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  1. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products; Availability; Agency Information Collection Activities; Proposed...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 The draft guidance is intended to assist...

  2. 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

    ... premarket approval application (PMA) file. 814.9 Section 814.9 Food and Drugs FOOD AND DRUG ADMINISTRATION... 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 the...

  3. 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

    ... premarket approval application (PMA) file. 814.9 Section 814.9 Food and Drugs FOOD AND DRUG ADMINISTRATION... 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 the...

  4. 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

    ... HUMAN SERVICES Food and Drug Administration User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  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

    ..., 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...

  6. 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

    ..., 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...

  7. 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 and...

  8. 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.

  9. 76 FR 48058 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for... requirement for premarket approval applications or product development protocols for cardiovascular permanent... progress reports and records of the trials conducted under the protocol on the safety and effectiveness...

  10. 77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-13

    ... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY... CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903......... Synapse NEURX DPS DIAPHRAGM PACING September 28, 2011. Biomedical, Inc.. SYSTEM. II. Electronic Access...

  11. 76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... proposed to require the filing of a premarket approval application or a notice of completion of a product development protocol for the class III preamendments device: Cardiovascular permanent pacemaker electrode....

  12. 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.

  13. Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.

    PubMed

    Saito, Masami; Iwasaki, Kiyotaka

    2017-03-01

    Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries. Standards in Japan required evaluation of blood compatibility and reporting of acute adverse effects by a premarketing clinical trial in 6 of 86 applications with semipermeable membrane materials deemed to be different to those of previously approved devices from 1983 to 31 August 2015. By comparison, the clinical trial was required in one of 545 approvals in the US from 1976 to 29 January 2016, but blood compatibility was not the point. All postmarketing adverse effects identified in Japan were included in the set of 'warnings'. The more stringent requirements for evaluation of blood compatibility and acute adverse effects in Japan seemed to be related to differences in the history of quality management systems for medical devices between the two countries. This study revealed that there were differences between Japan and the US in requiring the premarketing clinical trials for the hemodialyzers. Our findings could be useful for constructing sophisticated premarketing safety evaluation.

  14. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0735, FDA-2011-M-0736, FDA-2011-M...-2011-M-0917] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  15. 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... use, and the directions for its use. Where applicable, photographs or engineering drawings should be...

  16. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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 be...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  18. 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

    ... the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist... current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final...

  19. 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

    ...; 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.'' This... for certain in vitro diagnostic and radiology devices under the regulations. DATES: Submit...

  20. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Exemption from premarket notification. 807.85 Section 807.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... offered through labeling or advertising by the manufacturer, importer, or distributor thereof for...

  1. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Exemption from premarket notification. 807.85 Section 807.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... offered through labeling or advertising by the manufacturer, importer, or distributor thereof for...

  2. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Exemption from premarket notification. 807.85 Section 807.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... offered through labeling or advertising by the manufacturer, importer, or distributor thereof for...

  3. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Exemption from premarket notification. 807.85 Section 807.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... offered through labeling or advertising by the manufacturer, importer, or distributor thereof for...

  4. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Exemption from premarket notification. 807.85 Section 807.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... offered through labeling or advertising by the manufacturer, importer, or distributor thereof for...

  5. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Requirement for premarket notification. 190.6 Section 190.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification...

  6. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Requirement for premarket notification. 190.6 Section 190.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification...

  7. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 190.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (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...

  8. 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 food...

  9. 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 Information...

  10. 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

    ... means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21... substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device..., the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act, and...

  11. Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice.

    PubMed

    1998-02-02

    The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified.

  12. Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.

    PubMed

    1998-11-12

    The Food and Drug Administration (FDA) is proposing to amend 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 proposing to designate 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 Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.

  13. 76 FR 32214 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... food supply of new dietary ingredients and dietary supplements that contain new dietary ingredients, in... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient AGENCY: Food and Drug...

  14. 75 FR 24708 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the...

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

    PubMed

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

    2012-07-01

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

  16. 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 Drugs...

  17. 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 Drugs...

  18. 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

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2011-04-01 2011-04-01 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...

  19. 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 Drugs...

  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 § 170...

  1. 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. 170.105...

  2. 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. 170.105...

  3. 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. 170.105...

  4. 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. 170.105...

  5. 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 § 170...

  6. 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. 170.105...

  7. 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.

  8. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... go into effect. If we receive any significant adverse comment regarding the direct final rule we will... mean one of the following populations: Neonates; Infants; Children; or Adolescents. We have previously...'' letters, see FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review...

  9. 75 FR 16347 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ...: Neonates; Infants; Children; or Adolescents. We have previously issued guidance recommending the age range... FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and... that does not individually or cumulatively have a significant effect on the human environment...

  10. 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

    2015-06-08

    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.

  11. 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 §...

  12. 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 §...

  13. 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 §...

  14. 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 food...

  15. 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 food...

  16. 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 ADDITIVES...

  17. 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 food...

  18. 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 ADDITIVES...

  19. 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 ADDITIVES...

  20. 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 food...

  1. 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 ADDITIVES...

  2. 77 FR 39924 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... device to meet the statute's approval requirements and the benefits to the public from the use of the... benefit to the public from the use of the device; (3) an opportunity for the submission of comments on the... premarket approval requirements of the FD&C Act, and the benefits to the public from use of the device....

  3. 21 CFR 890.3 - 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. 890.3 Section 890.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.3 Effective dates...

  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, 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 Effective...

  6. 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 SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

  7. 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 Effective...

  8. 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 Effective...

  9. 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 SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.3 Effective...

  10. 21 CFR 890.3 - 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. 890.3 Section 890.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.3 Effective...

  11. 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 § 878.3...

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  13. 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 SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  14. 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...

  15. 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...

  16. 21 CFR 892.3 - 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. 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...

  17. 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...

  18. 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 § 866.3...

  19. 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 § 866.3...

  20. 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 § 866.3...

  1. The inadequacies of pre-market chemical risk assessment's toxicity studies-the implications.

    PubMed

    Tweedale, Anthony C

    2017-01-01

    Industry provides essentially all the data for most (pre-market) chemical risk assessments (RA); academics study a chemical once it is marketed. For two randomly-chosen high production chemicals, despite new European Union mandates to evaluate all data, just 13% of the herbicide bentazon and 15% of the flame-retardant hexabromocyclododecane's published toxicity studies were found in their pre-market RA, and a systematic review on bentazon concludes it has greater hazards than indicated in its RA. More important, for both, academia's toxicity studies were designated as lower quality than industries were, despite showing hazards at lower doses. The accuracy of industry's test methods is analyzed and found to be replicable but insensitive, thus inaccurate. The synthetic pharmaceutical industry originated them, and by 1983 the Organization for Economic Cooperation & Development mandated their test guidelines (TG) methods be accepted for any new study for pre-market RA. For existing studies, industry's "Klimisch" criterion is universally used to evaluate quality, but it only states that TG studies produce the best data. However, no TG can answer the realistic exposure effect hypotheses of academics; therefore, crucially in pre-market RA, tens of thousands of published experimental findings (increasingly at low dose) are ignored to determine the safe dose. Few appreciate this, so scientific debate on the most accurate elements of toxicity tests is urgently indicated. Copyright © 2016 John Wiley & Sons, Ltd.

  2. 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 SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.3 Effective dates of...

  3. 21 CFR 872.3 - 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. 872.3 Section 872.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.3 Effective dates of...

  4. 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 § 878.3...

  5. 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...

  6. 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 of...

  7. 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...

  8. 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...

  9. 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 Provisions...

  10. 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 § 866.3...

  11. 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 § 866.3...

  12. 78 FR 52773 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... introduction into the food supply of new dietary ingredients and dietary supplements that contain new dietary... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient AGENCY: Food and Drug...

  13. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). DATES: Submit...

  14. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and.... FDA is publishing this notice to obtain comments in accordance with procedures established by the Food...

  15. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on a premarket notification. 807.100 Section 807.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  16. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on a premarket notification. 807.100 Section 807.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  17. 21 CFR 888.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirement for premarket approval. A device included in this part that is classified into class III... day of the 30th full calendar month after the regulation that classifies the device into class III is..., is classified by statute (section 513(f) of the act) into class III without any grace period and...

  18. 21 CFR 886.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirement for premarket approval. A device included in this part that is classified into class III... day of the 30th full calendar month after the regulation that classifies the device into class III is..., is classified by statute (section 513(f) of the act) into class III without any grace period and...

  19. 21 CFR 872.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirement for premarket approval. A device included in this part that is classified into class III... day of the 30th full calendar month after the regulation that classifies the device into class III is..., is classified by statute (section 513(f) of the act) into class III without any grace period and...

  20. 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 Effective...

  1. 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 Effective...

  2. 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...

  3. 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...

  4. 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...

  5. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

    PubMed

    Yang, Brian W; Iorio, Matthew L; Day, Charles S

    2017-03-15

    The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

  6. 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

    ... current thinking in regards to information that should be included in a premarket submission for a non... guidance represents the Agency's current thinking on non-invasive pulse oximeters intended for prescription...

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

    PubMed

    2003-04-22

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

  8. EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES.

    PubMed

    Levin, Leslie

    2015-01-01

    With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2012-08-01

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

  11. 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).

  12. 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) FOOD...

  13. 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) FOOD...

  14. 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 ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  15. 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) FOOD...

  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) FOOD...

  17. 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 ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  18. 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) FOOD...

  19. 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) FOOD...

  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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; 30- Day Notices, 135-Day Premarket Approval Supplements and 75-Day Humanitarian Device Exemption Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration...

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

    PubMed

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

    2017-06-01

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

  2. 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.

  3. [Do premarketing trials help to predict drug-related iatrogenic effects in elderly patients?].

    PubMed

    Bouvenot, Gilles; Villani, Patrick

    2004-01-01

    Premarketing trials contribute poorly to predicting drug-related iatrogenic effects in elderly patients. Since their main goal is the demonstration of drug efficacy, these trials are characterised by a simplistic design, they include a limited number of young participants (volunteers only), are of a short duration, and follow a strict protocol. Results of studies in young people cannot be extrapolated to elderly people. Although licensing authorities recommend the recruitment of a meaningful number of elderly people in clinical trials (with an age distribution comparable to that expected when the drug is in routine use), even in trials that are not devoted to geriatric illnesses, elderly people remain substantially under-represented in most instances for methodological reasons (to avoid increased variance introduced by a heterogenous population), safety reasons (at this stage of drug development, it could be deleterious to include patients with comorbid conditions and unfair with regard to the brand image of the products), and ethical reasons (the decision to participate could not be taken by the elderly people alone). Exclusion of elderly participants, who are particularly exposed to drug-related iatrogenic effects, influences the generalisability of study findings. The recruitment of elderly participants, a vulnerable population, is necessary to allow valid conclusions regarding elderly people, recommendations on the appropriate dosage adjustment for elderly individuals, the avoidance of prescribing decisions based on inadequate information (with respect to a more informative summary of the characteristics of the products), and the maximum benefit for elderly people from research.

  4. Premarket assessment of devices for treatment of critical limb ischemia: the role of Objective Performance Criteria and Goals.

    PubMed

    Geraghty, Patrick J; Matsumura, Jon S; Conte, Michael S

    2009-12-01

    Medical devices are cleared for marketing approval through the Food and Drug Administration (FDA). Unique statutory requirements, such as the "least burdensome mandate," have allowed the FDA to employ non-concurrent controls in its evaluation of prospective therapies. The use of Objective Performance Criteria and Goals (OPC and OPG) for the premarket evaluation of cardiovascular devices has become established as an alternative to randomized, controlled trials (RCTs). These single-armed comparisons may facilitate rapid entry of novel devices to the market. Unlike RCTs, they do not establish superiority or non-inferiority of the examined therapy, and study populations must be carefully inspected to ensure validity of comparisons to historical controls.

  5. Incidence and Antimicrobial Susceptibility to Clostridium perfringens in Premarket Broilers in Taiwan.

    PubMed

    Fan, Yang-Chi; Wang, Chia-Lan; Wang, Chinling; Chen, Tsung-Cheng; Chou, Chung-Hsi; Tsai, Hsiang-Jung

    2016-06-01

    Clostridium perfringens infection causes subclinical and clinical necrotic enteritis in poultry flocks, and it is estimated to result in US$2 billion of losses worldwide every year. The aims of this study were to determine the incidence, toxin types, and antimicrobial resistance levels to C. perfringens isolated from premarket, 5-wk-old, clinically healthy broiler chickens in Taiwan, and to examine the relationships between intestinal lesions and the numbers of C. perfringens in intestinal contents. In total, 435 samples of chicken ileum contents were collected from 98 broiler farms during June 2012 to February 2013. The C. perfringens isolation rate was 9.9% (43/435). The positive rate of tested farms was 29.6% (29/98). All the isolates were C. perfringens type A, only possessing the cpa gene encoding for toxin α. No netB gene encoding NetB toxin associated with necrotic enteritis, and no cpe gene encoding for the C. perfringens enterotoxin causing human intestinal disorder were detected. A quantitative PCR analysis revealed that the mean C. perfringens number in the intestinal contents was 3.9 × 10(6) colony-forming units (CFU)/g, ranging from 6.85 × 10(2) to 1.61 × 10(7) CFU/g. The gross and histopathologic lesions revealed a positive correlation (p < 0.05) between lesion score and C. perfringens number in the ilea of C. perfringens -positive chickens. Antimicrobial susceptibility tests of all C. perfringens isolates indicated that the minimum inhibitory concentration inhibiting 50% of isolates (MIC50) for amoxicillin, bacitracin, chlortetracycline, enrofloxacin, erythromycin, florfenicol, and lincomycin was ≤0.125, 0.5, 128, 0.25, ≥256, 2, and ≥256 μg/ml, respectively. Most of the C. perfringens isolates were susceptible to amoxicillin, bacitracin, and enrofloxacin but resistant to chlortetracycline, erythromycin, and lincomycin. Interestingly, C. perfringens isolated from chickens with severe lesions had higher MIC50 for erythromycin and lincomycin

  6. 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 ADDITIVES...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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) ...

  12. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

    PubMed

    Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

    2015-08-11

    The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer

  13. Predictive and External Validity of a Pre-Market Study to Determine the Most Effective Pictorial Health Warning Label Content for Cigarette Packages.

    PubMed

    Huang, Li-Ling; Thrasher, James F; Reid, Jessica L; Hammond, David

    2016-05-01

    Studies examining cigarette package pictorial health warning label (HWL) content have primarily used designs that do not allow determination of effectiveness after repeated, naturalistic exposure. This research aimed to determine the predictive and external validity of a pre-market evaluation study of pictorial HWLs. Data were analyzed from: (1) a pre-market convenience sample of 544 adult smokers who participated in field experiments in Mexico City before pictorial HWL implementation (September 2010); and (2) a post-market population-based representative sample of 1765 adult smokers in the Mexican administration of the International Tobacco Control Policy Evaluation Survey after pictorial HWL implementation. Participants in both samples rated six HWLs that appeared on cigarette packs, and also ranked HWLs with four different themes. Mixed effects models were estimated for each sample to assess ratings of relative effectiveness for the six HWLs, and to assess which HWL themes were ranked as the most effective. Pre- and post-market data showed similar relative ratings across the six HWLs, with the least and most effective HWLs consistently differentiated from other HWLs. Models predicting rankings of HWL themes in post-market sample indicated: (1) pictorial HWLs were ranked as more effective than text-only HWLs; (2) HWLs with both graphic and "lived experience" content outperformed symbolic content; and, (3) testimonial content significantly outperformed didactic content. Pre-market data showed a similar pattern of results, but with fewer statistically significant findings. The study suggests well-designed pre-market studies can have predictive and external validity, helping regulators select HWL content. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. 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

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

    PubMed

    Iijima, Kazuo; Umezu, Mitsuo; Iwasaki, Kiyotaka

    2016-01-01

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

  16. 21 CFR 888.5980 - Manual cast application and removal instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual cast application and removal instrument... and removal instrument. (a) Identification. A manual cast application and removal instrument is a...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures...

  17. 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.

  18. 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.

  19. A critical first assessment of the new pre-market approval regime for new psychoactive substances (NPS) in New Zealand.

    PubMed

    Wilkins, Chris

    2014-10-01

    New Zealand has recently attempted to address the underlying drivers of the escalating new psychoactive substances (NPS) ('legal highs') problem by establishing the world's first pre-market approval regulatory regime for NPS. NPS products which can be shown with clinical trial data to pose a 'low risk' of harm will be approved for legal manufacture and sale. This paper critically assesses the new regime, drawing on experience of the pharmaceutical sector and legal BZP market. A number of characteristics of the recreational use of NPS may not be well addressed by standard medical clinical trials, including binge use, polydrug use, use by vulnerable groups and high-risk modes of administration. The overt advertising and covert promotion of approved NPS products on the internet may make them fairly visible to young people. The black market for unapproved NPS may be difficult to suppress given that unapproved NPS will be physically identical to approved NPS. If the legal market for NPS encourages the use of NPS, alcohol and other drugs there may be an increase in drug-related harm. Alternatively, if the legal NPS market reduces the use of more harmful drugs, there may be a considerable public health benefit. The clinical trials required for NPS products should address the characteristics of recreational NPS use. Enforcement resources and technical solutions are required to clearly distinguish legal NPS products. The impact the new NPS regime has on other drug use is a key issue and demands further study. © 2014 Society for the Study of Addiction.

  20. 78 FR 44128 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... respondents, including through the use of automated collection techniques, when appropriate, and other forms.... An approved PMA is, in effect, a private license granted to the applicant for marketing a particular...

  1. 76 FR 17136 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0519, FDA-2010-M-0556, FDA-2010-M-0558, FDA- 2010-M-0557, and FDA-2010-M-0591] Medical Devices; Availability of Safety and Effectiveness..., 2010 PMA No. Docket No. Applicant Trade name Date of action P100016 FDA-2010-M-0556.........

  2. 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. (2) Any protocol for a test or study unless the protocol is shown to constitute trade..., product experience report, consumer complaint, and other similar data and information, after deletion...

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

    PubMed

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

    2009-04-01

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

  4. 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.

  5. The Trading with the Enemy Act of 1917 and synthetic drugs: relieving scarcity, controlling prices, and establishing pre-market licensing controls.

    PubMed

    Cooper, Dale

    2005-01-01

    The "Trading with the Enemy Act" (TWEA) was enacted in October 1917 after America's entry into World War I and during a period of wartime scarcity and rising prices of synthetic drugs and dyestuffs that began in 1914. It was described as "An Act to define, regulate, and punish trading with the enemy, and for other purposes." The act and subsequent executive orders authorized an "Alien Property Custodian" to take control of all enemy property within the United States. Also, The Federal Trade Commission (FTC) was authorized to issue licenses for the use of enemy owned patents, which covered a range of industrial and consumer products. Significantly, the FTC was given the power to set the conditions for use of the patents and to fix the price for those products necessary for health. The effect of these measures was to bring federal pre-marketing control over the production, testing, and pricing of the most therapeutically significant synthetic drugs of the day. Enactment of the TWEA and the events preceding and surrounding it are significant parts of the history of the American pharmaceutical industry and federal regulation.

  6. Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule.

    PubMed

    1998-04-10

    The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.

  7. 10 CFR 903.1 - Purpose and scope; application.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., approval, and placement in effect on an interim basis by the Deputy Secretary of the Department of Energy... Marketing Administrations (PMAs) which are commenced after these regulations become effective or were...

  8. 10 CFR 903.1 - Purpose and scope; application.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., approval, and placement in effect on an interim basis by the Deputy Secretary of the Department of Energy... Marketing Administrations (PMAs) which are commenced after these regulations become effective or were...

  9. 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.

  10. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (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...

  11. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed...

  12. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed...

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

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... 用乘以消耗因数(CF)求得膳食中食品接触物质的浓度。然后用膳食浓度乘 以每人每天消耗的食品总量求得估计日摄入量。美国食品和药品管理局假设 ...

  14. A premarketing multicenter trial of lorazepam injection.

    PubMed

    Philbrook, F A; Hatt, D L

    1983-01-01

    Before the introduction of lorazepam injection to the Canadian market, its usefulness and acceptability were assessed in an open multicenter study. Anesthesiologists in teaching hospitals across the country were asked to substitute lorazepam injection for their usual anxiolytic premedicant in ten patients and to complete a brief case report on each patient. The results from 360 patients showed that suitable preoperative sedation, accompanied by anxiolysis but without undue effects on arousability, was obtained in 88% of the patients prior to surgery. The adverse effect most often reported, accounting for 84% of the drug-related adverse reactions, was postoperative drowsiness, which highlighted the need to administer the drug at least two hours before surgery. The anesthesiologists found lorazepam injection to be a satisfactory premedicant, rating it excellent to good in 73% of the patients treated.

  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 to...

  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

    2015-01-08

    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.

  18. Wavelength- or Polarization-Selective Thermal Infrared Detectors for Multi-Color or Polarimetric Imaging Using Plasmonics and Metamaterials.

    PubMed

    Ogawa, Shinpei; Kimata, Masafumi

    2017-05-04

    Wavelength- or polarization-selective thermal infrared (IR) detectors are promising for various novel applications such as fire detection, gas analysis, multi-color imaging, multi-channel detectors, recognition of artificial objects in a natural environment, and facial recognition. However, these functions require additional filters or polarizers, which leads to high cost and technical difficulties related to integration of many different pixels in an array format. Plasmonic metamaterial absorbers (PMAs) can impart wavelength or polarization selectivity to conventional thermal IR detectors simply by controlling the surface geometry of the absorbers to produce surface plasmon resonances at designed wavelengths or polarizations. This enables integration of many different pixels in an array format without any filters or polarizers. We review our recent advances in wavelength- and polarization-selective thermal IR sensors using PMAs for multi-color or polarimetric imaging. The absorption mechanism defined by the surface structures is discussed for three types of PMAs-periodic crystals, metal-insulator-metal and mushroom-type PMAs-to demonstrate appropriate applications. Our wavelength- or polarization-selective uncooled IR sensors using various PMAs and multi-color image sensors are then described. Finally, high-performance mushroom-type PMAs are investigated. These advanced functional thermal IR detectors with wavelength or polarization selectivity will provide great benefits for a wide range of applications.

  19. [Literature review on premarketing and postmarketing evidence of xiyanping injection].

    PubMed

    Wang, Zhi-Fei; Chen, Xiao; Zhang, Wen; Xie, Yan-Ming

    2014-09-01

    This article systematically summarizes the non-clinical safety studies, pharmacological studies and postmarketing safety studies of Xiyanping injection based on literature. These studies include acute toxicity test, long-term toxicity test, reproductive toxicity test, active and passive anaphylaxis test, curative mechanism study, clinical trials of effectiveness, active surveillance, security analysis of passive monitoring data, the real world analysis of hospital information system (HIS) data, literature analysis, etcetera This article also analysis the relationship of the different evidence, summarizes the strategy of the researches, in order to make it to be a reference for making a systemic research program of traditional Chinese medicine injection.

  20. Premarket Regulation of Tissue Engineered Medical Products in China.

    PubMed

    Wang, Chunren; Wang, Anqi; Feng, Xiaoming; Ke, Linnan; Huang, Yuanli; Han, Qianqian; Sun, Xue; Yang, Zhaopeng

    2015-12-01

    Tissue engineered medical products (TEMPs) use state-of-the-art technologies and offer the patients with alternative clinical options for diseases that conventional treatments may fail or be incompetent. However promising, this technology is comparatively new with very limited hands-on experiences with both manufacturing and clinical therapy. Of great significance to products with such complexity and novelty is the establishment of a complete jurisdiction framework and a standardization database so that the safety of the technique in clinical treatment can be ensured. Although different regulatory routes are adopted in different countries, risks are generally considered to be derived from the cellular components within the product, the material scaffolds, and potentially from the final products. This article is to provide an insight of the regulatory considerations and the role of China Food and Drug Administration (CFDA) in the supervision of TEMPs.

  1. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Section 190.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (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...

  2. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 190.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (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...

  3. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  4. 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...

  5. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a... before making a change affecting the safety or effectiveness of the device for which the applicant has...

  6. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  7. 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...

  8. Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters.

    PubMed

    Kumsa, Doe; Steinke, G Karl; Molnar, Gregory F; Hudak, Eric M; Montague, Fred W; Kelley, Shawn C; Untereker, Darrel F; Shi, Alan; Hahn, Benjamin P; Condit, Chris; Lee, Hyowon; Bardot, Dawn; Centeno, Jose A; Krauthamer, Victor; Takmakov, Pavel A

    2017-08-07

    The Shannon model is often used to define an expected boundary between non-damaging and damaging modes of electrical neurostimulation. Numerous preclinical studies have been performed by manufacturers of neuromodulation devices using different animal models and a broad range of stimulation parameters while developing devices for clinical use. These studies are mostly absent from peer-reviewed literature, which may lead to this information being overlooked by the scientific community. We aimed to locate summaries of these studies accessible via public regulatory databases and to add them to a body of knowledge available to a broad scientific community. We employed web search terms describing device type, intended use, neural target, therapeutic application, company name, and submission number to identify summaries for premarket approval (PMA) devices and 510(k) devices. We filtered these records to a subset of entries that have sufficient technical information relevant to safety of neurostimulation. We identified 13 product codes for 8 types of neuromodulation devices. These led us to devices that have 22 PMAs and 154 510(k)s and six transcripts of public panel meetings. We found one PMA for a brain, peripheral nerve, and spinal cord stimulator and five 510(k) spinal cord stimulators with enough information to plot in Shannon coordinates of charge and charge density per phase. Analysis of relevant entries from public regulatory databases reveals use of pig, sheep, monkey, dog, and goat animal models with deep brain, peripheral nerve, muscle and spinal cord electrode placement with a variety of stimulation durations (hours to years); frequencies (10-10,000 Hz) and magnitudes (Shannon k from below zero to 4.47). Data from located entries indicate that a feline cortical model that employs acute stimulation might have limitations for assessing tissue damage in diverse anatomical locations, particularly for peripheral nerve and spinal cord simulation. © 2017

  9. 21 CFR 814.3 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.3 Definitions. Link to an amendment published at 79 FR... a medical device. (e) PMA means any premarket approval application for a class III medical...

  10. Development of an integrated modeling approach for identifying multilevel non-point-source priority management areas at the watershed scale

    NASA Astrophysics Data System (ADS)

    Chen, Lei; Zhong, Yucen; Wei, Guoyuan; Cai, Yanpeng; Shen, Zhenyao

    2014-05-01

    The identification of priority management areas (PMAs) at the large-basin scale is notably complex because of the random nature of watershed processes, which complicates the application of traditional deterministic PMAs. In this study, a multilevel PMA (ML-PMA) framework is designed as a new tool to pinpoint these sensitive areas, within a basin, that contribute the most to water quality deterioration. The main advantage of the ML-PMA framework is the wide availability of its supplementary tools and its complete framework, which integrates both watershed and river processes in addressing PMAs at the watershed scale. The watershed model, stream model, and a Markov chain approach are integrated to depict the dynamics of watershed processes and various water quality statutes. Based on the results of this study, the river migration process is vital for water quality degradation in the river network and significantly influenced the final PMA map. In addition, the proposed ML-PMA framework considers the impact of climatic conditions and hydrological properties and allows for a more cost-effective allocation of PMAs among different years. In the authors' view, the connectivity of PMAs in terms of flux distribution and propagation downstream on which the ML-PMA is based makes the ML-PMA framework particularly interesting for watershed non-point-source pollution control.

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... Office of Management and Budget Approval; Product Jurisdiction: Assignment of Agency Component for Review... Jurisdiction: Assignment of Agency Component for Review of Premarket Applications'' has been approved by the...

  13. 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 Central

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

    2016-01-01

    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

  14. 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.

  15. Wavelength- or Polarization-Selective Thermal Infrared Detectors for Multi-Color or Polarimetric Imaging Using Plasmonics and Metamaterials

    PubMed Central

    Ogawa, Shinpei; Kimata, Masafumi

    2017-01-01

    Wavelength- or polarization-selective thermal infrared (IR) detectors are promising for various novel applications such as fire detection, gas analysis, multi-color imaging, multi-channel detectors, recognition of artificial objects in a natural environment, and facial recognition. However, these functions require additional filters or polarizers, which leads to high cost and technical difficulties related to integration of many different pixels in an array format. Plasmonic metamaterial absorbers (PMAs) can impart wavelength or polarization selectivity to conventional thermal IR detectors simply by controlling the surface geometry of the absorbers to produce surface plasmon resonances at designed wavelengths or polarizations. This enables integration of many different pixels in an array format without any filters or polarizers. We review our recent advances in wavelength- and polarization-selective thermal IR sensors using PMAs for multi-color or polarimetric imaging. The absorption mechanism defined by the surface structures is discussed for three types of PMAs—periodic crystals, metal-insulator-metal and mushroom-type PMAs—to demonstrate appropriate applications. Our wavelength- or polarization-selective uncooled IR sensors using various PMAs and multi-color image sensors are then described. Finally, high-performance mushroom-type PMAs are investigated. These advanced functional thermal IR detectors with wavelength or polarization selectivity will provide great benefits for a wide range of applications. PMID:28772855

  16. Allen Denver Russell Memorial Lecture, 2006. The use of microbicides in infection control: a critical look at safety, testing and applications.

    PubMed

    Sattar, S A

    2006-10-01

    Microbial pathogens continue as major threats to health. Indeed, many ongoing societal changes are enhancing our vulnerability and exposure to several frank and opportunistic pathogens. This, together with rampant antimicrobial resistance and reduced prospects for newer drugs and vaccines, is forcing a higher reliance on microbiocides in infection prevention and control. That this reliance may not be well-founded becomes apparent from a closer look at current ways of testing and registering microbiocides, their label claims as well as human and environmental safety of certain widely used microbicidal chemicals. Many methods to test microbiocides for registration are flawed and/or entail test conditions irrelevant to field use. Pathogens listed on product labels may not be among those amenable to interruption through microbiocide use. The wide variations and discrepancies in existing national/regional regulations for registering microbiocides for sale stifle innovation. This is a critical look at the above-mentioned issues with emphasis on chemicals meant for use on environmental surfaces and medical devices. It highlights better ways to test microbiocides and to attain global harmonization of testing and product registration. It also details the known and potential dangers of microbiocide use and what to consider in choosing such formulations for optimal safety and effectiveness. End users are advised to be more critical and prudent in the selection and application of microbicidal chemicals, manufacturers are encouraged to explore infection control products and technologies that are safer in the workplace and for the environment, and regulators are urged to review and update the requirements and procedures for premarket review of microbiocide efficacy data and label claims. Independent investigations are also urgently needed to document the proportion of nosocomial infections that would be amenable to prevention through chemical disinfection of environmental

  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 HBsAg April 12, 2012. Qualitative, ARCHITECT HBsAg Qualitative Confirmatory, ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent, ARCHITECT HBsAg Qualitative Calibrators, and ARCHITECT...

  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

    ... Medical Devices'' to the Division of Small Manufacturers, International, and Consumer Assistance, Center..., subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21...

  19. 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...

  20. 75 FR 54154 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... BRONCHIAL THERMOPLASTY April 27, 2010 FDA-2010-0242 P090007 Roche Diagnostics ELECSYS ANTI-HCV IMMUNOASSAY AND April 29, 2010 FDA-2010-M-0261 Corp. ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE COBAS E411 IMMUNOASSAY ANALYZER P090008 Roche Diagnostics ELECSYS ANTI-HCV IMMUNOASSAY AND April 29, 2010...

  1. 75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane... document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic...

  2. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ........ Boston Scientific TAXUS Express2 February 22, 2012. Corp. Paclitaxel-Eluting Coronary Stent System... the Agency's Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and...

  3. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2012-M-0712, FDA-2012-M-0713, FDA-2012-M...-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability of Safety and Effectiveness...

  4. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... Pipeline embolization device.... April 6, 2011. Technologies, Inc. P100034 FDA-2011-M-0295....... NovoCure.... P070015 (S54) FDA-2011-M-0431. Abbott Vascular....... Xience nano everolimus-eluting May 24, 2011...

  5. 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

    ... addition to normal breast health routine by visualizing translucent tissue for the diagnosis of cancer... breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or... safety and effectiveness of the device for the diagnosis of cancer, other conditions, diseases,...

  6. 75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Availability of Safety and Effectiveness..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... 18, 2010. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological...

  7. 21 CFR 860.132 - Procedures when the Commissioner initiates a performance standard or premarket approval...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE CLASSIFICATION PROCEDURES Reclassification § 860.132 Procedures... the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding either to develop a performance standard for the device if in class II,...

  8. 21 CFR 860.132 - Procedures when the Commissioner initiates a performance standard or premarket approval...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Procedures when the Commissioner initiates a... Section 860.132 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE CLASSIFICATION PROCEDURES Reclassification § 860.132...

  9. 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

    ... Approval for an Implantable Pacemaker Pulse Generator AGENCY: Food and Drug Administration, HHS. ACTION... protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding... PMA or notice of completion of a PDP for the implantable pacemaker pulse generator. In accordance with...

  10. 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

    ... Implantable Pacemaker Pulse Generator AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule... preamendments device implantable pacemaker pulse generator. The Agency is also summarizing its proposed findings...). IV. Device Subject to This Proposal--Implantable Pacemaker Pulse Generator (21 CFR 870.3610) A...

  11. 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...

  12. 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

    ... Drug Administration Amendments Act of 2007 (Public Law 110-85), establish a comprehensive system for... circulatory blood flow. The device is either totally or partially implanted in the body. 2. Summary of Data...

  13. 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...

  14. 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

    ... of DNA and RNA characteristics and their relation to drug exposure and/or response. Drug exposure... information obtained from genomic investigations during the course of drug development (and from...

  15. 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

    ... 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, or...

  16. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions... the act applies to the device. (b) Any new, not substantially equivalent, device introduced into...

  17. 76 FR 48062 - Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ...) analyzed only a subgroup of ``psychiatric subjects'' which included many types of anxiety disorders as well as non-anxiety psychiatric disorders. The subgroup represents a diagnostically heterogeneous group... under investigation was preoperative anxiety, which may not be indicative of an Axis I anxiety...

  18. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic compatibility and electrical safety. Firms are now...

  19. 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

    ... Standard: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic compatibility and electrical...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts...

  20. 78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... Second Sight Medical ArgusTM II Retinal February 13, 2013. Products, Inc. Prosthesis System. P110032, FDA..., Inc. ArterX Surgical March 1, 2013. Sealant. II. Electronic Access Persons with access to the Internet...

  1. 75 FR 32476 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement under Sec. 814.39(a) and are eligible to be the subject of a 30-day notice. A... organization and the indexing of records into identifiable files to ensure the device's continued safety...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Health, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002. (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 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended... effectiveness of the device, or the device is to be marketed for a new or different indication for use, the... considered what consequences and effects the change or modification or new use might have on the safety...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND.... (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. 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

    ... labeling, guidance documents, and postmarket surveillance. A meeting of the Circulatory System Devices...Materials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm240575.htm . List... Approval for Automated External Defibrillator System. AGENCY: Food and Drug Administration, HHS....

  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

    ...); implantable defibrillators (LWS); cardiac resynchronization pacemakers (CRT-P, NKE) and implantable defibrillators (CRT-D, NIK) they have been entirely reviewed within the PMA program for more than a decade....

  7. 77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... (LWP); implantable defibrillators (LWS); cardiac resynchronization pacemakers (CRT-P, NKE); and implantable defibrillators (CRT-D, NIK), they have been entirely reviewed within the PMA program for more...

  8. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the... Vascular Closure January 31, 2013. System (VCS). P070026/S004, FDA-2013-M-0462 DePuy Orthopaedics, DuPuy Ceramax Ceramic Total April 2, 2013. Inc.. Hip System. P960043/S080, FDA-2013-M-0464 Abbott Vascular...

  9. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access... PREMOUNTED STENT SYSTEM 2010 Corp. P090006 Medtronic COMPLETE SE VASCULAR March 17, FDA-2010-M-0158 Vascular STENT SYSTEM 2010 II. Electronic Access Persons with access to the Internet may obtain the documents at...

  10. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ... Assist System. P120008, FDA-2012-M-1176 Abbott Laboratories.. ARCHITECT AFP Assay, November 28, 2012. ARCHITECT AFP Calibrators and ARCHITECT AFP Controls. II. Electronic Access Persons with access to...

  11. 78 FR 44130 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... (OMB Control Number 0910-0120)--Extension Section 510(k) of the Federal Food, Drug, and Cosmetic Act... form. The most likely respondents to this information collection will be specification developers...

  12. 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.

  13. 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)

  14. 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.

  15. Biomedical Applications

    NASA Astrophysics Data System (ADS)

    Méndez, Vicenç; Fedotov, Sergei; Horsthemke, Werner

    Reaction-transport equations have found many applications to biological processes of interest in medicine and microbiology. Examples range from cancer invasion to virus dispersal and transport in spiny dendrites.

  16. 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

  17. Technology applications

    NASA Technical Reports Server (NTRS)

    Anuskiewicz, T.; Johnston, J.; Leavitt, W.; Zimmerman, R. R.

    1972-01-01

    A summary of NASA Technology Utilization programs for the period of 1 December 1971 through 31 May 1972 is presented. An abbreviated description of the overall Technology Utilization Applications Program is provided as a background for the specific applications examples. Subjects discussed are in the broad headings of: (1) cancer, (2) cardiovascular disease, (2) medical instrumentation, (4) urinary system disorders, (5) rehabilitation medicine, (6) air and water pollution, (7) housing and urban construction, (8) fire safety, (9) law enforcement and criminalistics, (10) transportation, and (11) mine safety.

  18. 21 CFR 3.2 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Assignment of Agency Component for Review of Premarket Applications § 3.2 Definitions. For the purpose of... means any person who submits or plans to submit an application to the Food and Drug Administration for.... (1) A constituent part has a biological product mode of action if it acts by means of a virus...

  19. 21 CFR 3.2 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Assignment of Agency Component for Review of Premarket Applications § 3.2 Definitions. For the purpose of... means any person who submits or plans to submit an application to the Food and Drug Administration for.... (1) A constituent part has a biological product mode of action if it acts by means of a virus...

  20. 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... Jurisdiction: Assignment of Agency Component for Review of Premarket Applications--(OMB Control Number 0910... applicant may obtain an assignment or designation determination. The regulation requires that the request...

  1. 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

    ... Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency...: Assignment of Agency Component for Review of Premarket Applications--(OMB Control Number 0910-0523... dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or...

  2. 21 CFR 814.42 - Filing a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.42 Filing a PMA. (a) The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within 45 days after a PMA is received by FDA, the agency will notify...

  3. 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.

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

    PubMed

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

    2015-01-01

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

  5. 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.

  6. 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.

  7. 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.

  8. 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...

  9. 75 FR 4407 - The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn... discuss, make recommendations, and vote on a premarket approval application for the Deep Brain Stimulation... before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting...

  10. 78 FR 19713 - Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... design and conduct of research, the oversight of specific studies, and the distribution of sponsor funds... premarket tobacco product applications and other submissions to FDA, as well as research designed to... product research could be subject to third-party governance? For example, should both the design and...

  11. 21 CFR 814.84 - Reports.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the...

  12. 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...

  13. 21 CFR 814.126 - Postapproval requirements and reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (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...

  14. 21 CFR 814.84 - Reports.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the...

  15. 21 CFR 814.84 - Reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the...

  16. 21 CFR 812.38 - Confidentiality of data and information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... date of a notice of completion of a product development protocol except as provided in this section... application for premarket approval of the device subject to the IDE; or a notice of completion of a product development protocol for the device has become effective. (b) Availability of summaries or data. (1) FDA...

  17. 75 FR 41986 - Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer... available pediatric medical device information as a part of premarket approval applications, requests...

  18. 78 FR 8543 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... premarket notifications, 12 panel track supplements, 180 real-time supplements, 127 180-day supplements, 749... necessary to either initiate or defer the application review. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden No. of Average Form FDA No. No....

  19. 21 CFR 3.9 - Effect of letter of designation.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Effect of letter of designation. 3.9 Section 3.9 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...

  20. 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 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...

  1. 78 FR 69095 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ..., distributors, warehouses, exporters, and importers. In the Federal Register of August 26, 2013 (78 FR 52773... document. One comment suggested providing drop-down menus to facilitate data entry. FDA appreciates this... believes that collecting and compiling data under applicable regulatory requirements for the premarket...

  2. 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 which...

  3. 21 CFR 3.3 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Scope. 3.3 Section 3.3 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 § 3.3 Scope. This section applies to: (a) Any...

  4. 21 CFR 3.3 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Scope. 3.3 Section 3.3 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 § 3.3 Scope. This section applies to: (a) Any...

  5. 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

    ... 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 Valves... for heart valves. This draft guidance document is not final, nor is it in effect at this time. DATES...

  6. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is...

  7. 21 CFR 814.15 - Research conducted outside the United States.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.15 Research... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Research conducted outside the United States. 814... paragraph (b) or (c) of this section, as applicable. (b) Research begun on or after effective date. FDA...

  8. 21 CFR 812.38 - Confidentiality of data and information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... date of a notice of completion of a product development protocol except as provided in this section... application for premarket approval of the device subject to the IDE; or a notice of completion of a product development protocol for the device has become effective. (b) Availability of summaries or data. (1) FDA...

  9. 21 CFR 60.22 - Regulatory review period determinations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application for premarket approval of the device or a notice of completion of a product development protocol... notice of completion of a product development protocol is initially submitted under section 515 of the... completion of a product development protocol, or a petition is initially submitted on the date it...

  10. 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)...

  11. 78 FR 30312 - Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All... 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...

  12. 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

    ... Minutes, Meeting of the Circulatory System Devices Advisory Panel, Center for Devices and Radiological... system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S... Standards Matched to North American Industry Classification System Codes,'' available at http://www.sba.gov...

  13. Premarket Evaluations of the IMDx C. difficile for Abbott m2000 Assay and the BD Max Cdiff Assay

    PubMed Central

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

    2014-01-01

    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. PMID:24554744

  14. Performance of premarket rapid hepatitis C virus antibody assays in 4 national human immunodeficiency virus behavioral surveillance system sites.

    PubMed

    Smith, Bryce D; Teshale, Eyasu; Jewett, Amy; Weinbaum, Cindy M; Neaigus, Alan; Hagan, Holly; Jenness, Sam M; Melville, Sharon K; Burt, Richard; Thiede, Hanne; Al-Tayyib, Alia; Pannala, Praveen R; Miles, Iisa W; Oster, Alexa M; Smith, Amanda; Finlayson, Teresa; Bowles, Kristina E; Dinenno, Elizabeth A

    2011-10-01

    Performance characteristics of rapid assays for hepatitis C virus antibody were evaluated in 4 National HIV Behavioral Surveillance System injection drug use sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira and OraSure tests were 94.0%, 78.9%, and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. The Centers for Disease Control and Prevention (CDC) estimates that 4.1 million Americans have been infected with hepatitis C virus (HCV) and 75%-80% of them are living with chronic HCV infection, many unaware of their infection. Persons who inject drugs (PWID) account for 57.5% of all persons with HCV antibody (anti-HCV) in the United States. Currently no point-of-care tests for HCV infection are approved for use in the United States. Surveys and testing for human immunodeficiency virus (HIV) and anti-HCV were conducted among persons who reported injection drug use in the past 12 months as part of the National HIV Behavioral Surveillance System in 2009. The sensitivity and specificity of point-of-care tests (finger-stick and 2 oral fluid rapid assays) from 3 manufacturers (Chembio, MedMira, and OraSure) were evaluated in field settings in 4 US cities. Sensitivity (78.9%-97.4%) and specificity (80.0%-100.0%) were variable across assays and sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira, and OraSure tests were 94.0%, 78.9% and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. In multivariate analysis, false-negative anti-HCV results were associated with HIV positivity for the Chembio oral assay (adjusted odds ratio, 8.4-9.1; P < .01) in 1 site (New York City). Sensitive rapid anti-HCV assays are appropriate and feasible for high-prevalence, high-risk populations such as PWID, who can be reached through social service settings such as syringe exchange programs and methadone maintenance treatment programs.

  15. 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... conference is to discuss the most current information and thinking about clinical and basic aspects of the... more susceptible than others, combining views of both basic science and clinical experts, and selecting...

  16. Assessing new developments in the pre-market regulatory process of medical devices in the People's Republic of China.

    PubMed

    Zhang, Shixuan; Kriza, Christine; Kolominsky-Rabas, Peter L

    2014-09-01

    The objective of this paper is to provide a systematic overview of the Chinese medical device registration processes, identify challenges and suggest how these can be addressed. In addition, the paper will outline the impact of new policies and regulations since the restructuring of the China FDA. A systematic review was performed for journal articles between the year of 2009 and 2013 in the following databases: PubMed, ScienceDirect and Zhongguozhiwang. The review has identified 184 papers which were potentially relevant. Seventeen articles were included in the review, which highlights the challenges and opportunities related to the medical device registration process. In order to understand the actual impact of the regulation environment and its policies including the lack of regulatory guidance regular assessment updates are crucial. The results of this paper are aimed at informing regulatory bodies, health policy decision makers, national and international Health Technology Assessment networks as well as medical devices manufacturers.

  17. 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.

  18. Teleneurology applications

    PubMed Central

    Wechsler, Lawrence R.; Tsao, Jack W.; Levine, Steven R.; Swain-Eng, Rebecca J.; Adams, Robert J.; Demaerschalk, Bart M.; Hess, David C.; Moro, Elena; Schwamm, Lee H.; Steffensen, Steve; Stern, Barney J.; Zuckerman, Steven J.; Bhattacharya, Pratik; Davis, Larry E.; Yurkiewicz, Ilana R.; Alphonso, Aimee L.

    2013-01-01

    Objective: To review current literature on neurology telemedicine and to discuss its application to patient care, neurology practice, military medicine, and current federal policy. Methods: Review of practice models and published literature on primary studies of the efficacy of neurology telemedicine. Results: Teleneurology is of greatest benefit to populations with restricted access to general and subspecialty neurologic care in rural areas, those with limited mobility, and those deployed by the military. Through the use of real-time audio-visual interaction, imaging, and store-and-forward systems, a greater proportion of neurologists are able to meet the demand for specialty care in underserved communities, decrease the response time for acute stroke assessment, and expand the collaboration between primary care physicians, neurologists, and other disciplines. The American Stroke Association has developed a defined policy on teleneurology, and the American Academy of Neurology and federal health care policy are beginning to follow suit. Conclusions: Teleneurology is an effective tool for the rapid evaluation of patients in remote locations requiring neurologic care. These underserved locations include geographically isolated rural areas as well as urban cores with insufficient available neurology specialists. With this technology, neurologists will be better able to meet the burgeoning demand for access to neurologic care in an era of declining availability. An increase in physician awareness and support at the federal and state level is necessary to facilitate expansion of telemedicine into further areas of neurology. PMID:23400317

  19. BPPD Internal Application Checklists

    EPA Pesticide Factsheets

    EPA, Office of Pesticide Programs, BPPD internal application checklists for internal guidance to assist BPPD employees in their evaluation of applications submitted to BPPD by applicants and/or registrants.

  20. 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.

  1. 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.

  2. Application Statistics, 1984.

    ERIC Educational Resources Information Center

    Council of Ontario Universities, Toronto. Research Div.

    Summary statistics on fall 1984 application and registration patterns of applicants wishing to pursue full-time study in first-year places in Ontario, Canada, universities are presented. Each applicant was allowed to indicate up to three choices of universities and programs. Each choice was considered to be a distinct application, even though the…

  3. Immobilisation of fully sulfonated polyaniline on nanostructured calcium silicate.

    PubMed

    Borrmann, Thomas; Dominis, Anton; McFarlane, Andrew J; Johnston, James H; Richardson, Michael J; Kane-Maguire, Leon A P; Wallace, Gordon G

    2007-12-01

    Up to 7.4% (w/w) of the sulfonated polyaniline, poly(2-methoxyaniline-5-sulfonic acid) (PMAS) can be absorbed onto nanostructured calcium silicates. Spectroscopic and leaching studies on the novel PMAS-silicate nanocomposites obtained indicate that attachment of the PMAS occurs via electrostatic binding of PMAS sulfonate groups to Ca2+ sites on the silicates. The surface area and pore volume of the nanocomposites are comparable to those of pure silicate and increase the surface area of the PMAS polymer by several orders of magnitude. The PMAS emeraldine salt in the nanocomposites retains its chemical reactivity, being readily oxidised and reduced to its pernigraniline and leucoemeraldine forms, respectively. The conductivity of the composite is comparable to that of the pure PMAS, several orders of magnitude higher than that of dried nanostructured calcium silicate.

  4. 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.

  5. RHC Technologies and Applications

    EPA Pesticide Factsheets

    This page provides a portal to learning about several of the most common types of renewable heating and cooling technologies and end use applications. A clickable diagram compares technologies and applications with respect to their working temperatures.

  6. Application Submission and Screening

    EPA Pesticide Factsheets

    Applications for pesticide registration include many components, described in the Pesticide Registration Manual. When we receive an application, we quickly evaluate it against a checklist to determine if the basic components are present.

  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. EPA Geospatial Applications

    EPA Pesticide Factsheets

    EPA has developed many applications that allow users to explore and interact with geospatial data. This page highlights some of the flagship geospatial web applications but these represent only a fraction of the total.

  9. 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.

  10. Entomopathogenic nematode application technology

    USDA-ARS?s Scientific Manuscript database

    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...

  11. Biomedical Applications of Graphene

    PubMed Central

    Shen, He; Zhang, Liming; Liu, Min; Zhang, Zhijun

    2012-01-01

    Graphene exhibits unique 2-D structure and exceptional phyiscal and chemical properties that lead to many potential applications. Among various applications, biomedical applications of graphene have attracted ever-increasing interests over the last three years. In this review, we present an overview of current advances in applications of graphene in biomedicine with focus on drug delivery, cancer therapy and biological imaging, together with a brief discussion on the challenges and perspectives for future research in this field. PMID:22448195

  12. Reincarnation of Streaming Applications

    DTIC Science & Technology

    2009-10-01

    while preserving the original specification (the soul). 15. SUBJECT TERMS Legacy Application Code, Program Reincarnation, Parallelization, Multicores... original specification (“the soul”). Our technique originally focused on streaming applications such as multimedia, graphics, and signal processing...engineer the exact algorithm implemented and any special cases handled by the application. The original programmers are no longer available in many

  13. 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.

  14. Inertial MEMS System Applications

    DTIC Science & Technology

    2010-03-01

    Inertial MEMS System Applications N. Barbour, R. Hopkins, A. Kourepenis, P. Ward The Charles Stark Draper Laboratory (P-4993) 555 Technology...driven by gun-launched projectile requirements. The application of silicon MEMS inertial technology to competent munitions efforts began in the early...requirements. These applications have a unique combination of requirements including, performance over temperature, high-g launch survivability, fast

  15. Application Statistics, 1977.

    ERIC Educational Resources Information Center

    Council of Ontario Universities, Toronto. Research Div.

    Summary statistics are presented for the fall of 1977 on application and registration patterns of applicants wishing to pursue full-time study in first-year places in Ontario universities. This is the fifth in a series of annual reports that began with admissions in the fall of 1973. Statistics deal only with applicants processed by the…

  16. Biopharmaceutical applications of nanogold

    PubMed Central

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

    2010-01-01

    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. PMID:24936133

  17. 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.

  18. SNS application programming plan.

    SciTech Connect

    Chu, C. M.; Galambos, J. D.; Wei, J.; Allen, C.; McGehee, P. M.; Malitsky, N.

    2001-01-01

    The plan for Spallation Neutron Source accelerator physics application programs is presented. These high level applications involve processing and managing information from the diagnostic instruments, the machine control system, models and static databases and will be used to investigate and control beam behavior. Primary components include an SNS global database and Java-based XAL Application Toolkit. A key element in the SNS application programs is time synchronization of data used in these applications, due to the short pulse (1 ms), pulsed (60 Hz) nature of the device. The data synchronization progress is also presented.

  19. Application Portable Parallel Library

    NASA Technical Reports Server (NTRS)

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

    1995-01-01

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

  20. Application Portable Parallel Library

    NASA Technical Reports Server (NTRS)

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

    1995-01-01

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

  1. Electronic Submissions of Pesticide Applications

    EPA Pesticide Factsheets

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

  2. 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.

  3. Applications of micromixing technology.

    PubMed

    Jeong, Gi Seok; Chung, Seok; Kim, Chang-Beom; Lee, Sang-Hoon

    2010-03-01

    This review presents an application of micromixer technologies, which have driven a number of critical research trends over the past few decades, particularly for chemical and biological fields. Micromixer technologies in this review are categorized according to their applications: (1) chemical applications, including chemical synthesis, polymerization, and extraction; (2) biological applications, including DNA analysis, biological screening enzyme assays, protein folding; and (3) detection/analysis of chemical or biochemical content combined with NMR, FTIR, or Raman spectroscopies. In the chemical application, crystallization, extraction, polymerization, and organic synthesis have been reported, not only for laboratory studies, but also for industrial applications. Microscale techniques are used in chemical synthesis to develop microreactors. In clinical medicine and biological studies, microfluidic systems have been widely applied to the identification of biochemical products, diagnosis, drug discovery, and investigation of disease symptoms. The biological and biochemical applications also include enzyme assays, biological screening assays, cell lysis, protein folding, and biological analytical assays. Nondestructive analytical/detection methods have yielded a number of benefits to chemical and biochemical processes. In this chapter, we introduce analytical methods those are frequently integrated into micromixing technologies, such as NMR, FT-IR, and Raman spectroscopies. From the study of micromixers, we discovered that the Re number and mixing time depends on the specific application, and we clustered micromixers in various applications according to the Re number and mixing performance (mixing time). We expect that this clustering will be helpful in designing of micromixers for specific applications.

  4. 49 CFR 1150.3 - Information about applicant(s).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 8 2012-10-01 2012-10-01 false Information about applicant(s). 1150.3 Section... RAILROAD LINES Applications Under 49 U.S.C. 10901 § 1150.3 Information about applicant(s). (a) The name... regulated carriers. Also a list of entities, corporation(s) individual(s), or group(s) who control applicant...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 8 2013-10-01 2013-10-01 false Information about applicant(s). 1150.3 Section... RAILROAD LINES Applications Under 49 U.S.C. 10901 § 1150.3 Information about applicant(s). (a) The name... regulated carriers. Also a list of entities, corporation(s) individual(s), or group(s) who control applicant...

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Irregular Applications: Architectures & Algorithms

    SciTech Connect

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

    2012-02-06

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

  11. 76 FR 60836 - Applicants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ..., Officers: Diana Espinal Acevedo, Vice President/ Secretary (Qualifying Individual), Aleido J. Cabrera..., President (Qualifying Individual), Daniel Freire, Controller, Application Type: New NVO & OFF License...

  12. 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.

  13. 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.

  14. 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.)

  15. 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.

  16. Aerospace applications of batteries

    NASA Technical Reports Server (NTRS)

    Habib, Shahid

    1993-01-01

    NASA has developed battery technology to meet the demanding requirements for aerospace applications; specifically, the space vacuum, launch loads, and high duty cycles. Because of unique requirements and operating environments associated with space applications, NASA has written its own standards and specifications for batteries.

  17. Network aware distributed applications

    SciTech Connect

    Agarwal, Deborah; Tierney, Brian L.; Gunter, Dan; Lee, Jason; Johnston, William

    2001-02-04

    Most distributed applications today manage to utilize only a small percentage of the needed and available network bandwidth. Often application developers are not aware of the potential bandwidth of the network, and therefore do not know what to expect. Even when application developers are aware of the specifications of the machines and network links, they have few resources that can help determine why the expected performance was not achieved. What is needed is a ubiquitous and easy-to-use service that provides reliable, accurate, secure, and timely estimates of dynamic network properties. This service will help advise applications on how to make use of the network's increasing bandwidth and capabilities for traffic shaping and engineering. When fully implemented, this service will make building currently unrealizable levels of network awareness into distributed applications a relatively mundane task. For example, a remote data visualization application could choose between sending a wireframe, a pre-rendered image, or a 3-D representation, based on forecasts of CPU availability and power, compression options, and available bandwidth. The same service will provide on-demand performance information so that applications can compare predicted with actual results, and allow detailed queries about the end-to-end path for application and network tuning and debugging.

  18. Understanding University Undergraduate Applications.

    ERIC Educational Resources Information Center

    Molinero, Cecilio Mar

    1990-01-01

    Much marketing information can be obtained for admissions policy formation and forecasting from existing data sources, including course perceptions, the nature of the competition, and the admissions policies of the competition. The British university application system would benefit by exploiting computer applications of this concept. (MSE)

  19. 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…

  20. 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…

  1. RPVs - Exploring civilian applications

    NASA Technical Reports Server (NTRS)

    Gregory, T. J.; Bailey, R. O.; Nelms, W. P.

    1974-01-01

    Discussion of the civilian application possibilities for remotely piloted vehicle (RPV) systems. Following a listing of all possible desert, coastal, forest, agricultural, and urban RPV missions, a thorough examination is presented of such possible RPV aircraft applications as those of forest-fire detection and mapping. Some of the major obstacles to such civilian missions are also reviewed.

  2. 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.)

  3. NASA Applications Data Service

    NASA Technical Reports Server (NTRS)

    Brown, L. E.

    1979-01-01

    The NASA Applications Data Service (ADS), which is being developed to provide timely, affordable access to readily usable multisource data products and services for NASA-affliliated space-technology applications researchers, is presented. The system concept of a decentralized information network, which retrieves data from existing data bases and provides it to the user, has been adopted, and feasibility studies of the compatibility of the ADS with other existing or planned network data systems are under way. Other current efforts include the definition of the requirements and services necessary to support NASA applications experiments and encourage private industry to design the system and commercially implement it, as well as applications scenarios support, commercialization potential, standards identification, and concept justification with respect to future applications missions.

  4. NASA Applications Data Service

    NASA Technical Reports Server (NTRS)

    Brown, L. E.

    1979-01-01

    The NASA Applications Data Service (ADS), which is being developed to provide timely, affordable access to readily usable multisource data products and services for NASA-affliliated space-technology applications researchers, is presented. The system concept of a decentralized information network, which retrieves data from existing data bases and provides it to the user, has been adopted, and feasibility studies of the compatibility of the ADS with other existing or planned network data systems are under way. Other current efforts include the definition of the requirements and services necessary to support NASA applications experiments and encourage private industry to design the system and commercially implement it, as well as applications scenarios support, commercialization potential, standards identification, and concept justification with respect to future applications missions.

  5. 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.

  6. 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.

  7. Industrial application experiment series

    NASA Technical Reports Server (NTRS)

    Bluhm, S. A.

    1980-01-01

    The deployment of parabolic dish systems into the industrial sector for the purpose of providing users, suppliers, sponsors, and developers with a realistic assessment of system feasibility in selected near-term industrial applications will be accomplished initially through the industrial module experiment and later through additional experiments involving thermal, electric, and combined thermal and electrical systems. The approach is to progress through steps, from single module to multi-module systems, from thermal-only applications to more complex combined thermal and electric applications. The experience of other solar thermal experiments, particularly those involving parabolic dish hardware, will be utilized to the fullest extent possible in experiment planning and implementation.

  8. 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.

  9. 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.

  10. Automotive Applications of MEMS

    NASA Astrophysics Data System (ADS)

    Barua, Debojit

    2001-03-01

    Application of MEMS (Microelectromechanical systems) in the automotive industry has a relatively long history with the introduction of pressure sensors for engine control systems. The next significant inroad came with the introduction of silicon accelerometers for safety systems. Opportunities for MEMS are opening up with other sensor requirements in systems such as Vehicle Dynamics and Navigation. We shall discuss some of the automotive applications of MEMS from the users point of view. In particular, requirements due to harsh environment, reliability and durability, and of course, cost will be reviewed. Finally, we will discuss some applications in the area of actuators.

  11. 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

  12. Food and Drug Administration Efforts to Mitigate Contact Lens Discomfort.

    PubMed

    Hampton, Denise; Green, Joffre Angelo; Robboy, Marc; Eydelman, Malvina

    2017-01-01

    The premarket review of contact lenses and accessories by the FDA involves the assessment of nonclinical and clinical information in support of clearance or approval of marketing applications. The review process for these medical devices, including attributes, which may contribute to comfort for lens wearers, is summarized, as are mechanisms by which FDA continues to assess and improve recommendations through the review process and through collaboration with external entities.

  13. Applications of supercritical fluids.

    PubMed

    Brunner, Gerd

    2010-01-01

    This review discusses supercritical fluids in industrial and near-to-industry applications. Supercritical fluids are flexible tools for processing materials. Supercritical fluids have been applied to mass-transfer processes, phase-transition processes, reactive systems, materials-related processes, and nanostructured materials. Some applications are already at industrial capacity, whereas others remain under development. In addition to extraction, application areas include impregnation and cleaning, multistage countercurrent separation, particle formation, coating, and reactive systems such as hydrogenation, biomass gasification, and supercritical water oxidation. Polymers are modified with supercritical fluids, and colloids and emulsions as well as nanostructured materials exhibit interesting phenomena when in contact with supercritical fluids that can be industrially exploited. For these applications to succeed, the properties of supercritical fluids in combination with the materials processed must be clearly determined and fundamental knowledge of the complex behavior must be made readily available.

  14. 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.

  15. Land Application of Biosolids

    EPA Pesticide Factsheets

    Recycling biosolids through land application serves several purposes. It improves soil properties, such as texture and water holding capacity, which make conditions more favorable for root growth and increases the drought tolerance of vegetation.

  16. 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.

  17. 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.

  18. Novel Applications of Computers

    ERIC Educational Resources Information Center

    Levi, Barbara G.

    1970-01-01

    Presents some novel applications of the computer to physics research. They include (1) a computer program for calculating Compton scattering, (2) speech simulation, (3) data analysis in spectrometry, and (4) measurement of complex alpha-particle spectrum. Bibliography. (LC)

  19. Photochemical Modeling Applications

    EPA Pesticide Factsheets

    Provides access to modeling applications involving photochemical models, including modeling of ozone, particulate matter (PM), and mercury for national and regional EPA regulations such as the Clean Air Interstate Rule (CAIR) and the Clean Air Mercury Rule

  20. BIOSENSORS FOR ENVIRONMENTAL APPLICATIONS

    EPA Science Inventory

    A review, with 19 references, is given on challenges and possible opportunities for the development of biosensors for environmental monitoring applications. The high cost and slow turnaround times typically associated with the measurement of regulated pollutants clearly indicates...

  1. Pedagogical Applications of Telematics.

    ERIC Educational Resources Information Center

    Verloove, George

    1993-01-01

    Discusses the primary educational applications of telematics, defined as a fusion of information and communications technologies. Electronic mail, teleconferencing, electronic bulletin boards, and databanks are described and their uses by teachers and students are noted. (KRN)

  2. Application Interoperability with SAMP

    NASA Astrophysics Data System (ADS)

    Fitzpatrick, M.; Laurino, O.; Paioro, L.; Taylor, M. B.

    2013-10-01

    The Simple Applications Messaging Protocol (SAMP) is a Virtual Observatory (VO) specification that enables astronomy software tools to exchange control information and data, allowing desktop applications to work as an integrated suite of tools rather than requiring complex functionality to be (redundantly) built into tools individually. In addition, SAMP allows new workflows to be created for the science user that leverages the advantages of each tool (e.g. visualization of tables or images, analysis, etc.), greatly reducing the time needed to switch between applications and tasks. We present here a short introduction to the protocol itself, a survey of some toolkits for application authors who wish to introduce SAMP functionality into their tools, and some examples of real-world usage.

  3. Potential Applications for AQUATOX

    EPA Pesticide Factsheets

    AQUATOX has a myriad of potential applications to water management issues and programs, including water quality criteria and standards, TMDLs (Total Maximum Daily Loads), and ecological risk assessments of aquatic systems.

  4. Applications of control theory

    NASA Technical Reports Server (NTRS)

    Taft, C. K.; Pokoski, J. L.; Murdoch, J. B.; Limbert, D. E.; Alperi, R. W.

    1972-01-01

    Applications of control theory are considered in the areas of decoupling and wake steering control of submersibles, a method of electrohydraulic conversion with no moving parts, and socio-economic system modelling.

  5. Applications for alliform carbon

    DOEpatents

    Gogotsi, Yury; Mochalin, Vadym; McDonough, IV, John Kenneth; Simon, Patrice; Taberna, Pierre Louis

    2017-02-21

    This invention relates to novel applications for alliform carbon, useful in conductors and energy storage devices, including electrical double layer capacitor devices and articles incorporating such conductors and devices. Said alliform carbon particles are in the range of 2 to about 20 percent by weight, relative to the weight of the entire electrode. Said novel applications include supercapacitors and associated electrode devices, batteries, bandages and wound healing, and thin-film devices, including display devices.

  6. Aluminum powder applications

    SciTech Connect

    Gurganus, T.B.

    1995-08-01

    Aluminum powders have physical and metallurgical characteristics related to their method of manufacture that make them extremely important in a variety of applications. They can propel rockets, improve personal hygiene, increase computer reliability, refine exotic alloys, and reduce weight in the family sedan or the newest Air Force fighter. Powders formed into parts for structural and non-structural applications hold the key to some of the most exciting new developments in the aluminum future.

  7. 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.

  8. 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.

  9. Galileo Timing Applications

    DTIC Science & Technology

    2007-11-01

    relevant for many banking services such as: transactions, online banking and e - commerce , time-sensitive conditions (e.g., cancellation of a financial...which will ensure positioning with enough precision for rescue recommendation E .911 and for a particular set of services dedicated to terminal...Summary of application domains for the use of time in cryptography. B2G B2B B2C Applications Military waypoints, judicial reports, construction

  10. 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, and some total dose results.

  11. Nanotubes in biological applications.

    PubMed

    Mundra, Ruchir V; Wu, Xia; Sauer, Jeremy; Dordick, Jonathan S; Kane, Ravi S

    2014-08-01

    Researchers over the last few years have recognized carbon nanotubes (CNTs) as promising materials for a number of biological applications. CNTs are increasingly being explored as potent drug carriers for cancer treatment, for biosensing, and as scaffolds for stem cell culture. Moreover, the integration of CNTs with proteins has led to the development of functional nanocomposites with antimicrobial properties. This review aims at understanding the critical role of CNTs in biological applications with a particular emphasis on more recent studies.

  12. 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.

  13. Industrial applications of holography

    NASA Astrophysics Data System (ADS)

    Robillard, Jean; Caulfield, H. J.

    Topics presented include the holographic basis for intelligent machines, holographic stereograms of computer-generated objects made using a liquid crystal spatial modulator, the principles and applications of electronic speckle pattern interferometer, and high-temperature optical strain measurement. Also presented are the application of holography to underwater visual inspection, dry polymer for holographic recording, variable index materials for optical data processing, and holographic optical head for optical memories.

  14. Applications Of Artificial Intelligence

    NASA Astrophysics Data System (ADS)

    Trivedi, Mohan M.; Gilmore, John F.

    1986-03-01

    Intelligence evolves out of matter, so said the Sankhya philosophers of ancient India. The discipline of artificial intelligence (Al), which was established some 30 years ago, has confirmed the validity of the above assertion. Recently, a number of AI applications have been successfully demonstrated, generating a great deal of excitement and interest in scientific and technical circles. In this special issue of Optical Engineering a representative set of applications that incorporate Al principles is presented.

  15. Applications of electrospun fibers.

    PubMed

    Lu, Ping; Ding, Bin

    2008-01-01

    The simplicity of the electrospinning fabrication process, the diversity of electrospinnable materials, and the unique features associated with electrospun fibers make this technique and resultant structures attractive for various applications. The past few years witnessed the significant progresses in the application areas of electrospun fibers, which were demonstrated by the numbers of the recent published patents on electrospinning. It is very apparent that the current focus has been shifted from studying the modification of the electrospinning conditions and apparatus for obtaining fibers with different sizes, shapes, morphologies, structures, alignments before 2000 to looking for the possible applications of these resultant nanofibers with broad functionalities after 2001. The current paper presents a systematic review on the recent applications of electrospun nanofibers in a broad range of fields including biomedical applications such as drug delivery, tissue engineering, wound dressing and cosmetics, functional materials and devices such as composite reinforcement, filters, protective clothing and smart textiles, and energy and electronics such as batteries/cells and capacitors, sensors and catalysts. Although some of these applications may be still remained in the laboratory in the current stage, plenty of successful examples have proved that electrospun nanofibers have a bright future in a variety of industries.

  16. Applications of cavity optomechanics

    NASA Astrophysics Data System (ADS)

    Metcalfe, Michael

    2014-09-01

    "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.

  17. 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.

  18. 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.

  19. 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.

  20. Automated Inadvertent Intruder Application

    SciTech Connect

    Koffman, Larry D.; Lee, Patricia L.; Cook, James R.; Wilhite, Elmer L.

    2008-01-15

    The Environmental Analysis and Performance Modeling group of Savannah River National Laboratory (SRNL) conducts performance assessments of the Savannah River Site (SRS) low-level waste facilities to meet the requirements of DOE Order 435.1. These performance assessments, which result in limits on the amounts of radiological substances that can be placed in the waste disposal facilities, consider numerous potential exposure pathways that could occur in the future. One set of exposure scenarios, known as inadvertent intruder analysis, considers the impact on hypothetical individuals who are assumed to inadvertently intrude onto the waste disposal site. Inadvertent intruder analysis considers three distinct scenarios for exposure referred to as the agriculture scenario, the resident scenario, and the post-drilling scenario. Each of these scenarios has specific exposure pathways that contribute to the overall dose for the scenario. For the inadvertent intruder analysis, the calculation of dose for the exposure pathways is a relatively straightforward algebraic calculation that utilizes dose conversion factors. Prior to 2004, these calculations were performed using an Excel spreadsheet. However, design checks of the spreadsheet calculations revealed that errors could be introduced inadvertently when copying spreadsheet formulas cell by cell and finding these errors was tedious and time consuming. This weakness led to the specification of functional requirements to create a software application that would automate the calculations for inadvertent intruder analysis using a controlled source of input parameters. This software application, named the Automated Inadvertent Intruder Application, has undergone rigorous testing of the internal calculations and meets software QA requirements. The Automated Inadvertent Intruder Application was intended to replace the previous spreadsheet analyses with an automated application that was verified to produce the same calculations and

  1. 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 residents...

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Applications of Cell Microencapsulation.

    PubMed

    Opara, Emmanuel C

    2017-01-01

    The goal of this chapter is to provide an overview of the different purposes for which the cell microencapsulation technology can be used. These include immunoisolation of non-autologous cells used for cell therapy; immobilization of cells for localized (targeted) delivery of therapeutic products to ablate, repair, or regenerate tissue; simultaneous delivery of multiple therapeutic agents in cell therapy; spatial compartmentalization of cells in complex tissue engineering; expansion of cells in culture; and production of different probiotics and metabolites for industrial applications. For each of these applications, specific examples are provided to illustrate how the microencapsulation technology can be utilized to achieve the purpose. However, successful use of the cell microencapsulation technology for whatever purpose will ultimately depend upon careful consideration for the choice of the encapsulating polymers, the method of fabrication (cross-linking) of the microbeads, which affects the permselectivity, the biocompatibility and the mechanical strength of the microbeads as well as environmental parameters such as temperature, humidity, osmotic pressure, and storage solutions.The various applications discussed in this chapter are illustrated in the different chapters of this book and where appropriate relevant images of the microencapsulation products are provided. It is hoped that this outline of the different applications of cell microencapsulation would provide a good platform for tissue engineers, scientists, and clinicians to design novel tissue constructs and products for therapeutic and industrial applications.

  7. 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.

  8. Fiberglass cast application.

    PubMed

    Smith, Gillian D; Hart, Raymond G; Tsai, Tsu-Min

    2005-05-01

    Plaster of Paris has been largely superceded for casting in orthopedic departments by synthetic cast materials. Despite its weight, its relative brittleness, its unpopularity with patients, and its messiness in application, plaster of Paris remains the mainstay of casting in the emergency department. This is due to a combination of economic reasons, the belief that synthetic casts leave less room for swelling and its relative ease of application compared to synthetic materials. We present a technique for synthetic cast application that avoids the problems of the rapidly setting cast and therefore allows the time for less experienced hands to produce a well-fitting cast or splint. We believe that this option, which allows the patient to have a lighter synthetic cast, rather than the traditional plaster of Paris cast, will be welcomed by both the patient and physician.

  9. 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.

  10. 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.

  11. Earth Science Applications Showcase

    NASA Image and Video Library

    2014-08-05

    NASA Administrator Charles Bolden speaks with young professionals about their project during the annual DEVELOP Earth Science Application Showcase at NASA headquarters Tuesday, August 5, 2014. The Earth Science Applications Showcase highlights the work of over 150 participants in the 10-week DEVELOP program that started in June. The DEVELOP Program bridges the gap between NASA Earth science and society, building capacity in both its participants and partner organizations, to better prepare them to handle the challenges that face our society and future generations. Photo Credit: (NASA/Aubrey Gemignani)

  12. Earth Science Applications Showcase

    NASA Image and Video Library

    2014-08-05

    Michael Gao presents his project on Southeast Asian disasters during the annual DEVELOP Earth Science Application Showcase at NASA headquarters Tuesday, August 5, 2014. The Earth Science Applications Showcase highlights the work of over 150 participants in the 10-week DEVELOP program that started in June. The DEVELOP Program bridges the gap between NASA Earth science and society, building capacity in both its participants and partner organizations, to better prepare them to handle the challenges that face our society and future generations. Photo Credit: (NASA/Aubrey Gemignani)

  13. Earth Science Applications Showcase

    NASA Image and Video Library

    2014-08-05

    Lisa Waldron and Justin Roberts-Pierel present their project on Texas health and air quality during the annual DEVELOP Earth Science Application Showcase at NASA headquarters Tuesday, August 5, 2014. The Earth Science Applications Showcase highlights the work of over 150 participants in the 10-week DEVELOP program that started in June. The DEVELOP Program bridges the gap between NASA Earth science and society, building capacity in both its participants and partner organizations, to better prepare them to handle the challenges that face our society and future generations. Photo Credit: (NASA/Aubrey Gemignani)

  14. Earth Science Applications Showcase

    NASA Image and Video Library

    2014-08-05

    NASA Administrator Charles Bolden poses for a selfie after a quick rap performance by some young professionals during the annual DEVELOP Earth Science Application Showcase at NASA headquarters Tuesday, August 5, 2014. The Earth Science Applications Showcase highlights the work of over 150 participants in the 10-week DEVELOP program that started in June. The DEVELOP Program bridges the gap between NASA Earth science and society, building capacity in both its participants and partner organizations, to better prepare them to handle the challenges that face our society and future generations. Photo Credit: (NASA/Aubrey Gemignani)

  15. Earth Science Applications Showcase

    NASA Image and Video Library

    2014-08-05

    NASA Administrator Charles Bolden asks young professionals about their projects after posing for a group photo during the annual DEVELOP Earth Science Application Showcase at NASA headquarters Tuesday, August 5, 2014. The Earth Science Applications Showcase highlights the work of over 150 participants in the 10-week DEVELOP program that started in June. The DEVELOP Program bridges the gap between NASA Earth science and society, building capacity in both its participants and partner organizations, to better prepare them to handle the challenges that face our society and future generations. Photo Credit: (NASA/Aubrey Gemignani)

  16. Clinical applications of magnetoencephalography.

    PubMed

    Stufflebeam, Steven M; Tanaka, Naoaki; Ahlfors, Seppo P

    2009-06-01

    Magnetoencephalography (MEG), in which magnetic fields generated by brain activity are recorded outside of the head, is now in routine clinical practice throughout the world. MEG has become a recognized and vital part of the presurgical evaluation of patients with epilepsy and patients with brain tumors. We review investigations that show an improvement in the postsurgical outcomes of patients with epilepsy by localizing epileptic discharges. We also describe the most common clinical MEG applications that affect the management of patients, and discuss some applications that are close to having a clinical impact on patients.

  17. 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.

  18. Applications of fuzzy logic

    SciTech Connect

    Zargham, M.R.

    1995-06-01

    Recently, fuzzy logic has been applied to many areas, such as process control, image understanding, robots, expert systems, and decision support systems. This paper will explain the basic concepts of fuzzy logic and its application in different fields. The steps to design a control system will be explained in detail. Fuzzy control is the first successful industrial application of fuzzy logic. A fuzzy controller is able to control systems which previously could only be controlled by skilled operators. In recent years Japan has achieved significant progress in this area and has applied it to variety of products such as cruise control for cars, video cameras, rice cookers, washing machines, etc.

  19. 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.

  20. Polyimide composites: Application histories

    NASA Technical Reports Server (NTRS)

    Poveromo, L. M.

    1985-01-01

    Advanced composite hardware exposed to thermal environments above 127 C (260 F) must be fabricated from materials having resin matrices whose thermal/moisture resistance is superior to that of conventional epoxy-matrix systems. A family of polyimide resins has evolved in the last 10 years that exhibits the thermal-oxidative stability required for high-temperature technology applications. The weight and structural benefits for organic-matrix composites can now be extended by designers and materials engineers to include structures exposed to 316 F (600 F). Polyimide composite materials are now commercially available that can replace metallic or epoxy composite structures in a wide range of aerospace applications.

  1. 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.

  2. Applications Spacelab missions

    NASA Technical Reports Server (NTRS)

    Pellerin, C. J., Jr.

    1979-01-01

    The paper presents the plans of the Office of Space and Terrestrial Applications for the Shuttle/Spacelab missions. It is reported that the current program contains dedicated low-gravity mission (Spacelab 3 mission) and several minor missions planned for flight during 1980-1982. It is noted that these missions have either Materials Processing or Earth viewing emphasis. Finally, several representative experiments are used to illustrate the Applications Spacelab Program, such as the Materials Experiment Assembly (MEA), and the Atmospheric Trace Molecule Measured by Spectroscopy (ATMOS) experiment.

  3. Earth Science Applications Showcase

    NASA Image and Video Library

    2014-08-05

    NASA Administrator Charles Bolden speaks with young professionals about their project on New England water resources during the annual DEVELOP Earth Science Application Showcase at NASA headquarters Tuesday, August 5, 2014. The Earth Science Applications Showcase highlights the work of over 150 participants in the 10-week DEVELOP program that started in June. The DEVELOP Program bridges the gap between NASA Earth science and society, building capacity in both its participants and partner organizations, to better prepare them to handle the challenges that face our society and future generations. Photo Credit: (NASA/Aubrey Gemignani)

  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. 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.

  6. 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.

  7. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard

    2000-01-01

    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 will start a series of notes concentrating on analysis techniques with this issues section discussing worst-case analysis requirements.

  8. 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.

  9. 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.

  10. Microcontroller for automation application

    NASA Technical Reports Server (NTRS)

    Cooper, H. W.

    1975-01-01

    The description of a microcontroller currently being developed for automation application was given. It is basically an 8-bit microcomputer with a 40K byte random access memory/read only memory, and can control a maximum of 12 devices through standard 15-line interface ports.

  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. Assessment Applications of Ontologies.

    ERIC Educational Resources Information Center

    Chung, Gregory K. W. K.; Niemi, David; Bewley, William L.

    This paper discusses the use of ontologies and their applications to assessment. An ontology provides a shared and common understanding of a domain that can be communicated among people and computational systems. The ontology captures one or more experts' conceptual representation of a domain expressed in terms of concepts and the relationships…

  13. 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;…

  14. 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)

  15. 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.

  16. 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.

  17. 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.

  18. Applications of aerospace technology

    NASA Technical Reports Server (NTRS)

    Rouse, D. J.; Brown, J. N., Jr.; Cleland, John; Lehrman, Stephen; Trachtman, Lawrence; Wallace, Robert; Winfield, Daniel; Court, Nancy; Maggin, Bernard; Barnett, Reed

    1987-01-01

    Highlights are presented for the Research Triangle Institute (RTI) Applications Team activities over the past quarter. Progress in fulfilling the requirements of the contract is summarized, along with the status of the eight add-on tasks. New problem statements are presented. Transfer activities for ongoing projects with the NASA Centers are included.

  19. 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.

  20. 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;…

  1. Supergravity:. Foundations and Applications

    NASA Astrophysics Data System (ADS)

    Ceresole, Anna; Ferrara, Sergio

    2012-12-01

    We briefly discuss the foundations of Supergravity as a gauge theory of supersymmetry, its mathematical structure and the basic lagrangians for N-extended supersymmetry. As applications, we describe the basic elements of the supersymmetry breaking mechanism and various aspects of the physics of extremal black holes.

  2. 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)

  3. 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.

  4. 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.…

  5. Computer applications in bioprocessing.

    PubMed

    Bungay, H R

    2000-01-01

    Biotechnologists have stayed at the forefront for practical applications for computing. As hardware and software for computing have evolved, the latest advances have found eager users in the area of bioprocessing. Accomplishments and their significance can be appreciated by tracing the history and the interplay between the computing tools and the problems that have been solved in bioprocessing.

  6. Applications of kinetic theory

    SciTech Connect

    Gidaspow, D.

    1992-01-01

    The overall objective of this investigation is to develop experimentally verified models for circulating fluidized bed (CFB) combustors. This report presents the author's derivation of analytical solutions useful in understanding the operation of a CFB. The report is in a form of a chapter that reviews the kinetic theory applications.

  7. 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)

  8. Oncologic applications of endoscopy.

    PubMed

    Magne, M L

    1995-01-01

    Endoscopic examinations provide a valuable, noninvasive adjunct in the diagnosis and staging of many neoplastic disorders (Table 1). Additionally, the clinical applications of endoscopic-guided laser or photodynamic therapy have yet to be investigated thoroughly in companion animals. Endoscopy does not eliminate the need for other diagnostics, rather it should be considered complementary to more "traditional" procedures such as radiography, surgery, and ultrasonography.

  9. 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)

  10. 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.

  11. 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.

  12. Oxide Films RF Applications

    DTIC Science & Technology

    2006-06-01

    AUTHOR(S) 5d. PROJECT NUMBER SKOWRONSKI , Marek 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING...Report Title: Oxide Films RF applications University: Carnegie Mellon University PIs: M. Skowronski & P. Salvador Agency: Office of Naval Research Award

  13. Applications of polychlorinated biphenyls.

    PubMed

    Erickson, Mitchell D; Kaley, Robert G

    2011-02-01

    In the 50 years or so that polychlorinated biphenyls (PCBs) were manufactured in the USA and elsewhere, they were widely used in numerous applications because of their desirable properties. The purpose of this paper is to review and summarize in one place the factual information about the uses of PCBs, as well as to correct some misconceptions that have arisen over the years. The focus is on applications in the USA for which there is ample documentation. However, use patterns were probably similar worldwide. Review. PCBs were used primarily as electrical insulating fluids in capacitors and transformers and also as hydraulic, heat transfer, and lubricating fluids. PCBs were blended with other chemicals as plasticizers and fire retardants and used in a range of products including caulks, adhesives, plastics, and carbonless copy paper. In the USA, PCBs were manufactured from 1929 through mid-1977, although many products remained in service for decades after the manufacture of PCBs was terminated. This article reviews the historic uses of PCBs in the USA and discusses, where possible, the relative sales volumes. Especially with smaller volume, military, and third-party uses, documenting a use and/or differentiating between a commercial use and an experimental test batch is not possible. A major contribution of this paper is to differentiate reported commercial applications of PCBs that can be documented from those which cannot. Undocumented uses may include actual minor uses as well as reported applications that are unlikely ever to have been commercialized.

  14. AUTOMATED INADVERTENT INTRUDER APPLICATION

    SciTech Connect

    Koffman, L; Patricia Lee, P; Jim Cook, J; Elmer Wilhite, E

    2007-05-29

    The Environmental Analysis and Performance Modeling group of Savannah River National Laboratory (SRNL) conducts performance assessments of the Savannah River Site (SRS) low-level waste facilities to meet the requirements of DOE Order 435.1. These performance assessments, which result in limits on the amounts of radiological substances that can be placed in the waste disposal facilities, consider numerous potential exposure pathways that could occur in the future. One set of exposure scenarios, known as inadvertent intruder analysis, considers the impact on hypothetical individuals who are assumed to inadvertently intrude onto the waste disposal site. Inadvertent intruder analysis considers three distinct scenarios for exposure referred to as the agriculture scenario, the resident scenario, and the post-drilling scenario. Each of these scenarios has specific exposure pathways that contribute to the overall dose for the scenario. For the inadvertent intruder analysis, the calculation of dose for the exposure pathways is a relatively straightforward algebraic calculation that utilizes dose conversion factors. Prior to 2004, these calculations were performed using an Excel spreadsheet. However, design checks of the spreadsheet calculations revealed that errors could be introduced inadvertently when copying spreadsheet formulas cell by cell and finding these errors was tedious and time consuming. This weakness led to the specification of functional requirements to create a software application that would automate the calculations for inadvertent intruder analysis using a controlled source of input parameters. This software application, named the Automated Inadvertent Intruder Application, has undergone rigorous testing of the internal calculations and meets software QA requirements. The Automated Inadvertent Intruder Application was intended to replace the previous spreadsheet analyses with an automated application that was verified to produce the same calculations and

  15. Analysis of longitudinal laboratory data in the presence of common selection mechanisms: a view toward greater emphasis on pre-marketing pharmaceutical safety.

    PubMed

    Schildcrout, Jonathan S; Jenkins, Cathy A; Ostroff, Jack H; Gillen, Daniel L; Harrell, Frank E; Trost, Donald C

    2008-05-30

    Pharmaceutical safety has received substantial attention in the recent past; however, longitudinal clinical laboratory data routinely collected during clinical trials to derive safety profiles are often used ineffectively. For example, these data are frequently summarized by comparing proportions (between treatment arms) of participants who cross pre-specified threshold values at some time during follow-up. This research is intended, in part, to encourage more effective utilization of these data by avoiding unnecessary dichotomization of continuous data, acknowledging and making use of the longitudinal follow-up, and combining data from multiple clinical trials. However, appropriate analyses require careful consideration of a number of challenges (e.g. selection, comparability of study populations, etc.). We discuss estimation strategies based on estimating equations and maximum likelihood for analyses in the presence of three response history-dependent selection mechanisms: dropout, follow-up frequency, and treatment discontinuation. In addition, because clinical trials' participants usually represent non-random samples from target populations, we describe two sensitivity analysis approaches. All discussions are motivated by an analysis that aims to characterize the dynamic relationship between concentrations of a liver enzyme (alanine aminotransferase) and three distinct doses (no drug, low dose, and high dose) of an nk-1 antagonist across four Phase II clinical trials.

  16. 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.

  17. 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

  18. NEXUS: Roadmaps and Applications

    NASA Astrophysics Data System (ADS)

    El-Fatatry, Ayman

    2003-01-01

    The NEXUS Association, a European initiative that has established a world-wide Network of users and suppliers of Microsystems, was initially set up in the early 90s to assist European industry exploit the potential of microsystems (MST/MEMS) and microsystem-based technologies. To date, NEXUS members (over 600) have embarked on analysing market opportunities and technology roadmaps for MST/MEMS products and applications. Directed, primarily, by application-driven technology users, NEXUS has initiated a number of tasks to help provide strategic guidance for industry and research to encourage the uptake of the technology beyond its conventional realm. In this context, NEXUS through its User-Supplier-Clubs (USCs), in general, and that for telecommunications (USC-T), in particular, has produced forecasts addressing the potential of microsystems insertion into telecommunication systems over the next 10 years in the context of functionality advancements and network evolution.

  19. Antimicrobial applications of copper.

    PubMed

    Vincent, Marin; Hartemann, Philippe; Engels-Deutsch, Marc

    2016-10-01

    Copper has long been known to have antimicrobial activity and is used in drinking water treatment and transportation. It has been recognized by the American Environmental Protection Agency as the first metallic antimicrobial agent in 2008. With ongoing waterborne hospital-acquired infections and antibiotic resistance, research on copper as an antimicrobial agent is again very attractive. Many studies have shown that the use of copper surface and copper particles could significantly reduce the environmental bioburden. This review highlights in its first part all the conditions described in the literature to enhance copper antimicrobial activity. Secondly, the different antimicrobial applications of copper in water treatment, hospital care units and public applications are presented. Finally, the future research needs on copper as an antimicrobial agent are discussed. Copyright © 2016 Elsevier GmbH. All rights reserved.

  20. 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.

  1. 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.

  2. 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.

  3. Glyconanomaterials for Biosensing Applications

    PubMed Central

    Hao, Nanjing; Neranon, Kitjanit

    2015-01-01

    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

  4. Biochemiluminescence and biomedical applications.

    PubMed

    Champiat, D; Roux, A; Lhomme, O; Nosenzo, G

    1994-12-01

    Although used for analytical purposes for more than 40 years it is only recently that biochemiluminescence (BCL) has found widespread acceptance. Methods employing BCL reactions now play an important role in biomedical research and laboratory medicine. The main attractions for the assay technology include exquisite sensitivity (attomole-zeptomole), high selectivity, speed and simplicity. In biomedical research, the most important applications of BCL are: (1) to estimate microbial numbers and to assess cellular states (e.g., after exposure to antibiotic or cytotoxic agents) and in reporter gene studies (firefly luciferase gene); (2) NAD(P)H involved in redox/dehydrogenase studies using Vibrio luciferase complex; (3) BCL labels and CL detection of enzyme labels in immunoassays are the most widespread routine application for this technology. BCL enzyme immunoassays represent the most active area of development, e.g., enhanced BCL method for peroxidase and BCL assays for alkaline phosphatase labels using adamantyl 1,2-dioxetane.

  5. 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.

  6. 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.

  7. 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.

  8. Space vehicle accelerometer applications

    NASA Technical Reports Server (NTRS)

    1972-01-01

    The physics of accelerometer applications are reviewed, and details are given on accelerometer instruments and the principles of their operations. The functions to which accelerometers are applied are listed, and terms commonly used in accelerometer reports are defined. Criteria guides state what rule, limitation, or standard must be imposed on each essential design element to insure successful design. Elaboration of these criteria in the form of recommended practices show how to satisfy each of these criteria, with the best procedure described when possible.

  9. 1994 Technology Applications Report

    DTIC Science & Technology

    1994-01-01

    Pentagon, Washington, DC Descriptors, Keywords: Technology Applications Report BMDO Medical Environmental Sensor Energy Information Superhighway...Softwar Mcroelectronics Superconductor Dual -Use Transfer Pages: 00096 Cataloged Date: Apr 13,1995 Document Type: HC Number of Copies In Library...dedicated to the concepts of dual -use defense technology and a joint military/market industrial base. This program is an integral part of our BMDO

  10. 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.

  11. 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.

  12. Fresnel lens light applicator

    SciTech Connect

    Castel, J.C.; Kerwin, R.G.

    1987-09-01

    A therapeutic laser radiation applicator is described which consists of: means for providing laser radiation in an elliptical transverse distribution; and means for converting the elliptical transverse distribution of the laser radiation into a circular distribution thereof comprising at least two axially spaced fresnel lenses, and means for mounting the fresnel lenses in preselected association with the laser radiation means for refracting a portion of a laser radiation to the circular distribution adapted to provide a therapeutic tissue irradiation pattern.

  13. 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.

  14. Nanotechnology in Aerospace Applications

    DTIC Science & Technology

    2007-03-01

    generate power during sunlight for charging the batteries of various devices in the soldier- gear NRC Report, 2003 • Carbon nanotubes, nanofibers...modulus ~ 1 TPa ⇒ the in-plane value for defect -free graphite • Problems - Creating good interface between CNTs and polymer matrix necessary for effective...independent of helicity and the number of layers • Applications: Nanoelectronic devices, composites • Techniques: Arc discharge, laser ablation

  15. 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).

  16. Opportunities for PV applications

    NASA Technical Reports Server (NTRS)

    Scott-Monck, John A.; Rahilly, W. Patrick

    1987-01-01

    Workshop members devoted the majority of time to discussing future prospects for technology support of photovoltaic applications. Photovoltaics has provided power for almost every spacecraft launched in the free world in the last 25 years. Over this time, photovoltaics has demonstrated impressive growth in power level, operating lifetime and specific power (W/kg and W/square m). Yet, the current attitude toward this reliable form of space power generation is likely to preclude further dramatic performance gains.

  17. 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.

  18. Glyconanoparticles for biomedical applications.

    PubMed

    Dong, Chang-Ming

    2011-03-01

    Over the past two decades, glycosylated nanoparticles (i.e., glyconanoparticles having sugar residues on the surface) received much attention for biomedical applications such as bioassays and targeted drug delivery. This minireview focuses on three aspects: (1) glycosylated gold nanoparticles, (2) glycosylated quantum dots, and (3) glyconanoparticles self-assembled from amphiphilic glycopolymers. The synthetic methods and the multivalent interactions between glyconanoparticles and lectins is shortly illustrated.

  19. Nonmilitary applications of uranium

    SciTech Connect

    Polson, C.E.; Blasch, E.B.

    1981-01-01

    Uranium and its alloys should be considered for any application where weight and/or strength is required, or where weight to volume is important. There is considerable literature on uranium and its alloys. The fear of handling metallic uranium should not be a factor. It is the least hazardous of all long-lived isotopes. Sound industrial hygiene practices will provide adequate protection. In general, safety controls are similar to those required for other heavy metals.

  20. 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.

  1. 1997 Technology Applications Report,

    DTIC Science & Technology

    1997-01-01

    proper- ties of certain molecules embedded in an optical medium can be altered to store information. The SERODS system uses a writing laser , a reading... laser , a photometric detector, and an opti- cal disk or a 3-D multilayer optical storage medium. The writing laser encodes bit information by altering...tial confinement fusion experiments and BMDO’s free -electron laser weapons system. MANUFACTURING 1997 TECHNOLOGY APPLICATIONS REPORT REAL-TIME SOFTWARE

  2. Technology Applications Report

    DTIC Science & Technology

    1995-01-01

    Networks Ease Machine Distress 59 Diamond-Coated Tools Cut Through Commercial Barriers .60 Lasers Find New Markets In Micromachining 61 R&D Targeted... Lasers Find New Markets in Micromachining (1141) R&D Targeted to Lower Costs for Semiconductor Manufacturers (1142) lonwerks’ Measure of Success...Technology Applications Report Manufacturing LASERS FIND NEW MARKETS IN MICROMACHINING A micrometer (or micron), one-millionth of a meter, is less

  3. QMRPACK and applications

    SciTech Connect

    Freund, R.W.; Nachtigal, N.M.

    1994-10-01

    QMRPACK is a package of quasi-minimal residual algorithms for the iterative solution of linear systems. In this paper, the authors describe the main features of QMRPACK, comment on the implementations found in the package, and discuss how they would be invoked in a user code. They briefly describe two applications of the codes in the area of simulation of material properties from first principles, and in circuit simulation. They conclude by presenting future directions for QMRPACK.

  4. 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.

  5. 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.

  6. 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.

  7. Fuel cell market applications

    SciTech Connect

    Williams, M.C.

    1995-12-31

    This is a review of the US (and international) fuel cell development for the stationary power generation market. Besides DOE, GRI, and EPRI sponsorship, the US fuel cell program has over 40% cost-sharing from the private sector. Support is provided by user groups with over 75 utility and other end-user members. Objectives are to develop and demonstrate cost-effective fuel cell power generation which can initially be commercialized into various market applications using natural gas fuel by the year 2000. Types of fuel cells being developed include PAFC (phosphoric acid), MCFC (molten carbonate), and SOFC (solid oxide); status of each is reported. Potential international applications are reviewed also. Fuel cells are viewed as a force in dispersed power generation, distributed power, cogeneration, and deregulated industry. Specific fuel cell attributes are discussed: Fuel cells promise to be one of the most reliable power sources; they are now being used in critical uninterruptible power systems. They need hydrogen which can be generated internally from natural gas, coal gas, methanol landfill gas, or other fuels containing hydrocarbons. Finally, fuel cell development and market applications in Japan are reviewed briefly.

  8. 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.

  9. 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.

  10. Panoramic lens applications revisited

    NASA Astrophysics Data System (ADS)

    Thibault, Simon

    2008-04-01

    During the last few years, innovative optical design strategies to generate and control image mapping have been successful in producing high-resolution digital imagers and projectors. This new generation of panoramic lenses includes catadioptric panoramic lenses, panoramic annular lenses, visible/IR fisheye lenses, anamorphic wide-angle attachments, and visible/IR panomorph lenses. Given that a wide-angle lens images a large field of view on a limited number of pixels, a systematic pixel-to-angle mapping will help the efficient use of each pixel in the field of view. In this paper, we present several modern applications of these modern types of hemispheric lenses. Recently, surveillance and security applications have been proposed and published in Security and Defence symposium. However, modern hemispheric lens can be used in many other fields. A panoramic imaging sensor contributes most to the perception of the world. Panoramic lenses are now ready to be deployed in many optical solutions. Covered applications include, but are not limited to medical imaging (endoscope, rigiscope, fiberscope...), remote sensing (pipe inspection, crime scene investigation, archeology...), multimedia (hemispheric projector, panoramic image...). Modern panoramic technologies allow simple and efficient digital image processing and the use of standard image analysis features (motion estimation, segmentation, object tracking, pattern recognition) in the complete 360° hemispheric area.

  11. Applications of nuclear physics.

    PubMed

    Hayes, A C

    2017-02-01

    Today the applications of nuclear physics span a very broad range of topics and fields. This review discusses a number of aspects of these applications, including selected topics and concepts in nuclear reactor physics, nuclear fusion, nuclear non-proliferation, nuclear-geophysics, and nuclear medicine. The review begins with a historic summary of the early years in applied nuclear physics, with an emphasis on the huge developments that took place around the time of World War II, and that underlie the physics involved in designs of nuclear explosions, controlled nuclear energy, and nuclear fusion. The review then moves to focus on modern applications of these concepts, including the basic concepts and diagnostics developed for the forensics of nuclear explosions, the nuclear diagnostics at the National Ignition Facility, nuclear reactor safeguards, and the detection of nuclear material production and trafficking. The review also summarizes recent developments in nuclear geophysics and nuclear medicine. The nuclear geophysics areas discussed include geo-chronology, nuclear logging for industry, the Oklo reactor, and geo-neutrinos. The section on nuclear medicine summarizes the critical advances in nuclear imaging, including PET and SPECT imaging, targeted radionuclide therapy, and the nuclear physics of medical isotope production. Each subfield discussed requires a review article unto itself, which is not the intention of the current review; rather, the current review is intended for readers who wish to get a broad understanding of applied nuclear physics.

  12. 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.

  13. Applications of nuclear physics

    NASA Astrophysics Data System (ADS)

    Hayes, A. C.

    2017-02-01

    Today the applications of nuclear physics span a very broad range of topics and fields. This review discusses a number of aspects of these applications, including selected topics and concepts in nuclear reactor physics, nuclear fusion, nuclear non-proliferation, nuclear-geophysics, and nuclear medicine. The review begins with a historic summary of the early years in applied nuclear physics, with an emphasis on the huge developments that took place around the time of World War II, and that underlie the physics involved in designs of nuclear explosions, controlled nuclear energy, and nuclear fusion. The review then moves to focus on modern applications of these concepts, including the basic concepts and diagnostics developed for the forensics of nuclear explosions, the nuclear diagnostics at the National Ignition Facility, nuclear reactor safeguards, and the detection of nuclear material production and trafficking. The review also summarizes recent developments in nuclear geophysics and nuclear medicine. The nuclear geophysics areas discussed include geo-chronology, nuclear logging for industry, the Oklo reactor, and geo-neutrinos. The section on nuclear medicine summarizes the critical advances in nuclear imaging, including PET and SPECT imaging, targeted radionuclide therapy, and the nuclear physics of medical isotope production. Each subfield discussed requires a review article unto itself, which is not the intention of the current review; rather, the current review is intended for readers who wish to get a broad understanding of applied nuclear physics.

  14. [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.

  15. 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.

  16. Application Kit for Federal Assistance

    EPA Pesticide Factsheets

    The Federal Grant & Cooperative Agreement Act of 1977 requires Federal agencies to use a contract to acquire property or services that directly benefit the Federal government.This letter to the applicant explains the Application Kit for Federal Assistance.

  17. 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.

  18. Laser Ablation for Medical Applications

    NASA Astrophysics Data System (ADS)

    Hayashi, Ken-Ichi

    Medical applications of laser are measurement, laser surgery, in-situ monitoring, and processing of medical devices. In this paper, author briefly reviews the trends of medical applications, describes some new applications, and then discuss about the future trends and problems of medical applications. At present, the domestic market of laser equipment for medical applications is nearly 1/10 of that for industrial applications, which has registered significant growth continuously. Laser surgery as a minimum invasive surgery under arthroscope is expected to decrease the pain of patients. Precise processing such as cutting and welding is suitable for manufacturing medical devices. Pulsed laser deposition has been successfully applied to the thin film coating. The corneal refractive surgery by ArF excimer laser has been widely accepted for its highly safe operation. Laser ablation for retinal implant in the visual prosthesis is one of the promising applications of laser ablation in medicine. New applications with femtosecond laser are expected in the near future.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. Medical Professionals and Smartphone Applications.

    PubMed

    Arunagiri, Varun; Parimala, M; Ragumani, P; Anbalagan, Kothai

    2017-06-01

    Ever since the advent of Smartphones, Smartphone applications (SAs) are revolutionizing the contemporary medicine. Smartphone application which was created in view of swift communications among the general public has now intruded the medical fraternity. But the ethics for using these applications to transfer patients' medical records through SA is bewildering among the medical professionals (MPs).

  4. Technological Applications in Science Assessment.

    ERIC Educational Resources Information Center

    Helgeson, Stanley L.; Kumar, David D.

    Educational technology has been a focus of development and research in science teaching and learning. This document reviews research dealing with computer and hypermedia applications to assessment in science education. The paper reports the findings first for computer applications for assessment and then for hypermedia applications in assessment.…

  5. 76 FR 37895 - Merger Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... Office of Thrift Supervision Merger Applications AGENCY: Office of Thrift Supervision (OTS), Treasury... collection. Title of Proposal: Merger Applications. OMB Number: 1550-0016. Form Number: N/A. Description: No savings association may, without application to and approval by the OTS combine with any insured...

  6. Checklists for Describing Job Applicants.

    ERIC Educational Resources Information Center

    Hakel, Milton D.; And Others

    Historically, interviewers have been unable to reach high agreement on applicant potential even when they interview the same applicant. However, it has been recently demonstrated that interviewers can do a good job of gathering relevant data and predicting applicant success. This document is a report on research conducted to learn what factors…

  7. Birthdates of Medical School Applicants

    ERIC Educational Resources Information Center

    Abel, Ernest L; Sokol, Robert J.; Kruger, Michael L.; Yargeau, Dawn

    2008-01-01

    We determined if the "relative age" effect, wherein older students in an age cohort in early grades do better academically, extends to birthdates of applicants to medical schools, and if birthdates are related to the success of their applications. We examined birthdays of applicants from Michigan to Wayne State University's School of…

  8. Liquid lubrication for space applications

    NASA Technical Reports Server (NTRS)

    Fusaro, Robert L.; Khonsari, Michael M.

    1993-01-01

    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.

  9. 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)

  10. Systems Applications in Higher Education.

    ERIC Educational Resources Information Center

    Schure, Alexander

    This paper discusses the application of computers for higher education and describes a philosophy and initial application of an accountability system that can aid in coping with the problems of occupationally related schools. Discussed are: (1) the role of computers in systems application; (2) the need for systems related information: the…

  11. Is long-term pharmacist-managed anticoagulation service efficient? A pragmatic randomized controlled trial.

    PubMed

    Lalonde, Lyne; Martineau, Josée; Blais, Normand; Montigny, Martine; Ginsberg, Jeffrey; Fournier, Martine; Berbiche, Djamal; Vanier, Marie-Claude; Blais, Lucie; Perreault, Sylvie; Rodrigues, Isabel

    2008-07-01

    Some pharmacist-managed anticoagulation services (PMAS) provide initial follow-up to patients on oral anticoagulant, who are transferred to their physician once they are stabilized. This may be as effective as and less expensive than long-term PMAS follow-up. Once PMAS patients were stabilized and ready for discharge, they were randomized to be transferred to their physician or stay with the PMAS. Quality of international normalized ratio (INR) control, incidence of complications, health-related quality of life, use of health care services, and direct incremental cost of PMAS follow-up were evaluated. One hundred thirty-eight physicians and 250 patients participated. Patients were initially followed at the PMAS for a mean of 11.3 weeks and afterwards were followed by their physician (n = 122) or by the PMAS pharmacists (n = 128) for a mean of 14.9 and 14.5 weeks, respectively. Pharmacist-managed anticoagulation services' and physician's patients were within the exact target range 77.3% and 76.7% of the time (95% CI of the difference -4.9% to 6.0%) and within the extended range 93.0% and 91.6% of the time (95% CI -2.1% to 4.7%), respectively. Pharmacist-managed anticoagulation services patients have seen their family physician less often (95% CI -3.1 to -0.1 visit per year). Number of INR tests, incidence of complications, and health-related quality of life were similar in both groups. The incremental cost of PMAS follow-up was estimated at CAN$123.80 per patient year. Once PMAS patients are well stabilized, maintaining a PMAS follow-up or transferring them to their physician is associated with excellent INR control. However, long-term PMAS follow-up may be more expensive.

  12. Radar applications overview

    NASA Astrophysics Data System (ADS)

    Greenspan, Marshall

    1996-06-01

    During the fifty years since its initial development as a means of providing early warning of airborne attacks against allied countries during World War II, radar systems have developed to the point of being highly mobile and versatile systems capable of supporting a wide variety of remote sensing applications. Instead of being tied to stationary land-based sites, radar systems have found their way into highly mobile land vehicles as well as into aircraft, missiles, and ships of all sizes. Of all these applications, however, the most exciting revolution has occurred in the airborne platform arena where advanced technology radars can be found in all shapes and sizes...ranging from the large AWACS and Joint STARS long range surveillance and targeting systems to small millimeter wave multi-spectral sensors on smart weapons that can detect and identify their targets through the use of highly sophisticated digital signal processing hardware and software. This paper presents an overview of these radar applications with the emphasis on modern airborne sensors that span the RF spectrum. It will identify and describe the factors that influence the parameters of low frequency and ultra wide band radars designed to penetrate ground and dense foliage environments and locate within them buried mines, enemy armor, and other concealed or camouflaged weapons of war. It will similarly examine the factors that lead to the development of airborne radar systems that support long range extended endurance airborne surveillance platforms designed to detect and precision-located both small high speed airborne threats as well as highly mobile time critical moving and stationary surface vehicles. The mission needs and associated radar design impacts will be contrasted with those of radar systems designed for high maneuverability rapid acquisition tactical strike warfare platforms, and shorter range cued air-to-surface weapons with integral smart radar sensors.

  13. 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.

  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. 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.

  16. Antenna applications of superconductors

    NASA Astrophysics Data System (ADS)

    Hansen, R. C.

    1991-09-01

    The applicability of superconductors to antennas is examined. Potential implementations that are examined are superdirective arrays; electrically small antennas; tuning and matching of these two; high-gain millimeter-wavelength arrays; and kinetic inductance slow wave structures for array phasers and traveling wave array feeds. It is thought that superdirective arrays and small antennas will not benefit directly, but their tuning/matching networks will undergo major improvements. Miniaturization of antennas will not be aided, but much higher gain millimeter-wave arrays will be realizable. Kinetic inductance slow-wave lines appear advantageous for improved array phasers and time delay, as well as for traveling-wave array feeds.

  17. Composite prepreg application device

    NASA Technical Reports Server (NTRS)

    Sandusky, Donald A. (Inventor); Marchello, Joseph M. (Inventor)

    1996-01-01

    A heated shoe and cooled pressure roller assembly for composite prepreg application is provided. The shoe assembly includes a heated forward contact surface having a curved pressure surface. The following cooled roller provides a continuous pressure to the thermoplastic while reducing the temperature to approximately 5.degree. C. below glass transition temperature. Electric heating coils inside the forward portion of the shoe heat a thermoplastic workpiece to approximately 100.degree. C. above the glass transition. Immediately following the heated contact surface, a cooled roller cools the work. The end sharpened shape of the heated shoe trailing edge tends to prevent slag buildup and maintain a uniform, relaxed stress fabrication.

  18. Electromagnetic levitation applications

    SciTech Connect

    Bayazitoglu, Y.

    1996-11-01

    At high temperatures, most materials react with the walls of their containers. This inevitably leads to material contamination and property degradation. Therefore, it becomes difficult to process materials to the required degree of purity and/or measure their properties at high temperatures. Levitation melting has been used on earth and microgravity since to circumvent this problem. In this paper, first a broad survey of the work done in electromagnetic levitation since its invention is given. Then the heat generation due to an alternating magnetic field is studied. Finally, the application of levitation melting in the determination of thermal diffusivity, emissivity, surface tension and viscosity of liquid metals is presented.

  19. Microdosimetry: Principles and applications

    PubMed Central

    Santa Cruz, Gustavo A.

    2016-01-01

    Aim to present the most important aspects of Microdosimetry, a research field in radiation biophysics. Background microdosimetry is the branch of radiation biophysics that systematically studies the spatial, temporal and spectral aspects of the stochastic nature of the energy deposition processes in microscopic structures. Materials and Methods we briefly review its history, the people, the formalism and the theories and devices that allowed researchers to begin to understand the true nature of radiation action on living matter. Results and Conclusions we outline some of its applications, especially to Boron Neutron Capture Therapy, attempting to explain the biological effectiveness of the boron thermal neutron capture reaction. PMID:26933397

  20. Introduction to Medical Applications

    NASA Astrophysics Data System (ADS)

    Welch, Ashley J.; van Gemert, Martin J. C.

    The first two parts of this book describe various theories associated with light propagation in tissue and the resulting response. If coherence or polarization information is not needed, we assume that the transport equation governs the optical interaction of light with tissue and the heat conduction equation provides the basis for estimating the thermal response of tissue to laser radiation. In part III of this book, the theory for optical and thermal interactions of laser light with tissue are used to analyze medical applications. In particular, the concepts of parts I and II

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Widening ERTS applications

    NASA Technical Reports Server (NTRS)

    Mercanti, E. P.

    1974-01-01

    In less than two years of operation ERTS-1 is shown to have successfully completed its experimental mission and to be delivering an ever-increasing roster of benefits. The widening ERTS applications reviewed include air quality and weather modification, aid to oil exploration, ore-deposit exploration, short-lived event observation, flood area assessment and flood-plain mapping, land and water quality assessment, soil association mapping, crop production measurements, wildlife resources, drought and desertification studies, ground-water exploration, watershed surveys, snow and ice monitoring, surface water mapping, and iceberg surveys. Future projects and developments are also briefly reviewed.

  6. Widening ERTS applications

    NASA Technical Reports Server (NTRS)

    Mercanti, E. P.

    1974-01-01

    In less than two years of operation ERTS-1 is shown to have successfully completed its experimental mission and to be delivering an ever-increasing roster of benefits. The widening ERTS applications reviewed include air quality and weather modification, aid to oil exploration, ore-deposit exploration, short-lived event observation, flood area assessment and flood-plain mapping, land and water quality assessment, soil association mapping, crop production measurements, wildlife resources, drought and desertification studies, ground-water exploration, watershed surveys, snow and ice monitoring, surface water mapping, and iceberg surveys. Future projects and developments are also briefly reviewed.

  7. Ultracapacitors for automotive applications

    NASA Astrophysics Data System (ADS)

    Ashtiani, Cyrus; Wright, Randy; Hunt, Gary

    In response to a growing consensus in the auto industry that ultracapacitors can potentially play a key role in the modern vehicle power distribution network, a task force was created at the United States Advanced Battery Consortium (USABC) to tackle issues facing the fledging industry. The task force embarked on first developing and establishing standards for performance and abuse tolerance of ultracapacitors in collaboration with the U.S. Department of Energy and National Labs. Subsequently, potential applications in the automotive industry were identified and a consensus requirement specification was drawn as a development guide for the industry.

  8. Composite prepreg application device

    NASA Technical Reports Server (NTRS)

    Sandusky, Donald A. (Inventor); Marchello, Joseph M. (Inventor)

    1995-01-01

    A heated shoe and cooled pressure roller assembly for composite prepreg application is provided. The shoe assembly includes a heated forward contact surface having a curved pressure surface. The following cooled roller provides a continuous pressure to the thermoplastic while reducing the temperature to approximately 5 C below glass transition temperature. Electric heating coils inside the forward portion of the shoe heat a thermoplastic workpiece to approximately 100 C above the glass transition. Immediately following the heated contact surface, a cooled roller cools the work. The end sharpened shape of the heated shoe trailing edge tends to prevent slag buildup and maintain a uniform, relaxed stress fabrication.

  9. Lubricants in conveyor applications

    SciTech Connect

    Paton, C.G.; Bland, S.B.; Melley, R.E.

    1995-01-01

    This paper looks at four critical lubricants used in the conveyor systems of the northern Albertan oil sand facility. The requirements for the lubricants used in the electric motors and gear boxes of the drive systems, the pulley bearings and the idler bearings are discussed in terms of the application and the environment. A number of developments that have occurred in recent years are presented. Data from the field and from custom designed testing in the laboratory are used to support the role of simulation testing in problem solving in this area of technology. 9 refs., 21 figs.

  10. 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.

  11. Digital communications: Microwave applications

    NASA Astrophysics Data System (ADS)

    Feher, K.

    Transmission concepts and techniques of digital systems are presented; and practical state-of-the-art implementation of digital communications systems by line-of-sight microwaves is described. Particular consideration is given to statistical methods in digital transmission systems analysis, digital modulation methods, microwave amplifiers, system gain, m-ary and QAM microwave systems, correlative techniques and applications to digital radio systems, hybrid systems, digital microwave systems design, diversity and protection switching techniques, measurement techniques, and research and development trends and unsolved problems.

  12. 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.

  13. 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)

  14. Gel integration for microfluidic applications.

    PubMed

    Zhang, Xuanqi; Li, Lingjun; Luo, Chunxiong

    2016-05-21

    Molecular diffusive membranes or materials are important for biological applications in microfluidic systems. Hydrogels are typical materials that offer several advantages, such as free diffusion for small molecules, biocompatibility with most cells, temperature sensitivity, relatively low cost, and ease of production. With the development of microfluidic applications, hydrogels can be integrated into microfluidic systems by soft lithography, flow-solid processes or UV cure methods. Due to their special properties, hydrogels are widely used as fluid control modules, biochemical reaction modules or biological application modules in different applications. Although hydrogels have been used in microfluidic systems for more than ten years, many hydrogels' properties and integrated techniques have not been carefully elaborated. Here, we systematically review the physical properties of hydrogels, general methods for gel-microfluidics integration and applications of this field. Advanced topics and the outlook of hydrogel fabrication and applications are also discussed. We hope this review can help researchers choose suitable methods for their applications using hydrogels.

  15. Applications of nuclear physics

    DOE PAGES

    Hayes-Sterbenz, Anna Catherine

    2017-01-10

    Today the applications of nuclear physics span a very broad range of topics and fields. This review discusses a number of aspects of these applications, including selected topics and concepts in nuclear reactor physics, nuclear fusion, nuclear non-proliferation, nuclear-geophysics, and nuclear medicine. The review begins with a historic summary of the early years in applied nuclear physics, with an emphasis on the huge developments that took place around the time of World War II, and that underlie the physics involved in designs of nuclear explosions, controlled nuclear energy, and nuclear fusion. The review then moves to focus on modern applicationsmore » of these concepts, including the basic concepts and diagnostics developed for the forensics of nuclear explosions, the nuclear diagnostics at the National Ignition Facility, nuclear reactor safeguards, and the detection of nuclear material production and trafficking. The review also summarizes recent developments in nuclear geophysics and nuclear medicine. The nuclear geophysics areas discussed include geo-chronology, nuclear logging for industry, the Oklo reactor, and geo-neutrinos. The section on nuclear medicine summarizes the critical advances in nuclear imaging, including PET and SPECT imaging, targeted radionuclide therapy, and the nuclear physics of medical isotope production. Lastly, each subfield discussed requires a review article unto itself, which is not the intention of the current review; rather, the current review is intended for readers who wish to get a broad understanding of applied nuclear physics.« less

  16. 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.

  17. 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...

  18. 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.

  19. 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

  20. 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. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. 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

  2. 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.

  3. 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.

  4. Plasma core reactor applications

    NASA Technical Reports Server (NTRS)

    Latham, T. S.; Rodgers, R. J.

    1976-01-01

    Analytical and experimental investigations were conducted to demonstrate the feasibility of fissioning uranium plasma core reactors and to characterize space and terrestrial applications for such reactors. Uranium hexafluoride fuel is injected into core cavities and confined away from the surface by argon buffer gas injected tangentially from the peripheral walls. Radiant heat transfer calculations were performed for a six-cavity reactor configuration. Axial working fluid channels are located along a fraction of each cavity peripheral wall. Results of calculations for outward-directed radiant energy fluxes corresponding to radiating temperatures of 2000 to 5000 K indicate total operating pressures from 80 to 650 atm, centerline temperatures from 6900 to 30,000 K, and total radiated powers from 25 to 2500 MW, respectively. Applications are described for this type of reactor such as (1) high-thrust, high specific impulse space propulsion, (2) highly efficient systems for generation of electricity, and (3) hydrogen or synthetic fuel production systems using the intense radiant energy fluxes.

  5. Plasma core reactor applications

    NASA Technical Reports Server (NTRS)

    Latham, T. S.; Rodgers, R. J.

    1976-01-01

    Analytical and experimental investigations were conducted to demonstrate the feasibility of fissioning uranium plasma core reactors and to characterize space and terrestrial applications for such reactors. Uranium hexafluoride fuel is injected into core cavities and confined away from the surface by argon buffer gas injected tangentially from the peripheral walls. Radiant heat transfer calculations were performed for a six-cavity reactor configuration. Axial working fluid channels are located along a fraction of each cavity peripheral wall. Results of calculations for outward-directed radiant energy fluxes corresponding to radiating temperatures of 2000 to 5000 K indicate total operating pressures from 80 to 650 atm, centerline temperatures from 6900 to 30,000 K, and total radiated powers from 25 to 2500 MW, respectively. Applications are described for this type of reactor such as (1) high-thrust, high specific impulse space propulsion, (2) highly efficient systems for generation of electricity, and (3) hydrogen or synthetic fuel production systems using the intense radiant energy fluxes.

  6. 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.

  7. 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

  8. Microwave radiometry and applications

    NASA Astrophysics Data System (ADS)

    Polívka, Jiří

    1995-09-01

    a chance to penetrate surfaces of non-metallic objects down to some wavelengths, by which it is advantageous in certain applications over e.g. IR waves. An extreme example of capabilities of the microwave radiometry is found in radio astronomy, where it determines temperatures and spectral features of bodies so remote that their distance from us is measured in millions of light years. Other apparatus serve in remote observation of Earth s resources: soils, water regions and atmosphere. Similar systems also have found applications in medical studies of human body, e.g. in cancer and inflammation diagnostics. The paper presents a background of the radiometric method, comments to equipment design and outlines some of the applications.

  9. 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 ...

  10. 45 CFR 149.40 - Application.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... application the applicant must submit the following: (1) Applicant's Tax Identification Number. (2) Applicant... determination shows on its face that an error was made; or (3) At any time in instances of fraud or similar...

  11. 45 CFR 149.40 - Application.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... application the applicant must submit the following: (1) Applicant's Tax Identification Number. (2) Applicant... determination shows on its face that an error was made; or (3) At any time in instances of fraud or similar...

  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. 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

  14. Web Platform Application

    SciTech Connect

    Paulsworth, Ashley; Kurtz, Jim; Brun de Pontet, Stephanie

    2016-06-15

    Sunvestment Energy Group (previously called Sunvestment Group) was established to create a web application that brings together site hosts, those who will obtain the energy from the solar array, with project developers and funders, including affinity investors. Sunvestment Energy Group (SEG) uses a community-based model that engages with investors who have some affinity with the site host organization. In addition to a financial return, these investors receive non-financial value from their investments and are therefore willing to offer lower cost capital. This enables the site host to enjoy more savings from solar through these less expensive Community Power Purchase Agreements (CPPAs). The purpose of this award was to develop an online platform to bring site hosts and investors together virtually.

  15. Topography measurements and applications

    NASA Astrophysics Data System (ADS)

    Song, Junfeng; Vorburger, Theodore

    2006-11-01

    Based on auto- and cross-correlation functions (ACF and CCF), a new surface parameter called profile (or topography) difference, D s, has been developed for quantifying differences between 2D profiles or between 3D topographies with a single number. When D s = 0, the two compared 2D profiles or 3D topographies must be exactly the same (point by point). A 2D and 3D topography measurement system was established at NIST. This system includes data acquisition stations using a stylus instrument and a confocal microscope, and a correlation program using the proposed parameters D s and the cross-correlation function maximum CCF max. Applications in forensic science and surface metrology are described; those include profile signature measurements for 40 NIST Standard Reference Material (SRM) 2460 standard bullets, and comparisons of profile measurements with four different techniques. An approach to optimizing the Gaussian filter long wavelength cutoff, λc, is proposed for topography measurements.

  16. Terahertz technology and applications

    NASA Technical Reports Server (NTRS)

    Siegel, P.

    2002-01-01

    Despite great scientific interest since at least the 1920's, the THz frequency range remains on e of the least tapped regions of the electromagnetic spectrum. Sandwiched between traditional microwave and optical technologies where there is a limited atmospheric propagation path, little commercial emphasis has been placed on THz systems. This has, perhaps fortunately, preserved some unique science and applications for tomorrow's technologies. For over 25 years the sole niche for THz technology has been in the high resolution spectroscopy and remote sensing areas where heterodyne and Fourier transform techniques have allowed astronomers, chemists, Earth, planetary and space scientists to measure, catalog and map thermal emission lines for a wide variety of lightweight molecules. As it turns out, no where else in the electromagnetic spectrum do we receive so much information about these chemical species. In fact, the universe is bathed in THz energy, most of it going unnoticed and undetected.

  17. 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

  18. 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.

  19. 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.

  20. 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