Sample records for production test authorization

  1. Production test IP-376-D, Supplement B Irradiation of MGCR-HDR-3 Test Element

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Baars, R.E.

    The objective of this supplement to PT-IP-376-D, Irradiation of MGCR-HDR-3 Test Element is to authorize 1000 hours of operation at a maximum test specimen surface temperature of 1700 F. The original production test authorized a test duration of four months at a maximum specimen surface temperature of 1500 F; supplement A authorized extension of the test duration to ten months. The desired increase in surface temperature is requested to demonstrate the general feasibility of operation of the fuel element at 1700 F, and to obtain specific information on the performance of Hastelloy-X cladding and fuel bodies. The increased temperature hasmore » been approved by the Atomic Energy Commission.« less

  2. Comparative Toxicity of Eight Oil Dispersant Products on Two Gulf of Mexico Aquatic Test Species

    EPA Science Inventory

    This report is the first of a round of toxicity testing data for eight oil dispersants that have been authorized for use on the National Contingency Plan (NCP) Product Schedule, which is a list of authorized dispersants and other chemicals that may be used to respond to oil disch...

  3. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  4. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  5. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  6. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  7. Pre-production Test Report for Transformer Abort Sensing and Control Unit.

    DTIC Science & Technology

    The purpose of the report is to describe the test equipment and procedure required for the pre-production testing of a transformer, pressure switch excitation, abort sensing and control unit. (Author)

  8. 78 FR 44355 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... central nervous system (``CNS'') depression, decreased heart rate, and depressed ventilation in children... Product Certification Regarding Representative Samples for Periodic Testing of Children's Products. 303... Certification Regarding Representative Samples for Periodic Testing of Children's Products Legal Authority: 15 U...

  9. 9 CFR 145.23 - Terminology and classification; flocks and products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Terminology and classification; flocks and products. 145.23 Section 145.23 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as...

  10. 9 CFR 145.23 - Terminology and classification; flocks and products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Terminology and classification; flocks and products. 145.23 Section 145.23 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as...

  11. [Testing of medicinal products produced from pooled plasma].

    PubMed

    Unkelbach, U; Hunfeld, A; Breitner-Ruddock, S

    2014-10-01

    Medicinal products produced from human plasma fall under the administrative batch release procedure of the competent authority. In Germany, this has been carried out since 1995 by the Paul Ehrlich Institute (PEI), the responsible state control agency for blood products. Medicinal products released for the European and national market are tested for quality, efficacy and safety. Experimental testing of the final product and the starting materials, the plasma pools, as well as control of the production documentation guarantee a constantly high product safety. In the 28,000 batches tested since the beginning of the state controlled batch release testing of these blood products at the PEI, there has been no transmission of infectious viruses (HIV, HBV and HCV) to any patient. The batch release has made a contribution to the improvement of product quality. This procedure is still an important tool to ensure safety of blood products. The PEI is integrated in the batch release network of the European Directorate for the Quality of Medicines & Health Care (EDQM) in Strasbourg. Regulations and guidelines for official control authority batch release (OCABR) ensure harmonized procedures for mutual recognition of batch release on the European level. The EU certificates and German national certificates are requested and accepted in over 70 countries worldwide. Experimental testing in the EU and the requisite certificates have developed into a seal of quality for the world market.

  12. 9 CFR 145.43 - Terminology and classification; flocks and products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Terminology and classification; flocks and products. 145.43 Section 145.43 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official...

  13. 9 CFR 145.43 - Terminology and classification; flocks and products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Terminology and classification; flocks and products. 145.43 Section 145.43 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official...

  14. 9 CFR 145.43 - Terminology and classification; flocks and products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Terminology and classification; flocks and products. 145.43 Section 145.43 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official...

  15. 9 CFR 147.51 - Authorized laboratory minimum requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Authorized laboratory minimum requirements. 147.51 Section 147.51 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE.... The testing procedures at the laboratory must be run or overseen by a laboratory technician who has...

  16. 9 CFR 147.51 - Authorized laboratory minimum requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Authorized laboratory minimum requirements. 147.51 Section 147.51 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE.... The testing procedures at the laboratory must be run or overseen by a laboratory technician who has...

  17. 9 CFR 147.51 - Authorized laboratory minimum requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Authorized laboratory minimum requirements. 147.51 Section 147.51 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE.... The testing procedures at the laboratory must be run or overseen by a laboratory technician who has...

  18. 9 CFR 147.51 - Authorized laboratory minimum requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Authorized laboratory minimum requirements. 147.51 Section 147.51 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE.... The testing procedures at the laboratory must be run or overseen by a laboratory technician who has...

  19. 9 CFR 147.51 - Authorized laboratory minimum requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Authorized laboratory minimum requirements. 147.51 Section 147.51 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE.... The testing procedures at the laboratory must be run or overseen by a laboratory technician who has...

  20. Antimicrobial activity of chemomechanical gingival retraction products.

    PubMed

    Hsu, Belinda; Lee, Stephanie; Schwass, Donald; Tompkins, Geoffrey

    2017-07-01

    Application of astringent hemostatic agents is the most widely used technique for gingival retraction, and a variety of products are offered commercially. However, these products may have additional unintended yet clinically beneficial properties. The authors assessed the antimicrobial activities of marketed retraction products against plaque-associated bacteria in both planktonic and biofilm assays, in vitro. The authors assessed hemostatic solutions, gels, pellets, retraction cords, pastes, and their listed active agents against a collection of microorganisms by means of conventional agar diffusion and minimum bacteriostatic and bactericidal concentration determinations. The authors then tested the most active products against monospecies biofilms grown on hydroxyapatite disks. All of the tested retraction products exhibited some antimicrobial activity. The results of the most active products were comparable with those of a marketed mouthwash. The listed retraction-active agents displayed relatively little activity when tested in pure form. At 10% dilution, some products evidenced inhibitory activity against most tested bacteria within 3 minutes of exposure, whereas others displayed variable effects after 10 minutes. The most active agents reduced, but did not completely prevent, the metabolic activity of a monospecies biofilm. Commercial gingival retraction products exhibit antimicrobial effects to various degrees in vitro. Some products display rapid bactericidal activity. The antimicrobial activity is not owing to the retraction-active agents. Biofilm bacteria are less sensitive to the antimicrobial effects of the agents. The rapidity of killing by some hemostatic agents suggests an antimicrobial effect that may be efficacious during clinical placement. The results of this in vitro study suggest that clinicians should be aware of the potential antimicrobial effects of some hemostatic agents, but more research is needed to confirm these observations in clinical use. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

  1. Pilot Scale Production and Testing of a Recombinant Staphylococcal Enterotoxin (SEB) Triple Mutant

    DTIC Science & Technology

    2017-09-01

    1 PILOT-SCALE PRODUCTION AND TESTING OF A RECOMBINANT STAPHYLOCOCCAL ENTEROTOXIN (SEB) TRIPLE MUTANT ECBC...Disclaimer The findings in this report are not to be construed as an official Department of the Army position unless so designated by other authorizing...TYPE Final 3. DATES COVERED (From - To) Mar 2010 – Dec 2011 4. TITLE AND SUBTITLE Pilot-Scale Production and Testing of a Recombinant

  2. Presentation Order Effects in Product Taste Tests.

    ERIC Educational Resources Information Center

    Dean, Michael L.

    1980-01-01

    Presentation order in paired-comparison testing was varied to measure the impact of primacy v recency effects on consumer product evaluation. First position preference bias characterized the findings, lending support to the attention decrement hypothesis or a suggested palate desensitization effect on subsequent taste trial behavior. (Author)

  3. A Student's Perspective: The Green Team's Project

    ERIC Educational Resources Information Center

    Pratt, Kyle

    2011-01-01

    In Mr. Wood's technology class, students learned about many aspects of engineering, including design of a product, teamwork, testing hypotheses, and testing the final product. In this article, the author describes how his class, particularly his team, applied everything they learned about the process to their kayak design challenge using the IDEAL…

  4. Tests for the determination of the effect of antimitotic products on immune reactions*

    PubMed Central

    Amiel, J. L.; Mathé, G.; Matsukura, M.; Méry, A. M.; Daguet, G.; Tenenbaum, R.; Garattini, S.; Brézin, C.; Palma, V.

    1964-01-01

    The differences reported by various authors in regard to the inhibitory effect of the same antimitotic product on the production of antibodies, may be attributable in particular to the antigen used and to the technique of administration of the product. These differences have made it necessary to work out a test that is not subject to criticism in these respects. After an investigation of the cytological reactions provoked in the mouse by various antigens, the authors have singled out three of these antigens: human albumin, the poliomyelitis virus and an allogeneic skin graft. The hyperbasophilic cells which are predominantly present in the lymphoid centres are, respectively, lymphocytes for the first, plasmocytes for the second and histiocytes for the third of these antigens. In view of the different mechanisms of action that are possible with the different antimitotic products the authors used three methods of administration: entirely `before' the antigenic stimulus; total dose administered entirely `after' the antigenic stimulus; total dose administered partially `before' and partially `after' the antigenic stimulus. PMID:14218267

  5. In Situ Biological Treatment Test at Kelly Air Force Base. Volume 2. Field Test Results and Cost Model

    DTIC Science & Technology

    1987-07-01

    Groundwater." Developments in Industrial Microbiology, Volume 24, pp. 225-234. Society of Industrial Microbiology, Arlington, Virginia. 18. Product ...ESL-TR-85-52 cv) VOLUME II CN IN SITU BIOLOGICAL TREATMENT TEST AT KELLY AIR FORCE BASE, VOLUME !1: FIELD TEST RESULTS AND COST MODEL R.S. WETZEL...Kelly Air Force Base, Volume II: Field Test Results and Cost Model (UNCLASSIFIED) 12 PERSONAL AUTHOR(S) Roger S. Wetzel, Connie M. Durst, Donald H

  6. 9 CFR 107.2 - Products under State license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... establishments that produce such products; and (2) The State has the authority to review the purity, safety... to review product test results to assure compliance with applicable standards of purity, safety, and... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Products under State license. 107.2...

  7. 21 CFR 170.17 - Exemption for investigational use and procedure for obtaining authorization to market edible...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... Contains a new food additive for investigational use only in laboratory research animals or for tests in... and if the edible products of the animals are to be marketed as food, permission for the marketing of the edible products as food has been requested by the sponsor, and authorization has been granted by...

  8. Vigilance in industry: cosmetics and household cleaning products. Balance sheet of case report from 2005 to 2007.

    PubMed

    Kornfeld-Lecanu, S; Zajaczkowski, F; Dubourg, S; Martin, L; Lefort, S; Siest, S

    2010-12-01

    Unlike medicinal products, cosmetics are not subject to marketing authorization in France. Nevertheless, the Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSAPS; French Agency for the Safety of Healthcare Products) has been working on the development of a cosmetovigilance system for several years, with the aim of establishing standard procedures for collecting adverse reactions to cosmetics from the manufacturers. To assess the incidence of skin reactions to cosmetics or household products. Unilever established its own 'vigilance' standard system in France in late 2003. This report describes the experience acquired from 2005 to 2007. Case reports were collected in compliance with a standard procedure. The cases were then analysed by the consultant dermatologist in accordance with a pharmacovigilance-based method (chronological criteria, clinical criteria, possible rechallenge test, patch tests). During the period 2005 to 2007, a total of 102,689 consumers contacted the consumer department, including 842 (0.82%) who reported skin reactions. After analysis of the collected data, 0.144 skin reaction cases per million units sold were found to be attributable to cosmetic or household products. The implementation of a structured vigilance system in the cosmetics and household products industry is an efficient tool for manufacturers, both for information purposes and for product improvement, as well as meeting the transparency requirements of health authorities and consumers. © 2010 The Author(s). Journal compilation © 2010 British Association of Dermatologists.

  9. Sustaining Software-Intensive Systems

    DTIC Science & Technology

    2006-05-01

    2.2 Multi- Service Operational Test and Evaluation .......................................4 2.3 Stable Software Baseline...or equivalent document • completed Multi- Service Operational Test and Evaluation (MOT&E) for the potential production software package (or OT&E if...not multi- service ) • stable software production baseline • complete and current software documentation • Authority to Operate (ATO) for an

  10. Guide to In-Flight Thrust Measurement of Turbojets and Fan Engines

    DTIC Science & Technology

    1979-01-01

    test toi test Lirt series escaorT Ts tter I=~~ Fta -F teEnier 193 7 REFERENCES No. Author(s) Title. etc. 0-I MIDAP Study Group Guide to Procedures for...Research and P L Goldsmith Production. Oliver and Boyd, 4th edition, 1972 4-9 M J Moroney Facts from Figures. Penguin Books, 1958 4-10 F W Burcham An

  11. Neurocognition in schizophrenia: a study of the productivity and visibility of Spanish authors.

    PubMed

    Guilera, Georgina; Pino, Oscar; Gómez-Benito, Juana; Rojo, J Emilio

    2012-02-01

    This paper provides a map of the scientific productivity of authors affiliated to a Spanish institution and who have addressed one of the most important current topics in schizophrenia: The study of cognitive performance. A search of the Web of Science yielded 125 articles that met the inclusion criteria. In order to provide a comprehensive overview of scientific productivity, we examine several bibliometric indicators, concerning both productivity and impact or visibility. The analysis also focuses on qualitative aspects of key theoretical importance, such as the kinds of cognitive functions that are most often assessed and the tests most widely used to evaluate them in clinical practice. The study shows that interest in the subject of cognitive function in schizophrenia has increased considerably in Spain since the beginning of this century. The results also highlight the need to standardize the type of tests to be used in the cognitive assessment of patients with schizophrenia.

  12. The Construct Validity of Higher Order Structure-of-Intellect Abilities in a Battery of Tests Emphasizing the Product of Transformations: A Confirmatory Maximum Likelihood Factor Analysis.

    ERIC Educational Resources Information Center

    Khattab, Ali-Maher; And Others

    1982-01-01

    A causal modeling system, using confirmatory maximum likelihood factor analysis with the LISREL IV computer program, evaluated the construct validity underlying the higher order factor structure of a given correlation matrix of 46 structure-of-intellect tests emphasizing the product of transformations. (Author/PN)

  13. A Psychological Theory of Educational Productivity.

    ERIC Educational Resources Information Center

    Walberg, Herbert J.

    To solve problems of causality and measurement in educational research, this paper combines seven variables into a proposed model of educational productivity on achievement tests. The authors first review psychological models of educational production that relate learning to aptitude and environment, and note that these models do not allow for…

  14. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Boverhof, Joshua R.; Agawal, Deborah A.; Jackson, Keith R.

    Nettest is a secure, real-time network utility. The nettest framework is designed to incorporate existing and new network tests, and be run as a daemon or an interactive process. Requests for network tests are received via a SSL connection or the user interface and are authorized using a ACL list (in the future authorization using Akenti will also be supported). For tests that require coordination between the two ends of the test, Nettest establishes an SSL connection to accomplish this coordination. A test between two remote computers can be requested via the user interlace if the Nettest daemon is runningmore » on both remote machines and the user is authorized. Authorization for the test is through a chain of trust estabtished by the nettest daemons. Nettest is responsible for determining if the test request is authorized, but it does nothing further to secure the test once the test is running. Currently the Nettest framework incorporates lperf-vl.2, a simple ping type test, and a tuned TCP test that uses a given required throughput and ping results to determine the round trip time to set a buffer size (based on the delay bandwidth product) and then performs an iperf TCP throughput test. Additional network test tools can be integrated into the Nettest framework in the future.« less

  15. 19 CFR 115.31 - Examination, inspection, and testing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.31 Examination, inspection, and testing... Authority shall conduct such examinations, inspections, and tests of the production run containers as it...

  16. 19 CFR 115.31 - Examination, inspection, and testing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.31 Examination, inspection, and testing... Authority shall conduct such examinations, inspections, and tests of the production run containers as it...

  17. 19 CFR 115.31 - Examination, inspection, and testing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.31 Examination, inspection, and testing... Authority shall conduct such examinations, inspections, and tests of the production run containers as it...

  18. 19 CFR 115.31 - Examination, inspection, and testing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.31 Examination, inspection, and testing... Authority shall conduct such examinations, inspections, and tests of the production run containers as it...

  19. 19 CFR 115.31 - Examination, inspection, and testing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.31 Examination, inspection, and testing... Authority shall conduct such examinations, inspections, and tests of the production run containers as it...

  20. Predictors of Student Productivity in Biomedical Graduate School Applications.

    PubMed

    Hall, Joshua D; O'Connell, Anna B; Cook, Jeanette G

    2017-01-01

    Many US biomedical PhD programs receive more applications for admissions than they can accept each year, necessitating a selective admissions process. Typical selection criteria include standardized test scores, undergraduate grade point average, letters of recommendation, a resume and/or personal statement highlighting relevant research or professional experience, and feedback from interviews with training faculty. Admissions decisions are often founded on assumptions that these application components correlate with research success in graduate school, but these assumptions have not been rigorously tested. We sought to determine if any application components were predictive of student productivity measured by first-author student publications and time to degree completion. We collected productivity metrics for graduate students who entered the umbrella first-year biomedical PhD program at the University of North Carolina at Chapel Hill from 2008-2010 and analyzed components of their admissions applications. We found no correlations of test scores, grades, amount of previous research experience, or faculty interview ratings with high or low productivity among those applicants who were admitted and chose to matriculate at UNC. In contrast, ratings from recommendation letter writers were significantly stronger for students who published multiple first-author papers in graduate school than for those who published no first-author papers during the same timeframe. We conclude that the most commonly used standardized test (the general GRE) is a particularly ineffective predictive tool, but that qualitative assessments by previous mentors are more likely to identify students who will succeed in biomedical graduate research. Based on these results, we conclude that admissions committees should avoid over-reliance on any single component of the application and de-emphasize metrics that are minimally predictive of student productivity. We recommend continual tracking of desired training outcomes combined with retrospective analysis of admissions practices to guide both application requirements and holistic application review.

  1. Detailed requirements document for the Interactive Financial Management System (IFMS), volume 1

    NASA Technical Reports Server (NTRS)

    Dodson, D. B.

    1975-01-01

    The detailed requirements for phase 1 (online fund control, subauthorization accounting, and accounts receivable functional capabilities) of the Interactive Financial Management System (IFMS) are described. This includes information on the following: systems requirements, performance requirements, test requirements, and production implementation. Most of the work is centered on systems requirements, and includes discussions on the following processes: resources authority, allotment, primary work authorization, reimbursable order acceptance, purchase request, obligation, cost accrual, cost distribution, disbursement, subauthorization performance, travel, accounts receivable, payroll, property, edit table maintenance, end-of-year, backup input. Other subjects covered include: external systems interfaces, general inquiries, general report requirements, communication requirements, and miscellaneous. Subjects covered under performance requirements include: response time, processing volumes, system reliability, and accuracy. Under test requirements come test data sources, general test approach, and acceptance criteria. Under production implementation come data base establishment, operational stages, and operational requirements.

  2. 9 CFR 104.4 - Products for research and evaluation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the producer for a small quantity of such product for in vitro Research and Evaluation tests: Provided... Administrator may require in order to assess the product's impact on the environment. (b)(1) A permit to import... and evaluation anywhere in or from the United States unless authorized by the Administrator in...

  3. 9 CFR 104.4 - Products for research and evaluation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the producer for a small quantity of such product for in vitro Research and Evaluation tests: Provided... Administrator may require in order to assess the product's impact on the environment. (b)(1) A permit to import... and evaluation anywhere in or from the United States unless authorized by the Administrator in...

  4. [Typing of skin staphylococci using the commercial identification system Staphy-Test].

    PubMed

    Pospísil, L; Pospísilova, A; Kocur, M

    1989-01-01

    The authors examined 150 strains of S. aureus and 180 strains of S. epidermidis isolated from different dermatoses. The determination of S. aureus and S. epidermidis was based on common routine tests as plasmacoagulase, production of hemolysin, acid production from mannitol and production of pigment. This determination was verified with the aid of a new identification system STAPHYtest. The STAPHYtest confirmed the previous diagnosis of S. aureus in 60.66% and that of S. epidermidis in 31.66% of strains only. The remaining strains were identified by means of STAPHYtest as S. simulans, S. xylosus, S. hominis, S. haemolyticus, S. warneri, S. auricularis, S. sciuri and Micrococcus sp. The authors discuss the importance of an curate identification of skin staphylococci by means of STAPHYtest for taxonomic purposes and for classification of staphylococci influence on different dermatoses.

  5. Development of Computer-Based Resources for Textile Education.

    ERIC Educational Resources Information Center

    Hopkins, Teresa; Thomas, Andrew; Bailey, Mike

    1998-01-01

    Describes the production of computer-based resources for students of textiles and engineering in the United Kingdom. Highlights include funding by the Teaching and Learning Technology Programme (TLTP), courseware author/subject expert interaction, usage test and evaluation, authoring software, graphics, computer-aided design simulation, self-test…

  6. Newer Approaches to Identify Potential Untoward Effects in Functional Foods.

    PubMed

    Marone, Palma Ann; Birkenbach, Victoria L; Hayes, A Wallace

    2016-01-01

    Globalization has greatly accelerated the numbers and variety of food and beverage products available worldwide. The exchange among greater numbers of countries, manufacturers, and products in the United States and worldwide has necessitated enhanced quality measures for nutritional products for larger populations increasingly reliant on functionality. These functional foods, those that provide benefit beyond basic nutrition, are increasingly being used for their potential to alleviate food insufficiency while enhancing quality and longevity of life. In the United States alone, a steady import increase of greater than 15% per year or 24 million shipments, over 70% products of which are food related, is regulated under the Food and Drug Administration (FDA). This unparalleled growth has resulted in the need for faster, cheaper, and better safety and efficacy screening methods in the form of harmonized guidelines and recommendations for product standardization. In an effort to meet this need, the in vitro toxicology testing market has similarly grown with an anticipatory 15% increase between 2010 and 2015 of US$1.3 to US$2.7 billion. Although traditionally occupying a small fraction of the market behind pharmaceuticals and cosmetic/household products, the scope of functional food testing, including additives/supplements, ingredients, residues, contact/processing, and contaminants, is potentially expansive. Similarly, as functional food testing has progressed, so has the need to identify potential adverse factors that threaten the safety and quality of these products. © The Author(s) 2015.

  7. 75 FR 31223 - Energy Conservation Program for Consumer Products: Test Procedure for Residential Central Air...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ...., Washington, DC 20585-0121. Please submit one signed paper original. Hand Delivery/Courier: Ms. Brenda Edwards...., Washington, DC 20024. Telephone: (202) 586-2945. Please submit one signed paper original. Instructions: [email protected] . SUPPLEMENTARY INFORMATION: I. Authority and Background A. Authority B. Background II...

  8. Dissolution testing of orally disintegrating tablets.

    PubMed

    Kraemer, Johannes; Gajendran, Jayachandar; Guillot, Alexis; Schichtel, Julian; Tuereli, Akif

    2012-07-01

    For industrially manufactured pharmaceutical dosage forms, product quality tests and performance tests are required to ascertain the quality of the final product. Current compendial requirements specify a disintegration and/or a dissolution test to check the quality of oral solid dosage forms. These requirements led to a number of compendial monographs for individual products and, at times, the results obtained may not be reflective of the dosage form performance. Although a general product performance test is desirable for orally disintegrating tablets (ODTs), the complexity of the release controlling mechanisms and short time-frame of release make such tests difficult to establish. For conventional oral solid dosage forms (COSDFs), disintegration is often considered to be the prerequisite for subsequent dissolution. Hence, disintegration testing is usually insufficient to judge product performance of COSDFs. Given the very fast disintegration of ODTs, the relationship between disintegration and dissolution is worthy of closer scrutiny. This article reviews the current status of dissolution testing of ODTs to establish the product quality standards. Based on experimental results, it appears that it may be feasible to rely on the dissolution test without a need for disintegration studies for selected ODTs on the market. © 2012 The Authors. JPP © 2012 Royal Pharmaceutical Society.

  9. A Multivariate Analysis of the Sociodemographic Predictors of Methamphetamine Production and Use

    ERIC Educational Resources Information Center

    Armstrong, Todd A.; Armstrong, Gaylene S.

    2013-01-01

    To date, research testing the community characteristics associated with methamphetamine production and use has found that the community-level sociodemographic predictors of methamphetamine production and use vary from those of drug use in general. In this study, the authors furthered the research in this area using data from all 102 counties in…

  10. Feature Characteristics of Spontaneous Speech Production in Young Deaf Children.

    ERIC Educational Resources Information Center

    Geffner, Donna

    1980-01-01

    Sixty-five six-year-old deaf children from state supported schools were given an adaptation of the Goldman Fristoe test of articulation to assess their spontaneous speech production. Journal availability: Elsevier North Holland, Inc., 52 Vanderbilt Avenue, New York, NY 10017. (Author)

  11. 9 CFR 146.10 - Supervision.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Supervision. 146.10 Section 146.10 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks...

  12. 9 CFR 145.11 - Supervision.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Supervision. 145.11 Section 145.11 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing...

  13. 9 CFR 146.10 - Supervision.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Supervision. 146.10 Section 146.10 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks...

  14. 9 CFR 145.11 - Supervision.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Supervision. 145.11 Section 145.11 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing...

  15. 9 CFR 146.10 - Supervision.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Supervision. 146.10 Section 146.10 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks...

  16. 9 CFR 145.11 - Supervision.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Supervision. 145.11 Section 145.11 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing...

  17. 9 CFR 146.10 - Supervision.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Supervision. 146.10 Section 146.10 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks...

  18. 9 CFR 146.10 - Supervision.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Supervision. 146.10 Section 146.10 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks...

  19. Sleep underpins the plasticity of language production.

    PubMed

    Gaskell, M Gareth; Warker, Jill; Lindsay, Shane; Frost, Rebecca; Guest, James; Snowdon, Reza; Stackhouse, Abigail

    2014-07-01

    The constraints that govern acceptable phoneme combinations in speech perception and production have considerable plasticity. We addressed whether sleep influences the acquisition of new constraints and their integration into the speech-production system. Participants repeated sequences of syllables in which two phonemes were artificially restricted to syllable onset or syllable coda, depending on the vowel in that sequence. After 48 sequences, participants either had a 90-min nap or remained awake. Participants then repeated 96 sequences so implicit constraint learning could be examined, and then were tested for constraint generalization in a forced-choice task. The sleep group, but not the wake group, produced speech errors at test that were consistent with restrictions on the placement of phonemes in training. Furthermore, only the sleep group generalized their learning to new materials. Polysomnography data showed that implicit constraint learning was associated with slow-wave sleep. These results show that sleep facilitates the integration of new linguistic knowledge with existing production constraints. These data have relevance for systems-consolidation models of sleep. © The Author(s) 2014.

  20. Translating research into licensed vaccines and validated and licensed diagnostic tests.

    PubMed

    Hill, R E; Foley, P L; Clough, N E; Ludemann, L R; Murtle, D C

    2013-01-01

    The USDA Center for Veterinary Biologics (CVB) has the regulatory authority to issue licenses and permits that allow the marketing of pure, safe, potent, and effective veterinary biological products. Under the standard licensing or permitting process, a manufacturer develops, characterizes, and evaluates a product prior to licensure. The CVB evaluates the submitted information, inspects the manufacturing facilities and methods of production and testing, and confirms key product test results through independent testing. This complete and comprehensive evaluation may not be possible during the emergence of a new animal disease or in response to an introduction of a significant transboundary animal disease agent. Processes are in place in the US that allow for more rapid availability of veterinary products in an emerging or emergency animal health situation. But, it can be advantageous to attain preapproval of products prior to their anticipated need. In this article, issues associated with obtaining approval for use of a biological product under emerging or emergency conditions are discussed.

  1. Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products.

    PubMed

    Jenke, Dennis

    2015-01-01

    An accelerating trend in the pharmaceutical industry is the use of plastic components in systems used to produce an active pharmaceutical ingredient or a finished drug product. If the active pharmaceutical ingredient, the finished drug product, or any solution used to generate them (for example, a process stream such as media, buffers, eluents, and the like) is contacted by a plastic component at any time during the production process, substances leached from the component may accumulate in the active pharmaceutical ingredient or finished drug product, affecting its safety and/or efficacy. In this article the author develops and justifies a semi-quantitative risk evaluation matrix that is used to determine the amount and rigor of component testing necessary and appropriate to establish that the component is chemically suitable for its intended use. By considering key properties of the component, the contact medium, the contact conditions, and the active pharmaceutical ingredient's or finished drug product's clinical conditions of use, use of the risk evaluation matrix produces a risk score whose magnitude reflects the accumulated risk that the component will interact with the contact solution to such an extent that component-related extractables will accumulate in the active pharmaceutical ingredient or finished drug product as leachables at levels sufficiently high to adversely affect user safety. The magnitude of the risk score establishes the amount and rigor of the testing that is required to select and qualify the component, and such testing is broadly grouped into three categories: baseline assessment, general testing, and full testing (extractables profiling). Production suites used to generate pharmaceuticals can include plastic components. It is possible that substances in the components could leach into manufacturing solutions and accumulate in the pharmaceutical product. In this article the author develops and justifies a semi-quantitative risk evaluation matrix that can be used to determine the amount and rigor of component testing that may be necessary and appropriate to establish that the component is suitable for its intended use. Use of the risk evaluation matrix allows a user of a component to determine the type and amount of testing that should be performed to establish the patient safety risk associated with using that component in order to manufacture an active pharmaceutical ingredient or a finished drug product. © PDA, Inc. 2015.

  2. Enhancement of methane production from co-digestion of chicken manure with agricultural wastes.

    PubMed

    Abouelenien, Fatma; Namba, Yuzaburo; Kosseva, Maria R; Nishio, Naomichi; Nakashimada, Yutaka

    2014-05-01

    The potential for methane production from semi-solid chicken manure (CM) and mixture of agricultural wastes (AWS) in a co-digestion process has been experimentally evaluated at thermophilic and mesophilic temperatures. To the best of author(')s knowledge, it is the first time that CM is co-digested with mixture of AWS consisting of coconut waste, cassava waste, and coffee grounds. Two types of anaerobic digestion processes (AD process) were used, process 1 (P1) using fresh CM (FCM) and process 2 (P2) using treated CM (TCM), ammonia stripped CM, were conducted. Methane production in P1 was increased by 93% and 50% compared to control (no AWS added) with maximum methane production of 502 and 506 mL g(-1)VS obtained at 55°C and 35°C, respectively. Additionally, 42% increase in methane production was observed with maximum volume of 695 mL g(-1)VS comparing P2 test with P2 control under 55°C. Ammonia accumulation was reduced by 39% and 32% in P1 and P2 tests. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Characterization and Leaching Tests of the Fluidized Bed Steam Reforming (FBSR) Waste Form for LAW Immobilization - 13400

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Neeway, James J.; Qafoku, Nikolla P.; Peterson, Reid A.

    2013-07-01

    Several supplemental technologies for treating and immobilizing Hanford low activity waste (LAW) have been evaluated. One such immobilization technology is the Fluidized Bed Steam Reforming (FBSR) granular product. The FBSR granular product is composed of insoluble sodium aluminosilicate (NAS) feldspathoid minerals. Production of the FBSR mineral product has been demonstrated both at the industrial and laboratory scale. Pacific Northwest National Laboratory (PNNL) was involved in an extensive characterization campaign. The goal of this campaign was to study the durability of the FBSR mineral product and the encapsulated FBSR product in a geo-polymer monolith. This paper gives an overview of resultsmore » obtained using the ASTM C 1285 Product Consistency Test (PCT), the EPA Test Method 1311 Toxicity Characteristic Leaching Procedure (TCLP), and the ASTMC 1662 Single-Pass Flow-Through (SPFT) test. Along with these durability tests an overview of the characteristics of the waste form has been collected using Scanning Electron Microscopy (SEM), X-ray Diffraction (XRD), microwave digestions for chemical composition, and surface area from Brunauer, Emmett, and Teller (BET) theory. (authors)« less

  4. 21 CFR 113.83 - Establishing scheduled processes.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... shall be performed according to procedures recognized by competent processing authorities. If incubation... actual commercial production runs during the period of instituting the process. The incubation tests for... of the process and associated incubation tests shall be prepared and shall be permanently retained by...

  5. Making Sense of Learner Performance on Tests of Productive Vocabulary Knowledge

    ERIC Educational Resources Information Center

    Fitzpatrick, Tess; Clenton, Jon

    2017-01-01

    This article offers a solution to a significant problem for teachers and researchers of language learning that confounds their interpretations and expectations of test data: The apparent simplicity of tests of vocabulary knowledge masks the complexity of the constructs they claim to measure. The authors first scrutinise task elements in two widely…

  6. 76 FR 12733 - Shenzhen Tangreat Technology Co., Ltd., Grantee of Equipment Authorization FCC ID No. XRLTG-VIPJAMM

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... test units'' from a supplier located in China.\\16\\ Share indicated that it had offered only three units... certain apparent discrepancies between the application, test report, and equipment certification as to the... description of the product: ``computer peripheral for preprocessing data.'' \\25\\ Similarly, the test report...

  7. ELT-572(v)2 DIRCM: simulation, system design and DTE process to protect ItAF platforms against ManPADS

    NASA Astrophysics Data System (ADS)

    Borriello, G.; Bonori, V.; Cresti, M.; Dente, E.; Ideo, L.; Mazzi, G.; Usai, A.; Tafuto, A.; Togna, F.

    2014-10-01

    In this paper authors provide a description of the currently deployed Man Portable Air Defense System (ManPADS) heat-seeking missiles. Principles of IR seeking and Aircraft signatures are shortly described. Basic information are listed on currently designed Infra-Red Counter Measure Systems, intended to protect Aircrafts against ManPADS. Authors provide an overview on ELT-572(v)2 DIRCM Program, funded by Italian Air Force, currently in low rate production phase. Description of the Design and Development phase, completed in Elettronica SpA in 2013, is reported. Development Test and Evaluation (DTE) Activities on ELT-572(v)2 DIRCM, jointly performed by Elettronica Spa and Italian Air Force Flight Test Centre, are shortly described. A summary of tests and some results are also discussed. Platform Installation Programs, using the low rate production units from ELT-572(v)2 DIRCM Program, are finally listed.

  8. 76 FR 77767 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-14

    ...; post-exposure management and monitoring plans; scrapie test records; application for indemnity payments... authority to promulgate regulations designed to prevent the importation, preparation, sale, or shipment of... applications, product and test report forms and field study summaries. Need and Use of the Information: APHIS...

  9. Savvy Consumers through Science

    ERIC Educational Resources Information Center

    Kahn, Sami

    2005-01-01

    Is Bounty the "quicker picker-upper?" Are expensive shampoos better? Are all antacids the same? The authors' fourth-grade students posed and answered these questions and many more during their recent "Consumer Product Testing" unit in which they designed experiments to assess these products' qualities and learned to question the advertising that…

  10. Scientific collaboration and endorsement: Network analysis of coauthorship and citation networks

    PubMed Central

    Ding, Ying

    2010-01-01

    Scientific collaboration and endorsement are well-established research topics which utilize three kinds of methods: survey/questionnaire, bibliometrics, and complex network analysis. This paper combines topic modeling and path-finding algorithms to determine whether productive authors tend to collaborate with or cite researchers with the same or different interests, and whether highly cited authors tend to collaborate with or cite each other. Taking information retrieval as a test field, the results show that productive authors tend to directly coauthor with and closely cite colleagues sharing the same research interests; they do not generally collaborate directly with colleagues having different research topics, but instead directly or indirectly cite them; and highly cited authors do not generally coauthor with each other, but closely cite each other. PMID:21344057

  11. Predictors of Student Productivity in Biomedical Graduate School Applications

    PubMed Central

    O’Connell, Anna B.; Cook, Jeanette G.

    2017-01-01

    Many US biomedical PhD programs receive more applications for admissions than they can accept each year, necessitating a selective admissions process. Typical selection criteria include standardized test scores, undergraduate grade point average, letters of recommendation, a resume and/or personal statement highlighting relevant research or professional experience, and feedback from interviews with training faculty. Admissions decisions are often founded on assumptions that these application components correlate with research success in graduate school, but these assumptions have not been rigorously tested. We sought to determine if any application components were predictive of student productivity measured by first-author student publications and time to degree completion. We collected productivity metrics for graduate students who entered the umbrella first-year biomedical PhD program at the University of North Carolina at Chapel Hill from 2008–2010 and analyzed components of their admissions applications. We found no correlations of test scores, grades, amount of previous research experience, or faculty interview ratings with high or low productivity among those applicants who were admitted and chose to matriculate at UNC. In contrast, ratings from recommendation letter writers were significantly stronger for students who published multiple first-author papers in graduate school than for those who published no first-author papers during the same timeframe. We conclude that the most commonly used standardized test (the general GRE) is a particularly ineffective predictive tool, but that qualitative assessments by previous mentors are more likely to identify students who will succeed in biomedical graduate research. Based on these results, we conclude that admissions committees should avoid over-reliance on any single component of the application and de-emphasize metrics that are minimally predictive of student productivity. We recommend continual tracking of desired training outcomes combined with retrospective analysis of admissions practices to guide both application requirements and holistic application review. PMID:28076439

  12. Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa: a noninferiority study.

    PubMed

    Baldursson, Baldur Tumi; Kjartansson, Hilmar; Konrádsdóttir, Fífa; Gudnason, Palmar; Sigurjonsson, Gudmundur F; Lund, Sigrún Helga

    2015-03-01

    A novel product, the fish skin acellular dermal matrix (ADM) has recently been introduced into the family of biological materials for the treatment of wounds. Hitherto, these products have been produced from the organs of livestock. A noninferiority test was used to compare the effect of fish skin ADM against porcine small-intestine submucosa extracellular matrix in the healing of 162 full-thickness 4-mm wounds on the forearm of 81 volunteers. The fish skin product was noninferior at the primary end point, healing at 28 days. Furthermore, the wounds treated with fish skin acellular matrix healed significantly faster. These results might give the fish skin ADM an advantage because of its environmental neutrality when compared with livestock-derived products. The study results on these acute full-thickness wounds might apply for diabetic foot ulcers and other chronic full-thickness wounds, and the shorter healing time for the fish skin-treated group could influence treatment decisions. To test the autoimmune reactivity of the fish skin, the participants were tested with the following ELISA (enzyme-linked immunosorbent assay) tests: RF, ANA, ENA, anti ds-DNA, ANCA, anti-CCP, and anticollagen I and II. These showed no reactivity. The results demonstrate the claims of safety and efficacy of fish skin ADM for wound care. © The Author(s) 2015.

  13. Going to the 'Dogs' to Test Hypotheses.

    ERIC Educational Resources Information Center

    Kramm, Kenneth R.

    1982-01-01

    Describes an alternative method for using live animals in the classroom. A toy dog, the "Trail Tracker Hound Dog" (manufactured by CPG Products Corporation, Cincinnati, Ohio), is used to encourage development of such skills as observation, hypothesis testing, and collection and analysis of scientific data. (Author/JN)

  14. Comparison of Performance of Eight-Year-Old Children on Three Auditory Sequential Memory Tests.

    ERIC Educational Resources Information Center

    Chermak, Gail D.; O'Connell, Vickie I.

    1981-01-01

    Twenty normal children were administered three tests of auditory sequential memory. A Pearson product-moment correlation of .50 and coefficients of determination showed all but one relationship to be nonsignificant and predictability between pairs of scores to be poor. (Author)

  15. 48 CFR 252.235-7003 - Frequency authorization.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Officer during the initial planning, experimental, or developmental phase of contract performance. (c) The... development, production, construction, testing, or operation of a device for which a radio frequency...

  16. 48 CFR 252.235-7003 - Frequency authorization.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Officer during the initial planning, experimental, or developmental phase of contract performance. (c) The... development, production, construction, testing, or operation of a device for which a radio frequency...

  17. 48 CFR 252.235-7003 - Frequency authorization.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Officer during the initial planning, experimental, or developmental phase of contract performance. (c) The... development, production, construction, testing, or operation of a device for which a radio frequency...

  18. Assessment of genotoxicity of herbal medicinal products: application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root).

    PubMed

    Kelber, Olaf; Wegener, Tankred; Steinhoff, Barbara; Staiger, Christiane; Wiesner, Jacqueline; Knöss, Werner; Kraft, Karin

    2014-01-01

    An assessment of genotoxicity is a precondition for marketing authorization respectively registration of herbal medicinal products (HMPs), as well as for inclusion into the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' established by the European Commission in accordance with Directive 2001/83/EC as amended, and based on proposals from the Committee on Herbal Medicinal Products (HMPC). In the 'Guideline on the assessment of genotoxicity of herbal substances/preparations' (EMEA/HMPC/107079/2007) HMPC has described a stepwise approach for genotoxicity testing, according to which the Ames test is a sufficient base for the assessment of genotoxicity in case of an unequivocally negative result. For reducing efforts for testing of individual herbal substances/preparations, HMPC has also developed the 'guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products' (EMEA/HMPC/67644/2009) with the aim to allow testing of a standard range of test materials which could be considered representative of the commonly used preparations from a specific herbal drug according to a 'bracketing/matrixing' approach. The purpose of this paper is to provide data on the practical application of this bracketing and matrixing concept using the example of Valerianae radix, with the intention of facilitating its inclusion in the "Community list". Five extraction solvents, representing the extremes of the polarity range and including also mid-range extraction solvents, were used, covering the entire spectrum of phytochemical constituents of Valerianae radix, thereby including polar and non-polar constituents. Extracts were tested in the Ames test according to all relevant guidelines. Results were unequivocally negative for all extracts. A review of the literature showed that this result is in accordance with the available data, thus demonstrating the lack of a genotoxic potential. In conclusion the two guidelines on genotoxicity provide a practically applicable concept. Valerianae radix has no genotoxic potential, supporting its use in HMPs and its inclusion in the Community list. Copyright © 2014 The Authors. Published by Elsevier GmbH.. All rights reserved.

  19. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Iseki, Tadahiro; Inaba, Makoto; Takahashi, Naoki

    During the second and third steps of Active Test at Rokkasho Reprocessing Plant (RRP), the performances of the Separation Facility have been checked; (A) diluent washing efficiency, (B) plutonium stripping efficiency, (C) decontamination factor of fission products and (D) plutonium and uranium leakage into raffinate and spent solvent. Test results were equivalent to or better than expected. (authors)

  20. 76 FR 480 - Airworthiness Directives; Dassault-Aviation Model FALCON 7X Airplanes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... repetitive functional test of the RAT heater * * *. Non-deployment of the RAT could result in insufficient... Requirements of This Proposed AD This product has been approved by the aviation authority of another country... work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate...

  1. Assessment of different pre-treatment methods for the removal of limonene in citrus waste and their effect on methane potential and methane production rate.

    PubMed

    Ruiz, Begoña; de Benito, Amparo; Rivera, José Daniel; Flotats, Xavier

    2016-12-01

    The objective of this study was to assess the limonene removal efficiency of three pre-treatment methods when applied to citrus waste and to evaluate their effects on the biochemical methane potential and the methane production rate using batch anaerobic tests. The methods tested were based on removal (biological pretreatment by fungi) or recovery (steam distillation and ethanol extraction) of limonene. All the treatments decreased the concentration of limonene in orange peel, with average efficiencies of 22%, 44% and 100% for the biological treatment, steam distillation and ethanol extraction, respectively. By-products from limonene biodegradation by fungi exhibited an inhibitory effect also, not making interesting the biological pretreatment. The methane potential and production rate of the treated orange peel increased significantly after applying the recovery strategies, which separated and recovered simultaneously other inhibitory components of the citrus essential oil. Apart from the high recovery efficiency of the ethanol extraction process, it presented a favourable energy balance. © The Author(s) 2016.

  2. An overview of platelet products (PRP, PRGF, PRF, etc.) in the Iranian studies.

    PubMed

    Raeissadat, Seyed Ahmad; Babaee, Marzieh; Rayegani, Seyed Mansour; Hashemi, Zahra; Hamidieh, Amir Ali; Mojgani, Parviz; Fouladi Vanda, Hossein

    2017-11-01

    The aim of the study was to carry out a review of published studies on various platelet products in Iranian studies. Electronic databases were searched for relevant articles. Two review authors independently extracted data via a tested extraction sheet, and disagreements were resolved by a meeting with a third review author. Bone disorders (25%), wound and fistula (16%), dental and gingival disorders (14%) and osteoarthritis (11%) have more relative frequency based on different fields. The necessity of pursuing standard protocols in the preparation of platelet products, stating the precise content of platelets and growth factors, and long-term follow-up of study subjects were the most important points in Iranian studies.

  3. 9 CFR 130.16 - User fees for veterinary diagnostic serology tests performed at NVSL (excluding FADDL) or at...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false User fees for veterinary diagnostic serology tests performed at NVSL (excluding FADDL) or at authorized sites. 130.16 Section 130.16 Animals... USER FEES § 130.16 User fees for veterinary diagnostic serology tests performed at NVSL (excluding...

  4. 9 CFR 130.17 - User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false User fees for other veterinary... FEES USER FEES § 130.17 User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites. (a) User fees for veterinary diagnostics tests performed at the...

  5. 9 CFR 130.17 - User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false User fees for other veterinary... FEES USER FEES § 130.17 User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites. (a) User fees for veterinary diagnostics tests performed at the...

  6. 9 CFR 130.16 - User fees for veterinary diagnostic serology tests performed at NVSL (excluding FADDL) or at...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false User fees for veterinary diagnostic serology tests performed at NVSL (excluding FADDL) or at authorized sites. 130.16 Section 130.16 Animals... USER FEES § 130.16 User fees for veterinary diagnostic serology tests performed at NVSL (excluding...

  7. Testing mechanistic models of growth in insects.

    PubMed

    Maino, James L; Kearney, Michael R

    2015-11-22

    Insects are typified by their small size, large numbers, impressive reproductive output and rapid growth. However, insect growth is not simply rapid; rather, insects follow a qualitatively distinct trajectory to many other animals. Here we present a mechanistic growth model for insects and show that increasing specific assimilation during the growth phase can explain the near-exponential growth trajectory of insects. The presented model is tested against growth data on 50 insects, and compared against other mechanistic growth models. Unlike the other mechanistic models, our growth model predicts energy reserves per biomass to increase with age, which implies a higher production efficiency and energy density of biomass in later instars. These predictions are tested against data compiled from the literature whereby it is confirmed that insects increase their production efficiency (by 24 percentage points) and energy density (by 4 J mg(-1)) between hatching and the attainment of full size. The model suggests that insects achieve greater production efficiencies and enhanced growth rates by increasing specific assimilation and increasing energy reserves per biomass, which are less costly to maintain than structural biomass. Our findings illustrate how the explanatory and predictive power of mechanistic growth models comes from their grounding in underlying biological processes. © 2015 The Author(s).

  8. Prevalence of nucleic acid sequences specific for human parvoviruses, hepatitis A and hepatitis E viruses in coagulation factor concentrates.

    PubMed

    Modrow, S; Wenzel, J J; Schimanski, S; Schwarzbeck, J; Rothe, U; Oldenburg, J; Jilg, W; Eis-Hübinger, A M

    2011-05-01

    Due to their high resistance to inactivation procedures, nonenveloped viruses such as parvovirus B19, human bocavirus (HBoV), human parvovirus 4 (PARV4), hepatitis A (HAV) and hepatitis E virus (HEV) pose a particular threat to blood products. Virus transmission to patients treated with blood products presents an additional burden to disease. We determined the frequency and the amount of nucleic acid specific for nonenveloped viruses in recently manufactured preparations of commercial coagulation factor concentrates. At least three different batches of each of 13 different plasma-derived and recombinant coagulation factor products were tested for the presence and the amount of nucleic acid for parvovirus B19, HBoV, human parvovirus 4, hepatitis A virus and HEV by using quantitative polymerase chain reaction. Whereas none of the recombinant products tested positive for any of these viruses, parvovirus B19 DNA with amounts ranging between 2×10(1) and 1.3×10(3) genome equivalents/ml was detected in five plasma-derived products. In addition to parvovirus B19 genotype 1, genotypes 2 and 3 were observed in two batches of a factor VIII/von-Willebrand factor product. In two products (one factor VIII concentrate and one activated prothrombin complex concentrate), a combination of both genotypes 1 and 2 of parvovirus B19 was detected. The data show that nucleic acids from several relevant nonenveloped viruses are not found at detectable levels in coagulation factor concentrates. In some cases, parvovirus B19 DNA was detectable at low levels. Testing of the plasma pools for the full range of parvovirus genotypes is advocated for ensuring product safety. © 2010 The Author(s). Vox Sanguinis © 2010 International Society of Blood Transfusion.

  9. Attending to Student Epistemological Framing in a Science Classroom

    ERIC Educational Resources Information Center

    Hutchison, Paul; Hammer, David

    2010-01-01

    Studies of learning in school settings indicate that many students frame activities in science classes as the production of answers for the teacher or test, rather than as making new sense of the natural world. A case study of an episode from a class taught by the first author demonstrates what productive and unproductive student framing can look…

  10. Effect of Subject Types on the Production of Auxiliary "Is" in Young English-Speaking Children

    ERIC Educational Resources Information Center

    Guo, Ling-Yu; Owen, Amanda J.; Tomblin, J. Bruce

    2010-01-01

    Purpose: In this study, the authors tested the unique checking constraint (UCC) hypothesis and the usage-based approach concerning why young children variably use tense and agreement morphemes in obligatory contexts by examining the effect of subject types on the production of auxiliary "is". Method: Twenty typically developing 3-year-olds were…

  11. Value-Added Models and the Measurement of Teacher Productivity. CALDER Working Paper No. 54

    ERIC Educational Resources Information Center

    Harris, Douglas; Sass, Tim; Semykina, Anastasia

    2010-01-01

    Research on teacher productivity, and recently developed accountability systems for teachers, rely on value-added models to estimate the impact of teachers on student performance. The authors test many of the central assumptions required to derive value-added models from an underlying structural cumulative achievement model and reject nearly all…

  12. 21 CFR 570.17 - Exemption for investigational use and procedure for obtaining authorization to market edible...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.17 Exemption for.... Contains a new food additive for investigational use only in laboratory research animals or for tests in... and if the edible products of the animals are to be marketed as food, permission for the marketing of...

  13. 21 CFR 570.17 - Exemption for investigational use and procedure for obtaining authorization to market edible...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.17 Exemption for.... Contains a new food additive for investigational use only in laboratory research animals or for tests in... and if the edible products of the animals are to be marketed as food, permission for the marketing of...

  14. 78 FR 44142 - Modification of Two National Customs Automation Program (NCAP) Tests Concerning Automated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... efforts are accomplished through phased releases of ACE component functionality designed to introduce new... designed to evaluate planned components of the NCAP. This test is authorized pursuant to Sec. 101.9(b) of... import meat, poultry, or egg products or ``Samples for Laboratory Examination, Research, Evaluative...

  15. 40 CFR 89.606 - Inspection and testing of imported nonroad engines.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... engines. (a) In order to allow the Administrator to determine whether an ICI's production nonroad engines... imported by the ICI. The ICI must admit an EPA enforcement officer or authorized representative during... facility where any nonroad engine imported by the ICI under this subpart was or is being modified, tested...

  16. 40 CFR 89.606 - Inspection and testing of imported nonroad engines.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... engines. (a) In order to allow the Administrator to determine whether an ICI's production nonroad engines... imported by the ICI. The ICI must admit an EPA enforcement officer or authorized representative during... facility where any nonroad engine imported by the ICI under this subpart was or is being modified, tested...

  17. 40 CFR 89.606 - Inspection and testing of imported nonroad engines.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... engines. (a) In order to allow the Administrator to determine whether an ICI's production nonroad engines... imported by the ICI. The ICI must admit an EPA enforcement officer or authorized representative during... facility where any nonroad engine imported by the ICI under this subpart was or is being modified, tested...

  18. 40 CFR 89.606 - Inspection and testing of imported nonroad engines.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... engines. (a) In order to allow the Administrator to determine whether an ICI's production nonroad engines... imported by the ICI. The ICI must admit an EPA enforcement officer or authorized representative during... facility where any nonroad engine imported by the ICI under this subpart was or is being modified, tested...

  19. 40 CFR 89.606 - Inspection and testing of imported nonroad engines.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... engines. (a) In order to allow the Administrator to determine whether an ICI's production nonroad engines... imported by the ICI. The ICI must admit an EPA enforcement officer or authorized representative during... facility where any nonroad engine imported by the ICI under this subpart was or is being modified, tested...

  20. 76 FR 33271 - Energy Conservation Program for Consumer Products: Decision and Order Granting a Waiver to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... authorizes the Secretary of Energy to prescribe test procedures that are reasonably designed to produce... conditions is met: (1) The petitioner's basic model contains one or more design characteristics that prevent..., BSH asserts, design characteristics of these models prevent testing according to the currently...

  1. A Query System Implementation Case Study.

    ERIC Educational Resources Information Center

    Hiser, Judith N.; Neil, M. Elizabeth

    1985-01-01

    The Department of Administrative Programming Services of Clemson University investigated products available in user-friendly retrieval systems. The test of INTELLECT, a natural language query system written by Artifical Intelligence Corporation, is described. (Author/MLW)

  2. THAI Multi-Compartment Containment Test Program

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kanzleiter, T.; Poss, G.; Funke, F.

    2006-07-01

    The THAI experimental programme includes combined-effect investigations on thermal hydraulics, hydrogen, and fission product (iodine and aerosols) behaviour in LWR containments under severe accident conditions. An overview on the experiments performed up to now and on the future test program is presented, in combination with a selection of typical results to illustrate the versatility of the test facility and the broad variety of topics investigated. (authors)

  3. Testing therapeutic potency of anticancer drugs in animal studies: a commentary.

    PubMed

    Den Otter, Willem; Steerenberg, Peter A; Van der Laan, Jan Willem

    2002-04-01

    Regulatory authorities for medicines in European countries deal with many applications for admission to the market of anticancer drugs. Each application must be supported by preclinical and clinical data, among which testing of the therapeutic activity of drugs in animals is important. Recently, the Committee for Proprietary Medicinal Products (CPMP) has released a note for guidance on the preclinical evaluation of anticancer medicinal products. This note provides only general statements regarding tests of anticancer drugs in rodents. This stimulates considerations on how to organize and how to evaluate these tests. In this article we describe our considerations regarding these items based on our experience with applications in The Netherlands since 1993. (c) 2002 Elsevier Science (USA).

  4. EMI Standards for Wireless Voice and Data on Board Aircraft

    NASA Technical Reports Server (NTRS)

    Ely, Jay J.; Nguyen, Truong X.

    2002-01-01

    The use of portable electronic devices (PEDs) on board aircraft continues to be an increasing source of misunderstanding between passengers and flight-crews, and consequently, an issue of controversy between wireless product manufacturers and air transport regulatory authorities. This conflict arises primarily because of the vastly different regulatory objectives between commercial product and airborne equipment standards for avoiding electromagnetic interference (EMI). This paper summarizes international regulatory limits and test processes for measuring spurious radiated emissions from commercially available PEDs, and compares them to international standards for airborne equipment. The goal is to provide insight for wireless product developers desiring to extend the freedom of their customers to use wireless products on-board aircraft, and to identify future product characteristics, test methods and technologies that may facilitate improved wireless freedom for airline passengers.

  5. An overview of platelet products (PRP, PRGF, PRF, etc.) in the Iranian studies

    PubMed Central

    Raeissadat, Seyed Ahmad; Babaee, Marzieh; Rayegani, Seyed Mansour; Hashemi, Zahra; Hamidieh, Amir Ali; Mojgani, Parviz; Fouladi Vanda, Hossein

    2017-01-01

    Aim: The aim of the study was to carry out a review of published studies on various platelet products in Iranian studies. Materials & methods: Electronic databases were searched for relevant articles. Two review authors independently extracted data via a tested extraction sheet, and disagreements were resolved by a meeting with a third review author. Results: Bone disorders (25%), wound and fistula (16%), dental and gingival disorders (14%) and osteoarthritis (11%) have more relative frequency based on different fields. Conclusion: The necessity of pursuing standard protocols in the preparation of platelet products, stating the precise content of platelets and growth factors, and long-term follow-up of study subjects were the most important points in Iranian studies. PMID:29134118

  6. Practical experiences with an extended screening strategy for genetically modified organisms (GMOs) in real-life samples.

    PubMed

    Scholtens, Ingrid; Laurensse, Emile; Molenaar, Bonnie; Zaaijer, Stephanie; Gaballo, Heidi; Boleij, Peter; Bak, Arno; Kok, Esther

    2013-09-25

    Nowadays most animal feed products imported into Europe have a GMO (genetically modified organism) label. This means that they contain European Union (EU)-authorized GMOs. For enforcement of these labeling requirements, it is necessary, with the rising number of EU-authorized GMOs, to perform an increasing number of analyses. In addition to this, it is necessary to test products for the potential presence of EU-unauthorized GMOs. Analysis for EU-authorized and -unauthorized GMOs in animal feed has thus become laborious and expensive. Initial screening steps may reduce the number of GMO identification methods that need to be applied, but with the increasing diversity also screening with GMO elements has become more complex. For the present study, the application of an informative detailed 24-element screening and subsequent identification strategy was applied in 50 animal feed samples. Almost all feed samples were labeled as containing GMO-derived materials. The main goal of the study was therefore to investigate if a detailed screening strategy would reduce the number of subsequent identification analyses. An additional goal was to test the samples in this way for the potential presence of EU-unauthorized GMOs. Finally, to test the robustness of the approach, eight of the samples were tested in a concise interlaboratory study. No significant differences were found between the results of the two laboratories.

  7. Sensory analysis of characterising flavours: evaluating tobacco product odours using an expert panel.

    PubMed

    Krüsemann, Erna J Z; Lasschuijt, Marlou P; de Graaf, C; de Wijk, René A; Punter, Pieter H; van Tiel, Loes; Cremers, Johannes W J M; van de Nobelen, Suzanne; Boesveldt, Sanne; Talhout, Reinskje

    2018-05-23

    Tobacco flavours are an important regulatory concept in several jurisdictions, for example in the USA, Canada and Europe. The European Tobacco Products Directive 2014/40/EU prohibits cigarettes and roll-your-own tobacco having a characterising flavour. This directive defines characterising flavour as 'a clearly noticeable smell or taste other than one of tobacco […]'. To distinguish between products with and without a characterising flavour, we trained an expert panel to identify characterising flavours by smelling. An expert panel (n=18) evaluated the smell of 20 tobacco products using self-defined odour attributes, following Quantitative Descriptive Analysis. The panel was trained during 14 attribute training, consensus training and performance monitoring sessions. Products were assessed during six test sessions. Principal component analysis, hierarchical clustering (four and six clusters) and Hotelling's T-tests (95% and 99% CIs) were used to determine differences and similarities between tobacco products based on odour attributes. The final attribute list contained 13 odour descriptors. Panel performance was sufficient after 14 training sessions. Products marketed as unflavoured that formed a cluster were considered reference products. A four-cluster method distinguished cherry-flavoured, vanilla-flavoured and menthol-flavoured products from reference products. Six clusters subdivided reference products into tobacco leaves, roll-your-own and commercial products. An expert panel was successfully trained to assess characterising odours in cigarettes and roll-your-own tobacco. This method could be applied to other product types such as e-cigarettes. Regulatory decisions on the choice of reference products and significance level are needed which directly influences the products being assessed as having a characterising odour. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Adolescent Reasoning about Advertisements: Preliminary Investigations.

    ERIC Educational Resources Information Center

    Linn, Marcia C.; And Others

    1982-01-01

    Three studies investigate the role of competence factors (defined as acquisition of Piagetian formal reasoning) and performance factors (defined as influences from content and expectations) with respect to adolescents' reasoning about advertisements reporting product tests. (Author/MP)

  9. SMART operational field test evaluation : operations database report : final report

    DOT National Transportation Integrated Search

    1997-09-01

    Based on the Suburban Mobility Authority For Regional Transportations (SMART) weekly operating reports from its Macomb, Wayne, Troy, and Pontiac terminals, this Operations Database Report explores productivity measures over time, and examines how ...

  10. P-8A Poseidon Multi-Mission Maritime Aircraft (P-8A)

    DTIC Science & Technology

    2013-12-01

    NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND...2013 rated the P-8A as operationally effective , operationally suitable, and recommended Fleet introduction. Integrated testing of deficiency...lot through effective negotiations with the prime contractor and through development and implementation of production process improvement

  11. Perovskite Solar Cell Stability Workshop: Quick Look Report

    DTIC Science & Technology

    2016-08-12

    Commercialization of Perovskite PV – Markets, Concerns, Opportunities” by Dirk Weiss, First Solar , USA j. “Expectations for PV Product Testing Today” by Sarah...Perovskite Solar Cell Stability Workshop Quick-Look Report Held by the Office of Naval Research at University...Workshop Summary, 11-12 Aug 2016 4. TITLE AND SUBTITLE Perovskite Solar Cell Stability Workshop: Quick-Look Report 5. FUNDING NUMBERS 6. AUTHOR(S

  12. Air contamination in the sclerosing foam for the treatment of varicose veins.

    PubMed

    de Franciscis, S; Nobile, Cga; Larosa, E; Montemurro, R; Serra, R

    2016-03-01

    Fluids and drugs formulated for intravenous infusion may potentially promote the growth of microorganisms that can cause infections. The aim of this study is to test the sterility of sclerosing foam. Polidocanol was used for the production of the foam. The Tessari method was used in order to generate the foam. The preparation was carried out both in the operating theater and in an outpatient room. A validation test with microorganisms was also performed. The measurements showed no evident growth of microorganisms and in the validation tests the foam appeared to even display bacteriostatic and/or bactericide properties. Sclerosing foam seems to be safe from a microbiological point of view. © The Author(s) 2014.

  13. Production test IP-544-A, irradiation of 1.6% enriched thick walled single tube elements in KER-1 and 2

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kratzer, W.K.; Wise, M.J.

    1962-12-12

    The objective of this production test is to authorize the irradiation of coextruded Zr-2 jacketed thick walled 1.6% enriched tubular elements in KER loops 1 and 2 to evaluate the swelling behavior of fuel elements at high uranium temperatures Coextruded Zr-2 jacketed 1.6% enriched tubular fuel elements 1.79 inch OD, 0.97 inch ID, and 12 inches long will be irradiated KER loops 1 and 2 to exposures no greater than 2500 MWD/T.

  14. Saving two birds with one stone: using active substance avian acute toxicity data to predict formulated plant protection product toxicity.

    PubMed

    Maynard, Samuel K; Edwards, Peter; Wheeler, James R

    2014-07-01

    Environmental safety assessments for exposure of birds require the provision of acute avian toxicity data for both the pesticidal active substance and formulated products. As an example, testing on the formulated product is waived in Europe using an assessment of data for the constituent active substance(s). This is often not the case globally, because some countries require acute toxicity tests with every formulated product, thereby triggering animal welfare concerns through unnecessary testing. A database of 383 formulated products was compiled from acute toxicity studies conducted with northern bobwhite (Colinus virginianus) or Japanese quail (Coturnix japonica) (unpublished regulatory literature). Of the 383 formulated products studied, 159 contained only active substances considered functionally nontoxic (median lethal dose [LD50] > highest dose tested). Of these, 97% had formulated product LD50 values of >2000 mg formulated product/kg (limit dose), indicating that no new information was obtained in the formulated product study. Furthermore, defined (point estimated) LD50 values for formulated products were compared with LD50 values predicted from toxicity of the active substance(s). This demonstrated that predicted LD50 values were within 2-fold and 5-fold of the measured formulated product LD50 values in 90% and 98% of cases, respectively. This analysis demonstrates that avian acute toxicity testing of formulated products is largely unnecessary and should not be routinely required to assess avian acute toxicity. In particular, when active substances are known to be functionally nontoxic, further formulated product testing adds no further information and unnecessarily increases bird usage in testing. A further analysis highlights the fact that significant reductions (61% in this dataset) could be achieved by using a sequential testing design (Organisation for Economic Co-operation and Development test guideline 223), as opposed to established single-stage designs. © 2014 The Authors.

  15. Kid Categories: A Comparison of the Category Productions of LSES and MSES Elementary School Children

    ERIC Educational Resources Information Center

    Williams, Rihana S.; Terry, Nicole Patton; Metzger, Isha

    2013-01-01

    The current study compares the productivity (number of responses) and the typical responses to taxonomic and slot-filler prompts in 39 African American children from low-income backgrounds and a diverse group of 21 children from middle-income backgrounds. The authors tested the hypothesis that socioeconomic status would exert a global influence on…

  16. Ultrasonic-Based Nondestructive Evaluation Methods for Wood: A Primer and Historical Review

    Treesearch

    Adam C. Senalik; Greg Schueneman; Robert J. Ross

    2014-01-01

    The authors conducted a review of ultrasonic testing and evaluation of wood and wood products, starting with a description of basic ultrasonic inspection setups and commonly used equations. The literature review primarily covered wood research presented between 1965 and 2013 in the Proceedings of the Nondestructive Testing of Wood Symposiums. A table that lists the...

  17. 9 CFR 147.8 - Procedures for preparing egg yolk samples for diagnostic tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Procedures for preparing egg yolk... IMPROVEMENT PLAN Blood Testing Procedures § 147.8 Procedures for preparing egg yolk samples for diagnostic... chapter. (a) Under the supervision of an Authorized Agent or State Inspector, the eggs which are used in...

  18. Simon Fraser University's New Interactive Learning System to Teach French as a Second Language.

    ERIC Educational Resources Information Center

    Kirchner, Glenn

    1988-01-01

    Provides an overview of the design, production, and preliminary testing of a microcomputer-controlled interactive learning workstation developed at Simon Fraser University to teach French as a Second Language. Criteria and guidelines are discussed; the authoring system is explained; and field testing with grades four through seven is described.…

  19. 9 CFR 130.15 - User fees for veterinary diagnostic isolation and identification tests performed at NVSL...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false User fees for veterinary diagnostic isolation and identification tests performed at NVSL (excluding FADDL) or other authorized site. 130.15... AGRICULTURE USER FEES USER FEES § 130.15 User fees for veterinary diagnostic isolation and identification...

  20. 9 CFR 130.15 - User fees for veterinary diagnostic isolation and identification tests performed at NVSL...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false User fees for veterinary diagnostic isolation and identification tests performed at NVSL (excluding FADDL) or other authorized site. 130.15... AGRICULTURE USER FEES USER FEES § 130.15 User fees for veterinary diagnostic isolation and identification...

  1. Use a rabbit or a rhino to sell a carrot? The effect of character-product congruence on children's liking of healthy foods.

    PubMed

    de Droog, Simone M; Buijzen, Moniek; Valkenburg, Patti M

    2012-01-01

    This study investigated whether unfamiliar characters are as effective as familiar characters in stimulating children's affective responses toward healthy foods. In particular, the authors investigated whether an unfamiliar character which is congruent with a product can be as effective as a familiar character. The authors tested 2 types of character-product congruence: conceptual congruence (on the basis of a familiar link), and perceptual congruence (on the basis of color similarity). In a repeated measures design, 166 children (4-6 years old) were exposed to a picture of a carrot combined randomly with 5 different types of character: an (incongruent) familiar character and four unfamiliar characters varying in character-product congruence (i.e., both conceptually and perceptually congruent, conceptual only, perceptual only, and incongruent). The authors measured children's automatic affective responses toward these character-product combinations using a time-constrained task, and elaborate affective responses using a nonconstrained task. Results revealed that the conceptually congruent unfamiliar characters were just as effective as the familiar character in increasing children's automatic affective responses. However, the familiar character triggered the most positive elaborate affective responses. Results are explained in light of processing fluency and parasocial relationship theories.

  2. As the pendulum swings--medical products class actions litigation in Canada: recent developments.

    PubMed

    Pliszka, Peter J; Armstrong, Sarah J

    2013-03-01

    During the relatively short history of class proceedings in Canada, developers and manufacturers of medical devices and pharmaceuticals ("medical products"), including medical products designed for patients with diabetes, have found themselves at the receiving end of a significant number of class action claims. As a result, medical products litigation has become the battleground for some of the most significant developments in Canadian class actions law. This article provides a broad overview of some of the most significant developments. The authors pay particular attention to developments regarding the test for class action certification and consider whether high-profile dismissals of certification motions represent a trend toward raising the threshold for plaintiffs seeking to obtain certification of a proposed class action. The authors also consider a decision arising out of a lengthy class action common issues trial in which the medical device company was victorious. In the authors' view, the class action pendulum in Canada, particularly as it relates to medical products claims, remains in motion. It behooves all affected players to keep their eye on this ball with rapt attention to see where it may move next. © 2013 Diabetes Technology Society.

  3. Ex vivo effectiveness of French over-the-counter products against head lice (Pediculus humanus capitis De Geer, 1778).

    PubMed

    Combescot-Lang, Catherine; Vander Stichele, Robert H; Toubate, Berthine; Veirron, Emilie; Mumcuoglu, Kosta Y

    2015-05-01

    Head lice infestation is still a public health problem worldwide, with an intracountry and intercountry prevalence variation of 0.7 to 59%. There is a large variety of over-the-counter anti-louse products, but their efficacy is not always well assessed. Our objective was to test the pediculicidal and ovicidal efficacy of 21 over-the-counter head louse products, available in France during the period of 2008 to 2012. We tested children living in Tours City in central France and visiting preschools, primary schools, kindergarten, camps, and child care facilities, as well as children in their family houses, and were examined for the presence of lice. The products were collected from randomly selected pharmacies by covert investigators and then tested in the laboratory on an ex vivo sample of head lice and their eggs, collected from the hair of infested children. Living lice and unharmed eggs were collected from the scalps of 3-12 years old. The laboratory conditions for ex vivo testing mimicked the manufacturers' instructions for exposure time and application method. In 21 runs, 3919 living lice and 4321 undamaged living eggs were collected from the scalp of over 400 children. The 21 products were classified in three groups: 6 products in a group of potentially 100% pediculicidal activity and potentially 100% ovicidal activity, 8 products in a group of potentially 100% pediculicidal activity but insufficient ovicidal activity (including 2 products with claims of single application treatment), and 7 products in a group of insufficient pediculicidal activity and ovicidal activity. The pharmaceutical market for head lice products in France is swamped with poorly tested and ineffective products. Rigorous efficacy testing preregistration and periodic screening and testing of effectiveness in the post-registration period should be endorsed by the health authorities.

  4. Introduction of the 2007-2008 JOGMEC/NRCan/Aurora Mallik Gas Hydrate Production Research Program, NWT, Canada

    NASA Astrophysics Data System (ADS)

    Yamamoto, K.; Dallimore, S. R.; Numasawa, M.; Yasuda, M.; Fujii, T.; Fujii, K.; Wright, J.; Nixon, F.

    2007-12-01

    Japan Oil, Gas and Metals National Corporation (JOGMEC) and Natural Resource Canada (NRCan) have embarked on a new research program to study the production potential of gas hydrates. The program is being carried out at the Mallik gas hydrate field in the Mackenzie Delta, a location where two previous scientific investigations have been carried in 1998 and 2002. In the 2002 program that was undertaken by seven partners from five countries, 468m3 of gas flow was measured during 124 hours of thermal stimulation using hot warm fluid. Small-scale pressure drawdown tests were also carried out using Schlumberger's Modular Dynamics Tester (MDT) wireline tool, gas flow was observed and the inferred formation permeabilities suggested the possible effectiveness of the simple depressurization method. While the testing undertaken in 2002 can be cited as the first well constrained gas production from a gas hydrate deposit, the results fell short of that required to fully calibrate reservoir simulation models or indeed establish the technical viability of long term production from gas hydrates. The objectives of the current JOGMEC/NRCan/Aurora Mallik production research program are to undertake longer term production testing to further constrain the scientific unknowns and to demonstrate the technical feasibility of sustained gas hydrate production using the depressurization method. A key priority is to accurately measure water and gas production using state-of-art production technologies. The primary production test well was established during the 2007 field season with the re-entry and deepening of JAPEX/JNOC/GSC Mallik 2L-38 well, originally drilled in 1998. Production testing was carried out in April of 2007 under a relatively low drawdown pressure condition. Flow of methane gas was measured from a 12m perforated interval of gas-hydrate-saturated sands from 1093 to 1105m. The results establish the potential of the depressurization method and provide a basis for future prolonged testing planned in the near future. The authors acknowledge the Research Consortium for Methane Hydrate Resources in Japan (MH21), the Ministry of Economy, Trade and Industry (METI) and NRCan for the support and funding. The Mallik 2002 program was undertaken jointly by JNOC, NRCan, GeoForschungsZentrum Potsdam (GFZ), the United State Geological Survey (USGS), the United States Department of Energy (USDOE), the India Ministry of Petroleum and Natural Gas (MOPNG)-Gas Authority of India (GAIL), and the BP-Chevron Texaco Mackenzie Delta Joint Venture.

  5. A novel hybrid tobacco product that delivers a tobacco flavour note with vapour aerosol (Part 2): In vitro biological assessment and comparison with different tobacco-heating products.

    PubMed

    Breheny, Damien; Adamson, Jason; Azzopardi, David; Baxter, Andrew; Bishop, Emma; Carr, Tony; Crooks, Ian; Hewitt, Katherine; Jaunky, Tomasz; Larard, Sophie; Lowe, Frazer; Oke, Oluwatobiloba; Taylor, Mark; Santopietro, Simone; Thorne, David; Zainuddin, Benjamin; Gaça, Marianna; Liu, Chuan; Murphy, James; Proctor, Christopher

    2017-08-01

    This study assessed the toxicological and biological responses of aerosols from a novel hybrid tobacco product. Toxicological responses from the hybrid tobacco product were compared to those from a commercially available Tobacco Heating Product (c-THP), a prototype THP (p-THP) and a 3R4F reference cigarette, using in vitro test methods which were outlined as part of a framework to substantiate the risk reduction potential of novel tobacco and nicotine products. Exposure matrices used included total particulate matter (TPM), whole aerosol (WA), and aqueous aerosol extracts (AqE) obtained after machine-puffing the test products under the Health Canada Intense smoking regime. Levels of carbonyls and nicotine in these matrices were measured to understand the aerosol dosimetry of the products. The hybrid tobacco product tested negative across the in vitro assays including mutagenicity, genotoxicity, cytotoxicity, tumour promotion, oxidative stress and endothelial dysfunction. All the THPs tested demonstrated significantly reduced responses in these in vitro assays when compared to 3R4F. The findings suggest these products have the potential for reduced health risks. Further pre-clinical and clinical assessments are required to substantiate the risk reduction of these novel products at individual and population levels. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. Brief report on the United States Food and Drug Administration Blood Products Advisory Committee recommendations for management of donors and units testing positive for hepatitis B virus DNA.

    PubMed

    Lucey, C

    2006-11-01

    This article briefly recounts the 21st July 2005, Blood Products Advisory Committee (BPAC) meeting concerning recommendations for management of donors and units testing positive for hepatitis B virus (HBV) DNA. The author attended the meeting. The United States Food and Drug Administration (FDA) web site was used for meeting materials, and handouts were collected at the meeting to provide narrative information. Two European experts assisted with HBV subject matter. The proceedings of the advisory committee, the issue briefing materials, and testing algorithms are presented. BPAC voted concurrence with the FDA algorithm for Management of Donors and Units Testing Positive for Hepatitis B Virus DNA.

  7. Development of an agricultural biotechnology crop product: testing from discovery to commercialization.

    PubMed

    Privalle, Laura S; Chen, Jingwen; Clapper, Gina; Hunst, Penny; Spiegelhalter, Frank; Zhong, Cathy X

    2012-10-17

    "Genetically modified" (GM) or "biotech" crops have been the most rapidly adopted agricultural technology in recent years. The development of a GM crop encompasses trait identification, gene isolation, plant cell transformation, plant regeneration, efficacy evaluation, commercial event identification, safety evaluation, and finally commercial authorization. This is a lengthy, complex, and resource-intensive process. Crops produced through biotechnology are the most highly studied food or food component consumed. Before commercialization, these products are shown to be as safe as conventional crops with respect to feed, food, and the environment. This paper describes this global process and the various analytical tests that must accompany the product during the course of development, throughout its market life, and beyond.

  8. Caregivers' interest in using smokeless tobacco products: Novel methods that may reduce children's exposure to secondhand smoke.

    PubMed

    Wagener, Theodore L; Tackett, Alayna P; Borrelli, Belinda

    2016-10-01

    The study examined caregivers' interest in using potentially reduced exposure tobacco products for smoking cessation, reduction, and to help them not smoke in places such as around their child, as all three methods would potentially lead to reduced secondhand smoke exposure for their children. A sample of 136 caregivers completed carbon monoxide testing to assess smoking status and a brief survey. Few caregivers had ever used potentially reduced exposure tobacco products (<1%), but a majority were interested in trying them as means of smoking reduction (54%), to quit/stay quit from smoking (51%), and to help them not smoke around their child or in the home (55%). Caregivers less motivated to quit smoking and with no home smoking ban were more interested in using potentially reduced exposure tobacco products to help them quit/stay quit from smoking (p < .05). © The Author(s) 2015.

  9. Corrosion Assessment of Steel Bars Used in Reinforced Concrete Structures by Means of Eddy Current Testing

    PubMed Central

    de Alcantara, Naasson P.; da Silva, Felipe M.; Guimarães, Mateus T.; Pereira, Matheus D.

    2015-01-01

    This paper presents a theoretical and experimental study on the use of Eddy Current Testing (ECT) to evaluate corrosion processes in steel bars used in reinforced concrete structures. The paper presents the mathematical basis of the ECT sensor built by the authors; followed by a finite element analysis. The results obtained in the simulations are compared with those obtained in experimental tests performed by the authors. Effective resistances and inductances; voltage drops and phase angles of wound coil are calculated using both; simulated and experimental data; and demonstrate a strong correlation. The production of samples of corroded steel bars; by using an impressed current technique is also presented. The authors performed experimental tests in the laboratory using handmade sensors; and the corroded samples. In the tests four gauges; with five levels of loss-of-mass references for each one were used. The results are analyzed in the light of the loss-of-mass and show a strong linear behavior for the analyzed parameters. The conclusions emphasize the feasibility of the proposed technique and highlight opportunities for future works. PMID:26712754

  10. Corrosion Assessment of Steel Bars Used in Reinforced Concrete Structures by Means of Eddy Current Testing.

    PubMed

    de Alcantara, Naasson P; da Silva, Felipe M; Guimarães, Mateus T; Pereira, Matheus D

    2015-12-24

    This paper presents a theoretical and experimental study on the use of Eddy Current Testing (ECT) to evaluate corrosion processes in steel bars used in reinforced concrete structures. The paper presents the mathematical basis of the ECT sensor built by the authors; followed by a finite element analysis. The results obtained in the simulations are compared with those obtained in experimental tests performed by the authors. Effective resistances and inductances; voltage drops and phase angles of wound coil are calculated using both; simulated and experimental data; and demonstrate a strong correlation. The production of samples of corroded steel bars; by using an impressed current technique is also presented. The authors performed experimental tests in the laboratory using handmade sensors; and the corroded samples. In the tests four gauges; with five levels of loss-of-mass references for each one were used. The results are analyzed in the light of the loss-of-mass and show a strong linear behavior for the analyzed parameters. The conclusions emphasize the feasibility of the proposed technique and highlight opportunities for future works.

  11. The botulinum neurotoxin LD50 test - problems and solutions.

    PubMed

    Bitz, Silke

    2010-01-01

    Apart from the fact that the LD50 test is generally considered a procedure causing severe distress, which alone should result in its immediate deletion, it also conflicts with the EU wide ban on cosmetic testing in animals in the case of Botulinum Neurotoxin (BoNT) testing. The European Pharmacopoeia monograph allows for the use of three alternative methods provided they are validated. However these alternative assays are neither implemented by the manufactures of BoNT products nor are they enforced by the responsible authorities, e.g. by deleting the LD50 from the European Pharmacopoeia. The number of animals used for the testing of BoNT is not officially recorded. However, data from an undercover investigation allow the estimation that the number of mice used in LD50tests for BoNT products is greater than 600,000 per year worldwide.

  12. Design of clinical trials for therapeutic cancer vaccines development.

    PubMed

    Mackiewicz, Jacek; Mackiewicz, Andrzej

    2009-12-25

    Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.

  13. Pyrogen tests of infusions, blood anticoagulant solutions, plastic materials and rubber products.

    PubMed

    Pintér, J; Zsdánszky, C; Györffy, G

    1977-01-01

    The methods of the pyrogen test in rabbit as adopted by the authors are presented. The test includes positive and negative controls. The conditions of using the same rabbits on two consecutive days are discussed. Methods of sampling of sterile infusions and the preparation for pyrogen test of anticoagulant solutions containing citrate, phosphate and/or edetate ions are presented. The necessity of pyrogen control of distilled water is stressed. Attention is called on the importance of testing for pyrogenicity of the plastic materials and the rubber-wares to be applied during the production of anticoagulant solutions and infusions. A pyrogen test highly sensitive for detecting traces of detergent is applied for washed glassware. It is emphasized that sensitive pyrogen tests are indispensable not only when new derivatives are being introduced, but also during routine control, because occasional changes in the manufacturer's technology may sometimes be demonstrable in this way.

  14. [The principle of registration, evaluation and testing of disinfecting preparations].

    PubMed

    Röhm-Rodowald, Ewa; Jakimiak, Bozenna; Podgórska, Marta

    2008-01-01

    Disinfectants are used to produce a state in which the number of living micro-organisms has been reduced to a level which is appropriate to the practical situation. For any products which are included in the Biocidal Directive 98/8/EC, for which specific activity is claimed, test data has to be approved by the regulatory authority and a product license obtained before the product can be offered for sale. Disinfectants can be recorded as biocidal products or medical devices. Presently, it is possible to measure the activity of a product on defined micro-organisms in specified experimental conditions. Efficacy is the result of the use of a product according to a defined application. To allow different requirements in different areas of application, separate tests and pass criteria have been or will be prepared for each of following three areas of application: medical, veterinary and group comprising food, industrial, domestic and institutional areas. The laboratory methods to be used for testing the activity of chemical disinfectants meets the European standards. The tests are categorised on a modular basis as follows: phase 1 tests, phase 2 step 1 tests, phase 2 step 2 tests and phase 3 tests. In order to claim that a product has disinfectant properties, suitable for use in the medical area, the product shall be tested according to European standards: phase 2 step 1 tests, phase 2 step 2 tests. Phase 1 tests are not required to support claims for chemical disinfectants used in human medicine. Only phase 1 tests are required to support claims for active substances for which no particular area of application is specified. Medical devices are subjects to the European Directive 93/42/EEC which requires that a product must carry a CE mark. Disinfectants which are intended specifically by its manufacturer to be used on medical devices are themselves medical devices and so these products, as well as conforming to the instrument disinfection European standards as specified in EN 14885, are also required to carry a CE mark.

  15. Characteristics of the organic fraction of municipal solid waste and methane production: A review.

    PubMed

    Campuzano, Rosalinda; González-Martínez, Simón

    2016-08-01

    Anaerobic digestion of the organic fraction of municipal solid waste (OFMSW) is a viable alternative for waste stabilization and energy recovery. Biogas production mainly depends on the type and amount of organic macromolecules. Based on results from different authors analysing OFMSW from different cities, this paper presents the importance of knowing the OFMSW composition to understand how anaerobic digestion can be used to produce methane. This analysis describes and discusses physical, chemical and bromatological characteristics of OFMSW reported by several authors from different countries and cities and their relationship to methane production. The main conclusion is that the differences are country and not city dependant. Cultural habits and OFMSW management systems do not allow a generalisation but the individual analysis for specific cities allow understanding the general characteristics for a better methane production. Not only are the OFMSW characteristics important but also the conditions under which the methane production tests were performed. Copyright © 2016. Published by Elsevier Ltd.

  16. Vicious circles of gender bias, lower positions, and lower performance: Gender differences in scholarly productivity and impact

    PubMed Central

    Sandström, Ulf

    2017-01-01

    It is often argued that female researchers publish on average less than male researchers do, but male and female authored papers have an equal impact. In this paper we try to better understand this phenomenon by (i) comparing the share of male and female researchers within different productivity classes, and (ii) by comparing productivity whereas controlling for a series of relevant covariates. The study is based on a disambiguated Swedish author dataset, consisting of 47,000 researchers and their WoS-publications during the period of 2008-2011 with citations until 2015. As the analysis shows, in order to have impact quantity does make a difference for male and female researchers alike—but women are vastly underrepresented in the group of most productive researchers. We discuss and test several possible explanations of this finding, using a data on personal characteristics from several Swedish universities. Gender differences in age, authorship position, and academic rank do explain quite a part of the productivity differences. PMID:28841666

  17. Vicious circles of gender bias, lower positions, and lower performance: Gender differences in scholarly productivity and impact.

    PubMed

    van den Besselaar, Peter; Sandström, Ulf

    2017-01-01

    It is often argued that female researchers publish on average less than male researchers do, but male and female authored papers have an equal impact. In this paper we try to better understand this phenomenon by (i) comparing the share of male and female researchers within different productivity classes, and (ii) by comparing productivity whereas controlling for a series of relevant covariates. The study is based on a disambiguated Swedish author dataset, consisting of 47,000 researchers and their WoS-publications during the period of 2008-2011 with citations until 2015. As the analysis shows, in order to have impact quantity does make a difference for male and female researchers alike-but women are vastly underrepresented in the group of most productive researchers. We discuss and test several possible explanations of this finding, using a data on personal characteristics from several Swedish universities. Gender differences in age, authorship position, and academic rank do explain quite a part of the productivity differences.

  18. Lead-contaminated imported tamarind candy and children's blood lead levels.

    PubMed

    Lynch, R A; Boatright, D T; Moss, S K

    2000-01-01

    In 1999, an investigation implicated tamarind candy as the potential source of lead exposure for a child with a significantly elevated blood lead level (BLL). The Oklahoma City-County Health Department tested two types of tamarind suckers and their packaging for lead content. More than 50% of the tested suckers exceeded the US Food and Drug Administration (FDA) Level of Concern for lead in this type of product. The authors calculated that a child consuming one-quarter to one-half of either of the two types of suckers in a day would exceed the maximum FDA Provis onal Tolerable Intake for lead. High lead concentrations in the two types of wrappers suggested leaching as a potential source of contamination. The authors used the Environmental Protection Agency's Integrated Exposure Uptake Biokinetic (IEUBK) model to predict the effects of consumption of contaminated tamarind suckers on populat on BLLs. The IEUBK model predicted that consumption of either type of sucker at a rate of one per day would result in dramatic increases in mean BLLs for children ages 6-84 months in Oklahoma and in the percentage of children wth elevated BLLs (> or =10 micrograms per deciliter [microg/dL]). The authors conclude that consumption of these products represents a potential public health threat. In addition, a history of lead contamination in imported tamarind products suggests that import control measures may not be completely effective in preventing additional lead exposure.

  19. The positive and negative consequences of multiple-choice testing.

    PubMed

    Roediger, Henry L; Marsh, Elizabeth J

    2005-09-01

    Multiple-choice tests are commonly used in educational settings but with unknown effects on students' knowledge. The authors examined the consequences of taking a multiple-choice test on a later general knowledge test in which students were warned not to guess. A large positive testing effect was obtained: Prior testing of facts aided final cued-recall performance. However, prior testing also had negative consequences. Prior reading of a greater number of multiple-choice lures decreased the positive testing effect and increased production of multiple-choice lures as incorrect answers on the final test. Multiple-choice testing may inadvertently lead to the creation of false knowledge.

  20. Critical attributes of transdermal drug delivery system (TDDS)--a generic product development review.

    PubMed

    Ruby, P K; Pathak, Shriram M; Aggarwal, Deepika

    2014-11-01

    Bioequivalence testing of transdermal drug delivery systems (TDDS) has always been a subject of high concern for generic companies due to the formulation complexity and the fact that they are subtle to even minor manufacturing differences and hence should be clearly qualified in terms of quality, safety and efficacy. In recent times bioequivalence testing of transdermal patches has gained a global attention and many regulatory authorities worldwide have issued recommendations to set specific framework for demonstrating equivalence between two products. These current regulatory procedures demand a complete characterization of the generic formulation in terms of its physicochemical sameness, pharmacokinetics disposition, residual content and/or skin irritation/sensitization testing with respect to the reference formulation. This paper intends to highlight critical in vitro tests in assessing the therapeutic equivalence of products and also outlines their valuable applications in generic product success. Understanding these critical in vitro parameters can probably help to decode the complex bioequivalence outcomes, directing the generic companies to optimize the formulation design in reduced time intervals. It is difficult to summarize a common platform which covers all possible transdermal products; hence few case studies based on this approach has been presented in this review.

  1. Randomized controlled study of a cosmetic treatment for mild acne.

    PubMed

    Capitanio, B; Sinagra, J L; Weller, R B; Brown, C; Berardesca, E

    2012-06-01

    Cosmetic products are not tested with the same rigour as medical treatments, but recent high-quality studies have shown significant reductions in changes of skin ageing with use of cosmetic antiageing products. To test whether a cosmetic 'anti-spot' two-step treatment containing a complex of seaweed-derived oligosaccharide and zinc would produce a significant improvement in mild acne. A double-blind, vehicle-controlled trial of this treatment was performed for 8 weeks on 60 age-matched participants with mild acne. They were divided into two groups: 30 participants were treated with vehicle control and 30 with the active treatment containing a seaweed-derived oligosaccharide complexed with 0.1% zinc pyrrolidone. After 8 weeks, both groups had a reduction in comedones, papules and pustules, and this was significantly greater in the active than control group at 2, 4 and 8 weeks. Cosmetic products may offer some benefit for mild acne and still meet the requirements of the European Cosmetic Directive. In particular, the seaweed-derived oligosaccharide complexed with 0.1% zinc pyrrolidone used in this study produced a significant reduction in acne vs. a control treatment. Cosmetic companies should conduct blinded controlled trials of their product's efficacy and publish the results. © The Author(s). CED © 2012 British Association of Dermatologists.

  2. [Batch release of immunoglobulin and monoclonal antibody products].

    PubMed

    Gross, S

    2014-10-01

    The Paul-Ehrlich Institute (PEI) is an independent institution of the Federal Republic of Germany responsible for performing official experimental batch testing of sera. The institute decides about the release of each batch and performs experimental research in the field. The experimental quality control ensures the potency of the product and also the absence of harmful impurities. For release of an immunoglobulin batch the marketing authorization holder has to submit the documentation of the manufacture and the results of quality control measures together with samples of the batch to the PEI. Experimental testing is performed according to the approved specifications regarding the efficacy and safety. Since implementation of the 15th German drug law amendment, the source of antibody is not defined anymore. According to § 32 German drug law, all batches of sera need to be released by an official control laboratory. Sera are medicinal products, which contain antibodies, antibody fragments or fusion proteins with a functional antibody portion. Therefore, all batches of monoclonal antibodies and derivatives must also be released by the PEI and the marketing authorization holder has to submit a batch release application. Under certain circumstances a waiver for certain products can be issued with regard to batch release. The conditions for such a waiver apply to the majority of monoclonal antibodies.

  3. The evolution of floral scent and olfactory preferences in pollinators: coevolution or pre-existing bias?

    PubMed

    Schiestl, Florian P; Dötterl, Stefan

    2012-07-01

    Coevolution is thought to be a major factor in shaping plant-pollinator interactions. Alternatively, plants may have evolved traits that fitted pre-existing preferences or morphologies in the pollinators. Here, we test these two scenarios in the plant family of Araceae and scarab beetles (Coleoptera, Scarabaeidae) as pollinators. We focused on floral volatile organic compounds (VOCs) and production/detection of VOCs by scarab beetles. We found phylogenetic structure in the production/detection of methoxylated aromatics in scarabs, but not plants. Within the plants, most of the compounds showed a well-supported pattern of correlated evolution with scarab-beetle pollination. In contrast, the scarabs showed no correlation between VOC production/detection and visitation to Araceae flowers, with the exception of the VOC skatole. Moreover, many VOCs were found in nonpollinating beetle groups (e.g., Melolonthinae) that are ancestors of pollinating scarabs. Importantly, none of the tested VOCs were found to have originated in pollinating taxa. Our analysis indicates a Jurassic origin of VOC production/detection in scarabs, but a Cretaceous/Paleocene origin of floral VOCs in plants. Therefore, we argue against coevolution, instead supporting the scenario of sequential evolution of floral VOCs in Araceae driven by pre-existing bias of pollinators. © 2012 The Author(s).

  4. Above- and below-ground effects of plant diversity depend on species origin: an experimental test with multiple invaders.

    PubMed

    Kuebbing, Sara E; Classen, Aimée T; Sanders, Nathan J; Simberloff, Daniel

    2015-11-01

    Although many plant communities are invaded by multiple nonnative species, we have limited information on how a species' origin affects ecosystem function. We tested how differences in species richness and origin affect productivity and seedling establishment. We created phylogenetically paired native and nonnative plant communities in a glasshouse experiment to test diversity-productivity relationships and responsible mechanisms (i.e. selection or complementarity effects). Additionally, we tested how productivity and associated mechanisms influenced seedling establishment. We used diversity-interaction models to describe how species' interactions influenced diversity-productivity relationships. Communities with more species had higher total biomass than did monoculture communities, but native and nonnative communities diverged in root : shoot ratios and the mechanism responsible for increased productivity: positive selection effect in nonnative communities and positive complementarity effect in native communities. Seedling establishment was 46% lower in nonnative than in native communities and was correlated with the average selection effect. Interspecific interactions contributed to productivity patterns, but the specific types of interactions differed between native and nonnative communities. These results reinforce findings that the diversity-productivity mechanisms in native and nonnative communities differ and are the first to show that these mechanisms can influence seedling establishment and that different types of interactions influence diversity-productivity relationships. © 2015 The Authors. New Phytologist © 2015 New Phytologist Trust.

  5. Study of Strain-Stress Behavior of Non-Pressure Reinforced Concrete Pipes Used in Road Building

    NASA Astrophysics Data System (ADS)

    Rakitin, B. A.; Pogorelov, S. N.; Kolmogorova, A. O.

    2017-11-01

    The article contains the results of the full-scale tests performed for special road products - large-diameter non-pressure concrete pipes reinforced with a single space cylindrical frame manufactured with the technology of high-frequency vertical vibration molding with an immediate demolding. The authors studied the change in the strain-stress behavior of reinforced concrete pipes for underground pipeline laying depending on their laying depth in the trench and the transport load considering the properties of the surrounding ground mass. The strain-stress behavior of the reinforced concrete pipes was evaluated using the strain-gauge method based on the application of active resistance strain gauges. Based on the completed research, the authors made a conclusion on the applicability of a single space frame for reinforcement of large-diameter non-pressure concrete pipes instead of a double frame which allows one to significantly reduce the metal consumption for the production of one item. As a result of the full-scale tests of reinforced concrete pipes manufactured by vertical vibration molding, the authors obtained new data on the deformation of a pipeline cross-section depending on the placement of the transport load with regard to the axis.

  6. Is the Drugstore Safe? Counterfeit Diabetes Products on the Shelves

    PubMed Central

    Cheng, May M.

    2009-01-01

    It is no longer possible to identify counterfeit medical products, including medications and devices, by simply checking packaging and labeling. Improvements in technology have made it cheaper and easier to produce fake packaging and labels, making it nearly impossible for consumers and authorities to detect counterfeits without conducting tests on the products themselves, as illustrated by the sale of over one million counterfeit blood glucose test strips sold to unsuspecting U.S. consumers at drugstores in more than 35 states and in other countries around the world in the fall of 2006. The pricier the drugs, the more counterfeiters seek to mimic them to maximize returns, victimizing those patients at highest risk who rely on life-saving medications. PMID:20144408

  7. 14 CFR 21.293 - Current records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... option authorization— (i) A technical data file that includes the type design drawings, specifications, reports on tests prescribed by this part, and the original type inspection report and amendments to that... his factory, for each product type certificated under a delegation option authorization, current...

  8. The Iodine-Clock Reaction--A Spreadsheet Simulation To Test.

    ERIC Educational Resources Information Center

    Swain, P. A.

    1997-01-01

    Describes a spreadsheet activity for the iodine-clock reaction which follows the concentrations of all reactions and products for 200 seconds and gives the induction period. Explains that, although there are limitations to the spreadsheet, it is nevertheless illuminating. (Author/ASK)

  9. Effects of ivermectin application on the diversity and function of dung and soil fauna: Regulatory and scientific background information.

    PubMed

    Adler, Nicole; Bachmann, Jean; Blanckenhorn, Wolf U; Floate, Kevin D; Jensen, John; Römbke, Jörg

    2016-08-01

    The application of veterinary medical products to livestock can impact soil organisms in manure-amended fields or adversely affect organisms that colonize dung pats of treated animals and potentially retard the degradation of dung on pastures. For this reason, the authorization process for veterinary medicinal products in the European Union includes a requirement for higher-tier tests when adverse effects on dung organisms are observed in single-species toxicity tests. However, no guidance documents for the performance of higher-tier tests are available. Hence, an international research project was undertaken to develop and validate a proposed test method under varying field conditions of climate, soil, and endemic coprophilous fauna at Lethbridge (Canada), Montpellier (France), Zurich (Switzerland), and Wageningen (The Netherlands). The specific objectives were to determine if fecal residues of an anthelmintic with known insecticidal activity (ivermectin) showed similar effects across sites on 1) insects breeding in dung of treated animals, 2) coprophilous organisms in the soil beneath the dung, and 3) rates of dung degradation. By evaluating the effects of parasiticides on communities of dung-breeding insects and soil fauna under field conditions, the test method meets the requirements of a higher-tier test as mandated by the European Union. The present study provides contextual information on authorization requirements for veterinary medicinal products and on the structure and function of dung and soil organism communities. It also provides a summary of the main findings. Subsequent studies on this issue provide detailed information on different aspects of this overall project. Environ Toxicol Chem 2016;35:1914-1923. © 2015 SETAC. © 2015 SETAC.

  10. Impact of Dean Vortices on the Integrity Testing of a Continuous Viral Inactivation Reactor.

    PubMed

    Amarikwa, Linus; Orozco, Raquel; Brown, Matthew; Coffman, Jon

    2018-05-26

    We propose a standard protocol for integrity testing the residence-time distribution (RTD) in a "Jig in a Box" design (JIB)-a previously described tortuous-path, tubular, low-pH, continuous viral inactivation reactor, ensuring that biopharmaceutical products will be incubated for the required minimum residence time, t min . t min is the time by which just 0.001% of the total product containing virus has exited the incubation chamber (i.e., t 0.00001 ). This t 0.00001 is selected to ensure a >4-log reduction in viral load. As current tracers and in-line analytical technologies may not be able to detect tracers at the 0.001% level, an alternative approach is required. The authors describe a method for deriving t min from t 0.005 (i.e., the time at which 0.5% of the product has emerged from the reactor outlet) and an experimentally confirmed offset value, t offset  = t 0.005 -t 0.00001 . The authors also evaluate tracer candidates-including 100-nm-diameter gold nanoparticles, dextrose, monoclonal antibody, and riboflavin-for pre-process acceptability and the effects of viscosity, molecular diffusion coefficient, and particle size. The authors show that a JIB will yield t min and RTDs that are nearly identical for multiple tracers due to Dean vortex induced mixing. Results indicate that almost any small-molecule tracer that is generally recognized as safe can be used in pre-use integrity testing of a continuous viral inactivation reactor under the Deans values (De) of 119-595. © 2018 Boehringer Ingelheim Fremont Inc. Biotechnology Journal published by Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. Validity and test-retest reliability of an at-work production loss instrument.

    PubMed

    Aboagye, E; Jensen, I; Bergström, G; Hagberg, J; Axén, I; Lohela-Karlsson, M

    2016-07-01

    Besides causing ill health, a poor work environment may contribute to production loss. Production loss assessment instruments emphasize health-related consequences but there is no instrument to measure reduced work performance related to the work environment. To examine convergent validity and test-retest reliability of health-related production loss (HRPL) and work environment-related production loss (WRPL) against a valid comparable instrument, the Health and Work Performance Questionnaire (HPQ). Cross-sectional study of employees, not on sick leave, who were asked to self-rate their work performance and production losses. Using the Pearson correlation and Bland and Altman's Test of Agreement, convergent validity was examined. Subgroup analyses were performed for employees recording problem-specific reduced work performance. Consistency of pairs of HRPL and WRPL for samples responding to both assessments was expressed using Intraclass Correlation Coefficient (ICC) and tests of repeatability. A total of 88 employees participated and 44 responded to both assessments. Test of agreement between measurements estimates a mean difference of 0.34 for HRPL and -0.03 for WRPL compared with work performance. This indicates that the production loss questions are valid and moderately associated with work performance for the total sample and subgroups. ICC for paired HRPL assessments was 0.90 and 0.91 for WRPL, i.e. the test-retest reliability was good and suggests stability in the instrument. HRPL and WRPL can be used to measure production loss due to health-related and work environment-related problems. These results may have implications for advancing methods of assessing production loss, which represents an important cost to employers. © The Author 2016. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. The use of fatigue tests in the manufacture of automotive steel wheels.

    NASA Astrophysics Data System (ADS)

    Drozyner, P.; Rychlik, A.

    2016-08-01

    Production for the automotive industry must be particularly sensitive to the aspect of safety and reliability of manufactured components. One of such element is the rim, where durability is a feature which significantly affects the safety of transport. Customer complaints regarding this element are particularly painful for the manufacturer because it is almost always associated with the event of accident or near-accident. Authors propose original comprehensive method of quality control at selected stages of rims production: supply of materials, production and pre-shipment inspections. Tests by the proposed method are carried out on the originally designed inertial fatigue machine The machine allows bending fatigue tests in the frequency range of 0 to 50 Hz at controlled increments of vibration amplitude. The method has been positively verified in one of rims factory in Poland. Implementation resulted in an almost complete elimination of complaints resulting from manufacturing and material errors.

  13. In Vivo Testing of Chemopreventive Agents Using the Dog Model of Spontaneous Prostate Carcinogenesis

    DTIC Science & Technology

    2003-03-01

    Carcinogenesis 6. AUTHOR(S) David J. Waters, Ph.D., DVM 7. PERFORMING ORGANIZATION NAME (S) AND ADDRESS(ES) S. PERFORMING ORGANIZATION Purdue Research...Foundation REPORT NUMBER West Lafayette, IN 47907-1021 E-Mail: waters@vet .purdue .edu 9. SPONSORING / MONITORING 10. SPONSORING I MONITORING AGENCY NAME (S...commercial organizations and trade names in this report do not constitute an official Department of Army endorsement or approval of the products or services

  14. Hydraulic fluids and jet engine oil: pyrolysis and aircraft air quality.

    PubMed

    van Netten, C; Leung, V

    2001-01-01

    Incidents of smoke in aircraft cabins often result from jet engine oil and/or hydraulic fluid that leaks into ventilation air, which can be subjected to temperatures that exceed 500 degrees C. Exposed flight-crew members have reported symptoms, including dizziness, nausea, disorientation, blurred vision, and tingling in the legs and arms. In this study, the authors investigated pyrolysis products of one jet engine oil and two hydraulic fluids at 525 degrees C. Engine oil was an important source of carbon monoxide. Volatile agents and organophosphate constituents were released from all the agents tested; however, the neurotoxin trimethyl propane phosphate was not found. The authors hypothesized that localized condensation of pyrolysis products in ventilation ducts, followed by mobilization when cabin heat demand was high, accounted for mid-flight incidents. The authors recommended that carbon monoxide data be logged continuously to capture levels during future incidents.

  15. Application of NEPA to nuclear weapons production, storage, and testing Weinberger v. Catholic Action of Hawaii/Peace Education Project

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sauber, A.J.

    The National Environmental Policy Act (NEPA) requirement of environmental impact statements for the testing of military equipment, specifically nuclear weapons, conflicts with national security objectives. The author examines NEPA and the Freedom of Information Act (FOIA) in terms of the environmental effects of weapons testing and the relevant case law. The Supreme Court's decision in Catholic Action of Hawaii/Peace Education Project sought to resolve the conflict by distinguishing between a project which is contemplated and one which is proposed. The classification scheme embodied in the FOIA exemption for national security may cause unwarranted frustration of NEPA's goals. The author outlinesmore » a new classification system and review mechanism that could curb military abuse in this area.« less

  16. 40 CFR 272.751 - Indiana state-administered program: Final authorization.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... Hazardous Waste Management System; Testing and Monitoring Activities (Checklist 158) 62 FR 32452 June 13... Management System; Carbamate Production, Identification and Listing of Hazardous Waste; Land Disposal... Indiana Department of Environmental Management, signed by the Commissioner of the IDEM on February 14...

  17. Influence of Examiner Differences on Rorschach Productivity in Children

    ERIC Educational Resources Information Center

    Tuma, June M.; McCraw, Ronald K.

    1975-01-01

    Rorschach test protocols for a matched sample of male and female subjects, in the child and adolescent range, were scored for total responses. The data was analyzed for evidence of interactions between sex of experimenter and sex and age of subject. (Author/BJG)

  18. Tobacco and Nicotine Product Testing

    PubMed Central

    Biener, Lois; Leischow, Scott J.; Zeller, Mitch R.

    2012-01-01

    Introduction: Tobacco product testing is a critical component of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which grants the Food and Drug Administration the authority to regulate tobacco products. The availability of methods and measures that can provide accurate data on the relative health risks across types of tobacco products, brands, and subbrands of tobacco products on the validity of any health claims associated with a product, and on how consumers perceive information on products toxicity or risks is crucial for making decisions on the product's potential impact on public health. These tools are also necessary for making assessments of the impact of new indications for medicinal products (other than cessation) but more importantly of tobacco products that may in the future be marketed as cessation tools. Objective: To identify research opportunities to develop empirically based and comprehensive methods and measures for testing tobacco and other nicotine-containing products so that the best science is available when decisions are made about products or policies. Methods: Literature was reviewed to address sections of the FSPTCA relevant to tobacco product evaluation; research questions were generated and then reviewed by a committee of research experts. Results: A research agenda was developed for tobacco product evaluation in the general areas of toxicity and health risks, abuse liability, consumer perception, and population effects. Conclusion: A cohesive, systematic, and comprehensive assessment of tobacco products is important and will require building consensus and addressing some crucial research questions. PMID:21460383

  19. Pharmacokinetics and Bioequivalence Evaluation of 2 Loxoprofen Tablets in Healthy Egyptian Male Volunteers.

    PubMed

    Helmy, Sally A

    2013-04-01

    The objective of this study was to assess the in vitro dissolution and to evaluate the bioavailability of two brands of Loxoprofen sodium dihydrate tablets. Loxoprofen tablets (68.1 mg loxoprofen sodium dihydrate equivalent to 60 mg loxoprofen; test) relative to Roxonin tablets (68.1 mg loxoprofen sodium dihydrate equivalent to 60 mg loxoprofen; reference). In vitro study was adopted to determine and compare the dissolution behavior of both products. In vivo study was conducted according to a single-center, randomized, single-dose, and laboratory-blinded, 2-period, 2-sequence, crossover design with a washout period of 1 week. Under fasting conditions, 24 healthy Egyptian adult male volunteers were randomly allocated to receive a single dose of either test or reference product. Blood samples were collected at specified time intervals, and plasma was analyzed for loxoprofen concentrations using a validated high-performance liquid chromatography assay method. The pharmacokinetic parameters Cmax , AUC0-t , AUC0-∞ , tmax , and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio Cmax , AUC0-t , and AUCt-∞ of the test product over those of reference were within the acceptable range (0.8-1.25) for bioequivalence. On the basis of these results, the two-loxoprofen formulations are considered bioequivalent. © The Author(s) 2013.

  20. An Analysis of the Distinction between Deep and Shallow Expert Systems

    DTIC Science & Technology

    1989-08-01

    will also be important as we discuss in later sections of this paper. The following test has been proposed by which one may decide whether one program...which is explicitly represented or computed in M"’ (Klein and Finin, 1987). The authors of this test acknowledge that notions such as implicit and...constraints in (DeKleer and Brown, 1984) is that the if-then form of production rules "falsely implies the passage of time" between the test and action

  1. Lead-contaminated imported tamarind candy and children's blood lead levels.

    PubMed Central

    Lynch, R A; Boatright, D T; Moss, S K

    2000-01-01

    In 1999, an investigation implicated tamarind candy as the potential source of lead exposure for a child with a significantly elevated blood lead level (BLL). The Oklahoma City-County Health Department tested two types of tamarind suckers and their packaging for lead content. More than 50% of the tested suckers exceeded the US Food and Drug Administration (FDA) Level of Concern for lead in this type of product. The authors calculated that a child consuming one-quarter to one-half of either of the two types of suckers in a day would exceed the maximum FDA Provis onal Tolerable Intake for lead. High lead concentrations in the two types of wrappers suggested leaching as a potential source of contamination. The authors used the Environmental Protection Agency's Integrated Exposure Uptake Biokinetic (IEUBK) model to predict the effects of consumption of contaminated tamarind suckers on populat on BLLs. The IEUBK model predicted that consumption of either type of sucker at a rate of one per day would result in dramatic increases in mean BLLs for children ages 6-84 months in Oklahoma and in the percentage of children wth elevated BLLs (> or =10 micrograms per deciliter [microg/dL]). The authors conclude that consumption of these products represents a potential public health threat. In addition, a history of lead contamination in imported tamarind products suggests that import control measures may not be completely effective in preventing additional lead exposure. PMID:11354337

  2. 'I think it will eventually be done away with': Attitudes among healthcare professionals towards the current system of animal experimentation.

    PubMed

    Dignon, Andrée

    2016-08-01

    This article describes a study of attitudes to the current system of animal experimentation (for the production of health interventions) among 52 UK healthcare professionals. These healthcare professionals participated in three separate focus groups (of 18, 17 and 17 participants) and were invited to respond to the question 'what is your opinion about the current system of animal testing?' The study focused specifically on their views of the current system (rather than their views of animal testing in general). The healthcare professionals were critical of the current system, particularly with regard to regulation, secrecy, validity, unnecessary suffering and welfare. © The Author(s) 2014.

  3. Dependent or Productive? A New Approach to Understanding the Social Positioning of Older South Africans Through Living Arrangements.

    PubMed

    Schatz, Enid; Madhavan, Sangeetha; Collinson, Mark; Gómez-Olivé, F Xavier; Ralston, Margaret

    2015-08-01

    South Africa's population is aging. Most of the older Black South Africans continue to live in extended household structures with children, grandchildren, and other kin. They also constitute a source of income through a means-tested noncontributory state-funded pension available at age 60. Using census data from the Agincourt Health and Demographic Surveillance System in 2000, 2005, and 2010, we develop a typology of living arrangements that is reflective of the social positioning of elderly persons as dependent or productive household members and analyze changes in the distribution over time. Older persons, in general, live in large, complex, and multigenerational households. Multigenerational households with "productive" older persons are increasing in proportion over the period, although there are few differences by gender or pension eligibility at any time point. © The Author(s) 2014.

  4. A Cross-cultural Study of Verbal Elaboration Productivity and Memory in Young Children

    ERIC Educational Resources Information Center

    Buium, Nissan; Turnure, James E.

    1977-01-01

    Fifty-six normal 5-year-old Israeli children were tested to determine whether questioning procedures found to be successful with American children for enhancing memory processes would be successful with children from another culture who spoke a different language. (Author/JMB)

  5. Technical Committee on Aricultural Chemical Safety (ACSA) Life Stages Task Force

    EPA Science Inventory

    This document takes a life stages approach to the assessment of risk attributable to crop protection products, and well-known experts in the field are contributing authors. The paper presents an in-depth justification for proposed changes in current protocols for toxicity testing...

  6. 78 FR 1574 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Infusion Pumps. 281 Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product Constituents... Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Legal Authority: 21 U.S.C... proposing to amend the classification of infusion pumps from class II (performance standards) to class II...

  7. Auditory Perception, Suprasegmental Speech Processing, and Vocabulary Development in Chinese Preschoolers.

    PubMed

    Wang, Hsiao-Lan S; Chen, I-Chen; Chiang, Chun-Han; Lai, Ying-Hui; Tsao, Yu

    2016-10-01

    The current study examined the associations between basic auditory perception, speech prosodic processing, and vocabulary development in Chinese kindergartners, specifically, whether early basic auditory perception may be related to linguistic prosodic processing in Chinese Mandarin vocabulary acquisition. A series of language, auditory, and linguistic prosodic tests were given to 100 preschool children who had not yet learned how to read Chinese characters. The results suggested that lexical tone sensitivity and intonation production were significantly correlated with children's general vocabulary abilities. In particular, tone awareness was associated with comprehensive language development, whereas intonation production was associated with both comprehensive and expressive language development. Regression analyses revealed that tone sensitivity accounted for 36% of the unique variance in vocabulary development, whereas intonation production accounted for 6% of the variance in vocabulary development. Moreover, auditory frequency discrimination was significantly correlated with lexical tone sensitivity, syllable duration discrimination, and intonation production in Mandarin Chinese. Also it provided significant contributions to tone sensitivity and intonation production. Auditory frequency discrimination may indirectly affect early vocabulary development through Chinese speech prosody. © The Author(s) 2016.

  8. Design and field test of collaborative tools in the service of an innovative organization

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    De Beler, N.; Parfouru, S.

    2012-07-01

    This paper presents the design process of collaborative tools, based on ICT, aiming at supporting the tasks of the team that manages an outage of an energy production plant for maintenance activities. The design process follows an iterative and multidisciplinary approach, based on a collective tasks modeling of the outage management team in the light of Socio Organizational and Human (SOH) field studies, and on the state of the art of ICT. Field test of the collaborative tools designed plays a great place in this approach, allowing taking into account the operational world but involves also some risks which mustmore » be managed. To implement tools on all the production plants, we build an 'operational concept' with a level of description which authorizes the evolution of tools and allows some local adaptations. The field tests provide lessons on the ICT topics. For examples: the status of the remote access tools, the potential of use of a given information input by an actor for several individual and collective purposes, the actors perception of the tools meaning, and the requirements for supporting the implementation of change. (authors)« less

  9. Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System.

    PubMed

    Jenke, Dennis

    2012-01-01

    An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered. Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.

  10. Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

    PubMed

    Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K

    2015-01-01

    During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.

  11. Interactive visualisation for interpreting diagnostic test accuracy study results.

    PubMed

    Fanshawe, Thomas R; Power, Michael; Graziadio, Sara; Ordóñez-Mena, José M; Simpson, John; Allen, Joy

    2018-02-01

    Information about the performance of diagnostic tests is typically presented in the form of measures of test accuracy such as sensitivity and specificity. These measures may be difficult to translate directly into decisions about patient treatment, for which information presented in the form of probabilities of disease after a positive or a negative test result may be more useful. These probabilities depend on the prevalence of the disease, which is likely to vary between populations. This article aims to clarify the relationship between pre-test (prevalence) and post-test probabilities of disease, and presents two free, online interactive tools to illustrate this relationship. These tools allow probabilities of disease to be compared with decision thresholds above and below which different treatment decisions may be indicated. They are intended to help those involved in communicating information about diagnostic test performance and are likely to be of benefit when teaching these concepts. A substantive example is presented using C reactive protein as a diagnostic marker for bacterial infection in the older adult population. The tools may also be useful for manufacturers of clinical tests in planning product development, for authors of test evaluation studies to improve reporting and for users of test evaluations to facilitate interpretation and application of the results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. B physics and Quarkonia in CMS

    NASA Astrophysics Data System (ADS)

    Fiorendi, Sara

    2017-12-01

    The heavy-flavor sector offers the opportunity to perform indirect tests of beyond the Standard Model physics through precision measurements and of quantum chromodynamics (QCD) through particle production studies. A review of recent measurements on heavy flavors from the CMS experiment is presented. Results are based on data collected during LHC Run I and Run II and include measurements of heavy flavor production and properties, rare decays, CP violation, exotic and standard quarkonia. Warning, no authors found for 2017EPJWC.16407006.

  13. The scientific production in trauma of an emerging country

    PubMed Central

    2012-01-01

    Background The study aims to examine whether the end of specialty in trauma surgery in 2003 influenced the scientific productivity of the area in Brazil. Methods We identified and classified the manuscripts and their authors, from databases such as PubMed, Scielo and Plataforma Lattes and sites like Google, in addition to the list of members of SBAIT, the sole society in Brazil to congregate surgeons involved in trauma care in the country. We applied statistical tests to compare the periods of 1997-2003 and 2004-2010. We also analyzed the following variables: impact factor of journals in which manuscripts were published, journals, regional origin of authors, time since graduation, and conducting post-doctorate abroad. Results We observed a significant increase in publication rates of the analyzed groups over the years. There was a predominance of quantitative studies from the Southeast (especially the state of São Paulo). More time elapsed after graduation and the realization of postdoctoral studies abroad influenced the individual scientific productivity. Conclusion The number of articles published by authors from the area of trauma has been growing over the past 14 years in Brazil. The end of the specialty in trauma surgery in the country did not influence the scientific productivity in the area. PMID:23531364

  14. Effect of guaifenesin on mucin production, rheology, and mucociliary transport in differentiated human airway epithelial cells.

    PubMed

    Seagrave, JeanClare; Albrecht, Helmut; Park, Yong Sung; Rubin, Bruce; Solomon, Gail; Kim, K Chul

    2011-12-01

    Guaifenesin is widely used to alleviate symptoms of excessive mucus accumulation in the respiratory tract. However, its mechanism of action is poorly understood. The authors hypothesized that guaifenesin improves mucociliary clearance in humans by reducing mucin release, by decreasing mucus viscoelasticity, and by increasing mucociliary transport. To test these hypotheses, human differentiated airway epithelial cells, cultured at an air-liquid interface, were treated with clinically relevant concentrations of guaifenesin by addition to the basolateral medium. To evaluate the effect on mucin secretion, the authors used an anzyme-linked immunosorbent assay (ELISA) to measure the amounts of MUC5AC protein in apical surface fluid and cell lysates. To measure mucociliary transportability, additional cultures were treated for 1 or 6 hours with guaifenesin, and the movement of cell debris was measured from video data. Further, the authors measured mucus dynamic viscoelasticity using a micro cone and plate rheometer with nondestructive creep transformation. Guaifenesin suppressed mucin production in a dose-dependent manner at clinically relevant concentrations. The reduced mucin production was associated with increased mucociliary transport and decreased viscoelasticity of the mucus. Viability of the cultures was not significantly affected. These results suggest that guaifenesin could improve mucociliary clearance in humans by reducing the release and/or production of mucins, thereby altering mucus rheology.

  15. The Regulatory Evaluation of Vaccines for Human Use.

    PubMed

    Baylor, Norman W

    2016-01-01

    A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to result in the prevention, amelioration, or therapy of any disease or infection (US Food and Drug Administration. Guidance for Industry: content and format of chemistry, manufacturing, and controls information and establishment description information for a vaccine or related product). A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive characterization and testing. Special expertise and procedures are needed for their manufacture, control, and regulation. The Food and Drug Administration (FDA) is the National Regulatory Authority (NRA) in the United States responsible for assuring quality, safety, and effectiveness of all human medical products, including vaccines for human use.The Center for Biologics Evaluation and Research (CBER) within the US FDA is responsible for overseeing the regulation of therapeutic and preventative vaccines against infectious diseases. Authority for the regulation of vaccines resides in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C). Vaccines are regulated as biologics and licensed based on the demonstration of safety and effectiveness. The vaccine development process can be divided into two major categories: those events that are not under the regulatory authority of the FDA and are exploratory in nature and those events that are subject to regulatory authority by the FDA. Exploratory events or research and development cover basic research drug discovery processes that occur before the sponsor submits an investigational new drug application (IND) to the FDA. There are four main stages of vaccine development under the purview of regulatory authorities: preclinical, clinical (IND), licensing, and post-licensure. Throughout their life cycle from preclinical evaluation to post-licensure lot release testing, vaccines are subject to rigorous testing and oversight by manufacturers and NRAs. In this chapter an overview of the regulatory evaluation and testing requirements for vaccines is presented.

  16. Glutamine supplementation, citrulline production, and de novo arginine synthesis: Is there a relation?

    USDA-ARS?s Scientific Manuscript database

    We would like to comment on the recent publications by Buijs et al. The authors hypothesized that a parenteral supplement of glutamine stimulates citrulline formation and enhances de novo arginine synthesis. To test this hypothesis, they conducted an experiment with stable isotopes in patients under...

  17. 77 FR 49739 - Energy Conservation Standards for Residential Dehumidifiers: Public Meeting and Availability of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-17

    ... dehumidifiers. DOE also encourages written comments on potential amended standards, including comments on the... INFORMATION: I. Introduction and Legal Authority II. Test Procedures III. Energy Conservation Standards I... standard on the manufacturers and consumers of the affected products; (2) The savings in operating costs...

  18. Testing a Readable Writing Approach to Text Revision.

    ERIC Educational Resources Information Center

    Duffy, Thomas M.; Kabance, Paula

    1982-01-01

    The present findings imply that a readability formula is not an effective writing production criterion, even when the writer does not deliberately write to the formula. Comprehensibility of text might be better controlled through the proper use of the transformer concept (MacDonald-Ross and Waller). (Author/PN)

  19. 76 FR 54953 - Medicare Program; Changes to the Electronic Prescribing (eRx) Incentive Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

    ... That Encourage the Use of Health Information Technology,'' available at http://www.gao.gov/products/GAO... Coordinator for Health Information Technology (at the present time, these bodies are the Office of the National Coordinator for Health Information Technology (ONC)-Authorized Testing and Certification Bodies...

  20. Occurrence of pesticide residues in fruiting vegetables from production farms in south-eastern region of Poland

    PubMed

    Słowik-Borowiec, Magdalena; Szpyrka, Ewa; Rupar, Julian; Podbielska, Magdalena; Matyaszek, Aneta

    Considering the fact that pesticides are commonly used in agriculture, continuous monitoring of these substances in food products is of great significance. Residues of these substances can be present in crops after harvest. The aim of this study was to evaluate presence of pesticide residues in fruiting vegetables from production farms in south-eastern region of Poland in 2012–2015. 138 samples were tested using accredited test methods. The monitoring programme covered determination of 242 pesticides. The tests covered tomato, cucumber and pepper crops. The test results were interpreted in accordance with criteria included in the European Commission recommendations published in the document SANCO/12571/2013 (now superseded by Document SANTE 2015), as well as on a basis of the maximum residue levels in force in the EU Member States. Pesticide residues were found in 47 samples, representing 34% of all tested samples. 17 active substances were found, belonging to fungicides and insecticides. Azoxystrobin (38%), boscalid (28%) and chlorothalonil (21%) were most commonly found in fruiting vegetables testing samples. Non-compliances related to use of plant protection product not authorized for protection of a given crop were observed in 6% of analysed samples. However, pesticide residues of fruiting vegetables in quantities that exceed the maximum residue levels (NDP, ang. MRLs), as well as substances which use for plant protection is forbidden were no found. Crops monitoring is used to determine to what extent such products are contaminated with pesticide residues, and ensures protection of customer health.

  1. PHARMACEUTICAL QUALITY OF GENERIC ATORVASTATIN PRODUCTS COMPARED WITH THE INNOVATOR PRODUCT: A NEED FOR REVISING PRICING POLICY IN PALESTINE.

    PubMed

    Shawahna, Ramzi; Hroub, Abdel Kareem; Abed, Eliama; Jibali, Sondos; Al-Saghir, Ruba; Zaid, Abdel Naser

    2016-01-01

    Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution. Three out of four generics were less expensive than the innovator. Pharmaceutical quality assessments were satisfactory and within limits for all atorvastatin tested products. The average weight ranged from 206.6 ± 8.40 to 330 ± 3.92 mg and the %RSDs were within the permitted limits as per USP. Tablet hardness ranged from 102 ± 1.41 to 197.4 ± 6.88 kg and drug contents ranged from 92.2% to 105.3%. All products disintegrated within permitted time limits and showed very rapid dissolution. Products released more than 85% of their drug contents in less than 15 min. Our results showed that all tested innovator and generic atorvastatin products were of good pharmaceutical quality. Despite the lack of in vivo evaluation, our results indicate that these products are equivalent in vitro. Considering the in vitro release characteristics, these products might be used interchangeably. However, regulatory authorities permit the use of in vitro data in establishing similarity between immediate release oral dosage forms containing biopharmaceutical classification system class I and III drugs only.

  2. Online test application development using framework CodeIgniter

    NASA Astrophysics Data System (ADS)

    Wibawa, S. C.; Wahyuningsih, Y.; Sulistyowati, R.; Abidin, R.; Lestari, Y.; Noviyanti; Maulana, D. A.

    2018-01-01

    The purpose of this study is developing application an online test for vocational students and to know the user acceptance testing on the application. The method used in this research is the Research and Development (R & D) only up to the pilot phase of the product. The stage of the procedure of the research namely: (1) Analyze the exam using paper compared to using web-based application test online. (2) Design the media in accordance with the design of the author. (3) To test the product by including a questionnaire instrument against the application that has been done. Researchers carried out tests on class X on the computer and network engineering Vocational High School (SMK) Darul Ma’wa Plumpang. It can be concluded that: (1) application online test was created gets the value of the validator with the percentage of lowest value and the highest value for the validation of products: 25% and 100%. With a total number of 14 questions, after validation of the products obtained from the three aspects of the assessment scale from 81.25 to 100 obtained from 2 different validators with the meaning of an application that has been developed and very suitable for use in school. (2) Based on User Acceptance Testing (UAT), applications can be very well received by the students and recommend to replay the final semester and others. With the successful acquisition of a category which means it’s ready and qualified.

  3. Development of a bar code-based exposure assessment method to evaluate occupational exposure to disinfectants and cleaning products: a pilot study.

    PubMed

    Quinot, Catherine; Amsellem-Dubourget, Sylvie; Temam, Sofia; Sevin, Etienne; Barreto, Christine; Tackin, Arzu; Félicité, Jérémy; Lyon-Caen, Sarah; Siroux, Valérie; Girard, Raphaële; Descatha, Alexis; Le Moual, Nicole; Dumas, Orianne

    2018-05-14

    Healthcare workers are highly exposed to various types of disinfectants and cleaning products. Assessment of exposure to these products remains a challenge. We aimed to investigate the feasibility of a method, based on a smartphone application and bar codes, to improve occupational exposure assessment among hospital/cleaning workers in epidemiological studies. A database of disinfectants and cleaning products used in French hospitals, including their names, bar codes and composition, was developed using several sources: ProdHyBase (a database of disinfectants managed by hospital hygiene experts), and specific regulatory agencies and industrial websites. A smartphone application has been created to scan bar codes of products and fill a short questionnaire. The application was tested in a French hospital. The ease of use and the ability to record information through this new approach were estimated. The method was tested in a French hospital (7 units, 14 participants). Through the application, 126 records (one record referred to one product entered by one participant/unit) were registered, majority of which were liquids (55.5%) or sprays (23.8%); 20.6% were used to clean surfaces and 15.9% to clean toilets. Workers used mostly products with alcohol and quaternary ammonium compounds (>90% with weekly use), followed by hypochlorite bleach and hydrogen peroxide (28.6%). For most records, information was available on the name (93.7%) and bar code (77.0%). Information on product compounds was available for all products and recorded in the database. This innovative and easy-to-use method could help to improve the assessment of occupational exposure to disinfectants/cleaning products in epidemiological studies. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

    PubMed

    Kroes, Burt H

    2014-12-02

    In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Use of the conditional marketing authorization pathway for oncology medicines in Europe.

    PubMed

    Hoekman, J; Boon, W P C; Bouvy, J C; Ebbers, H C; de Jong, J P; De Bruin, M L

    2015-11-01

    Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in marketing authorization of oncology medicines in the period 2006 to 2013. We show that compared to full marketing authorization, CMA is granted based on less comprehensive data. However, this is accompanied by significantly longer assessment times and less consensus among regulators about marketing authorization. Moreover, development time from first-in-human testing to marketing authorization did not differ between full marketing authorization and CMA, but was significantly longer for CMA compared to accelerated approved products in the United States (US). Results indicate that CMA is not used by companies as a prospectively planned pathway to obtain early access, but as a "rescue option" when submitted data are not strong enough to justify full marketing authorization. © 2015, The American Society for Clinical Pharmacology and Therapeutics.

  6. Agricultural resources investigations in northern Italy and southern France (Agreste project). Part 1: Activity performed on the Italian test-sites

    NASA Technical Reports Server (NTRS)

    Megier, J. (Principal Investigator)

    1976-01-01

    The author has identified the following significant results. Some qualitative results were obtained out of the experiment of reflectance measurements under greenhouse conditions. An effort was made to correlate phenological stages, production, and radiometric measurements. It was found that the first order effect of exposure variability to sun irradiation is responsible for different rice productivity classes. Effects of rice variety and fertilization become second order, because they are completely masked by the first order effects.

  7. Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.

    PubMed

    Verbeeck, Roger K; Kanfer, Isadore; Löbenberg, Raimar; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, D W; Langguth, Peter; Polli, James E; Parr, Alan; Shah, Vinod P; Mehta, Mehul; Dressman, Jennifer B

    2017-08-01

    Literature data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the marketing authorization of immediate-release, solid oral dosage forms containing enalapril maleate are reviewed. Enalapril, a prodrug, is hydrolyzed by carboxylesterases to the active angiotensin-converting enzyme inhibitor enalaprilat. Enalapril as the maleate salt is shown to be highly soluble, but only 60%-70% of an orally administered dose of enalapril is absorbed from the gastrointestinal tract into the enterocytes. Consequently, enalapril maleate is a Biopharmaceutics Classification System class III substance. Because in situ conversion of the maleate salt to the sodium salt is sometimes used in production of the finished drug product, not every enalapril maleate-labeled finished product actually contains the maleate salt. Enalapril is not considered to have a narrow therapeutic index. With this background, a biowaiver-based approval procedure for new generic products or after major revisions to existing products is deemed acceptable, provided the in vitro dissolution of both test and reference preparation is very rapid (at least 85% within 15 min at pH 1.2, 4.5, and 6.8). Additionally, the test and reference product must contain the identical active drug ingredient. Copyright © 2017 American Pharmacists Association®. All rights reserved.

  8. The CERN disposal of the FELIX project proposal: some comments on and justification for it.

    NASA Astrophysics Data System (ADS)

    Bhattacharyya, S.; Roy, D.

    1998-12-01

    The authors seriously questioned and still continue to question the overemphasised "prospects" in the past of the so-called FELIX project in the domain of ultrahigh-energy astroparticle physics and the optimism that was nurtured around it. This was and is somewhat irrational because there is so far no dearth in the accumulated data for the testing of the models for particle production. But that up to now we failed to build up a really and concretely standard theory of particle production is due to our poverty in outlook and philosophy. The authors picked up and pointed out the very basic down-to-earth observables which even in the available energy range would really suffice to judge the merits and successes of any of the models. That the spirit of FELIX-like proposals might resurrect with just some other name even after the present (and temporary?) setback of the FELIX project remains the point of concern to the authors.

  9. Measuring healthcare productivity - from unit to system level.

    PubMed

    Kämäräinen, Vesa Johannes; Peltokorpi, Antti; Torkki, Paulus; Tallbacka, Kaj

    2016-04-18

    Purpose - Healthcare productivity is a growing issue in most Western countries where healthcare expenditure is rapidly increasing. Therefore, accurate productivity metrics are essential to avoid sub-optimization within a healthcare system. The purpose of this paper is to focus on healthcare production system productivity measurement. Design/methodology/approach - Traditionally, healthcare productivity has been studied and measured independently at the unit, organization and system level. Suggesting that productivity measurement should be done in different levels, while simultaneously linking productivity measurement to incentives, this study presents the challenges of productivity measurement at the different levels. The study introduces different methods to measure productivity in healthcare. In addition, it provides background information on the methods used to measure productivity and the parameters used in these methods. A pilot investigation of productivity measurement is used to illustrate the challenges of measurement, to test the developed measures and to prove the practical information for managers. Findings - The study introduces different approaches and methods to measure productivity in healthcare. Practical implications - A pilot investigation of productivity measurement is used to illustrate the challenges of measurement, to test the developed measures and to prove the practical benefits for managers. Originality/value - The authors focus on the measurement of the whole healthcare production system and try to avoid sub-optimization. Additionally considering an individual patient approach, productivity measurement is examined at the unit level, the organizational level and the system level.

  10. The Analysis of Discourse as Evaluation of Productive Thinking.

    ERIC Educational Resources Information Center

    Tripp, D. H.

    This paper provides a thorough description of a method of analyzing and scoring group discussions from a particular point of view. After discussing shortcomings of traditional methods of reporting data from group discussions and problems inherent in the use of paper-and-pencil creativity tests, the author describes a method which was developed as…

  11. Can Self-Determination Theory Explain What Underlies the Productive, Satisfying Learning Experiences of Collectivistically Oriented Korean Students?

    ERIC Educational Resources Information Center

    Jang, Hyungshim; Reeve, Johnmarshall; Ryan, Richard M.; Kim, Ahyoung

    2009-01-01

    Recognizing recent criticisms concerning the cross-cultural generalizability of self-determination theory (SDT), the authors tested the SDT view that high school students in collectivistically oriented South Korea benefit from classroom experiences of autonomy support and psychological need satisfaction. In Study 1, experiences of autonomy,…

  12. 75 FR 57556 - Energy Conservation Program for Consumer Products: Test Procedure for Residential Clothes Washers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... signed original paper copy. 4. Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy...) 586-2945. Please submit one signed original paper copy. For detailed instructions on submitting....Edwards @ee.doe.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Background and Legal Authority II...

  13. 75 FR 75289 - Energy Conservation Program for Consumer Products: Test Procedures for Residential Dishwashers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-02

    .... Please submit one signed paper original. 4. Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of.... Telephone: (202) 586-2945. Please submit one signed paper original. For detailed instructions on submitting... INFORMATION: Table of Contents I. Background and Authority II. Summary of the Proposal III. Discussion A...

  14. 75 FR 42612 - Energy Conservation Program for Consumer Products: Test Procedure for Microwave Ovens

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-22

    ...., Washington, DC 20585-0121. Please submit one signed original paper copy. 4. Hand Delivery/Courier: Ms. Brenda... Plaza, SW., Washington, DC 20024. Telephone: (202) 586-2945. Please submit one signed original paper... . SUPPLEMENTARY INFORMATION: Table of Contents I. Background and Legal Authority II. Summary of the Proposal III...

  15. How and Why of User Studies: RLG's RedLightGreen as a Case Study

    ERIC Educational Resources Information Center

    Proffitt, Merrilee

    2006-01-01

    This article documents a lifecycle approach to employing user-centered design, covering both qualitative and quantitative data gathering methods in support of using this approach for product design, usability testing, and market research. The author provides specific case studies of usability studies, focus groups, interviews, ethnographic…

  16. The Effects of a Multiple-Talent Teaching Program.

    ERIC Educational Resources Information Center

    Gordon, H. James; Shaver, James P.

    1985-01-01

    A study of 450 elementary students was made to examine the effects of Talents Unlimited (TU) teaching on students' productive and creative thinking scores. Results were not consistent across grade levels, nor from class to class. There seemed to be small to moderate associations between TU teaching and test scores. (Author/MT)

  17. 75 FR 21666 - Canadian Standards Association; Application for Expansion of Recognition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... provides its final decision on the application. These notices set forth the NRTL's scope of recognition or... . Each NRTL's scope of recognition has three elements: (1) The type of products the NRTL may test, with.... OSHA will publish a public notice of this final decision in the Federal Register. Authority and...

  18. 27 CFR 19.34 - Experimental or research operations by scientific institutions and colleges of learning.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... learning. (a) General. The appropriate TTB officer may authorize any scientific university, college of learning, or institution of scientific research to produce, receive, blend, treat, test, and store spirits... operations by scientific institutions and colleges of learning. 19.34 Section 19.34 Alcohol, Tobacco Products...

  19. 21 CFR 570.17 - Exemption for investigational use and procedure for obtaining authorization to market edible...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.17 Exemption for.... A food additive or food containing a food additive intended for investigational use by qualified.... Contains a new food additive for investigational use only in laboratory research animals or for tests in...

  20. Designing User Manuals for the Online Public Access Catalog.

    ERIC Educational Resources Information Center

    Seiden, Peggy; Sullivan, Patricia

    1986-01-01

    Describes the process of developing and revising a brochure to guide library patrons in conducting an author search on an online public access catalog in order to demonstrate the application of four steps in production of a functional document--analysis; planning; development; evaluation, testing, and revision. Three sources are given. (EJS)

  1. Cognitive Capitalism: Economic Freedom Moderates the Effects of Intellectual and Average Classes on Economic Productivity.

    PubMed

    Coyle, Thomas R; Rindermann, Heiner; Hancock, Dale

    2016-10-01

    Cognitive ability stimulates economic productivity. However, the effects of cognitive ability may be stronger in free and open economies, where competition rewards merit and achievement. To test this hypothesis, ability levels of intellectual classes (top 5%) and average classes (country averages) were estimated using international student assessments (Programme for International Student Assessment; Trends in International Mathematics and Science Study; and Progress in International Reading Literacy Study) (N = 99 countries). The ability levels were correlated with indicators of economic freedom (Fraser Institute), scientific achievement (patent rates), innovation (Global Innovation Index), competitiveness (Global Competitiveness Index), and wealth (gross domestic product). Ability levels of intellectual and average classes strongly predicted all economic criteria. In addition, economic freedom moderated the effects of cognitive ability (for both classes), with stronger effects at higher levels of freedom. Effects were particularly robust for scientific achievements when the full range of freedom was analyzed. The results support cognitive capitalism theory: cognitive ability stimulates economic productivity, and its effects are enhanced by economic freedom. © The Author(s) 2016.

  2. Questionnaire survey of customer satisfaction for product categories towards certification of ergonomic quality in design.

    PubMed

    Mochimaru, Masaaki; Takahashi, Miwako; Hatakenaka, Nobuko; Horiuchi, Hitoshi

    2012-01-01

    Customer satisfaction was surveyed for 6 product categories (consumer electronics, daily commodities, home equipment, information systems, cars, and health appliances) by questionnaires based on the Analytic Hierarchy Process. Analyzing weight of evaluation factors, the 6 product categories were reorganized into 4 categories, those were related to 4 aspects in daily living that formed by two axes: home living - mobility life and healthy life - active communication. It was found that consumers were attracted by the actual user test by public institutes for all product categories. The certification based on the design process standard established by authorities, such as EQUID was the second best attractor for consumers.

  3. A framework for evaluating electronic health record vendor user-centered design and usability testing processes.

    PubMed

    Ratwani, Raj M; Zachary Hettinger, A; Kosydar, Allison; Fairbanks, Rollin J; Hodgkins, Michael L

    2017-04-01

    Currently, there are few resources for electronic health record (EHR) purchasers and end users to understand the usability processes employed by EHR vendors during product design and development. We developed a framework, based on human factors literature and industry standards, to systematically evaluate the user-centered design processes and usability testing methods used by EHR vendors. We reviewed current usability certification requirements and the human factors literature to develop a 15-point framework for evaluating EHR products. The framework is based on 3 dimensions: user-centered design process, summative testing methodology, and summative testing results. Two vendor usability reports were retrieved from the Office of the National Coordinator's Certified Health IT Product List and were evaluated using the framework. One vendor scored low on the framework (5 pts) while the other vendor scored high on the framework (15 pts). The 2 scored vendor reports demonstrate the framework's ability to discriminate between the variabilities in vendor processes and to determine which vendors are meeting best practices. The framework provides a method to more easily comprehend EHR vendors' usability processes and serves to highlight where EHR vendors may be falling short in terms of best practices. The framework provides a greater level of transparency for both purchasers and end users of EHRs. The framework highlights the need for clearer certification requirements and suggests that the authorized certification bodies that examine vendor usability reports may need to be provided with clearer guidance. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  4. Comparison of agar dilution and antibiotic gradient strip test with broth microdilution for susceptibility testing of swine Brachyspira species.

    PubMed

    Mirajkar, Nandita S; Gebhart, Connie J

    2016-03-01

    Production-limiting diseases in swine caused by Brachyspira are characterized by mucohemorrhagic diarrhea (B. hyodysenteriae and "B. hampsonii") or mild colitis (B. pilosicoli), while B. murdochii is often isolated from healthy pigs. Emergence of novel pathogenic Brachyspira species and strains with reduced susceptibility to commonly used antimicrobials has reinforced the need for standardized susceptibility testing. Two methods are currently used for Brachyspira susceptibility testing: agar dilution (AD) and broth microdilution (BMD). However, these tests have primarily been used for B. hyodysenteriae and rarely for B. pilosicoli. Information on the use of commercial susceptibility testing products such as antibiotic gradient strips is lacking. Our main objective was to validate and compare the susceptibility results, measured as the minimum inhibitory concentration (MIC), of 6 antimicrobials for 4 Brachyspira species (B. hyodysenteriae, "B. hampsonii", B. pilosicoli, and B. murdochii) by BMD and AD (tiamulin, valnemulin, lincomycin, tylosin, and carbadox) or antibiotic gradient strip (doxycycline) methods. In general, the results of a high percentage of all 4 Brachyspira species differed by ±1 log2 dilution or less by BMD and AD for tiamulin, valnemulin, lincomycin, and tylosin, and by BMD and antibiotic gradient strip for doxycycline. The carbadox MICs obtained by BMD were 1-5 doubling dilutions different than those obtained by AD. BMD for Brachyspira was quicker to perform with less ambiguous interpretation of results when compared with AD and antibiotic gradient strip methods, and the results confirm the utility of BMD in routine diagnostics. © 2016 The Author(s).

  5. Ciência & Saúde Coletiva: scientific production analysis and collaborative research networks.

    PubMed

    Conner, Norma; Provedel, Attilio; Maciel, Ethel Leonor Noia

    2017-03-01

    The purpose of this metric and descriptive study was to identify the most productive authors and their collaborative research networks from articles published in Ciência & Saúde Coletiva between, 2005, and 2014. Authors meeting the cutoff criteria of at least 10 articles were considered the most productive authors. VOSviewer and Network Workbench technologies were applied for visual representations of collaborative research networks involving the most productive authors in the period. Initial analysis recovered 2511 distinct articles, with 8920 total authors with an average of 3.55 authors per article. Author analysis revealed 6288 distinct authors, 24 of these authors were identified as the most productive. These 24 authors generated 287 articles with an average of 4.31 authors per article, and represented 8 separate collaborative partnerships, the largest of which had 14 authors, indicating a significant degree of collaboration among these authors. This analysis provides a visual representation of networks of knowledge development in public health and demonstrates the usefulness of VOSviewer and Network Workbench technologies in future research.

  6. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  7. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  8. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  9. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  10. Gas fired boilers: Perspective for near future fuel composition and impact on burner design process

    NASA Astrophysics Data System (ADS)

    Schiro, Fabio; Stoppato, Anna; Benato, Alberto

    2017-11-01

    The advancements on gas boiler technology run in parallel with the growth of renewable energy production. The renewable production will impact on the fuel gas quality, since the gas grid will face an increasing injection of alternative fuels (biogas, biomethane, hydrogen). Biogas allows producing energy with a lower CO2 impact; hydrogen production by electrolysis can mitigate the issues related to the mismatch between energy production by renewable and energy request. These technologies will contribute to achieve the renewable production targets, but the impact on whole fuel gas production-to-consumption chain must be evaluated. In the first part of this study, the Authors present the future scenario of the grid gas composition and the implications on gas fed appliances. Given that the widely used premixed burners are currently designed mainly by trial and error, a broader fuel gas quality range means an additional hitch on this design process. A better understanding and structuring of this process is helpful for future appliance-oriented developments. The Authors present an experimental activity on a premixed condensing boiler setup. A test protocol highlighting the burners' flexibility in terms of mixture composition is adopted and the system fuel flexibility is characterized around multiple reference conditions.

  11. Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

    PubMed

    Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

    2011-11-29

    In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches.

  12. Safety of laboratory analyzers for infection testing - results of the market surveillance by the BfArM until end 2007

    PubMed Central

    2009-01-01

    The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) stipulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of issues and field corrective actions, the manufacturers have to inform the responsible Competent Authorities (CA). In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, with a small subset of IVD for immune hematological and infectiological testing as well as tissue typing as specified in Annex II of the Directive, being within the responsibility of the Paul-Ehrlich-Institute (PEI). In this study, all issues regarding laboratory analyzers for infection testing and their consumables, but not reagents, kits and general culture media, reported to the BfArM between begin 1999 and end of 2007 were analyzed in respect to the sources of report, the underlying product failure and the performed corrective actions. Within the observation period a total of 1471 reports for IVD were received of which 73 related to the IVD for infection testing were included in our study. Reports were predominantly received from manufacturers (56) and competent authorities (15). Affected products were most frequently those for immunological analysis (42) whereas those based on culturing techniques (17) and molecular biological techniques (14) played only minor roles. In all these groups, laboratory analyzers (55) were more frequently affected than their consumables (18). Investigations of the manufacturers were able to identify the underlying root causes of product failures in 62 cases (84.9%). In 2 cases (2.7%) the root cause remained unclear and in 9 cases (12.3%) a product failure was excluded or a user error was the underlying cause. Product failures in laboratory analyzers were most frequently caused by software errors (31) and constructional faults (8) whereas the predominant cause of product failure in consumables were errors in production and quality control (8). Manufacturers issued corrective measures in 66 cases (90.4%) from which 49 and 17 were related to laboratory analyzers and their consumables, respectively. Based on the underlying root causes of product failures these were predominantly customer information (48), recalls (40), software-updates (30) and design changes (9) in the product group of laboratory analyzers as well as customer information (16), recalls (12) and modifications of production and quality management (11) in the group of consumables. The results and experiences obtained since 1999 suggest that the system for post marketing surveillance of IVD is an established tool to ensure product safety, even though the current system can be further enhanced. PMID:20156760

  13. Initiation of depleted uranium oxide and spent fuel testing for the spent fuel sabotage aerosol ratio program.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gregson, Michael Warren; Mo, Tin; Sorenson, Ken Bryce

    The authors provide a detailed overview of an on-going, multinational test program that is developing aerosol data for some spent fuel sabotage scenarios on spent fuel transport and storage casks. Experiments are being performed to quantify the aerosolized materials plus volatilized fission products generated from actual spent fuel and surrogate material test rods, due to impact by a high-energy-density device. The program participants in the United States plus Germany, France and the United Kingdom, part of the international Working Group for Sabotage Concerns of Transport and Storage Casks (WGSTSC) have strongly supported and coordinated this research program. Sandia National Laboratoriesmore » has the lead role for conducting this research program; test program support is provided by both the US Department of Energy and the US Nuclear Regulatory Commission. The authors provide a summary of the overall, multiphase test design and a description of all explosive containment and aerosol collection test components used. They focus on the recently initiated tests on 'surrogate' spent fuel, unirradiated depleted uranium oxide and forthcoming actual spent fuel tests, and briefly summarize similar results from completed surrogate tests that used non-radioactive, sintered cerium oxide ceramic pellets in test rods.« less

  14. Measurement of endocrine disrupting and asthma-associated chemicals in hair products used by Black women.

    PubMed

    Helm, Jessica S; Nishioka, Marcia; Brody, Julia Green; Rudel, Ruthann A; Dodson, Robin E

    2018-08-01

    Personal care products are a source of exposure to endocrine disrupting and asthma-associated chemicals. Because use of hair products differs by race/ethnicity, these products may contribute to exposure and disease disparities. This preliminary study investigates the endocrine disrupting and asthma-associated chemical content of hair products used by U.S. Black women. We used gas chromatography/mass spectrometry (GC/MS) to test 18 hair products in 6 categories used by Black women: hot oil treatment, anti-frizz/polish, leave-in conditioner, root stimulator, hair lotion, and relaxer. We tested for 66 chemicals belonging to 10 chemical classes: ultraviolet (UV) filters, cyclosiloxanes, glycol ethers, fragrances, alkylphenols, ethanolamines, antimicrobials, bisphenol A, phthalates, and parabens. The hair products tested contained 45 endocrine disrupting or asthma-associated chemicals, including every targeted chemical class. We found cyclosiloxanes, parabens, and the fragrance marker diethyl phthalate (DEP) at the highest levels, and DEP most frequently. Root stimulators, hair lotions, and relaxers frequently contained nonylphenols, parabens, and fragrances; anti-frizz products contained cyclosiloxanes. Hair relaxers for children contained five chemicals regulated by California's Proposition 65 or prohibited by EU cosmetics regulation. Targeted chemicals were generally not listed on the product label. Hair products used by Black women and children contained multiple chemicals associated with endocrine disruption and asthma. The prevalence of parabens and DEP is consistent with higher levels of these compounds in biomonitoring samples from Black women compared with White women. These results indicate the need for more information about the contribution of consumer products to exposure disparities. A precautionary approach would reduce the use of endocrine disrupting chemicals in personal care products and improve labeling so women can select products consistent with their values. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  15. Feedforward and Feedback Control in Apraxia of Speech: Effects of Noise Masking on Vowel Production

    ERIC Educational Resources Information Center

    Maas, Edwin; Mailend, Marja-Liisa; Guenther, Frank H.

    2015-01-01

    Purpose: This study was designed to test two hypotheses about apraxia of speech (AOS) derived from the Directions Into Velocities of Articulators (DIVA) model (Guenther et al., 2006): the feedforward system deficit hypothesis and the feedback system deficit hypothesis. Method: The authors used noise masking to minimize auditory feedback during…

  16. 77 FR 43370 - TUV Rheinland of North America, Inc.; Application for Expansion of Recognition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-24

    ... scope of recognition has three elements: (1) The type of products the NRTL may test, with each type... Assistant Secretary will make the final decision on granting the application and, in making this decision... notice of this final decision in the Federal Register. Authority and Signature David Michaels, Ph.D., MPH...

  17. A University-Wide ePortfolio Initiative at Federation University Australia: Software Analysis, Test-to-Production, and Evaluation Phases

    ERIC Educational Resources Information Center

    Hains-Wesson, Rachael; Wakeling, Lara; Aldred, Peter

    2014-01-01

    This paper describes an ePortfolio implementation strategy at Federation University Australia, Victoria (formerly the University of Ballarat). The authors combined a personal and practical viewpoint to elicit pitfalls, challenges, and recommendations for improvement. The paper is divided into three main areas in order to outline the experiments…

  18. A stepwise, 'test-all-positives' methodology to assess gluten-kernel contamination at the serving-size level in gluten-free (GF) oat production.

    PubMed

    Chen, Yumin; Fritz, Ronald D; Kock, Lindsay; Garg, Dinesh; Davis, R Mark; Kasturi, Prabhakar

    2018-02-01

    A step-wise, 'test-all-positive-gluten' analytical methodology has been developed and verified to assess kernel-based gluten contamination (i.e., wheat, barley and rye kernels) during gluten-free (GF) oat production. It targets GF claim compliance at the serving-size level (of a pouch or approximately 40-50g). Oat groats are collected from GF oat production following a robust attribute-based sampling plan then split into 75-g subsamples, and ground. R-Biopharm R5 sandwich ELISA R7001 is used for analysis of all the first15-g portions of the ground sample. A >20-ppm result disqualifies the production lot, while a >5 to <20-ppm result triggers complete analysis of the remaining 60-g of ground sample, analyzed in 15-g portions. If all five 15-g test results are <20ppm, and their average is <10.67ppm (since a 20-ppm contaminant in 40g of oats would dilute to 10.67ppm in 75-g), the lot is passed. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. 78 FR 49254 - Foreign-Trade Zone 158-Vicksburg/Jackson, Mississippi; Authorization of Production Activity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    .../Jackson, Mississippi; Authorization of Production Activity; Extension of Production Authority; Bauhaus USA... Foreign-Trade Zone, Inc., grantee of FTZ 158, submitted a notification of proposed production activity to... determined that no further review of the activity is warranted at this time. The production activity...

  20. E-learning platform for automated testing of electronic circuits using signature analysis method

    NASA Astrophysics Data System (ADS)

    Gherghina, Cǎtǎlina; Bacivarov, Angelica; Bacivarov, Ioan C.; Petricǎ, Gabriel

    2016-12-01

    Dependability of electronic circuits can be ensured only through testing of circuit modules. This is done by generating test vectors and their application to the circuit. Testability should be viewed as a concerted effort to ensure maximum efficiency throughout the product life cycle, from conception and design stage, through production to repairs during products operating. In this paper, is presented the platform developed by authors for training for testability in electronics, in general and in using signature analysis method, in particular. The platform allows highlighting the two approaches in the field namely analog and digital signature of circuits. As a part of this e-learning platform, it has been developed a database for signatures of different electronic components meant to put into the spotlight different techniques implying fault detection, and from this there were also self-repairing techniques of the systems with this kind of components. An approach for realizing self-testing circuits based on MATLAB environment and using signature analysis method is proposed. This paper analyses the benefits of signature analysis method and simulates signature analyzer performance based on the use of pseudo-random sequences, too.

  1. Authorised allergen products for intracutaneous testing may no longer be available in Germany: Allergy textbooks have to be re-written.

    PubMed

    Klimek, Ludger; Werfel, Thomas; Vogelberg, Christian; Jung, Kirsten

    Beside the skin prick test, the intracutaneous test represents the most important skin test method for detecting type-1 allergies. With the incorporation of European directives into national law, test allergens used for allergy diagnosis are deemed medicinal products within the meaning of the German Medicinal Products Act (Arzneimittelgesetz) and therefore require marketing authorisation for distribution in Germany. The high costs of acquiring and maintaining these authorisations have lead to no new finished intracutaneous test products being authorized in Germany for more than 20 years. Instead, most manufacturers have voluntarily withdrawn their existing marketing authorisations for intracutaneous test extracts. The last manufacturer to offer approved finished allergen products for intracutaneous tests recently announced that it would now cease production and distribution of these solutions. Research on the current European and German legislation; selective literature search in Medline, including national and international guidelines and Cochrane meta-analyses; licensing information on the Paul-Ehrlich-Institute homepage (www.pei.de) as well as in the Bundesanzeiger (Federal Gazette). According to information on www.pei.de, marketing authorisations still existed as of 31.01.2015 for intracutaneous test solutions of six grass/cereal/herbal pollens, seven tree pollens, ten food allergens, twelve moulds and yeasts as well as two fungal mixtures, five house dust and storage mites and five animal epithelia/danders, all held by only one company in Germany. These marketing authorisations were granted between 16th March 1987 and 17th January 1992; more recent marketing authorisations do not exist. European legislation and the associated increase in production and licensing costs have already lead to numerous suppliers withdrawing their marketing authorisation for diagnostic test allergens - marketing authorisations for 443 diagnostic allergens were voluntarily withdrawn by manufacturers in 2013 alone. If the announced restrictions on the allergen portfolio go ahead, considerable problems in the management of allergy patients in Germany due to the discontinuation of the intracutaneous test are likely to be encountered. Moreover, the fact that a diagnostic procedure that has been established for decades seems set to disappear quite simply because all the requisite substances vanish from the market in one fell swoop may well be without parallel in modern medicine. The situation for skin prick test allergens is less dramatic, although, here again, the available range is becoming increasingly limited.

  2. Leather waste--potential threat to human health, and a new technology of its treatment.

    PubMed

    Kolomaznik, K; Adamek, M; Andel, I; Uhlirova, M

    2008-12-30

    In this paper, the authors deal with the problem of processing various types of waste generated by leather industry, with special emphasis to chrome-tanned waste. The agent that makes this waste potentially hazardous is hexavalent chromium. Its compounds can have negative effects on human health and some CrVI salts are considered carcinogens. The authors present the risks of spontaneous oxidization of CrIII to CrVI in the open-air dumps as well as the possible risks of wearing bad quality shoes, in which the chromium content is not controlled. There are several ways of handling primary leather waste, but no satisfactory technology has been developed for the secondary waste (manipulation waste, e.g. leather scraps and used leather products). In this contribution, a new three-step hybrid technology of processing manipulation waste is presented and tested under laboratory, pilot-scale and industrial conditions. The filtrate can be used as a good quality NPK fertilizer. The solid product, titanium-chromium sludge, can serve as an inorganic pigment in glass and ceramic industry. Further, the authors propose selective collection of used leather products (e.g. old shoes), the hydrolysable parts of which can be also processed by the new hybrid technology.

  3. A regulator of ubiquitin-proteasome activity, 2-hexyldecanol, suppresses melanin synthesis and the appearance of facial hyperpigmented spots.

    PubMed

    Hakozaki, T; Laughlin, T; Zhao, S; Wang, J; Deng, D; Jewell-Motz, E; Elstun, L

    2013-07-01

    2-Hexyldecanol has long been used in skin-care products, but has not previously been reported as an active ingredient for skin benefits. To evaluate 2-hexyldecanol in in vitro and ex vivo systems and, if found to be active, progress it to topical clinical testing to determine effects on pigmentation in skin. 2-Hexyldecanol was tested in melanocyte cell culture systems (B16 mouse melanoma cells and normal human melanocytes) for its effect on proteolytic activity and melanin production, in the absence and presence of the proteasome-specific inhibitor, MG132. It was further tested in a human skin explant model for its effect on melanin production. Lastly, topically applied 2-hexyldecanol was evaluated for its effect on the appearance of facial pigmentation in an 8-week, randomized, double-blind, vehicle-controlled, split-face incomplete block design study in Chinese women. In submerged cell culture, 2-hexyldecanol upregulated proteolytic activity and decreased melanin synthesis. These effects were antagonized by the proteasome-specific inhibitor MG132. MG132, tested in the absence of 2-hexyldecanol, increased melanin production. In a human skin explant model, topical 2-hexyldecanol suppressed the production of melanin vs. a vehicle control. In a human clinical study in Chinese women (n = 110 observations per test material), a 2-hexyldecanol-containing formulation significantly reduced the appearance of facial hyperpigmented spots vs. its control. These data indicate that regulation of proteasome activity is a viable target for control of melanin production, that 2-hexyldecanol upregulates proteasomal activity in melanocytes, and that topical 2-hexyldecanol reduces the appearance of hyperpigmentation. © 2013 The Authors BJD © 2013 British Association of Dermatologists.

  4. The Classes of Authoring Programs.

    ERIC Educational Resources Information Center

    Kozel, Kathy

    1997-01-01

    Provides an overview of developments in authoring tools and describes ways to categorize products by platform, type of end-product, sophistication of end-product, and authoring metaphor. Discusses products from AimTech, Allegiant, Allen Communication, Asymetrix, Corel, Discovery Systems International, Enigma, Harrow Media, Horizons, Innovus,…

  5. Biowaiver monograph for immediate-release solid oral dosage forms: acetylsalicylic acid.

    PubMed

    Dressman, Jennifer B; Nair, Anita; Abrahamsson, Bertil; Barends, Dirk M; Groot, D W; Kopp, Sabine; Langguth, Peter; Polli, James E; Shah, Vinod P; Zimmer, Markus

    2012-08-01

    A biowaiver monograph for acetylsalicylic acid (ASA) is presented. Literature and experimental data indicate that ASA is a highly soluble and highly permeable drug, leading to assignment of this active pharmaceutical ingredient (API) to Class I of the Biopharmaceutics Classification System (BCS). Limited bioequivalence (BE) studies reported in the literature indicate that products that have been tested are bioequivalent. Most of the excipients used in products with a marketing authorization in Europe are not considered to have an impact on gastrointestinal motility or permeability. Furthermore, ASA has a wide therapeutic index. Thus, the risks to the patient that might occur if a nonbioequivalent product were to be incorrectly deemed bioequivalent according to the biowaiver procedure appear to be minimal. As a result, the BCS-based biowaiver procedure can be recommended for approval of new formulations of solid oral dosage forms containing ASA as the only API, including both multisource and reformulated products, under the following conditions: (1) excipients are chosen from those used in ASA products already registered in International Conference on Harmonization and associated countries and (2) the dissolution profiles of the test and the comparator products comply with the BE guidance. Copyright © 2012 Wiley Periodicals, Inc.

  6. A Comparison of Concentrations of Sodium and Related Nutrients (Potassium, Total Dietary Fiber, Total and Saturated Fat, and Total Sugar) in Private-Label and National Brands of Popular, Sodium-Contributing, Commercially Packaged Foods in the United States.

    PubMed

    Ahuja, Jaspreet K C; Pehrsson, Pamela R; Cogswell, Mary

    2017-05-01

    Private-label brands account for about one in four foods sold in US supermarkets. They provide value to consumers due to their low cost. We know of no US studies comparing the nutrition content of private-label products with corresponding national brand products. The objective was to compare concentrations of sodium and related nutrients (potassium, total dietary fiber, total and saturated fat, and total sugar) in popular sodium-contributing, commercially packaged foods by brand type (national or private-label brand). During 2010 to 2014, the Nutrient Data Laboratory of the US Department of Agriculture obtained 1,706 samples of private-label and national brand products from up to 12 locations nationwide and chemically analyzed 937 composites for sodium and related nutrients. The samples came from 61 sodium-contributing, commercially packaged food products for which both private-label and national brands were among the top 75% to 80% of brands for US unit sales. In this post hoc comparative analysis, the authors assigned a variable brand type (national or private label) to each composite and determined mean nutrient contents by brand type overall and by food product and type. The authors tested for significant differences (P<0.05) by brand type using independent sample t tests or Mann-Whitney U tests when appropriate. Overall for all foods sampled, differences between brand types were not statistically significant for any of the nutrients studied. However, differences in both directions exist for a few individual food products and food categories. Concentrations of sodium and related nutrients (potassium, total dietary fiber, total and saturated fat, and total sugar) do not differ systematically between private-label and national brands, suggesting that brand type is not a consideration for nutritional quality of foods in the United States. The study data provide public health officials with baseline nutrient content by brand type to help focus US sodium-reduction efforts. Published by Elsevier Inc.

  7. [Effect of pyrolysis products of polypropylene plastic on the defence mechanisms of the respiratory system (author's transl)].

    PubMed

    Bouley, G; Dubreuil, A; Jouany, J M; Boudène, C

    1981-01-01

    Since the use of plastic materials, a change in the pathology of fire victims has been observed. We studied the effects of a single short-term inhalation (30 min) of a sub-lethal dose of polypropylene pyrolysis products (one LD-0). Including control and test animals, 66 rats and 112 mice were used. The exposure provoked disturbances in the antixenic defense mechanisms of the respiratory system, chiefly in tracheo-bronchial defenses, since we observed a lowering of ciliary activity of 35 to 78% in test animals exposed a few hours before, compared with the controls. These changes provoked a significant increase in death-rate of test animals, following experimental airborne infection by Klebsiella pneumoniae. The combustion products of polypropylene plastic materials did not contain hydrocyanic acid nor hydrochloric acid, and neither the temperature of the inhaled air, nor the concentration of carbon monoxide could explain these effects. On the contrary, we can suspect the well known irritative properties of aldehyde compounds formed during smoldering combustion of polypropylene.

  8. The challenge of a ban on animal testing for the development of a regulated legal market for new psychoactive substances (NPS) ('legal highs') in New Zealand: Issues and options for resolution.

    PubMed

    Rychert, Marta; Wilkins, Chris

    2015-12-01

    In mid-July 2013, New Zealand passed the Psychoactive Substances Act (PSA), which allowed 'low risk' psychoactive products ('legal highs') to be approved for legal sale. In early May 2014, following public protest, the Psychoactive Substances Amendment Act (PSAA) was passed banning animal testing of psychoactive products, potentially making the new regime unworkable. To investigate strategies to overcome the impasse created by the animal testing ban. Solutions to the impasse were investigated using 'scenario' and 'stakeholder' analysis. Legislation, parliamentary debates, and regulatory statements related to the PSA and animal testing were reviewed. Strategies to resolve the impasse were discussed with stakeholders including the Psychoactive Substances Regulatory Authority (PSRA) officials, health officials, a legal high industry lawyer, and a leading legal highs manufacturer. This process generated six possible scenarios and five decision-making criteria of key importance to major stakeholders. Scenarios were then evaluated based on feedback from the industry and regulators. The six scenarios were: (1) pragmatic modification of the animal testing ban; (2) waiting until new non-animal test models are internationally accepted; (3) use of non-validated replacement test methods; (4) judicial challenge of the animal testing ban; (5) 'creative compliance' by only presenting human clinical trial results; and (6) philosophical re-conceptualisation of the 'benefits' from psychoactive products. Options 1 and 5 appear to be the most attractive overall solutions. However, both rely on a new political consensus and astute framing of the issues by political communicators. Political decision makers may be happy to accept Scenario 2 which would impose significant delays. A 'failed' pharmaceutical product with psychoactive effects may have the test data required to be approved under Scenarios 1 and 5. Ultimately, the pleasurable benefits from psychoactive products may need to be included in the debate. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. Qualitative and Semiquantitative Analysis of Doping Products Seized at the Swiss Border.

    PubMed

    Weber, Christina; Krug, Oliver; Kamber, Matthias; Thevis, Mario

    2017-05-12

    Substances developed for therapeutic use are also known to be misused by athletes as doping agents and, outside of regulated sport, for image-enhancement. This has generated a market for counterfeit doping substances. Counterfeit doping agents may be of poor pharmaceutical quality and therefore constitute health risks to consumers. This study aims to investigate the pharmaceutical quality of 1,190 doping products seized at the Swiss border. Swiss customs authorities seize incoming shipments potentially containing doping agents. Qualitative and semiquantitative analyses were performed in order to test for prohibited doping substances. The main analytical methods utilized for characterizing confiscated compounds were liquid chromatography-high resolution mass spectrometry, polyacrylamide gel electrophoresis with subsequent in-gel tryptic digestion and identification of peptidic compounds using nanoliquid chromatography-tandem mass spectrometry, and electrochemiluminescence immuno assay. For 889 (75%) of the analyzed products, the label suggested the content of anabolic agents, for 146 samples (12%) peptide hormones or growth factors, and for 113 items (9%) antiestrogens, aromatase inhibitors or other metabolic modulators. For the majority of the investigated products, the pharmaceutical quality was an unsatisfactory standard: nonapproved substances were detected and less than 20% of the products contained the claimed substance in the respective amount. A comprehensive sample of confiscated doping products was analyzed, allowing for monitoring of developments regarding the use of doping substances in Switzerland and for anticipating future trends and challenges in sports drug testing. An alarming number of tested products was of substandard pharmaceutical quality.

  10. 3-(Bromomethyl)-2-chloro-4-(methylsulfonyl)- benzoic acid: a new cause of sensitiser induced occupational asthma, rhinitis and urticaria.

    PubMed

    Suojalehto, Hille; Karvala, Kirsi; Ahonen, Saana; Ylinen, Katriina; Airaksinen, Liisa; Suuronen, Katri; Suomela, Sari; Lindström, Irmeli

    2018-04-01

    3-(Bromomethyl)-2-chloro-4-(methylsulfonyl)-benzoic acid (BCMBA) has not previously been identified as a respiratory sensitiser. We detected two cases who presented respiratory and urticaria symptoms related to BCMBA and had positive skin prick tests to the agent. Subsequently, we conducted outbreak investigations at the BCMBA-producing factory and performed clinical examinations to confirm occupational diseases. The outbreak investigations included observations of work processes, assessment of exposure, a medical survey with a questionnaire and skin prick tests with 0.5% BCMBA water solution on 85 exposed workers and 9 unexposed workers. We used specific inhalation or nasal challenge and open skin application test to investigate BCMBA-related occupational asthma, rhinitis and contact urticaria. We identified nine workers with respiratory and/or skin symptoms and positive skin prick tests to BCMBA in a chemical factory. A survey among chemical factory workers indicated a BCMBA-related sensitisation rate of 8% among all exposed workers; the rate was highest (25%) among production workers in the production hall. Sensitisation was detected only in workers with the estimated highest exposure levels. Six cases of occupational asthma, rhinitis and/or contact urticaria caused by BCMBA were confirmed with challenge tests. Asthma-provoking doses in specific inhalation challenges were very low (0.03% or 0.3% BCMBA in lactose). We identified a new low molecular weight agent causing occupational asthma, rhinitis and contact urticaria. A typical clinical picture of allergic diseases and positive skin prick tests suggest underlying IgE-mediated disease mechanisms. Stringent exposure control measures are needed in order to prevent BCMBA-related diseases. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. Patients’ mobility as an indicator for (in)efficiency:a panel data analysis on Italian health care authorities

    PubMed Central

    2013-01-01

    Abstract This paper investigates the influence of internal managerial patterns of heath care authorities on the decision of patients to migrate towards different health care organizations to avail treatments. The efficiency and productivity issues are analyzed, considering the (passive) migration as a proxy for the (in)efficient service availed. We follow the “vote by feet” theorization by Tiebout , assuming that citizens can choose to avail a health treatment in a public service provider different from their resident one. The choice for a center that is far from home implies a negative judgment to the alternative health care supplier that is closer to the patient. Testing Fixed Effects Panel Model on a sample of Italian health care authorities, a strong correlation is found among variables in our model and some relevant dependence is tested between patients’ mobility behavior and their resident authorities’ efficiency in allocating resources on the proper operating cost. Spending in the proper way on health care could bring about an enhancement of performances. Instead, wasting resources is immediately perceived by the patient, who consequently seems to move to a different health care authority. JEL code M48 PMID:23422329

  12. Conspicuous plumage colours are highly variable.

    PubMed

    Delhey, Kaspar; Szecsenyi, Beatrice; Nakagawa, Shinichi; Peters, Anne

    2017-01-25

    Elaborate ornamental traits are often under directional selection for greater elaboration, which in theory should deplete underlying genetic variation. Despite this, many ornamental traits appear to remain highly variable and how this essential variation is maintained is a key question in evolutionary biology. One way to address this question is to compare differences in intraspecific variability across different types of traits to determine whether high levels of variation are associated with specific trait characteristics. Here we assess intraspecific variation in more than 100 plumage colours across 55 bird species to test whether colour variability is linked to their level of elaboration (indicated by degree of sexual dichromatism and conspicuousness) or their condition dependence (indicated by mechanism of colour production). Conspicuous colours had the highest levels of variation and conspicuousness was the strongest predictor of variability, with high explanatory power. After accounting for this, there were no significant effects of sexual dichromatism or mechanisms of colour production. Conspicuous colours may entail higher production costs or may be more sensitive to disruptions during production. Alternatively, high variability could also be related to increased perceptual difficulties inherent to discriminating highly elaborate colours. Such psychophysical effects may constrain the exaggeration of animal colours. © 2017 The Author(s).

  13. Marx and Dahrendorf on Income Inequality, Class Consciousness and Class Conflict: An Empirical Test.

    ERIC Educational Resources Information Center

    Robinson, Robert V.; Kelley, Jonathan

    The issue addressed by this paper is the lack of empirical research on the class theories of Karl Marx and Ralf Dahrendorf. In order to bridge this gap, data are analyzed on the theoretical and statistical implications of Marx's theory (which focuses on ownership of the means of production) and Dahrendorf's theory (which focuses on authority in…

  14. 40 CFR Appendix 4 to Subpart A of... - Protocol for the Determination of Degradation of Non-Aqueous Base Fluids in a Marine Closed...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... test evaluates base fluid biodegradation rates by monitoring gas production due to microbial... ppm) evaluates the anaerobic (redox) condition of the bottles (dye is blue when oxygen is present... this publication is for descriptive use only, and does not constitute endorsement by EPA or the authors...

  15. 40 CFR Appendix 4 to Subpart A of... - Protocol for the Determination of Degradation of Non-Aqueous Base Fluids in a Marine Closed...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... test evaluates base fluid biodegradation rates by monitoring gas production due to microbial... ppm) evaluates the anaerobic (redox) condition of the bottles (dye is blue when oxygen is present... this publication is for descriptive use only, and does not constitute endorsement by EPA or the authors...

  16. 40 CFR Appendix 4 to Subpart A of... - Protocol for the Determination of Degradation of Non-Aqueous Base Fluids in a Marine Closed...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... test evaluates base fluid biodegradation rates by monitoring gas production due to microbial... ppm) evaluates the anaerobic (redox) condition of the bottles (dye is blue when oxygen is present... this publication is for descriptive use only, and does not constitute endorsement by EPA or the authors...

  17. Industrial planting of E. viminalis in Mendocino County

    Treesearch

    Peter C. Passof; John W. Sweeley

    1983-01-01

    The authors trace the development of a Eucalyptus reforestation program on private industrial forest land from early testing to production planting. Data is presented on a 14.2 hectare manna gum plantation which has produced an estimated yield of 481 cubic meters/ hectare after 20 years. Because manna gum has about 60 percent greater density than Douglas-fir or redwood...

  18. 77 FR 7946 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... for Infusion Pumps. 344 Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product... Infusion Pumps Legal Authority: 21 U.S.C. 351; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C... infusion pumps. An analysis of the reports reveals that a majority of the recalls and failures were caused...

  19. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Smith, R.V.

    This book reports on remedial measures for gas wells and new methods for calculating the position of the stabilized performance curves for gas wells as well as the heating value for natural gases from compositional analyses. In addition, the author includes problem solutions in an appendix and a section showing the relation between the conventional empirical equation and the theoretical performance equation of A.S. Odeh. The author successfully bridges the gap between the results of empirical testing and the theory of unsteady-state flow in porous media. It strengthens the bond between conventional reservoir engineering practices and understanding gas well behavior.more » Problems listed at the end of each chapter are excellent exercises for practitioners. This book provides information on: Natural Gas Engineering; Properties of natural gas; Application of gas laws to reservoir engineering; Gas measurement; Flow of natural gas in circular pipe and annular conductors; Flow of gas in porous media (a review); Gas well testing; Unsteady-state flow behavior of gas wells; Production forecasting for gas wells; Production decline curves for gas wells; Sizing flow strings for gas wells; Remedial measures for gas wells; Gas sales contracts; and appendices on Compressibility for natural gas, Gas measurement factors, SI metric conversion factors, and Solutions to problems.« less

  20. The longitudinal effect of drug use on productivity status of nonmetropolitan african american young adults.

    PubMed

    Roldós, María Isabel

    2014-01-01

    The purpose of this study was to investigate the longitudinal effect of marijuana and heavy alcohol use on the productivity status of nonmetropolitan African American young adults. This analysis was based on secondary data from the Family and Community Health Study. For alcohol, the study evaluated the effects on productivity status for individuals with heavy alcohol use trajectories from adolescence into young adulthood while marijuana effects were evaluated during the period when adolescents are more likely to have initiated usage (14-16 years of age). Productivity status was measured when study participants were between 18 and 21 years, for both alcohol and marijuana. Multivariate logistic regression models were used to test the association between subjects' drug use and productivity. Bivariate analysis of the effects of marijuana use indicate that marijuana users by age 16 are 35% less likely to be productive at age 21 than those who have not initiated marijuana use (p < .005). After controlling for individual, community, and family factors, the multivariate logistic models for alcohol and marijuana use suggest that early adolescence drug use (marijuana and heavy alcohol use) do not have an impact on productivity status during early adulthood. Analyzing and understanding the different drug use trajectories in relation to a productivity outcome is important for policies and research geared to preventing drug use and in identifying its relation with micro- and macro-level labor market outcomes. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  1. Cell-free synthetic biology for in vitro prototype engineering.

    PubMed

    Moore, Simon J; MacDonald, James T; Freemont, Paul S

    2017-06-15

    Cell-free transcription-translation is an expanding field in synthetic biology as a rapid prototyping platform for blueprinting the design of synthetic biological devices. Exemplar efforts include translation of prototype designs into medical test kits for on-site identification of viruses (Zika and Ebola), while gene circuit cascades can be tested, debugged and re-designed within rapid turnover times. Coupled with mathematical modelling, this discipline lends itself towards the precision engineering of new synthetic life. The next stages of cell-free look set to unlock new microbial hosts that remain slow to engineer and unsuited to rapid iterative design cycles. It is hoped that the development of such systems will provide new tools to aid the transition from cell-free prototype designs to functioning synthetic genetic circuits and engineered natural product pathways in living cells. © 2017 The Author(s).

  2. Gender trends of urology manuscript authors in the United States: a 35-year progression.

    PubMed

    Weiss, Dana A; Kovshilovskaya, Bogdana; Breyer, Benjamin N

    2012-01-01

    The presence of women in urology has gradually increased in the last 35 years with an accelerated rate in the last decade. We evaluated manuscript authorship trends by gender. Manuscript authorship is a metric that has been used as a marker of academic productivity. We hypothesized that the number of first and last author publications by women has increased proportionately to the number of women in the field during the last 35 years. We performed a bibliometric study to examine authorship gender in The Journal of Urology® and Urology®. We reviewed all original articles published from American institutions in 1974, 1979, 1984, 1989, 1994, 1999, 2004 and 2009. Of the 8,313 articles reviewed 5,461 were from American institutions, including 97.5% for which we determined author gender. There were 767 articles with female authors, including 440 first and 327 last authors. First and last female authorship increased from 2.7% of all authors in 1979 to 26.5% in 2009 (test for trend p <0.001). This authorship rate surpasses the rate of growth of women in urology, which increased from 0.24% in 1975 to 6.2% in 2008. Based on authorship gender analysis women urologists produce manuscripts at a rate that exceeds their number in the field. Findings show that women in urology are productive, active members of the academic community. Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  3. Phosphodiesterase-5 inhibitors and their analogues as adulterants of herbal and food products: analysis of the Malaysian market, 2014-16.

    PubMed

    Bujang, Nur Baizura; Chee, Chin Fei; Heh, Choon Han; Rahman, Noorsaadah Abd; Buckle, Michael J C

    2017-07-01

    Adulteration of herbal health supplements with phosphodiesterase-5 (PDE-5) inhibitors and their analogues is becoming a worldwide problem. The aim of this study was to investigate herbal and food products sold in the Malaysian market for the presence of these adulterants. Sixty-two products that claim to enhance men's sexual health were sampled between April 2014 and April 2016. These products included unregistered products seized by the Pharmacy Enforcement Division of the Ministry of Health (n = 39), products sent to the National Pharmaceutical Regulatory Agency for pre-registration testing (n = 9) and products investigated under the post-registration market surveillance programme (n = 14). The products were tested against an in-house spectral library consisting of 61 PDE-5 inhibitors and analogues using a validated liquid chromatography-mass spectrometry ion-trap-time-of-flight (LC-MS IT-TOF) method. Thirty-two (82%) of the unregistered products and two (14%) of the registered products were found to be adulterated with at least one PDE-5 inhibitor or analogue, while none of the pre-registration products contained adulterants. A total of 16 different adulterants were detected and 36% of the adulterated products contained a mixture of two or more adulterants. This study has demonstrated that the adulteration of unregistered herbal products in the Malaysian market is an alarming issue that needs to be urgently addressed by the relevant authorities.

  4. Game changer: the topology of creativity.

    PubMed

    de Vaan, Mathijs; Stark, David; Vedres, Balazs

    2015-01-01

    This article examines the sociological factors that explain why some creative teams are able to produce game changers--cultural products that stand out as distinctive while also being critically recognized as outstanding. The authors build on work pointing to structural folding--the network property of a cohesive group whose membership overlaps with that of another cohesive group. They hypothesize that the effects of structural folding on game changing success are especially strong when overlapping groups are cognitively distant. Measuring social distance separately from cognitive distance and distinctiveness independently from critical acclaim, the authors test their hypothesis about structural folding and cognitive diversity by analyzing team reassembly for 12,422 video games and the career histories of 139,727 video game developers. When combined with cognitive distance, structural folding channels and mobilizes a productive tension of rules, roles, and codes that promotes successful innovation. In addition to serving as pipes and prisms, network ties are also the source of tools and tensions.

  5. The rehabilitation engineering research center for the advancement of cognitive technologies.

    PubMed

    Heyn, Patricia Cristine; Cassidy, Joy Lucille; Bodine, Cathy

    2015-02-01

    Barring few exceptions, allied health professionals, engineers, manufacturers of assistive technologies (ATs), and consumer product manufacturers have developed few technologies for individuals with cognitive impairments (CIs). In 2004, the National Institute on Disability Rehabilitation Research (NIDRR) recognized the need to support research in this emergent field. They funded the first Rehabilitation Engineering Research Center for the Advancement of Cognitive Technologies (RERC-ACT). The RERC-ACT has since designed and evaluated existing and emerging technologies through rigorous research, improving upon existing AT devices, and creating new technologies for individuals with CIs. The RERC-ACT has contributed to the development and testing of AT products that assist persons with CIs to actively engage in tasks of daily living at home, school, work, and in the community. This article highlights the RERC-ACT's engineering development and research projects and discusses how current research may impact the quality of life for an aging population. © The Author(s) 2014.

  6. The importance of regulatory data protection or exclusive use and other forms of intellectual property rights in the crop protection industry.

    PubMed

    Carroll, Michael J

    2016-09-01

    In order for a chemical plant protection product to be authorised for sale a registration dossier has to be assembled to demonstrate safety and efficacy to the satisfaction of government regulators. These studies and tests are protected for a period of 10 years in Europe, North America and some other jurisdictions from the date of first product authorisation so that only the data owner can gain commercial benefit from the data. Subsequent regulatory reviews which require new studies should not result in further periods of regulatory data protection exclusive use for the new data but compensation should be payable to the data generator. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

  7. [Recent developments on the European ban on animal experiments for cosmetics].

    PubMed

    Ruhdel, I W

    2001-01-01

    For the second time the European Commission has postponed the sales ban on cosmetics products that have been developed and tested in animal experiments now until 2002. In the meantime the Commission wants to adopt the Seventh Amendment of the EU Cosmetics Directive. In its draft the Commission proposes to scrap the sales ban and replace it with an animal testing ban. This change would avoid possible conflicts with the WTO, however, from the animal welfare point of view would result in animal testing moving into third countries instead of avoiding them. This is because cosmetics products tested on animals outside the EU could be sold in the EU without any restrictions. As a consequence this measure would take the pressure from authorities and industry to further develop and adopt alternative methods. Other proposed measures are not acceptable from the animal welfare point of view, e.g. because they contradict Directive 86/609 and would result in a delay of the application of validated alternative methods. The Deutscher Tierschutzbund therefore still demands an immediate and complete sales ban in connection with an animal testing ban within the EU.

  8. Development of taxation system for oil production companies in Russia

    NASA Astrophysics Data System (ADS)

    Salmina, S. V.; Sboeva, I. M.; Selivanovskaya, J. I.; Khafizova, A. R.; Fomin, V. P.

    2018-01-01

    The present article is devoted to the taxation system for oil production companies in Russia. The role of oil production companies in the realization of the fiscal function of the state is shown. Tax and due receipts at the consolidated budget of the Russian Federation from major economic sectors in the years 2013-2015 are presented and analysed. An investigation of oil production taxation peculiarities is carried out. In particular, mineral extraction tax analysis is made, the said tax being one of the basic taxes paid by oil production companies. The authors come to a conclusion that mineral extraction tax in Russia needs reforming. Based on the investigation realized possible ways of taxation system development in respect of oil production companies in Russia are proposed. Thus, taking into account the fact that oil industry is very important for budget revenue formation, initially it is planned to test the new taxation system principles in a limited number of deposits, so called ‘pilot projects’. For highly profitable minefield deposits it is planned to introduce progressive and regressive index, varying depending on oil prices. Within the framework of the investigation the authors come to a conclusion that it is necessary to introduce gradually the taxation system based on the definition of surplus profit depending on the cost effectiveness and taking into account oil prices.

  9. Performance of the dot product function in radiative transfer code SORD

    NASA Astrophysics Data System (ADS)

    Korkin, Sergey; Lyapustin, Alexei; Sinyuk, Aliaksandr; Holben, Brent

    2016-10-01

    The successive orders of scattering radiative transfer (RT) codes frequently call the scalar (dot) product function. In this paper, we study performance of some implementations of the dot product in the RT code SORD using 50 scenarios for light scattering in the atmosphere-surface system. In the dot product function, we use the unrolled loops technique with different unrolling factor. We also considered the intrinsic Fortran functions. We show results for two machines: ifort compiler under Windows, and pgf90 under Linux. Intrinsic DOT_PRODUCT function showed best performance for the ifort. For the pgf90, the dot product implemented with unrolling factor 4 was the fastest. The RT code SORD together with the interface that runs all the mentioned tests are publicly available from ftp://maiac.gsfc.nasa.gov/pub/skorkin/SORD_IP_16B (current release) or by email request from the corresponding (first) author.

  10. 76 FR 4284 - Grant of Authority for Subzone Status; Tulkoff Food Products, Inc. (Dehydrated Garlic), Baltimore...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ... Status; Tulkoff Food Products, Inc. (Dehydrated Garlic), Baltimore, MD Pursuant to its authority under..., has made application to the Board for authority to establish a special-purpose subzone at the garlic... garlic products at the Tulkoff Food Products, Inc., facility located in Baltimore, Maryland (Subzone 74C...

  11. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  12. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  13. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  14. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  15. Early deictic but not other gestures predict later vocabulary in both typical development and autism.

    PubMed

    Özçalışkan, Şeyda; Adamson, Lauren B; Dimitrova, Nevena

    2016-08-01

    Research with typically developing children suggests a strong positive relation between early gesture use and subsequent vocabulary development. In this study, we ask whether gesture production plays a similar role for children with autism spectrum disorder. We observed 23 18-month-old typically developing children and 23 30-month-old children with autism spectrum disorder interact with their caregivers (Communication Play Protocol) and coded types of gestures children produced (deictic, give, conventional, and iconic) in two communicative contexts (commenting and requesting). One year later, we assessed children's expressive vocabulary, using Expressive Vocabulary Test. Children with autism spectrum disorder showed significant deficits in gesture production, particularly in deictic gestures (i.e. gestures that indicate objects by pointing at them or by holding them up). Importantly, deictic gestures-but not other gestures-predicted children's vocabulary 1 year later regardless of communicative context, a pattern also found in typical development. We conclude that the production of deictic gestures serves as a stepping-stone for vocabulary development. © The Author(s) 2015.

  16. Isolation and quantification of botulinum neurotoxin from complex matrices using the BoTest matrix assays.

    PubMed

    Dunning, F Mark; Piazza, Timothy M; Zeytin, Füsûn N; Tucker, Ward C

    2014-03-03

    Accurate detection and quantification of botulinum neurotoxin (BoNT) in complex matrices is required for pharmaceutical, environmental, and food sample testing. Rapid BoNT testing of foodstuffs is needed during outbreak forensics, patient diagnosis, and food safety testing while accurate potency testing is required for BoNT-based drug product manufacturing and patient safety. The widely used mouse bioassay for BoNT testing is highly sensitive but lacks the precision and throughput needed for rapid and routine BoNT testing. Furthermore, the bioassay's use of animals has resulted in calls by drug product regulatory authorities and animal-rights proponents in the US and abroad to replace the mouse bioassay for BoNT testing. Several in vitro replacement assays have been developed that work well with purified BoNT in simple buffers, but most have not been shown to be applicable to testing in highly complex matrices. Here, a protocol for the detection of BoNT in complex matrices using the BoTest Matrix assays is presented. The assay consists of three parts: The first part involves preparation of the samples for testing, the second part is an immunoprecipitation step using anti-BoNT antibody-coated paramagnetic beads to purify BoNT from the matrix, and the third part quantifies the isolated BoNT's proteolytic activity using a fluorogenic reporter. The protocol is written for high throughput testing in 96-well plates using both liquid and solid matrices and requires about 2 hr of manual preparation with total assay times of 4-26 hr depending on the sample type, toxin load, and desired sensitivity. Data are presented for BoNT/A testing with phosphate-buffered saline, a drug product, culture supernatant, 2% milk, and fresh tomatoes and includes discussion of critical parameters for assay success.

  17. Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union.

    PubMed

    Bolognesi, Claudia; Castoldi, Anna F; Crebelli, Riccardo; Barthélémy, Eric; Maurici, Daniela; Wölfle, Detlef; Volk, Katharina; Castle, Laurence

    2017-06-01

    Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European "Union list" of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety "in use". If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating "non standard" food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  18. KIGAM Seafloor Observation System (KISOS) for the baseline study in monitoring of gas hydrate test production in the Ulleung Basin, Korea

    NASA Astrophysics Data System (ADS)

    Lee, Sung-rock; Chun, Jong-hwa

    2013-04-01

    For the baseline study in the monitoring gas hydrate test production in the Ulleung Basin, Korea Institute of Geoscience and Mineral Resources (KIGAM) has developed the KIGAM Seafloor Observation System (KISOS) for seafloor exploration using unmanned remotely operated vehicle connected with a ship by a cable. The KISOS consists of a transponder of an acoustic positioning system (USBL), a bottom finding pinger, still camera, video camera, water sampler, and measuring devices (methane, oxygen, CTD, and turbidity sensors) mounted on the unmanned ROV, and a sediment collecting device collecting sediment on the seafloor. It is very important to monitoring the environmental risks (gas leakage and production water/drilling mud discharge) which may be occurred during the gas hydrate test production drilling. The KISOS will be applied to solely conduct baseline study with the KIGAM seafloor monitoring system (KIMOS) of the Korean gas hydrate program in the future. The large scale of environmental monitoring program includes the environmental impact assessment such as seafloor disturbance and subsidence, detection of methane gas leakage around well and cold seep, methane bubbles and dissolved methane, change of marine environments, chemical factor variation of water column and seabed, diffusion of drilling mud and production water, and biological factors of biodiversity and marine habitats before and after drilling test well and nearby areas. The design of the baseline survey will be determined based on the result of SIMAP simulation in 2013. The baseline survey will be performed to provide the gas leakage and production water/drilling mud discharge before and after gas hydrate test production. The field data of the baseline study will be evaluated by the simulation and verification of SIMAP simulator in 2014. In the presentation, the authors would like introduce the configuration of KISOS and applicability to the seafloor observation for the gas hydrate test production in the Ulleung Basin. This work was financially supported by the the Ministry of Knowledge Economy(MKE) and Gas Hydrate R/D Organization(GHDO)

  19. A cross-sectional investigation of the quality of selected medicines in Cambodia in 2010

    PubMed Central

    2014-01-01

    Background Access to good-quality medicines in many countries is largely hindered by the rampant circulation of spurious/falsely labeled/falsified/counterfeit (SFFC) and substandard medicines. In 2006, the Ministry of Health of Cambodia, in collaboration with Kanazawa University, Japan, initiated a project to combat SFFC medicines. Methods To assess the quality of medicines and prevalence of SFFC medicines among selected products, a cross-sectional survey was carried out in Cambodia. Cefixime, omeprazole, co-trimoxazole, clarithromycin, and sildenafil were selected as candidate medicines. These medicines were purchased from private community drug outlets in the capital, Phnom Penh, and Svay Rieng and Kandal provinces through a stratified random sampling scheme in July 2010. Results In total, 325 medicine samples were collected from 111 drug outlets. Non-licensed outlets were more commonly encountered in rural than in urban areas (p < 0.01). Of all the samples, 93.5% were registered and 80% were foreign products. Samples without registration numbers were found more frequently among foreign-manufactured products than in domestic ones (p < 0.01). According to pharmacopeial analytical results, 14.5%, 4.6%, and 24.6% of the samples were unacceptable in quantity, content uniformity, and dissolution test, respectively. All the ultimately unacceptable samples in the content uniformity tests were of foreign origin. Following authenticity investigations conducted with the respective manufacturers and medicine regulatory authorities, an unregistered product of cefixime collected from a pharmacy was confirmed as an SFFC medicine. However, the sample was acceptable in quantity, content uniformity, and dissolution test. Conclusions The results of this survey indicate that medicine counterfeiting is not limited to essential medicines in Cambodia: newer-generation medicines are also targeted. Concerted efforts by both domestic and foreign manufacturers, wholesalers, retailers, and regulatory authorities should help improve the quality of medicines. PMID:24593851

  20. Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

    PubMed

    Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

    2017-07-01

    The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  1. 31 CFR 593.510 - Transactions related to the importation of any round log or timber product originating in Liberia...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... importation of any round log or timber product originating in Liberia authorized. 593.510 Section 593.510... importation of any round log or timber product originating in Liberia authorized. Except as otherwise... into the United States of any round log or timber product originating in Liberia are authorized. ...

  2. 31 CFR 593.510 - Transactions related to the importation of any round log or timber product originating in Liberia...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... importation of any round log or timber product originating in Liberia authorized. 593.510 Section 593.510... importation of any round log or timber product originating in Liberia authorized. Except as otherwise... into the United States of any round log or timber product originating in Liberia are authorized. ...

  3. Development and regulation of biosimilars: current status and future challenges.

    PubMed

    Tsiftsoglou, Asterios S; Ruiz, Sol; Schneider, Christian K

    2013-06-01

    Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems. The licencing of these products, however, relies on the experience gained with the original biopharmaceuticals. Critical issues related to this class of medicinal products include their terminology (to avoid confusion with generics and non-innovator copy versions that have not been tested according to the biosimilar guidelines), manufacturing, and regulation. The European Union (EU) has been the first to establish a regulatory framework for marketing authorization application (MAA) and has named these products biosimilars, a term also recently adopted by the US FDA. Unlike the conventional, more common small molecular weight human medicines and chemical generics, protein-based medicines exhibit higher molecular weight, complexity in structure and function that can be affected by changes in the manufacturing process. Therefore, biosimilars represent a relatively heterogeneous class of medicinal products that make their regulation quite challenging. According to the current understanding in the EU, a biosimilar is a copy version of an already authorized biopharmaceutical (or reference product) with similar biologic activity, physicochemical characteristics, efficacy, and safety, based on a full comparability exercise at quality, preclinical and clinical level to ensure similar efficacy and safety. Guidance has been provided through several Committee for Medicinal Products for Human Use (CHMP) guidelines as well as individual scientific advice requested from the European Medicines Agency (EMA) by various companies for the development and regulation of biosimilars. This review is mainly focused on the current status of regulation of biosimilars in the EU as well as on future challenges lying ahead for the improvement of the requirements needed for the marketing authorization of biosimilars. Emphasis is given on the quality requirements concerning these medicinal products (biologics).

  4. Marketing of personalized cancer care on the web: an analysis of Internet websites.

    PubMed

    Gray, Stacy W; Cronin, Angel; Bair, Elizabeth; Lindeman, Neal; Viswanath, Vish; Janeway, Katherine A

    2015-05-01

    Internet marketing may accelerate the use of care based on genomic or tumor-derived data. However, online marketing may be detrimental if it endorses products of unproven benefit. We conducted an analysis of Internet websites to identify personalized cancer medicine (PCM) products and claims. A Delphi Panel categorized PCM as standard or nonstandard based on evidence of clinical utility. Fifty-five websites, sponsored by commercial entities, academic institutions, physicians, research institutes, and organizations, that marketed PCM included somatic (58%) and germline (20%) analysis, interpretive services (15%), and physicians/institutions offering personalized care (44%). Of 32 sites offering somatic analysis, 56% included specific test information (range 1-152 tests). All statistical tests were two-sided, and comparisons of website content were conducted using McNemar's test. More websites contained information about the benefits than limitations of PCM (85% vs 27%, P < .001). Websites specifying somatic analysis were statistically significantly more likely to market one or more nonstandard tests as compared with standard tests (88% vs 44%, P = .04). © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  5. Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

    PubMed

    Kraft, Marc

    2008-09-03

    Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

  6. Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices

    PubMed Central

    Kraft, Marc

    2008-01-01

    Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority. PMID:20204095

  7. CARETS: A prototype regional environmental information system. Volume 12: User evaluation of experimental land use maps and related products from the central Atlantic test site

    NASA Technical Reports Server (NTRS)

    Alexander, R. H. (Principal Investigator); Mcginty, H. K., III

    1975-01-01

    The author has identified the following significant results. Recommendations resulting from the CARETS evaluation reflect the need to establish a flexible and reliable system for providing more detailed raw and processed land resource information as well as the need to improve the methods of making information available to users.

  8. 15 CFR 700.51 - Requests for priority rating authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (Continued) BUREAU OF INDUSTRY AND SECURITY, DEPARTMENT OF COMMERCE NATIONAL SECURITY INDUSTRIAL BASE... authorized include: (1) Production or construction equipment; (2) Computers when not used as production items... construction equipment. (1) A request for priority rating authority for production or construction equipment...

  9. Geologic Tests for Snowmelt Runoff on Early Mars

    NASA Astrophysics Data System (ADS)

    Kite, E. S.; Sneed, J.; Mayer, D. P.

    2017-12-01

    Data from the Curiosity rover have sharpened the question: was Early Mars climate warm enough for rainfall, or was the climate cold? The hypothesis of a cold (snow-and-ice melt) climate on Early Mars can be tested using runoff production. Runoff production cannot exceed snowmelt rate in a cold climate. Therefore, high runoff production would rule out cold conditions, and would suggest rain (or catastrophic melting of snow). How can runoff production be reliably measured? To constrain runoff production, the lead author is measuring paleochannel widths and meander wavelengths for Early Mars watersheds with well-defined drainage area. The measurement method is the same as in Kite et al., EPSL, 2015. >250 channel-width measurements and 89 meander wavelength measurements are included, representing 158 drainage areas. The catalog emphasizes better-preserved (post-Noachian) paleochannels, but includes a re-survey of previously-reported paleochannel width and wavelength measurement sites. Channel widths and wavelengths are a proxy for paleodischarge. Discharge (m3/s) can be divided by drainage area (m2) to obtain a lower bound on runoff-production (mm/hr). If runoff production >(1-3) mm/hr, then a seasonal melting snow-and-ice climate is strongly disfavored. However, high runoff production would be consistent with rainfall. Initial results will be reported at the conference. The figure shows the locations of measurement sites for Early Mars channel width (black) and meander wavelength (red).

  10. Safety, effectiveness and comparability of professional skin cleansers.

    PubMed

    Terhaer, Flora K; Bock, Meike; Fartasch, Manigé; Gabard, Bernard; Elsner, Peter; Kleesz, Peter; Landeck, Lilla; Pohrt, Ute; Seyfarth, Florian; Schliemann, Sibylle; Diepgen, Thomas L; Zagrodnik, Fred; John, Swen Malte

    2010-10-01

    There are no widely-accepted methodical specifications with which to objectify cleansing effectiveness and skin compatibility of occuptional skin cleansing products in Europe. Therefore the German Social Insurance Agency (DGUV) initiated a study with the goal to evaluate such products in view of the potency and the safety of hand cleansers. A market analysis was a part of the project. The product descriptions and safety data sheets of 120 products (5-20/manufacturer) of 11 manufacturers were evaluated between 02/2008 and 04/2008. The manufacturers used mainly ingredients of low irritancy. The declaration of the applied ingredients was in the majority of the cases correctly labeled according to the INCI Declaration. Although there was documentation of skin tolerability for most products, the manufacturers used widely differing tests of skin compatibility. Evidences for cleansing effectiveness were not declared or have not been provided. One manufacturer even promised medical effects of its products. There was no uniform general classification of products making it difficult to identify characteristics of cleansers and choose between them. Presently, there are no commonly accepted criteria to classify products in view of cleansing effectiveness und skin compatibility. Generally accepted criteria and test methods are needed for the evaluation of hand cleansers in order to provide the possibility of transparency and comparability. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.

  11. Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators.

    PubMed

    Dodt, J; Hubbard, A R; Wicks, S J; Gray, E; Neugebauer, B; Charton, E; Silvester, G

    2015-07-01

    A workshop organized by the European Medicines Agency and the European Directorate for the Quality of Medicines and HealthCare was held in London, UK on November 28-29, 2013, to provide an overview of the current knowledge of the characterization of new factor VIII (FVIII) and factor IX (FIX) concentrates with respect to potency assays and testing of postinfusion material. The objective was to set the basis for regulatory authorities' discussion on the most appropriate potency assay for the individual products, and European Pharmacopoeia (Ph. Eur.) discussion on whether to propose revision of the Ph. Eur. monographs with respect to potency assays in the light of information on new FVIII and FIX concentrates. The workshop showed that for all products valid assays vs. the international concentrate standards were obtained and potency could be expressed in International Units. The Ph. Eur. chromogenic potency assay gave valid assay results which correlate with in vivo functionality of rFVIII products. For some modified rFVIII products and all modified rFIX products, one-stage clotting assay methods result in different potencies depending on the activated partial thromboplastin time reagent. As a consequence, monitoring of patients' postinfusion levels is challenging but it was pointed out that manufacturers are responsible for providing the users with appropriate information for use and laboratory testing of their product. Strategies to avoid misleading determination of patents' plasma levels, e.g. information on suitable assays, laboratory standards or correction factors were discussed. © 2015 John Wiley & Sons Ltd.

  12. New challenges in assuring vaccine quality.

    PubMed Central

    Dellepiane, N.; Griffiths, E.; Milstien, J. B.

    2000-01-01

    In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

  13. Potency testing of veterinary vaccines: the way from in vivo to in vitro.

    PubMed

    Romberg, Judith; Lang, Stefan; Balks, Elisabeth; Kamphuis, Elisabeth; Duchow, Karin; Loos, Daniela; Rau, Henriette; Motitschke, Andreas; Jungbäck, Carmen

    2012-01-01

    Current quality control of inactivated animal vaccines still focuses on the potency of final products in a batch-wise manner. Animal welfare concerns as well as scientific considerations have led to the '3Rs-concept' that comprises the refinement of animal procedures, the reduction of animal numbers, and the replacement of animal models. Although the 3Rs-concept has been widely accepted as a fundamental principle, the number of approved alternatives for in vivo tests is still limited. To promote further progress, the international scientific workshop 'Potency Testing of Veterinary Vaccines: The Way from in vivo to in vitro' was held at the Paul-Ehrlich-Institut in Langen, Germany, on 01-03 December 2010. More than 130 participants from industry, academia and regulatory authorities discussed the current state of the 3Rs-concept, examples of its successful implementation as well as still existing hurdles. Special emphasis was laid on the 'consistency approach' that aims to ensure relevant quality attributes of vaccine batches by in vitro analyses during production rather than by in vivo potency tests on the final product. This report provides an overview of the insights gained, including the recommendations produced at the end of the workshop. Copyright © 2011. Published by Elsevier Ltd.. All rights reserved.

  14. Oromucosal film preparations: classification and characterization methods.

    PubMed

    Preis, Maren; Woertz, Christina; Kleinebudde, Peter; Breitkreutz, Jörg

    2013-09-01

    Recently, the regulatory authorities have enlarged the variety of 'oromucosal preparations' by buccal films and orodispersible films. Various film preparations have entered the market and pharmacopoeias. Due to the novelty of the official monographs, no standardized characterization methods and quality specifications are included. This review reports the methods of choice to characterize oromucosal film preparations with respect to biorelevant characterization and quality control. Commonly used dissolution tests for other dosage forms are not transferable for films in all cases. Alternatives and guidance on decision, which methods are favorable for film preparations are discussed. Furthermore, issues about requirements for film dosage forms are reflected. Oromucosal film preparations offer a wide spectrum of opportunities. There are a lot of suggestions in the literature on how to control the quality of these innovative products, but no standardized tests are available. Regulatory authorities need to define the standards and quality requirements more precisely.

  15. Do pressures to publish increase scientists' bias? An empirical support from US States Data.

    PubMed

    Fanelli, Daniele

    2010-04-21

    The growing competition and "publish or perish" culture in academia might conflict with the objectivity and integrity of research, because it forces scientists to produce "publishable" results at all costs. Papers are less likely to be published and to be cited if they report "negative" results (results that fail to support the tested hypothesis). Therefore, if publication pressures increase scientific bias, the frequency of "positive" results in the literature should be higher in the more competitive and "productive" academic environments. This study verified this hypothesis by measuring the frequency of positive results in a large random sample of papers with a corresponding author based in the US. Across all disciplines, papers were more likely to support a tested hypothesis if their corresponding authors were working in states that, according to NSF data, produced more academic papers per capita. The size of this effect increased when controlling for state's per capita R&D expenditure and for study characteristics that previous research showed to correlate with the frequency of positive results, including discipline and methodology. Although the confounding effect of institutions' prestige could not be excluded (researchers in the more productive universities could be the most clever and successful in their experiments), these results support the hypothesis that competitive academic environments increase not only scientists' productivity but also their bias. The same phenomenon might be observed in other countries where academic competition and pressures to publish are high.

  16. Sample size determination for a three-arm equivalence trial of Poisson and negative binomial responses.

    PubMed

    Chang, Yu-Wei; Tsong, Yi; Zhao, Zhigen

    2017-01-01

    Assessing equivalence or similarity has drawn much attention recently as many drug products have lost or will lose their patents in the next few years, especially certain best-selling biologics. To claim equivalence between the test treatment and the reference treatment when assay sensitivity is well established from historical data, one has to demonstrate both superiority of the test treatment over placebo and equivalence between the test treatment and the reference treatment. Thus, there is urgency for practitioners to derive a practical way to calculate sample size for a three-arm equivalence trial. The primary endpoints of a clinical trial may not always be continuous, but may be discrete. In this paper, the authors derive power function and discuss sample size requirement for a three-arm equivalence trial with Poisson and negative binomial clinical endpoints. In addition, the authors examine the effect of the dispersion parameter on the power and the sample size by varying its coefficient from small to large. In extensive numerical studies, the authors demonstrate that required sample size heavily depends on the dispersion parameter. Therefore, misusing a Poisson model for negative binomial data may easily lose power up to 20%, depending on the value of the dispersion parameter.

  17. Clinical studies of sweat rate reduction by an over-the-counter soft-solid antiperspirant and comparison with a prescription antiperspirant product in male panelists.

    PubMed

    Swaile, D F; Elstun, L T; Benzing, K W

    2012-03-01

    Individuals with axillary hyperhidrosis have much higher than average sweat rates and are often prescribed anhydrous aluminum chloride (AlCl(3)) solutions. Topical application of these solutions can be irritating to the skin, resulting in poor compliance and lower than desired efficacy. Demonstrate the efficacy of an over the counter "clinical strength" soft-solid antiperspirant using a night time application regimen and compare to a prescription aluminum chloride (6.5%) antiperspirant using male panelists. Gravimetric hot room efficacy testing (100 F and 35% Humidity) was performed comparing an over the counter soft-solid antiperspirant to placebo in a single test. Two separate gravimetric tests were placed comparing a prescription aluminum chloride (6.5%) antiperspirant to the same soft solid product using an intent to treat model. Skin irritation was assessed daily by a trained grader. Placebo testing resulted in 85% of panelists having a reduction in sweating rate greater than 50%. Comparison testing showed the over the counter soft solid reduced sweat rate by an average of 34% better than the prescription product while resulting significantly less skin irritation. Over the counter "clinical strength" soft-solid antiperspirants can be considered as an alternative treatment to aluminum chloride antiperspirants for the treatment of heavy sweating. © 2012 The Author. BJD © 2012 British Association of Dermatologists.

  18. Machining and brazing of accelerating RF cavity

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ghodke, S.R.; Barnwal, Rajesh; Mondal, Jayant, E-mail: ghodke_barc@yahoo.co.in

    2014-07-01

    BARC has developed 2856 MHz accelerating cavities for 6 MeV, 9 MeV and 10 MeV RF Linac. New vendors are developed for mass production of accelerating cavity for future projects. New vendors are developing for diamond turning machining, cleaning and brazing processes. Fabrication involved material testing, CNC diamond turning of cavity, cavity cleaning and brazing. Before and after brazing resonance frequency (RF) of cavity was checked with vector network analyser (VNA). A power feed test setup is also fabricated to test power feed cavity before brazing. This test setup will be used to find out assembly performance of power feedmore » cavity and its coupler. This paper discusses about nano machining, cleaning and brazing processes of RF cavities. (author)« less

  19. Facilitating the exploitation of ERTS imagery using snow enhancement techniques. [geological mapping of New England test area

    NASA Technical Reports Server (NTRS)

    Wobber, F. J.; Martin, K. R. (Principal Investigator); Amato, R. V.; Leshendok, T.

    1974-01-01

    The author has identified the following significant results. The procedure for conducting a regional geological mapping program utilizing snow-enhanced ERTS-1 imagery has been summarized. While it is recognized that mapping procedures in geological programs will vary from area to area and from geologist to geologist, it is believed that the procedure tested in this project is applicable over a wide range of mapping programs. The procedure is designed to maximize the utility and value of ERTS-1 imagery and aerial photography within the initial phase of geological mapping programs. Sample products which represent interim steps in the mapping formula (e.g. the ERTS Fracture-Lineament Map) have been prepared. A full account of these procedures and products will be included within the Snow Enhancement Users Manual.

  20. Identification and ultra-high-performance liquid chromatography coupled with high-resolution mass spectrometry characterization of biosurfactants, including a new surfactin, isolated from oil-contaminated environments.

    PubMed

    Moro, Glaci V; Almeida, Rafaela T R; Napp, Amanda P; Porto, Carla; Pilau, Eduardo J; Lüdtke, Diogo S; Moro, Angélica V; Vainstein, Marilene H

    2018-05-14

    Biosurfactant-producing bacteria were isolated from samples collected in areas contaminated with crude oil. The isolates were screened for biosurfactant production using qualitative drop-collapse test, oil-spreading and emulsification assays, and measurement of their tensoactive properties. Five isolates tested positive for in the screening experiments and displayed decrease in the surface tension below 30 mN m -1 . The biosurfactants produced by these isolates were further investigated and their molecular identification revealed that they are bacteria related to the Bacillus genus. Additionally, the biosurfactants produced were chemically characterized via UHPLC-HRMS experiments, indicating the production of surfactin homologues, including a new class of these molecules. © 2018 The Authors. Microbial Biotechnology published by John Wiley & Sons Ltd and Society for Applied Microbiology.

  1. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... Authority. The Administrator shall perform, for and under the supervision of the Secretary, such duties as...

  2. [Research on Kathon CG in cosmetic and personal hygiene products].

    PubMed

    Vezia, V; Renacco, E; Castelain, P Y; Caperan, A; Lanza, M; Pastor, J

    1990-09-01

    Kathon is an anti-microbial agent that is used as a preservative in cosmetics and bodily hygiene products. At the recommended levels of usage Kathon is innocuous and has a recognised efficacy. Nevertheless, following reappearance of contact allergic eczemas due to cosmetics and bodily hygiene products different authors have reported increase in sensitisation to it. We have met the same problems in the Service de Dermatology++ of the Hospital Sainte Marguerite at Marseille and we wished to make a deeper examination of the question and to ascertain whether the current cosmetics contained Kathon CG. For this we have developed a technique of liquid chromatography and tested 44 creams. Eight contained Kathon CG, of which 2 were responsible for contact eczema in patients.

  3. Equivalence testing using existing reference data: An example with genetically modified and conventional crops in animal feeding studies.

    PubMed

    van der Voet, Hilko; Goedhart, Paul W; Schmidt, Kerstin

    2017-11-01

    An equivalence testing method is described to assess the safety of regulated products using relevant data obtained in historical studies with assumedly safe reference products. The method is illustrated using data from a series of animal feeding studies with genetically modified and reference maize varieties. Several criteria for quantifying equivalence are discussed, and study-corrected distribution-wise equivalence is selected as being appropriate for the example case study. An equivalence test is proposed based on a high probability of declaring equivalence in a simplified situation, where there is no between-group variation, where the historical and current studies have the same residual variance, and where the current study is assumed to have a sample size as set by a regulator. The method makes use of generalized fiducial inference methods to integrate uncertainties from both the historical and the current data. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.

    PubMed

    Koren, Eugen; Smith, Holly W; Shores, Elizabeth; Shankar, Gopi; Finco-Kent, Deborah; Rup, Bonita; Barrett, Yu-Chen; Devanarayan, Viswanath; Gorovits, Boris; Gupta, Shalini; Parish, Thomas; Quarmby, Valerie; Moxness, Michael; Swanson, Steven J; Taniguchi, Gary; Zuckerman, Linda A; Stebbins, Christopher C; Mire-Sluis, Anthony

    2008-04-20

    The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major importance for their successful development and licensure. Antibodies elicited by these products in many cases cause no detectable clinical effects in humans. However, antibodies to some therapeutic proteins have been shown to cause a variety of clinical consequences ranging from relatively mild to serious adverse events. In addition, antibodies can affect drug efficacy. In non-clinical studies, anti-drug antibodies (ADA) can complicate interpretation of the toxicity, pharmacokinetic (PK) and pharmacodynamic (PD) data. Therefore, it is important to develop testing strategies that provide valid assessments of antibody responses in both non-clinical and clinical studies. This document provides recommendations for antibody testing strategies stemming from the experience of contributing authors. The recommendations are intended to foster a more unified approach to antibody testing across the biopharmaceutical industry. The strategies proposed are also expected to contribute to better understanding of antibody responses and to further advance immunogenicity evaluation.

  5. Leaching of biocides used in façade coatings under laboratory test conditions.

    PubMed

    Schoknecht, Ute; Gruycheva, Jana; Mathies, Helena; Bergmann, Hannelore; Burkhardt, Michael

    2009-12-15

    The European Biocidal Products Directive 98/8/EC requires a risk assessment concerning possible effects of active ingredients on the environment. Biocides can be leached from treated materials exposed to outdoor use. These emissions have to be estimated and evaluated during the authorization procedure. Different immersion and irrigation tests were performed to investigate leaching of biocides from façade coatings. Several marketed formulations of textured coatings and paints spiked with a mixture of commonly used active ingredients (OIT, DCOIT, IPBC, carbendazim, isoproturon, diuron, terbutryn, and Irgarol 1051) were investigated. The emission process can be described by time-dependent functions that depend on the test conditions. The results of all test procedures confirm that leachability is related to water solubility and n-octanol-water partition coefficient of the active ingredients and that leaching of biocides from façade coatings is mainly a diffusion controlled process. Other factors like the composition of the product, availability and transport of water, concentration of active ingredients in the coatings, as well as UV-exposure of the coatings influence biocide emissions.

  6. The effects of diseases, drugs, and chemicals on the creativity and productivity of famous sculptors, classic painters, classic music composers, and authors.

    PubMed

    Wolf, Paul L

    2005-11-01

    Many myths, theories, and speculations exist as to the exact etiology of the diseases, drugs, and chemicals that affected the creativity and productivity of famous sculptors, classic painters, classic music composers, and authors. To emphasize the importance of a modern clinical chemistry laboratory and hematology coagulation laboratory in interpreting the basis for the creativity and productivity of various artists. This investigation analyzed the lives of famous artists, including classical sculptor Benvenuto Cellini; classical sculptor and painter Michelangelo Buonarroti; classic painters Ivar Arosenius, Edvard Munch, and Vincent Van Gogh; classic music composer Louis Hector Berlioz; and English essayist Thomas De Quincey. The analysis includes their illnesses, their famous artistic works, and the modern clinical chemistry, toxicology, and hematology coagulation tests that would have been important in the diagnosis and treatment of their diseases. The associations between illness and art may be close and many because of both the actual physical limitations of the artists and their mental adaptation to disease. Although they were ill, many continued to be productive. If modern clinical chemistry, toxicology, and hematology coagulation laboratories had existed during the lifetimes of these various well-known individuals, clinical laboratories might have unraveled the mysteries of their afflictions. The illnesses these people endured probably could have been ascertained and perhaps treated. Diseases, drugs, and chemicals may have influenced their creativity and productivity.

  7. [International trend of guidance for nanomaterial risk assessment].

    PubMed

    Hirose, Akihiko

    2013-01-01

    In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

  8. 78 FR 35603 - Foreign-Trade Zone 83-Huntsville, Alabama; Application for Production Authority; Toray Carbon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-13

    ..., Alabama; Application for Production Authority; Toray Carbon Fibers America, Inc.; (Polyacrylonitrile Fiber/Carbon Fiber Production), Decatur, Alabama An application has been submitted to the Foreign-Trade Zones... authority on behalf of Toray Carbon Fibers America, Inc. (Toray), located in Decatur, Alabama. The...

  9. [Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].

    PubMed

    Renisch, B; Lauer, W

    2014-12-01

    An integral part of the conformity assessment process for medical devices is a clinical evaluation based on clinical data. Particularly in the case of implantable devices and products of risk class III clinical trials must be performed. Since March 2010 applications for the authorization of clinical trials as well as for the waiver of the authorization requirement must be submitted centrally in Germany to the appropriate federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). In addition to authorization, approval by the responsible ethics committee is also required under law in order to begin clinical testing of medical devices in Germany. In this paper, the legal framework for the clinical testing of medical devices as well as those involved and possible procedures including evaluation criteria for the initial application of a trial and subsequent amendments are presented in detail. In addition, the reporting requirements for serious adverse events (SAEs) are explained and possible consequences of the evaluation are presented. Finally, a summary of application and registration numbers for all areas of extensive experience of the BfArM as well as requests and guidance for applicants are presented.

  10. The art and science of patient storytelling-harnessing narrative communication for behavioral interventions: the ACCE project.

    PubMed

    Houston, Thomas K; Cherrington, Andrea; Coley, Heather L; Robinson, Kimberly M; Trobaugh, John A; Williams, Jessica H; Foster, Pamela H; Ford, Daniel E; Gerber, Ben S; Shewchuk, Richard M; Allison, Jeroan J

    2011-08-01

    Narrative communication is an emerging form of persuasive communication used in health education to solicit actual patient stories. Eliciting a narrative is an open-ended process and may or may not map to desired intervention objectives or underlying behavioral constructs. In addition, incorporating actual, unscripted narratives into multimedia interventions is challenging. The authors evaluated a protocol of editing narratives for a multimedia intervention to promote smoking cessation in the African American community that maintains fidelity to the original message and was related to behavioral constructs from social cognitive theory. The authors used four steps: (a) narrative collection (videotaping), (b) narrative review (rating of content), (c) narrative editing (documentary style), and (d) pilot testing (usability and assessment of transportation). The authors videotaped 50 personal smoking cessation narratives. After coding for presence of theoretical constructs, perceived risks of smoking (present in 53% of narratives) was the most common related behavioral construct. Four narratives were chosen for inclusion in the DVD. Pilot testing showed viewers reported high level of transportation into the narrative. The authors found that some behavioral constructs were rare and difficult to solicit in this population but that the final product was engaging to the viewers. Lessons learned may be useful for other video-based behavioral interventions that incorporate personal narratives.

  11. Use of advanced modeling techniques to optimize thermal packaging designs.

    PubMed

    Formato, Richard M; Potami, Raffaele; Ahmed, Iftekhar

    2010-01-01

    Through a detailed case study the authors demonstrate, for the first time, the capability of using advanced modeling techniques to correctly simulate the transient temperature response of a convective flow-based thermal shipper design. The objective of this case study was to demonstrate that simulation could be utilized to design a 2-inch-wall polyurethane (PUR) shipper to hold its product box temperature between 2 and 8 °C over the prescribed 96-h summer profile (product box is the portion of the shipper that is occupied by the payload). Results obtained from numerical simulation are in excellent agreement with empirical chamber data (within ±1 °C at all times), and geometrical locations of simulation maximum and minimum temperature match well with the corresponding chamber temperature measurements. Furthermore, a control simulation test case was run (results taken from identical product box locations) to compare the coupled conduction-convection model with a conduction-only model, which to date has been the state-of-the-art method. For the conduction-only simulation, all fluid elements were replaced with "solid" elements of identical size and assigned thermal properties of air. While results from the coupled thermal/fluid model closely correlated with the empirical data (±1 °C), the conduction-only model was unable to correctly capture the payload temperature trends, showing a sizeable error compared to empirical values (ΔT > 6 °C). A modeling technique capable of correctly capturing the thermal behavior of passively refrigerated shippers can be used to quickly evaluate and optimize new packaging designs. Such a capability provides a means to reduce the cost and required design time of shippers while simultaneously improving their performance. Another advantage comes from using thermal modeling (assuming a validated model is available) to predict the temperature distribution in a shipper that is exposed to ambient temperatures which were not bracketed during its validation. Thermal packaging is routinely used by the pharmaceutical industry to provide passive and active temperature control of their thermally sensitive products from manufacture through end use (termed the cold chain). In this study, the authors focus on passive temperature control (passive control does not require any external energy source and is entirely based on specific and/or latent heat of shipper components). As temperature-sensitive pharmaceuticals are being transported over longer distances, cold chain reliability is essential. To achieve reliability, a significant amount of time and resources must be invested in design, test, and production of optimized temperature-controlled packaging solutions. To shorten the cumbersome trial and error approach (design/test/design/test …), computer simulation (virtual prototyping and testing of thermal shippers) is a promising method. Although several companies have attempted to develop such a tool, there has been limited success to date. Through a detailed case study the authors demonstrate, for the first time, the capability of using advanced modeling techniques to correctly simulate the transient temperature response of a coupled conductive/convective-based thermal shipper. A modeling technique capable of correctly capturing shipper thermal behavior can be used to develop packaging designs more quickly, reducing up-front costs while also improving shipper performance.

  12. A Brief Test of the Tokyo Sokushin VSE-355G3 Strong Motion Velocity Seismometer

    USGS Publications Warehouse

    Hutt, Charles R.; Evans, John R.; Yokoi, Isamu

    2008-01-01

    The VSE-355G3 seismometer is a broadband seismometer (called a 'servo velocity meter' by Tokyo Sokushin) with a specified clip level of 2 m/s and a flat response to earth velocity from 0.008 Hertz (Hz) to 70 Hz. Mr. Yokoi and Mr. Kurahashi of Tokyo Sokushin shipped one instrument to the U. S. Geological Survey's Albuquerque Seismological Laboratory (ASL) for testing in early September 2007. They gave a presentation on this instrument and some of their other products to the authors and others on September 6, 2007. Testing of the VSE-355G3, Serial Number 70520, commenced on Friday, September 7, 2007.

  13. Paraquat and pine trees in east Tennessee

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Schnell, R.L.; Toennisson, R.L.

    The Tennessee Valley Authority started a series of 8% Paraquat tests in east Tennessee on loblolly, shortleaf, and Virginia pines in the spring of 1974. In addition to species, we are also testing the effects of season of treatment application and the length of time between the completed treatment and the harvest cut. Wood samples are being analyzed by the Botany Department at the University of Tennessee in Knoxville. All three species have shown increased oleoresin production. Season of treatment did not have a significant effect on enhancement nor did length of time between treatment and harvest.

  14. 40 CFR Appendix A to Subpart Bb of... - State Requirements Incorporated by Reference in Subpart BB of Part 147 of the Code of Federal...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... Construction-no conflict with board of land commissioners' authority. Section 82-11-105 through 82-11-110... Cuttings. Rule 36.22.1013. Filing of Completion Reports, Well Logs, Analyses, Reports, and Surveys. Rule 36.... Gas Oil Ratio Tests. Rule 36.22.1217. Water Production Report. Rule 36.22.1218. Gas to be Metered...

  15. 40 CFR Appendix A to Subpart Bb of... - State Requirements Incorporated by Reference in Subpart BB of Part 147 of the Code of Federal...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... Construction-no conflict with board of land commissioners' authority. Section 82-11-105 through 82-11-110... Cuttings. Rule 36.22.1013. Filing of Completion Reports, Well Logs, Analyses, Reports, and Surveys. Rule 36.... Gas Oil Ratio Tests. Rule 36.22.1217. Water Production Report. Rule 36.22.1218. Gas to be Metered...

  16. 40 CFR Appendix A to Subpart Bb of... - State Requirements Incorporated by Reference in Subpart BB of Part 147 of the Code of Federal...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... Construction-no conflict with board of land commissioners' authority. Section 82-11-105 through 82-11-110... Cuttings. Rule 36.22.1013. Filing of Completion Reports, Well Logs, Analyses, Reports, and Surveys. Rule 36.... Gas Oil Ratio Tests. Rule 36.22.1217. Water Production Report. Rule 36.22.1218. Gas to be Metered...

  17. 40 CFR Appendix A to Subpart Bb of... - State Requirements Incorporated by Reference in Subpart BB of Part 147 of the Code of Federal...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... Construction-no conflict with board of land commissioners' authority. Section 82-11-105 through 82-11-110... Cuttings. Rule 36.22.1013. Filing of Completion Reports, Well Logs, Analyses, Reports, and Surveys. Rule 36.... Gas Oil Ratio Tests. Rule 36.22.1217. Water Production Report. Rule 36.22.1218. Gas to be Metered...

  18. 40 CFR Appendix A to Subpart Bb of... - State Requirements Incorporated by Reference in Subpart BB of Part 147 of the Code of Federal...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... Construction-no conflict with board of land commissioners' authority. Section 82-11-105 through 82-11-110... Cuttings. Rule 36.22.1013. Filing of Completion Reports, Well Logs, Analyses, Reports, and Surveys. Rule 36.... Gas Oil Ratio Tests. Rule 36.22.1217. Water Production Report. Rule 36.22.1218. Gas to be Metered...

  19. Drug development and nonclinical to clinical translational databases: past and current efforts.

    PubMed

    Monticello, Thomas M

    2015-01-01

    The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

  20. Accelerated in-vitro release testing methods for extended-release parenteral dosage forms.

    PubMed

    Shen, Jie; Burgess, Diane J

    2012-07-01

    This review highlights current methods and strategies for accelerated in-vitro drug release testing of extended-release parenteral dosage forms such as polymeric microparticulate systems, lipid microparticulate systems, in-situ depot-forming systems and implants. Extended-release parenteral dosage forms are typically designed to maintain the effective drug concentration over periods of weeks, months or even years. Consequently, 'real-time' in-vitro release tests for these dosage forms are often run over a long time period. Accelerated in-vitro release methods can provide rapid evaluation and therefore are desirable for quality control purposes. To this end, different accelerated in-vitro release methods using United States Pharmacopeia (USP) apparatus have been developed. Different mechanisms of accelerating drug release from extended-release parenteral dosage forms, along with the accelerated in-vitro release testing methods currently employed are discussed. Accelerated in-vitro release testing methods with good discriminatory ability are critical for quality control of extended-release parenteral products. Methods that can be used in the development of in-vitro-in-vivo correlation (IVIVC) are desirable; however, for complex parenteral products this may not always be achievable. © 2012 The Authors. JPP © 2012 Royal Pharmaceutical Society.

  1. 78 FR 49254 - Foreign-Trade Zone 158-Vicksburg/Jackson, Mississippi; Authorization of Production Activity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    .../Jackson, Mississippi; Authorization of Production Activity; Extension of Production Authority; H.M... the Foreign-Trade Zones (FTZ) Board on behalf of H.M. Richards, Inc., in Guntown, Mississippi. The...) is limited to 6.5 million square yards. 2. H.M. Richards, Inc., must admit all foreign upholstery...

  2. 78 FR 36523 - Foreign-Trade Zone 84-Houston, Texas; Authorization of Production Activity; Toshiba International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-17-2013] Foreign-Trade Zone 84--Houston, Texas; Authorization of Production Activity; Toshiba International Corporation; (Hybrid Electric Vehicle Motors and Generators Production); Houston, Texas On February 11, 2013, the Port of Houston Authority, grantee of FTZ 84...

  3. 9 CFR 590.620 - Authority of applicant.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority of applicant. 590.620 Section 590.620 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg...

  4. 9 CFR 590.620 - Authority of applicant.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority of applicant. 590.620 Section 590.620 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg...

  5. Does humor in radio advertising affect recognition of novel product brand names?

    PubMed

    Berg, E M; Lippman, L G

    2001-04-01

    The authors proposed that item selection during shopping is based on brand name recognition rather than recall. College students rated advertisements and news stories of a simulated radio program for level of amusement (orienting activity) before participating in a surprise recognition test. Humor level of the advertisements was varied systematically, and content was controlled. According to signal detection analysis, humor did not affect the strength of recognition memory for brand names (nonsense units). However, brand names and product types were significantly more likely to be associated when appearing in humorous advertisements than in nonhumorous advertisements. The results are compared with prior findings concerning humor and recall.

  6. An evaluation of author productivity in international radiography journals 2004–2011

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Snaith, Beverly A

    Radiography, the allied health profession, has changed beyond recognition over the last century; however, in academic terms radiography is a relatively young profession. It is therefore still establishing its professional knowledge base. This article uses peer-review author productivity distribution to evaluate its scholarly maturity. Four peer-reviewed journals in medical radiation sciences were examined over an 8-year period (2004–2011) and author productivity was compared to Lotka's law. Further analysis of the most prolific authors provided an evaluation of their characteristics. The 1306 unique authors contributed 835 articles during the study period. Of these, 1012 (77.5%) contributed only one article to themore » journals studied, with an inverse power relationship of author productivity. At the 0.1 level of significance, radiography does not fit Lotka's law (n = −2.334; c = 0.712; D{sub max} = 0.0627; Critical threshold = 0.0337). There was a significant correlation between the most prolific authors and collaboration (P = 0.002), although variation was noted in author discipline and location. The results of this study add to the discussion of radiography scholarship and demonstrate that the radiography authors have similar productivity distribution to other professions, but do not follow Lotka's law.« less

  7. Biogas crops grown in energy crop rotations: Linking chemical composition and methane production characteristics.

    PubMed

    Herrmann, Christiane; Idler, Christine; Heiermann, Monika

    2016-04-01

    Methane production characteristics and chemical composition of 405 silages from 43 different crop species were examined using uniform laboratory methods, with the aim to characterise a wide range of crop feedstocks from energy crop rotations and to identify main parameters that influence biomass quality for biogas production. Methane formation was analysed from chopped and over 90 days ensiled crop biomass in batch anaerobic digestion tests without further pre-treatment. Lignin content of crop biomass was found to be the most significant explanatory variable for specific methane yields while the methane content and methane production rates were mainly affected by the content of nitrogen-free extracts and neutral detergent fibre, respectively. The accumulation of butyric acid and alcohols during the ensiling process had significant impact on specific methane yields and methane contents of crop silages. It is proposed that products of silage fermentation should be considered when evaluating crop silages for biogas production. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  8. The relationship between human resource investments and organizational performance: a firm-level examination of equilibrium theory.

    PubMed

    Subramony, Mahesh; Krause, Nicole; Norton, Jacqueline; Burns, Gary N

    2008-07-01

    It is commonly believed that human resource investments can yield positive performance-related outcomes for organizations. Utilizing the theory of organizational equilibrium (H. A. Simon, D. W. Smithburg, & V. A. Thompson, 1950; J. G. March & H. A. Simon, 1958), the authors proposed that organizational inducements in the form of competitive pay will lead to 2 firm-level performance outcomes--labor productivity and customer satisfaction--and that financially successful organizations would be more likely to provide these inducements to their employees. To test their hypotheses, the authors gathered employee-survey and objective performance data from a sample of 126 large publicly traded U.S. organizations over a period of 3 years. Results indicated that (a) firm-level financial performance (net income) predicted employees' shared perceptions of competitive pay, (b) shared pay perceptions predicted future labor productivity, and (c) the relationship between shared pay perceptions and customer satisfaction was fully mediated by employee morale.

  9. Accelerated Stability Studies on Dried Extracts of Centella asiatica Through Chemical, HPLC, HPTLC, and Biological Activity Analyses.

    PubMed

    Kaur, Ishtdeep; Suthar, Nancy; Kaur, Jasmeen; Bansal, Yogita; Bansal, Gulshan

    2016-10-01

    Regulatory guidelines recommend systematic stability studies on a herbal product to establish its shelf life. In the present study, commercial extracts (Types I and II) and freshly prepared extract (Type III) of Centella asiatica were subjected to accelerated stability testing for 6 months. Control and stability samples were evaluated for organoleptics, pH, moisture, total phenolic content (TPC), asiatic acid, kaempherol, and high-performance thin layer chromatography fingerprints, and for antioxidant and acetylcholinesterase inhibitory activities. Markers and TPC and both the activities of each extract decreased in stability samples with respect to control. These losses were maximum in Type I extract and minimum in Type III extract. Higher stability of Type III extract than others might be attributed to the additional phytoconstituents and/or preservatives in it. Pearson correlation analysis of the results suggested that TPC, asiatic acid, and kaempferol can be taken as chemical markers to assess chemical and therapeutic shelf lives of herbal products containing Centella asiatica. © The Author(s) 2016.

  10. Income Mobility Breeds Tolerance for Income Inequality: Cross-National and Experimental Evidence.

    PubMed

    Shariff, Azim F; Wiwad, Dylan; Aknin, Lara B

    2016-05-01

    American politicians often justify income inequality by referencing the opportunities people have to move between economic stations. Though past research has shown associations between income mobility and resistance to wealth redistribution policies, no experimental work has tested whether perceptions of mobility influence tolerance for inequality. In this article, we present a cross-national comparison showing that income mobility is associated with tolerance for inequality and experimental work demonstrating that perceptions of higher mobility directly affect attitudes toward inequality. We find support for both the prospect of upward mobility and the view that peoples' economic station is the product of their own efforts, as mediating mechanisms. © The Author(s) 2016.

  11. Lotka's Law and Institutional Productivity.

    ERIC Educational Resources Information Center

    Kumar, Suresh; Sharma, Praveen; Garg, K. C.

    1998-01-01

    Examines the applicability of Lotka's Law, negative binomial distribution, and lognormal distribution for institutional productivity in the same way as it is to authors and their productivity. Results indicate that none of the distributions are applicable for institutional productivity in engineering sciences. (Author/LRW)

  12. Methane production from thermophilic co-digestion of dairy manure and waste milk obtained from therapeutically treated cows.

    PubMed

    Beneragama, Nilmini; Iwasaki, Masahiro; Umetsu, Kazutaka

    2017-02-01

    Methane production from co-digestion of dairy manure and waste milk, milk from cows treated with antibiotics for mastitis, was tested in a 2 × 4 factorial design. Four different waste milk percentages (w/w): 0% (SM), 10% (SMWM10), 20% (SMWM20) and 30% (SMWM30), were tested with two slurry percentages (w/w): 50% (A) and 25% (B) and the rest being manure at 55°C for 12 days in batch digesters. The results analyzed using a Gompertz model showed SMWM10 produced the highest methane production potential (P m )/g volatile solids added followed by SM in both A and B. This P m of SMWM10 in A and B was statistically non-significant (P > 0.05). More than 96% of cefazolin-resistant bacteria and 100% of multi-drug-resistant bacteria reductions were observed in all the treatments. Inclusion of waste milk at 10% in single stage digester enhances the methane production from dairy manure and could offer added benefit of waste milk treatment and disposal. © 2016 The Authors. Animal Science Journal published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Animal Science.

  13. Rape oil methyl ester (RME) and used cooking oil methyl ester (UOME) as alternative fuels

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hohl, G.H.

    1995-12-31

    The author presents a review about the fleet tests carried out by the Austrian Armed Forces concerning the practical application of a vegetable oil, i.e Rape Oil Methyl Ester (RME) and Used Cooking Oil Methyl Ester (UOME) as alternative fuels for vehicles under military conditions, and reviews other research results carried out in Austria. As a result of over-production in Western European agriculture, the increase in crop yields has led to tremendous surpluses. Alternative agricultural products have been sought. One alternative can be seen in biological fuel production for tractors, whereby the farmer is able to produce his own fuelmore » supply as was the case when he previously provided self-made feed for his horses. For the market introduction different activities were necessary. A considerable number of institutes and organizations including the Austrian Armed Forces have investigated, tested and developed these alternative fuels. The increasing disposal problems of used cooking oil have initiated considerations for its use. The recycling of this otherwise waste product, and its preparation for use as an alternative fuel to diesel oil, seems to be most promising.« less

  14. High resolution identity testing of inactivated poliovirus vaccines.

    PubMed

    Mee, Edward T; Minor, Philip D; Martin, Javier

    2015-07-09

    Definitive identification of poliovirus strains in vaccines is essential for quality control, particularly where multiple wild-type and Sabin strains are produced in the same facility. Sequence-based identification provides the ultimate in identity testing and would offer several advantages over serological methods. We employed random RT-PCR and high throughput sequencing to recover full-length genome sequences from monovalent and trivalent poliovirus vaccine products at various stages of the manufacturing process. All expected strains were detected in previously characterised products and the method permitted identification of strains comprising as little as 0.1% of sequence reads. Highly similar Mahoney and Sabin 1 strains were readily discriminated on the basis of specific variant positions. Analysis of a product known to contain incorrect strains demonstrated that the method correctly identified the contaminants. Random RT-PCR and shotgun sequencing provided high resolution identification of vaccine components. In addition to the recovery of full-length genome sequences, the method could also be easily adapted to the characterisation of minor variant frequencies and distinction of closely related products on the basis of distinguishing consensus and low frequency polymorphisms. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Motion laws synthesis for cam mechanisms with multiple follower displacement

    NASA Astrophysics Data System (ADS)

    Podgornyj, Yu I.; Skeeba, V. Yu; Kirillov, A. V.; Martynova, T. G.; Skeeba, P. Yu

    2018-03-01

    The research discusses the cam mechanisms design. The analysis of specialized literature indicates that the synthesis of the cam mechanisms laws of motion is currently done mainly by a standard set of acceleration curves. In some cases, the designer needs to synthesize a new acceleration law which should be task-specific and enforce a certain production step. The values of the technological loads and inertia forces loads generated by the mechanism are calculated to analyze the slay mechanism behavior in the production of closely woven fabrics. Mathematical packages MathCad and SolidWorks are used in calculations. As a result of the research, the authors propose the methodology for synthesizing the slay mechanism with multiple follower displacements for the point of contact between the reed and the fabric edge. Theoretical studies have been tested on a specific machine model (STB loom). The authors have synthesized the motion law of the filling threads beat-up mechanism for the production of strong fabrics. New basic and closing cam profiles are proposed. The results are designed to enhance the possibilities of the looms and to recommend the most efficient equipment operation modes for the producers.

  16. Gasoline risk management: a compendium of regulations, standards, and industry practices.

    PubMed

    Swick, Derek; Jaques, Andrew; Walker, J C; Estreicher, Herb

    2014-11-01

    This paper is part of a special series of publications regarding gasoline toxicology testing and gasoline risk management; this article covers regulations, standards, and industry practices concerning gasoline risk management. Gasoline is one of the highest volume liquid fuel products produced globally. In the U.S., gasoline production in 2013 was the highest on record (API, 2013). Regulations such as those pursuant to the Clean Air Act (CAA) (Clean Air Act, 2012: § 7401, et seq.) and many others provide the U.S. federal government with extensive authority to regulate gasoline composition, manufacture, storage, transportation and distribution practices, worker and consumer exposure, product labeling, and emissions from engines and other sources designed to operate on this fuel. The entire gasoline lifecycle-from manufacture, through distribution, to end-use-is subject to detailed, complex, and overlapping regulatory schemes intended to protect human health, welfare, and the environment. In addition to these legal requirements, industry has implemented a broad array of voluntary standards and best management practices to ensure that risks from gasoline manufacturing, distribution, and use are minimized. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  17. 78 FR 13857 - Foreign-Trade Zone 93-Raleigh-Durham, NC; Authorization of Production Activity; Revlon Consumer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-01

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-77-2012] Foreign-Trade Zone 93--Raleigh-Durham, NC; Authorization of Production Activity; Revlon Consumer Products Corporation (Hair Coloring Products); Oxford, NC On October 10, 2012, Revlon Consumer Products Corporation, the operator of FTZ 93G, submitted a notification of proposed production...

  18. 77 FR 72816 - Foreign-Trade Zone 20-Suffolk, VA; Authorization of Production Activity; Usui International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-06

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-53-2012] Foreign-Trade Zone 20--Suffolk, VA; Authorization of Production Activity; Usui International Corporation (Diesel Engine Fuel Lines); Chesapeake, VA On June 28, 2012, the Virginia Port Authority, grantee of FTZ 20, submitted a notification of proposed production activity to the...

  19. Mold growth on gypsum wallboard--a summary of three techniques.

    PubMed

    Menetrez, M Y; Foarde, K K; Webber, T D; Dean, T R; Betancourt, D A

    2009-01-01

    Reducing occupant exposure to mold growing on damp gypsum wallboard and controlling mold contamination in the indoor environment was studied through 1) delineation of environmental conditions required to promote and avoid mold growth and 2) efficacy testing of antimicrobial products, specifically cleaners and paints, on gypsum wallboard (GWB) surfaces. The effects of moisture and relative humidity (RH) on mold growth and transport are important in avoiding and eliminating problems. These effects have been demonstrated on GWB and are discussed in this article for use as control guidance. The authors discuss the efficacy of antimicrobial cleaners and paints to remove, eliminate, or control mold growth on GWB. Research to control Stachybotrys chartarum growth using 13 separate antimicrobial cleaners and nine varieties of antimicrobial paint on contaminated GWB was performed in laboratory testing. GWB surfaces were subjected to high RH. GWB control measures are summarized and combined, and the antimicrobial product results are explained.

  20. 27 CFR 17.6 - Signature authority.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Signature authority. 17.6... PRODUCTS General Provisions § 17.6 Signature authority. No claim, bond, tax return, or other required... other proper notification of signature authority has been filed with the TTB office where the required...

  1. Productivity--The Concept and its Uses.

    ERIC Educational Resources Information Center

    Whitmarsh, David

    1982-01-01

    Defines various aspects of productivity and indicates appropriate ways of measuring them. The author explains how productivity ratios can be used to evaluate both the technical and allocative efficiency of economic systems. The use of productivity analysis in growth accounting is also examined. (Author/RM)

  2. Microengineering of Metals and Ceramics: Part II: Special Replication Techniques, Automation and Properties; Volume 4: Advanced Micro & Nanosystems

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Brand, Oliver; Fedder, Gary K.; Hierold, Christofer; Korvink, Jan G.; Tabata, Osamu; Löhe, Detlef; Haußelt, Jürgen

    2005-10-01

    Microstructures, electronics, nanotechnology - these vast fields of research are growing together as the size gap narrows and many different materials are combined. Current research, engineering sucesses and newly commercialized products hint at the immense innovative potentials and future applications that open up once mankind controls shape and function from the atomic level right up to the visible world without any gaps. Continuing from the previous volume, authors from three major competence centres for microengineering here cover all aspects of specialized replication techniques and how to employ state-of-the-art technologies for testing and characterizing micro-scale components, and illustrate quality control aspects and strategies for automation of production procedures in view of future industrial production and commercialisation.

  3. [First results of varietal comparison and nitrogen fertilization of rapeseed in Italy (author's transl)].

    PubMed

    Benvenuti, A; Lotti, G; Izzo, R; Vicentini, G

    1975-01-01

    Some experiments of varietal comparison of various cultivars of rapeseed were carried out, determining the productivity, the oil yield and the analytical characteristics of the oils. Moreover the effects of nitrogen fertilization on the seed production and on oil characteristics were tested. The achieved results have pointed out that, referring to the chosen environment, the cv. "Matador" and "Leonessa" show the highest seed and oil productions, whereas oils extracted from the cv. "Sinus", "Erusine" and "Sinera" contain the minor quantities of erucic acid. It seem that nitrogen fertilization exerts no appreciable influence on rapeseed oil composition. The possibility of the utilization of cv. with law content in erucic acid confirms the practical validity of the cultivation of rapeseed as on oil plant.

  4. The PHENIX PbSc calorimeter and its performance

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    David, G.; Goto, Y.; Kistenev, E.

    1997-11-01

    The authors have recently completed the production of the 15552 channel PbSc Electromagnetic calorimeter for the PHENIX experiment at RHIC. The design features a single 4 tower module which is repeated throughout and which was produced with a number of QC steps designed to achieve consistent, large light yield in all channels. They present results on uniformity of the calorimeter, accuracy of a cosmic muon based precalibration scheme and test beam performance.

  5. Foreign Comparative Testing (FCT) Program Procedures Manual

    DTIC Science & Technology

    1994-01-01

    Public Law 101-189, "National Defense Authorization Act for Fiscal Years 1990 and 1991," November 29, 1989 (e) Federal Acquisition Regulation (FAR...reference (b)) shall be met for any subsequent acquisition (assuming the T&E is successful ). f. Factors, if any, that would mandate subsequent production of...States on an urgent basis. The Commander, U.S. Army Chemical Defense Research Institute, Fort Pinkerton, AL, acting in his capacity as the User

  6. 78 FR 62583 - Foreign-Trade Zone 39-Dallas-Fort Worth, Texas; Authorization of Production Activity; Lasko...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-22

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-54-2013] Foreign-Trade Zone 39--Dallas-Fort Worth, Texas; Authorization of Production Activity; Lasko Products, Inc. (Household Electric Fans); Fort Worth, Texas On May 21, 2013, Lasko Products, Inc., submitted a notification of proposed production...

  7. Time lapse survey plan on the first offshore methane hydrate production test in 2013 around the eastern Nankai Trough area by multi-component OBC seismic tool

    NASA Astrophysics Data System (ADS)

    Inamori, T.; Hayashi, T.; Asakawa, E.; Takahashi, H.; Saeki, T.

    2011-12-01

    We are planning to conduct the multi-component ocean bottom cable (hereafter OBC) seismic survey to monitor the methane hydrate dissociation zone at the 1st offshore methane hydrate production test site in the eastern Nankai Trough, Japan, in 2013. We conducted the first OBC survey in the methane hydrate concentrated zone around the eastern Nankai Trough area in 2006 by RSCS which we developed. We obtained to the good image of methane hydrate bearing layer by P-P section as similar as the conventional surface seismic survey. However, we could not obtain the good image from P-S section compared with P-P section. On the other hand, we studied the sonic velocity distribution at the Mallik 2nd production test before and after in 2007, by the sonic tool data. We could clearly delineate the decrease of S-wave velocity, however, we could not detect the decrease of P-wave velocity because of the presence of the dissociated methane gas from methane hydrate. From these reason we guess the S-wave data is more proper to delineate the condition of the methane hydrate zone at the methane hydrate production tests than P-wave data. We are now developing the new OBC system, which we call Deep-sea Seismic System (hereafter DSS). The sensor of the DSS will install three accelerometers and one hydrophone. A feasibility study to detect the methane hydrate dissociation with the DSS was carried out and we found that the methane hydrate dissociation could be detected with the DSS depending on the zone of the dissociation. And the baseline survey will be held at the 1st offshore methane hydrate production test site in summer 2012. Two monitoring surveys are planned after the methane hydrate production test in 2013. We believe that we will get the good images to delineate the methane hydrate dissociated zone from this time lapse survey. The Authors would like to thank METI, MH21 consortium and JOGMEC for permissions to publish this paper.

  8. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

    PubMed

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura; Gratieri, Tais

    2017-01-01

    Objective . The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods . A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results . Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion . Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.

  9. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

    PubMed Central

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. PMID:28280742

  10. Preliminary investigations on the use of uranium silicide targets for fission Mo-99 production

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cols, H.; Cristini, P.; Marques, R.

    1997-08-01

    The National Atomic Energy Commission (CNEA) of Argentine Republic owns and operates an installation for production of molybdenum-99 from fission products since 1985, and, since 1991, covers the whole national demand of this nuclide, carrying out a program of weekly productions, achieving an average activity of 13 terabecquerel per week. At present they are finishing an enlargement of the production plant that will allow an increase in the volume of production to about one hundred of terabecquerel. Irradiation targets are uranium/aluminium alloy with 90% enriched uranium with aluminium cladding. In view of international trends held at present for replacing highmore » enrichment uranium (HEU) for enrichment values lower than 20 % (LEU), since 1990 the authors are in contact with the RERTR program, beginning with tests to adapt their separation process to new irradiation target conditions. Uranium silicide (U{sub 3}Si{sub 2}) was chosen as the testing material, because it has an uranium mass per volume unit, so that it allows to reduce enrichment to a value of 20%. CNEA has the technology for manufacturing miniplates of uranium silicide for their purposes. In this way, equivalent amounts of Molybdenum-99 could be obtained with no substantial changes in target parameters and irradiation conditions established for the current process with Al/U alloy. This paper shows results achieved on the use of this new target.« less

  11. Potential market for novel tuberculosis diagnostics: worth the investment?

    PubMed

    Kik, Sandra V; Denkinger, Claudia M; Jefferson, Carole; Ginnard, Janet; Pai, Madhukar

    2015-04-01

    The potential available market (PAM) for new diagnostics for tuberculosis that meet the specifications of the high-priority target product profiles (TPPs) is currently unknown. We estimated the PAM in 2020 in 4 high-burden countries (South Africa, Brazil, China, and India) for tests that meet the specifications outlined in the TPPs. The yearly PAM was estimated for the most likely application of each TPP. In 2020 the PAM for all 4 countries together was estimated to be (1) 12M tests/year with a value of 48M-71M USD for a sputum smear-replacement test; (2) 16M tests/year with a value of 65M-97M USD for a biomarker test; (3) 18M tests/year with a value of 18M-35M USD for a triage test; (4) 12M tests/year with a value of 59M-2238M USD for a tuberculosis detection plus drug susceptibility test (DST) all-in-one or 1.5M tests/year for a DST that follows a positive tuberculosis detection test with a corresponding value of 75M-121M for both tuberculosis detection and DST. Although there is a considerable potential market for novel tuberculosis diagnostics that fit the specification of the TPPs in the 4 high-burden countries, the actual market for an individual product remains uncertain. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  12. Determination of pre-cecal phosphorus digestibility of inorganic phosphates and bone meal products in broilers.

    PubMed

    van Harn, J; Spek, J W; van Vuure, C A; van Krimpen, M M

    2017-05-01

    A broiler study was performed to determine the pre-cecal phosphorus (P) digestibility of 5 P sources, 3 from animal (Delfos, Calfos, and porcine bone meal) and 2 of inorganic (monocalcium phosphate [MCP] and dicalcium phosphate [DCP]) origin. Delfos is processed from bones resulting in a dicalcium phosphate product, and Calfos is processed from bones in which part of the gelatin is removed but in which the hydroxy-apatite matrix is preserved. During the first 14 d, birds were housed in floor pens bedded with wood shavings and received a commercial starter diet. At d 14, broilers were randomly assigned to pens (0.9 m2, 10 birds/pen) with a slatted floor. From d 14 onwards, one of the 6 experimental diets (a basal diet, and 5 diets containing the P sources) was provided. Test diets were replicated 6 times, and the basal diet 8 times. Electron microscopy images of test products were made in order to verify whether the spatial structure of the test products could be related to the pre-cecal P digestibility of the same products. Diets met or exceeded CVB (2011) requirements for all nutrients except for P and were formulated to contain a calcium to total P ratio of between 1.4 and 1.6 and a minimal amount of phytate P. Diets contained 5 g/kg titanium oxide as a marker to determine digestibility of P. At d 24 all birds were euthanized, after which the content of the terminal part of the ileum was sampled. The P digestibility was calculated by linear regression according to World's Poultry Science Association (WPSA) protocol for determination of pre-cecal P digestibility. Pre-cecal P digestibility of MCP, DCP, Delfos, Calfos, and porcine bone meal was 88.5, 82.4, 94.5, 86.9, and 78.2%, respectively. Based on visual inspection of electron microscopy images of test products, the spatial structure of the test products might be related to P digestibility. It is concluded that processing of bone meal increases the pre-cecal P digestibility in broilers. © The Author 2017. Published by Oxford University Press on behalf of Poultry Science Association.

  13. Optimized solar-wind-powered drip irrigation for farming in developing countries

    NASA Astrophysics Data System (ADS)

    Barreto, Carolina M.

    The two billion people produce 80% of all food consumed in the developing world and 1.3 billion lack access to electricity. Agricultural production will have to increase by about 70% worldwide by 2050 and to achieve this about 50% more primary energy has to be made available by 2035. Energy-smart agri-food systems can improve productivity in the food sector, reduce energy poverty in rural areas and contribute to achieving food security and sustainable development. Agriculture can help reduce poverty for 75% of the world's poor, who live in rural areas and work mainly in farming. The costs associated with irrigation pumping are directly affected by energy prices and have a strong impact on farmer income. Solar-wind (SW) drip irrigation (DI) is a sustainable method to meet these challenges. This dissertation shows with onsite data the low cost of SW pumping technologies correlating the water consumption (evapotranspiration) and the water production (SW pumping). The author designed, installed, and collected operating data from the six SWDI systems in Peru and in the Tohono O'odham Nation in AZ. The author developed, tested, and a simplified model for solar engineers to size SWDI systems. The author developed a business concept to scale up the SWDI technology. The outcome was a simplified design approach for a DI system powered by low cost SW pumping systems optimized based on the logged on site data. The optimization showed that the SWDI system is an income generating technology and that by increasing the crop production per unit area, it allowed small farmers to pay for the system. The efficient system resulted in increased yields, sometimes three to four fold. The system is a model for smallholder agriculture in developing countries and can increase nutrition and greater incomes for the world's poor.

  14. Full-scale flight tests of aircraft morphing structures using SMA actuators

    NASA Astrophysics Data System (ADS)

    Mabe, James H.; Calkins, Frederick T.; Ruggeri, Robert T.

    2007-04-01

    In August of 2005 The Boeing Company conducted a full-scale flight test utilizing Shape Memory Alloy (SMA) actuators to morph an engine's fan exhaust to correlate exhaust geometry with jet noise reduction. The test was conducted on a 777-300ER with GE-115B engines. The presence of chevrons, serrated aerodynamic surfaces mounted at the trailing edge of the thrust reverser, have been shown to greatly reduce jet noise by encouraging advantageous mixing of the free, and fan streams. The morphing, or Variable Geometry Chevrons (VGC), utilized compact, light weight, and robust SMA actuators to morph the chevron shape to optimize the noise reduction or meet acoustic test objectives. The VGC system was designed for two modes of operation. The entirely autonomous operation utilized changes in the ambient temperature from take-off to cruise to activate the chevron shape change. It required no internal heaters, wiring, control system, or sensing. By design this provided one tip immersion at the warmer take-off temperatures to reduce community noise and another during the cooler cruise state for more efficient engine operation, i.e. reduced specific fuel consumption. For the flight tests a powered mode was added where internal heaters were used to individually control the VGC temperatures. This enabled us to vary the immersions and test a variety of chevron configurations. The flight test demonstrated the value of SMA actuators to solve a real world aerospace problem, validated that the technology could be safely integrated into the airplane's structure and flight system, and represented a large step forward in the realization of SMA actuators for production applications. In this paper the authors describe the development of the actuator system, the steps required to integrate the morphing structure into the thrust reverser, and the analysis and testing that was required to gain approval for flight. Issues related to material strength, thermal environment, vibration, electrical power, controls, data acquisition, and engine operability are discussed. Furthermore the authors layout a road map for the next stage of development of SMA aerospace actuators. A detailed look at the requirements and specifications that may define a production SMA actuator and the technology development required to meet them are presented. A path for meeting production requirements and achieving the next level of technology readiness for both autonomous and controlled SMA actuators is proposed. This path relies strongly on cross functional and organizational teaming including industry, academia, and government.

  15. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120...

  16. To empower or not to empower your sales force? An empirical examination of the influence of leadership empowerment behavior on customer satisfaction and performance.

    PubMed

    Ahearne, Michael; Mathieu, John; Rapp, Adam

    2005-09-01

    This research focuses on the impact of leadership empowerment behavior (LEB) on customer service satisfaction and sales performance, as mediated by salespeople's self-efficacy and adaptability. Moreover, the authors propose an interactive relationship whereby LEB will be differentially effective as a function of employees' empowerment readiness. The authors' hypotheses are tested using survey data from a sample of 231 salespeople in the pharmaceutical field, along with external ratings of satisfaction from 864 customers and archival sales performance information. Results indicated that contrary to popular belief, employees with low levels of product/industry knowledge and low experience benefit the most from leadership behaviors that are empowering, whereas high-knowledge and experienced employees reap no clear benefit. The authors conclude with directions for future research and application. Copyright 2005 APA, all rights reserved.

  17. Splitting blood and blood product packaging reduces donor exposure for patients undergoing cardiopulmonary bypass.

    PubMed

    Nuszkowski, M M; Jonas, R A; Zurakowski, D; Deutsch, N

    2015-11-01

    Cardiopulmonary bypass for congenital heart surgery requires packed red cells (PRBC) and fresh frozen plasma (FFP) to be available, both for priming of the circuit as well as to replace blood loss. This study examines the hypothesis that splitting one unit of packed red blood cells and one unit of fresh frozen plasma into two half units reduces blood product exposure and wastage in the Operating Room. Beginning August 2013, the blood bank at Children's National Medical Center began splitting one unit of packed red blood cells (PRBC) and one unit of fresh frozen plasma (FFP) for patients undergoing cardiopulmonary bypass (CPB). The 283 patients who utilized CPB during calendar year 2013 were divided into 2 study groups: before the split and after the split. The principal endpoints were blood product usage and donor exposure intra-operatively and within 72 hours post-operatively. There was a significant decrease in median total donor exposures for FFP and cryoprecipitate from 5 to 4 per case (p = 0.007, Mann-Whitney U-test). However, there was no difference in the volume of blood and blood products used; in fact, there was a significant increase in the amount of FFP that was wasted with the switch to splitting the unit of FFP. We found that modification of blood product packaging can decrease donor exposure. Future investigation is needed as to how to modify packaging to minimize wastage. © The Author(s) 2015.

  18. Production of DNA minicircles less than 250 base pairs through a novel concentrated DNA circularization assay enabling minicircle design with NF-κB inhibition activity.

    PubMed

    Thibault, Thomas; Degrouard, Jeril; Baril, Patrick; Pichon, Chantal; Midoux, Patrick; Malinge, Jean-Marc

    2017-03-17

    Double-stranded DNA minicircles of less than 1000 bp in length have great interest in both fundamental research and therapeutic applications. Although minicircles have shown promising activity in gene therapy thanks to their good biostability and better intracellular trafficking, minicircles down to 250 bp in size have not yet been investigated from the test tube to the cell for lack of an efficient production method. Herein, we report a novel versatile plasmid-free method for the production of DNA minicircles comprising fewer than 250 bp. We designed a linear nicked DNA double-stranded oligonucleotide blunt-ended substrate for efficient minicircle production in a ligase-mediated and bending protein-assisted circularization reaction at high DNA concentration of 2 μM. This one pot multi-step reaction based-method yields hundreds of micrograms of minicircle with sequences of any base composition and position and containing or not a variety of site-specifically chemical modifications or physiological supercoiling. Biochemical and cellular studies were then conducted to design a 95 bp minicircle capable of binding in vitro two NF-κB transcription factors per minicircle and to efficiently inhibiting NF-κB-dependent transcriptional activity in human cells. Therefore, our production method could pave the way for the design of minicircles as new decoy nucleic acids. © The Author(s) 2016. Published by Oxford University Press on behalf of Nucleic Acids Research.

  19. An evaluation of fish early life stage tests for predicting reproductive and longer-term toxicity from plant protection product active substances.

    PubMed

    Wheeler, James R; Maynard, Samuel K; Crane, Mark

    2014-08-01

    The chronic toxicity of chemicals to fish is routinely assessed by using fish early life stage (ELS) test results. Fish full life cycle (FLC) tests are generally required only when toxicity, bioaccumulation, and persistence triggers are met or when there is a suspicion of potential endocrine-disrupting properties. This regulatory approach is based on a relationship between the results of fish ELS and FLC studies first established more than 35 yrs ago. Recently, this relationship has been challenged by some regulatory authorities, and it has been recommended that more substances should undergo FLC testing. In addition, a project proposal has been submitted to the Organisation for Economic Cooperation and Development (OECD) to develop a fish partial life cycle (PLC) test including a reproductive assessment. Both FLC and PLC tests are animal- and resource-intensive and technically challenging and should therefore be undertaken only if there is clear evidence that they are necessary for coming to a regulatory decision. The present study reports on an analysis of a database of paired fish ELS and FLC endpoints for plant protection product active substances from European Union draft assessment reports and the US Environmental Protection Agency Office of Pesticide Programs Pesticide Ecotoxicity Database. Analysis of this database shows a clear relationship between ELS and FLC responses, with similar median sensitivity across substances when no-observed-effect concentrations (NOECs) are compared. There was also no indication that classification of a substance as a mammalian reproductive toxicant leads to more sensitive effects in fish FLC tests than in ELS tests. Indeed, the response of the ELS tests was generally more sensitive than the most sensitive reproduction NOEC from a FLC test. This analysis indicates that current testing strategies and guidelines are fit for purpose and that there is no need for fish full or partial life cycle tests for most plant protection product active substances. © 2014 SETAC.

  20. Real-time PCR Tests in Dutch Exotic Mosquito Surveys; Implementation of Aedes aegypti and Aedes albopictus Identification Tests, and the Development of Tests for the Identification of Aedes atropalpus and Aedes japonicus japonicus (Diptera: Culicidae).

    PubMed

    van de Vossenberg, B T L H; Ibáñez-Justicia, A; Metz-Verschure, E; van Veen, E J; Bruil-Dieters, M L; Scholte, E J

    2015-05-01

    Since 2009, The Netherlands Food and Consumer Product Safety Authority carries out surveys focusing on, amongst others, the presence of invasive mosquito species (IMS). Special attention is given to exotic container-breeding Aedes species Aedes aegypti (L.), Aedes albopictus (Skuse), Aedes atropalpus (Coquillett), and Aedes japonicus japonicus (Theobald). This study describes the implementation of real-time PCR tests described by Hill et al. (2008) for the identification of Ae. aegypti and Ae. albopictus, and the development of two novel real-time PCR tests for the identification of Ae. atropalpus and Ae. j. japonicus. Initial test showed that optimization of elements of the Ae. aegypti and Ae. albopictus tests was needed. Method validation tests were performed to determine if the implemented and newly developed tests are fit for routine diagnostics. Performance criteria of analytical sensitivity, analytical specificity, selectivity, repeatability, and reproducibility were determined. In addition, experiments were performed to determine the influence of environmental conditions on the usability of DNA extracted from mosquito specimens trapped in BG-Sentinel traps. The real-time PCR tests were demonstrated to be sensitive, specific, repeatable, reproducible, and are less prone to false negative results compared to partial cytochrome c oxidase I gene sequencing owing to the DNA fragmentation caused by environmental influences. © The Authors 2015. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Central atlantic regional ecological test site: A prototype regional environmental information system, volume 1. [Pennsylvania, Delaware, Maryland, Virginia, and the District of Columbia

    NASA Technical Reports Server (NTRS)

    Alexander, R. H. (Principal Investigator)

    1979-01-01

    The author has identified the following significant results. LANDSAT data showed the test region in 1972 to be 9% urban and built-up land, 38% agriculture, 50% forest, 3% nonforested wetlands, and less than 1% barren land, exclusive of water-covered areas. A comprehensive user evaluation revealed greatest demand for high-altitude aerial photography and the detailed maps and data products that can be derived from the metropolitan areas agencies, found relatively little use for LANDSAT imagery at 1:250,000 scale and corresponding manually interpreted land use maps.

  2. 78 FR 37203 - Authorization of Production Activity; Subzone 196A; TTI, Inc. (Electromechanical and Circuit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-20-2013] Authorization of Production Activity; Subzone 196A; TTI, Inc. (Electromechanical and Circuit Protection Devices Production/Kitting); Fort Worth, Texas On February 13, 2013, TTI, Inc. submitted a notification of proposed production activity to the...

  3. 40 CFR 300.910 - Authorization of use.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... substantially reduce a hazard to human life. Whenever the OSC authorizes the use of a product pursuant to this... product, including products not on the Schedule, as soon as possible. Once the threat to human life has...

  4. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

    PubMed Central

    Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

    2018-01-01

    Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine-benazepril capsules), with an overall rate of 8.2 per 100 person years across all drug products. Adjusted switchback rates were consistently lower for patients who switched from branded to authorized generic drug products compared with branded to generic drug products in the primary cohort (pooled hazard ratio 0.72, 95% confidence interval 0.64 to 0.81). Similar results (0.75, 0.62 to 0.91) were observed in the replication cohort. Conclusion Switching from branded to authorized generic drug products was associated with lower switchback rates compared with switching from branded to generic drug products. PMID:29615391

  5. Clinical Usage of an Extracellular, Collagen-rich Matrix: A Case Series.

    PubMed

    AbouIssa, Abdelfatah; Mari, Walid; Simman, Richard

    2015-11-01

    OASIS Ultra (Smith and Nephew, St. Petersburg, FL) is an extracellular, collagen-rich matrix derived from submucosa of porcine intestine. It is composed of collagen type I, glycosaminoglycan, and proteoglycans. This extracellular matrix (ECM) differs from the single layer in thickness and offers ease of handling and application. It also stimulates cell migration and structural support, provides moisture environment, decreases inflammation, and induces cell proliferation and cellular attachments. In this case series, the authors present their experience with this product in various clinical scenarios. The authors used the product in a variety of wounds with different etiologies to test the clinical outcome of the ECM. This was an observational case series with prospective review of 6 different patients with different types of wounds who received treatment with the ECM during their treatment. The product was applied on the following types of wounds: chronic venous ulcer, nonhealing Achilles tendon vasculitic wound, Marjolin's ulcer, posttraumatic wound, stage IV sacral-coccygeal pressure wound, and complicated transmetatarsal amputation of gangrenous left forefoot diabetic wound. All of these wounds healed within the expected time periods and without complications. In general, healing was achieved in 4-16 weeks using 1-12 applications of the ECM. Wounds with different etiologies were successfully treated with an extracellular, collagen-rich matrix. By replacing the lost ECM to guide cellular growth and migration, this product did ultimately hasten the healing process.

  6. Reduction in blood transfusion in a cohort of infants having cardiac surgery with cardiopulmonary bypass after instituting a goal-directed transfusion policy.

    PubMed

    Machovec, Kelly A; Smigla, Gregory; Ames, Warwick A; Schwimer, Courtney; Homi, H Mayumi; Dhakal, Ishwori B; Jaquiss, Robert D B; Lodge, Andrew J; Jooste, Edmund H

    2016-10-01

    Current trends in pediatric cardiac surgery and anesthesiology include goal-directed allogeneic blood transfusion, but few studies address the transfusion of platelets and cryoprecipitate. We report a quality improvement initiative to reduce the transfusion of platelets and cryoprecipitate in infants having cardiac surgery with cardiopulmonary bypass (CPB). Data from 50 consecutive patients weighing four to ten kilograms having cardiac surgery with CPB were prospectively collected after the institution of a policy to obtain each patient's platelet and fibrinogen levels during the rewarming phase of CPB. Data from 48 consecutive patients weighing four to ten kilograms having cardiac surgery with CPB prior to the implementation of the policy change were retrospectively collected. Demographics, laboratory values and blood product transfusion data were compared between the groups, using the Chi-square/Fisher's exact test or the T-Test/Wilcoxon Rank-Sum test, as appropriate. The results showed more total blood product exposures in the control group during the time from bypass through the first twenty-four post-operative hours (median of 2 units versus 1 unit in study group, p=0.012). During the time period from CPB separation through the first post-operative day, 67% of patients in the control group received cryoprecipitate compared to 32% in the study group (p=0.0006). There was no difference in platelet exposures between the groups. Checking laboratory results during the rewarming phase of CPB reduced cryoprecipitate transfusion by 50%. This reproducible strategy avoids empiric and potentially unnecessary transfusion in this vulnerable population. © The Author(s) 2016.

  7. Compost maturity and nitrogen availability by co-composting of paddy husk and chicken manure amended with clinoptilolite zeolite.

    PubMed

    Latifah, Omar; Ahmed, Osumanu Haruna; Susilawati, Kassim; Majid, Nik Muhamad

    2015-04-01

    The availability of paddy husk from rice processing plants remains high owing to increase in the worldwide rice consumption. Increasing demand for chicken products leads to poultry wastes production. Co-composting of the aforementioned wastes could solve the indiscriminate disposal of these wastes. Thus, co-composting of paddy husk and chicken slurry with clinoptilolite zeolite and urea as additive was carried out. Clinoptilolite zeolite was used to enhance ammonium and nitrate retention in the compost. Temperature of the compost was monitored three times daily for 55 days. Cation exchange capacity, organic matter, ash, humic acids, pH, total C, N, C/N ratio; total P, exchangeable Ca, Mg, K, NH4+, NO3-, and heavy metals contents were determined using standard procedures. pH, total N, humic acids, ash, NH4+, NO3-, P, Ca, Mg, and K contents increased but the salinity, heavy metals contents, and microbial population were low after the co-composting process. Zea mays L. (test crop) seed germination rate in distilled water and the compost were not significantly different. Growth of Spinach oleracea (test crop) on a peat-based growing medium and the compost was also not significantly different. These findings were possible because the clinoptilolite zeolite used in co-composting reduced accumulation of heavy metals that may have damage effects on the test crops. Mature compost with good agronomic properties can be produced by co-composting chicken slurry and paddy husk using clinoptilolite zeolite and urea as additives. © The Author(s) 2015.

  8. Quantification of effective exoelectrogens by most probable number (MPN) in a microbial fuel cell.

    PubMed

    Heidrich, Elizabeth S; Curtis, Thomas P; Woodcock, Stephen; Dolfing, Jan

    2016-10-01

    The objective of this work was to quantify the number of exoelectrogens in wastewater capable of producing current in a microbial fuel cell by adapting the classical most probable number (MPN) methodology using current production as end point. Inoculating a series of microbial fuel cells with various dilutions of domestic wastewater and with acetate as test substrate yielded an apparent number of exoelectrogens of 17perml. Using current as a proxy for activity the apparent exoelectrogen growth rate was 0.03h(-1). With starch or wastewater as more complex test substrates similar apparent growth rates were obtained, but the apparent MPN based numbers of exoelectrogens in wastewater were significantly lower, probably because in contrast to acetate, complex substrates require complex food chains to deliver the electrons to the electrodes. Consequently, the apparent MPN is a function of the combined probabilities of members of the food chain being present. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  9. 47 CFR 1.1181 - Authority to prescribe and collect fees for competitive bidding-related services and products.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Authority to prescribe and collect fees for... § 1.1181 Authority to prescribe and collect fees for competitive bidding-related services and products. Authority to prescribe, impose, and collect fees for expenses incurred by the government is governed by the...

  10. 27 CFR 1.35 - Authority to issue, amend, deny, suspend, revoke, or annul basic permits.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Authority to issue, amend, deny, suspend, revoke, or annul basic permits. 1.35 Section 1.35 Alcohol, Tobacco Products and Firearms... SALES AND BOTTLING OF DISTILLED SPIRITS Basic Permits Authorization § 1.35 Authority to issue, amend...

  11. Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.

    PubMed

    Davis, Gregory C; Beals, John M; Johnson, Craig; Mayer, Mark H; Meiklejohn, Bruce I; Mitlak, Bruce H; Roth, Jody L; Towns, John K; Veenhuizen, Melissa

    2009-07-01

    Policy makers around the world are currently considering the creation of a regulatory pathway for follow-on biologics (FOB), which will have to account for the substantial technical challenges associated with FOB development. These challenges will likely involve more complexity than comparability assessments of process changes made by the same manufacturer. The history of industry-regulator comparability discussions helps explain why the same degree of testing and flexibility now applied to change-control within a manufacturer's own process, at this time, cannot be extrapolated to the observed and possibly unknown differences between two manufacturing processes that are independently developed by different (non-collaborating) parties. This commentary provides recommendations on the technical aspects that should be considered in the creation of an approval pathway for FOB products. In the authors' view, analytical methodology in its current state cannot alone provide full assurance that the FOB is sufficiently similar to the innovator product. Moreover, the FOB manufacturer will not have access to the extensive knowledge accumulated by the innovator manufacturer from early development through marketing. Thus, extensive clinical evaluation will likely be necessary to provide assurance that the FOB is safe and efficacious. If such testing demonstrates the FOB is safe and efficacious per existing regulatory standards, the product should receive marketing approval as a 'similar' product. Since 'similarity' is a fundamentally different determination than establishing interchangeability between the two products, an interchangeability determination must be based on additional testing and market experience to ensure patient safety. Post-marketing surveillance of the FOB should be conducted to ensure that the approved molecule has similar clinical safety and efficacy as the innovator product, prior to any consideration of interchangeability.

  12. [Professor Buytendijk's miracle drug. The vitamin preparation Eviunis and the risks of scientists doing publicity work].

    PubMed

    Huijnen, Pim

    2010-01-01

    The discovery of vitamins at the start of the 20th century not only stimulated new areas of scientific research in the field of nutrition and pharmacy; vitamins also turned out to be profitable products for new or existing industries. Consequently, vitamins drove scientists and commercial vitamin producers into each others' arms during the first decades of the century. Several publications--by Harmke Kamminga and Sally Horrocks for instance--deal with the causes and effects of forms of co-operation between science and industry in the nutritional and pharmaceutical sector. They mostly stress--using examples from Great-Britain--the interconnected interests from which both profited: industry-sponsored vitamin research made vitamins available to a larger public of consumers, with scientists authorizing the health claims of the products these companies tried to sell. This article shows how Dutch scientists and vitamin producers were concerned with the same issue in the inter-war period. Not only does it focus on the interconnected interests, but particularly on the conflicts of interests scientists were experiencing whilst performing advisory or research work for the industry. The article singles out E.J.J. Buytendijk, nowadays remembered for his pioneering research in the field of phenomenological psychology after the Second World War, and his involvement with the Swiss vitamin preparation Eviunis at the end of the nineteen-twenties. Buytendijk actively promoted the introduction of this particular preparation on the Dutch market. He was confronted with a growing number of critics, however, after tests demonstrated how the preparation could hardly sustain any of the claims that had been made with regard to its vitamin-like performance. Buytendijk's strongest critics accused him of misusing his scientific authority to sell a fraudulent product--after all, he that maintained his own tests had confirmed Eviunis' claims. A final, state-ordered counter test of Eviunis resulted in the ban of the preparation from the Dutch market. However, it did not condemn Buytendijks commitment to the product. It only concluded that the physiologist had been mistaken in his interpretation of the working of Eviunis. Buytendijk's reputation as a vitamin researcher compromised nonetheless, because of his spirited commitment to a product that turned out to sell an illusion.

  13. The CE marking in the dimension stone sector: difficulties, contradictions, possible solutions

    NASA Astrophysics Data System (ADS)

    Primavori, Piero

    2017-04-01

    In accordance with the requirements of the CPR 305/11, no stone products (covered by harmonized standards) can be introduced in the EU market, irrespective of their country of origin, unless they are supported with a Declaration of Performance (DoP) and CE certificate (= CE Marking). The CE marking became compulsory for all stone and marble products as early as 2003, under the legal framework of the CPD 89/106/CE, the EU Directive which, on July 1st, 2013, has been officially replaced by the CPR 305/11. The CE Marking of construction products has been described as one of the most significant change being faced by the construction industry for a decade. Nevertheless, after thirteen years from the introduction of the first products standard, serious difficulties for the CE Marking application still exist. The aim of this contribution is to draw the attention on the effective meaningfulness, applicability and reliability of the CE Marking, on the related aspects for the economic operators (manufacturers, authorized representatives, importers, distributors etc.) and, most of all, for the customers. The following topics and issues are dealt with: - Criteria of the mandatory tests; - Criteria for testing procedures (meaningfulness/reliability/frequency of the TT); - Non-applicability of the testing methods in particular circumstances; - Economic aspects for the companies; - Interpretation of the FPC philosophy; - Formulation of the finished products standards; - Traceability criteria of the stone material; - Threshold-values for the acceptance of a stone material; - Guarantees for the manufacturers and for the customers; - Effective precision and reliability of the DoP and related consequences for manufacturers and customers.

  14. An inventory of methods suitable to assess additive-induced characterising flavours of tobacco products.

    PubMed

    Talhout, Reinskje; van de Nobelen, Suzanne; Kienhuis, Anne S

    2016-04-01

    Products with strong non-tobacco flavours are popular among young people, and facilitate smoking initiation. Similar to the U.S. Food and Drug Administration Tobacco Control Act, the new European Tobacco Product Directive (TPD) prohibits cigarettes and roll-your-own tobacco with a characterising flavour other than tobacco. However, no methods are prescribed or operational to assess characterising flavours. This is the first study to identify, review and synthesize the existing peer-reviewed and tobacco industry literature in order to provide an inventory of methods suitable to assess characterising flavours. Authors gathered key empirical and theoretical papers examining methods suitable to assess characterising flavours. Scientific literature databases (PubMed and Scopus) and tobacco industry documents were searched, based on several keyword combinations. Inclusion criteria were relevance for smoked tobacco products, and quality of data. The findings reveal that there is a wide variation in natural tobacco flavours. Flavour differences from natural tobacco can be described by both expert and consumer sensory panels. Most methods are based on smoking tests, but odour evaluation has also been reported. Chemical analysis can be used to identify and quantify levels of specific flavour additives in tobacco products. As flavour perception is subjective, and requires human assessment, sensory analysis in consumer or expert panel studies is necessitated. We recommend developing validated tests for descriptive sensory analysis in combination with chemical-analytical measurements. Testing a broad range of brands, including those with quite subtle characterizing flavours, will provide the concentration above which an additive will impart a characterising flavour. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Individual differences in motivational activation influence responses to pictures of taboo products.

    PubMed

    Lang, Annie; Yegiyan, Narine

    2011-11-01

    In this article, the authors investigated responses to pictures of products whose use is socially or legally restricted for teens and young adults (e.g., beer, liquor, cigarettes). The authors theorized and found that these pictures are motivationally relevant and therefore elicit automatic activation in the appetitive/approach or aversive/defensive motivational systems, which leads to increased attention, arousal, emotional response, and memory for the risky products. The authors also found that these responses are mediated by individual differences in motivational reactivity. The authors suggest that placing images of these products in prevention messages may work against the prevention goal by increasing appetitive activation and positive emotion in populations more inclined to take risks.

  16. [Plant protection products and their residues : Aspects of consumer safety in context of the new EU regulations].

    PubMed

    Banasiak, U; Michalski, B; Pfeil, R; Solecki, R

    2010-06-01

    The law regulating plant protection products (PPP) in the European Union (EU) was fundamentally revised through the introduction of Regulation (EC) No. 1107/2009 which is due to enter into force on 14 June 2011. EU-wide harmonized maximum residue levels (MRLs) for the active substances of PPP in foods are laid down in Regulation (EC) No. 396/2005 and apply since entry into force of the regulation on 1 September 2008. The goal of both regulations is to strengthen the level of consumer protection. PPP are subject to a strict assessment of active substances, which is regulated at the EU level as well as an authorization procedure in the EU Member States. Prior to application for authorization of a PPP, the active substance(s) it contains must be included in a positive list. Tests regarding the toxicity and residue behavior of PPP must be conducted by the applicant, and the respective documents must be submitted to the authorities for evaluation. Following review of the required data, toxicological threshold values are derived, consumer exposure is assessed, and the risk to health is evaluated. The goal of this evaluation is to ensure that the use of PPP according to good plant protection practice does not have any harmful effects on human health.

  17. Artistic productivity and creative thinking in Parkinson's disease.

    PubMed

    Canesi, M; Rusconi, M L; Isaias, I U; Pezzoli, G

    2012-03-01

    Creative drive and enhanced artistic-like production may emerge in patients with Parkinson's disease (PD) during dopaminergic therapy. However, it has not been described to date whether this artistic-like production results from dopaminergic drugs triggering innate skills or it could be considered as a repeated behavior possibly associated with impulse control disorders (ICDs). We investigated creative drive in a cohort of cognitively preserved patients with PD by means of the Torrance Test of Creative Thinking (TTCT). We also investigated a putative association between creative drive and ICDs in 36 PD patients with (PD-c) or without (PD-nc) increased artistic-like production and 36 healthy controls (HC). We considered artistic-like productivity to be enhanced if patients reported working on any form of art more than 2h per day after the introduction of dopaminergic treatment. The TTCT, the Barratt Impulsiveness Scale (BIS-11A), the Minnesota Impulsive Disorders Interview (MIDI), and the Punding Rating Scale were applied. Mean TTCT score of PD-c was found to be similar to HC (169.4±51.6 vs. 170.2±69.7, respectively), and both PD-c and HC had significantly higher TTCT scores than patients with PD-nc (125.4±46.1 P<0.05). TTCT did not correlate with any demographic or clinical data in both PD subgroups. No correlation was found between TTCT, BIS-11A, and MIDI. Our study suggests that newly acquired artistic-like production in patients with PD is not associated with impulsivity or ICDs. Artistic-like production might represent the emerging of innate skills in a subset of predisposed patients with PD on dopaminergic therapy. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

  18. 30 CFR 285.104 - Do I need an MMS lease or other authorization to produce or support the production of electricity...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... to produce or support the production of electricity or other energy product from a renewable energy... authorization to produce or support the production of electricity or other energy product from a renewable... construct, operate, or maintain any facility to produce, transport, or support generation of electricity or...

  19. 40 CFR 403.6 - National pretreatment standards: Categorical standards.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Control Authority calculating equivalent mass-per-day limitations under paragraph (c)(2) of this section... production shall be estimated using projected production. (4) A Control Authority calculating equivalent... Control Authority convert the limits to equivalent mass limits. The determination to convert concentration...

  20. 40 CFR 403.6 - National pretreatment standards: Categorical standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Control Authority calculating equivalent mass-per-day limitations under paragraph (c)(2) of this section... production shall be estimated using projected production. (4) A Control Authority calculating equivalent... Control Authority convert the limits to equivalent mass limits. The determination to convert concentration...

  1. 40 CFR 403.6 - National pretreatment standards: Categorical standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Control Authority calculating equivalent mass-per-day limitations under paragraph (c)(2) of this section... production shall be estimated using projected production. (4) A Control Authority calculating equivalent... Control Authority convert the limits to equivalent mass limits. The determination to convert concentration...

  2. 40 CFR 403.6 - National pretreatment standards: Categorical standards.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Control Authority calculating equivalent mass-per-day limitations under paragraph (c)(2) of this section... production shall be estimated using projected production. (4) A Control Authority calculating equivalent... Control Authority convert the limits to equivalent mass limits. The determination to convert concentration...

  3. 40 CFR 403.6 - National pretreatment standards: Categorical standards.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Control Authority calculating equivalent mass-per-day limitations under paragraph (c)(2) of this section... production shall be estimated using projected production. (4) A Control Authority calculating equivalent... Control Authority convert the limits to equivalent mass limits. The determination to convert concentration...

  4. Employee motivation in laboratory animal science: creating the conditions for a happy and productive staff.

    PubMed

    Chick, John F

    2006-01-01

    High rates of employee turnover are the source of a considerable loss of time and resources, but managers are not always aware of the reasons that motivate employees to stay in their positions. The author compares prominent theories of employee motivation and then puts them to the test by surveying 82 cagewashers, animal caretakers, animal technicians, and supervisors working in a laboratory animal facility to determine the job characteristics that motivate them.

  5. [Microbiological rationale for using whey on salting salmon caviar].

    PubMed

    Kim, I N; Shtan'ko, T I

    2011-01-01

    The paper provides a rationale for the use of whey to salt salmon fishes instead of traditional preservatives, including those exported from low industrial potential countries, which do not undergo comprehensive sanitary and hygienic tests. On the basis of the performed studies, the authors recommend to use whey to salt salmon caviar, which ensures the ecological purity of the product containing the minimum amount of preservatives and other substances that fail to affect its organoleptic properties.

  6. FABRICATION AND DEPLOYMENT OF THE 9979 TYPE AF RADIOACTIVE WASTE PACKAGING FOR THE DEPARTMENT OF ENERGY

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Blanton, P.; Eberl, K.

    2013-10-10

    This paper summarizes the development, testing, and certification of the 9979 Type A Fissile Packaging that replaces the UN1A2 Specification Shipping Package eliminated from Department of Transportation (DOT) 49 CFR 173. The DOT Specification Package was used for many decades by the U.S. nuclear industry as a fissile waste container until its removal as an authorized container by DOT. This paper will discuss stream lining procurement of high volume radioactive material packaging manufacturing, such as the 9979, to minimize packaging production costs without sacrificing Quality Assurance. The authorized content envelope (combustible and non-combustible) as well as planned content envelope expansionmore » will be discussed.« less

  7. Federal Parity and Access to Behavioral Health Care in Private Health Plans.

    PubMed

    Hodgkin, Dominic; Horgan, Constance M; Stewart, Maureen T; Quinn, Amity E; Creedon, Timothy B; Reif, Sharon; Garnick, Deborah W

    2018-04-01

    The 2008 Mental Health Parity and Addiction Equity Act (MHPAEA) sought to improve access to behavioral health care by regulating health plans' coverage and management of services. Health plans have some discretion in how to achieve compliance with MHPAEA, leaving questions about its likely effects on health plan policies. In this study, the authors' objective was to determine how private health plans' coverage and management of behavioral health treatment changed after the federal parity law's full implementation. A nationally representative survey of commercial health plans was conducted in 60 market areas across the continental United States, achieving response rates of 89% in 2010 (weighted N=8,431) and 80% in 2014 (weighted N=6,974). Senior executives at responding plans were interviewed regarding behavioral health services in each year and (in 2014) regarding changes. Student's t tests were used to examine changes in services covered, cost-sharing, and prior authorization requirements for both behavioral health and general medical care. In 2014, 68% of insurance products reported having expanded behavioral health coverage since 2010. Exclusion of eating disorder coverage was eliminated between 2010 (23%) and 2014 (0%). However, more products reported excluding autism treatment in 2014 (24%) than 2010 (8%). Most plans reported no change to prior-authorization requirements between 2010 and 2014. Implementation of federal parity legislation appears to have been accompanied by continuing improvement in behavioral health coverage. The authors did not find evidence of widespread noncompliance or of unintended effects, such as dropping coverage of behavioral health care altogether.

  8. Interaction Effect Between Herbivory and Plant Fertilization on Extrafloral Nectar Production and on Seed Traits: An Experimental Study With Ricinus communis (Euphorbiaceae).

    PubMed

    De Sibio, P R; Rossi, M N

    2016-08-01

    It is known that the release of volatile chemicals by many plants can attract the natural enemies of herbivorous insects. Such indirect interactions are likely when plants produce nectar from their extrafloral nectaries, and particularly when the production of extrafloral nectar (EFN) is induced by herbivory. In the present study, we conducted experiments to test whether foliar herbivory inflicted by Spodoptera frugiperda Smith (Noctuidae) increases nectar production by extrafloral nectaries on one of its host plants, Ricinus communis L. (Euphorbiaceae). Due to the current economic importance of R. communis, we also investigated whether the following seed traits-water content, dry mass, and essential oil production-are negatively affected by herbivory. Finally, we tested whether or not nectar production and seed traits are influenced by plant fertilization (plant quality). We found that nectar production was increased after herbivory, but it was not affected by the type of fertilization. Seed dry mass was higher in plants that were subjected to full fertilization, without herbivory; plants maintained in low fertilization conditions, however, had higher seed mass when subjected to herbivory. The same inverted pattern was observed for oil production. Therefore, our results suggest that EFN production in R. communis may act as an indirect defense strategy against herbivores, and that there is a trade-off between reproduction and plant growth when low-fertilized plants are subjected to herbivory. © The Authors 2016. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  9. 48 CFR 206.001 - Applicability.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... OF DEFENSE ACQUISITION PLANNING COMPETITION REQUIREMENTS 206.001 Applicability. (b) As authorized by... production contracts for products developed pursuant to the “other transactions” authority of 10 U.S.C. 2371... production contract; (2) The contracting officer receives sufficient information from the agreements officer...

  10. 48 CFR 206.001 - Applicability.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... OF DEFENSE ACQUISITION PLANNING COMPETITION REQUIREMENTS 206.001 Applicability. (b) As authorized by... production contracts for products developed pursuant to the “other transactions” authority of 10 U.S.C. 2371... production contract; (2) The contracting officer receives sufficient information from the agreements officer...

  11. 48 CFR 206.001 - Applicability.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... OF DEFENSE ACQUISITION PLANNING COMPETITION REQUIREMENTS 206.001 Applicability. (b) As authorized by... production contracts for products developed pursuant to the “other transactions” authority of 10 U.S.C. 2371... production contract; (2) The contracting officer receives sufficient information from the agreements officer...

  12. 48 CFR 206.001 - Applicability.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... OF DEFENSE ACQUISITION PLANNING COMPETITION REQUIREMENTS 206.001 Applicability. (b) As authorized by... production contracts for products developed pursuant to the “other transactions” authority of 10 U.S.C. 2371... production contract; (2) The contracting officer receives sufficient information from the agreements officer...

  13. 9 CFR 201.3 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 201.3 Section 201.3 Animals and Animal Products GRAIN INSPECTION, PACKERS AND STOCKYARDS ADMINISTRATION (PACKERS AND STOCKYARDS....3 Authority. The Administrator shall perform such duties as the Secretary may require in enforcing...

  14. 0.15 {mu}m InGaAs/AlGaAs/GaAs HEMT production process for high performance and high yield v-band power MMICs

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lai, R.; Biedenbender, M.; Lee, J.

    1995-12-31

    The authors present a unique high yield, high performance 0.15 {mu}m HEMT production process which supports fabrication of MMW power MMICs up to 70 GHz. This process has been transferred successfully from an R&D process to TRW`s GaAs production line. This paper reports the on-wafer test results of more than 1300 V-band MMIC PA circuits measured over 24 wafers. The best 2-stage V-band power MMICs have demonstrated state-of-the-art performance with 9 dB power gain, 20% PAE and 330 mW output power. An excellent RF yield of 60% was achieved with an 8 dB power gain and 250 mW output powermore » specification.« less

  15. Dewatering Treatment Scale-up Testing Results of Hanford Tank Wastes

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Tedeschi, A.R.; May, T.H.; Bryan, W.E.

    2008-07-01

    This report documents CH2M HILL Hanford Group Inc. (CH2M HILL) 2007 dryer testing results in Richland, WA at the AMEC Nuclear Ltd., GeoMelt Division (AMEC) Horn Rapids Test Site. It provides a discussion of scope and results to qualify the dryer system as a viable unit-operation in the continuing evaluation of the bulk vitrification process. A 10,000 liter (L) dryer/mixer was tested for supplemental treatment of Hanford tank low activity wastes, drying and mixing a simulated non-radioactive salt solution with glass forming minerals. Testing validated the full scale equipment for producing dried product similar to smaller scale tests, and qualifiedmore » the dryer system for a subsequent integrated dryer/vitrification test using the same simulant and glass formers. The dryer system is planned for installation at the Hanford tank farms to dry/mix radioactive waste for final treatment evaluation of the supplemental bulk vitrification process. (authors)« less

  16. Key Technical Aspects Influencing the Accuracy of Tablet Subdivision.

    PubMed

    Teixeira, Maíra T; Sá-Barreto, Lívia C L; Gratieri, Taís; Gelfuso, Guilherme M; Silva, Izabel C R; Cunha-Filho, Marcílio S S

    2017-05-01

    Tablet subdivision is a common practice used mainly for dose adjustment. The aim of this study was to investigate how the technical aspects of production as well as the method of tablets subdivision (employing a tablet splitter or a kitchen knife) influence the accuracy of this practice. Five drugs commonly used as subdivided tablets were selected. For each drug, the innovator drug product, a scored-generic and a non-scored generic were investigated totalizing fifteen drug products. Mechanical and physical tests, including image analysis, were performed. Additionally, comparisons were made between tablet subdivision method, score, shape, diluent composition and coating. Image analysis based on surface area was a useful tool as an alternative assay to evaluate the accuracy of tablet subdivision. The tablet splitter demonstrates an advantage relative to a knife as it showed better results in weight loss and friability tests. Oblong, coated and scored tablets had better results after subdivision than round, uncoated and non-scored tablets. The presence of elastic diluents such as starch and dibasic phosphate dehydrate conferred a more appropriate behaviour for the subdivision process than plastic materials such as microcrystalline cellulose and lactose. Finally, differences were observed between generics and their innovator products in all selected drugs with regard the quality control assays in divided tablet, which highlights the necessity of health regulations to consider subdivision performance at least in marketing authorization of generic products.

  17. Inspection authorization knowledge test guide : July 2010.

    DOT National Transportation Integrated Search

    2010-07-01

    FAA-G-8082-11B, Inspection Authorization Knowledge Test Guide, provides information for preparing to take the following knowledge test. This document supersedes FAA-G-8082-11A, dated 2004. : TEST NAME: Inspection Authorization TEST CODE: IAR : The Fe...

  18. 47 CFR 2.805 - Operation of radio frequency products prior to equipment authorization.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) Evaluation of performance and determination of customer acceptability, during developmental, design, or pre... performance and determination of customer acceptability, during developmental, design, or pre-production... under the authority of an experimental radio service authorization issued under part 5 of this chapter...

  19. Department of Defense Congressional Action on FY 1984 Authorization Request.

    DTIC Science & Technology

    1983-10-11

    AUTHORIZATION NOTE: The Military Construction Bill authorization recommendation totaIS dIO not include projects authorized using savings or authorized for...change from the request). &DE9rooi)00 ti M S in Million (Zallocki- Proc. of Ammunition. Armsy Nerve gas artillery shells .185 Bethune) Proc. of...Ammunitioin. Army Nerve gas production -96S (Gore) Missile Proc, Air Force MX Production funds -357 8 (Byron) ROTE, Air Force T-46A Trainer Aircraft . 200

  20. Acute drug induced hepatitis secondary to a weight loss product purchased over the internet

    PubMed Central

    Joshi, Deepak; Cross, Tim JS; Wong, Voi Shim

    2007-01-01

    Background Many people now seek alternative methods of weight loss. The internet provides a readily available source of weight reduction products, the ingredients of which are often unclear. The authors describe a case of acute hepatitis in a 20 year old woman caused by such a product purchased over the internet. Case Presentation A 20-year old woman presented with a two day history of abdominal pain, vomiting and jaundice. There were no identifiable risk factors for chronic liver disease. Liver function tests demonstrated an acute hepatitis (aminoaspartate transaminase 1230 IU/L). A chronic liver disease screen was negative. The patient had started a weight loss product (Pro-Lean), purchased over the internet two weeks prior to presentation. The patient was treated conservatively, and improved. The sequence of events suggests an acute hepatitis caused by an herbal weight loss product. Conclusion This case report highlights the dangers of weight loss products available to the public over the internet, and the importance of asking specifically about alternative medicines in patients who present with an acute hepatitis. PMID:17597525

  1. 9 CFR 592.90 - Authority and duties of inspection program personnel performing service.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority and duties of inspection program personnel performing service. 592.90 Section 592.90 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Performance of Services § 592.90 Authorit...

  2. 9 CFR 592.90 - Authority and duties of inspection program personnel performing service.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority and duties of inspection program personnel performing service. 592.90 Section 592.90 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Performance of Services § 592.90 Authorit...

  3. 9 CFR 592.90 - Authority and duties of inspection program personnel performing service.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority and duties of inspection program personnel performing service. 592.90 Section 592.90 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Performance of Services § 592.90 Authorit...

  4. A new food frequency questionnaire to assess chocolate and cocoa consumption.

    PubMed

    Vicente, Filipa; Saldaña-Ruíz, Sandra; Rabanal, Manel; Rodríguez-Lagunas, María J; Pereira, Paula; Pérez-Cano, Francisco J; Castell, Margarida

    2016-01-01

    Cocoa has been highlighted as a food with potential benefits to human health because of its polyphenol content. However, few studies show the contribution of cocoa and chocolate products in polyphenol intake. The aim of this work was to develop a food frequency questionnaire (FFQ) for evaluating the intake of food products containing cocoa (C-FFQ). A sample of 50 university students was recruited to complete the 90-item questionnaire, a validated questionnaire (called here European Food Safety Authority [EFSA]-Q) as well as a 24-hour dietary recall (24 HDR). Spearman correlation test, Bland-Altman plots, and quintile classification analysis were conducted together with the Wilcoxon test and descriptive statistics. Significant correlations between the C-FFQ and the EFSA-Q for the most common cocoa/chocolate products were observed (P < 0.05), as well as between data from the C-FFQ and 24 HDR (P < 0.05). However, a number of cocoa/chocolate products frequently consumed by the participants were detected by the C-FFQ and 24 HDR which were not included in the EFSA-Q. According to the C-FFQ, chocolate bars were the main source of cocoa in university students, but dairy products also provided an important amount of cocoa. The developed C-FFQ questionnaire can be considered as a valid option for assessing the consumption frequency of cocoa/chocolate-derived products, thereby allowing the evaluation of cocoa polyphenol intake in further studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Productivity, impact, and collaboration differences between transdisciplinary and traditionally trained doctoral students: A comparison of publication patterns.

    PubMed

    Keck, Anna-Sigrid; Sloane, Stephanie; Liechty, Janet M; Fiese, Barbara H; Donovan, Sharon M

    2017-01-01

    Transdisciplinary (TD) approaches are increasingly used to address complex public health problems such as childhood obesity. Compared to traditional grant-funded scientific projects among established scientists, those designed around a TD, team-based approach yielded greater publication output after three to five years. However, little is known about how a TD focus throughout graduate school training may affect students' publication-related productivity, impact, and collaboration. The objective of this study was to compare the publication patterns of students in traditional versus TD doctoral training programs. Productivity, impact, and collaboration of peer-reviewed publications were compared between traditional (n = 25) and TD (n = 11) students during the first five years of the TD program. Statistical differences were determined by t-test or chi square test at p < 0.05. The publication rate for TD students was 5.2 ± 10.1 (n = 56) compared to 3.6 ± 4.5 per traditional student (n = 82). Publication impact indicators were significantly higher for TD students vs. traditional students: 5.7 times more citations in Google Scholar, 6.1 times more citations in Scopus, 1.3 times higher journal impact factors, and a 1.4 times higher journal h-index. Collaboration indicators showed that publications by TD students had significantly more co-authors (1.3 times), and significantly more disciplines represented among co-authors (1.3 times), but not significantly more organizations represented per publication compared to traditional students. In conclusion, compared to doctoral students in traditional programs, TD students published works that were accepted into higher impact journals, were more frequently cited, and had more cross-disciplinary collaborations.

  6. In vitro screening of inhibition of PPAR-γ activity as a first step in identification of potential breast carcinogens.

    PubMed

    Kopp, T I; Lundqvist, J; Petersen, R K; Oskarsson, A; Kristiansen, K; Nellemann, C; Vogel, U

    2015-11-01

    Alcohol consumption and increased estrogen levels are major risk factors for breast cancer, and peroxisome proliferator-activated receptor γ (PPAR-γ) plays an important role in alcohol-induced breast cancer. PPAR-γ activity is inhibited by ethanol, leading to increased aromatase activity and estrogen biosynthesis ultimately leading to breast cancer. If other organic solvents inhibit PPAR-γ activity, they should also lead to increased oestrogen biosynthesis and thus be potential breast carcinogens. Ten commonly used hydrophilic organic solvents were first tested in a cell-based screening assay for inhibitory effects on PPAR-γ transactivation. The chemicals shown to inhibit PPAR-γ were tested with vectors encoding PPAR-γ with deleted AB domains and only the ligand-binding domain to rule out unspecific toxicity. Next, the effects on biosynthesis of estradiol, testosterone and oestrone sulphate were measured in the H295R steroidogenesis assay after incubation with the chemicals. Ethylene glycol, ethyl acetate, and dimethyl sulphoxide inhibited PPAR-γ transactivation in a dose-dependent manner. The inhibitory effect on PPAR-γ was specific for PPAR-γ since the AB domain of PPAR-γ was required for the inhibitory effect. In the second step, ethylene glycol significantly increased production of oestradiol by 19% (p < 0.05) and ethyl acetate inhibited production of testosterone (p < 0.05). We here show that screening of 10 commonly used organic solvents for the ability to inhibit PPAR-γ transactivation followed by a well-established steroidogenesis assay for production of sex hormones in exposed H295 R cells may provide a screening tool for potential breast carcinogens. This initial screening thus identified ethylene glycol and possibly ethyl acetate as potential breast carcinogens. © The Author(s) 2015.

  7. Productivity, impact, and collaboration differences between transdisciplinary and traditionally trained doctoral students: A comparison of publication patterns

    PubMed Central

    Sloane, Stephanie; Liechty, Janet M.; Fiese, Barbara H.; Donovan, Sharon M.

    2017-01-01

    Transdisciplinary (TD) approaches are increasingly used to address complex public health problems such as childhood obesity. Compared to traditional grant-funded scientific projects among established scientists, those designed around a TD, team-based approach yielded greater publication output after three to five years. However, little is known about how a TD focus throughout graduate school training may affect students’ publication-related productivity, impact, and collaboration. The objective of this study was to compare the publication patterns of students in traditional versus TD doctoral training programs. Productivity, impact, and collaboration of peer-reviewed publications were compared between traditional (n = 25) and TD (n = 11) students during the first five years of the TD program. Statistical differences were determined by t-test or chi square test at p < 0.05. The publication rate for TD students was 5.2 ± 10.1 (n = 56) compared to 3.6 ± 4.5 per traditional student (n = 82). Publication impact indicators were significantly higher for TD students vs. traditional students: 5.7 times more citations in Google Scholar, 6.1 times more citations in Scopus, 1.3 times higher journal impact factors, and a 1.4 times higher journal h-index. Collaboration indicators showed that publications by TD students had significantly more co-authors (1.3 times), and significantly more disciplines represented among co-authors (1.3 times), but not significantly more organizations represented per publication compared to traditional students. In conclusion, compared to doctoral students in traditional programs, TD students published works that were accepted into higher impact journals, were more frequently cited, and had more cross-disciplinary collaborations. PMID:29244832

  8. Silent oceans: ocean acidification impoverishes natural soundscapes by altering sound production of the world's noisiest marine invertebrate.

    PubMed

    Rossi, Tullio; Connell, Sean D; Nagelkerken, Ivan

    2016-03-16

    Soundscapes are multidimensional spaces that carry meaningful information for many species about the location and quality of nearby and distant resources. Because soundscapes are the sum of the acoustic signals produced by individual organisms and their interactions, they can be used as a proxy for the condition of whole ecosystems and their occupants. Ocean acidification resulting from anthropogenic CO2 emissions is known to have profound effects on marine life. However, despite the increasingly recognized ecological importance of soundscapes, there is no empirical test of whether ocean acidification can affect biological sound production. Using field recordings obtained from three geographically separated natural CO2 vents, we show that forecasted end-of-century ocean acidification conditions can profoundly reduce the biological sound level and frequency of snapping shrimp snaps. Snapping shrimp were among the noisiest marine organisms and the suppression of their sound production at vents was responsible for the vast majority of the soundscape alteration observed. To assess mechanisms that could account for these observations, we tested whether long-term exposure (two to three months) to elevated CO2 induced a similar reduction in the snapping behaviour (loudness and frequency) of snapping shrimp. The results indicated that the soniferous behaviour of these animals was substantially reduced in both frequency (snaps per minute) and sound level of snaps produced. As coastal marine soundscapes are dominated by biological sounds produced by snapping shrimp, the observed suppression of this component of soundscapes could have important and possibly pervasive ecological consequences for organisms that use soundscapes as a source of information. This trend towards silence could be of particular importance for those species whose larval stages use sound for orientation towards settlement habitats. © 2016 The Author(s).

  9. The provision of assistive technology products and services for people with dementia in the United Kingdom.

    PubMed

    Gibson, Grant; Newton, Lisa; Pritchard, Gary; Finch, Tracy; Brittain, Katie; Robinson, Louise

    2016-07-01

    In this review we explore the provision of assistive technology products and services currently available for people with dementia within the United Kingdom. A scoping review of assistive technology products and services currently available highlighted 171 products or product types and 331 services. In addition, we assimilated data on the amount and quality of information provided by assistive technology services alongside assistive technology costs. We identify a range of products available across three areas: assistive technology used 'by', 'with' and 'on' people with dementia. Assistive technology provision is dominated by 'telecare' provided by local authorities, with services being subject to major variations in pricing and information provision; few currently used available resources for assistive technology in dementia. We argue that greater attention should be paid to information provision about assistive technology services across an increasingly mixed economy of dementia care providers, including primary care, local authorities, private companies and local/national assistive technology resources. © The Author(s) 2014.

  10. 78 FR 16247 - Foreign-Trade Zone 38-Spartanburg County, South Carolina; Authorization of Production Activity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-14

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-86-2012] Foreign-Trade Zone 38--Spartanburg County, South Carolina; Authorization of Production Activity; ZF Transmissions Gray Court, LLC (Automatic Transmissions); Gray Court, South Carolina On November 8, 2012, the South Carolina State Ports Authority...

  11. Knowledge Production in Small and Medium Sized Enterprises

    ERIC Educational Resources Information Center

    Van der Meer, Han

    2010-01-01

    This article presents the author's response to Hisham B. Ghassib's (2010) article entitled "Where Does Creativity Fit into a Productivist Industrial Model of Knowledge Production?" When the author tries to characterise Ghassib's (2010) world, three words come into mind: University, Scientific Knowledge, and Marx. The author's world on the other…

  12. Enhancing Interactivity and Productivity through Object-Oriented Authoring: An Instructional Designer's Perspective.

    ERIC Educational Resources Information Center

    Chapman, Bryan L.

    1994-01-01

    Discusses the effect of object-oriented programming on the evolution of authoring systems. Topics include the definition of an object; examples of object-oriented authoring interfaces; what object-orientation means to an instructional developer; how object orientation increases productivity and enhances interactivity; and the future of courseware…

  13. 27 CFR 19.733 - Authorized transfers between alcohol fuel plants.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Authorized transfers between alcohol fuel plants. 19.733 Section 19.733 Alcohol, Tobacco Products and Firearms ALCOHOL AND... Spirits for Fuel Use Transfer of Spirits Between Alcohol Fuel Plants § 19.733 Authorized transfers between...

  14. 9 CFR 329.8 - Authority for condemnation or seizure under other provisions of law.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority for condemnation or seizure... PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION DETENTION; SEIZURE AND CONDEMNATION; CRIMINAL OFFENSES § 329.8 Authority for condemnation or seizure under other provisions of law. The...

  15. Thermal treatment of electronic waste in a fluidised bed and chemical digestion of solid products.

    PubMed

    Woynarowska, Amelia; Żukowski, Witold; Żelazny, Sylwester

    2016-07-01

    The article presents the results of e-waste thermal treatment in a fluidised bed reactor and solid products digestion under acidic conditions. During the processes, measurements of carbon monoxide, carbon dioxide, volatile organic compounds, nitrogen oxides, sulphur dioxide, hydrogen chloride, hydrogen bromide, hydrogen cyanide, ammonia, phenol, aliphatic and aromatic hydrocarbons, hydrogen fluoride and phosgene were carried out. Several digestion tests of the solid residue in sulphuric acid (VI) at 25 °C-65 °C, for 55 min-24 h were conducted. In each case, the dilution method was used, i.e. preliminary digestion in concentrated sulphuric acid (VI) (95%) for 40 min, and then dilution to expected concentrations (30%-50%). Most preferred results were obtained using sulphuric acid (VI) with a target concentration of 40% at 65 °C, where the leaching degrees were 76.56% for copper, 71.67% for iron, 91.89% for zinc and 97.40% for tin. The time necessary to effectively carry out the digestion process was 220 min. © The Author(s) 2016.

  16. The peats of Costa Rica

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Thayer, G.R.; Williamson, K.D. Jr.; Ramirez, O.

    The authors compare the competitive position of peat for energy with coal, oil, and cogenerative systems in gasifiers and solid-fuel boilers. They also explore the possibility for peat use in industry. To identify the major factors, they analyze costs using a Los Alamos levelized cost code, and they study parametric costs, comparing peat production in constant dollars with interest rates and return on investment. They consider costs of processing plant construction, sizes and kinds of boilers, retrofitting, peat drying, and mining methods. They examine mining requirements for Moin, Changuinola, and El Cairo and review wet mining and dewatering methods. Peatmore » can, indeed, be competitive with other energy sources, but this depends on the ratio of fuel costs to boiler costs. This ratio is nearly constant in comparison with cogeneration in a steam-only production system. For grate boilers using Costa Rican high-ash peat, and for small nonautomatic boilers now used in Costa Rica, the authors recommend combustion tests. An appendix contains a preliminary mining plan and cost estimate for the El Cairo peat deposit. 8 refs., 43 figs., 19 tabs.« less

  17. Be aware of the Adjusted Treatment Index.

    PubMed

    Langford, Melvyn

    2015-10-01

    The authors of the interim report relating to the Review of Operational Productivity in NHS providers, published in June of this year, are, as many will know, developing a set of Adjusted Treatment Index (ATI) metrics, and are also to publish a model of their interpretation of what an estates department should look like in terms of its operational productivity and cost. This article argues that the underlying reason for the past failures was the creation of static 'point-value' metrics similar to the ATIs proposed, and that this can only be overcome by designing and populating a series of non-linear dynamic simulation models with feedback control of an organisation's estate in relation to its asset base and condition with respect to time, together with the resultant financial capital and revenue consequences. It concludes by calling on IHEEM's Council to urgently make representation to the authors of the June 2015 report, and suggests that the Institute's members be fully involved in the design, testing, and interpretation, of the estates model and ATIs. IHEEM's Technology Platforms are ideally placed to play a central role in this.

  18. Characterization and energy potential of food waste from catering service in Hangzhou, China.

    PubMed

    Guo, Xiao-Hui; Sun, Fa-Qian; Sun, Ying-Jun; Lu, Hao-Hao; Wu, Wei-Xiang

    2014-08-01

    Safe disposal of food waste is becoming an impending issue in China with the rapid increase of its production and the promotion of environmental awareness. Food waste from catering services in Hangzhou, China, was surveyed and characterized in this study. A questionnaire survey involving 632 units across the urban districts showed that 83.5% of the food waste was not properly treated. Daily food waste production from catering units was estimated to be 1184.5 tonnes. The ratio of volatile solid to total solid, easily biodegradable matter (including crude fat, crude protein and total starch) content in total solid and the ratio of total organic carbon to nitrogen varied in ranges of 90.1%-93.9%, 60.9%-72.1%, and 11.9-19.9, respectively. Based on the methane yield of 350 mL g VS(-1) in anaerobic batch tests, annual biogas energy of 1.0 × 10(9) MJ was estimated to be recovered from the food waste. Food waste from catering services was suggested to be an attractive clean energy source by anaerobic digestion. © The Author(s) 2014.

  19. Development of an adverse events reporting form for Korean folk medicine.

    PubMed

    Park, Jeong Hwan; Choi, Sun-Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min-Kyeoung; Lee, Sanghun

    2017-05-01

    We developed an adverse events (AEs) reporting form for Korean folk medicine. The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

  20. Gender and Radiology Publication Productivity: An Examination of Academic Faculty From Four Health Systems in the United States.

    PubMed

    McDonald, Jennifer S; McDonald, Robert J; Davenport, Matthew S; Jaffe, Tracy A; Cook, Tessa S; Kallmes, David F; Kotsenas, Amy L

    2017-08-01

    To compare male and female radiology faculty publication productivity metrics at four major academic centers. All Radiology Department faculty members at four academic medical centers from January 1, 2000, to December 31, 2015, were included. Publication metrics including total number of manuscripts published; h- and m-indices; number of publications where faculty member was listed as first, last, or sole author; whether a woman was listed as one of the first five coauthors; and year of first publication were retrieved from Scopus. Publication metrics were compared between genders using the Wilcoxon signed-rank and χ 2 tests. A total of 711 faculty members (519 male, 192 [27%] female members) were identified. Male faculty had a significantly higher number of total publications (median 54 versus 24, P < .0001), publications per year (median 2.9 versus 1.6, P < .0001), and h- (median 17 versus 10, P < .0001) and m-indices (median 0.83 versus 0.60, P < .0001) than female faculty. Male faculty had a significantly higher percentage of single author (median 1% versus 0%, P = .0014) and last author (median 16% versus 11%, P < .0001) publications than female faculty. Female faculty had a significantly higher percentage of first author publications (21% versus 17%, P = .0025) and were significantly more likely to have another woman in their first five coauthor list (70% versus 45%, P < .0001) than male faculty. Large differences exist between female and male faculty in total publications; h- and m-indices; publications per year; number of first, single, last author papers; and percentage of faculty that have a female coauthor in their top five coauthor lists. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  1. Effects of a Commercial Drink on Acceleration Tolerance and Cognitive Performance

    DTIC Science & Technology

    2009-11-01

    funded by a $120,000 grant from Coca - Cola Company, Atlanta GA. The authors wish to thank Mr. Mac Baker, Capt Julia McGregor, Mr. Tom Beltran, and Mr...recommendation or endorsement of the Coca Cola Company or the product tested. v Approved for public release; distribution unlimited; Approved by 311 th...drink (Full Throttle®, made by the Coca - Cola Company, at volumes equating to a caffeine dose of 5 mg caffeine per kg of body weight), an uncaffeinated

  2. Wheat productivity estimates using LANDSAT data

    NASA Technical Reports Server (NTRS)

    Nalepka, R. F.; Colwell, J. (Principal Investigator)

    1975-01-01

    The author has identified the following significant results. The electro-optical leaf area meter was the most accurate of the approaches tested on harvested wheat samples, but it is very time consuming. It was decided to infer leaf area from dry weight biomass after establishing a relationship between dry weight biomass and area as measured by the leaf area meter. There is a good correlation between leaf area as measured by the meter and dry leaf biomass. There is a less consistent relationship between stem area and stem biomass.

  3. openECA Platform and Analytics Alpha Test Results

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Robertson, Russell

    The objective of the Open and Extensible Control and Analytics (openECA) Platform for Phasor Data project is to develop an open source software platform that significantly accelerates the production, use, and ongoing development of real-time decision support tools, automated control systems, and off-line planning systems that (1) incorporate high-fidelity synchrophasor data and (2) enhance system reliability while enabling the North American Electric Reliability Corporation (NERC) operating functions of reliability coordinator, transmission operator, and/or balancing authority to be executed more effectively.

  4. HIGH-TEMPERATURE SAFETY TESTING OF IRRADIATED AGR-1 TRISO FUEL

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Stempien, John D.; Demkowicz, Paul A.; Reber, Edward L.

    High-Temperature Safety Testing of Irradiated AGR-1 TRISO Fuel John D. Stempien, Paul A. Demkowicz, Edward L. Reber, and Cad L. Christensen Idaho National Laboratory, P.O. Box 1625 Idaho Falls, ID 83415, USA Corresponding Author: john.stempien@inl.gov, +1-208-526-8410 Two new safety tests of irradiated tristructural isotropic (TRISO) coated particle fuel have been completed in the Fuel Accident Condition Simulator (FACS) furnace at the Idaho National Laboratory (INL). In the first test, three fuel compacts from the first Advanced Gas Reactor irradiation experiment (AGR-1) were simultaneously heated in the FACS furnace. Prior to safety testing, each compact was irradiated in the Advanced Testmore » Reactor to a burnup of approximately 15 % fissions per initial metal atom (FIMA), a fast fluence of 3×1025 n/m2 (E > 0.18 MeV), and a time-average volume-average (TAVA) irradiation temperature of about 1020 °C. In order to simulate a core-conduction cool-down event, a temperature-versus-time profile having a peak temperature of 1700 °C was programmed into the FACS furnace controllers. Gaseous fission products (i.e., Kr-85) were carried to the Fission Gas Monitoring System (FGMS) by a helium sweep gas and captured in cold traps featuring online gamma counting. By the end of the test, a total of 3.9% of an average particle’s inventory of Kr-85 was detected in the FGMS traps. Such a low Kr-85 activity indicates that no TRISO failures (failure of all three TRISO layers) occurred during the test. If released from the compacts, condensable fission products (e.g., Ag-110m, Cs-134, Cs-137, Eu-154, Eu-155, and Sr-90) were collected on condensation plates fitted to the end of the cold finger in the FACS furnace. These condensation plates were then analyzed for fission products. In the second test, five loose UCO fuel kernels, obtained from deconsolidated particles from an irradiated AGR-1 compact, were heated in the FACS furnace to a peak temperature of 1600 °C. This test had two primary goals. First, the test was intended to assess the retention of fission products in loose kernels without the effects of the other TRISO layers (buffer, IPyC, SiC, and OPyC) or the graphitic matrix material comprising the compact. Second, this test served as an evaluation of the FACS fission product condensation plate collection efficiency.« less

  5. Tell Me Your Name and I'll Tell You How Creative Your Work Is: Author's Name and Gender as Factors Influencing Assessment of Products' Creativity in Four Different Domains

    ERIC Educational Resources Information Center

    Lebuda, Izabela; Karwowski, Maciej

    2013-01-01

    The main goal of this study was to examine the effects of authors' name and gender on judges' assessment of product creativity in 4 different domains (art, science, music, and poetry). A total of 119 participants divided into 5 groups assessed products signed with a fictional author's name (unique vs. typical, male vs. female) or in an anonymous…

  6. 77 FR 71167 - Foreign-Trade Zone 59-Lincoln, Nebraska, Authorization of Production Activity, Novartis Consumer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-64-2012] Foreign-Trade Zone 59--Lincoln, Nebraska, Authorization of Production Activity, Novartis Consumer Health, Inc. (Pharmaceutical and Related Preparations Production), Lincoln, Nebraska Novartis Consumer Health, Inc. submitted a notification of proposed...

  7. 27 CFR 19.826 - Authorized operations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Authorized operations. 19.826 Section 19.826 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS DISTILLED SPIRITS PLANTS Production of Vinegar by the Vaporizing Process...

  8. Participative Knowledge Production of Learning Objects for E-Books.

    ERIC Educational Resources Information Center

    Dodero, Juan Manuel; Aedo, Ignacio; Diaz, Paloma

    2002-01-01

    Defines a learning object as any digital resource that can be reused to support learning and thus considers electronic books as learning objects. Highlights include knowledge management; participative knowledge production, i.e. authoring electronic books by a distributed group of authors; participative knowledge production architecture; and…

  9. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  10. Application of Non-pressure Reinforced Concrete Pipes in Modern Construction and Reconstruction of Highways

    NASA Astrophysics Data System (ADS)

    Rakitin, B. A.; Pogorelov, S. N.; Kolmogorova, A. O.

    2017-11-01

    Modern highway construction technologies provide for the quality water discharge systems to increase facilities’ service life. Pipeline operating conditions require the use of durable and reliable materials and structures. The experience in using reinforced concrete pipes for these purposes shows their utilization efficiency. The present paper considers the experience in the use of non-pressure reinforced concrete pipes manufactured by the German company SCHLOSSER-PFEIFFER under the Ural region geological and climatic conditions. The authors analyzed the actual operation of underground pipelines and effective loads upon them. A detailed study of the mechanical properties of reinforced concrete pipes is necessary to improve their production technology and to enhance their serviceability. The use of software-based methods helped to develop a mathematical model and to estimate the strength and crack resistance of reinforced concrete pipes at different laying depths. The authors carried out their complex research of the strain-stress behaviour of reinforced concrete pipes and identified the most hazardous sections in the structure. The calculations performed were confirmed by the results of laboratory tests completed in the construction materials, goods, and structures test center. Based on the completed research, the authors formulated their recommendations to improve the design and technology of non-pressure reinforced concrete pipes.

  11. A comparative approach to recombinantly produce the plant enzyme horseradish peroxidase in Escherichia coli.

    PubMed

    Gundinger, Thomas; Spadiut, Oliver

    2017-04-20

    Horseradish peroxidase (HRP) is used in various biotechnological and medical applications. Since its isolation from plant provides several disadvantages, the bacterium Escherichia coli was tested as recombinant expression host in former studies. However, neither production from refolded inclusion bodies nor active enzyme expression in the periplasm exceeded final titres of 10mg per litre cultivation broth. Thus, the traditional way of production of HRP from plant still prevails. In this study, we revisited the recombinant production of HRP in E. coli and investigated and compared both strategies, (a) the production of HRP as inclusion bodies (IBs) and subsequent refolding and (b) the production of active HRP in the periplasm. In fact, we were able to produce HRP in E. coli either way. We obtained a refolding yield of 10% from IBs giving a final titre of 100mgL -1 cultivation broth, and were able to produce 48mg active HRP per litre cultivation broth in the periplasm. In terms of biochemical properties, soluble HRP showed a highly reduced catalytic activity and stability which probably results from the fusion partner DsbA used in this study. Refolded HRP showed similar substrate affinity, an 11-fold reduced catalytic efficiency and 2-fold reduced thermal stability compared to plant HRP. In conclusion, we developed a toolbox for HRP engineering and production. We propose to engineer HRP by directed evolution or semi-rational protein design, express HRP in the periplasm of E. coli allowing straight forward screening for improved variants, and finally produce these variants as IB in high amounts, which are then refolded. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  12. Granulocytapheresis with modified fluid gelatin versus high-molecular-weight hydroxyethyl starch: a matched-pair analysis.

    PubMed

    Dullinger, Katharina; Pamler, Irene; Brosig, Andreas; Mohrez, Morad; Hähnel, Viola; Offner, Robert; Dormann, Frauke; Becke, Christine; Holler, Ernst; Ahrens, Norbert

    2017-02-01

    Granulocyte apheresis requires a sedimentation agent. Usually, hydroxyethyl starch (HES) is administered to donors for this purpose and, as granulocyte concentrate (GC) ingredient, also to patients. Authorities recently recommended suspending market authorizations for starch-containing products due to side effects. Therefore, we tested the efficacy of modified fluid gelatin (MFG, Gelafundin 4%) versus hetastarch (Hespan) for GC apheresis. This retrospective matched-pair analysis compared MFG- and hetastarch-derived GCs. Each group consisted of 15 unrelated male donors mobilized with dexamethasone and granulocyte-colony-stimulating factor for apheresis on 1 or 2 days with the COBE Spectra's PMN program. In each group, 24 GCs were collected from 15 male donors and analyzed. None of the HES-derived products, but two of the MFG-derived products (8.3%), had aggregates and could not be used. The HES-derived products had significantly higher neutrophil counts on the first day (7.7 × 10 10 /unit vs. 4.0 × 10 10 /unit; p = 0.00005) as well as second day of apheresis (4.0 × 10 10 /unit vs. 1.1 × 10 10 /unit; p = 0.0002). Median white blood cell collection efficacies were lower with MFG than with HES on Day 1 (24% vs. 43%) and Day 2 (15% vs. 37%). Twenty-one percent of the MFG-derived products had less than 1 × 10 10 granulocytes. These results indicate that granulocyte apheresis is feasible with MFG as well as with hetastarch and that the latter is superior for GC production, if used in the same dosage. In addition, aggregates in GC from the COBE Spectra were observed in the MFG group but not in the hetastarch group. © 2016 AABB.

  13. Parameterized examination in econometrics

    NASA Astrophysics Data System (ADS)

    Malinova, Anna; Kyurkchiev, Vesselin; Spasov, Georgi

    2018-01-01

    The paper presents a parameterization of basic types of exam questions in Econometrics. This algorithm is used to automate and facilitate the process of examination, assessment and self-preparation of a large number of students. The proposed parameterization of testing questions reduces the time required to author tests and course assignments. It enables tutors to generate a large number of different but equivalent dynamic questions (with dynamic answers) on a certain topic, which are automatically assessed. The presented methods are implemented in DisPeL (Distributed Platform for e-Learning) and provide questions in the areas of filtering and smoothing of time-series data, forecasting, building and analysis of single-equation econometric models. Questions also cover elasticity, average and marginal characteristics, product and cost functions, measurement of monopoly power, supply, demand and equilibrium price, consumer and product surplus, etc. Several approaches are used to enable the required numerical computations in DisPeL - integration of third-party mathematical libraries, developing our own procedures from scratch, and wrapping our legacy math codes in order to modernize and reuse them.

  14. Encapsulated Essential Oils as an Alternative to Insecticides in Funnel Traps.

    PubMed

    Pascual-Villalobos, M J; López, M D; Castañé, C; Soler, A; Riudavets, J

    2015-08-01

    Pheromone-lured funnel traps are widely used for pest monitoring and mass trapping in agricultural fields and stores. DDVP vapona (dichlorvos), the insecticide of choice as a killing agent inside traps, has been banned, and research on new products is being pursued. Essential oils (EO) could be an alternative if properly formulated. To test their potential, beads of encapsulated coriander and basil EO were tested in funnel traps in stores of almonds and pet foods during 2 mo. The number of adult moth (Plodia interpunctella (Hübner) and Ephestia kuehniella Zeller) dead captures was similar with either coriander or basil EO beads and with vapona tablets while there were more insects alive in the control. These preliminary results indicate a good potential for the development of such natural products as an alternative to synthetic insecticides to include them inside funnel traps. © The Authors 2015. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  15. International regulatory requirements for skin sensitization testing.

    PubMed

    Daniel, Amber B; Strickland, Judy; Allen, David; Casati, Silvia; Zuang, Valérie; Barroso, João; Whelan, Maurice; Régimbald-Krnel, M J; Kojima, Hajime; Nishikawa, Akiyoshi; Park, Hye-Kyung; Lee, Jong Kwon; Kim, Tae Sung; Delgado, Isabella; Rios, Ludmila; Yang, Ying; Wang, Gangli; Kleinstreuer, Nicole

    2018-06-01

    Skin sensitization test data are required or considered by chemical regulation authorities around the world. These data are used to develop product hazard labeling for the protection of consumers or workers and to assess risks from exposure to skin-sensitizing chemicals. To identify opportunities for regulatory uses of non-animal replacements for skin sensitization tests, the needs and uses for skin sensitization test data must first be clarified. Thus, we reviewed skin sensitization testing requirements for seven countries or regions that are represented in the International Cooperation on Alternative Test Methods (ICATM). We noted the type of skin sensitization data required for each chemical sector and whether these data were used in a hazard classification, potency classification, or risk assessment context; the preferred tests; and whether alternative non-animal tests were acceptable. An understanding of national and regional regulatory requirements for skin sensitization testing will inform the development of ICATM's international strategy for the acceptance and implementation of non-animal alternatives to assess the health hazards and risks associated with potential skin sensitizers. Copyright © 2018 Elsevier Inc. All rights reserved.

  16. 76 FR 37636 - Substantial Product Hazard List: Hand-Supported Hair Dryers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... to be substantial product hazards. Authority: 15 U.S.C. 2064(j). Sec. 1120.1 Authority. Under the... subsection (j). That subsection delegates authority to the Commission to specify by rule, for a consumer... been substantial compliance with it. 15 U.S.C. 2064(j). Underwriters Laboratories' (``UL'') Standard...

  17. Author Productivity and Publication Trends in Autism-Specific Journals from 1997 to 2004

    ERIC Educational Resources Information Center

    de la Cruz, Berenice; Cannella-Malone, Helen I.; Edrisinha, Chaturi; Sigafoos, Jeff; Robinson, Dan; Son, Seung-Hyun

    2006-01-01

    The 20 most productive authors (in terms of number of articles authored) were identified across three major autism-specific journals ("Autism: An International Journal of Research and Practice, Focus on Autism and Other Developmental Disabilities," and the "Journal of Autism and Developmental Disorders") published between 1997…

  18. 28 CFR Appendix to Subpart B of... - Redelegation of Authority to the Deputy Assistant Attorney General for Litigation, Antitrust...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Assistant Attorney General for Litigation, Antitrust Division, To Authorize Production or Disclosure of... Assistant Attorney General for Litigation, Antitrust Division, To Authorize Production or Disclosure of... described in 28 CFR 16.21(a) is hereby redelegated to the Deputy Assistant Attorney General for Litigation...

  19. Attributions of Productive Authors in Educational Psychology Journals

    ERIC Educational Resources Information Center

    Mayrath, Michael C.

    2008-01-01

    Are there similarities in the writing approaches and practices among the top-producing authors in our field? If so, perhaps knowing this information may benefit graduate students or recent graduates. In this paper, I asked 13 authors to explain why they were so productive in terms of publishing in educational psychology journals. Four categories…

  20. 36 CFR 261.6 - Timber and other forest products.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... or otherwise damaging any timber, tree, or other forest product, except as authorized by a special-use authorization, timber sale contract, or Federal law or regulation. (b) Cutting any standing tree... otherwise identifying any tree or other forest product in a manner similar to that employed by forest...

  1. 14 CFR 183.63 - Continuing requirements: Products, parts or appliances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... appliances. 183.63 Section 183.63 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... Designation Authorization § 183.63 Continuing requirements: Products, parts or appliances. For any approval or certificate for a product, part or appliance issued under the authority of this subpart, or under the...

  2. 78 FR 68814 - Subzone 183B; Authorization of Production Activity; Samsung Austin Semiconductor, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-70-2013] Subzone 183B; Authorization of Production Activity; Samsung Austin Semiconductor, LLC (Semiconductors); Austin, Texas On June 26, 2013, Samsung Austin Semiconductor, LLC submitted a notification of proposed export production activity to the...

  3. 78 FR 60826 - Foreign-Trade Zone 155-Calhoun/Victoria Counties, Texas; Authorization of Production Activity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Foreign-Trade Zone 155--Calhoun/Victoria Counties, Texas; Authorization of Production Activity; Caterpillar, Inc. (Excavator and Frame Assembly Production); Victoria, Texas On May 29, 2013, The Calhoun-Victoria Foreign Trade Zone, Inc., grantee of FTZ 155...

  4. Architectures, Representations and Processes of Language Production

    ERIC Educational Resources Information Center

    Alario, F.-Xavier; Costa, Albert; Ferreira, Victor S.; Pickering, Martin J.

    2006-01-01

    The authors present an overview of recent research conducted in the field of language production based on papers presented at the first edition of the International Workshop on Language Production (Marseille, France, September 2004). This article comprises two main parts. In the first part, consisting of three sections, the authors review the…

  5. 78 FR 23220 - Foreign-Trade Zone 22-Chicago, Illinois, Authorization of Production Activity, Abbott...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-18

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-91-2012] Foreign-Trade Zone 22--Chicago, Illinois, Authorization of Production Activity, Abbott Laboratories, Inc., AbbVie, Inc. (Pharmaceutical Production), North Chicago, Illinois, Area On December 14, 2012, Abbott Laboratories, Inc., and AbbVie, Inc...

  6. 78 FR 7394 - Foreign-Trade Zone 121-Albany, NY; Authorization of Production Activity; Albany Molecular...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-01

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-72-2012] Foreign-Trade Zone 121--Albany, NY; Authorization of Production Activity; Albany Molecular Research, Inc.; Subzone 121A (Pharmaceutical Chemicals Production); Rensselaer, NY On September 26, 2012, Albany Molecular Research, Inc., submitted a notification...

  7. 36 CFR 261.6 - Timber and other forest products.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... or otherwise damaging any timber, tree, or other forest product, except as authorized by a special-use authorization, timber sale contract, or Federal law or regulation. (b) Cutting any standing tree... otherwise identifying any tree or other forest product in a manner similar to that employed by forest...

  8. 36 CFR 261.6 - Timber and other forest products.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... or otherwise damaging any timber, tree, or other forest product, except as authorized by a special-use authorization, timber sale contract, or Federal law or regulation. (b) Cutting any standing tree... otherwise identifying any tree or other forest product in a manner similar to that employed by forest...

  9. 36 CFR 261.6 - Timber and other forest products.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... or otherwise damaging any timber, tree, or other forest product, except as authorized by a special-use authorization, timber sale contract, or Federal law or regulation. (b) Cutting any standing tree... otherwise identifying any tree or other forest product in a manner similar to that employed by forest...

  10. 36 CFR 261.6 - Timber and other forest products.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... or otherwise damaging any timber, tree, or other forest product, except as authorized by a special-use authorization, timber sale contract, or Federal law or regulation. (b) Cutting any standing tree... otherwise identifying any tree or other forest product in a manner similar to that employed by forest...

  11. 75 FR 30777 - Grant of Authority for Subzone Status; South Florida Materials Corporation (Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ... Status; South Florida Materials Corporation (Distribution of Petroleum Products); Port Everglades, FL... petroleum product storage and distribution facility of South Florida Materials Corporation (d/b/a Vencenergy..., therefore, the Board hereby grants authority for subzone status for activity related to petroleum product...

  12. 77 FR 55182 - Foreign-Trade Zone 45-Portland, OR, Authorization of Production Activity, Shimadzu USA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-07

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-34-2012] Foreign-Trade Zone 45--Portland, OR, Authorization of Production Activity, Shimadzu USA Manufacturing, Inc., (Analytical Instruments-- Liquid Chromatographs and Mass Spectrometer Production), Canby, OR The Port of Portland, grantee of FTZ 45, submitted a...

  13. 77 FR 55455 - Foreign-Trade Zone 235-Lakewood, NJ, Authorization of Production Activity, Cosmetic Essence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-10

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-31-2012] Foreign-Trade Zone 235--Lakewood, NJ, Authorization of Production Activity, Cosmetic Essence Innovations, LLC, (Fragrance Bottling), Holmdel, NJ Cosmetic Essence Innovations, LLC (CEI) submitted a notification of proposed production activity to the...

  14. Microbiological contamination in counterfeit and unapproved drugs

    PubMed Central

    2014-01-01

    Background Counterfeit and unapproved medicines are inherently dangerous and can cause patient injury due to ineffectiveness, chemical or biological contamination, or wrong dosage. Growth of the counterfeit medical market in developed countries is mainly attributable to life-style drugs, which are used in the treatment of non-life-threatening and non-painful conditions, such as slimming pills, cosmetic-related pharmaceuticals, and drugs for sexual enhancement. One of the main tasks of health authorities is to identify the exact active pharmaceutical ingredients (APIs) in confiscated drugs, because wrong API compounds, wrong concentrations, and/or the presence of chemical contaminants are the main risks associated with counterfeit medicines. Serious danger may also arise from microbiological contamination. We therefore performed a market surveillance study focused on the microbial burden in counterfeit and unapproved medicines. Methods Counterfeit and unapproved medicines confiscated in Canada and Austria and controls from the legal market were examined for microbial contaminations according to the US and European pharmacopoeia guidelines. The microbiological load of illegal and legitimate samples was statistically compared with the Wilcoxon rank-sum test. Results Microbial cultivable contaminations in counterfeit and unapproved phosphodiesterase type 5 inhibitors were significantly higher than in products from the legal medicines market (p < 0.0001). Contamination levels exceeding the USP and EP limits were seen in 23% of the tested illegal samples in Canada. Additionally, microbiological contaminations above the pharmacopoeial limits were detected in an anabolic steroid and an herbal medicinal product in Austria (6% of illegal products tested). Conclusions Our results show that counterfeit and unapproved pharmaceuticals are not manufactured under the same hygienic conditions as legitimate products. The microbiological contamination of illegal medicinal products often exceeds USP and EP limits, representing a potential threat to consumer health. PMID:24965483

  15. Microbiological contamination in counterfeit and unapproved drugs.

    PubMed

    Pullirsch, Dieter; Bellemare, Julie; Hackl, Andreas; Trottier, Yvon-Louis; Mayrhofer, Andreas; Schindl, Heidemarie; Taillon, Christine; Gartner, Christian; Hottowy, Brigitte; Beck, Gerhard; Gagnon, Jacques

    2014-06-26

    Counterfeit and unapproved medicines are inherently dangerous and can cause patient injury due to ineffectiveness, chemical or biological contamination, or wrong dosage. Growth of the counterfeit medical market in developed countries is mainly attributable to life-style drugs, which are used in the treatment of non-life-threatening and non-painful conditions, such as slimming pills, cosmetic-related pharmaceuticals, and drugs for sexual enhancement. One of the main tasks of health authorities is to identify the exact active pharmaceutical ingredients (APIs) in confiscated drugs, because wrong API compounds, wrong concentrations, and/or the presence of chemical contaminants are the main risks associated with counterfeit medicines. Serious danger may also arise from microbiological contamination. We therefore performed a market surveillance study focused on the microbial burden in counterfeit and unapproved medicines. Counterfeit and unapproved medicines confiscated in Canada and Austria and controls from the legal market were examined for microbial contaminations according to the US and European pharmacopoeia guidelines. The microbiological load of illegal and legitimate samples was statistically compared with the Wilcoxon rank-sum test. Microbial cultivable contaminations in counterfeit and unapproved phosphodiesterase type 5 inhibitors were significantly higher than in products from the legal medicines market (p < 0.0001). Contamination levels exceeding the USP and EP limits were seen in 23% of the tested illegal samples in Canada. Additionally, microbiological contaminations above the pharmacopoeial limits were detected in an anabolic steroid and an herbal medicinal product in Austria (6% of illegal products tested). Our results show that counterfeit and unapproved pharmaceuticals are not manufactured under the same hygienic conditions as legitimate products. The microbiological contamination of illegal medicinal products often exceeds USP and EP limits, representing a potential threat to consumer health.

  16. [Evaluation of the journal Nutrición Hospitalaria. II. Productivity and collaboration].

    PubMed

    Iglesias Vázquez, E; Culebras, J M; García de Lorenzo, A

    2001-01-01

    An analysis is effected of the production by authors publishing their papers in Nutrición Hospitalaria (Hospital Nutrition), as well as by the institutions at which these authors work. The productivity figures indicate a large group of sporadic authors, whereas the "regular contributors" exceed figure 1 in the indices established. In terms of collaboration, Nutrición Hospitalaria articles present between 3 and 5 signatories per paper, lower than in other journals in the same scientific field.

  17. Methane production and isotopic fingerprinting in ethanol fuel contaminated sites.

    PubMed

    Freitas, Juliana G; Fletcher, Barbara; Aravena, Ramon; Barker, James F

    2010-01-01

    Biodegradation of organic compounds in groundwater can be a significant source of methane in contaminated sites. Methane might accumulate in indoor spaces posing a hazard. The increasing use of ethanol as a gasoline additive is a concern with respect to methane production since it is easily biodegraded and has a high oxygen demand, favoring the development of anaerobic conditions. This study evaluated the use of stable carbon isotopes to distinguish the methane origin between gasoline and ethanol biodegradation, and assessed the occurrence of methane in ethanol fuel contaminated sites. Two microcosm tests were performed under anaerobic conditions: one test using ethanol and the other using toluene as the sole carbon source. The isotopic tool was then applied to seven field sites known to be impacted by ethanol fuels. In the microcosm tests, it was verified that methane from ethanol (δ¹³C = -11.1‰) is more enriched in ¹³C, with δ¹³C values ranging from -20‰ to -30‰, while the methane from toluene (δ¹³C = -28.5‰) had a carbon isotopic signature of -55‰. The field samples had δ¹³C values varying over a wide range (-10‰ to -80‰), and the δ¹³C values allowed the methane source to be clearly identified in five of the seven ethanol/gasoline sites. In the other two sites, methane appears to have been produced from both sources. Both gasoline and ethanol were sources of methane in potentially hazardous concentrations and methane could be produced from organic acids originating from ethanol along the groundwater flow system even after all the ethanol has been completed biodegraded. Copyright © 2010 The Author(s). Journal compilation © 2010 National Ground Water Association.

  18. Eco-friendly porous concrete using bottom ash aggregate for marine ranch application.

    PubMed

    Lee, Byung Jae; Prabhu, G Ganesh; Lee, Bong Chun; Kim, Yun Yong

    2016-03-01

    This article presents the test results of an investigation carried out on the reuse of coal bottom ash aggregate as a substitute material for coarse aggregate in porous concrete production for marine ranch applications. The experimental parameters were the rate of bottom ash aggregate substitution (30%, 50% and 100%) and the target void ratio (15%, 20% and 25%). The cement-coated granular fertiliser was substituted into a bottom ash aggregate concrete mixture to improve marine ranch applications. The results of leaching tests revealed that the bottom ash aggregate has only a negligible amount of the ten deleterious substances specified in the Ministry of Environment - Enforcement Regulation of the Waste Management Act of Republic Korea. The large amount of bubbles/air gaps in the bottom ash aggregate increased the voids of the concrete mixtures in all target void ratios, and decreased the compressive strength of the porous concrete mixture; however, the mixture substituted with 30% and 10% of bottom ash aggregate and granular fertiliser, respectively, showed an equal strength to the control mixture. The sea water resistibility of the bottom ash aggregate substituted mixture was relatively equal to that of the control mixture, and also showed a great deal of improvement in the degree of marine organism adhesion compared with the control mixture. No fatality of fish was observed in the fish toxicity test, which suggested that bottom ash aggregate was a harmless material and that the combination of bottom ash aggregate and granular fertiliser with substitution rates of 30% and 10%, respectively, can be effectively used in porous concrete production for marine ranch application. © The Author(s) 2015.

  19. Comprehensive evaluation of the flavonol anti-oxidants, alpha-glycosyl isoquercitrin and isoquercitrin, for genotoxic potential.

    PubMed

    Hobbs, Cheryl A; Koyanagi, Mihoko; Swartz, Carol; Davis, Jeffrey; Kasamoto, Sawako; Maronpot, Robert; Recio, Leslie; Hayashi, Shim-Mo

    2018-03-01

    Quercetin and its glycosides possess potential benefits to human health. Several flavonols are available to consumers as dietary supplements, promoted as anti-oxidants; however, incorporation of natural quercetin glycosides into food and beverage products has been limited by poor miscibility in water. Enzymatic conjugation of multiple glucose moieties to isoquercitrin to produce alpha-glycosyl isoquercitrin (AGIQ) enhances solubility and bioavailability. AGIQ is used in Japan as a food additive and has been granted generally recognized as safe (GRAS) status. However, although substantial genotoxicity data exist for quercetin, there is very little available data for AGIQ and isoquercitrin. To support expanded global marketing of food products containing AGIQ, comprehensive testing of genotoxic potential of AGIQ and isoquercitrin was conducted according to current regulatory test guidelines. Both chemicals tested positive in bacterial reverse mutation assays, and exposure to isoquercitrin resulted in chromosomal aberrations in CHO-WBL cells. All other in vitro mammalian micronucleus and chromosomal aberration assays, micronucleus and comet assays in male and female B6C3F1 mice and Sprague Dawley rats, and Muta™ Mouse mutation assays evaluating multiple potential target tissues, were negative for both chemicals. These results supplement existing toxicity data to further support the safe use of AGIQ in food and beverage products. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. Prenatal developmental toxicity testing of petroleum substances: Application of the mouse embryonic stem cell test (EST) to compare in vitro potencies with potencies observed in vivo.

    PubMed

    Kamelia, Lenny; Louisse, Jochem; de Haan, Laura; Rietjens, Ivonne M C M; Boogaard, Peter J

    2017-10-01

    Prenatal developmental toxicity (PDT) as observed with some petroleum substances (PS) has been associated with the presence of 3-7 ring polycyclic aromatic hydrocarbons (PAHs). In the present study, the applicability of ES-D3 cell differentiation assay of the EST to evaluate in vitro embryotoxicity potencies of PS and gas-to-liquid (GTL) products as compared to their in vivo potencies was investigated. DMSO-extracts of a range of PS, containing different amounts of PAHs, and GTL-products, which are devoid of PAHs, were tested in the ES-D3 cell proliferation and differentiation assays of the EST. The results show that PS inhibited the differentiation of ES-D3 cells into cardiomyocytes in a concentration-dependent manner at non-cytotoxic concentrations, and that their potency was proportional to their PAH content. In contrast, as expected, GTL-products did not inhibit ES-D3 cell viability or differentiation at all. The in vitro PDT potencies were compared to published in vivo PDT studies, and a good correlation was found between in vitro and in vivo results (R 2 =0.97). To conclude, our results support the hypothesis that PAHs are the primary inducers of the PDT in PS. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate.

    PubMed

    Charoo, Naseem A; Shamsher, Areeg A A; Lian, Lai Y; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, D W; Kopp, Sabine; Langguth, Peter; Polli, James; Shah, Vinod P; Dressman, Jennifer

    2014-02-01

    Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing bisoprolol as the sole active pharmaceutical ingredient (API) are reviewed. Bisoprolol is classified as a Class I API according to the current Biopharmaceutics Classification System (BCS). In addition to the BCS class, its therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability problems are taken into consideration. Qualitative compositions of IR tablet dosage forms of bisoprolol with a marketing authorization (MA) in ICH (International Conference on Harmonisation) countries are tabulated. It was inferred that these tablets had been demonstrated to be bioequivalent to the innovator product. No reports of failure to meet BE standards have been made in the open literature. On the basis of all these pieces of evidence, a biowaiver can currently be recommended for bisoprolol fumarate IR dosage forms if (1) the test product contains only excipients that are well known, and used in normal amounts, for example, those tabulated for products with MA in ICH countries and (2) both the test and comparator dosage form are very rapidly dissolving, or, rapidly dissolving with similarity of the dissolution profiles demonstrated at pH 1.2, 4.5, and 6.8. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

  2. Pharmacovigilance in pharmaceutical companies: An overview

    PubMed Central

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-01-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs). PMID:24347978

  3. Pharmacovigilance in pharmaceutical companies: An overview.

    PubMed

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-12-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

  4. Evaluating Point of Sale Tobacco Marketing Using Behavioral Laboratory Methods

    PubMed Central

    Robinson, Jason D.; Drobes, David J.; Brandon, Thomas H.; Wetter, David W.; Cinciripini, Paul M.

    2018-01-01

    With passage of the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA has authority to regulate tobacco advertising. As bans on traditional advertising venues and promotion of tobacco products have grown, a greater emphasis has been placed on brand exposure and price promotion in displays of products at the point-of-sale (POS). POS marketing seeks to influence attitudes and behavior towards tobacco products using a variety of explicit and implicit messaging approaches. Behavioral laboratory methods have the potential to provide the FDA with a strong scientific base for regulatory actions and a model for testing future manipulations of POS advertisements. We review aspects of POS marketing that potentially influence smoking behavior, including branding, price promotions, health claims, the marketing of emerging tobacco products, and tobacco counter-advertising. We conceptualize how POS marketing potentially influence individual attention, memory, implicit attitudes, and smoking behavior. Finally, we describe specific behavioral laboratory methods that can be adapted to measure the impact of POS marketing on these domains.

  5. Development and application of operational techniques for the inventory and monitoring of resources and uses for the Texas coastal zone

    NASA Technical Reports Server (NTRS)

    Harwood, P. (Principal Investigator); Malin, P.; Finley, R.; Mcculloch, S.; Murphy, D.; Hupp, B.; Schell, J. A.

    1977-01-01

    The author has identified the following significant results. Four LANDSAT scenes were analyzed for the Harbor Island area test sites to produce land cover and land use maps using both image interpretation and computer-assisted techniques. When evaluated against aerial photography, the mean accuracy for three scenes was 84% for the image interpretation product and 62% for the computer-assisted classification maps. Analysis of the fourth scene was not completed using the image interpretation technique, because of poor quality, false color composite, but was available from the computer technique. Preliminary results indicate that these LANDSAT products can be applied to a variety of planning and management activities in the Texas coastal zone.

  6. Human parvovirus PARV4 in plasma pools of Chinese origin.

    PubMed

    Ma, Y-Y; Guo, Y; Zhao, X; Wang, Z; Lv, M-M; Yan, Q-P; Zhang, J-G

    2012-10-01

    Human parvovirus 4 (PARV4) is present in blood and blood products. As the presence and levels of PARV4 in Chinese source plasma pools have never been determined, we implemented real-time quantitative PCR to investigate the presence of PARV4 in source plasma pools in China. Results showed that 26·15% (51/195) of lots tested positive for PARV4. The amounts of DNA ranged from 2·83 × 10(3) copies/ml to 2·35×10(7) copies/ml plasma. The high level of PARV4 in plasma pools may pose a potential risk to recipients. Further studies on the pathogenesis of PARV4 are urgently required. © 2012 The Author(s). Vox Sanguinis © 2012 International Society of Blood Transfusion.

  7. Collaborating with human factors when designing an electronic textbook

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ratner, J.A.; Zadoks, R.I.; Attaway, S.W.

    The development of on-line engineering textbooks presents new challenges to authors to effectively integrate text and tools in an electronic environment. By incorporating human factors principles of interface design and cognitive psychology early in the design process, a team at Sandia National Laboratories was able to make the end product more usable and shorten the prototyping and editing phases. A critical issue was simultaneous development of paper and on-line versions of the textbook. In addition, interface consistency presented difficulties with distinct goals and limitations for each media. Many of these problems were resolved swiftly with human factors input using templates,more » style guides and iterative usability testing of both paper and on-line versions. Writing style continuity was also problematic with numerous authors contributing to the text.« less

  8. Container-content compatibility studies: a pharmaceutical team's integrated approach.

    PubMed

    Laschi, Alda; Sehnal, Natacha; Alarcon, Antoine; Barcelo, Beatrice; Caire-Maurisier, François; Delaire, Myriam; Feuilloley, Marc; Genot, Stéphanie; Lacaze, Catherine; Pisarik, Luc; Smati, Christophe

    2009-01-01

    Container-content compatibility studies are required as part of the submission of a new product market authorization file or for a change relating to the primary product-contact packaging. Many regulatory publications and guidances are available in the USA, Europe, and Japan. However these publications and guidances are not sufficiently precise enough to allow for consistent interpretation and implementation of the technical requirements. A working group has been formed by the French Society of Pharmaceutical Science and Technology (SFSTP) in order to propose guidance for container-content interaction studies that meet both European and US requirements, and allows consistent and standardized information to be presented by the industry to the regulators. When a pharmaceutical drug product remains in prolonged contact with a material, the two critical points to consider are the drug product's quality and safety. A pharmaceutical evaluation of the container-content relationship should be done based on the knowledge of the contact material (e.g., type, physicochemical properties), its manufacturing processes (e.g., the type of sterilization that could potentially alter the interactions), and the formulation components involved in contact with this material (e.g., physicochemical properties, pharmaceutical presentation, route of administration). Quality is evaluated using the stability study performed on the product. Safety is partially evaluated with the stability study and is analyzed in conjunction with toxicity testing, specifically with cytotoxicity testing. The toxicity aspect is the key point of the container-content compatibility study and of patient safety. Migration tests are conducted when an interaction is suspected, or found based on previous results, to identify the component responsible for this interaction and to help select a new material if needed. Therefore, such tests are perhaps not the best ones to use for the purpose of safety evaluation. Consequently, a decision tree based mainly on the toxicity aspect is proposed in order to support the pharmaceutical companies' container-content interaction approach and filing.

  9. Cantonese tone production performance of mainstream school children with hearing impairment.

    PubMed

    Cheung, Karen K L; Lau, Ada H Y; Lam, Joffee H S; Lee, Kathy Y S

    2014-12-01

    This study investigated the Cantonese tone production ability of children with hearing impairment studying in mainstream schools. The participants were 87 Cantonese-speaking children with mild-to-profound degrees of hearing loss aged 5.92-13.58 in Hong Kong. Most of the children were fitted with hearing aids (n = 65); 17 of them had profound hearing impairment, one who had severe hearing loss had cochlear implantation, and four who had mild hearing loss were without any hearing device. The Hong Kong Cantonese Articulation Test was administered, and the tones produced were rated by two of the authors and a speech-language pathologist. Group effects of tones, hearing loss level, and also an interaction of the two were found to be significant. The children with profound hearing impairment performed significantly worse than most of the other children. Tone 1 was produced most accurately, whereas tone 6 productions were the poorest. No relationship was found between the number of years of mainstreaming and tone production ability. Tone production error pattern revealed that confusion patterns in tone perception coincided with those in production. Tones having a similar fundamental frequency (F0) at the onset also posed difficulty in tone production for children with hearing impairment.

  10. Portrayal of Brain Death in Film and Television.

    PubMed

    Lewis, A; Weaver, J; Caplan, A

    2017-03-01

    We sought to evaluate whether television and cinematic coverage of brain death is educational or misleading. We identified 24 accessible productions that addressed brain death using the archives of the Paley Center for Media (160 000 titles) and the Internet Movie Database (3.7 million titles). Productions were reviewed by two board-certified neurologists. Although 19 characters were pronounced brain dead, no productions demonstrated a complete examination to assess for brain death (6 included an assessment for coma, 9 included an evaluation of at least 1 brainstem reflex, but none included an assessment of every brainstem reflex, and 2 included an apnea test). Subjectively, both authors believed only a small fraction of productions (13% A.L., 13% J.W.) provided the public a complete and accurate understanding of brain death. Organ donation was addressed in 17 productions (71%), but both reviewers felt that the discussions about organ donation were professional in a paucity of productions (9% for A.L., 27% for J.W.). Because television and movies serve as a key source for public education, the quality of productions that feature brain death must be improved. © Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.

  11. Variability in primary productivity determines metapopulation dynamics.

    PubMed

    Fernández, Néstor; Román, Jacinto; Delibes, Miguel

    2016-04-13

    Temporal variability in primary productivity can change habitat quality for consumer species by affecting the energy levels available as food resources. However, it remains unclear how habitat-quality fluctuations may determine the dynamics of spatially structured populations, where the effects of habitat size, quality and isolation have been customarily assessed assuming static habitats. We present the first empirical evaluation on the effects of stochastic fluctuations in primary productivity--a major outcome of ecosystem functions--on the metapopulation dynamics of a primary consumer. A unique 13-year dataset from an herbivore rodent was used to test the hypothesis that inter-annual variations in primary productivity determine spatiotemporal habitat occupancy patterns and colonization and extinction processes. Inter-annual variability in productivity and in the growing season phenology significantly influenced habitat colonization patterns and occupancy dynamics. These effects lead to changes in connectivity to other potentially occupied habitat patches, which then feed back into occupancy dynamics. According to the results, the dynamics of primary productivity accounted for more than 50% of the variation in occupancy probability, depending on patch size and landscape configuration. Evidence connecting primary productivity dynamics and spatiotemporal population processes has broad implications for metapopulation persistence in fluctuating and changing environments. © 2016 The Authors.

  12. Application of the DART Code for the Assessment of Advanced Fuel Behavior

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rest, J.; Totev, T.

    2007-07-01

    The Dispersion Analysis Research Tool (DART) code is a dispersion fuel analysis code that contains mechanistically-based fuel and reaction-product swelling models, a one dimensional heat transfer analysis, and mechanical deformation models. DART has been used to simulate the irradiation behavior of uranium oxide, uranium silicide, and uranium molybdenum aluminum dispersion fuels, as well as their monolithic counterparts. The thermal-mechanical DART code has been validated against RERTR tests performed in the ATR for irradiation data on interaction thickness, fuel, matrix, and reaction product volume fractions, and plate thickness changes. The DART fission gas behavior model has been validated against UO{sub 2}more » fission gas release data as well as measured fission gas-bubble size distributions. Here DART is utilized to analyze various aspects of the observed bubble growth in U-Mo/Al interaction product. (authors)« less

  13. Process or product: awareness vs. aesthetics.

    PubMed

    Naitove, C E

    1978-01-01

    A historic perspective on the roles of the patient and psychotherapist relative to creative expression clearly demonstrates an emphasis on content, on the projective interpretation of the product. The author challenges the emphasis on product rather than process, the educational 'shop-window' approach to achievers and the talented, as well as the negative effects of 'labeling', and the validity of some forms of projective psychological testing. Discussed is the influence exerted by the psychotherapist through Rogerian 'leakage'. In addition, techniques are suggested for expanding sensory awareness and synthesizing communication skills as a means of enhancing self-image and creative potential. The contention is that the more ways that a skill is synthesized, the more complete is the learning. The more complete the learning, the greater the sense of security. The more secure the individual, the more willing (s)he is to venture into other areas where risk of failure has been a deterrent.

  14. What is the health care product?

    PubMed

    France, K R; Grover, R

    1992-06-01

    Because of the current competitive environment, health care providers (hospitals, HMOs, physicians, and others) are constantly searching for better products and better means for delivering them. The health care product is often loosely defined as a service. The authors develop a more precise definition of the health care product, product line, and product mix. A bundle-of-elements concept is presented for the health care product. These conceptualizations help to address how health care providers can segment their market and position, promote, and price their products. Though the authors focus on hospitals, the concepts and procedures developed are applicable to other health care organizations.

  15. [Health risks from pest control products].

    PubMed

    Pieper, C; Holthenrich, D; Schneider, H

    2014-05-01

    According to European biocide legislation, pest control products require assessment and authorization by the responsible national or European authorities. Biocidal products can only be authorized if they have no unacceptable effects on human health. The health risk assessment performed for authorization comprises (a) the derivation of reference values for the active substances and substances of concern contained in the biocidal product and (b) an exposure assessment. These parameters are required for risk characterization. No unacceptable health risks are expected if the determined exposure is less than the relevant reference value. In addition, the toxicological information is used for classification of the biocidal product. The assessment may, where necessary, result in specific conditions for use or other restrictions aimed at minimizing risk. The risk to human health from pest control products is mainly based on the toxicological properties of their active substances. Commonly, the coformulants used in pest control products are of less concern than the active substances (e.g., food ingredients and animal feed products). For example, most rodenticides belong to the group of anticoagulants, which are also effective in humans. Regarding intoxications through insecticides, the group of pyrethroids is of particular importance. Fumigants containing metal phosphides, hydrogen cyanide, or sulfuryl difluoride are particularly toxic. This toxicity is linked to the high acute inhalation toxicity of the gaseous active substances themselves or, in the case of phosphides, of the released gas phosphane. The aim of health risk assessment for the authorization of biocidal products is to ensure their safe application for users and all other persons involved, assuming an adequate and label-compliant use.

  16. What the shark immune system can and cannot provide for the expanding design landscape of immunotherapy.

    PubMed

    Criscitiello, Michael F

    2014-07-01

    Sharks have successfully lived in marine ecosystems, often atop food chains as apex predators, for nearly one and a half billion years. Throughout this period they have benefitted from an immune system with the same fundamental components found in terrestrial vertebrates like man. Additionally, sharks have some rather extraordinary immune mechanisms which mammals lack. In this review the author briefly orients the reader to sharks, their adaptive immunity, and their important phylogenetic position in comparative immunology. The author also differentiates some of the myths from facts concerning these animals, their cartilage, and cancer. From thereon, the author explores some of the more remarkable capabilities and products of shark lymphocytes. Sharks have an isotype of light chain-less antibodies that are useful tools in molecular biology and are moving towards translational use in the clinic. These special antibodies are just one of the several tricks of shark lymphocyte antigen receptor systems. While shark cartilage has not helped oncology patients, shark immunoglobulins and T cell receptors do offer exciting novel possibilities for immunotherapeutics. Much of the clinical immunology developmental pipeline has turned from traditional vaccines to passively delivered monoclonal antibody-based drugs for targeted depletion, activation, blocking and immunomodulation. The immunogenetic tools of shark lymphocytes, battle-tested since the dawn of our adaptive immune system, are well poised to expand the design landscape for the next generation of immunotherapy products.

  17. Physicochemical and bacteriological quality of bottled drinking water in three sites of Amhara Regional State, Ethiopia.

    PubMed

    Biadglegne, Fantahun; Tessema, Belay; Kibret, Mulugeta; Abera, Bayeh; Huruy, Kahsay; Anagaw, Belay; Mulu, Andargachew

    2009-10-01

    The consumption of bottled drinking water is becoming increasing in Ethiopia. As a result there has been a growing concern about the chemical, physical and bacteriological quality of this product. Studies on the chemical, physical and bacteriological quality of bottled water is quite scarce in Ethiopia. This study was therefore aimed to assess the physicochemical and bacteriological qualities of three factories of bottled drinking water products produced in Amhara region. A Laboratory based comparative study was conducted to evaluate the physicochemical and bacteriological quality of three factories of bottled drinking water produced in Amhara region. Analysis on the quality of bottled drinking water from the sources, wholesalers and retailers were made with World Health Organization and Quality and Standards Authority of Ethiopia recommendations. Triplicate samples from three types of bottled drinking water were randomly collected and analyzed from June, 2006 to December, 2006. A total of 108 commercial bottled drinking water samples were analyzed. The result showed that except pH of factory A all the physicochemical parameters analyzed were with in the recommended limits. The pH value of factory A tested from sources is 5.3 and from wholesalers and retailers is 5.5 and 5.3, respectively, which is below the normal value set by World Health Organization (6.5-8.0) and Quality and Standards Authority of Ethiopia (6.0-8.5). Our analyses also demonstrated that 2 (16.7%) of the samples tested from sources and 1 (8.3%) from wholesalers of factory B were contaminated with total coliforms, where as 2 (16.7%) samples from retailers were also contaminated with total coliforms. On the other hand, 1 (8.3%) of the samples tested from wholesalers and 2 (16.7%) of the samples tested from retailers of factory A were also contaminated with total coliforms. Total coliforms were not detected from all samples of factory C, fecal coliforms were not also isolated from all samples. Percent of coefficient of variation showed that variations in total coliforms counts were significant with in the samples of both factory A and B (CV > 10%). Based on the recommended limit of World Health Organization and Quality and Standards Authority of Ethiopia, 7.4% of bottled drinking water sold commercially could be considered unfit for human consumption. Consumers of bottled water should be aware of this.

  18. 76 FR 36079 - Foreign-Trade Subzone 38A; Application for Expansion of Manufacturing Authority (Production...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Docket 43-2011] Foreign-Trade Subzone 38A; Application for Expansion of Manufacturing Authority (Production Capacity); BMW Manufacturing Co., LLC; (Motor Vehicles) A request has been submitted to the Foreign-Trade Zones Board (the Board) by the South Carolina State Ports Authority, grantee of FTZ...

  19. 78 FR 55056 - Approval for Manufacturing (Production) Authority; Foreign-Trade Zone 141; Firth Rixson, Inc. d/b...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1913] Approval for Manufacturing (Production) Authority; Foreign-Trade Zone 141; Firth Rixson, Inc. d/b/a Firth Rixson Monroe (Aircraft Turbine Components); Rochester, New York Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934...

  20. 21 CFR 170.17 - Exemption for investigational use and procedure for obtaining authorization to market edible...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals. 170.17 Section 170.17 Food and... procedure for obtaining authorization to market edible products from experimental animals. A food additive...

  1. 41 CFR 300-90.6 - What is authorized under the test programs?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the test programs? 300-90.6 Section 300-90.6 Public Contracts and Property Management Federal Travel Regulation System GENERAL AGENCY REQUIREMENTS 90-TELEWORK TRAVEL EXPENSES TEST PROGRAMS § 300-90.6 What is authorized under the test programs? Under a telework expenses test program authorized by the Administrator of...

  2. Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.

    PubMed

    Schutte, Katrin; Szczepanska, Anna; Halder, Marlies; Cussler, Klaus; Sauer, Ursula G; Stirling, Catrina; Uhlrich, Sylvie; Wilk-Zasadna, Iwona; John, David; Bopst, Martin; Garbe, Joerg; Glansbeek, Harrie L; Levis, Robin; Serreyn, Pieter-Jan; Smith, Dean; Stickings, Paul

    2017-07-01

    This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Ames Test to Detect Mutagenicity of 2-Alkylcyclobutanones: A Review.

    PubMed

    Barbezan, Angélica B; Martins, Regiane; Bueno, Jennifer B; Villavicencio, Anna Lúcia C H

    2017-07-01

    Food irradiation is an effective and safe method for preservation and long-term storage, and it is approved for use in over 60 countries for various applications in a wide variety of food products. This process is performed by use of accelerated electron beams, X-rays, or gamma radiation ( 60 Co or 137 Cs). 2-Alkylcyclobutanones (2-ACBs) are the only known radiolytic products generated from foods that have fatty acids (triglycerides) and are subjected to irradiation. Since the 1990s toxicological safety studies of 2-ACBs have been conducted extensively through synthetic compounds, then and tests to determine if the compounds have any mutagenic activity are strictly necessary. The Ames test was chosen by many researchers to assess the mutagenicity of 2-ACBs. The test uses distinct bacterial cell lines Salmonella typhimurium to detect point mutations at sites guanine-cytosine (G-C) and Escherichia coli to detect point mutations at sites adenine-thymine (A-T). This bibliographic research aims to bring together all the results obtained and a comparison and cell lines used, type of plates, and solvents. This research showed that no mutagenic activity was observed in any of the cell lines and concentrations evaluated by the works of authors, so the 2-ACBs compounds showed no mutagenic substance in concentrations detectable by the Ames test. © 2017 Institute of Food Technologists®.

  4. 77 FR 63290 - Foreign-Trade Zone 61-San Juan, Puerto Rico; Authorization of Production Activity, Pfizer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ..., Puerto Rico; Authorization of Production Activity, Pfizer Pharmaceuticals, LLC (Subzone 61A), (Ibuprofen Pharmaceutical Products), Guayama, Puerto Rico On June 13, 2012, the Puerto Rico Trade and Export Company... Pharmaceuticals, LLC (Subzone 61A) for its manufacturing facility located in Guayama, Puerto Rico. The...

  5. 78 FR 30269 - Foreign-Trade Zone 129-Bellingham, Washington; Authorization of Production Activity; T.C. Trading...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of T.C. Trading Company, Inc... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-8-2013] Foreign-Trade Zone 129--Bellingham, Washington; Authorization of Production Activity; T.C. Trading Company, Inc. (Eyeglass Assembly and Kitting...

  6. Key Authors in Business and Management Education Research: Productivity, Topics, and Future Directions

    ERIC Educational Resources Information Center

    Arbaugh, J. B.; Asarta, Carlos J.; Hwang, Alvin; Fornaciari, Charles J.; Bento, Regina F.; Dean, Kathy Lund

    2017-01-01

    Previous studies of author productivity in business and management education (BME) research have focused on single disciplinary areas, and even single journals. This study is the first to examine the productivity of BME scholars across multiple disciplinary areas (i.e., accounting, economics, finance, information systems, management, marketing,…

  7. 36 CFR 223.217 - Authority to dispose of special forest products.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 2 2010-07-01 2010-07-01 false Authority to dispose of special forest products. 223.217 Section 223.217 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE SALE AND DISPOSAL OF NATIONAL FOREST SYSTEM TIMBER Special Forest Products § 223...

  8. 77 FR 59890 - Foreign-Trade Zone 92-Gulfport, MS; Authorization of Production Activity; Gulf Ship, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-36-2012] Foreign-Trade Zone 92--Gulfport, MS; Authorization of Production Activity; Gulf Ship, LLC (Shipbuilding); Gulfport, MS On May 10, 2012, the Mississippi Coast Foreign-Trade Zone, Inc., grantee of FTZ 92, submitted a notification of proposed production...

  9. 78 FR 56859 - Foreign-Trade Zone 267-Fargo, North Dakota; Authorization of Production Activity; CNH America...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-51-2013] Foreign-Trade Zone 267--Fargo, North Dakota; Authorization of Production Activity; CNH America, LLC, (Construction and Agricultural Equipment..., submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of...

  10. 78 FR 68814 - Subzone 114F, Authorization of Production Activity, Easton-Bell Sports, Inc., (Sports Equipment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-74-2013] Subzone 114F, Authorization of Production Activity, Easton-Bell Sports, Inc., (Sports Equipment), Rantoul, Illinois On June 27, 2013, Easton-Bell Sports, Inc. submitted a notification of proposed production activity to the Foreign-Trade Zones...

  11. 77 FR 63290 - Foreign-Trade Zone 74-Baltimore, MD, Authorization of Production Activity, J.D. Neuhaus LP...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-47-2012] Foreign-Trade Zone 74--Baltimore, MD, Authorization of Production Activity, J.D. Neuhaus LP, (Overhead Lifting Equipment Production), Sparks, MD On June 13, 2012, the Baltimore Development Corporation, grantee of FTZ 74, submitted a notification of...

  12. Interacting effects of wildlife loss and climate on ticks and tick-borne disease.

    PubMed

    Titcomb, Georgia; Allan, Brian F; Ainsworth, Tyler; Henson, Lauren; Hedlund, Tyler; Pringle, Robert M; Palmer, Todd M; Njoroge, Laban; Campana, Michael G; Fleischer, Robert C; Mantas, John Naisikie; Young, Hillary S

    2017-09-13

    Both large-wildlife loss and climatic changes can independently influence the prevalence and distribution of zoonotic disease. Given growing evidence that wildlife loss often has stronger community-level effects in low-productivity areas, we hypothesized that these perturbations would have interactive effects on disease risk. We experimentally tested this hypothesis by measuring tick abundance and the prevalence of tick-borne pathogens ( Coxiella burnetii and Rickettsia spp . ) within long-term, size-selective, large-herbivore exclosures replicated across a precipitation gradient in East Africa. Total wildlife exclusion increased total tick abundance by 130% (mesic sites) to 225% (dry, low-productivity sites), demonstrating a significant interaction of defaunation and aridity on tick abundance. When differing degrees of exclusion were tested for a subset of months, total tick abundance increased from 170% (only mega-herbivores excluded) to 360% (all large wildlife excluded). Wildlife exclusion differentially affected the abundance of the three dominant tick species, and this effect varied strongly over time, likely due to differences among species in their host associations, seasonality, and other ecological characteristics. Pathogen prevalence did not differ across wildlife exclusion treatments, rainfall levels, or tick species, suggesting that exposure risk will respond to defaunation and climate change in proportion to total tick abundance. These findings demonstrate interacting effects of defaunation and aridity that increase disease risk, and they highlight the need to incorporate ecological context when predicting effects of wildlife loss on zoonotic disease dynamics. © 2017 The Author(s).

  13. [Chemicals toxic to the olfactory system. Analysis and description].

    PubMed

    Norès, J M; Biacabe, B; Bonfils, P

    2000-10-28

    AN IMPORTANT PROBLEM: Occupational exposure to chemical products can have toxic effects on the olfactory system. An important number of patients have experienced olfactory disorders subsequent to the development of the chemical industry and atmospheric pollution. EPIDEMIOLOGY DATA: Straightforward data are difficult to collect because several cofactors other than the toxic product are involved. Two lists of toxic products can be made. The first list includes products for which scientific data is available and the second products for which data is lacking. Olfactory tests also differ between authors and countries. TWO TYPES OF TOXICITY: Acute, accidental toxicity is evidenced by the lesions caused by inhalation of high-doses of strongly toxic agents. Chronic intoxication caused by lower concentrations of these inhaled agents does not produce a trigeminal reflex leading to a modified respiratory rate reducing the airborne aggression. APPROXIMATIONS: Clinical data describing the olfactory toxicity of certain industrial and chemical compounds are very significant but often cannot prove a cause and effect relationship. Data obtained with experimental models in rodents are difficult to extrapolate to humans.

  14. Hyperhidrosis plantaris - a randomized, half-side trial for efficacy and safety of an antiperspirant containing different concentrations of aluminium chloride.

    PubMed

    Streker, Meike; Reuther, Tilmann; Hagen, Linda; Kerscher, Martina

    2012-02-01

    Primary focal hyperhidrosis plantaris can cause impairment in social, physical, leisure and occupational activities. Topical treatment with aluminium chloride is the first-line treatment. The aim of this trial was to evaluate efficacy and safety of two different concentrations of aluminium chloride hexa-hydrate (12.5%, 30%) for 6 weeks. 20 volunteers with hyperhidrosis plantaris were included. Efficacy was evaluated using a clinical rating scale of the hyperhidrosis level and qualitative assessments including Minor's (iodine-starch) test and a standardized sniff test. Furthermore a patient questionnaire and measurements of skin surface pH were done to evaluate the subjective assessments and side effects. The hyperhidrosis level significantly decreased in both concentrations. There were no differences in tolerability regarding the skin surface pH and the patient questionnaires. In addition the hidrotic areas decreased after application of both products and the sniff test improved. Topical application of an antiperspirant containing aluminium chloride reduced sweat production in plantar hyperhidrosis significantly. As both 12.5% and 30% were efficacious and safe, we would recommend 12.5% for outpatient treatment. © The Author • Journal compilation © Blackwell Verlag GmbH, Berlin.

  15. Electrothermal Action of the Pulse of the Current of a Short Artificial-Lightning Stroke on Test Specimens of Wires and Cables of Electric Power Objects

    NASA Astrophysics Data System (ADS)

    Baranov, M. I.; Rudakov, S. V.

    2018-03-01

    The authors have given results of investigations of the electrothermal action of aperiodic pulses of temporal shape 10/350 μs of the current of a short artificial-lightning stroke on test specimens of electric wires and cables with copper and aluminum cores and sheaths with polyvinylchloride and polyethylene insulations of power circuits of industrial electric power objects. It has been shown that the thermal stability of such wires and cables is determined by the action integral of the indicated current pulse. The authors have found the maximum permissible and critical densities of this pulse in copper and aluminum current-carrying parts of the wires and cables. High-current experiments conducted under high-voltage laboratory conditions on a unique generator of 10/350 μs pulses of an artificial-lightning current with amplitude-time parameters normalized according to the existing requirements of international and national standards and with tolerances on them have confirmed the reliability of the proposed calculated estimate for thermal lightning resistance of cabling and wiring products.

  16. Electrothermal Action of the Pulse of the Current of a Short Artificial-Lightning Stroke on Test Specimens of Wires and Cables of Electric Power Objects

    NASA Astrophysics Data System (ADS)

    Baranov, M. I.; Rudakov, S. V.

    2018-05-01

    The authors have given results of investigations of the electrothermal action of aperiodic pulses of temporal shape 10/350 μs of the current of a short artificial-lightning stroke on test specimens of electric wires and cables with copper and aluminum cores and sheaths with polyvinylchloride and polyethylene insulations of power circuits of industrial electric power objects. It has been shown that the thermal stability of such wires and cables is determined by the action integral of the indicated current pulse. The authors have found the maximum permissible and critical densities of this pulse in copper and aluminum current-carrying parts of the wires and cables. High-current experiments conducted under high-voltage laboratory conditions on a unique generator of 10/350 μs pulses of an artificial-lightning current with amplitude-time parameters normalized according to the existing requirements of international and national standards and with tolerances on them have confirmed the reliability of the proposed calculated estimate for thermal lightning resistance of cabling and wiring products.

  17. Microbiological Challenge Testing for Listeria Monocytogenes in Ready-to-Eat Food: A Practical Approach.

    PubMed

    Spanu, Carlo; Scarano, Christian; Ibba, Michela; Pala, Carlo; Spanu, Vincenzo; De Santis, Enrico Pietro Luigi

    2014-12-09

    Food business operators (FBOs) are the primary responsible for the safety of food they place on the market. The definition and validation of the product's shelf-life is an essential part for ensuring microbiological safety of food and health of consumers. In the frame of the Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs, FBOs shall conduct shelf-life studies in order to assure that their food does not exceed the food safety criteria throughout the defined shelf-life. In particular this is required for ready-to-eat (RTE) food that supports the growth of Listeria monocytogenes . Among other studies, FBOs can rely on the conclusion drawn by microbiological challenge tests. A microbiological challenge test consists in the artificial contamination of a food with a pathogen microorganism and aims at simulating its behaviour during processing and distribution under the foreseen storage and handling conditions. A number of documents published by international health authorities and research institutions describes how to conduct challenge studies. The authors reviewed the existing literature and described the methodology for implementing such laboratory studies. All the main aspects for the conduction of L. monocytogenes microbiological challenge tests were considered, from the selection of the strains, preparation and choice of the inoculum level and method of contamination, to the experimental design and data interpretation. The objective of the present document is to provide an exhaustive and practical guideline for laboratories that want to implement L. monocytogenes challenge testing on RTE food.

  18. Infectivity of pre-seroconversion donations: an analysis of lookback exercises in The Netherlands, 2000-2006.

    PubMed

    Lieshout-Krikke, R W; van 't Ende, E A; Slot, E; Karomi, S; Kivit, R M H; Zaaijer, H L

    2012-04-01

    Blood can be infectious if it is donated shortly before infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) becomes detectable. Lookback exercises may detect infection in recipients of pre-seroconversion donations. This study provides an analysis of the Dutch lookback exercises in the years 2000 through 2006. All lookback procedures, triggered by 50 repeat donors seroconverting for HBV (n=32), HCV (n=3), HIV (n=14) and HBV + HIV (n=1), were analysed. Recipients and archived samples of the 96 implicated donations were tested. For 76 donations, a stored sample was available for HBV, HCV, or HIV PCR testing, revealing two HBV-DNA-positive pre-seroconversion donations. Ninety-three lookback procedures were initiated, to which 91 of 93 hospitals responded. In 87 of 91 cases, the implicated blood product had been administered. In 39 of 87 cases, the recipient was tested, revealing one HIV and two HBV infections. The HIV infection was considered pre-existent. The two HBV-positive patients received components from the donation of which the repository sample tested positive for HBV-DNA. Components of the second HBV-positive pre-seroconversion donation had not been administered. Among 39 recipients of pre-seroconversion donations, 2 (5%) were found HBV infected by transfusion. The labour-intensive lookback procedures did not reveal any conclusive transmissions additional to the infections detected by PCR testing of repository pre-seroconversion samples. © 2011 The Author(s). Vox Sanguinis © 2011 International Society of Blood Transfusion.

  19. Males that drop a sexually selected weapon grow larger testes.

    PubMed

    Joseph, Paul N; Emberts, Zachary; Sasson, Daniel A; Miller, Christine W

    2018-01-01

    Costly sexually selected weapons are predicted to trade off with postcopulatory traits, such as testes. Although weapons can be important for achieving access to females, individuals of some species can permanently drop (i.e. autotomize) their weapons, without regeneration, to escape danger. We capitalized on this natural behavior to experimentally address whether the loss of a sexually selected weapon leads to increased testes investment in the leaf-footed cactus bug, Narnia femorata Stål (Hemiptera: Coreidae). In a second experiment, we measured offspring production for males that lost a weapon during development. As predicted, males that dropped a hind limb during development grew significantly larger testes than the control treatments. Hind-limb autotomy did not result in the enlargement of other nearby traits. Our results are the first to experimentally demonstrate that males compensate for natural weapon loss by investing more in testes. In a second experiment we found that females paired with males that lost a hind limb had 40% lower egg hatching success than females paired with intact males, perhaps because of lower mating receptivity to males with a lost limb. Importantly, in those cases where viable offspring were produced, males missing a hind limb produced 42% more offspring than males with intact limbs. These results suggest that the loss of a hind-limb weapon can, in some cases, lead to greater fertilization success. © 2017 The Author(s). Evolution © 2017 The Society for the Study of Evolution.

  20. Well development by jetting using coiled tubing and simultaneous pumping.

    PubMed

    Rosberg, Jan-Erik; Bjelm, Leif

    2009-01-01

    During flow testing of a deep, 1927-m, gravel packed screen completed well, it became apparent that well development was needed to increase productivity. A hydrojetting system using coiled tubing in combination with simultaneous pumping was developed and tested and found to be successful. To verify whether the jetting improved the well, the results of a pumping test conducted before and after the jetting operation are compared. In addition, flowmeter logging and hydraulic properties obtained from pumping tests conducted during the jetting operation were also used to verify the improvements. Hydrojetting in combination with simultaneous pumping proved to be an effective cleaning method. After 100 min of pumping, around 110 m less drawdown and 15 L/s higher average flow rate were obtained compared to the values before the jetting operation. The skin factor was positive before the jetting operation and negative thereafter, thus providing additional evidence of improvements of the well. The flowmeter data also confirmed the improvements and were valuable in optimizing the jetting operation. It was also found, from the short-term pumping tests conducted during the jetting operation, that the Hantush-Jacob method for leaky confined aquifers is a valuable indicator of the well development. The combination of methods used for the well development in this case can easily be applied on other deep well projects to obtain a controlled and time-efficient well development. Copyright © 2009 The Author(s). Journal Compilation © 2009 National Ground Water Association.

  1. Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods

    PubMed Central

    Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

    2011-01-01

    Simple Summary Many vaccines are tested for quality in experiments that require the use of large numbers of animals in procedures that often cause significant pain and distress. Newer technologies have fostered the development of vaccine quality control tests that reduce or eliminate the use of animals, but the availability of these newer methods has not guaranteed their acceptance by regulators or use by manufacturers. We discuss a strategic approach that has been used to assess and ultimately increase the use of non-animal vaccine quality tests in the U.S. and U.K. Abstract In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches. PMID:26486625

  2. 12 CFR 325.201 - Authority, purpose, and reservation of authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... STATEMENTS OF GENERAL POLICY CAPITAL MAINTENANCE Annual Stress Test § 325.201 Authority, purpose, and... require each covered bank to conduct annual stress tests and establishes a definition of stress test, methodologies for conducting stress tests, and reporting and disclosure requirements. (c) Reservation of...

  3. 12 CFR 325.201 - Authority, purpose, and reservation of authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... STATEMENTS OF GENERAL POLICY CAPITAL MAINTENANCE Annual Stress Test § 325.201 Authority, purpose, and... require each covered bank to conduct annual stress tests and establishes a definition of stress test, methodologies for conducting stress tests, and reporting and disclosure requirements. (c) Reservation of...

  4. Zebrafish embryo toxicity of anaerobic biotransformation products from the insensitive munitions compound 2,4-dinitroanisole.

    PubMed

    Olivares, Christopher I; Sierra-Alvarez, Reyes; Abrell, Leif; Chorover, Jon; Simonich, Michael; Tanguay, Robert L; Field, Jim A

    2016-11-01

    2,4-Dinitroanisole (DNAN) is an emerging insensitive munitions compound that readily undergoes anaerobic nitro-group reduction to 2-methoxy-5-nitroaniline (MENA) and 2,4-diaminoanisole (DAAN), followed by formation of unique azo dimers. Currently there is little knowledge on the ecotoxicity of DNAN (bio)transformation products. In the present study, mortality, development, and behavioral effects of DNAN (bio)transformation products were assessed using zebrafish (Danio rerio) embryos. The authors tested individual products, MENA and DAAN, as well as dimer and trimer surrogates. As pure compounds, 3-nitro-4-methoxyaniline and 2,2'-dimethoxy-4,4'-azodianiline caused statistically significant effects, with lowest-observable-adverse effect levels (LOAEL) at 6.4 μM on 1 or 2 developmental endpoints, respectively. The latter had 6 additional statistically significant developmental endpoints with LOAELs of 64 μM. Based on light-to-dark swimming behavioral tests, DAAN (640 μM) caused reduction in swimming, suggestive of neurotoxicity. No statistically significant mortality occurred (≤64 μM) for any of the individual compounds. However, metabolite mixtures formed during different stages of MENA (bio)transformation in soil were characterized using high-resolution mass spectrometry in parallel with zebrafish embryo toxicity assays, which demonstrated statistically significant mortality during the onset of azo-dimer formation. Overall the results indicate that several DNAN (bio)transformation products cause different types of toxicity to zebrafish embryos. Environ Toxicol Chem 2016;35:2774-2781. © 2016 SETAC. © 2016 SETAC.

  5. Design for improved maintenance of the fiber-optic cable system (As carried out in a concurrent engineering environment)

    NASA Astrophysics Data System (ADS)

    Tremoulet, P. C.

    The author describes a number of maintenance improvements in the Fiber Optic Cable System (FOCS). They were achieved during a production phase pilot concurrent engineering program. Listed in order of importance (saved maintenance time and material) by maintenance level, they are: (1) organizational level: improved fiber optic converter (FOC) BITE; (2) Intermediate level: reduced FOC adjustments from 20 to 2; partitioned FOC into electrical and optical parts; developed cost-effective fault isolation test points and test using standard test equipment; improved FOC chassis to have lower mean time to repair; and (3) depot level: revised test requirements documents (TRDs) for common automatic test equipment and incorporated ATE testability into circuit and assemblies and application-specific integrated circuits. These improvements met this contract's tailored logistics MIL-STD 1388-1A requirements of monitoring the design for supportability and determining the most effective support equipment. Important logistics lessons learned while accomplishing these maintainability and supportability improvements on the pilot concurrent engineering program are also discussed.

  6. Quantitative Image Analysis Techniques with High-Speed Schlieren Photography

    NASA Technical Reports Server (NTRS)

    Pollard, Victoria J.; Herron, Andrew J.

    2017-01-01

    Optical flow visualization techniques such as schlieren and shadowgraph photography are essential to understanding fluid flow when interpreting acquired wind tunnel test data. Output of the standard implementations of these visualization techniques in test facilities are often limited only to qualitative interpretation of the resulting images. Although various quantitative optical techniques have been developed, these techniques often require special equipment or are focused on obtaining very precise and accurate data about the visualized flow. These systems are not practical in small, production wind tunnel test facilities. However, high-speed photography capability has become a common upgrade to many test facilities in order to better capture images of unsteady flow phenomena such as oscillating shocks and flow separation. This paper describes novel techniques utilized by the authors to analyze captured high-speed schlieren and shadowgraph imagery from wind tunnel testing for quantification of observed unsteady flow frequency content. Such techniques have applications in parametric geometry studies and in small facilities where more specialized equipment may not be available.

  7. Chemical Analysis and Simulated Pyrolysis of Tobacco Heating System 2.2 Compared to Conventional Cigarettes.

    PubMed

    Li, Xiangyu; Luo, Yanbo; Jiang, Xingyi; Zhang, Hongfei; Zhu, Fengpeng; Hu, Shaodong; Hou, Hongwei; Hu, Qingyuan; Pang, Yongqiang

    2018-01-08

    Tobacco Heating System 2.2 (THS 2.2, marketed as iQOS), is a heat-not-burn (HNB) tobacco product that has been successfully introduced to global markets. Despite its expanding market, few independent and systematic researches into THS 2.2 have been carried out to date. We tested a comprehensive list of total particulate matter (TPM), water, tar, nicotine, propylene glycol, glycerin, carbon monoxide, volatile organic compounds, aromatic amines, hydrogen cyanide, ammonia, N-nitrosamines, phenol, and polycyclic aromatic hydrocarbon under both ISO and HCI regimes. We also simulated pyrolysis of THS 2.2 heating sticks and made comparisons with conventional cigarette tobacco fillers using comprehensive gas chromatography-mass spectrometry (GC × GC-MS) to determine whether the specially designed ingredients help reduce harmful constituents. Other than some carbonyls, ammonia, and N-nitrosoanabasine (NAB), the delivered releases from THS 2.2 were at least 80% lower than those from 3R4F. Tar and nicotine remained almost the same as 3R4F. Interestingly, the normalized yield of THS 2.2 to 3R4F under the HCI regime was lower than under the ISO regime. THS 2.2 delivered fewer harmful constituents than the conventional cigarette 3R4F. Simulated pyrolysis results showed that the lower temperature instead of specially designed ingredients contributed to the distinct shift. In particular, if smoking machines are involved to evaluate the HNB products, smoking regimes of heat-not-burn tobacco products should be carefully chosen. To our knowledge, few independent studies of HNB products have been published. In this paper, a comprehensive list of chemical releases was tested systematically and compared to those from 3R4F. Although THS 2.2 generates lower levels of harmful constituents, the nicotine and tar levels were almost identical to 3R4F.The results should be discussed carefully in the future when assess the dual-use with other conventional cigarettes, nicotine dependence of HNB products, etc. This study also suggests that regulatory agencies should pay attention to the smoking regimes that are adopted to evaluate HNB tobacco products. © The Author(s) 2018. 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.

  8. Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

    PubMed

    Bartlett, Jeremy A; Brewster, Marcus; Brown, Paul; Cabral-Lilly, Donna; Cruz, Celia N; David, Raymond; Eickhoff, W Mark; Haubenreisser, Sabine; Jacobs, Abigail; Malinoski, Frank; Morefield, Elaine; Nalubola, Ritu; Prud'homme, Robert K; Sadrieh, Nakissa; Sayes, Christie M; Shahbazian, Hripsime; Subbarao, Nanda; Tamarkin, Lawrence; Tyner, Katherine; Uppoor, Rajendra; Whittaker-Caulk, Margaret; Zamboni, William

    2015-01-01

    At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

  9. Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance

    NASA Astrophysics Data System (ADS)

    Stryzhak, Y.; Vasilina, V.; Kurbatov, V.

    2002-01-01

    For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified procedures to define risks related to the specific component application and evaluate safety for the entire program implementation. In the eyes of the authors, those features together with a number of other conceptual proposals should constitute a unified standard-technical basis for implementing international space programs.

  10. Quality of omeprazole purchased via the Internet and personally imported into Japan: comparison with products sampled in other Asian countries.

    PubMed

    Rahman, Mohammad Sofiqur; Yoshida, Naoko; Sugiura, Sakura; Tsuboi, Hirohito; Keila, Tep; Kiet, Heng Bun; Zin, Theingi; Tanimoto, Tsuyoshi; Kimura, Kazuko

    2018-03-01

    To evaluate the quality of omeprazole personally imported into Japan via the Internet and to compare the quality of these samples with previously collected samples from two other Asian countries. The samples were evaluated by observation, authenticity investigation and pharmacopoeial quality analysis. Quality comparison of some selected samples was carried out by dissolution profiling, Raman spectroscopy and principle component analysis (PCA). Observation of the Internet sites and samples revealed some discrepancies including the delivery of a wrong sample and the selling of omeprazole without a prescription, although it is a prescription medicine. Among the 28 samples analysed, all passed the identification test, 26 (93%) passed the quantity and content uniformity tests and all passed the dissolution test. Dissolution profiling confirmed that all the personally imported omeprazole samples remained intact in the acid medium. On the other hand, six samples from two of the same manufacturers, previously collected during surveys in Cambodia and Myanmar, frequently showed premature omeprazole release in acid. Raman spectroscopy and PCA showed significant variation between omeprazole formulations in personally imported samples and the samples from Cambodia and Myanmar. Our results indicate that the pharmaceutical quality of omeprazole purchased through the Internet was sufficient, as determined by pharmacopeial tests. However, omeprazole formulations distributed in different market segments by the same manufacturers were of diverse quality. Measures are needed to ensure consistent quality of products and to prevent entry of substandard products into the legitimate supply chain. © 2018 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

  11. 47 CFR 73.1515 - Special field test authorizations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 4 2014-10-01 2014-10-01 false Special field test authorizations. 73.1515 Section 73.1515 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Rules Applicable to All Broadcast Stations § 73.1515 Special field test authorizations. (a) A special field test...

  12. 47 CFR 73.1515 - Special field test authorizations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 4 2012-10-01 2012-10-01 false Special field test authorizations. 73.1515 Section 73.1515 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Rules Applicable to All Broadcast Stations § 73.1515 Special field test authorizations. (a) A special field test...

  13. 30 CFR 203.1 - What is BSEE's authority to grant royalty relief?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... specified for an OCS lease to promote increased production. (b) Under 43 U.S.C. 1337(a)(3)(B), we may reduce, modify, or eliminate any royalty or net profit share to promote development, increase production, or encourage production of marginal resources on certain leases or categories of leases. This authority is...

  14. 30 CFR 203.1 - What is BSEE's authority to grant royalty relief?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... specified for an OCS lease to promote increased production. (b) Under 43 U.S.C. 1337(a)(3)(B), we may reduce, modify, or eliminate any royalty or net profit share to promote development, increase production, or encourage production of marginal resources on certain leases or categories of leases. This authority is...

  15. 30 CFR 203.1 - What is BSEE's authority to grant royalty relief?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... specified for an OCS lease to promote increased production. (b) Under 43 U.S.C. 1337(a)(3)(B), we may reduce, modify, or eliminate any royalty or net profit share to promote development, increase production, or encourage production of marginal resources on certain leases or categories of leases. This authority is...

  16. 78 FR 20091 - Foreign-Trade Zone 26-Atlanta, Georgia, Authorization of Production Activity, Perkins Shibaura...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-90-2012] Foreign-Trade Zone 26--Atlanta, Georgia, Authorization of Production Activity, Perkins Shibaura Engines, LLC (Diesel Engines), Griffin, Georgia On November 29, 2012, Georgia Foreign-Trade Zone, Inc., grantee of FTZ 26, submitted a notification of proposed production activity to the...

  17. 78 FR 41911 - Foreign-Trade Zone 161-Sedgwick County, Kansas; Authorization of Production Activity; Siemens...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-12

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-27-2013] Foreign-Trade Zone 161--Sedgwick County, Kansas; Authorization of Production Activity; Siemens Energy, Inc. (Wind Turbine Nacelles and Hubs); Hutchinson, Kansas On March 7, 2013, Siemens Energy, Inc., an operator of FTZ 161, submitted a notification of proposed production activity to...

  18. Mis/Representations in School-Based Digital Media Production: An Ethnographic Exploration with Muslim Girls

    ERIC Educational Resources Information Center

    Dahya, Negin; Jenson, Jennifer

    2015-01-01

    In this article, the authors discuss findings from a digital media production club with racialized girls in a low-income school in Toronto, Ontario. Specifically, the authors consider how student-produced media is impacted by ongoing postcolonial structures relating to power and representation in the school and in the media production work of…

  19. 78 FR 51707 - Foreign-Trade Zone 59-Lincoln, Nebraska; Authorization of Production Activity; CNH America, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-40-2013] Foreign-Trade Zone 59--Lincoln, Nebraska; Authorization of Production Activity; CNH America, LLC; Subzone 59B (Agricultural Equipment Production); Grand Island, Nebraska On April 17, 2013, the Lincoln-Foreign Trade Zone, Inc., grantee of FTZ 59, submitted a notification of proposed...

  20. 78 FR 48413 - Foreign-Trade Zone 75-Phoenix, Arizona, Authorization of Production Activity, Orbital Sciences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-33-2013] Foreign-Trade Zone 75--Phoenix, Arizona, Authorization of Production Activity, Orbital Sciences Corporation, (Satellites and Spacecraft Launch Vehicles); Gilbert, Arizona On April 2, 2013, the City of Phoenix, grantee of FTZ 75, submitted a notification of proposed production activity...

Some links on this page may take you to non-federal websites. Their policies may differ from this site.
Top