endmember compositions. This is followed by a discussion of the application of groundwater He to the types of topics mentioned above using case studies from aquifers in California and Australia. Finally, we present possible future research directions involving dissolved He in groundwater.

  6. FLAPW: applications and implementations

    NASA Astrophysics Data System (ADS)

    Weinert, M.; Schneider, G.; Podloucky, R.; Redinger, J.

    2009-02-01

    Modern material design involves a close collaboration between experimental and computational materials scientists. To be useful, the theory must be able to accurately predict the stability and properties of new materials, describe the physics of the experiments, and be applicable to new and complex structures—the all-electron full-potential linearized augmented plane wave (FLAPW) is one such method that provides the requisite level of numerical accuracy, albeit at the cost of complexity. Technical aspects and modifications related to the choice of basis functions (energy parameters, core-valence orthogonality, extended local orbitals) that affect the applicability and accuracy of the method are described, as well as an approach for obtaining k-independent matrix elements. The inclusion of external electric fields is illustrated by results for the induced densities at the surfaces of both magnetic and non-magnetic metals, and the relationship to image planes and to nonlinear effects such as second harmonic generation. The magnetic coupling of core hole excitations in Fe, the calculation of intrinsic defect formation energies, the concentration-dependent chemical potentials, entropic contributions, and the relative phase stability of Zr-rich Zr-Al alloys are also discussed.

  7. Medicinal applications of fullerenes

    PubMed Central

    Bakry, Rania; Vallant, Rainer M; Najam-ul-Haq, Muhammad; Rainer, Matthias; Szabo, Zoltan; Huck, Christian W; Bonn, Günther K

    2007-01-01

    Fullerenes have attracted considerable attention in different fields of science since their discovery in 1985. Investigations of physical, chemical and biological properties of fullerenes have yielded promising information. It is inferred that size, hydrophobicity, three-dimensionality and electronic configurations make them an appealing subject in medicinal chemistry. Their unique carbon cage structure coupled with immense scope for derivatization make them a potential therapeutic agent. The study of biological applications has attracted increasing attention despite the low solubility of carbon spheres in physiological media. The fullerene family, and especially C60, has appealing photo, electrochemical and physical properties, which can be exploited in various medical fields. Fullerene is able to fit inside the hydrophobic cavity of HIV proteases, inhibiting the access of substrates to the catalytic site of enzyme. It can be used as radical scavenger and antioxidant. At the same time, if exposed to light, fullerene can produce singlet oxygen in high quantum yields. This action, together with direct electron transfer from excited state of fullerene and DNA bases, can be used to cleave DNA. In addition, fullerenes have been used as a carrier for gene and drug delivery systems. Also they are used for serum protein profiling as MELDI material for biomarker discovery. In this review we report the aspects of medicinal applications of fullerenes. PMID:18203430

  8. Novel oral laser applications

    NASA Astrophysics Data System (ADS)

    Yousif, A.; Strassl, M.; Beer, F.; Verhagen, L.; Wittschier, M.; Wintner, E.

    2007-03-01

    In dental hard tissue ablation, ultra-short laser pulses have proven sufficiently their potential for material ablation with negligible collateral damage providing many advantages. The absence of micro-cracks and the possibility to avoid overheating of the pulp during dental cavity preparation may be among the most important issues, the latter opening up an avenue for potential painless treatment. Beside the evident short interaction time of laser radiation with the irradiated tissue, scanning of the ultra-short pulse trains turned out to be crucial for ablating cavities of required quality and shape. Additionally, long-pulsed laser systems have demonstrated successfully their suitability for decontamination purposes. In this paper, an overview of different indications for laser application in dental therapies in both pulse regimes is presented. A special focus is set on the decontamination of dental implants in periimplantitis therapy. Having employed commercially available long pulse systems for dental applications and ultra-short 330 fs pulses, we present first results for temperature development and corresponding ablation thresholds for dental implants, as in the future more gentle implant cleaning by ultra-short laser pulses could become of interest.

  9. ): laser processing and applications

    NASA Astrophysics Data System (ADS)

    Fricke-Begemann, T.; Meinertz, J.; Weichenhain-Schriever, R.; Ihlemann, J.

    2014-10-01

    Substoichiometric silicon oxide SiOx with x < 2 in form of evaporated or sputtered thin films offers a versatile material basis for laser ablation techniques such as film patterning, laser-induced forward transfer, or laser-induced backside dry etching. Applications in the field of (micro-) optics are favoured strongly by the fact that SiOx can be oxidised to UV-transparent SiO2 by thermal treatment (furnace or laser annealing). On the other hand, with x ≈ 1, SiOx exhibits an absorption coefficient of >105 cm-1 in the deep UV below 250 nm, comparable to strongly absorbing polymers such as polyimide. This enables precise ablation with, e.g., excimer lasers at moderate fluences. For example, UV-transparent diffractive elements or phase masks are made by laser patterning of an appropriate SiOx film and subsequent oxidation to SiO2. Modifications of the basic film ablation process lead to novel surface topographies such as blister or cup arrays with potential non-optical applications, e.g., in micro-/nanofluidics.

  10. Cardiac Applications of Optogenetics

    PubMed Central

    Ambrosi, Christina M.; Klimas, Aleksandra; Yu, Jinzhu; Entcheva, Emilia

    2014-01-01

    In complex multicellular systems, such as the brain or the heart, the ability to selectively perturb and observe the response of individual components at the cellular level and with millisecond resolution in time, is essential for mechanistic understanding of function. Optogenetics uses genetic encoding of light sensitivity (by the expression of microbial opsins) to provide such capabilities for manipulation, recording, and control by light with cell specificity and high spatiotemporal resolution. As an optical approach, it is inherently scalable for remote and parallel interrogation of biological function at the tissue level; with implantable miniaturized devices, the technique is uniquely suitable for in vivo tracking of function, as illustrated by numerous applications in the brain. Its expansion into the cardiac area has been slow. Here, using examples from published research and original data, we focus on optogenetics applications to cardiac electrophysiology, specifically dealing with the ability to manipulate membrane voltage by light with implications for cardiac pacing, cardioversion, cell communication, and arrhythmia research, in general. We discuss gene and cell delivery methods of inscribing light sensitivity in cardiac tissue, functionality of the light-sensitive ion channels within different types of cardiac cells, utility in probing electrical coupling between different cell types, approaches and design solutions to all-optical electrophysiology by the combination of optogenetic sensors and actuators, and specific challenges in moving towards in vivo cardiac optogenetics. PMID:25035999

  11. Medicinal applications of fullerenes.

    PubMed

    Bakry, Rania; Vallant, Rainer M; Najam-ul-Haq, Muhammad; Rainer, Matthias; Szabo, Zoltan; Huck, Christian W; Bonn, Günther K

    2007-01-01

    Fullerenes have attracted considerable attention in different fields of science since their discovery in 1985. Investigations of physical, chemical and biological properties of fullerenes have yielded promising information. It is inferred that size, hydrophobicity, three-dimensionality and electronic configurations make them an appealing subject in medicinal chemistry. Their unique carbon cage structure coupled with immense scope for derivatization make them a potential therapeutic agent. The study of biological applications has attracted increasing attention despite the low solubility of carbon spheres in physiological media. The fullerene family, and especially C60, has appealing photo, electrochemical and physical properties, which can be exploited in various medical fields. Fullerene is able to fit inside the hydrophobic cavity of HIV proteases, inhibiting the access of substrates to the catalytic site of enzyme. It can be used as radical scavenger and antioxidant. At the same time, if exposed to light, fullerene can produce singlet oxygen in high quantum yields. This action, together with direct electron transfer from excited state of fullerene and DNA bases, can be used to cleave DNA. In addition, fullerenes have been used as a carrier for gene and drug delivery systems. Also they are used for serum protein profiling as MELDI material for biomarker discovery. In this review we report the aspects of medicinal applications of fullerenes.

  12. Superstatistics: Theory and Applications

    NASA Astrophysics Data System (ADS)

    Beck, C.

    2015-12-01

    Many driven nonequilibrium systems are described by a superposition of several dynamics on various time scales. If time scales are clearly separated then the formalism of superstatistics can be applied, leading effectively to a more general statistical mechanics relevant for complex systems. In these types of systems there is often dynamical behavior that is characterized by spatio-temporal fluctuations of an intensive parameter β. This parameter may be for example the inverse temperature, or an effective friction constant, or the amplitude of Gaussian white noise, or the energy dissipation in turbulent flows, or simply a local variance parameter extracted from a measured signal. A nonhomogenoeus spatially extended system with fluctuations in β on a large time scale, larger than the local relaxation time, leads to a superstatistical description, by averaging local Boltzmann factors using a suitable weight function f(β). Kappa distributions in space plasma physics are one example which naturally follows out of this formalism, but there are many applications in other areas as well. In this talk I will sketch the basic theory underlying the superstatistical approach and then describe a couple of recent applications.

  13. Surety applications in transportation

    SciTech Connect

    Matalucci, R.V.; Miyoshi, D.S.

    1998-01-01

    Infrastructure surety can make a valuable contribution to the transportation engineering industry. The lessons learned at Sandia National Laboratories in developing surety principles and technologies for the nuclear weapons complex and the nuclear power industry hold direct applications to the safety, security, and reliability of the critical infrastructure. This presentation introduces the concepts of infrastructure surety, including identification of the normal, abnormal, and malevolent threats to the transportation infrastructure. National problems are identified and examples of failures and successes in response to environmental loads and other structural and systemic vulnerabilities are presented. The infrastructure surety principles developed at Sandia National Laboratories are described. Currently available technologies including (a) three-dimensional computer-assisted drawing packages interactively combined with virtual reality systems, (b) the complex calculational and computational modeling and code-coupling capabilities associated with the new generation of supercomputers, and (c) risk-management methodologies with application to solving the national problems associated with threats to the critical transportation infrastructure are discussed.

  14. Environmental Applications of Nanotechnology

    NASA Astrophysics Data System (ADS)

    Keller, Arturo A.

    2014-07-01

    Engineered nanomaterials (ENMs) are currently used in many applications including agriculture (Gruère, 2012; Khot et al. 2012; Lopez-Moreno et al. 2010; Peralta-Videa et al. 2011; Zhao et al. 2012), aerogels (Bigall et al. 2009), aerospace (Baur and Silverman, 2007), automotive (Coelho et al. 2012; Presting and König, 2003; Salonitis et al. 2010), catalysts (Zhou et al. 2011), coatings, paints and pigments (Dhoke et al. 2009; Gopalakrishnan et al. 2011; Khanna, 2008), composites (Borchardt, 2003; Khanna and Bakshi, 2009; Petrov and Georgiev, 2012; Sahoo et al. 2010), construction (Lee et al. 2010), cosmetics (Musee, 2011; Sabitha et al. 2012; Singh and Nanda, 2012), electronics and optics (Alda et al. 2005; Avasthi et al. 2007; Song et al. 2012; Subramanian and Takhee, 2012), energy (Serrano et al. 2009), environmental remediation (Dionysiou 2004; Khin et al. 2012), filtration and purification (Dhakras, 2011; Savage and Diallo, 2005), food products (Blasco and Picó, 2011; Weiss et al. 2006), medical (Boisseau and Loubaton, 2011; Farokhzad and Langer, 2006), packaging (Silvestre et al. 2011), paper and board (Kharisov and Kharissova, 2010), plastics, security (Marín and Merkoçi, 2012), sensors (Ding et al. 2010; Duncan et al. 2012; Su et al. 2012; Tan et al. 2012), and textiles (Qian and Hinestroza, 2004; Wong et al. 2006), and research is underway on many new applications...

  15. Factorizing monolithic applications

    SciTech Connect

    Hall, J.H.; Ankeny, L.A.; Clancy, S.P.

    1998-12-31

    The Blanca project is part of the US Department of Energy`s (DOE) Accelerated Strategic Computing Initiative (ASCI), which focuses on Science-Based Stockpile Stewardship through the large-scale simulation of multi-physics, multi-dimensional problems. Blanca is the only Los Alamos National Laboratory (LANL)-based ASCI project that is written entirely in C++. Tecolote, a new framework used in developing Blanca physics codes, provides an infrastructure for gluing together any number of components; this framework is then used to create applications that encompass a wide variety of physics models, numerical solution options, and underlying data storage schemes. The advantage of this approach is that only the essential components for the given model need be activated at runtime. Tecolote has been designed for code re-use and to isolate the computer science mechanics from the physics aspects as much as possible -- allowing physics model developers to write algorithms in a style quite similar to the underlying physics equations that govern the computational physics. This paper describes the advantages of component architectures and contrasts the Tecolote framework with Microsoft`s OLE and Apple`s OpenDoc. An actual factorization of a traditional monolithic application into its basic components is also described.

  16. Cardiac applications of optogenetics.

    PubMed

    Ambrosi, Christina M; Klimas, Aleksandra; Yu, Jinzhu; Entcheva, Emilia

    2014-08-01

    In complex multicellular systems, such as the brain or the heart, the ability to selectively perturb and observe the response of individual components at the cellular level and with millisecond resolution in time, is essential for mechanistic understanding of function. Optogenetics uses genetic encoding of light sensitivity (by the expression of microbial opsins) to provide such capabilities for manipulation, recording, and control by light with cell specificity and high spatiotemporal resolution. As an optical approach, it is inherently scalable for remote and parallel interrogation of biological function at the tissue level; with implantable miniaturized devices, the technique is uniquely suitable for in vivo tracking of function, as illustrated by numerous applications in the brain. Its expansion into the cardiac area has been slow. Here, using examples from published research and original data, we focus on optogenetics applications to cardiac electrophysiology, specifically dealing with the ability to manipulate membrane voltage by light with implications for cardiac pacing, cardioversion, cell communication, and arrhythmia research, in general. We discuss gene and cell delivery methods of inscribing light sensitivity in cardiac tissue, functionality of the light-sensitive ion channels within different types of cardiac cells, utility in probing electrical coupling between different cell types, approaches and design solutions to all-optical electrophysiology by the combination of optogenetic sensors and actuators, and specific challenges in moving towards in vivo cardiac optogenetics.

  17. Applications of avian transgenesis.

    PubMed

    Scott, Benjamin B; Velho, Tarciso A; Sim, Shuyin; Lois, Carlos

    2010-01-01

    The ability to introduce foreign DNA into the genome of an organism has proven to be one of the most powerful tools in modern biology. Methods for the manipulation of the animal genome have been developed at an impressive pace for 3 decades, but only in the past 5 years have useful tools for avian transgenesis emerged. The most efficient technique involves the use of replication-deficient lentiviral vectors to deliver foreign DNA into the avian germline. Although lentiviral-mediated transgenesis presents some constraints, progress in this area has garnered interest in both industry and academia for its potential applications in biological research, biotechnology, and agriculture. In this review we evaluate methods for the production of transgenic birds, focusing on the advantages and limitations of lentiviral-mediated transgenesis. We also provide an overview of future applications of this technology. The most exciting of these include disease-resistant transgenic poultry, genetically modified hens that produce therapeutic proteins in their eggs, and transgenic songbirds that serve as a model to study communication disorders. Finally, we discuss technological advances that will be necessary to make avian transgenesis a more versatile tool.

  18. 7 CFR 4284.510 - Application processing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ....510 Application processing. (a) Applications. USDA will solicit applications on a competitive basis by... organizations receiving the assistance, and the transferability of its Cooperative development strategy...

  19. 30 CFR 7.83 - Application requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) Performance specifications of turbocharger, if applicable. (c) The application shall include dimensional... application shall include the following engine specifications— (1) Model number; (2) Number of...

  20. Applications of SLR

    NASA Technical Reports Server (NTRS)

    Schutz, Bob E.

    1993-01-01

    Satellite Laser Ranging (SLR) has a rich history of development which began in the 1960s with 10 meter-level first generation systems. These systems evolved with order of magnitude improvements to the systems that now produce several millimeter single shot range precisions. What began, in part, as an interesting application of the new laser technology has become an essential component of modern, precision space geodesy, which in turn enables contributions to a variety of science areas. Modern space geodesy is the beneficiary of technological developments which have enabled precision geodetic measurements. Aside from SLR and its closely related technique, Lunar Laser Ranging (LLR), Very Long Baseline Interferometry (VLBI) has made prominent science contributions also. In recent years, the Global Positioning System (GPS) has demonstrated a rapidly growing popularity as the result of demonstrated low cost with high precision instrumentation. Other modern techniques such as DORIS have demonstrated the ability to make significant science contributions; furthermore, PRARE can be expected to contribute in its own right. An appropriate question is 'why should several techniques be financially supported'? While there are several answers, I offer the opinion that, in consideration of the broad science areas that are the benefactors of space geodesy, no single technique can meet all the requirements and/or expectations of the science areas in which space geodesy contributes or has the potential for contributing. The more well-known science areas include plate tectonics, earthquake processes, Earth rotation/orientation, gravity (static and temporal), ocean circulation, land, and ice topography, to name a few applications. It is unfortunate that the modern space geodesy techniques are often viewed as competitive, but this view is usually encouraged by funding competition, especially in an era of growing needs but diminishing budgets. The techniques are, for the most part

  1. Clean Energy Application Center

    SciTech Connect

    Freihaut, Jim

    2013-09-30

    The Mid Atlantic Clean Energy Application Center (MACEAC), managed by The Penn State College of Engineering, serves the six states in the Mid-Atlantic region (Pennsylvania, New Jersey, Delaware, Maryland, Virginia and West Virginia) plus the District of Columbia. The goals of the Mid-Atlantic CEAC are to promote the adoption of Combined Heat and Power (CHP), Waste Heat Recovery (WHR) and District Energy Systems (DES) in the Mid Atlantic area through education and technical support to more than 1,200 regional industry and government representatives in the region. The successful promotion of these technologies by the MACEAC was accomplished through the following efforts; (1)The MACEAC developed a series of technology transfer networks with State energy and environmental offices, Association of Energy Engineers local chapters, local community development organizations, utilities and, Penn State Department of Architectural Engineering alumni and their firms to effectively educate local practitioners about the energy utilization, environmental and economic advantages of CHP, WHR and DES; (2) Completed assessments of the regional technical and market potential for CHP, WHR and DE technologies application in the context of state specific energy prices, state energy and efficiency portfolio development. The studies were completed for Pennsylvania, New Jersey and Maryland and included a set of incentive adoption probability models used as a to guide during implementation discussions with State energy policy makers; (3) Using the technical and market assessments and adoption incentive models, the Mid Atlantic CEAC developed regional strategic action plans for the promotion of CHP Application technology for Pennsylvania, New Jersey and Maryland; (4) The CHP market assessment and incentive adoption model information was discussed, on a continuing basis, with relevant state agencies, policy makers and Public Utility Commission organizations resulting in CHP favorable incentive

  2. Cardiac applications of PET.

    PubMed

    Sarikaya, Ismet

    2015-10-01

    Routine use of cardiac positron emission tomography (PET) applications has been increasing but has not replaced cardiac single-photon emission computerized tomography (SPECT) studies yet. The majority of cardiac PET tracers, with the exception of fluorine-18 fluorodeoxyglucose (18F-FDG), are not widely available, as they require either an onsite cyclotron or a costly generator for their production. 18F-FDG PET imaging has high sensitivity for the detection of hibernating/viable myocardium and has replaced Tl-201 SPECT imaging in centers equipped with a PET/CT camera. PET myocardial perfusion imaging with various tracers such as Rb-82, N-13 ammonia, and O-15 H2O has higher sensitivity and specificity than myocardial perfusion SPECT for the detection of coronary artery disease (CAD). In particular, quantitative PET measurements of myocardial perfusion help identify subclinical coronary stenosis, better define the extent and severity of CAD, and detect ischemia when there is balanced reduction in myocardial perfusion due to three-vessel or main stem CAD. Fusion images of PET perfusion and CT coronary artery calcium scoring or CT coronary angiography provide additional complementary information and improve the detection of CAD. PET studies with novel 18F-labeled perfusion tracers such as 18F-flurpiridaz and 18F-FBnTP have yielded high sensitivity and specificity in the diagnosis of CAD. These tracers are still being tested in humans, and, if approved for clinical use, they will be commercially and widely available. In addition to viability studies, 18F-FDG PET can also be utilized to detect inflammation/infection in various conditions such as endocarditis, sarcoidosis, and atherosclerosis. Some recent series have obtained encouraging results for the detection of endocarditis in patients with intracardiac devices and prosthetic valves. PET tracers for cardiac neuronal imaging, such as C-11 HED, help assess the severity of heart failure and post-transplant cardiac

  3. Biostatistical applications in epidemiology.

    PubMed

    Kier, Karen L

    2011-01-01

    Understanding the application of statistical methods is an essential component in the process of evaluating the medical literature. Statistical methods can differ when evaluating randomized controlled clinical trials (experimental design) compared with observational study designs such as cohort or case-control. A review of common statistical concepts includes variables, measures of central tendency, and measures of dispersion. Other methods include sensitivity, specificity, and predictive value. Observational study designs often include relative risk, odds ratios, relative risk reduction, attributable risk, number needed to treat, and forest plots. A critical component of drug literature evaluation is the understanding of the proper use of parametric and nonparametric statistical tests. Common parametric tests and their nonparametric equivalents are discussed.

  4. Biotechnological Applications of Transglutaminases

    PubMed Central

    Rachel, Natalie M.; Pelletier, Joelle N.

    2013-01-01

    In nature, transglutaminases catalyze the formation of amide bonds between proteins to form insoluble protein aggregates. This specific function has long been exploited in the food and textile industries as a protein cross-linking agent to alter the texture of meat, wool, and leather. In recent years, biotechnological applications of transglutaminases have come to light in areas ranging from material sciences to medicine. There has also been a substantial effort to further investigate the fundamentals of transglutaminases, as many of their characteristics that remain poorly understood. Those studies also work towards the goal of developing transglutaminases as more efficient catalysts. Progress in this area includes structural information and novel chemical and biological assays. Here, we review recent achievements in this area in order to illustrate the versatility of transglutaminases. PMID:24970194

  5. Scholars program applications deadline

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    2012-07-01

    The New York Academy of Sciences, in partnership with the U.S. Department of State and a consortium of nearly 40 women's colleges, has launched the NeXXt Scholars Program for the 2012ndash;2013 academic year. The program aims to “engage, connect, and advance young women from countries with predominantly Muslim populations and young American women to pursue undergraduate degrees in science, technology, engineering, and math (STEM) fields,” according to the academy. The academy will provide partnership, mentorship, and networking support for these scholars with a selected STEM mentor fellow. The deadline for applications is 10 August. For more information, see http://www.nyas.org/NexxtScholars.

  6. ICE SLURRY APPLICATIONS.

    PubMed

    Kauffeld, M; Wang, M J; Goldstein, V; Kasza, K E

    2010-12-01

    The role of secondary refrigerants is expected to grow as the focus on the reduction of greenhouse gas emissions increases. The effectiveness of secondary refrigerants can be improved when phase changing media are introduced in place of single phase media. Operating at temperatures below the freezing point of water, ice slurry facilitates several efficiency improvements such as reductions in pumping energy consumption as well as lowering the required temperature difference in heat exchangers due to the beneficial thermo-physical properties of ice slurry. Research has shown that ice slurry can be engineered to have ideal ice particle characteristics so that it can be easily stored in tanks without agglomeration and then be extractable for pumping at very high ice fraction without plugging. In addition ice slurry can be used in many direct contact food and medical protective cooling applications. This paper provides an overview of the latest developments in ice slurry technology. PMID:21528014

  7. Nanotechnology Applications for Glaucoma.

    PubMed

    Cetinel, Sibel; Montemagno, Carlo

    2016-01-01

    Glaucoma is the second leading cause of blindness worldwide, and the antiglaucoma treatments currently available suffer from various complications. Nanotechnology-based treatments show a great deal of promise in overcoming these complications and form the basis for next-generation glaucoma treatment strategies, with the help of applications such as controlled release, targeted delivery, increased bioavailability, diffusion limitations, and biocompatibility. Significant progress has been made in nanomedicine in the efficiency of antiglaucoma medications, nanofabrication systems such as microelectromechanical systems that remove the limitations of nanodevices, and tissue regeneration vesicles for developing glaucoma treatments not based on intraocular pressure. With the use of these advanced technologies, the prevention of glaucoma-induced blindness will be possible in the near future. Herein, we reviewed the recent advances in nanotechnology-based treatment strategies for glaucoma.

  8. Applications of gravitational lensing

    NASA Astrophysics Data System (ADS)

    Dalal, Neal

    I derive the basic principles of gravitational lensing, and proceed to describe several astrophysical applications. First, invariants in gravitational lensing magnification are derived using techniques of multidimensional residue calculus, and illustrated with example calculations. Then I discuss how these invariant quantities may be useful for measuring the properties of lenses. Next, I discuss the use of astrometric microlensing for studying extrasolar planets. Finally, the use of lensing for the study of substructure in dark matter halos is presented, along with ramifications for the small-scale power spectrum of matter fluctuations. The strongest bounds to date are placed on the mass of the dark matter particle, as well as bounds on the neutrino mass and slope of the primordial power spectrum.

  9. ICE SLURRY APPLICATIONS

    PubMed Central

    Kauffeld, M.; WANG, M. J.; Goldstein, V.; Kasza, K. E.

    2011-01-01

    The role of secondary refrigerants is expected to grow as the focus on the reduction of greenhouse gas emissions increases. The effectiveness of secondary refrigerants can be improved when phase changing media are introduced in place of single phase media. Operating at temperatures below the freezing point of water, ice slurry facilitates several efficiency improvements such as reductions in pumping energy consumption as well as lowering the required temperature difference in heat exchangers due to the beneficial thermo-physical properties of ice slurry. Research has shown that ice slurry can be engineered to have ideal ice particle characteristics so that it can be easily stored in tanks without agglomeration and then be extractable for pumping at very high ice fraction without plugging. In addition ice slurry can be used in many direct contact food and medical protective cooling applications. This paper provides an overview of the latest developments in ice slurry technology. PMID:21528014

  10. KAPPA -- Kernel Application Package

    NASA Astrophysics Data System (ADS)

    Currie, Malcolm J.; Berry, David. S.

    KAPPA is an applications package comprising about 180 general-purpose commands for image processing, data visualisation, and manipulation of the standard Starlink data format---the NDF. It is intended to work in conjunction with Starlink's various specialised packages. In addition to the NDF, KAPPA can also process data in other formats by using the `on-the-fly' conversion scheme. Many commands can process data arrays of arbitrary dimension, and others work on both spectra and images. KAPPA operates from both the UNIX C-shell and the ICL command language. This document describes how to use KAPPA and its features. There is some description of techniques too, including a section on writing scripts. This document includes several tutorials and is illustrated with numerous examples. The bulk of this document comprises detailed descriptions of each command as well as classified and alphabetical summaries.

  11. Laser applications in neurosurgery

    NASA Astrophysics Data System (ADS)

    Cerullo, Leonard J.

    1985-09-01

    The "false start" of the laser in neurosurgery should not be misconstrued as a denial of the inherent advantages of precision and gentleness in dealing with neural tissue. Rather, early investigators were frustrated by unrealistic expectations, cumbersome equipment, and a general ignorance of microtechnique. By the early 70s, microneurosurgery was well established, surgical laser equipment for free hand and microlinked application had been developed, and a more realistic view of the limitations of the laser had been established. Consequently, the late 70s really heralded the renaissance of the laser in neurosurgery. Since then, there has been an overwhelming acceptance of the tool in a variety of clinical situations, broadly categorized in five groups. 1)|Perhaps the most generally accepted area is in the removal of extra-axial tumors of the brain and spinal cord. These tumors, benign by histology but treacherous by location, do not present until a significant amount of neurological compensation has already occurred. The application of additional trauma to the neural tissue, whether by further tumor growth or surgical manipulation, frequently results in irreversible damage. Here, the ability of the laser to vaporize tissue, in a fairly hemostatic fashion, without mechanical or thermal damage to sensitive surrounding tissues, is essential. 2)|The ability to incise delicate neural tissue with minimal spread of thermal destruction to adjacent functioning tissue makes the laser the ideal instrument when tumors deep under the surface are encountered in the brain or spinal cord. Thus, the second group of applications is in the transgression of normal neural structures to arrive at deeper pathological tissue. 3)|The third area of benefit for the laser in neurosurgery has been in the performance of neuroablative procedures, calling for deliberate destruction of functioning neural tissue in a controlled fashion. Again, the precision and shape confinement of the destructive

  12. Panarchy: theory and application

    USGS Publications Warehouse

    Allen, Craig R.; Angeler, David G.; Garmestani, Ahjond S.; Gunderson, Lance H.; Holling, Crawford S.

    2014-01-01

    The concept of panarchy provides a framework that characterizes complex systems of people and nature as dynamically organized and structured within and across scales of space and time. It has been more than a decade since the introduction of panarchy. Over this period, its invocation in peer-reviewed literature has been steadily increasing, but its use remains primarily descriptive and abstract. Here, we discuss the use of the concept in the literature to date, highlight where the concept may be useful, and discuss limitations to the broader applicability of panarchy theory for research in the ecological and social sciences. Finally, we forward a set of testable hypotheses to evaluate key propositions that follow from panarchy theory.

  13. Nanotechnology Applications for Glaucoma.

    PubMed

    Cetinel, Sibel; Montemagno, Carlo

    2016-01-01

    Glaucoma is the second leading cause of blindness worldwide, and the antiglaucoma treatments currently available suffer from various complications. Nanotechnology-based treatments show a great deal of promise in overcoming these complications and form the basis for next-generation glaucoma treatment strategies, with the help of applications such as controlled release, targeted delivery, increased bioavailability, diffusion limitations, and biocompatibility. Significant progress has been made in nanomedicine in the efficiency of antiglaucoma medications, nanofabrication systems such as microelectromechanical systems that remove the limitations of nanodevices, and tissue regeneration vesicles for developing glaucoma treatments not based on intraocular pressure. With the use of these advanced technologies, the prevention of glaucoma-induced blindness will be possible in the near future. Herein, we reviewed the recent advances in nanotechnology-based treatment strategies for glaucoma. PMID:26693592

  14. Applications Outside HEP

    NASA Astrophysics Data System (ADS)

    Le Dû, Patrick

    High energy and particle physics has considerable acquired knowledge, expertise and resources that can, when transferred in a realistic way, significantly impact the practice of medical imaging for diagnosis and therapy. This overview introductory talk "from basic science to the clinical reality" intends to show how successful technology transfer between fundamental research in particle physics and medical imaging can be achieved using some specific examples. Using as input, the recent advance of HEP state of the art techniques and tools in detectors developments such as solid state and gaseous detectors, calorimeters, photodetectors, read-out electronics and simulations, some direct applications in medical and molecular imaging will be presented like Positron Emission Tomography (PET) and particle therapy.

  15. Stimulus Application? Not Me

    SciTech Connect

    Wiley, H. S.

    2009-06-01

    I am afraid the situation with respect to the Challenge Grants will be similar in that only a small fraction of the expected deluge of grants will be funded. NIH has provided a very specific list of over 60 topics and a simple calculation shows that only a couple of grants will be funded per topic. Science magazine quotes the Vice Chancellor for Research at the University of California, Irvine as saying that her campus will be submitting “over 200” Challenge Grants. My discussions with friends from other universities suggest that this is a typical response. Even if this is an overestimate by a factor of 2, this would still translate to many thousands of applications flooding into the NIH, putting the payline well below the 4% that I experienced from the DoD. As was the case with the Army grants, I suspect that if the topics are not addressed exactly, grants will not stand a chance.

  16. Electrodes for microfluidic applications

    DOEpatents

    Crocker, Robert W.; Harnett, Cindy K.; Rognlien, Judith L.

    2006-08-22

    An electrode device for high pressure applications. These electrodes, designed to withstand pressure of greater than 10,000 psi, are adapted for use in microfluidic devices that employ electrokinetic or electrophoretic flow. The electrode is composed, generally, of an outer electrically insulating tubular body having a porous ceramic frit material disposed in one end of the outer body. The pores of the porous ceramic material are filled with an ion conductive polymer resin. A conductive material situated on the upper surface of the porous ceramic frit material and, thus isolated from direct contact with the electrolyte, forms a gas diffusion electrode. A metal current collector, in contact with the gas diffusion electrode, provides connection to a voltage source.

  17. Magnesium for automotive applications

    SciTech Connect

    VanFleteren, R.

    1996-05-01

    Die cast magnesium parts are rapidly replacing steel and aluminum structural components in automotive applications, as design engineers seek to reduce assembly costs, raise fuel efficiency, and improve safety. Dozens of automotive components are now die cast from magnesium alloys, including seat stanchions, valve covers, steering wheels, and a variety of steering column components. Because of their excellent castability, complex magnesium die castings can sometimes consolidate several components and eliminate assembly steps. Highly ductile magnesium alloys such as AM60B (6% aluminum) and AM50A (5% aluminum) are important in helping to meet automotive industry crash-energy requirements for car seating and steering components. AZ91D (9% aluminum, 1% zinc) alloys are making removable rear seats in new minivans much easier to handle.

  18. Persuasive Mobile Health Applications

    NASA Astrophysics Data System (ADS)

    Garcia Wylie, Carlos; Coulton, Paul

    With many industrialized societies bearing the cost of an increasingly sedentary lifestyle on the health of their populations there is a need to find new ways of encouraging physical activity to promote better health and well being. With the increasing power of mobile phones and the recent emergence of personal heart rate monitors, aimed at dedicated amateur runners, there is now a possibility to develop “Persuasive Mobile Health Applications” to promote well being through the use of real-time physiological data and persuade users to adopt a healthier lifestyle. In this paper we present a novel general health monitoring software for mobile phones called Heart Angel. This software is aimed at helping users monitor, record, as well as improve their fitness level through built-in cardio-respiratory tests, a location tracking application for analyzing heart rate exertion over time and location, and a fun mobile-exergame called Health Defender.

  19. Applications of hypermedia systems

    SciTech Connect

    Lennon, J.; Maurer, H.

    1995-05-01

    In this paper, we consider several new aspects of modern hypermedia systems. The applications discussed include: (1) General Information and Communication Systems: Distributed information systems for businesses, schools and universities, museums, libraries, health systems, etc. (2) Electronic orientation and information displays: Electronic guided tours, public information kiosks, and publicity dissemination with archive facilities. (3) Lecturing: A system going beyond the traditional to empower both teachers and learners. (4) Libraries: A further step towards fully electronic library systems. (5) Directories of all kinds: Staff, telephone, and all sorts of generic directories. (6) Administration: A fully integrated system such as the one proposed will mean efficient data processing and valuable statistical data. (7) Research: Material can now be accessed from databases all around the world. The effects of networking and computer-supported collaborative work are discussed, and examples of new scientific visualization programs are quoted. The paper concludes with a section entitled {open_quotes}Future Directions{close_quotes}.

  20. High-resolution NMR spectroscopy of biological tissues usingprojected Magic Angle Spinning

    SciTech Connect

    Martin, Rachel W.; Jachmann, Rebecca C.; Sakellariou, Dimitris; Nielsen, Ulla Gro; Pines, Alexander

    2005-01-27

    High-resolution NMR spectra of materials subject toanisotropic broadening are usually obtained by rotating the sample aboutthe magic angle, which is 54.7 degrees to the static magnetic field. Inprojected Magic Angle Spinning (p-MAS), the sample is spun about twoangles, neither of which is the magic angle. This provides a method ofobtaining isotropic spectra while spinning at shallow angles. The p-MASexperiment may be used in situations where spinning the sample at themagic angle is not possible due to geometric or other constraints,allowing the choice of spinning angle to be determined by factors such asthe shape of the sample, rather than by the spin physics. The applicationof this technique to bovine tissue samples is demonstrated as a proof ofprinciple for future biological or medical applications.

  1. [Skeleton extractions and applications].

    SciTech Connect

    Quadros, William Roshan

    2010-05-01

    This paper focuses on the extraction of skeletons of CAD models and its applications in finite element (FE) mesh generation. The term 'skeleton of a CAD model' can be visualized as analogous to the 'skeleton of a human body'. The skeletal representations covered in this paper include medial axis transform (MAT), Voronoi diagram (VD), chordal axis transform (CAT), mid surface, digital skeletons, and disconnected skeletons. In the literature, the properties of a skeleton have been utilized in developing various algorithms for extracting skeletons. Three main approaches include: (1) the bisection method where the skeleton exists at equidistant from at least two points on boundary, (2) the grassfire propagation method in which the skeleton exists where the opposing fronts meet, and (3) the duality method where the skeleton is a dual of the object. In the last decade, the author has applied different skeletal representations in all-quad meshing, hex meshing, mid-surface meshing, mesh size function generation, defeaturing, and decomposition. A brief discussion on the related work from other researchers in the area of tri meshing, tet meshing, and anisotropic meshing is also included. This paper concludes by summarizing the strengths and weaknesses of the skeleton-based approaches in solving various geometry-centered problems in FE mesh generation. The skeletons have proved to be a great shape abstraction tool in analyzing the geometric complexity of CAD models as they are symmetric, simpler (reduced dimension), and provide local thickness information. However, skeletons generally require some cleanup, and stability and sensitivity of the skeletons should be controlled during extraction. Also, selecting a suitable application-specific skeleton and a computationally efficient method of extraction is critical.

  2. MedlinePlus Connect: Web Application

    MedlinePlus

    ... https://medlineplus.gov/connect/application.html MedlinePlus Connect: Web Application To use the sharing features on this ... please see our guidelines and instructions on linking. Web Application Overview The API for the Web application ...

  3. 8 CFR 316.4 - Application; documents.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... NATURALIZATION § 316.4 Application; documents. (a) The applicant will apply for naturalization in accordance with... the application for naturalization, the applicant may be required to establish the status of...

  4. 8 CFR 316.4 - Application; documents.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... NATURALIZATION § 316.4 Application; documents. (a) The applicant will apply for naturalization in accordance with... the application for naturalization, the applicant may be required to establish the status of...

  5. 8 CFR 316.4 - Application; documents.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... NATURALIZATION § 316.4 Application; documents. (a) The applicant will apply for naturalization in accordance with... the application for naturalization, the applicant may be required to establish the status of...

  6. Deaf mobile application accessibility requirements

    NASA Astrophysics Data System (ADS)

    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.

  7. USAF solar thermal applications overview

    NASA Technical Reports Server (NTRS)

    Hauger, J. S.; Simpson, J. A.

    1981-01-01

    Process heat applications were compared to solar thermal technologies. The generic process heat applications were analyzed for solar thermal technology utilization, using SERI's PROSYS/ECONOMAT model in an end use matching analysis and a separate analysis was made for solar ponds. Solar technologies appear attractive in a large number of applications. Low temperature applications at sites with high insolation and high fuel costs were found to be most attractive. No one solar thermal technology emerges as a clearly universal or preferred technology, however,, solar ponds offer a potential high payoff in a few, selected applications. It was shown that troughs and flat plate systems are cost effective in a large number of applications.

  8. Dynamic load balancing of applications

    DOEpatents

    Wheat, Stephen R.

    1997-01-01

    An application-level method for dynamically maintaining global load balance on a parallel computer, particularly on massively parallel MIMD computers. Global load balancing is achieved by overlapping neighborhoods of processors, where each neighborhood performs local load balancing. The method supports a large class of finite element and finite difference based applications and provides an automatic element management system to which applications are easily integrated.

  9. Dynamic load balancing of applications

    DOEpatents

    Wheat, S.R.

    1997-05-13

    An application-level method for dynamically maintaining global load balance on a parallel computer, particularly on massively parallel MIMD computers is disclosed. Global load balancing is achieved by overlapping neighborhoods of processors, where each neighborhood performs local load balancing. The method supports a large class of finite element and finite difference based applications and provides an automatic element management system to which applications are easily integrated. 13 figs.

  10. Medical applications of semiconductor lasers

    NASA Astrophysics Data System (ADS)

    Mancha, Sylvia D.; Keipert, Andreas; Prairie, Michael W.

    1994-06-01

    The High Power Semiconductor Laser Technology (HPSLT) program is currently developing, in-house, a belt pack medical laser. This compact semiconductor laser device provides the field paramedic or physician a unique portable laser capability. The pack consists of a completely self-contained laser system that fits inside a belt pack. Several other medical applications being investigated by the HPSLT program include urological applications, photodynamic therapy, and ophthalmic applications.

  11. Applications and limitations of radiomics

    NASA Astrophysics Data System (ADS)

    Yip, Stephen S. F.; Aerts, Hugo J. W. L.

    2016-07-01

    Radiomics is an emerging field in quantitative imaging that uses advanced imaging features to objectively and quantitatively describe tumour phenotypes. Radiomic features have recently drawn considerable interest due to its potential predictive power for treatment outcomes and cancer genetics, which may have important applications in personalized medicine. In this technical review, we describe applications and challenges of the radiomic field. We will review radiomic application areas and technical issues, as well as proper practices for the designs of radiomic studies.

  12. Porous microsphere and its applications

    PubMed Central

    Cai, Yunpeng; Chen, Yinghui; Hong, Xiaoyun; Liu, Zhenguo; Yuan, Weien

    2013-01-01

    Porous microspheres have drawn great attention in the last two decades for their potential applications in many fields, such as carriers for drugs, absorption and desorption of substances, pulmonary drug delivery, and tissue regeneration. The application of porous microspheres has become a feasible way to address existing problems. In this essay, we give a brief introduction of the porous microsphere, its characteristics, preparation methods, applications, and a brief summary of existing problems and research tendencies. PMID:23515359

  13. 7 CFR 97.14 - Joint applicants.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 3 2014-01-01 2014-01-01 false Joint applicants. 97.14 Section 97.14 Agriculture... PLANT VARIETY AND PROTECTION The Application § 97.14 Joint applicants. (a) Joint owners shall file a joint application by signing as joint applicants. (b) If an application for certificate is made by...

  14. 7 CFR 97.14 - Joint applicants.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 3 2012-01-01 2012-01-01 false Joint applicants. 97.14 Section 97.14 Agriculture... PLANT VARIETY AND PROTECTION The Application § 97.14 Joint applicants. (a) Joint owners shall file a joint application by signing as joint applicants. (b) If an application for certificate is made by...

  15. 7 CFR 97.14 - Joint applicants.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Joint applicants. 97.14 Section 97.14 Agriculture... PLANT VARIETY AND PROTECTION The Application § 97.14 Joint applicants. (a) Joint owners shall file a joint application by signing as joint applicants. (b) If an application for certificate is made by...

  16. 7 CFR 97.14 - Joint applicants.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Joint applicants. 97.14 Section 97.14 Agriculture... PLANT VARIETY AND PROTECTION The Application § 97.14 Joint applicants. (a) Joint owners shall file a joint application by signing as joint applicants. (b) If an application for certificate is made by...

  17. 7 CFR 97.14 - Joint applicants.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Joint applicants. 97.14 Section 97.14 Agriculture... PLANT VARIETY AND PROTECTION The Application § 97.14 Joint applicants. (a) Joint owners shall file a joint application by signing as joint applicants. (b) If an application for certificate is made by...

  18. 76 FR 35411 - Applications for Trademark Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... Trademark Electronic Application System (TEAS) using a regular TEAS application form or a TEAS Plus application form. Applicants that file their applications using the TEAS Plus form pay a reduced filing fee if... through TEAS, and agree to receive communications concerning the application by e-mail. TEAS...

  19. National Center for Supercomputer Applications

    NASA Technical Reports Server (NTRS)

    Arrott, Matthew

    1991-01-01

    Viewgraphs on the National Center for Supercomputer Applications are presented. The objective is to develop comprehensive computational research environments through the use of evolving software technology.

  20. Enabling network-aware applications

    SciTech Connect

    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.

  1. Tools for distributed application management

    NASA Technical Reports Server (NTRS)

    Marzullo, Keith; Wood, Mark; Cooper, Robert; Birman, Kenneth P.

    1990-01-01

    Distributed application management consists of monitoring and controlling an application as it executes in a distributed environment. It encompasses such activities as configuration, initialization, performance monitoring, resource scheduling, and failure response. The Meta system is described: a collection of tools for constructing distributed application management software. Meta provides the mechanism, while the programmer specifies the policy for application management. The policy is manifested as a control program which is a soft real time reactive program. The underlying application is instrumented with a variety of built-in and user defined sensors and actuators. These define the interface between the control program and the application. The control program also has access to a database describing the structure of the application and the characteristics of its environment. Some of the more difficult problems for application management occur when pre-existing, nondistributed programs are integrated into a distributed application for which they may not have been intended. Meta allows management functions to be retrofitted to such programs with a minimum of effort.

  2. Tools for distributed application management

    NASA Technical Reports Server (NTRS)

    Marzullo, Keith; Cooper, Robert; Wood, Mark; Birman, Kenneth P.

    1990-01-01

    Distributed application management consists of monitoring and controlling an application as it executes in a distributed environment. It encompasses such activities as configuration, initialization, performance monitoring, resource scheduling, and failure response. The Meta system (a collection of tools for constructing distributed application management software) is described. Meta provides the mechanism, while the programmer specifies the policy for application management. The policy is manifested as a control program which is a soft real-time reactive program. The underlying application is instrumented with a variety of built-in and user-defined sensors and actuators. These define the interface between the control program and the application. The control program also has access to a database describing the structure of the application and the characteristics of its environment. Some of the more difficult problems for application management occur when preexisting, nondistributed programs are integrated into a distributed application for which they may not have been intended. Meta allows management functions to be retrofitted to such programs with a minimum of effort.

  3. 24 CFR 232.505 - Application and application fee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the equipment is a reasonable cost estimate. (b) Filing of application. An application for insurance... HOUSING AND URBAN DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES,...

  4. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... or nationals of the United States of America may file international applications in the United States... resident or national of the United States of America, and at least one applicant: (1) Has indicated a... of the United States of America for international processing, for......

  5. 49 CFR 1150.3 - Information about applicant(s).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., address, and phone number of the representative to receive correspondence concerning this application. (b... the entity controls any other common carriers. (i) If applicant is a trustee, receiver, assignee, or a... paragraphs (f) through (i) of this section by making appropriate reference to the docket number of...

  6. 49 CFR 1150.3 - Information about applicant(s).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., address, and phone number of the representative to receive correspondence concerning this application. (b... the entity controls any other common carriers. (i) If applicant is a trustee, receiver, assignee, or a... paragraphs (f) through (i) of this section by making appropriate reference to the docket number of...

  7. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... for the national stage only if filed, by the inventor or as provided in §§ 1.422 or 1.423. Joint inventors must jointly apply for an international application. (c) For the purposes of designations other... power of attorney may be excused upon the request of another applicant where one or more...

  8. Apply Pesticides Correctly, A Guide for Commercial Applicators: Aerial Application.

    ERIC Educational Resources Information Center

    Wamsley, Mary Ann, Ed.; Vermeire, Donna M., Ed.

    This guide contains basic information to meet specific standards for pesticide applicators. The text is concerned with the calibration of dry and liquid pesticide systems for aerial application. Additionally, dispersal equipment is discussed with considerations for environmental and safety factors. (CS)

  9. Scaling Applications in hydrology

    NASA Astrophysics Data System (ADS)

    Gebremichael, Mekonnen

    2010-05-01

    Besides downscaling applications, scaling properties of hydrological fields can be used to address a variety of research questions. In this presentation, we will use scaling properties to address questions related to satellite evapotranspiration algorithms, precipitation-streamflow relationships, and hydrological model calibration. Most of the existing satellite-based evapotranspiration (ET) algorithms have been developed using fine-resolution Landsat TM and ASTER data. However, these algorithms are often applied to coarse-resolution MODIS data. Our results show that applying the satellite-based algorithms, which are developed at ASTER resolution, to MODIS resolution leads to ET estimates that (1) preserve the overall spatial pattern (spatial correlation in excess of 0.90), (2) increase the spatial standard deviation and maximum value, (3) have modest conditional bias: underestimate low ET rates (< 1 mm/day) and overestimate high ET rates; the overestimation is within 20%. The results emphasize the need for exploring alternatives for estimation of ET from MODIS. Understanding the relationship between the scaling properties of precipitation and streamflow is important in a number of applications. We present the results of a detailed river flow fluctuation analysis on daily records from 14 stations in the Flint River basin in Georgia in the United States with focus on effect of watershed area on long memory of river flow fluctuations. The areas of the watersheds draining to the stations range from 22 km2 to 19,606 km2. Results show that large watersheds have more persistent flow fluctuations and stronger long-term (time greater than scale break point) memory than small watersheds while precipitation time series shows weak long-term correlation. We conclude that a watershed acts as a 'filter' for a 'white noise' precipitation with more significant filtering in case of large watersheds. Finally, we compare the scaling properties of simulated and observed spatial soil

  10. Applications of quantum cloning

    NASA Astrophysics Data System (ADS)

    Pomarico, E.; Sanguinetti, B.; Sekatski, P.; Zbinden, H.; Gisin, N.

    2011-10-01

    Quantum Cloning Machines (QCMs) allow for the copying of information, within the limits imposed by quantum mechanics. These devices are particularly interesting in the high-gain regime, i.e., when one input qubit generates a state of many output qubits. In this regime, they allow for the study of certain aspects of the quantum to classical transition. The understanding of these aspects is the root of the two recent applications that we will review in this paper: the first one is the Quantum Cloning Radiometer, a device which is able to produce an absolute measure of spectral radiance. This device exploits the fact that in the quantum regime information can be copied with only finite fidelity, whereas when a state becomes macroscopic, this fidelity gradually increases to 1. Measuring the fidelity of the cloning operation then allows to precisely determine the absolute spectral radiance of the input optical source. We will then discuss whether a Quantum Cloning Machine could be used to produce a state visible by the naked human eye, and the possibility of a Bell Experiment with humans playing the role of detectors.

  11. Magnetism: Principles and Applications

    NASA Astrophysics Data System (ADS)

    Craik, Derek J.

    2003-09-01

    If you are studying physics, chemistry, materials science, electrical engineering, information technology or medicine, then you'll know that understanding magnetism is fundamental to success in your studies and here is the key to unlocking the mysteries of magnetism....... You can: obtain a simple overview of magnetism, including the roles of B and H, resonances and special techniques take full advantage of modern magnets with a wealth of expressions for fields and forces develop realistic general design programmes using isoparametric finite elements study the subtleties of the general theory of magnetic moments and their dynamics follow the development of outstanding materials appreciate how magnetism encompasses topics as diverse as rock magnetism, chemical reaction rates, biological compasses, medical therapies, superconductivity and levitation understand the basis and remarkable achievements of magnetic resonance imaging In his new book, Magnetism, Derek Craik throws light on the principles and applications of this fascinating subject. From formulae for calculating fields to quantum theory, the secrets of magnetism are exposed, ensuring that whether you are a chemist or engineer, physicist, medic or materials scientist Magnetism is the book for our course.

  12. Nuclear microscopy: biomedical applications

    NASA Astrophysics Data System (ADS)

    Watt, Frank; Landsberg, Judith P.

    1993-05-01

    Recent developments in high energy ion beam techniques and technology have enabled the scanning proton microprobe (SPM) to make advances in biomedical research. In particular the combination of proton induced X-ray emission (PIXE) to measure the elemental concentrations of inorganic elements, Rutherford backscattering spectrometry (RBS) to characterise the organic matrix, and scanning transmission ion microscopy (STIM) to provide information on the density and structure of the sample, represents a powerful set of techniques which can be applied simultaneously to the specimen under investigation. This paper reviews briefly the biomedical work using the proton microprobe that has been carried out since the 2nd Int. Conf. on Nuclear Microprobe Technology and Applications held in Melbourne, 1990. Three recent and diverse examples of medical research are also presented from work carried out using the Oxford SPM. The first is a preliminary experiment carried out using human hair as a monitor for potential toxicity, using PIXE elemental mapping across the hair cross section to differentiate between elements contained within the hair and contamination from external sources. The second example is in the use of STIM to map individual cells in freeze-dried tissue, showing the possibility of the in situ microanalysis of cells and their extracellular environment. The third is the use of PIXE, RBS and STIM to identify and analyse the elemental constituents of neuritic plaque cores in untreated freeze-dried Alzheimer's tissue. This work resolves a current controversy by revealing an absence of aluminium levels in plaque cores at the 15 ppm level.

  13. Dorsal column stimulator applications

    PubMed Central

    Yampolsky, Claudio; Hem, Santiago; Bendersky, Damián

    2012-01-01

    Background: Spinal cord stimulation (SCS) has been used to treat neuropathic pain since 1967. Following that, technological progress, among other advances, helped SCS become an effective tool to reduce pain. Methods: This article is a non-systematic review of the mechanism of action, indications, results, programming parameters, complications, and cost-effectiveness of SCS. Results: In spite of the existence of several studies that try to prove the mechanism of action of SCS, it still remains unknown. The mechanism of action of SCS would be based on the antidromic activation of the dorsal column fibers, which activate the inhibitory interneurons within the dorsal horn. At present, the indications of SCS are being revised constantly, while new applications are being proposed and researched worldwide. Failed back surgery syndrome (FBSS) is the most common indication for SCS, whereas, the complex regional pain syndrome (CRPS) is the second one. Also, this technique is useful in patients with refractory angina and critical limb ischemia, in whom surgical or endovascular treatment cannot be performed. Further indications may be phantom limb pain, chronic intractable pain located in the head, face, neck, or upper extremities, spinal lumbar stenosis in patients who are not surgical candidates, and others. Conclusion: Spinal cord stimulation is a useful tool for neuromodulation, if an accurate patient selection is carried out prior, which should include a trial period. Undoubtedly, this proper selection and a better knowledge of its underlying mechanisms of action, will allow this cutting edge technique to be more acceptable among pain physicians. PMID:23230533

  14. Medical applications of nanotechnology.

    PubMed

    Zdrojewicz, Zygmunt; Waracki, Mateusz; Bugaj, Bartosz; Pypno, Damian; Cabała, Krzysztof

    2015-10-29

    Nanotechnologies are new areas of research focusing on affecting matter at the atomic and molecular levels. It is beyond doubt that modern medicine can benefit greatly from it; thus nanomedicine has become one of the main branches of nanotechnological research. Currently it focuses on developing new methods of preventing, diagnosing and treating various diseases. Nanomaterials show very high efficiency in destroying cancer cells and are already undergoing clinical trials. The results are so promising that nanomaterials might become an alternative to traditional cancer therapy, mostly due to the fact that they allow cancer cells to be targeted specifically and enable detailed imaging of tissues, making planning further therapy much easier. Nanoscience might also be a source of the needed breakthrough in the fight against atherosclerosis, since nanostructures may be used in both preventing and increasing the stability of atherosclerotic lesions. One area of interest is creating nanomaterials that are not only efficient, but also well tolerated by the human body. Other potential applications of nanotechnology in medicine include: nanoadjuvants with immunomodulatory properties used to deliver vaccine antigens; the nano-knife, an almost non-invasive method of destroying cancer cells with high voltage electricity; and carbon nanotubes, which are already a popular way of repairing damaged tissues and might be used to regenerate nerves in the future. The aim of this article is to outline the potential uses of nanotechnology in medicine. Original articles and reviews have been used to present the new developments and directions of studies.

  15. Applications for Subvocal Speech

    NASA Technical Reports Server (NTRS)

    Jorgensen, Charles; Betts, Bradley

    2007-01-01

    A research and development effort now underway is directed toward the use of subvocal speech for communication in settings in which (1) acoustic noise could interfere excessively with ordinary vocal communication and/or (2) acoustic silence or secrecy of communication is required. By "subvocal speech" is meant sub-audible electromyographic (EMG) signals, associated with speech, that are acquired from the surface of the larynx and lingual areas of the throat. Topics addressed in this effort include recognition of the sub-vocal EMG signals that represent specific original words or phrases; transformation (including encoding and/or enciphering) of the signals into forms that are less vulnerable to distortion, degradation, and/or interception; and reconstruction of the original words or phrases at the receiving end of a communication link. Potential applications include ordinary verbal communications among hazardous- material-cleanup workers in protective suits, workers in noisy environments, divers, and firefighters, and secret communications among law-enforcement officers and military personnel in combat and other confrontational situations.

  16. Streamers and their applications

    NASA Astrophysics Data System (ADS)

    Pemen, A. J. M.

    2011-10-01

    In this invited lecture we give an overview of our 15 years of experience on streamer plasma research. Efforts are directed to integrating the competence areas of plasma physics, pulsed power technology and chemical processing. The current status is the development of a large scale pulsed corona system for gas treatment. Applications on biogas conditioning, VOC removal, odor abatement and control of traffic emissions have been demonstrated. Detailed research on electrical and chemical processes resulted in a boost of efficiencies. Energy transfer efficiency to the plasma was raised to above 90%. Simultaneous improvement of the plasma chemistry resulted in a highly efficient radical generation: O-radical production up to 50% of the theoretical maximum has been achieved. A major challenge in pulsed power driven streamers is to unravel, understand and ultimately control the complex interactions between the transient plasma, electrical circuits, and process. Even more a challenge is to yield electron energies that fit activation energies of the process. We will discuss our ideas on adjusting pulsed power waveforms and plasma reactor settings to obtain more controlled catalytic processing: the ``Chemical Transistor'' concept.

  17. Waiver Applicants Steer Wary Course

    ERIC Educational Resources Information Center

    McNeil, Michele

    2012-01-01

    The latest batch of states seeking relief under the No Child Left Behind Act dodge pitfalls that tripped up the first round of applicants. In the latest round of applications for waivers under the No Child Left Behind Act, states have learned lessons from their predecessors and dodged pitfalls that triggered some big revisions from first-round…

  18. Practical Applications of Space Systems.

    ERIC Educational Resources Information Center

    National Academy of Sciences - National Research Council, Washington, DC. Assembly of Engineering.

    This report gives an overview of a study conducted by the Space Applications Board (SAB) on the practical applications of space systems. In this study, the SAB considered how the nation's space capability might be used to solve problems such as the shortage of food and energy; the improvement of the physical environment; inventorying and…

  19. Processor Emulator with Benchmark Applications

    SciTech Connect

    Lloyd, G. Scott; Pearce, Roger; Gokhale, Maya

    2015-11-13

    A processor emulator and a suite of benchmark applications have been developed to assist in characterizing the performance of data-centric workloads on current and future computer architectures. Some of the applications have been collected from other open source projects. For more details on the emulator and an example of its usage, see reference [1].

  20. Clinical Applications of Otoacoustic Emissions.

    ERIC Educational Resources Information Center

    Lonsbury-Martin, Brenda L.; And Others

    1991-01-01

    This tutorial paper examines the potential of otoacoustic emissions (OAEs) in diagnostic audiology. It discusses classification of OAEs, basic properties of various types of OAEs, and clinical applications. It concludes that both transiently evoked and distortion product OAEs have beneficial clinical application resulting from their objectivity,…

  1. Expert systems development and application

    NASA Technical Reports Server (NTRS)

    Duke, E. L.; Regenie, V. A.

    1985-01-01

    Current research in the application of expert systems to problems in the flight research environment is discussed. In what is anticipated to be a broad research area, a real time expert system flight status monitor has been identified as the initial project. This real time expert system flight status monitor is described in terms of concept, application, development, and schedule.

  2. Application Process Improvement Yields Results.

    ERIC Educational Resources Information Center

    Holesovsky, Jan Paul

    1995-01-01

    After a continuing effort to improve its grant application process, the department of medical microbiology and immunology at the University of Wisconsin-Madison is submitting many more applications and realizing increased funding. The methods and strategy used to make the process more efficient and effective are outlined. (Author/MSE)

  3. 46 CFR Sec. 8 - Applicability.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 8 2014-10-01 2014-10-01 false Applicability. Sec. 8 Section 8 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION B-CONTROL AND UTILIZATION OF PORTS RESTRICTIONS UPON THE TRANSFER OR CHANGE IN USE OR IN TERMS GOVERNING UTILIZATION OF PORT FACILITIES Sec. 8 Applicability. This part...

  4. 46 CFR Sec. 8 - Applicability.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 8 2013-10-01 2013-10-01 false Applicability. Sec. 8 Section 8 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION B-CONTROL AND UTILIZATION OF PORTS RESTRICTIONS UPON THE TRANSFER OR CHANGE IN USE OR IN TERMS GOVERNING UTILIZATION OF PORT FACILITIES Sec. 8 Applicability. This part...

  5. 46 CFR Sec. 8 - Applicability.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 8 2011-10-01 2011-10-01 false Applicability. Sec. 8 Section 8 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION B-CONTROL AND UTILIZATION OF PORTS RESTRICTIONS UPON THE TRANSFER OR CHANGE IN USE OR IN TERMS GOVERNING UTILIZATION OF PORT FACILITIES Sec. 8 Applicability. This part...

  6. 46 CFR Sec. 8 - Applicability.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 8 2012-10-01 2012-10-01 false Applicability. Sec. 8 Section 8 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION B-CONTROL AND UTILIZATION OF PORTS RESTRICTIONS UPON THE TRANSFER OR CHANGE IN USE OR IN TERMS GOVERNING UTILIZATION OF PORT FACILITIES Sec. 8 Applicability. This part...

  7. Evaluating Application Resilience with XRay

    SciTech Connect

    Chen, Sui; Bronevetsky, Greg; Li, Bin; Casas-Guix, Marc; Peng, Lu

    2015-05-07

    The rising count and shrinking feature size of transistors within modern computers is making them increasingly vulnerable to various types of soft faults. This problem is especially acute in high-performance computing (HPC) systems used for scientific computing, because these systems include many thousands of compute cores and nodes, all of which may be utilized in a single large-scale run. The increasing vulnerability of HPC applications to errors induced by soft faults is motivating extensive work on techniques to make these applications more resiilent to such faults, ranging from generic techniques such as replication or checkpoint/restart to algorithmspecific error detection and tolerance techniques. Effective use of such techniques requires a detailed understanding of how a given application is affected by soft faults to ensure that (i) efforts to improve application resilience are spent in the code regions most vulnerable to faults and (ii) the appropriate resilience technique is applied to each code region. This paper presents XRay, a tool to view the application vulnerability to soft errors, and illustrates how XRay can be used in the context of a representative application. In addition to providing actionable insights into application behavior XRay automatically selects the number of fault injection experiments required to provide an informative view of application behavior, ensuring that the information is statistically well-grounded without performing unnecessary experiments.

  8. Microwave applicators for BPH thermotherapy

    NASA Astrophysics Data System (ADS)

    Vrba, Jan; Hlavac, R.; Herza, Jan; Chovanec, Roman; Cvek, Jakub; Oppl, L.

    2004-04-01

    Paper deals with new results in the field of intracavitary microwave applicators used for Benign Prostatic Hyperplasia (BPH) treatment. We demonstrate here that it is necessary to use more sophisticated applicators than a simple monopole radiating structure. One of the good possibilities for safe and efficient treatments we propose here is a helix structure.

  9. Automatix Incorporated in aerospace applications

    NASA Astrophysics Data System (ADS)

    Hilmer, C.

    1983-03-01

    Robotic assembly and artificial vision applications are currently employed or have potential in aerospace manufacturing. Automatix vision guided robotics have been used for electronic component assembly, welding of aluminum alloys with both gas metal arc welding (MIG). Other applications include gas tungsten arc welding (TIG), and visual gauging. The unique control concept has provided a single robotic controller with virtual robotic arm interchangeability.

  10. Rotary actuator for space applications

    NASA Astrophysics Data System (ADS)

    Andión, J. A.; Burgui, C.; Migliorero, G.

    2005-07-01

    SENER is developing a rotary actuator for space applications. The activity, partially funded under ESA GSTP contract, aims at the design, development and performance testing of an innovative rotary actuator concept for space applications. An engineering model has been manufactured and has been tested to demonstrate the compliance with the requirements specification.

  11. NGI performance for teleradiology applications

    NASA Astrophysics Data System (ADS)

    Mogel, Greg T.; Huang, H. K.; Cao, Fei; Zhou, Zheng; Dey, Partha S.; Gill, Michael J.; Liu, Brent J.

    2002-05-01

    Tele-medical imaging applications require low cost, and high-speed backbone wide area networks (WAN) to carry large amount of imaging data for rapid turn around interpretation. Current low cost commercially WAN is too slow for medical imaging applications, while high speed WAN is too costly. The next generation Internet (NGI) or Internet2 is federal initiatives for the integration of higher speed backbone communication networks (up to 2.4 Gbits/sec) as a means to replace the current inadequate Internet for many applications including medical imaging. This paper describes our preliminary experience of connecting to Internet2 for teleradiology application. A case study is given for the NGI WAN connection between Childrens Hospital Los Angeles and National Library of Medicine. NGI WAN performance for different image modalities, measured in throughput rate and application response time, were obtained and then compared to the T1 WAN connection between Childrens Hospital Los Angeles and Saint John's Health Center Santa Monica.

  12. Functionalized carbon nanotubes: biomedical applications

    PubMed Central

    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

  13. Corrugated pipe adhesive applicator apparatus

    DOEpatents

    Shirey, R.A.

    1983-06-14

    Apparatus for coating selected portions of the troughs of a corrugated pipe with an adhesive includes a support disposed within the pipe with a reservoir containing the adhesive disposed on the support. A pump, including a spout, is utilized for supplying the adhesive from the reservoir to a trough of the pipe. A rotatable applicator is supported on the support and contacts the trough of the pipe. The applicator itself is sized so as to fit within the trough, and contacts the adhesive in the trough and spreads the adhesive in the trough upon rotation. A trough shield, supported by the support and disposed in the path of rotation of the applicator, is utilized to prevent the applicator from contacting selected portions of the trough. A locator head is also disposed on the support and provides a way for aligning the spout, the applicator, and the trough shield with the trough. 4 figs.

  14. Printing Technologies for Medical Applications.

    PubMed

    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.

  15. MIDACO on MINLP space applications

    NASA Astrophysics Data System (ADS)

    Schlueter, Martin; Erb, Sven O.; Gerdts, Matthias; Kemble, Stephen; Rückmann, Jan-J.

    2013-04-01

    A numerical study on two challenging mixed-integer non-linear programming (MINLP) space applications and their optimization with MIDACO, a recently developed general purpose optimization software, is presented. These applications are the optimal control of the ascent of a multiple-stage space launch vehicle and the space mission trajectory design from Earth to Jupiter using multiple gravity assists. Additionally, an NLP aerospace application, the optimal control of an F8 aircraft manoeuvre, is discussed and solved. In order to enhance the optimization performance of MIDACO a hybridization technique, coupling MIDACO with an SQP algorithm, is presented for two of these three applications. The numerical results show, that the applications can be solved to their best known solution (or even new best solution) in a reasonable time by the considered approach. Since using the concept of MINLP is still a novelty in the field of (aero)space engineering, the demonstrated capabilities are seen as very promising.

  16. Studies on deaf mobile application

    NASA Astrophysics Data System (ADS)

    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.

  17. Corrugated pipe adhesive applicator apparatus

    DOEpatents

    Shirey, Ray A.

    1983-06-14

    Apparatus for coating selected portions of the troughs of a corrugated pipe within an adhesive includes a support disposed within the pipe with a reservoir containing the adhesive disposed on the support. A pump, including a spout, is utilized for supplying the adhesive from the reservoir to a trough of the pipe. A rotatable applicator is supported on the support and contacts the trough of the pipe. The applicator itself is sized so as to fit within the trough, and contacts the adhesive in the trough and spreads the adhesive in the trough upon rotation. A trough shield, supported by the support and disposed in the path of rotation of the applicator, is utilized to prevent the applicator from contacting selected portions of the trough. A locator head is also disposed on the support and provides a way for aligning the spout, the applicator, and the trough shield with the trough.

  18. RPCs in biomedical applications

    NASA Astrophysics Data System (ADS)

    Belli, G.; De Vecchi, C.; Giroletti, E.; Guida, R.; Musitelli, G.; Nardò, R.; Necchi, M. M.; Pagano, D.; Ratti, S. P.; Sani, G.; Vicini, A.; Vitulo, P.; Viviani, C.

    2006-08-01

    We are studying possible applications of Resistive Plate Chambers (RPCs) in the biomedical domain such as Positron Emission Tomography (PET). The use of RPCs in PET can provide several improvements on the usual scintillation-based detectors. The most striking features are the extremely good spatial and time resolutions. They can be as low as 50 μm and 25 ps respectively, to be compared to the much higher intrinsic limits in bulk detectors. Much efforts have been made to investigate suitable materials to make RPCs sensitive to 511 keV photons. For this reason, we are studying different types of coating employing high Z materials with proper electrical resistivity. Later investigations explored the possibility of coating glass electrodes by mean of serigraphy techniques, employing oxide based mixtures with a high density of high Z materials; the efficiency is strongly dependent on its thickness and it reaches a maximum for a characteristic value that is a function of the compound (usually a few hundred microns). The most promising mixtures seem to be PbO, Bi 2O 3 and Tl 2O. Preliminary gamma efficiency measurements for a Multigap RPC prototype (MRPC) are presented as well as simulations using GEANT4-based framework. The MRPC has 5 gas gaps; their spacings are kept by 0.3 mm diameter nylon fishing line, electrodes are made of thin glasses (1 mm for the outer electrodes, 0.15-0.4 mm for the inner ones). The detector is enclosed in a metallic gas-tight box, filled with a C 2H 2F 4 92.5%, SF 6 2.5%, C 4H 10 5% mixture. Different gas mixtures are being studied increasing the SF6 percentage and results of efficiency as a function of the new mixtures will be presented.

  19. Abortion applicants in Arkansas.

    PubMed

    Henker, F O

    1973-03-01

    The article reports upon the characteristics of 300 abortion applicants in Arkansas manifesting significant stress from unwanted pregnancy between May 1, 1970 and June 30, 1971. The sample is limited by the fact that all of these women had been willing to seek medical aid. Patients ranged from ages 13-47, 131 of them ages 17-21. 35% had had some college education; another 29% were high school graduates. 50.6%, 20.6%, and 27.3% were single, divorced, and married, respectively. 59.6% of the patients were primiparas. 18.3%, 9.6%, and 12.3% were classified as being neurotic, having psychophysiologic tendencies (gastrointestinal problems, obesity, chronic headaches), and having sociopathic features (passive-aggressive, frankly rebellious, delinquent, antisocial, alcoholic), respectively. 12 women had noticeable schizoid features; 4 women had mildly active schizophrenia. Fathers of the women were usually blue-collar workers (55.3%) or white-collar workers (24.6%). The most frequent ordinal sibling position among the women was oldest child (38%). Parental instability (1 or both parents lost through death, divorce, father usually away working, chronic alcoholism, etc.) was reported by 39.6% of the patients. Patients' attitudes toward the unwanted pregnancy included dislike of inexpediency of the situation (82.6%), self-depreciation (55.6%), and aversion (28.6%). Precipitated psychiatric disorders were for the greatest part mild. Manifesting symptoms included depression (66.7%), anxiety (21%), and mixed anxiety and depression (12.2%). Suicidal threats and gestures were made by 22 and 8 patients, respectively. In summary, the study reveals a group of predominantly Caucasian women from unstable, middle-class urban families who were going through an adjustment reaction to adolescence or adult life.

  20. Security Data Warehouse Application

    NASA Technical Reports Server (NTRS)

    Vernon, Lynn R.; Hennan, Robert; Ortiz, Chris; Gonzalez, Steve; Roane, John

    2012-01-01

    The Security Data Warehouse (SDW) is used to aggregate and correlate all JSC IT security data. This includes IT asset inventory such as operating systems and patch levels, users, user logins, remote access dial-in and VPN, and vulnerability tracking and reporting. The correlation of this data allows for an integrated understanding of current security issues and systems by providing this data in a format that associates it to an individual host. The cornerstone of the SDW is its unique host-mapping algorithm that has undergone extensive field tests, and provides a high degree of accuracy. The algorithm comprises two parts. The first part employs fuzzy logic to derive a best-guess host assignment using incomplete sensor data. The second part is logic to identify and correct errors in the database, based on subsequent, more complete data. Host records are automatically split or merged, as appropriate. The process had to be refined and thoroughly tested before the SDW deployment was feasible. Complexity was increased by adding the dimension of time. The SDW correlates all data with its relationship to time. This lends support to forensic investigations, audits, and overall situational awareness. Another important feature of the SDW architecture is that all of the underlying complexities of the data model and host-mapping algorithm are encapsulated in an easy-to-use and understandable Perl language Application Programming Interface (API). This allows the SDW to be quickly augmented with additional sensors using minimal coding and testing. It also supports rapid generation of ad hoc reports and integration with other information systems.