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

Science.gov (United States)

2010-04-01

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

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG... Provisions § 872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-04-01

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

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 888.9 Section 888.9 Food and Drugs FOOD AND DRUG... Provisions § 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG... Provisions § 892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 882.9 Section 882.9 Food and Drugs FOOD AND DRUG... Provisions § 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

MELHORIA DO PROCESSO DE CORREÇÃO GEOMÉTRICA DE IMAGENS CBERS-CCD PELO USO DE AMOSTRAS GEORREFERENCIADAS CLASSIFICADAS

OpenAIRE

Castejon, Emiliano Ferreira; Fonseca, Leila Maria Garcia; Forster, Carlos Henrique Quartucci

2015-01-01

As imagens da série de satélites CBERS são distribuídas gratuitamente, mas para que seja possível utilizá-las, é necessário aplicar um método de correção geométrica. É proposta uma melhoria do processo de correção automática de forma a selecionar as melhores amostras de referência a partir das quais é possível definir pontos de controle usados para o cálculo dos parâmetros do modelo usado na correção. Para demonstrar a eficácia, o método proposto é aplicado em um conjunto de imagens CBERS usa...

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-04-01

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

30 CFR 5.10 - Purpose and scope.

Science.gov (United States)

2010-07-01

... MINING PRODUCTS FEES FOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS § 5.10 Purpose and scope... control and security and document preparation directly supporting application processing; (3) A... is in support of application processing; and (4) Amortization of facility improvements and...

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

Science.gov (United States)

2013-03-04

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

40 CFR 52.510 - Small business assistance program.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Small business assistance program. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS District of Columbia § 52.510 Small business... Regulation Administration submitted a plan for the establishment and implementation of a Small Business...

78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

Science.gov (United States)

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Orientação de imagens CBERS-2B usando o modelo rigoroso de colinearidade com dados orbitais

Directory of Open Access Journals (Sweden)

José Marcato Junior

Full Text Available Atualmente, o imageamento orbital é uma das principais técnicas de coleta de informações geoespaciais. Embora os sistemas orbitais sejam equipados com sensores de orientação direta (GNSS, giroscópios, sensores de estrelas, dentre outros, nem sempre as imagens corrigidas a partir dos dados (efemérides e atitude provenientes destes sensores apresentam a acurácia requerida para certas aplicações. Uma das alternativas para solucionar este problema é a orientação dessas imagens considerando as informações de órbita (efemérides e atitude com o uso adicional de pontos de apoio. O objetivo principal deste trabalho consiste em avaliar experimentalmente o modelo de colinearidade com dados orbitais no processo de orientação de imagens CBERS-2B. Este modelo foi implementado no programa TMS (Triangulação MultiSsensor, seguindo a abordagem de triangulação multissensor. Foram realizados experimentos com imagens do nível 1 (com apenas correção radiométrica coletadas pelos sensores CCD e HRC. Nos casos estudados verificou-se que a utilização das informações de órbita possibilita a orientação de imagens CBERS-2B com um número reduzido de pontos de apoio.

Identifying Spatial Units of Human Occupation in the Brazilian Amazon Using Landsat and CBERS Multi-Resolution Imagery

Directory of Open Access Journals (Sweden)

Maria Isabel Sobral Escada

2012-01-01

Full Text Available Every spatial unit of human occupation is part of a network structuring an extensive process of urbanization in the Amazon territory. Multi-resolution remote sensing data were used to identify and map human presence and activities in the Sustainable Forest District of Cuiabá-Santarém highway (BR-163, west of Pará, Brazil. The limits of spatial units of human occupation were mapped based on digital classification of Landsat-TM5 (Thematic Mapper 5 image (30m spatial resolution. High-spatial-resolution CBERS-HRC (China-Brazil Earth Resources Satellite-High-Resolution Camera images (5 m merged with CBERS-CCD (Charge Coupled Device images (20 m were used to map spatial arrangements inside each populated unit, describing intra-urban characteristics. Fieldwork data validated and refined the classification maps that supported the categorization of the units. A total of 133 spatial units were individualized, comprising population centers as municipal seats, villages and communities, and units of human activities, such as sawmills, farmhouses, landing strips, etc. From the high-resolution analysis, 32 population centers were grouped in four categories, described according to their level of urbanization and spatial organization as: structured, recent, established and dependent on connectivity. This multi-resolution approach provided spatial information about the urbanization process and organization of the territory. It may be extended into other areas or be further used to devise a monitoring system, contributing to the discussion of public policy priorities for sustainable development in the Amazon.

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY...

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-04-01

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

40 CFR 1065.510 - Engine mapping.

Science.gov (United States)

2010-07-01

....510 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS... the atmospheric pressure near the engine's air inlet is not within ± 5 kPa of the atmospheric pressure recorded at the time of the last engine map. (3) If the engine or emission-control system has undergone...

77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

Science.gov (United States)

2012-07-27

...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...

Calorimetric study of alternating copolymer of bicyclo[2,2,1]-hepta-2,5-diene and carbon monoxide in the range from T->0 to 510K

International Nuclear Information System (INIS)

Smirnova, N.N.; Nikishchenkova, L.V.; Bykova, T.A.; Kulagina, T.G.; Belov, G.P.; Novikova, E.V.

2006-01-01

By adiabatic vacuum and dynamic calorimetry, the temperature dependence of heat capacity for alternating copolymer of bicyclo[2,2,1]-hepta-2,5-diene and carbon monoxide has been determined over the 6-510K range with an uncertainty of 0.2-0.5% between 6 and 350K and 0.5-1.5% from 330 to 510K. In the above temperature ranges, the physical transformations of the copolymer have been detected and their thermodynamic characteristics have been estimated. In a calorimeter with a static bomb and an isothermal shield, the energy of combustion of the copolymer has been measured at 298.15K. Based on the experimental data, the thermodynamic functions of the copolymer, namely, the heat capacity C p - bar (T), enthalpy H o (T)-H o (0), entropy S o (T)-S o (0) and Gibbs function G o (T)-H o (0) have been determined for the range from T->0 to 400K. The enthalpy of combustion Δ c H o and the thermodynamic parameters Δ f H o , Δ f S o , Δ f G o and lnK f - bar of reaction of formation of the copolymer from simple substances at T=298.15K and p=0.1MPa have been calculated. The data cited in the present work and literature data were used to calculate the thermodynamic characteristics of the alternating copolymerization in bulk of bicyclo[2,2,1]-hepta-2,5-diene and CO in the 0-340K range at standard pressure as well as to compare them with the thermodynamic characteristics of the synthesis of isomeric polyketone

Calorimetric study of alternating copolymer of bicyclo[2,2,1]-hepta-2,5-diene and carbon monoxide in the range from T->0 to 510K

Energy Technology Data Exchange (ETDEWEB)

Smirnova, N.N. [Research Institute of Chemistry, Nizhny Novgorod University, Gagarin Prospekt 23/5, 603950 Nizhny Novgorod (Russian Federation)]. E-mail: smirnova@ichem.unn.runnet.ru; Nikishchenkova, L.V. [Research Institute of Chemistry, Nizhny Novgorod University, Gagarin Prospekt 23/5, 603950 Nizhny Novgorod (Russian Federation); Bykova, T.A. [Research Institute of Chemistry, Nizhny Novgorod University, Gagarin Prospekt 23/5, 603950 Nizhny Novgorod (Russian Federation); Kulagina, T.G. [Research Institute of Chemistry, Nizhny Novgorod University, Gagarin Prospekt 23/5, 603950 Nizhny Novgorod (Russian Federation); Belov, G.P. [Institute of Problems of Chemical Physics of Russian Academy Sciences, 142432 Chernogolovka, Moscow Region (Russian Federation); Novikova, E.V. [Institute of Problems of Chemical Physics of Russian Academy Sciences, 142432 Chernogolovka, Moscow Region (Russian Federation)

2006-12-01

By adiabatic vacuum and dynamic calorimetry, the temperature dependence of heat capacity for alternating copolymer of bicyclo[2,2,1]-hepta-2,5-diene and carbon monoxide has been determined over the 6-510K range with an uncertainty of 0.2-0.5% between 6 and 350K and 0.5-1.5% from 330 to 510K. In the above temperature ranges, the physical transformations of the copolymer have been detected and their thermodynamic characteristics have been estimated. In a calorimeter with a static bomb and an isothermal shield, the energy of combustion of the copolymer has been measured at 298.15K. Based on the experimental data, the thermodynamic functions of the copolymer, namely, the heat capacity C{sub p}{sup -}bar (T), enthalpy H{sup o}(T)-H{sup o}(0), entropy S{sup o}(T)-S{sup o}(0) and Gibbs function G{sup o}(T)-H{sup o}(0) have been determined for the range from T->0 to 400K. The enthalpy of combustion {delta}{sub c}H{sup o} and the thermodynamic parameters {delta}{sub f}H{sup o}, {delta}{sub f}S{sup o}, {delta}{sub f}G{sup o} and lnK{sub f}{sup -}bar of reaction of formation of the copolymer from simple substances at T=298.15K and p=0.1MPa have been calculated. The data cited in the present work and literature data were used to calculate the thermodynamic characteristics of the alternating copolymerization in bulk of bicyclo[2,2,1]-hepta-2,5-diene and CO in the 0-340K range at standard pressure as well as to compare them with the thermodynamic characteristics of the synthesis of isomeric polyketone.

28 CFR 54.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Recruitment. 54.510 Section 54.510... in Employment in Education Programs or Activities Prohibited § 54.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

22 CFR 229.510 - Recruitment.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Recruitment. 229.510 Section 229.510 Foreign... in Education Programs or Activities Prohibited § 229.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring...

22 CFR 146.510 - Recruitment.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Recruitment. 146.510 Section 146.510 Foreign... Education Programs or Activities Prohibited § 146.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees...

14 CFR 1253.510 - Recruitment.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Recruitment. 1253.510 Section 1253.510... in Employment in Education Programs or Activities Prohibited § 1253.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

43 CFR 41.510 - Recruitment.

Science.gov (United States)

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Recruitment. 41.510 Section 41.510 Public... in Employment in Education Programs or Activities Prohibited § 41.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

49 CFR 25.510 - Recruitment.

Science.gov (United States)

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Recruitment. 25.510 Section 25.510 Transportation... Education Programs or Activities Prohibited § 25.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees...

40 CFR 5.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Recruitment. 5.510 Section 5.510... in Employment in Education Programs or Activities Prohibited § 5.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

6 CFR 17.510 - Recruitment.

Science.gov (United States)

2010-01-01

... 6 Domestic Security 1 2010-01-01 2010-01-01 false Recruitment. 17.510 Section 17.510 Domestic... in Employment in Education Programs or Activities Prohibited § 17.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

10 CFR 1042.510 - Recruitment.

Science.gov (United States)

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Recruitment. 1042.510 Section 1042.510 Energy DEPARTMENT... Education Programs or Activities Prohibited § 1042.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees...

Direct Determination of the Rate Coefficient for the Reaction of OH Radicals with Monoethanol Amine (MEA) from 296 to 510 K.

Science.gov (United States)

Onel, L; Blitz, M A; Seakins, P W

2012-04-05

Monoethanol amine (H2NCH2CH2OH, MEA) has been proposed for large-scale use in carbon capture and storage. We present the first absolute, temperature-dependent determination of the rate coefficient for the reaction of OH with MEA using laser flash photolysis for OH generation, monitoring OH removal by laser-induced fluorescence. The room-temperature rate coefficient is determined to be (7.61 ± 0.76) × 10(-11) cm(3) molecule(-1) s(-1), and the rate coefficient decreases by about 40% by 510 K. The temperature dependence of the rate coefficient is given by k1= (7.73 ± 0.24) × 10(-11)(T/295)(-(0.79±0.11)) cm(3) molecule(-1) s(-1). The high rate coefficient shows that gas-phase processing in the atmosphere will be competitive with uptake onto aerosols.

31 CFR 28.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Recruitment. 28.510 Section 28.510... Basis of Sex in Employment in Education Programs or Activities Prohibited § 28.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

29 CFR 36.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Recruitment. 36.510 Section 36.510 Labor Office of the... Activities Prohibited § 36.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has...

10 CFR 5.510 - Recruitment.

Science.gov (United States)

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Recruitment. 5.510 Section 5.510 Energy NUCLEAR REGULATORY... Prohibited § 5.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found...

21 CFR 556.510 - Penicillin.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Penicillin. 556.510 Section 556.510 Food and Drugs... Residues of New Animal Drugs § 556.510 Penicillin. Tolerances are established for residues of penicillin and the salts of penicillin in food as follows: (a) 0.05 part per million (negligible residue) in the...

K Basin sludge packaging design criteria (PDC) and safety analysis report for packaging (SARP) approval plan

International Nuclear Information System (INIS)

Brisbin, S.A.

1996-01-01

This document delineates the plan for preparation, review, and approval of the Packaging Design Crieteria for the K Basin Sludge Transportation System and the Associated on-site Safety Analysis Report for Packaging. The transportation system addressed in the subject documents will be used to transport sludge from the K Basins using bulk packaging

ASME N510 test results for Savannah River Site AACS filter compartments

Energy Technology Data Exchange (ETDEWEB)

Paul, J.D.; Punch, T.M. [Westinghouse Savannah River Company, Aiken, SC (United States)

1995-02-01

The K-Reactor at the Savannah River Site recently implemented design improvements for the Airborne Activity Confinement System (AACS) by procuring, installing, and testing new Air Cleaning Units, or filter compartments, to ASME AG-11, N509, and N510 requirements. Specifically, these new units provide documentable seismic resistance to a Design Basis Accident earthquake, provide 2 inch adsorber beds with 0.25 second residence time, and meet all AG-1, N509, and N510 requirements for testability and maintainability. This paper presents the results of the Site acceptance testing and discusses an issue associated with sample manifold qualification testing.

7 CFR 3052.510 - Audit findings.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Audit findings. 3052.510 Section 3052.510 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF THE CHIEF FINANCIAL OFFICER, DEPARTMENT OF AGRICULTURE AUDITS OF STATES, LOCAL GOVERNMENTS, AND NON-PROFIT ORGANIZATIONS Auditors § 3052.510 Audit...

47 CFR 73.510 - Antenna systems.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 4 2010-10-01 2010-10-01 false Antenna systems. 73.510 Section 73.510... Noncommercial Educational FM Broadcast Stations § 73.510 Antenna systems. (a) All noncommercial educational... § 73.316 concerning antenna systems contained in subpart B of this part. (b) Directional antenna. No...

Technology evaluation: ABT-510, Abbott.

NARCIS (Netherlands)

Westphal, J.R.

2004-01-01

ABT-510 is a small peptide thrombospondin-1 mimetic angiogenesis inhibitor under development by Abbott Laboratories for the potential treatment of solid tumors. ABT-510 is undergoing phase II clinical trials.

10 CFR 4.510 - Self-evaluation.

Science.gov (United States)

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Self-evaluation. 4.510 Section 4.510 Energy NUCLEAR... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission § 4.510 Self-evaluation. (a) The... representing handicapped persons, to participate in the self-evaluation process by submitting comments (both...

15 CFR 8a.510 - Recruitment.

Science.gov (United States)

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Recruitment. 8a.510 Section 8a.510... in Employment in Education Programs or Activities Prohibited § 8a.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

29 CFR 100.510 - Self-evaluation.

Science.gov (United States)

2010-07-01

... 29 Labor 2 2010-07-01 2010-07-01 false Self-evaluation. 100.510 Section 100.510 Labor Regulations... § 100.510 Self-evaluation. (a) The agency shall, by September 6, 1989, evaluate its current policies and... participate in the self-evaluation process by submitting comments (both oral and written). (c) The agency...

29 CFR 99.510 - Audit findings.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Audit findings. 99.510 Section 99.510 Labor Office of the Secretary of Labor AUDITS OF STATES, LOCAL GOVERNMENTS, AND NON-PROFIT ORGANIZATIONS Auditors § 99.510 Audit... schedule of prior audit findings prepared by the auditee in accordance with § 99.315(b) materially...

42 CFR 436.510 - Determination of dependency.

Science.gov (United States)

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Determination of dependency. 436.510 Section 436.510 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Requirements for Medicaid Eligibility Dependency § 436.510 Determination of dependency. For families with...

75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

Science.gov (United States)

2010-06-11

...] Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for... Biologics Evaluation and Research (CBER) are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product...

44 CFR 19.510 - Recruitment.

Science.gov (United States)

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Recruitment. 19.510 Section... Programs or Activities Prohibited § 19.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a...

K Basins Spent Nuclear Fuel (SNF) Project Safety Analysis Report for Packaging (SARP) approval plan

International Nuclear Information System (INIS)

1995-01-01

This document delineates the plan for preparation, review, and approval of the K Basins Spent Nuclear Fuel (SNF) Packaging Design Criteria (PDC) document and the on-site Safety Analysis Report for Packaging (SARP). The packaging addressed in these documents is used to transport SNF in a Multi- canister Overpack (MCO) configuration

6 CFR 5.10 - Preservation of records.

Science.gov (United States)

2010-01-01

... 6 Domestic Security 1 2010-01-01 2010-01-01 false Preservation of records. 5.10 Section 5.10 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY DISCLOSURE OF RECORDS AND INFORMATION Freedom of Information Act § 5.10 Preservation of records. Each component shall preserve all...

45 CFR 618.510 - Recruitment.

Science.gov (United States)

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Recruitment. 618.510 Section 618.510 Public... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

45 CFR 2555.510 - Recruitment.

Science.gov (United States)

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Recruitment. 2555.510 Section 2555.510 Public... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

32 CFR 196.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 32 National Defense 2 2010-07-01 2010-07-01 false Recruitment. 196.510 Section 196.510 National... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

24 CFR 3.510 - Recruitment.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Recruitment. 3.510 Section 3.510... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

1 CFR 5.10 - Forms of publication.

Science.gov (United States)

2010-01-01

... 1 General Provisions 1 2010-01-01 2010-01-01 false Forms of publication. 5.10 Section 5.10 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER THE FEDERAL REGISTER GENERAL § 5.10 Forms of publication. Pursuant to section 1506 of title 44, United States Code, the Administrative Committee publishes...

12 CFR 510.4 - Service of process.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Service of process. 510.4 Section 510.4 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY MISCELLANEOUS ORGANIZATIONAL REGULATIONS § 510.4 Service of process. (a) Service of Process. Service of process may be made upon the Office...

50 CFR 510.9 - Uniform pay guidelines.

Science.gov (United States)

2010-10-01

... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Uniform pay guidelines. 510.9 Section 510... ACT § 510.9 Uniform pay guidelines. (a) Compensation of members and staff of, and consultants to the... accordance with guidelines established by the Director of the Office of Management and Budget pursuant to...

22 CFR 510.1 - Service of process.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Service of process. 510.1 Section 510.1 Foreign Relations BROADCASTING BOARD OF GOVERNORS SERVICE OF PROCESS § 510.1 Service of process. (a) The General... accepting service of process for an employee in his/her official capacity, the General Counsel or his/her...

The "déjà vu effect:" evaluation of United States medical device legislation, regulation, and the Food and Drug Administration's contentious 510(k) program.

Science.gov (United States)

Bauman, Jordan

2012-01-01

With the Medical Device Amendments of 1976, Congress granted FDA authority to regulate medical devices by implementing a risk-based regulatory framework. Several years prior to this legislation, the Cooper Committee reviewed the medical device regulatory landscape and uncovered weaknesses that could be detrimental to public health. However, only after several high-profile incidents involving unsafe medical devices did Congress respond with strong legislation. Since 1976, additional medical device legislative revisions have been enacted to address deficiencies highlighted by various groups representing Congress, FDA, and industry. A repetitive conclusion from these groups has been that the 510(k) program is incapable of serving as a premarket evaluation of safety and effectiveness under the existing statutory framework. However, these legislative revisions did not change the statutory framework despite these repeated findings. In 2009, CDRH convened separate groups to again review the 510(k) program. While more comprehensive than previous initiatives, the observed deficiencies and the proposed recommendations are remarkably similar to those identified by their predecessors. This cyclical review of the medical device regulatory landscape whereby the same observations and recommendations are repeated yet the output of such review does not yield major legislative revision of the existing statutory framework can be described as the "déjà vu effect." This will continue unless Congress enacts legislation that implements a new statutory framework with a different standard other than substantial equivalence. In the past, Congress has implemented major legislation only after a public health crisis. Hopefully this will not be the driving force in the future.

75 FR 4081 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing...

Science.gov (United States)

2010-01-26

... any changes, in the product, production process, quality controls, equipment, facilities, or... from studies in animals). Section 601.93 provides that biological products approved under subpart H are... an Antibiotic Drug for Human Use'' to harmonize application procedures between CBER and CDER. The...

Caracterização espectral de áreas de gramíneas forrageiras infectadas com a doença "mela-das-sementes da braquiária" por meio de imagens CCD/CBERS-2 Spectral characterization of forage grasses infected with the disease "mela-das-sementes da braquiária" through CCD/CDBERS -2 images

Directory of Open Access Journals (Sweden)

José C. Rosatti

2006-12-01

Full Text Available Imagens CCD/CBERS-2, nas bandas espectrais CCD2, CCD3 e CCD4, dos anos de 2004 e 2005, de Mirante do Paranapanema - SP, foram transformadas em reflectância de superfície usando o modelo 5S de correção atmosférica e normalizadas radiometricamente. O objetivo principal foi caracterizar espectralmente áreas de pastagens de Brachiaria brizantha em fase de florescimento, isentas e infectadas com a doença "mela-das-sementes da braquiária", possibilitando a sua detecção por meio da comparação entre os valores de reflectância de superfície denominada de Fator de Reflectância Bidirecional de Superfície (FRBS. Teve-se, também, o objetivo de avaliar a eficácia das imagens CCD/CBERS-2 para a obtenção de respostas espectrais de pastagens. Os dosséis sadios e doentes da Brachiaria brizantha foram identificados por meio da análise dos valores de reflectância e dos dados observados no Índice de Estresse Hídrico Acumulativo Relativo da Cultura (ACWSI obtidos na área de estudo. Os resultados indicaram que as principais diferenças foram a diminuição da reflectância na banda CCD3 e o aumento da reflectância na banda CCD4 nas áreas doentes. A metodologia empregada com o uso de dados do sensor CCD/CBERS-2, associados ao ACWSI, mostrou-se eficaz para discriminar dosséis infectados com a "mela-das-sementes da braquiária".CCD/CBERS-2 images in the spectral bands of CCD2, CCD3 and CCD4 of the years 2004 and 2005, from Mirante do Paranapanema - SP (Brazil, were transformed into surface reflectance images using the 5S atmospheric correction model and radiometrically normalized. The main objective was to spectrally characterize pastures of Brachiaria brizantha in the flowering phase, exempt and infected with the disease "mela-das-sementes da braquiária" making it possible its detection through the comparison among the SBRF - Surface Bidirectional Reflectance Factor values. At the same time, it was aimed to evaluate the effectiveness of the

30 CFR 77.510 - Resistors; location and guarding.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Resistors; location and guarding. 77.510 Section 77.510 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE... COAL MINES Electrical Equipment-General § 77.510 Resistors; location and guarding. Resistors, heaters...

28 CFR 42.510 - Discrimination prohibited.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Discrimination prohibited. 42.510 Section...-Implementation of Section 504 of the Rehabilitation Act of 1973 Employment § 42.510 Discrimination prohibited. (a) General. (1) No qualified handicapped person shall on the basis of handicap be subjected to discrimination...

41 CFR 101-4.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 2 2010-07-01 2010-07-01 true Recruitment. 101-4.510... Employment in Education Programs or Activities Prohibited § 101-4.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring...

31 CFR 586.510 - Transactions related to telecommunications authorized.

Science.gov (United States)

2010-07-01

... telecommunications authorized. 586.510 Section 586.510 Money and Finance: Treasury Regulations Relating to Money and... Licensing Policy § 586.510 Transactions related to telecommunications authorized. All transactions with respect to the receipt and transmission of telecommunications involving the FRY (S&M) are authorized. This...

The Brazilian wide field imaging camera (WFI) for the China/Brazil earth resources satellite: CBERS 3 and 4

Science.gov (United States)

Scaduto, L. C. N.; Carvalho, E. G.; Modugno, R. G.; Cartolano, R.; Evangelista, S. H.; Segoria, D.; Santos, A. G.; Stefani, M. A.; Castro Neto, J. C.

2017-11-01

The purpose of this paper is to present the optical system developed for the Wide Field imaging Camera - WFI that will be integrated to the CBERS 3 and 4 satellites (China Brazil Earth resources Satellite). This camera will be used for remote sensing of the Earth and it is aimed to work at an altitude of 778 km. The optical system is designed for four spectral bands covering the range of wavelengths from blue to near infrared and its field of view is +/-28.63°, which covers 866 km, with a ground resolution of 64 m at nadir. WFI has been developed through a consortium formed by Opto Electrônica S. A. and Equatorial Sistemas. In particular, we will present the optical analysis based on the Modulation Transfer Function (MTF) obtained during the Engineering Model phase (EM) and the optical tests performed to evaluate the requirements. Measurements of the optical system MTF have been performed using an interferometer at the wavelength of 632.8nm and global MTF tests (including the CCD and signal processing electronic) have been performed by using a collimator with a slit target. The obtained results showed that the performance of the optical system meets the requirements of project.

42 CFR 435.510 - Determination of dependency.

Science.gov (United States)

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Determination of dependency. 435.510 Section 435... ISLANDS, AND AMERICAN SAMOA Categorical Requirements for Eligibility Dependency § 435.510 Determination of dependency. For families with dependent children who are not receiving AFDC, the agency must use the...

40 CFR 158.510 - Tiered testing options for nonfood pesticides.

Science.gov (United States)

2010-07-01

... pesticides. 158.510 Section 158.510 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS DATA REQUIREMENTS FOR PESTICIDES Toxicology § 158.510 Tiered testing options for nonfood pesticides. For nonfood use pesticides only, applicants have two options for generating and submitting...

Insight into the molecular mechanism of yeast acetyl-coenzyme A carboxylase mutants F510I, N485G, I69E, E477R, and K73R resistant to soraphen A

Science.gov (United States)

Gao, Jian; Liang, Li; Chen, Qingqing; Zhang, Ling; Huang, Tonghui

2018-02-01

Acetyl-coenzyme A carboxylases (ACCs) is the first committed enzyme of fatty acid synthesis pathway. The inhibition of ACC is thought to be beneficial not only for diseases related to metabolism, such as type-2 diabetes, but also for infectious disease like bacterial infection disease. Soraphen A, a potent allosteric inhibitor of BC domain of yeast ACC, exhibit lower binding affinities to several yeast ACC mutants and the corresponding drug resistance mechanisms are still unknown. We report here a theoretical study of binding of soraphen A to wild type and yeast ACC mutants (including F510I, N485G, I69E, E477R, and K73R) via molecular dynamic simulation and molecular mechanics/generalized Born surface area free energy calculations methods. The calculated binding free energies of soraphen A to yeast ACC mutants are weaker than to wild type, which is highly consistent with the experimental results. The mutant F510I weakens the binding affinity of soraphen A to yeast ACC mainly by decreasing the van der Waals contributions, while the weaker binding affinities of Soraphen A to other yeast ACC mutants including N485G, I69E, E477R, and K73R are largely attributed to the decreased net electrostatic (ΔE ele + ΔG GB) interactions. Our simulation results could provide important insights for the development of more potent ACC inhibitors.

20 CFR 405.510 - Claims remanded by a Federal court.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Claims remanded by a Federal court. 405.510 Section 405.510 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ADMINISTRATIVE REVIEW PROCESS FOR ADJUDICATING INITIAL DISABILITY CLAIMS Judicial Review § 405.510 Claims remanded by a Federal court. When a...

21 CFR 358.510 - Corn and callus remover active ingredients.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The...

Purification and characterization of plantaricin Y, a novel bacteriocin produced by Lactobacillus plantarum 510.

Science.gov (United States)

Chen, Yi-sheng; Wang, Yan-chong; Chow, Yiou-shing; Yanagida, Fujitoshi; Liao, Chen-chung; Chiu, Chi-ming

2014-03-01

Lactobacillus plantarum 510, previously isolated from a koshu vineyard in Japan, was found to produce a bacteriocin-like inhibitory substance which was purified and characterized. Mass spectrometry analysis showed that the mass of this bacteriocin is 4,296.65 Da. A partial sequence, NH2- SSSLLNTAWRKFG, was obtained by N-terminal amino acid sequence analysis. A BLAST search revealed that this is a unique sequence; this peptide is thus a novel bacteriocin produced by Lactobacillus plantarum 510 and was termed plantaricin Y. Plantaricin Y shows strong inhibitory activity against Listeria monocytogenes BCRC 14845, but no activity against other pathogens tested. Bacteriocin activity decreased slightly after autoclaving (121 °C for 15 min), but was completely inactivated by protease K. Furthermore, trypsin-digested bacteriocin product fragments retained activity against L. monocytogenes BCRC 14845 and exhibited a different inhibitory spectrum.

20 CFR 628.510 - Intake, referrals and targeting.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Intake, referrals and targeting. 628.510 Section 628.510 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR PROGRAMS... training have been provided subsequent to the objective assessment. (g) The SDA's method of meeting the...

46 CFR 401.510 - Operation without Registered Pilots.

Science.gov (United States)

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Operation without Registered Pilots. 401.510 Section 401... REGULATIONS Penalties; Operations Without Registered Pilots § 401.510 Operation without Registered Pilots. (a... Registered Pilot when the vessel or its cargo is in distress or jeopardy. (b) A vessel may be navigated in...

3-Aminomethyl derivatives of 4,11-dihydroxynaphtho[2,3-f]indole-5,10-dione for circumvention of anticancer drug resistance.

Science.gov (United States)

Shchekotikhin, Andrey E; Shtil, Alexander A; Luzikov, Yuri N; Bobrysheva, Tatyana V; Buyanov, Vladimir N; Preobrazhenskaya, Maria N

2005-03-15

A series of 3-aminomethyl derivatives of 4,11-dihydroxynaphtho[2,3-f]indole-5,10-dione was synthesized by Mannich reaction or by the transamination of 3-dimethylaminomethyl 4,11-dihydroxy- or 4,11-dimethoxynaphtho[2,3-f]indole-5,10-dione. The potency of novel derivatives was tested on a National Cancer Institute panel of 60 human tumor cell lines as well as in cells with genetically defined determinants of cytotoxic drug resistance, P-glycoprotein (Pgp) expression, and p53 inactivation. Mannich derivatives of 4,11-dihydroxynaphtho[2,3-f]indole-5,10-dione with an additional amino function in their side chain, demonstrated equal cytotoxicity against the parental K562 leukemia cells and their Pgp-positive subline, whereas the latter showed approximately 7-fold resistance to adriamycin, a Pgp transported drug. 3-(1-Piperazinyl)methyl and 3-(quinuclidin-3-yl)aminomethyl derivatives of 4,11-dihydroxynaphtho[2,3-f]indole-5,10-dione killed HCT116 colon carcinoma cells (carrying wild type p53) and their p53-null variant within the similar range of concentrations. We conclude that Mannich modification of 4,11-dihydroxynaphtho[2,3-f]indole-5,10-dione, especially when cyclic diamine (e.g., piperazine, quinuclidine) is used, confers an important feature to the resulting compounds, namely, the potency for tumor cells otherwise resistant to a variety of anticancer drugs.

12 CFR 510.2 - Provisions related to regulations of the Office.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Provisions related to regulations of the Office. 510.2 Section 510.2 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY MISCELLANEOUS ORGANIZATIONAL REGULATIONS § 510.2 Provisions related to regulations of the Office. (a) Amendments. The Office expressly reserves the righ...

Cooling performance of R510A in domestic water purifiers

International Nuclear Information System (INIS)

Park, Ki Jung; Lee, Yo Han; Jung, Dong Soo

2010-01-01

Cooling performance of R510A is examined both numerically and experimentally in an effort to replace HFC134a in the refrigeration system of domestic water purifiers. Although the use of HFC134a is currently dominant, it is being phased out in Europe and most developed countries due to its high potential contribution to global warming. To solve this problem, cycle simulation and experimental measurements are conducted with a new refrigerant mixture of 88%RE170/12%R600a using actual domestic water purifiers. This mixture has been recently numbered and listed as R510A by ASHRAE. Test results show that, due to the small internal volume of the refrigeration system of the domestic water purifiers, system performance with R510A is greatly influenced by the amount of charge. With the optimum charge amount of 20 to 21 g, approximately 50% that of HFC134a, the energy consumption of R510A is 22.3% lower than that of HFC134a. The compressor discharge temperature of R510A is 3.7 .deg. C lower than that of HFC134a at the optimum charge. Overall, R510A, a new, long term, and environmentally safe refrigerant, is a good alternative for HFC134a. Furthermore, it requires only minor changes in the refrigeration system of the domestic water purifiers

7 CFR 1755.510 - Construction and assembly unit drawings.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Construction and assembly unit drawings. 1755.510..., AND STANDARD CONTRACT FORMS § 1755.510 Construction and assembly unit drawings. (a) The construction and assembly unit drawings in this section shall be used by borrowers to assist the installer in...

20 CFR 669.510 - What planning documents must an NFJP grantee submit?

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false What planning documents must an NFJP grantee submit? 669.510 Section 669.510 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF... Accountability, Planning and Waiver Provision § 669.510 What planning documents must an NFJP grantee submit? Each...

42 CFR 422.510 - Termination of contract by CMS.

Science.gov (United States)

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Termination of contract by CMS. 422.510 Section 422... Advantage Organizations § 422.510 Termination of contract by CMS. (a) Termination by CMS. CMS may at any time terminate a contract if CMS determines that the MA organization meets any of the following: (1...

The Strange Use of דגל in Song of Songs 5:10

OpenAIRE

Andruska, Jennifer

2017-01-01

The use of the word דגל in the Song of Songs 5:10 has caused considerable confusion among commentators. Most occurrences of the word in the Song are thought to be related to an army or host carrying banners, except in 5:10, where this usage is said to make little sense. Scholars therefore interpret the woman’s use of דגל in 5:10 differently from when the man uses it to describe her awe-striking an unnerving appearance in 6:4 and 6:10. This has given some the impression that the lovers view ea...

29 CFR 510.20 - Wage surveys in Puerto Rico.

Science.gov (United States)

2010-07-01

... IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO... qualify for an extended minimum wage phase-in, the government of Puerto Rico would be required to furnish... 29 Labor 3 2010-07-01 2010-07-01 false Wage surveys in Puerto Rico. 510.20 Section 510.20 Labor...

38 CFR 23.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Recruitment. 23.510... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

36 CFR 1211.510 - Recruitment.

Science.gov (United States)

2010-07-01

... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Recruitment. 1211.510 Section... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

18 CFR 1317.510 - Recruitment.

Science.gov (United States)

2010-04-01

... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Recruitment. 1317.510... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

13 CFR 113.510 - Recruitment.

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Recruitment. 113.510 Section 113... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

33 CFR 183.510 - Fuel tanks.

Science.gov (United States)

2010-07-01

... SAFETY BOATS AND ASSOCIATED EQUIPMENT Fuel Systems Equipment Standards § 183.510 Fuel tanks. (a) Each fuel tank in a boat must have been tested by its manufacturer under § 183.580 and not leak when...

40 CFR 600.510-08 - Calculation of average fuel economy.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Calculation of average fuel economy. 600.510-08 Section 600.510-08 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Regulations for Model Year 1978 Passenger Automobiles...

40 CFR 600.510-93 - Calculation of average fuel economy.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Calculation of average fuel economy. 600.510-93 Section 600.510-93 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Regulations for Model Year 1978 Passenger Automobiles...

40 CFR 600.510-86 - Calculation of average fuel economy.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Calculation of average fuel economy. 600.510-86 Section 600.510-86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Regulations for Model Year 1978 Passenger Automobiles...

21 CFR 510.110 - Antibiotics used in food-producing animals.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Antibiotics used in food-producing animals. 510... Rulings and Decisions § 510.110 Antibiotics used in food-producing animals. (a) The Food and Drug... has requested an evaluation of the public health aspects of the use of antibiotics in veterinary...

p-p analyzing power excitation function between 510 and 725 MeV

International Nuclear Information System (INIS)

Beurtey, R.; Arvieux, J.; Boivin, M.; Boyard, J.L.; Durand, J.M.; Combes-Comets, M.P.; Courtat, P.; Gacougnolle, R.; Le Bornec, Y.; Garcon, M.

1993-01-01

In an earlier experiment some evidence was observed for narrow dibaryons in the analyzing power excitation function of p-p elastic scattering at √s=2160 MeV and 2192 MeV, with width Γ≅13-14 MeV. A different procedure has been carried out at the SATURNE synchrotron, in order to obtain a very high accuracy of the analyzing power for a large number of energies between 510 and 725 MeV. The results show no evidence for any structure with width ∼5 to 20 MeV. The reasons at the difference between the two experiments are discussed. (K.A.) 2 refs., 3 figs

20 CFR 667.510 - What is the Grant Officer resolution process?

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false What is the Grant Officer resolution process? 667.510 Section 667.510 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF... agreement and those where there is disagreement with the recipient's resolution, including the allowability...

Instrument evaluation no. 18. Mini instruments contamination meter type 5.10 EL

International Nuclear Information System (INIS)

Burgess, P.H.; Iles, W.J.

1980-04-01

An evaluation is given of the general purpose contamination monitor, the Mini-Instruments Type 5-10EL which comprises a probe connected by a coiled extensible cable to a ratemeter. The facilities and controls, radiation characteristics, electrical characteristics, environmental effects, mechanical characteristics, and the manual are considered. A summary is given of the instrument's performance showing that it is a useful general-purpose contamination monitor suitable for the monitoring of beta contamination at a level for non-active areas of 1 DL (3.7 Bq cm -2 (10 -4 μCi cm -2 )) for beta emitters of maximum energy at least that of 14 C, given a normal environmental gamma background. (U.K.)

29 CFR 510.22 - Industries eligible for minimum wage phase-in.

Science.gov (United States)

2010-07-01

... 29 Labor 3 2010-07-01 2010-07-01 false Industries eligible for minimum wage phase-in. 510.22... REGULATIONS IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO Classification of Industries § 510.22 Industries eligible for minimum wage phase-in...

21 CFR 172.510 - Natural flavoring substances and natural substances used in conjunction with flavors.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Natural flavoring substances and natural substances used in conjunction with flavors. 172.510 Section 172.510 Food and Drugs FOOD AND DRUG ADMINISTRATION....510 Natural flavoring substances and natural substances used in conjunction with flavors. Natural...

20 CFR 638.510 - Health care and services.

Science.gov (United States)

2010-04-01

... UNDER TITLE IV-B OF THE JOB TRAINING PARTNERSHIP ACT Center Operations § 638.510 Health care and services. The center operator shall provide a health program, including basic medical, dental, and mental...

Malrotation of the McGhan Style 510 prosthesis.

NARCIS (Netherlands)

Schots, J.M.; Fechner, M.R.; Hoogbergen, M.M.; Tits, H.W.H.J.

2010-01-01

BACKGROUND: Anatomically shaped cohesive silicone breast implants are frequently used in aesthetic and reconstructive surgery. After successful results with the Style 410 prosthesis, McGhan (Natrelle, Allergan) introduced the Style 510 prosthesis. After using this novel prosthesis, the authors

42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.

Science.gov (United States)

2010-10-01

... and pathology specimens. 414.510 Section 414.510 Public Health CENTERS FOR MEDICARE & MEDICAID... date of service for clinical laboratory and pathology specimens. The date of service for either a clinical laboratory test or the technical component of physician pathology service is as follows: (a...

12 CFR 510.5 - Release of unpublished OTS information.

Science.gov (United States)

2010-01-01

... ORGANIZATIONAL REGULATIONS § 510.5 Release of unpublished OTS information. (a) Scope. (1) This section applies to... their official capacities. Examples of unpublished information include: (i) Information in the memory of...

21 CFR 510.7 - Consignees of new animal drugs for use in the manufacture of animal feed.

Science.gov (United States)

2010-04-01

... manufacture of animal feed. 510.7 Section 510.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Provisions § 510.7 Consignees of new animal drugs for use in the manufacture of animal feed. (a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time...

Verkkosivuston käytettävyys : case: Tmi Niina Virtanen

OpenAIRE

Virtanen, Antti

2016-01-01

Tämän opinnäytetyön tarkoituksena oli toteuttaa responsiiviset verkkosivut case yritykselle, sekä samalla tehdä niistä käytettävyys- ja responsiivisuustutkimus. Sivuston responsiivisuutta testattiin tietokoneella, tabletilla ja puhelimella. Testauslaitteina toimivat Lenovo Ideapad Y510P, Huawei T1 ja OnePlus 3. Opinnäytetyössä perehdytään käytettävyyden teoriaan, siihen mitä se on, miten sitä voi hyödyntää ja miten sitä voi parantaa. Responsiivisuuden teoriaa ja käytäntöä on myös esitelty...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply when a returned dietary supplement is received? 111.510 Section 111.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

24 CFR 232.510 - Commitment and commitment fee.

Science.gov (United States)

2010-04-01

... HOUSING AND URBAN DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND... of Fire Safety Equipment Fees and Charges § 232.510 Commitment and commitment fee. (a) Issuance of...

HSE statement on the approval of dosimetry services

International Nuclear Information System (INIS)

1992-09-01

This statement is intended to assist dosimetry services who may wish to be approved by the U.K. Health and Safety Executive under Regulation 15 of the Ionising Radiations Regulations 1985. It also serves to inform approved dosimetry services of changes in the arrangements which HSE makes for approval and reassessment of dosimetry services. A general description of the administrative arrangements for making application is given and the subsequent processing of such applications by the HSE is outlined. Background notes on the requirements of the Regulations are given in Appendix I. The fees which are chargeable from 20/8/92 are given in Appendix II. (Author)

50 CFR 600.510 - Gear avoidance and disposal.

Science.gov (United States)

2010-10-01

... gear in the EEZ. (3) If these articles or substances are encountered, or in the event of accidental or... Section 600.510 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC AND... include: (1) The name of the reporting vessel. (2) A description of the incident and articles retrieved...

24 CFR 982.510 - Other fees and charges.

Science.gov (United States)

2010-04-01

... DEVELOPMENT SECTION 8 TENANT BASED ASSISTANCE: HOUSING CHOICE VOUCHER PROGRAM Rent and Housing Assistance Payment § 982.510 Other fees and charges. (a) The cost of meals or supportive services may not be included... meals or supportive services. Non-payment of such charges is not grounds for termination of tenancy. (c...

20 CFR 670.510 - Are Job Corps center operators responsible for providing all vocational training?

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Are Job Corps center operators responsible for providing all vocational training? 670.510 Section 670.510 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR THE JOB CORPS UNDER TITLE I OF THE WORKFORCE INVESTMENT ACT...

30 CFR 250.510 - Diesel engine air intakes.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Diesel engine air intakes. 250.510 Section 250... engine air intakes. Diesel engine air intakes must be equipped with a device to shut down the diesel engine in the event of runaway. Diesel engines that are continuously attended must be equipped with...

9 CFR 590.510 - Classifications of shell eggs used in the processing of egg products.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Classifications of shell eggs used in the processing of egg products. 590.510 Section 590.510 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS...

Assessing the Relative Ecological Importance and Deforestation Risks of Unprotected Areas in Western Brazil Using Landsat, CBERS and Quantum GIS

Science.gov (United States)

Smith, A.; Sevilla, C.; Lanclos, A.; Carson, C.; Larson, J.; Sankaran, M.; Saad, M.

2012-12-01

In addition to understanding Brazilian policies and currently utilized methodologies, the measurement of the impacts of deforestation is essential for enhancing techniques to reduce deforestation in the future. Adverse impacts of deforestation include biodiversity loss, increased carbon dioxide emissions, and a reduced rate of evapotranspiration, all of which contribute directly or indirectly to global warming. With the continual growth in population in developing countries such as Brazil, increased demands are placed on infrastructural development and food production. As a result, forested areas are cleared for agricultural production. Recently, exploration for hydrocarbons in Western Brazil has also intensified as a means to stimulate the economy, as abundant oil and gas is believed to be found in these regions. Unfortunately, hydrocarbon-rich regions of Western Brazil are also home to thousands of species. Many of these regions are as of yet untapped but are at risk of ecological disruption as a result of impending human activity. This project utilized Landsat 5 TM to monitor deforestation in a subsection of the Brazilian states of Rondônia and Amazonas. A risk map identifying areas susceptible to future deforestation, based on factors such as proximity to roads, bodies of water, cities, and proposed hydrocarbon activities such as pipeline construction, was created. Areas at higher risk of clearance were recommended to be a target for enhanced monitoring and law enforcement. In addition, an importance map was created based on biodiversity and location of endangered species. This map was used to identify potential areas for future protection. A Chinese-Brazilian satellite, CBERS 2B CCD was also utilized for comparison. The NDVI model was additionally replicated in Quantum GIS, an open source software, so that local communities and policymakers could benefit without having to pay for expensive ArcGIS software. The capabilities of VIIRS were also investigated to

40 CFR 600.510-12 - Calculation of average fuel economy and average carbon-related exhaust emissions.

Science.gov (United States)

2010-07-01

... and average carbon-related exhaust emissions. 600.510-12 Section 600.510-12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF... Transportation. (iv) [Reserved] (2) Average carbon-related exhaust emissions will be calculated to the nearest...

24 CFR 5.510 - Documents of eligible immigration status.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Documents of eligible immigration... Noncitizens § 5.510 Documents of eligible immigration status. (a) General. A responsible entity shall request and review original documents of eligible immigration status. The responsible entity shall retain...

Acetylcholinesterase Reactivators (HI-6, Obidoxime, Trimedoxime, K027, K075, K127, K203, K282: Structural Evaluation of Human Serum Albumin Binding and Absorption Kinetics

Directory of Open Access Journals (Sweden)

Filip Zemek

2013-08-01

Full Text Available Acetylcholinesterase (AChE reactivators (oximes are compounds predominantly targeting the active site of the enzyme. Toxic effects of organophosphates nerve agents (OPNAs are primarily related to their covalent binding to AChE and butyrylcholinesterase (BChE, critical detoxification enzymes in the blood and in the central nervous system (CNS. After exposure to OPNAs, accumulation of acetylcholine (ACh overstimulates receptors and blocks neuromuscular junction transmission resulting in CNS toxicity. Current efforts at treatments for OPNA exposure are focused on non-quaternary reactivators, monoisonitrosoacetone oximes (MINA, and diacylmonoxime reactivators (DAM. However, so far only quaternary oximes have been approved for use in cases of OPNA intoxication. Five acetylcholinesterase reactivator candidates (K027, K075, K127, K203, K282 are presented here, together with pharmacokinetic data (plasma concentration, human serum albumin binding potency. Pharmacokinetic curves based on intramuscular application of the tested compounds are given, with binding information and an evaluation of structural relationships. Human Serum Albumin (HSA binding studies have not yet been performed on any acetylcholinesterase reactivators, and correlations between structure, concentration curves and binding are vital for further development. HSA bindings of the tested compounds were 1% (HI-6, 7% (obidoxime, 6% (trimedoxime, and 5%, 10%, 4%, 15%, and 12% for K027, K075, K127, K203, and K282, respectively.

20 CFR 422.510 - Applications and related forms used in the health insurance for the aged program.

Science.gov (United States)

2010-04-01

... health insurance for the aged program. 422.510 Section 422.510 Employees' Benefits SOCIAL SECURITY... forms used in the health insurance for the aged program. (a) Application forms. The following forms are prescribed for use in applying for entitlement to benefits under the health insurance for the aged program...

13 CFR 121.510 - What is the size standard for leasing of Government land for uranium mining?

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false What is the size standard for leasing of Government land for uranium mining? 121.510 Section 121.510 Business Credit and Assistance... standard for leasing of Government land for uranium mining? A concern is small for this purpose if it...

China’s Relations with Portuguese-speaking Countries: A Growing but Unnoticed Relation

Science.gov (United States)

2012-09-01

Brazil and China Expand Satellite Program and African Countries Receive data from CBERS) Ministerio da Ciencia e Tecnologia do Brasil (Brazilian Ministry...Washington D.C. Ministerio da Ciencia e Tecnologia do Brasil (Brazilian Ministry of Science and Technology). “Brasil e China Ampliao Base do Programa CBERS

21 CFR 510.301 - Records and reports concerning experience with animal feeds bearing or containing new animal...

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Records and reports concerning experience with... application is in effect. 510.301 Section 510.301 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... or deterioration in the drug, or any failure of one or more distributed batches of the drug to meet...

Teaching for Creativity by Science Teachers in Grades 5-10

Science.gov (United States)

Al-Abdali, Nasser S.; Al-Balushi, Sulaiman M.

2016-01-01

This classroom observation study explored how science teachers (N = 22) teach for creativity in grades 5-10 in Oman. We designed an observation form with 4 main categories that targeted the instructional practices related to teaching for creativity: questioning strategy, teacher's responses to students' ideas, classroom activities to support…

An example of a component replacement when applying ASME N509 and ASME N510 to older ventilation systems

International Nuclear Information System (INIS)

Arndt, T.E.

1994-06-01

This paper presents an example of a component replacement (electric heater) when installed in an older ventilation system that was constructed before the issuance of ASME N509 and N510. Many of the existing ventilation systems at the Hanford Site were designed, fabricated, and installed before the issuance of ASME N509 and N510. Requiring the application of these codes to existing ventilation systems presents challenges to the engineer when design changes are needed. Although it may seem that the application of ASME N509 or N510 may be a hindrance at times, this does not need to occur. Proper preparation at the start of project or design modifications can minimize frustration to the engineer when it is judged that portions of ASME N509 and N510 do not apply in a particular application

40 CFR 59.510 - What records am I required to maintain?

Science.gov (United States)

2010-07-01

... PROGRAMS (CONTINUED) NATIONAL VOLATILE ORGANIC COMPOUND EMISSION STANDARDS FOR CONSUMER AND COMMERCIAL PRODUCTS National Volatile Organic Compound Emission Standards for Aerosol Coatings § 59.510 What records... providing the written certification to the Administrator in accordance with § 59.511(g), the certifying...

Uso de imagens orbitais como base de dados para projetos de reforma agrária The use of orbital images as subsidies to agrarian reform projects

Directory of Open Access Journals (Sweden)

Marina de Fátima Vilela

2005-08-01

Full Text Available Análises técnica e econômica foram realizadas em imagens dos sensores IKONOS, TM/Landsat 5, ETM+/Landsat 7 e CCD/CBERS, objetivando a verificação da viabilidade destas como base de dados em projetos de reforma agrária. Essas análises efetuadas e a situação de mercado indicaram que a imagem IKONOS apresenta excelente desempenho técnico, mas o custo de aquisição inviabiliza sua utilização como base de dados para a reforma agrária. A imagem do Landsat 7, com baixo custo de aquisição, apresentou grande viabilidade técnica para fins de reforma agrária. No entanto, a perda do contato com a plataforma Landsat 7 inviabilizou a compra de novas imagens do sensor ETM+. A imagem CCD/CBERS apresentou a segunda maior similaridade com a verdade de campo e o menor índice Kappa para a classificação. Apesar do baixo índice de exatidão para a classificação, as análises de custo, o lançamento do CBERS-2 e a possibilidade de correção dos problemas de radiometria podem tornar as imagens da plataforma CBERS-2 concorrentes de peso no mercado e, ainda, preencher a lacuna deixada pela perda do Landsat 7. A imagem do Landsat 5 apresentou o mais baixo desempenho técnico nas análises efetuadas. Entretanto, seu potencial como base de dados é amplamente reconhecido pelo INCRA, que ainda utiliza tais imagens. O declínio da vida útil do Landsat-5 atribui mais importância ao lançamento do CBERS-2.Technical and economical analyses were performed on IKONOS, Landsat TM 5 and Landsat ETM+ 7 and CCD/CBERS data in order to verify their feasibilities to subsidy agrarian reform projects. Results showed that IKONOS data presented excellent technical viability but its high cost prevents its use. Landsat ETM+ 7 data, with low cost, presented good technical viability, however due to the problems occurring in the satellite operation, its use was also prevented . CCD/CBERS data presented the second best similarity with the ground truth data, although it

Evaluation of optimum inclusion levels of Biostrong ® 510 as ...

African Journals Online (AJOL)

Biostrong® 510 was included at 0g, 15g, 17.5g and 20g/100 Kg diet for T1-T4 respectively while T5 and T6 had Oxytetracyclineand water-grade Neocyril plus respectively. Data was collected ongrowth performance indices, haematological parameters, liver function indices, ileum and ceacum microbial contents, tibia bone ...

An example of a component replacement when applying ASME N509 and ASME N510 to older ventilation systems

Energy Technology Data Exchange (ETDEWEB)

Arndt, T.E. [Westinghouse Hanford Company, Richland, WA (United States)

1995-02-01

This paper presents an example of a component replacement (electric heater) when installed in an older ventilation system that was constructed before the issuance of ASME N509{sup 1} and N510{sup 2}. Many of the existing ventilation systems at the Hanford Site were designed, fabricated, and installed before the issuance of ASME N509{sup 1} and N510{sup 2}. Requiring the application of these codes to existing ventilation systems presents challenges to the engineer when design changes are needed. Although it may seem that the application of ASME N509{sup 1} or N510{sup 2} may be a hindrance at times, this does not need to occur. Proper preparation at the start of project or design modifications can minimize frustration to the engineer when it is judged that portions of ASME N509{sup 1} and N510{sup 2} do not apply in a particular application.

Shifting to a non-vitamin K antagonist oral anticoagulation agent from vitamin K antagonist in atrial fibrillation

DEFF Research Database (Denmark)

Fosbøl, Emil L; Vinding, Naja Emborg; Lamberts, Morten

2017-01-01

Aims: After non-vitamin K antagonist (VKA) oral anticoagulation agents (NOAC) have been approved for thrombo-embolic prophylaxis in non-valvular atrial fibrillation (NVAF), utilization of oral anticoagulants (OAC) in NVAF has changed. Contemporary shifting from a VKA to a NOAC (dabigatran...

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

Science.gov (United States)

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. ...

33 CFR 148.510 - What happens when a petition for exemption involves the interests of an adjacent coastal State?

Science.gov (United States)

2010-07-01

... exemption involves the interests of an adjacent coastal State? 148.510 Section 148.510 Navigation and... petition for exemption involves the interests of an adjacent coastal State? If the petition for exemption concerns an adjacent coastal State, the Commandant (CG-5) forwards the petition to the Governor of the...

29 CFR 510.10 - Table of wage rates and effective dates.

Science.gov (United States)

2010-07-01

... REGULATIONS IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO Schedule of Minimum Wage Rates Applicable in Puerto Rico § 510.10 Table of wage rates and effective dates. (a) The following table provides effective dates of minimum wage increases...

Modeling and Simulation for an 8 kW Three-Phase Grid-Connected Photo-Voltaic Power System

OpenAIRE

Cen Zhaohui

2017-01-01

Gird-connected Photo-Voltaic (PV) systems rated as 5-10 kW level have advantages of scalability and energy-saving, so they are very typical for small-scale household solar applications. In this paper, an 8 kW three-phase grid-connected PV system model is proposed and studied. In this high-fidelity model, some basic PV system components such as solar panels, DC-DC converters, DC-AC inverters and three-phase utility grids are mathematically modelled and organized as a complete simulation model....

A quick guide to API 510 certified pressure vessel inspector syllabus example questions and worked answers

CERN Document Server

Matthews, Clifford

2010-01-01

The API Individual Certification Programs (ICPs) are well established worldwide in the oil, gas, and petroleum industries. This Quick Guide is unique in providing simple, accessible and well-structured guidance for anyone studying the API 510 Certified Pressure Vessel Inspector syllabus by summarizing and helping them through the syllabus and providing multiple example questions and worked answers.Technical standards are referenced from the API 'body of knowledge' for the examination, i.e. API 510 Pressure vessel inspection, alteration, rerating; API 572 Pressure vessel inspection; API

The PTPN11 loss-of-function mutation Q510E-Shp2 causes hypertrophic cardiomyopathy by dysregulating mTOR signaling.

Science.gov (United States)

Schramm, Christine; Fine, Deborah M; Edwards, Michelle A; Reeb, Ashley N; Krenz, Maike

2012-01-01

The identification of mutations in PTPN11 (encoding the protein tyrosine phosphatase Shp2) in families with congenital heart disease has facilitated mechanistic studies of various cardiovascular defects. However, the roles of normal and mutant Shp2 in the developing heart are still poorly understood. Furthermore, it remains unclear how Shp2 loss-of-function (LOF) mutations cause LEOPARD Syndrome (also termed Noonan Syndrome with multiple lentigines), which is characterized by congenital heart defects such as pulmonary valve stenosis and hypertrophic cardiomyopathy (HCM). In normal hearts, Shp2 controls cardiomyocyte size by regulating signaling through protein kinase B (Akt) and mammalian target of rapamycin (mTOR). We hypothesized that Shp2 LOF mutations dysregulate this pathway, resulting in HCM. For our studies, we chose the Shp2 mutation Q510E, a dominant-negative LOF mutation associated with severe early onset HCM. Newborn mice with cardiomyocyte-specific overexpression of Q510E-Shp2 starting before birth displayed increased cardiomyocyte sizes, heart-to-body weight ratios, interventricular septum thickness, and cardiomyocyte disarray. In 3-mo-old hearts, interstitial fibrosis was detected. Echocardiographically, ventricular walls were thickened and contractile function was depressed. In ventricular tissue samples, signaling through Akt/mTOR was hyperactivated, indicating that the presence of Q510E-Shp2 led to upregulation of this pathway. Importantly, rapamycin treatment started shortly after birth rescued the Q510E-Shp2-induced phenotype in vivo. If rapamycin was started at 6 wk of age, HCM was also ameliorated. We also generated a second mouse model in which cardiomyocyte-specific Q510E-Shp2 overexpression started after birth. In contrast to the first model, these mice did not develop HCM. In summary, our studies establish a role for mTOR signaling in HCM caused by Q510E-Shp2. Q510E-Shp2 overexpression in the cardiomyocyte population alone was sufficient to

Biosphere science news roundup. The Center for Biospheric Education and Research

Science.gov (United States)

Cotten, J H

1994-01-01

The Center for Biospheric Education and Research (CBER) is an exciting and truly unique addition to The Huntsville-Madison County Botanical Garden. The mission of CBER is to increase the knowledge and understanding of closed ecological life support systems, including both natural and man-made biospheres. Its primary emphasis will be on the Earth biosphere with particular attention to the role of plants in maintaining a balanced environment. Secondary emphasis will be on the space station and lunar habitation biospheres, both of which employ plants for environmental control, food, and aesthetics. CBER will serve as a catalyst providing both a forum and a facility for research, education, and display of methodologies and technologies relevant to the creation and maintenance of such biospheric systems.

Clinical use of PI3K inhibitors in B-cell lymphoid malignancies: today and tomorrow.

Science.gov (United States)

Greenwell, I B; Flowers, C R; Blum, K A; Cohen, J B

2017-03-01

PI3K inhibitors are an important new therapeutic option for the treatment of relapsed and refractory B-cell lymphoid malignancies. Idelalisib is a PI3Kδ inhibitor that has been approved for the treatment of lymphoma and chronic lymphocytic leukemia in the relapsed/refractory setting, and several other PI3K inhibitors are being developed targeting other isoforms of the PI3K enzyme, which results in distinct toxicities and variable efficacy in the clinical setting. Areas covered: We provide a general overview of PI3K inhibitors, recommended applications, and the mechanism and management of toxicities. We further review trials, ongoing and completed, leading to the approval of idelalisib as well other PI3K inhibitors currently in development. Articles were obtained from PubMed, and abstracts were searched for the past 5 years from the websites for ASCO, ASH, EHA, and ICML/Lugano. Expert commentary: PI3K inhibitors provide an important and powerful pharmacologic tool in the armamentarium against hematologic malignancies, especially for relapsed/refractory B-cell lymphoid malignancies. Unique toxicities are associated with inhibition of different isoforms of the PI3K enzyme, as demonstrated with the infectious and autoimmune toxicities associated with the PI3Kδ inhibitor, idelalisib. Due to these unique toxicities, PI3K inhibitors should only be used in formally approved combinations and settings.

40 CFR 174.510 - Bacillus thuringiensis Cry1Ac protein in all plants; exemption from the requirement of a tolerance.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Bacillus thuringiensis Cry1Ac protein in all plants; exemption from the requirement of a tolerance. 174.510 Section 174.510 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS Tolerances...

The Thrombospondin-1 Mimetic ABT-510 Increases the Uptake and Effectiveness of Cisplatin and Paclitaxel in a Mouse Model of Epithelial Ovarian Cancer

Directory of Open Access Journals (Sweden)

Nicole E. Campbell

2010-03-01

Full Text Available Epithelial ovarian cancer (EOC comprises approximately 90% of ovarian cancers and arises from the surface epithelium. Typical treatment of EOC involves cytoreductive surgery combined with chemotherapy. More recent therapies have targeted the tumor vasculature using antiangiogenic compounds such as thrombospondin-1 (TSP-1. TSP-1 mimetic peptides such as ABT-510 have been created and have been in various clinical trials. We have previously shown that ABT-510 reduces abnormal vasculature associated with tumor tissue and increases the presence of mature blood vessels. It has been hypothesized that treatment with antiangiogenic compounds would allow increased delivery of cytotoxic agents and enhance treatment. In this study, we evaluated the potential role of ABT-510 and various chemotherapeutics (cisplatin and paclitaxel on tumor progression, angiogenesis, and the benefits of combinational treatments on tissue uptake and perfusion using an orthotopic syngeneic mouse model of EOC. Animals were treated with ABT-510 (100 mg/kg per day alone or in combination with cisplatin (2 mg/kg per 3 days or paclitaxel (10 mg/kg per 2 days at 60 days after tumor induction. Radiolabeled and fluorescently labeled paclitaxel demonstrated a significant increase in tumor uptake after ABT-510 treatment. Combined treatment with ABT-510 and cisplatin or paclitaxel resulted in a significant increase in tumor cell and tumor endothelial cell apoptosis and a resultant decrease in ovarian tumor size. Combined treatment also regressed secondary lesions and eliminated the presence of abdominal ascites. The results from this study show that through vessel normalization, ABT-510 increases uptake of chemotherapy drugs and can induce regression of advanced ovarian cancer.

40 CFR 1048.510 - What transient duty cycles apply for laboratory testing?

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false What transient duty cycles apply for... Procedures § 1048.510 What transient duty cycles apply for laboratory testing? (a) Starting with the 2007 model year, measure emissions by testing the engine on a dynamometer with the duty cycle described in...

76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2011-10-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

19 CFR 10.510 - Filing of claim for preferential tariff treatment upon importation.

Science.gov (United States)

2010-04-01

... RATE, ETC. United States-Singapore Free Trade Agreement Import Requirements § 10.510 Filing of claim... method specified for equivalent reporting via an authorized electronic data interchange system. For all... classified, or by the method specified for equivalent reporting via an authorized electronic data interchange...

19 CFR 351.510 - Indirect taxes and import charges (other than export programs).

Science.gov (United States)

2010-04-01

... OF COMMERCE ANTIDUMPING AND COUNTERVAILING DUTIES Identification and Measurement of Countervailable Subsidies § 351.510 Indirect taxes and import charges (other than export programs). (a) Benefit—(1... the full or partial exemption or remission of an indirect tax or an import charge, a benefit exists to...

38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

Science.gov (United States)

2010-07-01

... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

Biological Mesh Implants for Abdominal Hernia Repair: US Food and Drug Administration Approval Process and Systematic Review of Its Efficacy.

Science.gov (United States)

Huerta, Sergio; Varshney, Anubodh; Patel, Prachi M; Mayo, Helen G; Livingston, Edward H

2016-04-01

Expensive biological mesh materials are increasingly used to reinforce abdominal wall hernia repairs. The clinical and cost benefit of these materials are unknown. To review the published evidence on the use of biological mesh materials and to examine the US Food and Drug Administration (FDA) approval history for these devices. Search of multiple electronic databases (Ovid, MEDLINE, EMBASE, Cochrane Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Cochrane National Health Service Economic Evaluation Database) to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials used to reinforce abdominal wall hernia repair. Keywords searched included surgical mesh, abdominal hernia, recurrence, infection, fistula, bioprosthesis, biocompatible materials, absorbable implants, dermis, and collagen. The FDA online database for 510(k) clearances was reviewed for all commercially available biological mesh materials. The median national price for mesh materials was established by a benchmarking query through several Integrated Delivery Network and Group Purchasing Organization tools. Of 274 screened articles, 20 met the search criteria. Most were case series that reported results of convenience samples of patients at single institutions with a variety of clinical problems. Only 3 of the 20 were comparative studies. There were no randomized clinical trials. In total, outcomes for 1033 patients were described. Studies varied widely in follow-up time, operative technique, meshes used, and patient selection criteria. Reported outcomes and clinical outcomes, such as fistula formation and infection, were inconsistently reported across studies. Conflicts of interest were not reported in 16 of the 20 studies. Recurrence rates ranged from 0% to 80%. All biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbiological predicate

The K-8 Aeronautics Internet Textbook

Science.gov (United States)

2002-01-01

Efforts were focused on web site migration, from UC (University of California) Davis to the National Business Aviation Association's (NBAA) web site. K8AIT (K-8 Aeronautics Internet Textbook), which has remained an unadvertised web site, receives almost two million hits per month. Project continuation funding with the National Business Aviation Association is being pursued. A Memorandum of Understanding (MOU) between NASA Ames LTP (Learning Technologies Project) and Cislunar has been drafted and approved by NASA's legal department. Additional web content on space flight and the Wright brothers has been added in English and Spanish.

Synthesis of the muscle relaxant [14C]L-637,510

International Nuclear Information System (INIS)

O'Connor, S.P.; Ellsworth, R.L.; Gatto, G.

1991-01-01

The synthesis of (E)-3-(9-chloro-5,6-dihydro-11H-pyrolo(2,1-b)(3)-benzazepin-11-ylidene)-N,N-dimethyl-1- [3- 14 C]-propanamine (Z)-2-butenedioate(1:1) ([ 14 C]L-637,510), a potential muscle relaxant product for which 14 C-labeling was required for metabolism studies, is described. Introduction of the label in the 3-position of the propanamine side chain was accomplished in eight steps from sodium [ 14 C]cyanide with an overall radiochemical yield of 4.8%. (author)

17 CFR 249.510 - Form 10-M, consent to service of process by a nonresident general partner of a broker-dealer firm.

Science.gov (United States)

2010-04-01

..., consent to service of process by a nonresident general partner of a broker-dealer firm. This form shall be... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 10-M, consent to service of process by a nonresident general partner of a broker-dealer firm. 249.510 Section 249.510...

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Science.gov (United States)

2010-04-01

... after manufacture. 115.41 Section 115.41 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT... PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.41 Certificate of approval for containers approved after manufacture. The Certifying Authority shall...

40 CFR 1039.510 - Which duty cycles do I use for transient testing?

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Which duty cycles do I use for... ENGINES Test Procedures § 1039.510 Which duty cycles do I use for transient testing? (a) Measure emissions by testing the engine on a dynamometer with one of the following transient duty cycles to determine...

75 FR 59771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

Science.gov (United States)

2010-09-28

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the Proposed Rule.... I. Introduction On July 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k... pertinent distribution-related information from its members in a timely fashion to facilitate its Regulation...

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

International Nuclear Information System (INIS)

Connor, Michael J.; Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C.; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J.; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A.

2017-01-01

Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ"2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

Energy Technology Data Exchange (ETDEWEB)

Connor, Michael J. [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States); University of California Irvine School of Medicine, Irvine, California (United States); Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C.; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J.; Pawlicki, Todd [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona A., E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States)

2017-06-01

Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.

24 CFR 598.510 - Nominations by Economic Development Corporations or the District of Columbia.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 3 2010-04-01 2010-04-01 false Nominations by Economic Development... ZONES: ROUND TWO AND THREE DESIGNATIONS Special Rules § 598.510 Nominations by Economic Development Corporations or the District of Columbia. Any urban area nominated by an Economic Development Corporation...

Introduction of a 20 kHz Nd:YVO4 laser into a hybrid quadrupole time-of-flight mass spectrometer for MALDI-MS imaging.

Science.gov (United States)

Trim, Paul J; Djidja, Marie-Claude; Atkinson, Sally J; Oakes, Keith; Cole, Laura M; Anderson, David M G; Hart, Philippa J; Francese, Simona; Clench, Malcolm R

2010-08-01

A commercial hybrid quadrupole time-of-flight mass spectrometer has been modified for high-speed matrix-assisted laser desorption ionisation (MALDI) imaging using a short-pulse optical technology Nd:YVO(4) laser. The laser operating in frequency-tripled mode (lambda = 355 nm) is capable of delivering 1.5-ns pulses of energy at up to 8 microJ at 5-10 kHz and 3 microJ at 20 kHz. Experiments to improve beam homogeneity and reduce laser speckle by mechanical vibration of the fibre-optic laser delivery system are reported along with data from trial and tissue imaging experiments using the modified instrument. The laser appeared to yield best results for MALDI-MS imaging experiments when operating at repetition rates 5-10 kHz. Combining this with raster imaging allowed images of rat brain sections to be recorded in 37 min. Similarly, images of the distribution of peptides in "on-tissue" digest experiments from tumour tissues were recorded in 1 h and 30 min rather than the 8-h acquisition time previously used. A brief investigation of targeted protein analysis/imaging by multiple reaction monitoring experiments "on-tissue" is reported. A total of 26 transitions were recorded over a 3-s cycle time and images of abundant proteins were successfully recorded.

FDA, CE mark or something else?-Thinking fast and slow.

Science.gov (United States)

Mishra, Sundeep

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Etude Analytique de 510 Cas Biopies Ganglionnaires Chirurgicales

Directory of Open Access Journals (Sweden)

HAMID SABETI

1975-06-01

Full Text Available 510 cases of surgical lymph node biopsies during a five year periode are reviewed with the following conclusionsThe lymph node biopsy constitues 5% of all the surgical biopsies, The cervical and axillary lymph nodes are the most commonly biopsicd nodes due to their easy accessibility and due to the fact that they drain the lymph from many vital organs: the next most commonly biopsied nodes are the sub-clavicular, grains, mesentric and mediastinal nodes, Among all the lymph node affections the metastatic tumours occupy the first place (23 % followed by the primary tumours (malignant lymphomas 16% and the specific inflammatory lesions (10% , Among the metastic nodes squamous cell carcinoma occupy the first place (8% followed by digestivetract, lung, thyroid glands, breast, testicular, pancreatic, ovarian and gall bladder tumours.

Delayed-rectifier K channels contribute to contrast adaptation in mammalian retinal ganglion cells.

Science.gov (United States)

Weick, Michael; Demb, Jonathan B

2011-07-14

Retinal ganglion cells adapt by reducing their sensitivity during periods of high contrast. Contrast adaptation in the firing response depends on both presynaptic and intrinsic mechanisms. Here, we investigated intrinsic mechanisms for contrast adaptation in OFF Alpha ganglion cells in the in vitro guinea pig retina. Using either visual stimulation or current injection, we show that brief depolarization evoked spiking and suppressed firing during subsequent depolarization. The suppression could be explained by Na channel inactivation, as shown in salamander cells. However, brief hyperpolarization in the physiological range (5-10 mV) also suppressed firing during subsequent depolarization. This suppression was selectively sensitive to blockers of delayed-rectifier K channels (K(DR)). In somatic membrane patches, we observed tetraethylammonium-sensitive K(DR) currents that activated near -25 mV. Recovery from inactivation occurred at potentials hyperpolarized to V(rest). Brief periods of hyperpolarization apparently remove K(DR) inactivation and thereby increase the channel pool available to suppress excitability during subsequent depolarization. Copyright © 2011 Elsevier Inc. All rights reserved.

Redfield Energy Approval

Science.gov (United States)

This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

Science.gov (United States)

DiMasi, Joseph A

2013-06-01

Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

24 CFR 1003.510 - Indian preference requirements.

Science.gov (United States)

2010-04-01

... without limiting the advertisement for bids or proposals to Indian organizations and Indian-owned economic... announced in the advertisement and bidding or proposal solicitation documents and the bidding and proposal... complaint. (Approved by the Office of Management and Budget under control number 2577-0191) ...

75 FR 61246 - Kaiser Federal Financial Group, Inc., Covina, CA; Approval of Conversion Application

Science.gov (United States)

2010-10-04

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-51: OTS No. H-4729] Kaiser Federal... September 28, 2010, the Office of Thrift Supervision approved the application of K-Fed Mutual Holding Company and Kaiser Federal Bank, Covina, California, to convert to the stock form of organization. Copies...

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

Science.gov (United States)

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

2017-01-01

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

77 FR 14461 - Approval of Noise Compatibility Program for W.K. Airport, Battle Creek, MI

Science.gov (United States)

2012-03-09

....K. Kellogg Airport noise compatibility program. All of the recommendations of the program were... Noise Compatibility Program for W.K. Kellogg Airport is February 16, 2012. FOR FURTHER INFORMATION... the Noise Compatibility Program for W.K. Kellogg Airport, effective February 16, 2012. Under section...

Optically stimulated luminescence of Tb{sup 3+}/Sm{sup 3+} doubly doped K{sub 2}YF{sub 5} single crystals

Energy Technology Data Exchange (ETDEWEB)

Camargo, L.; Marcazzo, J.; Santiago, M.; Caselli, E. [Universidad Nacional del Centro de la Provincia de Buenos Aires, Instituto de Fisica Arroyo Seco, Gral. Pinto 399, B7000GHG, Tandil (Argentina); Khaidukov, N. M., E-mail: jmarcass@exa.unicen.edu.ar [Kurnakov Institute of General and Inorganic Chemistry, RAS, Leninskii Prospekt 31, 119991 Moscow (Russian Federation)

2014-08-15

In this work optically stimulated luminescence (OSL) properties of K{sub 2}YF{sub 5} crystals doubly doped with Tb{sup 3+} and Sm{sup 3+} ions have been investigated for the first time. OSL responses for different dopant concentration and for optical stimulation with different wavelengths have been analyzed for each compound. Dosimetric properties of the most efficient composition, namely, K{sub 2}YF{sub 5}:1.0 at.% Tb{sup 3+}; 1.0 at.% Sm{sup 3+}, have been studied. Finally, the possible application of this single crystal as OSL dosimeter has been evaluated. (Author)

Stable structures of Al510–800 clusters and lowest energy sequence of truncated octahedral Al clusters up to 10,000 atoms

International Nuclear Information System (INIS)

Wu, Xia; He, Chengdong

2012-01-01

Highlights: ► The stable structures of Al 510–800 clusters are obtained with the NP-B potential. ► Al 510–800 clusters adopt truncated octahedral (TO) growth pattern based on complete TOs at Al 405 , Al 586 , and Al 711 . ► The lowest energy sequence of complete TOs up to the size 10,000 is proposed. -- Abstract: The stable structures of Al 510–800 clusters are obtained using dynamic lattice searching with constructed cores (DLSc) method by the NP-B potential. According to the structural growth rule, octahedra and truncated octahedra (TO) configurations are adopted as the inner cores in DLSc method. The results show that in the optimized structures two complete TO structures are found at Al 586 and Al 711 . Furthermore, Al 510–800 clusters adopt TO growth pattern on complete TOs at Al 405 , Al 586 , and Al 711 , and the configurations of the surface atoms are investigated. On the other hand, Al clusters with complete TO motifs are studied up to the size 10,000 by the geometrical construction method. The structural characteristics of complete TOs are denoted by the term “family”, and the growth sequence of Al clusters is investigated. The lowest energy sequence of complete TOs is proposed.

Application of Fast Neutron Activation to Determinate of N, P and K Element Contents in the Sludge

International Nuclear Information System (INIS)

Supriyatni E; Yazid M; Nuraini E; Sunardi

2003-01-01

The application of fast neutron activation to determinate of N, P and K element contents in the sludge has been performed. The aim of this research is to determine the content of N, P and K elements in the sludge for the possibility of reuse as organic fertilizer. Sludge sample was taken from waste water retainer at Bantul Waste Water Treatment Plant. The sample was dried and ground, then irradiated using 14.7 MeV fast neutron from neutron generator. Result was qualitatively and quantitatively analyses using gamma spectrometer. The result showed that the sludge contains N with energy 511 keV, P with energy 1778 keV and K with energy 1273 keV. The concentration of N is (4.101 ± 0.007) mg/g, P is = (640.510 ± 14.34) mg/g and K = (3.045 ± 0.064) mg/g. (author)

30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines constructed of components... APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.95 Approval of machines constructed of components approved...

submitter Manufacture and Test of ITER 10-kA HTSCL Prototypes

CERN Document Server

Zhou, Tingzhi; Liu, Chenglian; Lu, Kun; Ran, Qingxiang; Song, Yuntao; Niu, Erwu; Bauer, Pierre; Devred, Arnaud; Lee, Seungje; Taylor, Thomas; Yang, Yifeng

2016-01-01

To carry current for the ITER correction coils, the 10-kA high-temperature superconducting current leads studied here are designed. Current leads provide the transition from 4.5-K low temperature to room temperature. This paper summarizes the major design features of the prototypes, which is followed by a discussion of the manufacturing and testing. The test results approved their excellent performance on low joint resistance and long loss-of-flow accident time. The overheating time, mass flow, and heat loads to 5-K ends also reached the expectation.

75 FR 80828 - Draft Compliance Policy Guide Sec. 510.800 Beverages-Serving Size Labeling; Availability

Science.gov (United States)

2010-12-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0575] Draft Compliance Policy Guide Sec. 510.800 Beverages--Serving Size Labeling; Availability AGENCY: Food... comments on the draft CPG to the Division of Dockets Management (HFA-305), Food and Drug Administration...

30 CFR 285.510 - May MMS reduce or waive my lease or grant payments?

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false May MMS reduce or waive my lease or grant... Financial Assurance Requirements Payments § 285.510 May MMS reduce or waive my lease or grant payments? (a) The MMS Director may reduce or waive the rent or operating fee or components of the operating fee...

21 CFR 510.112 - Antibiotics used in veterinary medicine and for nonmedical purposes; required data.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Antibiotics used in veterinary medicine and for... DRUGS Specific Administrative Rulings and Decisions § 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data. (a) An ad hoc committee, Committee on the Veterinary...

Drugs Approved for Breast Cancer

Science.gov (United States)

... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Raloxifene Hydrochloride Tamoxifen Citrate Drugs ...

Expanding chromospheres of late G and K supergiants

Energy Technology Data Exchange (ETDEWEB)

Mallik, S V

1986-09-15

The radiative transfer problem in non-LTE moving atmospheres has been explicitly solved for H..cap alpha.. line profiles. These computations have been done for a schematic model of the line-forming region over a wide range of optical depths and velocity gradients in order to cover the observed characteristics in 23 G and K supergiants. The best theoretical fits yield optical depths in the range 10-500 and velocity fields in the range 0.5-3 Doppler widths. The computed mass-flow rates lie in the range 10/sup -5/-10/sup -7/ Solar Mass yr/sup -1/; the higher the extent of the line-forming region, the lower the mass-loss rates. The effect of the extent on the H..cap alpha.. emission components has also been investigated in some detail.

Drugs Approved for Thyroid Cancer

Science.gov (United States)

... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

14 CFR Appendix K to Part 25 - Extended Operations (ETOPS)

Science.gov (United States)

2010-01-01

... comply with this appendix, the applicant must demonstrate that: (1) The reliability of the APU is... constraints, and ETOPS approval in a CMP document. K25.1.7Airplane flight manual. The airplane flight manual... cargo or baggage compartments. (e) This statement: “The type-design reliability and performance of this...

Efficacy comparison of duloxetine and SSRIs at doses approved in Japan

Directory of Open Access Journals (Sweden)

Harada E

2015-01-01

Full Text Available Eiji Harada,1 Alexander Schacht,2 Tsukasa Koyama,3 Lauren Marangell,4,5 Toshinaga Tsuji,6 Rodrigo Escobar41Medical Science, Eli Lilly Japan K.K, Kobe, Japan; 2Global Statistical Sciences, Eli Lilly and Company, Bad Homburg, Germany; 3Clinical Research Center, Ohyachi Hospital, Sapporo, Japan; 4Eli Lilly and Company, Indianapolis, IN, 5The University of Texas Health Science Center, Houston, TX, USA; 6Medical Affairs, Shionogi & Co Ltd, Osaka, JapanBackground: Approved doses of antidepressants in Japan are usually lower than those in the USA and European Union, but to date meta-analyses comparing antidepressants have all used the higher doses approved in the USA and European Union and often have used indirect comparisons. The purpose of this study was to conduct an integrated database analysis of patient level data to compare the effects of duloxetine with those of selective serotonin reuptake inhibitors (SSRIs at the doses approved in Japan.Methods: Pooled data were analyzed from four randomized, double-blind, placebo-controlled studies that compared duloxetine at the dose range approved in Japan (40–60 mg/day with other SSRIs (paroxetine 20 mg/day or escitalopram 10 mg/day and placebo in patients with major depressive disorder. In total, 1,694 patients were included in the analysis (duloxetine, n=688; selective serotonin reuptake inhibitors, n=690; placebo, n=316. The primary outcome measure was the mean change from baseline at week 8 in 17-item Hamilton Rating Scale for Depression (HAMD17 total and subscale scores.Results: Duloxetine and both selective serotonin reuptake inhibitors were superior to placebo in HAMD17 total score at week 8 in both the all-randomized group and the more severe subgroup (HAMD17 total scores ≥19. Duloxetine was superior to SSRIs in improving the HAMD17 Retardation subscale score (least squares mean difference [95% confidence interval]: all-randomized group, −0.33 [−0.60, −0.07], P=0.015; severe subgroup, �

77 FR 27529 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of...

Science.gov (United States)

2012-05-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66922; File No. SR-ICC-2012-05] Self-Regulatory... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... of the Comptroller of the Currency, U.K. Financial Services Authority, or any other regulatory body...

76 FR 66763 - Models for Plant-Specific Adoption of Technical Specifications Task Force Traveler TSTF-510...

Science.gov (United States)

2011-10-27

....'' TSTF-510, Revision 2, is available in the Agencywide Documents Access and Management System (ADAMS... SG Tube Integrity specification (Limiting Condition for Operation (LCO) 3.4.17, LCO 3.4.20, and LCO 3... address implementation issues associated with the inspection periods, and address other administrative...

Prothrombin Complex Concentrate for Intracerebral Hemorrhage Secondary to Vitamin K Deficiency Bleeding in a 6-Week-Old Child.

Science.gov (United States)

Rech, Megan A; Wittekindt, Lindsay; Friedman, Samantha D; Kling, Kendall; Ubogy, David

2015-12-01

Four-factor prothrombin complex concentrate is approved for use of life-threatening bleeding secondary to vitamin K antagonism in adults. We describe the use of four-factor prothrombin complex concentrate for hemostasis in a 6-week-old child with life-threatening vitamin K dependent-bleeding who never received vitamin K prophylaxis at birth. Copyright © 2015 Elsevier Inc. All rights reserved.

Modeling and Simulation for an 8 kW Three-Phase Grid-Connected Photo-Voltaic Power System

Science.gov (United States)

Cen, Zhaohui

2017-09-01

Gird-connected Photo-Voltaic (PV) systems rated as 5-10 kW level have advantages of scalability and energy-saving, so they are very typical for small-scale household solar applications. In this paper, an 8 kW three-phase grid-connected PV system model is proposed and studied. In this high-fidelity model, some basic PV system components such as solar panels, DC-DC converters, DC-AC inverters and three-phase utility grids are mathematically modelled and organized as a complete simulation model. Also, an overall power controller with Maximum Power Point Control (MPPT) is proposed to achieve both high-efficiency for solar energy harvesting and grid-connection stability. Finally, simulation results demonstrate the effectiveness of the PV system model and the proposed controller, and power quality issues are discussed.

Modeling and Simulation for an 8 kW Three-Phase Grid-Connected Photo-Voltaic Power System

Directory of Open Access Journals (Sweden)

Cen Zhaohui

2017-09-01

Full Text Available Gird-connected Photo-Voltaic (PV systems rated as 5-10 kW level have advantages of scalability and energy-saving, so they are very typical for small-scale household solar applications. In this paper, an 8 kW three-phase grid-connected PV system model is proposed and studied. In this high-fidelity model, some basic PV system components such as solar panels, DC-DC converters, DC-AC inverters and three-phase utility grids are mathematically modelled and organized as a complete simulation model. Also, an overall power controller with Maximum Power Point Control (MPPT is proposed to achieve both high-efficiency for solar energy harvesting and grid-connection stability. Finally, simulation results demonstrate the effectiveness of the PV system model and the proposed controller, and power quality issues are discussed.

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

Energy Technology Data Exchange (ETDEWEB)

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

2014-06-15

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

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

International Nuclear Information System (INIS)

Morton, R

2014-01-01

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

Conceptual design of a high luminosity 510 MeV collider

International Nuclear Information System (INIS)

Pellegrini, C.; Robin, D.; Cornacchia, M.

1991-01-01

The authors discuss the magnetic lattice design of a high luminosity 510 MeV electron-positron collider, based on high field superconduction bending dipoles. The design criteria are flexibility in the choice of the tune and beta functions at the interaction point, horizontal emittance larger than 1 mm mrad to produce a luminosity larger than 10 32 cm -2 s -1 , large synchrotron radiation damping rate, and large momentum compaction. The RF system parameter are chosen to provide a short bunch length also when the beam energy spread is determined by the microwave instability. A satisfactory ring dynamic aperature, and a simultaneous small value of the horizontal and vertical beta function at the interaction point, the authors expect will be achieved by using Cornacchia-Halbach modified sextupoles

Gamma Radiation (5-10 Gy) Impairs Neuronal Function in the Guinea Pig Hippocampus

Science.gov (United States)

1993-01-01

Radiation (5-10 Gy) Impairs Neuronal Function in the Guinea Pig Hippocampus TERRY C. PELLMAR AND DENNIS L. LEPINSKI Ph.vsiology Department..Irmned Forces...L. Gamma Radiation ioral effects. Within hours of irradiation with 10 Gy and (5- 10 Gy) Impairs Neuronal Function in the Guinea Pig Hippo- less...acti v- Guinea pigs were exposed to 5 and 10 Gy ’y radiation. Hippo- ity (9) are evident. campal brain slices were isolated 30 min, I day, 3 days and 5

Isotope geochemistry of brasiliano age, coarsely porphyritic, K-calc-alkalic granitoids and associated K-diorites, northeast Brazil

International Nuclear Information System (INIS)

Sial, A.N.; Mariano, G.; Ferreira, V.P.

1989-01-01

Several porphyritic, K-calc-alkalic were syntectonically intruded in NE Brazil during the Brasiliano orogeny. They show bi-(qz) diorite and coarsely porphyritic granodiorite to qz monzonite ('Itaporanga-type') in commingling zones on a scale of cm to m irrespective of whether plutons are at the margins of the NE-trending Cachoeirinha-Salgueiro Fold Belt (CSF) or intruded metasediments of the Serido Fold Belt (SFB). The bi(qz) diorites are found in magmatic or stromatic structures and narrow dikes wich intruded the felsic facies. SiO 2 in the porphyritic facies ranges from 61 to 72% with K 2 O usually > Na 2 O. K-diorities exhibit SiO 2 from 50 to 58%, MgO from 2 to 10% and K 2 O from 2 to 5%. Both facies are usually Ba and Sr-enriched, with similar, highly fractionated REE patterns, lacking free of Eu anomaly. Quartz 180 values are considered homogeneous on the scale of these intrusions in the CSF, (8 to 10 per milSMOW). Bi-(qz) diorites exhibit slightly higher 180 (9.5 to 10.5 per milSMOW). In the SFB both facies are lower than 180. The oxygen isotope data for the porphyritic facies are compatible with I-type source with some metasedimentary component of variable proportion. As bi(qz) diorites were formed pre- to post-porphyritic facies intrusion, their high LREE, K and 180 reflect their source rather than the interaction with the potassic felsic magma. Preliminarly sulfur isotope values suggest that porphyritic facies of granitoids in the SBF are lower in 34S than those in the CSF. Rb and Sr isotopes reflect source heterogeneity, complicated by mixing relations. Ages span from 510 to 630 Ma suggesting that the Itaporanga-type association was formed during uplift and cooling of the Pan-African I and onset of the Pan-African II orogenies, recognized in West Africa. (author) [pt

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

International Nuclear Information System (INIS)

Connor, Michael J.; Marshall, Deborah C.; Moiseenko, Vitali; Moore, Kevin; Cervino, Laura; Atwood, Todd; Sanghvi, Parag; Mundt, Arno J.; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A.

2017-01-01

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ"2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

Energy Technology Data Exchange (ETDEWEB)

Connor, Michael J. [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California (United States); Marshall, Deborah C.; Moiseenko, Vitali; Moore, Kevin; Cervino, Laura; Atwood, Todd; Sanghvi, Parag; Mundt, Arno J.; Pawlicki, Todd [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona A., E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States)

2017-01-01

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance

49 CFR 510.3 - Compulsory process, the service thereof, claims for confidential treatment, and terms of compliance.

Science.gov (United States)

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Compulsory process, the service thereof, claims... OF TRANSPORTATION INFORMATION GATHERING POWERS § 510.3 Compulsory process, the service thereof... description of the documents or things to be produced. (c) Service of the compulsory processes specified in...

Electronic Approval of Invoices (AEF)

CERN Document Server

2004-01-01

With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

Beyond the International Linear Collider Driven by FEL with Energy Recovery at 5-10TeV

CERN Document Server

Hajima, R

2005-01-01

The international linear collider (ILC) at the extreme high energy frontier provides the best hope for the scientist to probe the finenst structure of matter and its origin and perhaps even the origin of the Universe. The technology that employs is based on superconducting RF technology. This technology may usher in a new era for the development of superconducting accelerator technology. On the other hand, the gradient that is allowed in such an accelerator is limited. If one wishes something beyond this after one learns the physics at such high energies(~0.5TeV) and utilizing such technology, one may need a new way to employ the supeconducting technology in providing high gradient compact accelerators. Inspired by a former work of 5-TeV colliders based on solid-state tera-watt lasers [1], we explore 5-10 TeV linear colliders driven by free-electron lasers equipped with energy-recovery system. A preliminary design study suggests that a 5-10 TeV collider with the luminosity of 10(34) can be realized by multi-s...

Evidence for K+ -> π+ νbar ν

International Nuclear Information System (INIS)

Kettell, S.

1998-01-01

The first observation of the decay K + -> π + νbar ν has been reported. The E787 experiment presented evidence for the K + r a rrow π + νbar ν decay, based on the observation of a single clean event from data collected during the 1995 run of the AGS (Alternating Gradient Synchrotron at Brookhaven National Laboratory). The branching ratio indicated by this observation, B(K + -> π + νbar ν) = 4.2 -3.5 +9.7 x 10 -10 , is consistent with the Standard Model expectation although the central experimental value is four times larger. The final E787 data sample, from the 1995--98 runs, should reach a sensitivity of about five times that of the 1995 run alone. A new experiment, E949, has been given scientific approval and should start data collection in 2001. It is expected to achieve a sensitivity of more than an order of magnitude below the prediction of the Standard Model

Marketing Approval of Ethical Kampo Medicines.

Science.gov (United States)

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

40 CFR 145.31 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process. (a...

40 CFR 52.2122 - Approval status.

Science.gov (United States)

2010-07-01

... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

Subsequent bilateral comparison to CCT-K3, CIPM key comparison CCT-K3.1: Comparison of standard platinum resistance thermometers at the triple point of water (T = 273.16 K) and at the melting point of gallium (T = 302.9146 K)

Science.gov (United States)

Picard, S.; Nonis, M.; Solve, S.; Allisy-Roberts, P. J.; Renaot, E.; Martin, C.

2011-01-01

A comparison of standard platinum resistance thermometers (SPRTs) has been carried out between the BIPM and the Laboratoire commun de métrologie LNE-CNAM using the melting point of gallium and the triple point of water. The temperature difference at Ga between the BIPM and the LNE-CNAM was determined as 108 µK with an associated combined standard uncertainty of 223 µK. This outcome indicates a present temperature difference of the BIPM of -65 µK with respect to an Average Reference Value from an earlier comparison, with an associated uncertainty of uc = 262 µK. It should be noted that the present BIPM scale is not independent, but traceable to cells used in KC7. The comparison results validate the re-establishment of thermometer calibrations at the BIPM for internal use. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCT, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

VCA-DVC VMware certified associate on vSphere study guide VCAD-510

CERN Document Server

Schmidt, Robert

2015-01-01

Use this expert guide to prepare for the VCA-DCV exam VCA-DCV VMware Certified Associate on vSphere Study Guide: VCAD-510 is a comprehensive study guide for the VMware Certified Associate - Data Center Virtualization exam. Hands-on examples, real-world scenarios, and expert review questions cover the full exam blueprint, and the companion website offers a suite of tools to help you prepare for the exam including practice exams, electronic flashcards, and a glossary of key terms. In addition, the website includes videos that demonstrate how to complete the more challenging tasks. Focused on p

75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

Science.gov (United States)

2010-08-10

....gov ). FOR FURTHER INFORMATION CONTACT: For information on credit account approval for reimbursable..., at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable... Inspection Service [Docket No. APHIS-2010-0071] Notice of Request for Extension of Approval of an Information...

78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

Science.gov (United States)

2013-09-05

...] Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval for... (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit account... Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable...

40 CFR 52.1772 - Approval status.

Science.gov (United States)

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans for... CTGs issued by the previous January. (b) New Source review permits issued pursuant to section 173 of...

9 CFR 147.52 - Approved tests.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry...

30 CFR 14.10 - Post-approval product audit.

Science.gov (United States)

2010-07-01

..., AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... based. MSHA will select an approved conveyor belt to be audited; the selected belt will be...

Thermal and Electrical Conductivity Measurements of CDA 510 Phosphor Bronze

Science.gov (United States)

Tuttle, James E.; Canavan, Edgar; DiPirro, Michael

2009-01-01

Many cryogenic systems use electrical cables containing phosphor bronze wire. While phosphor bronze's electrical and thermal conductivity values have been published, there is significant variation among different phosphor bronze formulations. The James Webb Space Telescope (JWST) will use several phosphor bronze wire harnesses containing a specific formulation (CDA 510, annealed temper). The heat conducted into the JWST instrument stage is dominated by these harnesses, and approximately half of the harness conductance is due to the phosphor bronze wires. Since the JWST radiators are expected to just keep the instruments at their operating temperature with limited cooling margin, it is important to know the thermal conductivity of the actual alloy being used. We describe an experiment which measured the electrical and thermal conductivity of this material between 4 and 295 Kelvin.

7 CFR 1710.406 - Loan approval.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the Administrator...

40 CFR 123.61 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process for...

Operational readiness review implementation plan for K Basin sludge water system

International Nuclear Information System (INIS)

IRWIN, R.M.

2003-01-01

This Implementation Plan (IP) has been prepared consistent with the requirements of U.S. Department of Energy (DOE) Order 425.1B, ''Startup and Restart of Nuclear Facilities'', and DOE-STD-3006-2000, ''Planning and Conduct of Operational Readiness Reviews'' (ORR) (DOE 2002). The scope of the DOE ORR is described in the RL ''Plan of Action, K Basin Sludge Water System'' (Veitenheimer 2003), prepared by DOE project line management and approved by the RL Manager, the designated Approval Authority, on March 20, 2003. The scope of the contractor ORR is described in the contractor ''Plan of Action for the K Basins Sludge Water System Operational Readiness Review'' (FH 2002a) which was prepared by Spent Nuclear Fuel (SNF) Project line management and approved by the DOE Richland Operations Office (RL) Manager on December 19, 2002. DOE Order 425.1B indicates that the Secretarial Officer is the Authorization Authority when substantial modifications are made to a Hazard Category 2 nuclear facility. This Authorization Authority has been delegated to the RL Manager by memorandum from Jessie Hill Roberson, dated February 5, 2003 (Roberson 2003). This IP provides the overall approach and guidelines for performance of the DOE ORR. Appendix A contains the Criteria and Review Approach Documents (CRAD), which define the review objectives and criteria as well as the approach for assessing each objective. ORR results will be published in a final report, as discussed in Section 9.4

76 FR 20598 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Control of Emissions of...

Science.gov (United States)

2011-04-13

... version of 3745-21-07 that is contained in Ohio's SIP. (K)(1)--Lists emission units subject to the control... approvable because it is consistent with the control requirements in the prior version of 3745-21-07 that is... control requirements in the prior version of 3745- 21-07 that is contained in Ohio's SIP. IV. Statutory...

40 CFR 52.1323 - Approval status.

Science.gov (United States)

2010-07-01

... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290 as.... (c) The Administrator approves Rule 10 CSR 10-2.230 as identified under § 52.1320, paragraph (c)(70... SIP would be the emission limits stated in the rule. (d) The Administrator approves Rule 10 CSR 10-5...

K-12 Schools: The Effect of Public School Choices on Marine Families’ Co-Location Decisions

Science.gov (United States)

2017-03-01

3. REPORT TYPE AND DATES COVERED Master’s thesis 4. TITLE AND SUBTITLE K-12 SCHOOLS: THE EFFECT OF PUBLIC SCHOOL CHOICES ON MARINE FAMILIES’ CO...be educated ? One theory regarding decision-making in general is the rational choice theory . This approach to explaining the process of making...NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release. Distribution is unlimited. K-12 SCHOOLS

21 CFR 510.106 - Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Labeling of antibiotic and antibiotic-containing... ANIMAL DRUGS Specific Administrative Rulings and Decisions § 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals. Whenever the labeling of an...

30 CFR 14.7 - Approval marking and distribution records.

Science.gov (United States)

2010-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.7 Approval marking and distribution records. (a) An approved conveyor belt must be marketed only under the name specified in the approval. (b) Approved conveyor belt must be legibly and...

Non-vitamin K antagonist oral anticoagulation agents in anticoagulant naïve atrial fibrillation patients

DEFF Research Database (Denmark)

Olesen, Jonas Bjerring; Sørensen, Rikke; Hansen, Morten Lock

2015-01-01

AIMS: Non-vitamin K antagonist oral anticoagulation (NOAC) agents have been approved for stroke prophylaxis in atrial fibrillation (AF). We investigated 'real-world' information on how these drugs are being adopted. METHODS AND RESULTS: Using Danish nationwide administrative registers, we identif...

Hairy Root Induction on Justicia gendarussa by Various Density of Agrobacterium rhizogenes strain LB 510

Directory of Open Access Journals (Sweden)

Dwi Kusuma Wahyuni

2017-04-01

Full Text Available Gandarusa (Justicia gendarussa Burm.f. is an Indonesian medicinal plant that has many benefits as drug and male contracetive. For industrial needs, Gandarusa must be  available in large quantity. Hairy root culture is one of methode to produce phytochemistry compound. The objective of the study was to examine the effect of various density of Agrobacterium rhizogenes strain LB510 on hairy roots induction of gandarusa (Justicia gendarussa Burm.f. leaf plant. Leaf explants were inoculated in MS liquid medium with various density of OD600 = 0.1; 0.2; 0.3; 0.4; and 0.5. Explants were co-cultivated for 2 days on MS solid medium without any hormone then sub-cultured on MS solid medium containing antibiotic cefotaxim 300 ppm, in dark condition. The data were analyzed descriptively and statistically. The results showed that various density of Agrobacterium rhizogenes strain LB510 was affected the lenght of hairy roots induction of J. gendarussa Burm.f., but these was not effected toward lenght formation time and number of hairy root. The treatment of OD600 0.2 was the best treatment for hairy root induction on Justicia gendarussa Burm. f. This data could be used for optimized the quality of methode of hairy root induction. 

Drugs Approved for Kidney (Renal Cell) Cancer

Science.gov (United States)

... Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Kidney (Renal Cell) Cancer Afinitor (Everolimus) Aldesleukin Avastin (Bevacizumab) Axitinib Bevacizumab Cabometyx ( ...

Fabrication of large diameter alumino-silicate K+ sources

International Nuclear Information System (INIS)

Baca, D.; Chacon-Golcher, E.; Kwan, J.W.; Wu, J.K.

2003-01-01

Alumino-silicate K + sources have been used in HIF experiments for many years. For example the Neutralized Transport Expt. (NTX) and the High Current Transport Expt. (HCX) are now using this type of ion source with diameters of 2.54 cm and 10 cm respectively. These sources have demonstrated ion currents of 80 mA and 700 mA, for typical HIF pulse lengths of 5-10 (micro)s. The corresponding current density is ∼ 10-15 mA/cm 2 , but much higher current density has been observed using smaller size sources. Recently we have improved our fabrication techniques and, therefore, are able to reliably produce large diameter ion sources with high quality emitter surface without defects. This note provides a detailed description of the procedures employed in the fabrication process. The variables in the processing steps affecting surface quality, such as substrate porosity, powder size distribution, coating technique on large area concave surfaces, drying, and heat firing temperature have been investigated

Structural distortions in 5-10 nm silver nanoparticles under high pressure

Energy Technology Data Exchange (ETDEWEB)

Koski, Kristie J.; Kamp, Noelle M.; Kunz, Martin; Knight, Jason K.; Alivisatos, A.P.; Smith, R.K.

2008-10-13

We present experimental evidence that silver nanoparticles in the size range of 5-10 nm undergo a reversible structural transformation under hydrostatic pressures up to 10 GPa. We have used x-ray diffraction with a synchrotron light source to investigate pressure-dependent and size-dependent trends in the crystal structure of silver nanoparticles in a hydrostatic medium compressed in a diamond-anvil cell. Results suggest a reversible linear pressure-dependent rhombohedral distortion which has not been previously observed in bulk silver. We propose a mechanism for this transition that considers the bond-length distribution in idealized multiply twinned icosahedral particles. To further support this hypothesis, we also show that similar measurements of single-crystal platinum nanoparticles reveal no such distortions.

Operational Readiness Review Implementation Plan for the K Basin Fuel Transfer System

International Nuclear Information System (INIS)

DAVIES, T.H.

2002-01-01

This implementation plan has been prepared to comply with the requirements of U.S. Department of Energy (DOE) Order 425.1A, Startup and Restart of Nuclear Facilities, and DOE-STD-3006-2000, Planning and Conduct of Operational Readiness Reviews (ORR) (DOE 2002). The scope of the ORR is described in the contractor K Basin Fuel Transfer System (FTS) Plan of Action (POA), which was prepared by Spent Nuclear Fuel (SNF) Project line management and approved by the DOE Richland Operations Office (RL) Manager on April 4, 2002 (FH 2002a). While the Project Hanford Management Contractor has been revised to include DOE Order 425.1B, the contractor implementing procedure, ''F-PRO-055, Startup Readiness (Revision 9) has not yet been approved by RL for contractor use. Appendix A provides a crosswalk between the requirements of DOE Order 425.1A and DOE Order 425.1B to show that all requirements of DOE 425.1B are covered by this implementation plan. DOE Order 425.1B indicates that the Secretarial Officer is the Authorization Authority when substantial modifications are made to a Hazard Category 2 nuclear facility. This Authorization Authority has been delegated to the RL Manager by memorandum from Jessie Hill Roberson, dated November 20, 2001 (Roberson 2001). The scope of the ORR is described in the RL Plan of Action, K Basin Fuel Transfer System, prepared by DOE project line management and approved by the RL Manager, the designated approval authority, on September 12, 2002 (Schlender 2002). This implementation plan provides the overall approach and guidelines for performance of the DOE ORR. Appendix B contains the Criteria and Review Approach Documents (CRAD), which define the review objectives and criteria as well as the approach for assessing each objective. ORR results will be published in a final report, as discussed in Section 9.4

Trial endpoints for drug approval in oncology: Chemoprevention.

Science.gov (United States)

Beitz, J

2001-04-01

As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

KEY COMPARISON: CCT-K2.1: NRC/VNIIFTRI bilateral comparison of capsule-type standard platinum resistance thermometers from 13.8 K to 273.16 K

Science.gov (United States)

Hill, K. D.; Steele, A. G.; Dedikov, Y. A.; Shkraba, V. T.

2005-01-01

The Consultative Committee for Thermometry Key Comparison 2 (CCT-K2) results were published two years ago (2002 Metrologia 39 551-71). NRC served as the pilot laboratory for CCT-K2 and remains able to provide a scale and measurement system suitable for performing bilateral comparisons linked to the original key comparison results. In March 2003, measurements of two VNIIFTRI 100 Ω capsule-style platinum resistance thermometers (CSPRTs), S/N 356 and 476, were undertaken to relate their local calibration to the results from the CCT-K2 exercise. The NRC Leeds and Northrup (L&N) CSPRT S/N 1872174 provides the link to the CCT-K2 results. The three CSPRTs were compared at the eight defining cryogenic temperatures of the International Temperature Scale of 1990 (ITS-90) in the range from 13.8033 K to 273.16 K. The reader is referred to the full text of the CCT-K2 report for a detailed explanation of the methodology employed for the comparison. Only the details unique to the measurements reported here will be addressed in this article. The NRC/VNIIFTRI bilateral comparison of capsule-style platinum resistance thermometers over the range 13.8 K to 273.16 K has revealed calibrations at VNIIFTRI to be in agreement with the KCRV of CCT-K2 within the expanded uncertainty for all temperatures of the comparison with the exception of the triple point of hydrogen at 13.8033 K. One of the two CSPRTs supplied by VNIIFTRI was found to be discrepant as revealed by differences at the triple point of water and at the lowest temperatures of the comparison, and was therefore excluded from further analysis. The linkage to the CCT-K2 data supports the evaluation of the VNIIFTRI CMCs in Appendix C of the KCDB. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCT, according to the provisions

Trends in global approvals of biotech crops (1992-2014).

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

40 CFR 52.2352 - Change to approved plan.

Science.gov (United States)

2010-07-01

... Utah's approved State Implementation Plan (SIP). This rule language pertains to State Sales Tax... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Change to approved plan. 52.2352... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Utah § 52.2352 Change to approved...

The Evolution of Approval Services.

Science.gov (United States)

Warzala, Martin

1994-01-01

Describes major developments in book approval plans used by academic libraries for acquisition and for information dissemination and document distribution services based on approval-like concepts. Topics addressed include publishers; marketing; the impact of library automation; value-added services; the economic climate; the influence of…

Approval plans issues and innovations

CERN Document Server

Katz, Linda S

2013-01-01

How can you, as an acquisition librarians, keep current on the output of hundreds of publishers? The answer, of course, is that you cannot. For over 30 years, approval plans have been used by librarians to acquire current titles, save staff time, and build core collections. Even today, these reasons seem appropriate, as libraries try to maintain up-to-date collections and control personnel and operating budgets. However, as shown in Approval Plans: Issues and Innovations, the use of approval plans is not so simple and straightforward; their use is subject to complex procedures and policies--an

48 CFR 750.7105 - Approving authorities.

Science.gov (United States)

2010-10-01

... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7105 Approving authorities. All authority to approve actions...

KEY COMPARISON: Final report on APMP.M.P-K6.1 pneumatic key comparison from 20 kPa to 105 kPa in gauge mode

Science.gov (United States)

Hung, Chen-Chuan; Jian, Wu; Changpan, Tawat

2009-01-01

This report describes the key comparison APMP.M.P-K6.1 among the three national metrology institutes, Center for Measurement Standards-ITRI (CMS-ITRI, Taiwan), SPRING Singapore and National Institute of Metrology (NIMT), in the pressure range from 20 kPa to 105 kPa in gas media and gauge mode executed during the period April 2003 to April 2004. This comparison was conducted by CMS-ITRI and was based on the calibration procedure of APMP pneumatic pressure comparison APMP.M.P-K6. We intended to link to the CCM.P-K6 key comparison through the APMP.M.P-K6 key comparison by using the proposed linkage method in the APMP.M.P-K6 key comparison to determine a linking factor that can transform the quantities measured in the APMP.M.P-K6.1 key comparison. All three participating institutes used pneumatic piston gauges as their pressure standards. The Ruska 2465 gas-operated piston-cylinder assembly TL-1409 used as transfer standard offered by CMS-ITRI was calibrated three times by the pilot institute during the comparison period and showed that it was very stable after evaluation. The comparison was conducted on the basis of cross-float experiments to determine the effective area of transfer standards from the national standards of three institutes. The comparison results (as shown in Table 6) were equivalent to the CCM.P-K6 comparison and the relative bilateral degrees of equivalence between two laboratories were smaller than 39.7 × 10-6 from 20 kPa to 105 kPa. These results showed all participating institutes measuring the same quantity in the whole pressure range lay within their expanded uncertainty with confidence level 95%. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCM, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

Vedolizumab: first global approval.

Science.gov (United States)

Poole, Raewyn M

2014-07-01

Vedolizumab [Entyvio(®) (US, Europe)], a humanized monoclonal antibody α4β7 integrin receptor antagonist, has been developed by Millennium Pharmaceuticals (d/b/a Takeda Pharmaceuticals International) for the treatment of ulcerative colitis and Crohn's disease. Vedolizumab has received its first global approval for the treatment of ulcerative colitis and Crohn's disease in the US, for use in adult patients with moderate-to-severe disease who have had an inadequate response, loss of response or intolerance to one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor-α inhibitor) or demonstrated dependence on corticosteroids. Vedolizumab has since been approved for ulcerative colitis and Crohn's disease in the EU, Norway, Iceland and Liechtenstein. This article summarizes the milestones in the development of vedolizumab leading to its first approval for the treatment of ulcerative colitis and Crohn's disease.

U. K. surface passenger transport sector. Energy consumption and policy options for conservation

Energy Technology Data Exchange (ETDEWEB)

Maltby, D; Monteath, I G; Lawler, K A

1978-12-01

Forecasts of U.K. energy consumption in this sector for four future scenarios based on different economic growth rates, energy prices, and energy conservation policies, show that by the year 2000, private transport will probably account for 76-94% of total energy consumption in surface passenger transport. A 33% increase in the average miles-per-gallon fuel consumption through technological improvements in private vehicles, conversion of private vehicles to diesel oil, additional fuel taxation equivalent to 25 or 50% fuel price increase, a 10% reduction in average car engine size (encouraged by taxation), and changes in public transport technology offer energy savings of about 20, 5-10, 6.3 or 12.5, 2-4, and 2%, respectively. There is considerable uncertainty about the outcome of these options.

19 CFR 115.55 - Termination of approval.

Science.gov (United States)

2010-04-01

... vehicle by a major repair or alteration of any of the essential features required in § 115.51. Repairs by... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Individual Road Vehicles § 115.55 Termination of approval. Approval of a road...

20 CFR 617.22 - Approval of training.

Science.gov (United States)

2010-04-01

.... Perkins Vocational and Applied Technology Education Act, and employers). (i) This means that training is...) Conditions for approval. Training shall be approved for an adversely affected worker if the State agency...) available for an adversely affected worker. (i) This means that for the worker for whom approval of training...

Ethical regulation on researches at Brazil: do we need the 510 Resolution?

Directory of Open Access Journals (Sweden)

Carlos Adriano Silva dos Santos

2018-02-01

Full Text Available Since 1996, with the implementation of the 196/96 National Health Council Resolution, Brazil has risen on the world stage as an important country with regard the regulatory aspect of research with human beings. New challenges, amendments and complements lead to a new Resolution, the 466/12. Since the implementation of 196/96 through to the present day with the 466/12, some groups of researchers in Social and Human Sciences displayed dissatisfaction with the Brazilian regulatory system and they proposed a new Resolution specific to research in the field of Social and Human Sciences. Thus, Resolution 510/16 was created. This article discusses if this Resolution is necessary.

SLUDGE BATCH 4 BASELINE MELT RATE FURNACE AND SLURRY-FED MELT RATE FURNACE TESTS WITH FRITS 418 AND 510 (U)

International Nuclear Information System (INIS)

Smith, M; Timothy Jones, T; Donald02 Miller, D

2007-01-01

Several Slurry-Fed Melt Rate Furnace (SMRF) tests with earlier projections of the Sludge Batch 4 (SB4) composition have been performed.1,2 The first SB4 SMRF test used Frits 418 and 320, however it was found after the test that the REDuction/OXidation (REDOX) correlation at that time did not have the proper oxidation state for manganese. Because the manganese level in the SB4 sludge was higher than previous sludge batches tested, the impact of the higher manganese oxidation state was greater. The glasses were highly oxidized and very foamy, and therefore the results were inconclusive. After resolving this REDOX issue, Frits 418, 425, and 503 were tested in the SMRF with the updated baseline SB4 projection. Based on dry-fed Melt Rate Furnace (MRF) tests and the above mentioned SMRF tests, two previous frit recommendations were made by the Savannah River National Laboratory (SRNL) for processing of SB4 in the Defense Waste Processing Facility (DWPF). The first was Frit 503 based on the June 2006 composition projections.3 The recommendation was changed to Frit 418 as a result of the October 2006 composition projections (after the Tank 40 decant was implemented as part of the preparation plan). However, the start of SB4 processing was delayed due to the control room consolidation outage and the repair of the valve box in the Tank 51 to Tank 40 transfer line. These delays resulted in changes to the projected SB4 composition. Due to the slight change in composition and based on preliminary dry-fed MRF testing, SRNL believed that Frit 510 would increase throughput in processing SB4 in DWPF. Frit 418, which was used in processing Sludge Batch 3 (SB3), was a viable candidate and available in DWPF. Therefore, it was used during the initial SB4 processing. Due to the potential for higher melt rates with Frit 510, SMRF tests with the latest SB4 composition (1298 canisters) and Frits 510 and 418 were performed at a targeted waste loading (WL) of 35%. The '1298 canisters

VCP5 VMware Certified Professional on vSphere 5 Study Guide Exam VCP-510

CERN Document Server

Atkinson, Brian

2012-01-01

The ideal study guide for candidates seeking the leading virtualization certification The VMware Certified Professional on vSphere 5 (VCP-510) is the most desired certification for virtualization professionals, and this study guide covers all the requirements. Skill in virtualization is a top priority for companies when hiring IT staff, and VMware skills are in high demand. Part of the highly acclaimed Sybex Study Guide series, this comprehensive book guides you through planning, installing, and upgrading ESXi; configuring networking, storage, and vCenter Server; deploying and managing virtual

30 CFR 75.1108 - Approved conveyor belts.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved conveyor belts. 75.1108 Section 75... Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1108 Approved conveyor belts. (a) Until December 31, 2009 conveyor belts placed in service in underground coal mines shall be: (1) Approved under...

45 CFR 1340.13 - Approval of applications.

Science.gov (United States)

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Approval of applications. 1340.13 Section 1340.13... NEGLECT PREVENTION AND TREATMENT PROGRAM CHILD ABUSE AND NEGLECT PREVENTION AND TREATMENT Grants to States § 1340.13 Approval of applications. (a) The Commissioner shall approve an application for an award for...

Development of K-Nearest Neighbour Regression Method in Forecasting River Stream Flow

Directory of Open Access Journals (Sweden)

Mohammad Azmi

2012-07-01

Full Text Available Different statistical, non-statistical and black-box methods have been used in forecasting processes. Among statistical methods, K-nearest neighbour non-parametric regression method (K-NN due to its natural simplicity and mathematical base is one of the recommended methods for forecasting processes. In this study, K-NN method is explained completely. Besides, development and improvement approaches such as best neighbour estimation, data transformation functions, distance functions and proposed extrapolation method are described. K-NN method in company with its development approaches is used in streamflow forecasting of Zayandeh-Rud Dam upper basin. Comparing between final results of classic K-NN method and modified K-NN (number of neighbour 5, transformation function of Range Scaling, distance function of Mahanalobis and proposed extrapolation method shows that modified K-NN in criteria of goodness of fit, root mean square error, percentage of volume of error and correlation has had performance improvement 45% , 59% and 17% respectively. These results approve necessity of applying mentioned approaches to derive more accurate forecasts.

Co-cultivation of mutant Penicillium oxalicum SAU(E)-3.510 and Pleurotus ostreatus for simultaneous biosynthesis of xylanase and laccase under solid-state fermentation.

Science.gov (United States)

Dwivedi, Pallavi; Vivekanand, V; Pareek, Nidhi; Sharma, Amit; Singh, Rajesh P

2011-10-01

Co-cultivation of mutant Penicillium oxalicum SAU(E)-3.510 and Pleurotus ostreatus MTCC 1804 was evaluated for the production of xylanase-laccase mixture under solid-state fermentation (SSF) condition. Growth compatibility between mutant P. oxalicum SAU(E)-3.510 and white rot fungi (P. ostreatus MTCC 1804, Trametes hirsuta MTCC 136 and Pycnoporus sp. MTCC 137) was analyzed by growing them on potato dextrose agar plate. Extracellular enzyme activities were determined spectrophotometrically. Under derived conditions, paired culturing of mutant P. oxalicum SAU(E)-3.510 and P. ostreatus MTCC 1804 resulted in 58% and 33% higher levels of xylanase and laccase production, respectively. A combination of sugarcane bagasse and black gram husk in a ratio of 3:1 was found to be the most ideal solid substrate and support for fungal colonization and enzyme production during co-cultivation. Maximum levels of xylanase (8205.31 ± 168.31 IU g(-1)) and laccase (375.53 ± 34.17 IU g(-1)) during SSF were obtained by using 4 g of solid support with 80% of moisture content. Furthermore, expressions of both xylanase and laccase were characterized during mixed culture by zymogram analysis. Improved levels of xylanase and laccase biosynthesis were achieved by co-culturing the mutant P. oxalicum SAU(E)-3.510 and P. ostreatus MTCC 1804. This may be because of efficient substrate utilization as compared to their respective monocultures in the presence of lignin degradation compounds because of synergistic action of xylanase and laccase. Understanding and developing the process of co-cultivation appears productive for the development of mixed enzyme preparation with tremendous potential for biobleaching. Copyright © 2011 Elsevier B.V. All rights reserved.

Comparison of API 510 pressure vessels inspection planning with API 581 risk-based inspection planning approaches

International Nuclear Information System (INIS)

Shishesaz, Mohammad Reza; Nazarnezhad Bajestani, Mohammad; Hashemi, Seyed Javad; Shekari, Elahe

2013-01-01

To ensure mechanical integrity, all pressure vessels shall be inspected at the intervals provided in inspection codes or based on a risk-based inspection (RBI) assessment. The RBI assessment may allow previously established inspection intervals to be extended. This paper describes the methodology, analysis and results of two RBI studies conducted on 293 pressure vessel components in two crude oil distillation units. Based on API RBI methodology in API 581 (2008), risk target concept was used for determining inspection dates. It was shown that when thinning is the major active damage, the RBI recommended intervals are as long as twice the API 510 intervals. This paper summarizes that, as a fundamental step in the risk calculation, RBI has a more defined methodology for evaluating equipment for multiple damage mechanisms and a more defined approach to specify the use of other inspection technologies beyond the traditional visual, ultrasonic, and radiography tests. -- Highlights: • RBI calculated inspection intervals are as long as twice of API 510 inspection code. • Two case studies verified the advantage of RBI in inspection planning. • RBI is a more reliable methodology when evaluating multiple damage mechanisms. • Damage factor calculations can be used for determining RSFa value in FFS assessments

27 CFR 5.55 - Certificates of label approval.

Science.gov (United States)

2010-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Approval of... certificates of label approval and certificates of exemption from label approval, as well as appeal procedures...

46 CFR 188.10-3 - Approved container.

Science.gov (United States)

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Approved container. 188.10-3 Section 188.10-3 Shipping... PROVISIONS Definition of Terms Used in This Subchapter § 188.10-3 Approved container. This term means a container which is properly labeled, marked and approved by DOT for the commodity which it contains. [CGFR...

Absorption-line detections of 10{sup 5}-10{sup 6} K gas in spiral-rich groups of galaxies

Energy Technology Data Exchange (ETDEWEB)

Stocke, John T.; Keeney, Brian A.; Danforth, Charles W.; Syphers, David; Yamamoto, H.; Shull, J. Michael; Green, James C.; Froning, Cynthia [Center for Astrophysics and Space Astronomy, Department of Astrophysical and Planetary Sciences, University of Colorado, 389 UCB, Boulder, CO 80309 (United States); Savage, Blair D.; Wakker, Bart; Kim, Tae-Sun [Department of Astronomy, University of Wisconsin, Madison, WI 53706 (United States); Ryan-Weber, Emma V.; Kacprzak, Glenn G., E-mail: john.stocke@colorado.edu [Centre for Astrophysics and Supercomputing, Swinburne University of Technology, VIC 3122 (Australia)

2014-08-20

Using the Cosmic Origins Spectrograph (COS) on the Hubble Space Telescope, the COS Science Team has conducted a high signal-to-noise survey of 14 bright QSOs. In a previous paper, these far-UV spectra were used to discover 14 'warm' (T ≥ 10{sup 5} K) absorbers using a combination of broad Lyα and broad O VI absorptions. A reanalysis of a few of this new class of absorbers using slightly relaxed fitting criteria finds as many as 20 warm absorbers could be present in this sample. A shallow, wide spectroscopic galaxy redshift survey has been conducted around these sight lines to investigate the warm absorber environment, which is found to be spiral-rich groups or cluster outskirts with radial velocity dispersions σ = 250-750 km s{sup –1}. While 2σ evidence is presented favoring the hypothesis that these absorptions are associated with the galaxy groups and not with the individual, nearest galaxies, this evidence has considerable systematic uncertainties and is based on a small sample size so it is not entirely conclusive. If the associations are with galaxy groups, the observed frequency of warm absorbers (dN/dz = 3.5-5 per unit redshift) requires them to be very extended as an ensemble on the sky (∼1 Mpc in radius at high covering factor). Most likely these warm absorbers are interface gas clouds whose presence implies the existence of a hotter (T ∼ 10{sup 6.5} K), diffuse, and probably very massive (>10{sup 11} M {sub ☉}) intra-group medium which has yet to be detected directly.

Electronic Approval of Invoices (AEF)

CERN Multimedia

2003-01-01

With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

Military Hearing Conservation Workshop Director Handbook,

Science.gov (United States)

1983-11-01

r HaigCnerainDrctrHnbo (b*T scp -asgnetsorrspniblt.s -:.--3 .’..................................................................an. HSHB-OB November...Approved Hearing Protective Devices and Related Equipment. a. Nonstandard. (NOT APPROVED). (I) Fingers (bi-digital earplugs). - - (2) Palms . (3...a) Single-flange (5-10 percent have different sizes between ears): () extra small (white) - 5 percent (ii) small (green) - 25 percent . oil . 5-26 9

Effect of Enzymatic Digestion of Protein Derivatives Obtained from Mucuna pruriens L. on Production of Proinflammatory Mediators by BALB/c Mouse Macrophages.

Science.gov (United States)

Martínez Leo, Edwin E; Arana Argáez, Victor E; Acevedo Fernández, Juan J; Puc, Rosa Moo; Segura Campos, Maira R

2018-04-25

Inflammation is considered to be a major risk factor for the pathogenesis of chronic non-communicable diseases. Macrophages are important immune cells, which regulate inflammation and host defense by secretion of proinflammatory mediators. Obtaining biopeptides by enzymatic hydrolysis adds value to proteins of vegetative origin, such as Mucuna pruriens L. The present study evaluated the effect of enzymatic digestion of protein derivatives obtained from M. pruriens L. on the production of proinflammatory mediators by BALB/c mouse macrophages. Five different molecular weight peptide fractions were obtained (F > 10, 5-10, 3-5, 1-3, and < 1 kDa, respectively). At 300 μg/mL, F5-10 kDa inhibited 50.26 and 61.00% NO and H 2 O 2 production, respectively. Moreover, F5-10 kDa reduced the IL-6 and TNFα levels to 60.25 and 69.54%, respectively. After enzymatic digestive simulation, F5-10 kDa decreased the inflammatory mediators.

Use of gold as monostandard for the determination of elemental concentrations in environmental SRMs and Ganga river sediments by the k0 method

International Nuclear Information System (INIS)

Ramakrishna, V.V.S.; Acharya, R.N.; Reddy, A.V.R.; Garg, A.N.

2001-01-01

Instrumental neutron activation analysis (INAA) using the k 0 method by employing gold as monostandard has been used for the determination of 18 elements (As, Ba, Br, Cl, Cr, Co, Cs, Dy, Fe, Hf, Ga, In, La, Mn, Na, Rb, Sc and Th) in standard reference materials (SRMs) of environmental origin and four sediment samples collected from the Ganga river in northern parts of India. Data obtained for SRMs agree within ±5-10% with the certified values for most elements. Merits and demerits of the k 0 method are discussed. An attempt has been made to identify the sources of heavy metal pollutants in the sediment samples and study the mobility pattern for toxic heavy metals originating from the tanneries along with the river flow

Trends in global approvals of biotech crops (1992–2014)

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

677C to T mutation in the 5,10-methylenetetrahydrofolate reductase (MTHFR) gene and plasma homocyst(e)ine levels in patients with TIA or minor stroke.

Science.gov (United States)

Lalouschek, W; Aull, S; Korninger, L; Mannhalter, C; Pabinger-Fasching, I; Schmid, R W; Schnider, P; Zeiler, K

1998-03-05

It was the aim of this study to determine the associations of clinical and laboratory data with plasma homocyst(e)ine levels in patients with transient ischemic attack (TIA) or minor stroke (MS), with special reference to their 677C to T mutation status in the 5,10-methylenetetrahydrofolate reductase (5,10-MTHFR) gene. Seventy-six patients with TIA or MS were investigated at least 3 months after their (last) clinical event. By means of univariate analysis, significant correlations of homocyst(e)ine levels with male gender (Pine levels. After adjustment for age, creatinine levels and homocyst(e)ine levels remained significantly correlated to each other (Pine levels was no longer significant (P=0.10). Mutation-positive patients exhibited moderately and statistically non-significantly higher homocyst(e)ine levels than mutation-negative patients, particularly those who were homozygous positive. Homocyst(e)ine levels were closely correlated with creatinine levels (Pine levels in patients with TIA or MS are dependent on the 5,10-MTHFR mutation status. Significant correlations between these variables were found only in mutation-positive but not in mutation-negative patients.

Evaluation of the Olympus AU-510 analyser.

Science.gov (United States)

Farré, C; Velasco, J; Ramón, F

1991-01-01

The selective multitest Olympus AU-510 analyser was evaluated according to the recommendations of the Comision de Instrumentacion de la Sociedad Española de Quimica Clinica and the European Committee for Clinical Laboratory Standards. The evaluation was carried out in two stages: an examination of the analytical units and then an evaluation in routine work conditions. The operational characteristics of the system were also studied.THE FIRST STAGE INCLUDED A PHOTOMETRIC STUDY: dependent on the absorbance, the inaccuracy varies between +0.5% to -0.6% at 405 nm and from -5.6% to 10.6% at 340 nm; the imprecision ranges between -0.22% and 0.56% at 405 nm and between 0.09% and 2.74% at 340 nm. Linearity was acceptable, apart from a very low absorbance for NADH at 340 nm; and the imprecision of the serum sample pipetter was satisfactory.TWELVE SERUM ANALYTES WERE STUDIED UNDER ROUTINE CONDITIONS: glucose, urea urate, cholesterol, triglycerides, total bilirubin, creatinine, phosphate, iron, aspartate aminotransferase, alanine aminotransferase and gamma-glutamyl transferase.The within-run imprecision (CV%) ranged from 0.67% for phosphate to 2.89% for iron and the between-run imprecision from 0.97% for total bilirubin to 7.06% for iron. There was no carryover in a study of the serum sample pipetter. Carry-over studies with the reagent and sample pipetters shows some cross contamination in the iron assay.

76 FR 76168 - Regulatory Site Visit Training Program

Science.gov (United States)

2011-12-06

... quality of its regulatory efforts and interactions, by providing CBER staff with a better understanding of... may include the following: (1) Packaging facilities, (2) quality control and pathology/toxicology...

76 FR 4919 - Regulatory Site Visit Training Program

Science.gov (United States)

2011-01-27

... quality of its regulatory efforts and interactions, by providing CBER staff with a better understanding of... may include the following: (1) Packaging facilities, (2) quality control and pathology/toxicology...

HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

Energy Technology Data Exchange (ETDEWEB)

Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

2007-05-15

The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

Analysis of the Education Program Approval Process: A Program Evaluation.

Science.gov (United States)

Fountaine, Charles A.; And Others

A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

Science.gov (United States)

2013-11-07

.... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

40 CFR 600.011-93 - Reference materials.

Science.gov (United States)

2010-07-01

... Density (Specific Gravity), or API Gravity of Crude Petroleum and Liquid Petroleum Products by Hydrometer... Petroleum and Liquid Petroleum Products by Hydrometer Method, IBR approved for §§ 600.113-93, 600.510-93...

76 FR 62072 - Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts...

Science.gov (United States)

2011-10-06

... Utilization of Science in Regulatory Decision Making (Task Force) and the 510(k) Working Group were... can take to enhance our 510(k) decision making. The Task Force was charged with making recommendations... technologies, and new scientific methods--into its decision making in as predictable a manner as is practical...

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

Science.gov (United States)

Mattingly, T Joseph; Simoni-Wastila, Linda

2017-10-01

Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

49 CFR 1522.109 - TSA review and approval.

Science.gov (United States)

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false TSA review and approval. 1522.109 Section 1522.109..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

49 CFR 1522.115 - Renewal of TSA approval.

Science.gov (United States)

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false Renewal of TSA approval. 1522.115 Section 1522.115..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

29 CFR 1952.157 - Changes to approved plan.

Science.gov (United States)

2010-07-01

... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS North Carolina § 1952.157 Changes to approved plan. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved North Carolina's... section 17 of the Act as amended on November 5, 1990. (2) [Reserved] (b) The Voluntary Protection Program...

48 CFR 2922.103-4 - Approvals.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Approvals. 2922.103-4 Section 2922.103-4 Federal Acquisition Regulations System DEPARTMENT OF LABOR SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2922.103-4 Approvals. The “agency...

38 CFR 21.7220 - Course approval.

Science.gov (United States)

2010-07-01

...) VOCATIONAL REHABILITATION AND EDUCATION All Volunteer Force Educational Assistance Program (Montgomery GI...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C...) Section 21.4265—Practical training approved as institutional training or on-job training; (10) Section 21...

Final report on COOMET Vickers PTB/VNIIFTRI key comparison (COOMET.M.H-K1.b and COOMET.M.H-K1.c)

Science.gov (United States)

Aslanyan, E.; Herrmann, K.

2013-01-01

This report describes a COOMET key comparison on Vickers hardness scales of two National Metrology Institutes—PTB and VNIIFTRI. The pilot laboratory was PTB, which was the linking institute with the key comparison reference values of CCM.H-K1. In the key comparison two sets of hardness reference blocks for the Vickers hardness scales HV1 and HV30, each consisting of three hardness reference blocks with the hardness levels 240 HV, 540 HV and 840 HV, are used. The same hardness reference blocks were used previously in the key comparison CCM.H-K1. The measurement results and uncertainty assessments, announced by VNIIFTRI, are in good agreement with the key comparison reference values of CCM.H-K1. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCM, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

33 CFR 115.70 - Advance approval of bridges.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges prior...

E-Approval Plans in Research Libraries

Science.gov (United States)

Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

2014-01-01

Research libraries have long invested in approval plan services, which offer an economical way to acquire scholarly and scientific publications. Traditional approval plans have evolved and now enable libraries to expand their e-book offerings to better serve researchers. Publishers offer a myriad of e-book purchasing options. These range from…

Premarket Approvals (PMA)

Data.gov (United States)

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

75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

Science.gov (United States)

2010-05-24

... proposal. This information is required for: (1) FHA lender approval, (2) Annual renewal of each FHA lender... following information: Title of Proposal: FHA Lender Approval, Annual Renewal, Periodic Updates and Required... and HUD-92001-C. Description of the Need for the Information and Its Proposed Use: This information is...

7 CFR 1710.105 - State regulatory approvals.

Science.gov (United States)

2010-01-01

... and Basic Policies § 1710.105 State regulatory approvals. (a) In States where a borrower is required... loans are approved by RUS: (1) Loans requiring an Environmental Impact Statement; (2) Loans to finance...

Perspectives used for gaining approval of budgets.

Science.gov (United States)

Franks-Joiner, G L

1990-01-01

Nurse executives think about problems using a certain perspective which may influence decisions on budgetary matters. The nurse executives' perspective used in decision-making may influence which budget proposals are developed and approved. A study was performed to determine the perspective used by nurse executives in decision-making on supplementary budget item proposals and whether perspective use influenced approval. Findings showed that use of the system view or dual-domain perspective in a proposal may enhance nurse executives' changes of gaining approval.

78 FR 2315 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-01-10

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 15402 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 11947 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-02-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 17281 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 16317 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 66909 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-11-07

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

77 FR 21143 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-09

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 25010 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

77 FR 34455 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-06-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55891 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55892 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 59239 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

Applying for ethical approval for research: the main issues.

Science.gov (United States)

Gelling, Leslie

2016-01-13

The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

Poet Marion Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

Poet Portland Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Alexandria Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Laddonia Approval

Science.gov (United States)

This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

Innovations in design and technology. The story of hip arthroplasty.

Science.gov (United States)

Amstutz, H C

2000-09-01

The current study reviews the early history of surgeon-initiated trial and error development in hip joint arthroplasty and the subsequent methodological evolution to proper criteria for hypothesis testing using bioengineers and other research scientists. The interplay and relationships to industry, universities, scientific organizations, and the Food and Drug Administration with respect to device development in hip arthroplasty are reviewed. The ethics of and responsibilities to involved parties are outlined, citing the history of many contemporary developments. Examples are provided from the evolution and introduction of unsuccessful innovations, and the problems inherent in the current methodology of the approval process from the Food and Drug Administration using the 5-10K, Investigative Device Exemption, and the Pre-Market Approval protocols. The pros and cons of randomized trials for devices are outlined with the conclusion that they are not appropriate for device introduction. The proper, rational methodology for introduction of new devices is a phased-in clinical trial process after pertinent bench testing. Finally, the ethical dilemmas created by managed care are addressed. Industry involvements of the surgeon-spokesmen are cited.

Poet Fostoria Approval

Science.gov (United States)

This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

Immunotherapy Combination Approved for Advanced Kidney Cancer

Science.gov (United States)

FDA has approved the combination of the immunotherapy drugs nivolumab (Opdivo) and ipilimumab (Yervoy) as an initial treatment for some patients with advanced kidney cancer. The approval is expected to immediately affect patient care, as this Cancer Currents post explains.

Energy Reflection Coefficients for 5-10 keV He Ions Incident on Au, Ag, and Cu

DEFF Research Database (Denmark)

Schou, Jørgen; Sørensen, H.; Littmark, U.

1978-01-01

The calorimetric deuterium-film method was used for measurements of the energy reflection coefficient γ for normal incidence of 5-10 keV He ions on Cu, Ag and Au. A theoretical calculation of γ by means of transport theory gives fair agreement with the experimental results. The experimental data...... the experimental and theoretical results for the He ions are in acceptable agreement with other experimental and theoretical results. For He ions, the experimental γ-values are 20-30% above the values for hydrogen ions for the same value of ε...

Poet Leipsic Approval

Science.gov (United States)

This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

Guidance for package approvals in the United Kingdom

International Nuclear Information System (INIS)

Morgan-Warren, E.J.

2004-01-01

Approval is required under the transport regulations for a wide range of package designs and operations, and applications for competent authority approval and validation are received from many sources, both in the UK and overseas. To assist package designers and applicants for approval, and to promote consistency in applications and their assessment, the UK Department for Transport issues guidance on the interpretation of the transport regulations and the requirements of an application for approval and its supporting safety case. The general guidance document, known as the Guide to an Application for UK Competent Authority Approval of Radioactive Material in Transport, has been issued for many years and updated to encompass the provisions of each successive edition of the IAEA transport regulations. The guide has been referred to in a number of international fora, including PATRAM, and was cited as a 'good practice' in the report of the IAEA TRANSAS appraisal of the UK in 2002. Specialist guides include the Guide to the Suitability of Elastomeric Seal Materials, which is the subject of a separate paper in this conference, and the Guide to the Approval of Freight Containers as Types IP-2 and IP-3 Packages. This paper discusses the guidance material and summarises the administrative and technical information required in support of applications for approval of package designs, special form and low-dispersible radioactive materials, shipments, special arrangements, modifications and validations. (author)

Tissue engineered constructs: perspectives on clinical translation.

Science.gov (United States)

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

2015-03-01

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

45 CFR 95.611 - Prior approval conditions.

Science.gov (United States)

2010-10-01

... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GENERAL ADMINISTRATION... for Department approval, signed by the appropriate State official, to the Director, Administration for... of procurement activities beyond that approved in the APD; (D) A change in system concept, or a...

Bilateral comparison of 10 kΩ standards (ongoing BIPM key comparison BIPM.EM-K13.b) between the NSAI-NML (Ireland) and the BIPM

Science.gov (United States)

Goebel, R.; Power, O.; Fletcher, N.; Stock, M.

2012-01-01

This report describes the results obtained from a NML(Ireland)-BIPM bilateral comparison of 10 kΩ resistance standards in 2010. The comparison was carried out in the framework of the BIPM ongoing key comparison BIPM.EM-K13.b. Two BIPM 10 kΩ travelling standards of SR104 type were calibrated first at the BIPM, then at the NMLI and again at the BIPM after their return. The stability of the transfer standards was such that the uncertainty associated with the transfer was significantly smaller than the uncertainty arising from the calibrations. The NMLI and the BIPM calibrations were found to be in agreement, with a mean difference smaller than the standard uncertainty of the comparison. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCEM, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

The Role of PI3K/Akt/mTOR Signaling in Gastric Carcinoma

International Nuclear Information System (INIS)

Matsuoka, Tasuku; Yashiro, Masakazu

2014-01-01

The phosphatidylinositol 3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathway is one of the key signaling pathways induced by various receptor-tyrosine kinases. Accumulating evidence shows that this pathway is an important promoter of cell growth, metabolism, survival, metastasis, and resistance to chemotherapy. Genetic alterations in the PI3K/Akt/mTOR pathway in gastric carcinoma have often been demonstrated. Many kinds of molecular targeting therapies are currently undergoing clinical testing in patients with solid tumors. However, with the exception of the ErbB2-targeting antibody, targeting agents, including PI3K/Akt/mTOR inhibitors, have not been approved for treatment of patients with gastric carcinoma. This review summarizes the current knowledge on PI3K/Akt/mTOR signaling in the pathogenesis of gastric carcinoma and the possible therapeutic targets for gastric carcinoma. Improved knowledge of the PI3K/Akt/mTOR pathway in gastric carcinoma will be useful in understanding the mechanisms of tumor development and for identifying ideal targets of anticancer therapy for gastric carcinoma

The Role of PI3K/Akt/mTOR Signaling in Gastric Carcinoma

Energy Technology Data Exchange (ETDEWEB)

Matsuoka, Tasuku [Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585 (Japan); Yashiro, Masakazu, E-mail: m9312510@med.osaka-cu.ac.jp [Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585 (Japan); Oncology Institute of Geriatrics and Medical Science, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585 (Japan)

2014-07-07

The phosphatidylinositol 3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathway is one of the key signaling pathways induced by various receptor-tyrosine kinases. Accumulating evidence shows that this pathway is an important promoter of cell growth, metabolism, survival, metastasis, and resistance to chemotherapy. Genetic alterations in the PI3K/Akt/mTOR pathway in gastric carcinoma have often been demonstrated. Many kinds of molecular targeting therapies are currently undergoing clinical testing in patients with solid tumors. However, with the exception of the ErbB2-targeting antibody, targeting agents, including PI3K/Akt/mTOR inhibitors, have not been approved for treatment of patients with gastric carcinoma. This review summarizes the current knowledge on PI3K/Akt/mTOR signaling in the pathogenesis of gastric carcinoma and the possible therapeutic targets for gastric carcinoma. Improved knowledge of the PI3K/Akt/mTOR pathway in gastric carcinoma will be useful in understanding the mechanisms of tumor development and for identifying ideal targets of anticancer therapy for gastric carcinoma.

Design and approval of EPS diesel systems in German NPP

Energy Technology Data Exchange (ETDEWEB)

Kollmer, A.A., E-mail: anton.kollmer@tuev-sued.de [TUV SUD Industrie Service GmbH, Munich (Germany)

2014-07-01

Not at least because of 'Fukushima accident', Emergency power supply (EPS) systems with diesel engines are regarded as higher safety-important as 20 years ago. This presentation shows the design and approval of the emergency power facilities of the German nuclear power plants. It deals with the essential details e. g.: EPS Diesel integration to main power grid of the German BWR and PWR; Procedure for 'Loss of off-site power (LOOP)-Design'; Design robustness of AC Power Supply (Design requirements: independent redundancies, airplane crash, explosion pressure wave, earth-quake); Cooling systems (chilled by river water, air, well water, stored water volume); Layout of the stationary emergency Diesel generator (fuel supply, starting system); Layout of the bunkered EDG with directly driven emergency feed water pump; Robustness of AC power supply beyond design; Layout of mobile chilling equipment for diesel engines; Layout of mobile Diesel gen-sets (200 kVA and 1250 kVA); German Requirements of KTA 3702 versus US-IEE 323; Construction, Materials and Testing of EDG; Maintenance (in-service inspections, operation, Repair); Lessons learned (e. g. crank house cracks, start failure due to too much oil in the combustion chamber) (author)

8 CFR 207.6 - Control over approved refugee numbers.

Science.gov (United States)

2010-01-01

... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Control over approved refugee numbers. 207... ADMISSION OF REFUGEES § 207.6 Control over approved refugee numbers. Current numerical accounting of approved refugees is maintained for each special group designated by the President. As refugee status is...

47 CFR 400.5 - Approval and award.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Approval and award. 400.5 Section 400.5 Telecommunication NATIONAL TELECOMMUNICATIONS AND INFORMATION ADMINISTRATION, DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E-911 GRANT PROGRAM § 400.5 Approval...

13 CFR 302.18 - Post-approval requirements.

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Post-approval requirements. 302.18 Section 302.18 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE... Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply with...

ORKA: Measurement of the $K^ \\to \\pi^+ \

Energy Technology Data Exchange (ETDEWEB)

Comfort, Joseph; /Arizona State U.; Bryman, Douglas; Doria, Luca; Numao, Toshio; Sher, Aleksey; Vavilov, Dimitry; /British Columbia U. /TRIUMF; Jaffe, David; Kettell, Steve; Littenberg, Laurence; Worcester, Elizabeth; /Brookhaven; Bellantoni, Leo; /Fermilab /Illinois U., Urbana /INFN, Naples /INFN, Pisa /Moscow, INR /Dubna, JINR /Northern British Columbia U. / /Mexico U. /San Luis Potosi U.

2011-11-28

A high precision measurement of the ultra-rare K{sup +} {yields} {pi}{sup +} {nu}{bar {nu}} decay at Fermilab would be one of the most incisive probes of quark flavor physics this decade. Its dramatic reach for uncovering new physics is due to several important factors: (1) The branching ratio is sensitive to most new physics models which extend the Standard Model to solve its considerable problems. (2) The Standard Model predictions for the K{sup +} {yields} {pi}{sup +} {nu}{bar {nu}} and K{sub L}{sup 0} {yields} {pi}{sup 0} {nu}{bar {nu}} branching fractions are broadly recognized to be theoretically robust at the 5-10% level. Only a precious few accessible loop-dominated quark processes can be predicted with this level of certainty. (3) The K{sup +} {yields} {pi}{sup +} {nu}{bar {nu}} branching fraction is highly suppressed in the Standard Model to the level < 10{sup -10} (<1 part in 10 billion). This suppression allows physics beyond the Standard Model to contribute dramatically to the branching fraction with enhancements of up to factors of 5 above the Standard Model level. (4) The certainty with which the Standard Model contribution to K{sup +} {yields} {pi}{sup +} {nu}{bar {nu}} can be predicted will permit a 5{sigma} discovery potential for new physics even for enhancements of the branching fraction as small as 35%. This sensitivity is unique in quark flavor physics and allows probing of essentially all models of new physics that couple to quarks within the reach of the LHC. Furthermore, a high precision measurement of K{sup +} {yields} {pi}{sup +} {nu}{bar {nu}} is sensitive to many models of new physics with mass scales well beyond the direct reach of the LHC. The experimental challenge of suppressing backgrounds to enable measurement of K{sup +} {yields} {pi}{sup +} {nu}{bar {nu}} at the 1 in 10-billion Standard Model rate has been met successfully. Several events of K{sup +} {yields} {pi}{sup +} {nu}{bar {nu}} decay have been clearly observed at BNL by

12 CFR 614.4470 - Loans subject to bank approval.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loans subject to bank approval. 614.4470 Section 614.4470 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS Loan Approval Requirements § 614.4470 Loans subject to bank approval. (a) The following loans...

Cross Sections for the Reactions e+e to K+ K- pi+pi-, K+ K- pi0pi0, and K+ K- K+ K- Measured Using Initial-State Radiation

Energy Technology Data Exchange (ETDEWEB)

Lees, J.P.; Poireau, V.; Prencipe, E.; Tisserand, V.; /Annecy, LAPP; Garra Tico, J.; Grauges, E.; /Barcelona U., ECM; Martinelli, M.; /INFN, Trieste /Trieste U.; Milanes, D.A.; /INFN, Trieste /Trieste U.; Palano, A.; /INFN, Trieste /Trieste U.; Pappagallo, M.; /INFN, Trieste /Trieste U. /INFN, Bari /Bari U. /Bari U. /INFN, Bari; Eigen, G.; Stugu, B.; Sun, L.; /Bergen U.; Brown, D.N.; Kerth, L.T.; Kolomensky, Yu.G.; Lynch, G.; Osipenkov, I.L.; /LBL, Berkeley /UC, Berkeley; Koch, H.; Schroeder, T.; /Ruhr U., Bochum; Asgeirsson, D.J.; /British Columbia U. /Brunel U. /Novosibirsk, IYF /UC, Irvine /UC, Riverside /UC, Santa Barbara /UC, Santa Cruz /Caltech /Cincinnati U. /Colorado U. /Colorado State U. /Dortmund U. /Dresden, Tech. U. /Ecole Polytechnique /Edinburgh U. /INFN, Trieste /INFN, Trieste /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Ferrara /Ferrara U. /Frascati /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Genoa /Genoa U. /Indian Inst. Tech., Guwahati /Harvard U. /Harvey Mudd Coll. /Heidelberg U. /Humboldt U., Berlin /Imperial Coll., London /Iowa State U. /Iowa State U. /Johns Hopkins U. /Orsay, LAL /LLNL, Livermore /Liverpool U. /Queen Mary, U. of London /Royal Holloway, U. of London /Louisville U. /Mainz U., Inst. Kernphys. /Manchester U., Comp. Sci. Dept. /Maryland U. /Massachusetts U., Amherst /MIT /McGill U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Milan /Milan U. /Mississippi U. /Montreal U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Naples /Naples U. /NIKHEF, Amsterdam /Notre Dame U. /Ohio State U. /Oregon U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Trieste /INFN, Trieste /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Padua /Padua U. /Paris U., VI-VII /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Perugia /Perugia U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Pisa /Princeton U. /INFN, Trieste /INFN, Trieste /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /INFN, Trieste /INFN, Trieste /INFN, Rome /Rome U. /Rostock U. /Rutherford /DAPNIA, Saclay /SLAC /South Carolina U. /Southern Methodist U. /Stanford U., Phys. Dept. /SUNY, Albany /Tel Aviv U. /Tennessee U. /Texas U. /Texas U., Dallas /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Turin /Turin U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /INFN, Trieste /Trieste U. /Valencia U., IFIC /Victoria U. /Warwick U. /Wisconsin U., Madison

2011-08-19

We study the processes e{sup +}e{sup -} {yields} K{sup +}K{sup -}{pi}{sup +}{pi}-{gamma}, K{sup +}K{sup -}{pi}{sup 0}{pi}{sup 0}{gamma}, and K{sup +}K{sup -}K{sup +}K{sup -}{gamma}, where the photon is radiated from the initial state. About 84000, 8000, and 4200 fully reconstructed events, respectively, are selected from 454 fb{sup -1} of BABAR data. The invariant mass of the hadronic final state defines the e{sup +}e{sup -} center-of-mass energy, so that the K{sup +}K{sup -}{pi}{sup +}{pi}{sup -}{gamma} data can be compared with direct measurements of the e{sup +}e{sup -} {yields} K{sup +}K{sup -}{pi}{sup +}{pi}{sup -} reaction. No direct measurements exist for the e{sup +}e{sup -} {yields} K{sup +}K{sup -}{pi}{sup 0}{pi}{sup 0} or e{sup +}e{sup -} {yields} K{sup +}K{sup -}K{sup +}K{sup -} reactions, and we present an update of our previous result with doubled statistics. Studying the structure of these events, we find contributions from a number of intermediate states, and extract their cross sections. In particular, we perform a more detailed study of the e{sup +}e{sup -} {yields} {phi}(1020){pi}{pi}{gamma} reaction, and confirm the presence of the Y (2175) resonance in the {phi}(1020)f{sub 0}(980) and K{sup +}K{sup -} f{sub 0}(980) modes. In the charmonium region, we observe the J/{psi} in all three final states and in several intermediate states, as well as the {phi}(2S) in some modes, and measure the corresponding branching fractions.

48 CFR 52.222-16 - Approval of Wage Rates.

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2010-10-01

... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Approval of Wage Rates. 52....222-16 Approval of Wage Rates. As prescribed in 22.407(b), insert the following clause: Approval of Wage Rates (FEB 1988) All straight time wage rates, and overtime rates based thereon, for laborers and...

7 CFR 1717.609 - RUS approval of general manager.

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2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of general manager. 1717.609 Section... Operational Controls § 1717.609 RUS approval of general manager. (a) If a borrower's mortgage or loan contract... general manager of the borrower's system, such approval is hereby granted provided that the borrower is in...

28 CFR 551.11 - Authority to approve a marriage.

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2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Authority to approve a marriage. 551.11... MISCELLANEOUS Marriages of Inmates § 551.11 Authority to approve a marriage. (a) The Warden may approve the marriage of a federal inmate confined in a federal institution. This authority may not be delegated below...

42 CFR 424.510 - Requirements for enrolling in the Medicare program.

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2010-10-01

... change the organization's enrollment information; (D) Be an individual that has an ownership or control interest in the organization or is a W-2 managing employee as defined in section 1126(b) of the Act; and (E... and suppliers seeking accreditation from a CMS-approved accreditation organization as specified in...

2016 in review: FDA approvals of new molecular entities.

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Griesenauer, Rebekah H; Kinch, Michael S

2017-11-01

An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

24 CFR 886.107 - Approval of applications.

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2010-04-01

...) The Owner's Affirmative Fair Housing Marketing Plan is approvable. (b) The HUD-approved unit rents are... climatic or geological conditions or local codes are examples which may justify such variations. (d) A... neighborhood in a substantially adverse manner. Examples of such adverse effects are (1) substantial move-outs...

78 FR 72893 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

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2013-12-04

..., including Source Plasma, unlicensed registered blood establishments, and transfusion services, who had... blood components including Source Plasma; (3) unlicensed registered blood establishments; (4... currently accept electronic filings) further streamlines the report submission process. CBER developed a Web...

75 FR 27347 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Science.gov (United States)

2010-05-14

... human blood and blood components, including Source Plasma; an unlicensed registered blood establishment... and blood components including Source Plasma, unlicensed registered blood establishments, transfusion... accept electronic filings) further streamlines the report submission process. CBER has developed an...

New Breast Cancer Treatment Approved | NIH MedlinePlus the Magazine

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... Breast Cancer Treatment Approved Follow us New Breast Cancer Treatment Approved Photo: Wikimedia Commons IN THE NEWS - Breast ... Food and Drug Administration approved a new breast cancer treatment that aims to reduce the risk of the ...

FDA approves efavirenz. Food and Drug Administration.

Science.gov (United States)

Highleyman, L

1998-10-01

The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

Accelerated approval of oncology products: the food and drug administration experience.

Science.gov (United States)

Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

2011-04-20

We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

14 CFR 21.8 - Approval of articles.

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2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

48 CFR 1819.7203 - Mentor approval process.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Mentor approval process... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

Supplement to CCM.D-K4 'Hydrometer' report: linkage of EURAMET.M.D-K4 comparison, SIM.M.D-K4 comparison and the supplementary SIM.M.D-S2 to CCM.D-K4 'Hydrometer'

Science.gov (United States)

Lorefice, S.; Becerra, L. O.

2017-01-01

Evaluation of different types of comparisons to a common set of reference values of a CIPM key comparison is essential to satisfy the concept of the CIPM Mutual Recognition Arrangement (CIPM MRA), where the DoEs of any participant who took part in comparisons should be within the Calibration and Measurement Capability (CMC) section of the CIPM MRA Key Comparison Data Base. The subject of this supplementary report is therefore to present the equivalence of each National Metrological Institute (NMI) participant in the CCM.D-K4 'Hydrometer' key comparison, which was performed in the density range 600 kg/m3 to 2000 kg/m3 at the temperature of 20 °C, and the linkage of the European and Inter-American NMI results performed in the RMO.M.D-K4 comparisons as well as those of the supplementary SIM.M.D-S2 to the common set of KCRVs of the CCM.D-K4 'Hydrometer'. The linking procedure has been obtained by numerical simulation, based on the Monte Carlo method, in which the differences in the results of the different comparison between the intended laboratory and one or more linking laboratory/ies, which took part in both comparisons, are correlated with a continuous function describing the DoEs of the linking laboratory/ies with respect to the common set of KCRVs of the CCM.D-K4. Main text To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCM, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

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

Science.gov (United States)

2013-03-04

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

[Reporting ethics board approval in German medical theses and journals].

Science.gov (United States)

Zenz, Michael; Zenz, Julia; Grieger, Maximilian

2018-06-05

Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

27 CFR 4.50 - Certificates of label approval.

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2010-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Approval of Labels of... of exemption from label approval, as well as appeal procedures, see part 13 of this chapter. [T.D...

14 CFR 21.609 - Approval for deviation.

Science.gov (United States)

2010-01-01

... deviation. (a) Each manufacturer who requests approval to deviate from any performance standard of a TSO shall show that the standards from which a deviation is requested are compensated for by factors or... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval for deviation. 21.609 Section 21...

Ordinal Position, Approval Motivation, and Interpersonal Attraction

Science.gov (United States)

Nowicki, Stephen, Jr.

1971-01-01

Results of the study suggest that birth-order effects might be included within the wider framework of approval-dependency theory. Females tend to account for a significant share of birth-order effects. More particularly, firstborn females accounted for much of the differences in expressed attraction as well as need for social approval. (Author)

Drugs Approved for Neuroblastoma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

42 CFR 102.73 - Approval of benefits.

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2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Approval of benefits. 102.73 Section 102.73 Public... PROGRAM Secretarial Determinations § 102.73 Approval of benefits. When the Secretary has determined that benefits will be paid to a requester and has calculated the type and amount of such benefits, he will...

76 FR 66117 - Projects Approved for Consumptive Uses of Water

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2011-10-25

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... notice lists the projects, described below, receiving approval for the consumptive use of water pursuant...

76 FR 53526 - Projects Approved for Consumptive Uses of Water

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2011-08-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... lists the projects, described below, receiving approval for the consumptive use of water pursuant to the...

76 FR 42159 - Projects Approved for Consumptive Uses of Water

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2011-07-18

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... lists the projects, described below, receiving approval for the consumptive use of water pursuant to the...

77 FR 4859 - Projects Approved for Consumptive Uses of Water

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2012-01-31

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... notice lists the projects, described below, receiving approval for the consumptive use of water pursuant...

Introducing a Global Optical Model Approach for Analysing 16O+16O Elastic Scattering at 5-10MeV/nucleon Region

Directory of Open Access Journals (Sweden)

Mehmet Küçükoğlu

2013-06-01

Full Text Available Abstract: In this paper, the experimental data on elastic scattering of the 16O+16O reaction for the energy range 5-10 MeV/nucleon have been analyzed within the optical model (OM formalism by using the phenomenological potential forms in Fresco code. When developing the shape of the nuclear potential for the calculations, we have used the Woods-Saxon (WS or Woods-Saxon squared (WS2 potentials for the imaginary part together with a WS2 type real part. Although most of the previous OM analyses using phenomenological potentials have provided reasonably good fits with the experimental measurements, none of them could completely relate the behavior of the imaginary potential to the energy of the projectile yet. However, we have managed to introduce two analyses that can keep the real potential parameters almost constant and suggest a linear expression for the depth of the imaginary part of the nuclear potential depending on the incidence energy. Thus, 16O+16O system within this wide energy range has been described globally by the optical potentials having a deep, attractive real potential part and a weaker, energy dependent absorptive imaginary potential part. It has been also shown that, our calculations with these potential forms can reproduce the experimental elastic scattering angular distributions successfully and the maxima and minima are predicted correctly for most of the energies. Key words: 16O+16O reaction, optical model, elastic scattering, cross-section, phenomenological potentials. 5-10MeV/nükleon Bölgesinde 16O+16O Esnek Saçılmasının Analizi için Global bir Optik Model Yaklaşımının Tanıtılması Özet: Bu çalışmada 5-10 MeV/nükleon enerji aralığında 16O+16O reaksiyonunun deneysel esnek saçılma verileri, optik model (OM formalizmi altında, Fresco kodunda fenomenolojik potansiyel formları kullanılarak analiz edilmektedir. Hesaplamalar için nükleer potansiyelin şekli oluşturulurken gerçel kısım için Woods

46 CFR 184.510 - Recommended emergency broadcast instructions.

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2010-10-01

... NAME), (INSERT VESSEL'S NAME), (INSERT VESSEL'S CALL SIGN), OVER.” (5) Release the microphone button... VESSEL'S NAME & CALL SIGN).” (14) If your situation permits, stand by the radio to await further... 2182 kHz. (Channel 16 VHF and 2182 kHz on SSB are for emergency and calling purposes only.) (3) Press...

Drugs Approved for Retinoblastoma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Time-dependent Dalitz-Plot Analysis of the Charmless Decay B^0 -> K^0S Pi Pi- at BABAR

Energy Technology Data Exchange (ETDEWEB)

Ilic, J

2009-10-17

A time-dependent amplitude analysis of B{sup 0} {yields} K{sub S}{sup 0}{pi}{sup +}{pi}{sup -} decays is performed in order to extract the CP violation parameters of f{sub 0}(980)K{sub S}{sup 0} and {rho}{sup 0}(770)K{sub S}{sup 0} and direct CP asymmetries of K*{sup +}(892){pi}{sup -}. The results are obtained from the final BABAR data sample of (465 {+-} 5)10{sup 6} B{bar B} decays, collected with the BABAR detector at the PEP-II asymmetric-energy B factory at SLAC. The time dependent CP asymmetry for f{sub 0}(980)K{sub S}{sup 0} and {rho}{sup 0}(770)K{sub S}{sup 0} are measured to be S(f{sub 0}(980)K{sub S}{sup 0}) = -0.97 {+-} 0.09 {+-} 0.01 {+-} 0.01, and S({rho}{sup 0}(770)K{sub S}{sup 0}) = 0.67 {+-} 0.20 {+-} 0.06 {+-} 0.04, respectively. In decays to K*{sup +}(892){pi}{sup -} the direct CP asymmetry is found to be A{sub CP}(K*{sup {+-}}(892){pi}{sup {-+}}) = -0.18 {+-} 0.10 {+-} 0.04 {+-} 0.00. The relative phases between B{sup 0} {yields} K*{sup +}(892){pi}{sup -} and {bar B}{sup 0} {yields} K*{sup -}(892){pi}{sup +}, relevant for the extraction of the unitarity triangle angle {gamma}, is measured to be {Delta}{phi}(K*(892){pi}) = (34.9 {+-} 23.1 {+-} 7.5 {+-} 4.7){sup o}, where uncertainties are statistical, systematic and model-dependent, respectively. Fit fractions, direct CP asymmetries and the relative phases of different other resonant modes have also been measured. A new method for extracting longitudinal shower development information from longitudinally unsegmented calorimeters is also presented. This method has been implemented as a part of the BABAR final particle identification algorithm. A significant improvement in low momenta muon identification at BABAR is obtained.

The approval mechanism solves the prisoner's dilemma theoretically and experimentally

OpenAIRE

Tatsuyoshi Saijo; Yoshitaka Okano; Takafumi Yamakawa

2015-01-01

Consider a situation where players in a prisoner's dilemma game can approve or reject the other's choice such as cooperation or defection. If both players approve the other's choice, the outcome is the one they chose, whereas if either one rejects the other's choice, the outcome is the one when both defect, which we name the approval mechanism herein (this is inspired by the Cold War doctrine of mutually assured destruction). Experimentally, we find that the cooperation rate with the approval...

REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

International Nuclear Information System (INIS)

Markman, D.W.

1999-01-01

Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

76 FR 58029 - Agency Information Collection Activities: Form N-600K, Extension of a Currently Approved...

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2011-09-19

... DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information... ACTION: 30-Day Notice of Information Collection Under Review: Form N- 600K; Application for Citizenship and Issuance of Certificate under Section 322. The Department of Homeland Security, U.S. Citizenship...

Comparison of a new adrenal scanning agent, 6-methyl-75Se-selenomethyl-19-norcholest-5(10)-en-3beta-ol(75Se-Scintadren) and 6beta-iodomethyl-19-norcholest-5(10)-en-3beta-ol(131I-Adosterol)

International Nuclear Information System (INIS)

Seto, Hikaru; Futatsuya, Ryusuke; Mori, Hirofumi; Koizumi, Kiyoshi; Hisada, Kinichi

1979-01-01

Tissue distribution study in rats and adrenal uptake in humans were carried out with 6 methyl- 75 Se-selenomethyl-19-norcholest-5(10)-en-3β-ol ( 75 Se-Scintadren) and 6β-iodomethyl-19-norcholest-5(10)-en-3β-ol ( 131 I-Adosterol). At Day 7, concentration of 75 Se-Scintadren in the adrenals was 8.9% kg dose/gm, which is approximately 40% of 131 I-Adosterol and adrenal-to-liver concentration ratio was about 30% of 131 I-Adosterol in rats. From the rat data and sequential adrenal uptake measurement in humans, it is recommended to take human adrenal images at 5 days later after a dose administration. However there are several advantages of 75 Se-Scintadren versus 131 I-Adosterol. On the contrary to the rat data, adrenal uptake in humans was calculated about 0.20 - 0.41% dose, which is nearly as same as that, of 131 I-Adosterol. Furthermore, counting efficiency of 75 Se with a scinitillation camera is 2.3 times that of 131 I. The advantages are as follows: (1) Administered dose can be reduced one-fourth of 131 I-Adosterol. (2) Estimated absorbed doses of adrenals were 99.8 rads/mCi extrapolated from the rat data and 31.6 - 63.2 rads/mCi from the human data, which are significantly less than that of 131 I-Adosterol per administered dose. (3) No thyroid-blocking is required. (4) Shelf-life is longer than that of 131 I-Adosterol. (author)

77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

Science.gov (United States)

2012-11-29

...] Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy... Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,'' dated November... Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this...

76 FR 26305 - Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To...

Science.gov (United States)

2011-05-06

... to satisfy the previously mentioned statutory requirement. The importance of obtaining these data.... Marketing Applications/Submissions In 2010, CDER and CBER received 165 new drug applications (NDA... ANDA marketing applications and submissions. It is assumed that the sponsor/applicant/submitter has...

42 CFR 8.6 - Withdrawal of approval of accreditation bodies.

Science.gov (United States)

2010-10-01

... PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Accreditation § 8.6 Withdrawal of approval of... 42 Public Health 1 2010-10-01 2010-10-01 false Withdrawal of approval of accreditation bodies. 8.6... to establish that the problems that were grounds for withdrawal of approval have been resolved. (2...

Establishment approval in international trade of animal products

NARCIS (Netherlands)

Rau, M.L.; Ge, L.; Valeeva, N.I.; Wagenberg, van C.P.A.

2012-01-01

This report provides an overview of different approaches of establishment approval as well as its implementation and organisation in international agrifood trade. The focus is on animal products as establishment approval is particularly used for exporting these products. Based on trade data, 8

Poet North Manchester Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

Psychometric properties of the Korean version of the Interpersonal Sensitivity Measure (IPSM-K).

Science.gov (United States)

Lee, Kyoung-Uk; Jung, Na Young; Rauch, Sheila A M; Chae, Jeong Ho; Lee, Hae-Kook; Kweon, Yong-Sil; Lee, Chung Tai

2013-10-01

The aim of this study was to investigate the psychometric properties of a Korean version of Interpersonal Sensitivity Measure (IPSM). A Korean version of the IPSM (IPSM-K) was produced through forward translation, reconciliation, and back translation. A total of 338 healthy, non-clinical participants were selected through screening and clinical interview, and they each were given a set of questionnaires including IPSM-K. All subscales, as well as a full-scale IPSM-K showed satisfactory internal consistency (Cronbach's alpha=0.73-0.83 and 0.94, respectively). Test-retest reliability at 2-week intervals was significant, with coefficient r ranging between .80 and .94. In terms of convergent validity, IPSM-K showed the significant positive correlation with sociotropy and autonomy subscale of Personal Style Inventory-II, as well as with neuroticism subscale of Neuroticism Extraversion Openness-Personality Inventory. IPSM-K had no correlation with Social Desirability Scale, thus demonstrated divergent validity with social desirability. A factor analysis of the scale was conducted and five factors emerged (low self-confidence, interpersonal awareness, lack of assertiveness/separation anxiety, interpersonal vulnerability, and need for approval). This study demonstrated that IPSM-K could be useful in assessing interpersonal sensitivity in Korean population. Crown Copyright © 2013. Published by Elsevier Inc. All rights reserved.

Cognitive Properties of Approval Voting : an Experimental Approach

Directory of Open Access Journals (Sweden)

Krzysztof Przybyszewski

2011-01-01

Full Text Available The paper summarizes two series of experiments demonstrating the cognitive properties of approval voting. The former series is devoted to mental processes induced in decision makers who use the method of approval voting. Based on cognitive effort, the use of choice strategies is presented in this paper. The observations of respondents show that most of them use relatively effortless strategy of eliminating alternatives and attributes. Few respondents use more sophisticated methods. The other series of experiments analyses the number of alternatives chosen in approval voting. It appears that the average number is not constant, even for similar votes but it depends on the subject of voting. The number of chosen alternatives and the subjective significance of the scope of voting are negatively or positively correlated in the case of special votes. The analyzed experiments show that the cognitive properties of approval voting have a diverse structure. (original abstract

7 CFR 1717.159 - Applications for RUS approvals of mergers.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Applications for RUS approvals of mergers. 1717.159... ELECTRIC LOANS Mergers and Consolidations of Electric Borrowers § 1717.159 Applications for RUS approvals of mergers. If a proposed merger requires RUS approval according to RUS regulations and/or the loan...

30 CFR 250.119 - Will MMS approve subsurface gas storage?

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Will MMS approve subsurface gas storage? 250....119 Will MMS approve subsurface gas storage? The Regional Supervisor may authorize subsurface storage of gas on the OCS, on and off-lease, for later commercial benefit. To receive MMS approval you must...

76 FR 6493 - Notice of Intent to Prepare an Environmental Impact Statement for the Proposed K Road/Moapa Band...

Science.gov (United States)

2011-02-04

... Impact Statement for the Proposed K Road/Moapa Band of Paiute Indians Photovoltaic Solar Facility, Clark... U.S.C. 415, is the BIA approval of a solar energy ground lease and associated agreements entered... proposed solar generation facility to an existing substation on a transmission line with a rating up to 500...

75 FR 36301 - Review and Approval of Projects

Science.gov (United States)

2010-06-25

... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY... document contains proposed rules that would amend the project review regulations of the Susquehanna River... the scope of withdrawals requiring review and approval; improve notice procedures for all project...

Editorial: Ethics approval: responsibilities of journal editors, authors ...

African Journals Online (AJOL)

Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply ...

29 CFR 1952.10 - Requirements for approval of State posters.

Science.gov (United States)

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

42 CFR 422.256 - Review, negotiation, and approval of bids.

Science.gov (United States)

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Review, negotiation, and approval of bids. 422.256... Information and Plan Approval § 422.256 Review, negotiation, and approval of bids. (a) Authority. Subject to... submitted under § 422.252 and conduct negotiations with MA organizations regarding these bids (including the...

Linaclotide: first global approval.

Science.gov (United States)

McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

2012-11-12

Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

A drug's life: the pathway to drug approval.

Science.gov (United States)

Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

2013-10-01

In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

Development of heart failure is independent of K+ channel-interacting protein 2 expression

DEFF Research Database (Denmark)

Speerschneider, Tobias; Grubb, Søren; Metoska, Artina

2013-01-01

of the transient outward K(+) current (Ito). We aim to investigate the possible significance of a changed KChIP2 expression on the development of HF and proarrhythmia. Transverse aortic constrictions (TAC) and sham operations were performed in wild-type (WT) and KChIP2(-/-) mice. Echocardiography was performed......(-/-) mice. Ventricular protein expression of KChIP2 was reduced by 70% after 10 weeks TAC in WT mice. The amplitudes of the J and T waves were enlarged in KChIP2(-/-) control mice. Ventricular effective refractory period, RR, QRS and QT intervals were longer in mice with HF compared to sham-operated mice...... of either genotype. Pacing-induced ventricular tachycardia (VT) was observed in 5/10 sham-operated WT mice compared with 2/10 HF WT mice with HF. Interestingly, and contrary to previously published data, sham-operated KChIP2(-/-) mice were resistant to pacing-induced VT resulting in only 1/10 inducible mice...

Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

Data.gov (United States)

U.S. Department of Health & Human Services — The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on...

44 CFR 78.9 - Planning grant approval process.

Science.gov (United States)

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

7 CFR 1703.121 - Approved purposes for grants.

Science.gov (United States)

2010-01-01

... Approved purposes for grants. For distance learning and telemedicine projects, grants shall finance only... studies relating to the establishment or expansion of the phase of the project that is being financed with... initial capital assets associated with the project. The following are approved grant purposes: (a...

Dabrafenib Plus Trametinib Approved for Melanoma, Thyroid Cancer

Science.gov (United States)

FDA recently approved the combination of dabrafenib (Taflinar) and trametinib (Mekinist) to treat some patients with melanoma and anaplastic thyroid cancer whose tumors have a mutation in the BRAF gene. As this Cancer Currents blog post explains, this is the first treatment approved specifically for anaplastic thyroid

Drugs Approved for Leukemia

Science.gov (United States)

This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Poet Lake Crystal Approval

Science.gov (United States)

This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

76 FR 4360 - Guidance for Industry on Process Validation: General Principles and Practices; Availability

Science.gov (United States)

2011-01-25

... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug...] Guidance for Industry on Process Validation: General Principles and Practices; Availability AGENCY: Food... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

75 FR 54351 - Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop

Science.gov (United States)

2010-09-07

...] Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop AGENCY: Food and Drug... Biologics Evaluation and Research (CBER) is announcing a public workshop entitled ``Cell and Gene Therapy... Institutional Review Boards (IRBs), gene and cellular therapy clinical researchers, and other stakeholders...

22 CFR 96.63 - Renewal of accreditation or approval.

Science.gov (United States)

2010-04-01

... for renewal in a timely fashion. Before deciding whether to renew the accreditation or approval of an... accrediting entity or the Secretary during its most current accreditation or approval cycle, the accrediting...

Clone of EPA Approved Regulations in the Texas SIP

Science.gov (United States)

changed name to EPA Approved Regulations in the Texas SIP, Add links to:Texas Read Me; Texas SIP History;Current/Previous SIP-Approved Regulations; Delete regulations--now in /node/191099, removed tables

CORN, LP Goldfield Approval

Science.gov (United States)

This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

The ratio Φ→K+K-/K0 anti K0

International Nuclear Information System (INIS)

Bramon, A.; Lucio, M.J.L.

2000-01-01

The ratio Φ→K + K - /K 0 K 0 is discussed and its present experimental value is compared with theoretical expectations. A difference larger than two standard deviations is observed. It is critically examined a number of mechanisms that could account for this discrepancy, which remains unexplained. Measurements at DAΦNE at the level of the per mille accuracy can clarify whether there exist any anomaly

Avelumab: First Global Approval.

Science.gov (United States)

Kim, Esther S

2017-05-01

Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

5 CFR 1320.16 - Delegation of approval authority.

Science.gov (United States)

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Delegation of approval authority. 1320.16... PAPERWORK BURDENS ON THE PUBLIC § 1320.16 Delegation of approval authority. (a) OMB may, after complying... delegation of review authority shall be made unless the agency demonstrates to OMB that the Senior Official...

Waste Feed Delivery Environmental Permits and Approvals Plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

2000-01-01

This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches

34 CFR 668.144 - Application for test approval.

Science.gov (United States)

2010-07-01

... quantitative skills; (9) If a test has been revised from the most recent edition approved by the Secretary, an... Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY... inquiries; (3) Each edition and form of the test for which the publisher requests approval; (4) The...

50 CFR 37.22 - Approval of exploration plan.

Science.gov (United States)

2010-10-01

... § 37.21(b), the Regional Director shall promptly publish notice of the application and text of the plan... exploration plan shall be approved by the Regional Director if he determines that it satisfies the....11(b), or minimize adverse impacts on subsistence uses, the Regional Director may approve or...

7 CFR 319.8-11 - From approved areas of Mexico.

Science.gov (United States)

2010-01-01

... 7 Agriculture 5 2010-01-01 2010-01-01 false From approved areas of Mexico. 319.8-11 Section 319.8... Conditions for the Entry of Cotton and Covers from Mexico § 319.8-11 From approved areas of Mexico. (a) Entry... in, and which were produced and handled only in approved areas of Mexico 5 may be authorized through...

A Good Year: FDA Approved Nine New Cancer Drugs in 2014

Science.gov (United States)

In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

38 CFR 21.9765 - Program of education approval.

Science.gov (United States)

2010-07-01

... education offered by an institution of higher learning if that program of education is approved under 38 U.S... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21...

Waste Feed Delivery Environmental Permits and Approvals Plan

Energy Technology Data Exchange (ETDEWEB)

TOLLEFSON, K.S.

2000-01-18

This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches.

Drugs Approved for Rhabdomyosarcoma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

KEY COMPARISON: Report on the Regional Comparison COOMET.AUV.A-K3

Science.gov (United States)

Barrera-Figueroa, Salvador; Nielsen, Lars; Rasmussen, Knud

2007-01-01

COOMET.AUV.A-K3 is a Regional Comparison that supplements the Key Comparison CCAUV.A-K3 organized by the CCAUV. The participating NMIs are GUM (Poland), INM (Romania), VNIIFTRI (Russia) and DP-NDI 'Systema' (Ukraine). The role of Pilot laboratory was undertaken by DPLADFM (Denmark). The measurements took place between May 2005 and February 2006. The time schedule was organized in a single star configuration. Initially, two LS2aP microphones were circulated. However, a sudden change of sensitivity of one of them forced the inclusion of an additional microphone. Nevertheless, the analysis was performed on all microphones involved. This report includes the measurement results from the participants, information about their calibration methods, and the analysis leading to the assignation of degrees of equivalence and the link to the CCAUV.A-K3. Main text. To reach the main text of this paper, click on Final Report. The final report has been peer-reviewed and approved for publication by the CCAUV, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

Why should ethics approval be required prior to publication of health promotion research?

Science.gov (United States)

Newson, Ainsley J; Lipworth, Wendy

2015-12-01

Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

Science.gov (United States)

2011-04-01

... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

Science.gov (United States)

2010-06-22

... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...

42 CFR 410.142 - CMS process for approving national accreditation organizations.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false CMS process for approving national accreditation... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving national accreditation organizations. (a) General rule. CMS may approve and recognize a nonprofit or not...

Comparison of thermal properties of fish collagen and bovine collagen in the temperature range 298-670K.

Science.gov (United States)

Gauza-Włodarczyk, Marlena; Kubisz, Leszek; Mielcarek, Sławomir; Włodarczyk, Dariusz

2017-11-01

The increased interest in fish collagen is a consequence of the risk of exposure to Creutzfeld-Jacob disease (CJD) and the bovine spongiform encephalopathy (BSE), whose occurrence is associated with prions carried by bovine collagen. Collagen is the main biopolymer in living organisms and the main component of the skin and bones. Until the discovery of the BSE, bovine collagen had been widely used. The BSE epidemic increased the interest in new sources of collagen such as fish skin collagen (FSC) and its properties. Although the thermal properties of collagen originating from mammals have been well described, less attention has been paid to the thermal properties of FSC. Denaturation temperature is a particularly important parameter, depending on the collagen origin and hydration level. In the reported experiment, the free water and bound water release processes along with thermal denaturation process were studied by means of the differential scanning calorimetry (DSC). Measurements were carried out using a DSC 7 instrument (Elmer-Perkin), in the temperature range 298-670K. The study material was FSC derived by acidic hydration method. The bovine Achilles tendon (BAT) collagen type I was used as the control material. The thermograms recorded revealed both, exothermic and endothermic peaks. For both materials, the peaks in the temperature range of 330-360K were assigned to the release of free water and bound water. The denaturation temperatures of FSC and BAT collagen were determined as 420K and 493K, respectively. Thermal decomposition process was observed at about 500K for FSC and at about 510K for BAT collagen. These results show that FSC is less resistant to high temperature than BAT collagen. Copyright © 2017 Elsevier B.V. All rights reserved.

Neratinib: First Global Approval.

Science.gov (United States)

Deeks, Emma D

2017-10-01

Neratinib (Nerlynx™) is an oral, irreversible inhibitor of the human epidermal growth factor receptors HER1 (EGFR), HER2 and HER4. The drug originally arose from research by Wyeth (now Pfizer) and is now being developed by Puma Biotechnology primarily for the treatment of HER2-positive (HER+) breast cancer. Neratinib is approved in the USA for the extended adjuvant treatment of patients with HER2+ early-stage breast cancer who have been previously treated with a trastuzumab-based adjuvant regimen, and is in the preregistration phase for this indication in the EU. Neratinib, as monotherapy and/or combination therapy, is also in phase 3 development for metastatic breast cancer and in phase 1/2 development for advanced breast cancer and other solid tumours, including non-small cell lung cancer, colorectal cancer and glioblastoma. This article summarizes the milestones in the development of neratinib leading to this first approval for breast cancer.

30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

Science.gov (United States)

2010-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES... having jurisdiction at the mine where such equipment is to be operated stating the modifications which...

Final report on CCQM-K27.2: Second Subsequent study: determination of ethanol in aqueous media

Science.gov (United States)

Schantz, Michele M.; Parris, Reenie M.; May, Willie E.; Rosso, Adriana; Puglisi, Celia; Marques Rodrigues Caixeiro, Janaína; Massiff, Gabriela; Camacho Frías, Evangelina; Pérez Urquiza, Melina; Archer, Marcellé; Visser, M. S.; deVos, Betty-Jayne

2013-01-01

Ethanol is important both forensically ('drunk driving' or driving while under the influence, 'DWI', regulations) and commercially (alcoholic beverages). Blood- and breath-alcohol testing can be imposed on individuals operating private vehicles such as cars, boats or snowmobiles, or operators of commercial vehicles like trucks, planes and ships. The various levels of blood alcohol that determine whether these operators are considered legally impaired vary depending on the circumstances and locality. Accurate calibration and validation of instrumentation is critical in areas of forensic testing where quantitative analysis directly affects the outcome of criminal prosecutions, as is the case with the determination of ethanol in blood and breath. Additionally, the accurate assessment of the alcoholic content of beverages is a commercially important commodity. In 2002, the CCQM conducted a key comparison (CCQM-K27) for the determination of ethanol in aqueous matrix with nine participants. A report on this project has been approved by the CCQM and can be found at the BIPM website. CCQM-K27 comprised three samples, one at low mass fraction of ethanol in water (nominal concentration of 0.8 mg/g), one at high level (nominal concentration of 120 mg/g) and one wine matrix (nominal concentration of 81 mg/g). Overall agreement among eight participants using gas chromatography with flame ionization detection (GC-FID), titrimetry, isotope dilution gas chromatography/mass spectrometry (GC-IDMS) and gas chromatography-combustion-isotope ratio mass spectrometry (ID-GC-C-IRMS) was good. The ninth participant used a headspace GC-FID method that had not been validated in an earlier pilot study (CCQM-P35). A follow-on key comparison, CCQM-K27-Subsequent, was initiated in 2003 to accommodate laboratories that had not been ready to benchmark their methods in the original CCQM-K27 study or that wished to benchmark a different method. Four levels of ethanol in water were used in the

Miracle drug: Brazil approves never-tested cancer medicine.

Science.gov (United States)

Kuchenbecker, Ricardo S; Mota, Daniel M

2017-07-01

Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.

Metal artifact correction for x-ray computed tomography using kV and selective MV imaging.

Science.gov (United States)

Wu, Meng; Keil, Andreas; Constantin, Dragos; Star-Lack, Josh; Zhu, Lei; Fahrig, Rebecca

2014-12-01

The overall goal of this work is to improve the computed tomography (CT) image quality for patients with metal implants or fillings by completing the missing kilovoltage (kV) projection data with selectively acquired megavoltage (MV) data that do not suffer from photon starvation. When both of these imaging systems, which are available on current radiotherapy devices, are used, metal streak artifacts are avoided, and the soft-tissue contrast is restored, even for regions in which the kV data cannot contribute any information. Three image-reconstruction methods, including two filtered back-projection (FBP)-based analytic methods and one iterative method, for combining kV and MV projection data from the two on-board imaging systems of a radiotherapy device are presented in this work. The analytic reconstruction methods modify the MV data based on the information in the projection or image domains and then patch the data onto the kV projections for a FBP reconstruction. In the iterative reconstruction, the authors used dual-energy (DE) penalized weighted least-squares (PWLS) methods to simultaneously combine the kV/MV data and perform the reconstruction. The authors compared kV/MV reconstructions to kV-only reconstructions using a dental phantom with fillings and a hip-implant numerical phantom. Simulation results indicated that dual-energy sinogram patch FBP and the modified dual-energy PWLS method can successfully suppress metal streak artifacts and restore information lost due to photon starvation in the kV projections. The root-mean-square errors of soft-tissue patterns obtained using combined kV/MV data are 10-15 Hounsfield units smaller than those of the kV-only images, and the structural similarity index measure also indicates a 5%-10% improvement in the image quality. The added dose from the MV scan is much less than the dose from the kV scan if a high efficiency MV detector is assumed. The authors have shown that it is possible to improve the image quality of

75 FR 29803 - Agency Information Collection Activity Seeking OMB Approval

Science.gov (United States)

2010-05-27

... Turbine Engine Powered Airplanes. Type of Request: Extension without change of a currently approved....S. EPA pollution requirements in lieu of searching through extensive paper records. ADDRESSES...

Drugs Approved for Pancreatic Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Lung Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Bladder Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Electronic Voucher Approval - Financial Management

Data.gov (United States)

US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...

30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...

The FDA approved PI3K inhibitor GDC-0941 enhances in vitro the anti-neoplastic efficacy of Axitinib against c-myc-amplified high-risk medulloblastoma.

Science.gov (United States)

Ehrhardt, Michael; Craveiro, Rogerio B; Velz, Julia; Olschewski, Martin; Casati, Anna; Schönberger, Stefan; Pietsch, Torsten; Dilloo, Dagmar

2018-04-01

Aberrant receptor kinase signalling and tumour neovascularization are hallmarks of medulloblastoma development and are both considered valuable therapeutic targets. In addition to VEGFR1/2, expression of PDGFR α/β in particular has been documented as characteristic of metastatic disease correlating with poor prognosis. Therefore, we have been suggested that the clinically approved multi-kinase angiogenesis inhibitor Axitinib, which specifically targets these kinases, might constitute a promising option for medulloblastoma treatment. Indeed, our results delineate anti-neoplastic activity of Axitinib in medulloblastoma cell lines modelling the most aggressive c-myc-amplified Non-WNT/Non-SHH and SHH-TP53-mutated tumours. Exposure of medulloblastoma cell lines to Axitinib results in marked inhibition of proliferation and profound induction of cell death. The differential efficacy of Axitinib is in line with target expression of medulloblastoma cells identifying VEGFR 1/2, PDGFR α/β and c-kit as potential markers for drug application. The high specificity of Axitinib and the consequential low impact on the haematopoietic and immune system render this drug ideal multi-modal treatment approaches. In this context, we demonstrate that the clinically available PI3K inhibitor GDC-0941 enhances the anti-neoplastic efficacy of Axitinib against c-myc-amplified medulloblastoma. Our findings provide a rational to further evaluate Axitinib alone and in combination with other therapeutic agents for the treatment of most aggressive medulloblastoma subtypes. © 2018 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

12 CFR 918.5 - Approval by Finance Board.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Approval by Finance Board. 918.5 Section 918.5 Banks and Banking FEDERAL HOUSING FINANCE BOARD GOVERNANCE AND MANAGEMENT OF THE FEDERAL HOME LOAN BANKS BANK DIRECTOR COMPENSATION AND EXPENSES § 918.5 Approval by Finance Board. Payments made to directors in compliance with the limits on annual...

Drugs Approved for Esophageal Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Kaposi Sarcoma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Skin Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Vulvar Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Bone Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Malignant Mesothelioma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Endometrial Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Is It Really FDA Approved?

Science.gov (United States)

... satisfaction before companies can market them in interstate commerce. Some examples of biologics that require approval are ... it means the agency has determined that the benefits of the product outweigh the known risks for ...

78 FR 70306 - Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use...

Science.gov (United States)

2013-11-25

... Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401...: Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug... Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448...

75 FR 35493 - Guidance for Industry on Systemic Lupus Erythematosus-Developing Medical Products for Treatment...

Science.gov (United States)

2010-06-22

...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD...-0002, 301- 796-2280; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM- 17), Food...

78 FR 49528 - Consolidation of Wound Care Products Containing Live Cells

Science.gov (United States)

2013-08-14

...] Consolidation of Wound Care Products Containing Live Cells AGENCY: Food and Drug Administration, HHS. ACTION... certain wound care products containing live cells from the Center for Devices and Radiological Health... CDRH and CBER. FDA believes that as more wound care products containing live cells are developed such...

75 FR 32786 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Science.gov (United States)

2010-06-09

... follow specific procedures to submit information to FDA of any changes, in the product, production... feasible (or based on evidence of effectiveness from studies in animals). Section 601.93 provides that... an Antibiotic Drug for Human Use'' to harmonize application procedures between CBER and CDER. The...

Drugs Approved for Liver Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Drugs Approved for Penile Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Acceptability of biscuits containing 10% cricket (Acheta domesticus) compared to milk biscuits among 5-10-year-old Kenyan schoolchildren

DEFF Research Database (Denmark)

Homann, A M; Ayieko, M A; Konyole, S O

2017-01-01

of the study was to develop a recipe for cricket biscuits suitable for school feeding programmes and test acceptability of the biscuits in Kenyan schoolchildren, in comparison with a similar biscuit with milk. The study was randomised and parallel. Fifty-four children aged 5-10 years were served 100 g (range...... 98-102 g) biscuits containing either 10% cricket powder or 10% milk powder during school days for four weeks. At baseline anthropometry (weight, height, mid upper arm circumference) was measured and information on insect consumption and allergies collected. Daily, weight of biscuits eaten...

75 FR 20401 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change, and...

Science.gov (United States)

2010-04-19

.... Proposed NYSE Amex Equities Rule 510 (Derivative Securities Products) The Exchange also proposes some... derivative securities products,'' as defined in Rule 19b-4(e) under the Act and traded pursuant to Rule 19b-4.../or approved by the Commission for the generic trading of derivative securities products based on...

K70Q adds high-level tenofovir resistance to "Q151M complex" HIV reverse transcriptase through the enhanced discrimination mechanism.

Directory of Open Access Journals (Sweden)

Atsuko Hachiya

2011-01-01

Full Text Available HIV-1 carrying the "Q151M complex" reverse transcriptase (RT mutations (A62V/V75I/F77L/F116Y/Q151M, or Q151Mc is resistant to many FDA-approved nucleoside RT inhibitors (NRTIs, but has been considered susceptible to tenofovir disoproxil fumarate (TFV-DF or TDF. We have isolated from a TFV-DF-treated HIV patient a Q151Mc-containing clinical isolate with high phenotypic resistance to TFV-DF. Analysis of the genotypic and phenotypic testing over the course of this patient's therapy lead us to hypothesize that TFV-DF resistance emerged upon appearance of the previously unreported K70Q mutation in the Q151Mc background. Virological analysis showed that HIV with only K70Q was not significantly resistant to TFV-DF. However, addition of K70Q to the Q151Mc background significantly enhanced resistance to several approved NRTIs, and also resulted in high-level (10-fold resistance to TFV-DF. Biochemical experiments established that the increased resistance to tenofovir is not the result of enhanced excision, as K70Q/Q151Mc RT exhibited diminished, rather than enhanced ATP-based primer unblocking activity. Pre-steady state kinetic analysis of the recombinant enzymes demonstrated that addition of the K70Q mutation selectively decreases the binding of tenofovir-diphosphate (TFV-DP, resulting in reduced incorporation of TFV into the nascent DNA chain. Molecular dynamics simulations suggest that changes in the hydrogen bonding pattern in the polymerase active site of K70Q/Q151Mc RT may contribute to the observed changes in binding and incorporation of TFV-DP. The novel pattern of TFV-resistance may help adjust therapeutic strategies for NRTI-experienced patients with multi-drug resistant (MDR mutations.

Hyapproval : final handbook for approval of hydrogen refuelling stations

NARCIS (Netherlands)

Wurster, R.; Landinger, H.; Machens, C.; Allidières, L.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.

2006-01-01

HyApproval is an EC co-financed Specific Targeted Research Project (STREP) to develop a Handbook facilitating the approval of Hydrogen Refuelling Stations (HRS). The project, started in October 2005, will be performed over 24 months by a balanced partnership including 25 partners from industry, SMEs

38 CFR 21.4263 - Approval of flight training courses.

Science.gov (United States)

2010-07-01

..., and aircraft identification number; (xi) An accounts receivable ledger; (xii) Individual instructor... higher learning are the only entities that can offer flight courses. A State approving agency may approve a flight course only if a flight school or an institution of higher learning offers the course. A...

Drugs Approved for Vaginal Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Nonperturbative-transverse-momentum effects and evolution in dihadron and direct photon-hadron angular correlations in p+p collisions at √s = 510 GeV

Czech Academy of Sciences Publication Activity Database

Adare, A.; Aidala, C.; Ajitanand, N.N.; Tomášek, Lukáš; Vrba, Václav

2017-01-01

Roč. 95, č. 7 (2017), s. 1-19, č. článku 072002. ISSN 2470-0010 Institutional support: RVO:68378271 Keywords : Drell-Yan process * fragmentation * quantum chromodynamics * factorization * violation * PYTHIA * PHENIX * 510 GeV-cms Subject RIV: BF - Elementary Particles and High Energy Physics OBOR OECD: Particles and field physics Impact factor: 4.568, year: 2016

Colourings of (k-r,k-trees

Directory of Open Access Journals (Sweden)

M. Borowiecki

2017-01-01

Full Text Available Trees are generalized to a special kind of higher dimensional complexes known as \\((j,k\\-trees ([L. W. Beineke, R. E. Pippert, On the structure of \\((m,n\\-trees, Proc. 8th S-E Conf. Combinatorics, Graph Theory and Computing, 1977, 75-80], and which are a natural extension of \\(k\\-trees for \\(j=k-1\\. The aim of this paper is to study\\((k-r,k\\-trees ([H. P. Patil, Studies on \\(k\\-trees and some related topics, PhD Thesis, University of Warsaw, Poland, 1984], which are a generalization of \\(k\\-trees (or usual trees when \\(k=1\\. We obtain the chromatic polynomial of \\((k-r,k\\-trees and show that any two \\((k-r,k\\-trees of the same order are chromatically equivalent. However, if \\(r\

Bilateral comparison of 1 Ω and 10 kΩ standards (ongoing BIPM key comparisons BIPM.EM-K13.a and 13.b) between the NSAI NML (Ireland) and the BIPM

Science.gov (United States)

Rolland, B.; Fletcher, N.; Power, O.

2017-01-01

This report gives the result of a bilateral comparison of resistance between the NSAI NML (Ireland) and the BIPM carried out in 2014-2015. Two 1 Ω and two 10 kΩ travelling standards belonging to the BIPM were used. The comparison was carried out with an 'A-B-A' pattern of measurements; the standards were measured first at the BIPM for a period of about one month, then for a similar period at the NSAI-NML, and finally again at the BIPM. The measurand was the 4 terminal dc resistance at low power. The BIPM was the pilot laboratory, and the comparison forms part of the ongoing BIPM key comparisons BIPM.EM-K13.a (for 1 Ω) and BIPM.EM-K13b (for 10 kΩ). The results from the NSAI NML and the BIPM were found to be in good agreement, with a difference smaller than the relative expanded uncertainties (95% confidence, k = 2) of 0.16 × 10-6 for 1 Ω and 0.42 × 10-6 for 10 kΩ. Main text To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCEM, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

7 CFR 1735.62 - Approval of acquisitions and mergers.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval of acquisitions and mergers. 1735.62 Section 1735.62 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE... Mortgage Controls on Acquisitions and Mergers § 1735.62 Approval of acquisitions and mergers. (a) If a...

5 CFR 7401.102 - Prior approval for outside employment.

Science.gov (United States)

2010-01-01

... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE MERIT SYSTEMS PROTECTION BOARD § 7401.102 Prior approval... written approval from the employee's supervisor and the concurrence of the Designated Agency Ethics... name of the employer or organization; (ii) The nature of the legal activity or other work to be...

40 CFR 1068.510 - How do I prepare and apply my remedial plan?

Science.gov (United States)

2010-07-01

... service identified by brand, trade, or corporate name unless we approved this approach with your original... other changes you will make to correct the affected engines/equipment. (3) A brief description of the... will determine the owners' names and addresses. (6) How you will notify owners; include copies of any...

Reporting ethics committee approval in public administration research.

Science.gov (United States)

Jordan, Sara R; Gray, Phillip W

2014-03-01

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

77 FR 48167 - Approved Tribal-State Class III Gaming Compact; Indian Gaming

Science.gov (United States)

2012-08-13

... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Approved Tribal--State Class III Gaming Compact; Indian Gaming AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice of Approved Tribal--State Class III Gaming Compact. SUMMARY: This notice publishes an approval of the gaming compact between...

75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2010-11-22

... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... for the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18...

Comparative study of cyanotoxins affecting cytoskeletal and chromatin structures in CHO-K1 cells.

Science.gov (United States)

Gácsi, Mariann; Antal, Otilia; Vasas, Gábor; Máthé, Csaba; Borbély, György; Saker, Martin L; Gyori, János; Farkas, Anna; Vehovszky, Agnes; Bánfalvi, Gáspár

2009-06-01

In this study we compared the effects of the two frequently occuring and most dangerous cyanobacterial toxins on the cellular organization of microfilaments, microtubules and on the chromatin structure in Chinese hamster ovary (CHO-K1) cells. These compounds are the widely known microcystin-LR (MC-LR) and cylindrospermopsin (CYN) classified as the highest-priority cyanotoxin. Toxic effects were tested in a concentration and time dependent manner. The hepatotoxic MC-LR did not cause significant cytotoxicity on CHO-K1 cells under 20 microM, but caused apoptotic changes at higher concentrations. Apoptotic shrinkage was associated with the shortening and loss of actin filaments and with a concentration dependent depolymerization of microtubules. No necrosis was observed over the concentration range (1-50 microM MC-LR) tested. Cylindrospermopsin did cause apoptosis at low concentrations (1-2 microM) and over short exposure periods (12h). Necrosis was observed at higher concentrations (5-10 microM) and following longer exposure periods (24 or 48h). Cyanotoxins also affected the chromatin structure. The condensation process was inhibited by MC-LR at a later stage and manifested as broken elongated prechromosomes. CYN inhibited chromatin condensation at the early fibrillary stage leading to blurred fluorescent images of apoptotic bodies and preventing the formation of metaphase chromosomes. Cylindrospermopsin exhibited a more pronounced toxic effect causing cytoskeletal and nuclear changes as well as apoptotic and necrotic alterations.

30 CFR 75.600-1 - Approved cables; flame resistance.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved cables; flame resistance. 75.600-1 Section 75.600-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE... cables; flame resistance. Cables shall be accepted or approved by MSHA as flame resistant. [57 FR 61223...

40 CFR 80.93 - Individual baseline submission and approval.

Science.gov (United States)

2010-07-01

... or methodology deviations will be approved or disapproved by the Director of the Office of Mobile... approval by the Director of the Office of Mobile Sources, or designee. (ii) Petitions, “showings,” and..., business address and business phone number of the company contact; (iii) Address and physical location of...

K-K-K-Kuninga kõne / Peter Conradi ; tõlkinud Kadri Karro

Index Scriptorium Estoniae

Conradi, Peter

2011-01-01

The Sunday Timesi ajakirjanik valgustab filmi "Kuninga kõne" (režissöör Tom Hooper, Inglise-Austraalia-USA, 2010) tagamaid. Film räägib kuningas George VI elust ja tema kõnedefektist, kogelemisest. Kuningat aitas Austraalia päritolu kõneterapeut Lionel Logue. Filmi stsenaariumi kirjutas David Seidler

77 FR 12312 - Electronic Submission of Nonclinical Study Data; Notice of Pilot Project

Science.gov (United States)

2012-02-29

...] Electronic Submission of Nonclinical Study Data; Notice of Pilot Project AGENCY: Food and Drug Administration... and Research (CBER) is announcing an invitation to participate in a pilot evaluation program to test.... Participation in the pilot program is open to all sponsors. The pilot program is intended to provide industry...

75 FR 15639 - Revision of the Requirements for Constituent Materials

Science.gov (United States)

2010-03-30

... preservative, except that a preservative need not be added to Yellow Fever Vaccine; Poliovirus Vaccine Live... and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as... and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD...

78 FR 20924 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for...

Science.gov (United States)

2013-04-08

..., Office of Blood Research and Review, Center for Biologics Evaluation and Research (HFM-375), Food and... assist CBER in the final development and release of this electronic program for use by industry. III... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0248...

Dalitz plot analysis of D0 hadronic decays D0->K0K-pi+, D0->antiK0K+pi- and D0->antiK0K+K-

International Nuclear Information System (INIS)

Palano, Antimo

2002-01-01

A Dalitz plot analysis of the D 0 hadronic decays D 0 → K 0 K - π + , D 0 → (bar K) 0 K + π - and D 0 → (bar K) 0 K + K - is presented. This analysis is based on a data sample of 22 fb -1 collected with the BABAR detector at the PEP-II asymmetric-energy B Factory at SLAC running on or near the Υ(4S) resonance. The events are selected from continuum e + e - annihilations using the decay D* + → D 0 π + . Preliminary measurements of the branching fractions of the above hadronic decays are obtained. Preliminary estimates of fractions and phases for resonant and nonresonant contributions to the Dalitz plot are also presented

Drugs Approved for Wilms Tumor

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2010-05-04

... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(e...

7 CFR 1735.90 - Preliminary approvals.

Science.gov (United States)

2010-01-01

... AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Requirements for... franchises, licenses, and permits; (4) All required regulatory body approvals; (5) All required corporate...

32 CFR 736.7 - Approval by the Attorney General.

Science.gov (United States)

2010-07-01

... 32 National Defense 5 2010-07-01 2010-07-01 false Approval by the Attorney General. 736.7 Section..., PATENTS, AND CONTRACTS DISPOSITION OF PROPERTY § 736.7 Approval by the Attorney General. Prior to the... inventions, irrespective of cost, the Department of the Navy must notify the Attorney General of the proposed...

5 CFR 6601.102 - Prior approval for outside employment.

Science.gov (United States)

2010-01-01

... approval for outside employment. (a) Before engaging in any outside employment with a prohibited source... (including the name of the person, group or other organization for whom the work is to be performed), and a... activity, and, if so, how much. (b) Approval shall be granted only upon determination that the outside...

24 CFR 990.145 - Dwelling units with approved vacancies.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Dwelling units with approved vacancies. 990.145 Section 990.145 Housing and Urban Development Regulations Relating to Housing and Urban...; Computation of Eligible Unit Months § 990.145 Dwelling units with approved vacancies. (a) A PHA is eligible to...

K-RAS and N-RAS mutations in testicular germ cell tumors

Directory of Open Access Journals (Sweden)

Bekir Muhammet Hacioglu

2017-05-01

Full Text Available Testicular cancer is a relatively rare tumor type, accounting for approximately 1% of all cancers in men. However, among men aged between 15 and 40 years, testicular cancer is the most commonly diagnosed malignancy. Testicular germ cell tumors (TGCTs are classified as seminoma and non-seminoma. The RAS oncogene controls several cellular functions, including cell proliferation, apoptosis, migration, and differentiation. Thus, RAS signaling is important for normal germ cell development. Mutations of the Kirsten RAS (K-RAS gene are present in over 20% of all cancers. RAS gene mutations have also been reported in TGCTs. We investigated K-RAS and N-RAS mutations in seminoma and non-seminoma TGCT patients. A total of 24 (55% pure seminoma cases and 19 (45% non-seminoma cases were included in the study. K-RAS and N-RAS analyses were performed in our molecular pathology laboratory, using K-RAS and N-RAS Pyro Kit 24 V1 (Qiagen. In total, a RAS mutation was present in 12 patients (27%: 7 seminoma (29% and 5 non-seminoma cases (26% [p = 0.55]. A K-RAS mutation was present in 4 pure seminoma tumors (16% and 3 non-seminoma tumors (15% [p = 0.63], and an N-RAS mutation was observed in 4 seminoma tumors (16% and 3 non-seminoma tumors (15% [p = 0.63]. Both, K-RAS and N-RAS mutations were present in two patients: one with seminoma tumor and the other with non-seminoma tumor. To date, no approved targeted therapy is available for the treatment of TGCTs. The analysis of K-RAS and N-RAS mutations in these tumors may provide more treatment options, especially in platinum-resistant tumors.

OMB Recommended vs Approved Operating Budget

Data.gov (United States)

Montgomery County of Maryland — This dataset includes the Fiscal Year 2015 County Executive Recommended and County Council Approved operating budgets for Montgomery County, for comparison purposes....

Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals

Directory of Open Access Journals (Sweden)

Bhaven C. Kataria

2013-01-01

Conclusion: This study confirms that there is a substantial drug lag in approval of new cardiovascular drugs in India compared with the United States and European Union. The impact of drug lag on health outcomes remains to be established.

12 CFR 563g.19 - Approval of the security.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Approval of the security. 563g.19 Section 563g.19 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY SECURITIES OFFERINGS § 563g.19 Approval of the security. Any securities of a savings association which are not exempt under...

Project W-314 phase I environmental permits and approvals plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

1999-01-01

This document describes the range of environmental actions, including required permits and other agency approvals, for Project W-314 activities in the Hanford Site's Tank Waste Remediation System. This document outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for waste feed delivery to proceed. This document also includes estimated costs and schedule to obtain the required permits and approvals based on the selected strategy. It also provides estimated costs for environmental support during design and construction based on the preliminary project schedule provided

25 CFR 1200.15 - What is the approval process for management plans?

Science.gov (United States)

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...

78 FR 29780 - Fees for Testing, Evaluation, and Approval of Mining Products

Science.gov (United States)

2013-05-21

... Approval of Mining Products AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice. SUMMARY..., and approval of mining products; it allows MSHA to collect fees up to $2,499,000 for the testing, evaluation, and approval of certain mining equipment. MSHA is continuing to collect these fees for 2013 as...

Search for two-photon production of resonances decaying into K anti K and K anti K. pi

Energy Technology Data Exchange (ETDEWEB)

Althoff, M; Braunschweig, W; Kirschfink, F J; Martyn, H U; Rosskamp, R; Siebke, H; Wallraff, W; Eisenmann, J; Fischer, H M; Hartmann, H

1985-11-01

An analysis of the production of Ksub(s)/sup 0/Ksub(s)/sup 0/ and Ksup(+-)Ksub (s)/sup 0/..pi..sup(-+) by two quasi-real photons is presented. The cross section for ..gamma gamma..->K/sup 0/ anti K/sup 0/, which is given for the ..gamma gamma.. invariant mass range from K anti K threshold to 2.5 GeV, is dominated by the f'(1,525) resonance and an enhancement near the K anti K threshold. Upper limits on the product of the two-photon width times the branching ratio into K anti K pairs are given for THETA(1,700), h(2,030), and zeta(2,220). For exclusive two-photon production of Ksup(+-)Ksub(s)/sup 0/..pi..-+ no significant signal was observed. Upper limits are given on the cross section of ..gamma gamma..->K/sup +/ anti K/sup 0/..pi../sup -/ or K/sup -/K/sup 0/..pi../sup +/ between 1.4 and 3.2 GeV and on the product of the ..gamma gamma.. width times the branching ratio into the Kanti K..pi.. final states for the etasub(c)(2,980) and the iota(1,440), yielding GAMMA(..gamma gamma..->iota(1,440)) . BR(iota(1,440)-> K anti K..pi..) < 2.2keV at 95% C.L.

Alcohol addiction - the safety of available approved treatment options.

Science.gov (United States)

Antonelli, Mariangela; Ferrulli, Anna; Sestito, Luisa; Vassallo, Gabriele A; Tarli, Claudia; Mosoni, Carolina; Rando, Maria M; Mirijello, Antonio; Gasbarrini, Antonio; Addolorato, Giovanni

2018-02-01

Alcohol Use Disorders (AUD) is a leading cause of mortality and morbidity worldwide. At present disulfiram, naltrexone and acamprosate are approved for the treatment of AUD in U.S. and Europe. Nalmefene is approved in Europe and sodium oxybate is approved in Italy and Austria only. Baclofen received a 'temporary recommendation for use' in France. Areas covered: The safety of the above mentioned medications on liver, digestive system, kidney function, nervous system, pregnancy and lactation and their possible side effects are described and discussed. Expert opinion: Mechanism of action and metabolism of these drugs as well as patients' clinical characteristics can affect the safety of treatment. All approved medications are valid tools for the treatment of AUD in patients without advanced liver disease. For some drugs, attention should be paid to patients with renal failure and medications may be used with caution, adjusting the dosage according to kidney function. In patients with AUD and advanced liver disease, at present only baclofen has been formally tested in randomized controlled trials showing its safety in this population.

Drugs Approved for Cervical Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Testicular Cancer

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Hodgkin Lymphoma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Myeloproliferative Neoplasms

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

An Experimental Study of the Decay $D^0 \\to K^- K^- K^+ \\pi^+$

Energy Technology Data Exchange (ETDEWEB)

Devmal, Shiral Cleophas [Cincinnati U.

2000-05-01

Using data from the E791 experiment at Fermi National Accelerator Laboratory (Fermilab), we have studied the Cabibbo favored, but phase space suppressed decay $D^0 \\to K^-K^- K^+ \\pi^+$ with the normalization channel $D^0 \\to K^- \\pi^- \\pi^+ \\pi^+$. We report the branching ratio of $D^0 \\to K^- K^- K^+ \\pi^+$ relative to the branching ratio of $D^0 \\to K^- \\pi^- \\pi^+ \\pi^+$. This value is (0.54 $\\pm$ 0.13 $\\pm$ 0.07)%. We see a clear signal of $K^-K^+$ resonance in the decay $D^0 \\to K^-K^-K^+\\pi^+$ from which we conclude that about (60 $\\pm$ 30)% of $KKK\\pi$ comes from $D^0 \\to \\phi K^-\\pi^+; \\phi \\to K^-K^+$. We also set the range (0.30% - 0.90%) for the ratio $P_{q\\overline{q}} = P_{NoPop}$ where $P_{q\\bar{q}}$ is the contribution from either $D^0 \\to K^-K^-K^+\\pi^+$ terms that pop an $s\\bar{s}$ or corresponding $D^0 \\to K^- \\pi^- \\pi^+ \\pi^+$ terms that pop either $u\\bar{u}$ or $d\\bar{d}$ pair and $P_{NoPop}$ is the contributions from the $D^0 \\to K^- \\pi^- \\pi^+ \\pi^+$ terms that do not have such corresponding popping.

30 CFR 285.614 - When may I begin conducting activities under my approved SAP?

Science.gov (United States)

2010-07-01

... approved SAP? 285.614 Section 285.614 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE... Plans and Information Requirements Activities Under An Approved Sap § 285.614 When may I begin conducting activities under my approved SAP? (a) You may begin conducting the activities approved in your SAP...

7 CFR 4290.480 - Prior approval of changes to RBIC's business plan.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Prior approval of changes to RBIC's business plan... § 4290.480 Prior approval of changes to RBIC's business plan. Without the Secretary's prior written approval, no change in your business plan, upon which you were selected and licensed as a RBIC, may take...

Wild Horse 69-kV transmission line environmental assessment

International Nuclear Information System (INIS)

1996-12-01

Hill County Electric Cooperative Inc. (Hill County) proposes to construct and operate a 69-kV transmission line from its North Gildford Substation in Montana north to the Canadian border. A vicinity project area map is enclosed as a figure. TransCanada Power Corporation (TCP), a Canadian power-marketing company, will own and construct the connecting 69-kV line from the international border to Express Pipeline's pump station at Wild Horse, Alberta. This Environmental Assessment is prepared for the Department of Energy (DOE) as lead federal agency to comply with the requirements of the National Environmental Policy Act (NEPA), as part of DOE's review and approval process of the applications filed by Hill County for a DOE Presidential Permit and License to Export Electricity to a foreign country. The purpose of the proposed line is to supply electric energy to a crude oil pump station in Canada, owned by Express Pipeline Ltd. (Express). The pipeline would transport Canadian-produced oil from Hardisty, Alberta, Canada, to Caster, Wyoming. The Express Pipeline is scheduled to be constructed in 1996--97 and will supply crude oil to refineries in Wyoming and the midwest

Wild Horse 69-kV transmission line environmental assessment

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-12-01

Hill County Electric Cooperative Inc. (Hill County) proposes to construct and operate a 69-kV transmission line from its North Gildford Substation in Montana north to the Canadian border. A vicinity project area map is enclosed as a figure. TransCanada Power Corporation (TCP), a Canadian power-marketing company, will own and construct the connecting 69-kV line from the international border to Express Pipeline`s pump station at Wild Horse, Alberta. This Environmental Assessment is prepared for the Department of Energy (DOE) as lead federal agency to comply with the requirements of the National Environmental Policy Act (NEPA), as part of DOE`s review and approval process of the applications filed by Hill County for a DOE Presidential Permit and License to Export Electricity to a foreign country. The purpose of the proposed line is to supply electric energy to a crude oil pump station in Canada, owned by Express Pipeline Ltd. (Express). The pipeline would transport Canadian-produced oil from Hardisty, Alberta, Canada, to Caster, Wyoming. The Express Pipeline is scheduled to be constructed in 1996--97 and will supply crude oil to refineries in Wyoming and the midwest.

21 CFR 610.53 - Dating periods for licensed biological products.

Science.gov (United States)

2010-04-01

... hours from date of collection, provided labeling recommends storage between 1 and 6 °C. Yellow Fever... Research (CBER). Pneumococcal Vaccine Polyvalent: 1. Final bulk powder ......do 24 months after potency... Evaluation and Research or the Director of the Center for Drug Evaluation and Research. [50 FR 4134, Jan. 29...

CCQM-K11.2 determination of glucose in human serum and CCQM-K12.2 determination of creatinine in human serum

Science.gov (United States)

Wise, Stephen A.; Phinney, Karen W.; Duewer, David L.; Sniegoski, Lorna T.; Welch, Michael J.; Pritchett, Jeanita; Pabello, Guiomar; Avila Calderon, Marco A.; Balderas, Miryan; Qinde, Liu; Kooi, Lee Tong; Rego, Eliane; Garrido, Bruno; Allegri, Gabriella; de La Cruz, Marcia; Barrabin, Juliana; Monteiro, Tânia; Lee, Hwashim; Kim, Byungjoo; Delatour, Vincent; Peignaux, Maryline; Kawaguchi, Migaku; Bei, Xu; Can, Quan; Nammoonnoy, Jintana; Schild, Katrin; Ohlendorf, Rüdiger; Henrion, Andre; Ceyhan Gören, Ahmet; Yılmaz, Hasibe; Bilsel, Mine; Konopelko, L.; Krylov, A.; Lopushanskaya, E.

2018-01-01

Glucose and creatinine are two of the most frequently measured substances in human blood/serum for assessing the health status of individuals. Because of their clinical significance, CCQM-K11 glucose in human serum and CCQM-K12 creatinine in human serum were the fourth and fifth key comparisons (KCs) performed by the Organic Analysis Working Group (OAWG). These KCs were conducted in parallel and were completed in 2001. The initial subsequent KCs for glucose, CCQM-K11.1, and creatinine, CCQM-K12.1, were completed in 2005. Measurements for the next KCs for these two measurands, CCQM-K11.2 and CCQM-K12.2, were completed in 2013. While designed as subsequent KCs, systematic discordances between the participants' and the anchor institution's results in both comparisons lead the OAWG to request reference results from two experienced laboratories that had participated in the 2001 comparisons. Based on the totality of the available information, the OAWG converted both CCQM-K11.2 and CCQM-K12.2 to 'Track C' KCs where the key comparison reference value is estimated by consensus. These comparisons highlighted that carrying out comparisons for complex chemical measurements and expecting to be able to treat them under the approaches used for formal CIPM subsequent comparisons is not an appropriate strategy. The approach used here is a compromise to gain the best value from the comparison; it is not an approach that will be used in the future. Instead, the OAWG will focus on Track A and Track C comparisons that are treated as stand-alone entities. Participation in CCQM-K11.2 demonstrates a laboratory's capabilities to measure a polar (pKow > 2), low molecular mass (100 g/mol to 500 g/mol) metabolite in human serum at relatively high concentrations (0.1 mg/g to 10 mg/g). Participation in CCQM-K12.2 demonstrates capabilities to measure similar classes of metabolites at relatively low concentrations (1 μg/g to 30 μg/g). The capabilities required for the analysis of complex

Dalitz Plot Analysis of the Decay B+ -> K+K+K-

Energy Technology Data Exchange (ETDEWEB)

Dvoretskii, Alexei; /SLAC /Caltech

2006-05-05

The authors perform an analysis of the three-body charmless decay B{sup {+-}} {yields} K{sup {+-}}K{sup {+-}}K{sup {-+}} using a sample of 226.0 {+-} 2.5 million B{bar B} pairs collected by the BABAR detector and measure the total branching fraction and Cp asymmetry to be {beta} = (35.2 {+-} 0.9 {+-} 1.6) x 10{sup -6} and A{sub CP} = (-1.7 {+-} 2.6 {+-} 1.5)%. They fit the Dalitz plot distribution using an isobar model and report the measured values of magnitudes and phases of the production coefficients. The decay dynamics is dominated by the K{sup +}K{sup -} S-wave, for which we perform a partial-wave analysis in the region m(K{sup +}K{sup -}) < 2 GeV/c{sup 2}. They find no evidence of CP violation for individual components of the isobar model.

21 CFR 56.113 - Suspension or termination of IRB approval of research.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Suspension or termination of IRB approval of research. 56.113 Section 56.113 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of...

24 CFR 574.260 - Amendments.

Science.gov (United States)

2010-04-01

..., location, service area, or objectives of an activity or the number of eligible persons served must be... proposed use of funds. Funds may not be expended for the revised proposed use of funds until: (1) HUD... funds has been completed in accordance with § 574.510. (Approved by the Office of Management and Budget...

21 CFR 558.295 - Iodinated casein.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Iodinated casein. 558.295 Section 558.295 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS... in Animal Feeds § 558.295 Iodinated casein. (a) Approvals. See 017762 in § 510.600(c) of this chapter...

Credit Risk Management - Loan Approval Process

Directory of Open Access Journals (Sweden)

Lulzim Rashiti

2016-03-01

Full Text Available The aim of this study is on understanding the international regulations issued by Basel I, Basel II and Basel III to best supervise and manage credit risk management policies. Part of paper will focus on the description and impacts of the regulations and the pivotal importance they play in providing a sound banking system. Credit risk represents another important element that will be analysed considering that it lays the foundation during the loan consideration and approval process. The paper will also explain in detail procedures and responsibilities shared along the process of loan acceptance by a banker. To sum up, the overall process from application to loan approval or denial will be explained pointing out the implications that are faced along the way

77 FR 46760 - Information Collections Approved by the Office of Management and Budget

Science.gov (United States)

2012-08-06

... approved by the Office of Management and Budget. SUMMARY: The Federal Communications Commission has received the Office of Management and Budget (OMB) approval for the following public information collection... FEDERAL COMMUNICATIONS COMMISSION Information Collections Approved by the Office of Management and...

A 205 Hour Krypton Propellant Life Test of the SPT-100 Operating at 3 kW

Science.gov (United States)

2013-09-01

nominal xenon condition (1.35 kW), tests have validated the SPT -100 life time as exceeding 2.71 million N -s (equivalent to approximately 9,000 hours of...condition – If correlation between erosion and energy throughput holds, SPT may be able to endure • Long term life test would be required to validate Kr as...shift (to zero center of SPT at r = 0) • Small rotation to correct for linear stage sag DISTRIBUTION A: Approved for public release; distribution

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; maintenance and... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.204 Approved sampling devices; maintenance and...

Two modes of polyamine block regulating the cardiac inward rectifier K+ current IK1 as revealed by a study of the Kir2.1 channel expressed in a human cell line.

Science.gov (United States)

Ishihara, Keiko; Ehara, Tsuguhisa

2004-04-01

The strong inward rectifier K(+) current, I(K1), shows significant outward current amplitude in the voltage range near the reversal potential and thereby causes rapid repolarization at the final phase of cardiac action potentials. However, the mechanism that generates the outward I(K1) is not well understood. We recorded currents from the inside-out patches of HEK 293T cells that express the strong inward rectifier K(+) channel Kir2.1 and studied the blockage of the currents caused by cytoplasmic polyamines, namely, spermine and spermidine. The outward current-voltage (I-V) relationships of Kir2.1, obtained with 5-10 microm spermine or 10-100 microm spermidine, were similar to the steady-state outward I-V relationship of I(K1), showing a peak at a level that is approximately 20 mV more positive than the reversal potential, with a negative slope at more positive voltages. The relationships exhibited a plateau or a double-hump shape with 1 microm spermine/spermidine or 0.1 microm spermine, respectively. In the chord conductance-voltage relationships, there were extra conductances in the positive voltage range, which could not be described by the Boltzmann relations fitting the major part of the relationships. The extra conductances, which generated most of the outward currents in the presence of 5-10 microm spermine or 10-100 microm spermidine, were quantitatively explained by a model that considered two populations of Kir2.1 channels, which were blocked by polyamines in either a high-affinity mode (Mode 1 channel) or a low-affinity mode (Mode 2 channel). Analysis of the inward tail currents following test pulses indicated that the relief from the spermine block of Kir2.1 consisted of an exponential component and a virtually instantaneous component. The fractions of the two components nearly agreed with the fractions of the blockages in Mode 1 and Mode 2 calculated by the model. The estimated proportion of Mode 1 channels to total channels was 0.9 with 0.1-10 microm

[Approval of ISO/IEC 17025 and quality control of laboratory testing].

Science.gov (United States)

Yamamoto, Shigeki; Asakura, Hiroshi; Machii, Kenji; Igimi, Shizunobu

2010-01-01

First section of Division of Biomedical Food Research, National Institute of Health Sciences (NIHS) was approved by ISO/IEC 17025 as a laboratory having an appropriate laboratory testing technique. NIHS is the first national laboratory approved by ISO/IEC 17025. NIHS has also been accepted the appropriate technique and facility for the BSL3 level pathogens by ISO/IEC 17025. NIHS is necessary to take an external audit almost every year. This approval is renewed every 4 years.

Determination of Cl, K, and Na in the blood serum of healthy elderly in the city of Sao Paulo, SP; Determinacao de Cl, K e Na em soro sanguineo de idosos saudaveis da cidade de Sao Paulo

Energy Technology Data Exchange (ETDEWEB)

Araujo, Nathalia Souza de; Saiki, Mitiko, E-mail: natsouzaraujo@yahoo.com.b, E-mail: mitiko@ipen.b [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

2009-07-01

This work determined the blood serum concentration of Cl, K, and Na from a healthy elderly population of the city of Sao Paulo, Sao Paulo, Brazil viewing the comparison with reference values used in clinical laboratories. For collecting these samples the present work were approved by the Ethic Committee of the FMUSP and IPEN-CNEN/SP. The quality of the analytical results were evaluated by the analysis of the reference material certification NIST 1577b Bovine Liver. The results presented good accuracy and precision due to the fact that they presented relative errors less than 5.2 % and standard deviation less than 8.6 %. The average concentrations (mmol L{sup -1}) of Cl in the analysed serum were 99.1; the K were 3.9 and the Na were 136.9. The obtained data allows the to conclude that the mostly of the elderly presented Cl, K and Na concentrations in the range of reference values used in the clinical laboratories

7 CFR 1425.4 - Approval.

Science.gov (United States)

2010-01-01

... AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS COOPERATIVE MARKETING ASSOCIATIONS § 1425.4 Approval. (a) For a cooperative to gain CMA status to participate in a marketing assistance loan or Loan deficiency... prepared in accordance with generally accepted accounting principles; (3) A copy of the articles of...

Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress.

Science.gov (United States)

Decter-Frain, Ari; Frimer, Jeremy A

2016-01-01

What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a "big data" approach-the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition.

Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress

Directory of Open Access Journals (Sweden)

Ari eDecter-Frain

2016-02-01

Full Text Available What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a big data approach—the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC, we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996-2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping. A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition.

75 FR 56663 - Agency Information Collection (Quarterly Report of State Approving Agency Activities); Activity...

Science.gov (United States)

2010-09-16

... a currently approved collection. Abstract: VA reimburses State Approving Agencies (SAAs) for expenses incurred in the approval and supervision of education and training programs. SAAs are required to...

30 CFR 90.205 - Approved sampling devices; operation; air flowrate.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...

19 CFR 210.69 - Approval of complainant's temporary relief bond.

Science.gov (United States)

2010-04-01

... 19 Customs Duties 3 2010-04-01 2010-04-01 false Approval of complainant's temporary relief bond. 210.69 Section 210.69 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION INVESTIGATIONS OF UNFAIR PRACTICES IN IMPORT TRADE ADJUDICATION AND ENFORCEMENT Temporary Relief § 210.69 Approval of...

Setting up a randomized clinical trial in the UK: approvals and process.

Science.gov (United States)

Greene, Louise Eleanor; Bearn, David R

2013-06-01

Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.

Timelines of translational science: From technology initiation to FDA approval.

Directory of Open Access Journals (Sweden)

Laura M McNamee

Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.

6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

Science.gov (United States)

2010-01-01

... Procedures for certification of approved products for Homeland Security. (a) Application Procedure. An applicant seeking a Certification of anti-terrorism Technology as an Approved Product for Homeland Security... application for renewal must be made using the “Application for Certification of an Approved Product for...

First report on the Oak Ridge K-25 Site Biological Monitoring and Abatement Program for Mitchell Branch

Energy Technology Data Exchange (ETDEWEB)

Smith, J.G. [ed.; Adams, S.M.; Kszos, L.A.; Ryon, M.G.; Southworth, G.R.; Loar, J.M.

1993-08-01

A modified National Pollutant Discharge Elimination System permit was issued to the Oak Ridge Gaseous Diffusion Plant (now referred to as the Oak Ridge K-25 Site) on September 11, 1986. The Oak Ridge K-25 Site is a former uranium-enrichment production facility, which is currently managed by Martin Marietta Energy Systems, Inc. for the US Department of Energy. As required in Part III (L) of that permit, a plan for the biological monitoring of Mitchell Branch (K-1700 stream) was prepared and submitted for approval to the US Environmental Protection Agency and the Tennessee Department of Environment and Conservation [formerly the Tennessee Department of Health and Environment (Loar et al. 1992b)]. The K-25 Site Biological Monitoring and Abatement Program (BMAP) described biomonitoring activities that would be conducted over the duration of the permit. Because it was anticipated that the composition of existing effluent streams entering Mitchell Branch would be altered shortly after the modified permit was issued, sampling of the benthic invertebrate and fish communities (Task 4 of BMAP) was initiated in August and September 1986 respectively.

First report on the Oak Ridge K-25 Site Biological Monitoring and Abatement Program for Mitchell Branch

International Nuclear Information System (INIS)

Smith, J.G.; Adams, S.M.; Kszos, L.A.; Ryon, M.G.; Southworth, G.R.; Loar, J.M.

1993-08-01

A modified National Pollutant Discharge Elimination System permit was issued to the Oak Ridge Gaseous Diffusion Plant (now referred to as the Oak Ridge K-25 Site) on September 11, 1986. The Oak Ridge K-25 Site is a former uranium-enrichment production facility, which is currently managed by Martin Marietta Energy Systems, Inc. for the US Department of Energy. As required in Part III (L) of that permit, a plan for the biological monitoring of Mitchell Branch (K-1700 stream) was prepared and submitted for approval to the US Environmental Protection Agency and the Tennessee Department of Environment and Conservation [formerly the Tennessee Department of Health and Environment (Loar et al. 1992b)]. The K-25 Site Biological Monitoring and Abatement Program (BMAP) described biomonitoring activities that would be conducted over the duration of the permit. Because it was anticipated that the composition of existing effluent streams entering Mitchell Branch would be altered shortly after the modified permit was issued, sampling of the benthic invertebrate and fish communities (Task 4 of BMAP) was initiated in August and September 1986 respectively

23 CFR 420.209 - What are the conditions for approval?

Science.gov (United States)

2010-04-01

... Management § 420.209 What are the conditions for approval? (a) As a condition for approval of FHWA planning... management process that identifies and results in implementation of RD&T activities expected to address high priority transportation issues. The management process must include: (1) An interactive process for...

75 FR 71187 - Wolverine Bank, MI; Approval of Conversion Application

Science.gov (United States)

2010-11-22

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-55: OTS Nos. 02620 and H4753] Wolverine Bank, MI; Approval of Conversion Application Notice is hereby given that on November 12, 2010, the Office of Thrift Supervision approved the application of Wolverine Bank, Midland, Michigan, to convert to...

Drugs Approved for Multiple Myeloma

Science.gov (United States)

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.