WorldWideScience

Sample records for cber 510k approval

  1. 75 FR 4402 - Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public...

    2010-01-27

    ... beginning at 7 a.m. If you need special accommodations due to a disability, please contact James Swink at...) under the 510(k) Paradigm, bundling of devices in 510(k) submissions, and reliance on 510(k) submitters...

  2. Center for Biologics Evaluation and Research (CBER)

    Federal Laboratory Consortium — CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal...

  3. 75 FR 47307 - Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and...

    2010-08-05

    ..., and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and...: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled ``510(k) Working Group Preliminary Report and Recommendations.'' Volume II...

  4. 78 FR 26786 - 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device...

    2013-05-08

    ....m. If you need special accommodations due to a disability, please contact Joyce Raines, 301-796-5709..., which ones? 5. Could critical specifications be implemented as an optional paradigm? This approach could... current 510(k) modifications decision-making paradigm. Please discuss the practical implications of this...

  5. 76 FR 45825 - Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report...

    2011-08-01

    ... Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled... assessment of the 510(k) process was an independent study by the IOM. At the request of FDA, IOM has..., 2011, IOM released the report ``Medical Devices and the Public's Health, The FDA 510(k) Clearance...

  6. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    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...

  7. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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). 886.9 Section 886.9 Food and Drugs FOOD AND DRUG... Provisions § 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

  8. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  9. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  10. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  11. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  12. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  13. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  14. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  15. Next generation hyper resolution wide swath and multi-channel optical payload for CBERS series

    Wang, Weigang

    2017-11-01

    The China-Brazilian Earth Resources Satellite (CBERS) program, (also called ZY-1) the result of a space technology agreement between China and Brazil, was officially signed in 1988 after the first joint work report produced by National Institute for Space Research (INPE) and the Chinese Academy of Space Technology (CAST). During the 26 years of its existence, the program of cooperation between China and Brazil in space has achieved the successful launch of three satellites. It has become a unique example of cooperation in cutting edge technology between emerging nations. CBERS satellite is the first generation data-transferring remote sensing satellite developed by China. CBERS satellite data are widely applied to crop yield estimation, exploration of land and resources, urban planning, environmental protection and monitoring, disaster reduction, and other fields. CBERS series is just like Landsat series of USA and SPOT series of France.

  16. Discussion on the fusing methods for HR and CCD images of CBERS

    Gao Zhangsheng; Zhao Yingjun

    2010-01-01

    CBERS-02B multi-spectral CCD data are different from HR panchromatic data in resolution, which causes difficulty in image fusion. With the method of Pansharping, HPF, Brovey transform, IHS transform, principal component transform, Gram Schmidt (GS) transform and wavelet transform, the authors have tested the fusion methods for CCD data and HR data of CBERS, and the fusion results are discussed and evaluated qualitatively and quantitatively. (authors)

  17. Application of CBERS-1 to monitoring of geological hazards in china

    Qiao, Y.

    China is a country with a great variety of wide and frequent geological disasters which is the most serious natural disasters bring damage to national economical construction and people's life and property and causes an annual direct economic loss over 200 hundred million Chinese yuan to China. In recent 20 years great work has been done to apply remote sensing to investigation and monitoring earthquake, collapse, landslide, mud-rock flow, river-band cave-in, lava collapse, earth crevise, ground coal bunker spontaneous combustion, and great contribution has been done for the control. The successful launch and operation of the China-Brazil Resources Satellite& "CBERS -1" provides us an even more convenient tool. In present paper it introduces the applications of CBERS remote sensing in monitoring of large scale slide in Yigong Tibet and in Yangyuan Shanxi for earthquake calamities combined with meteorological remote sensing data. The results demonstrate that CBERS data could get in time and accurate geo-disasters monitoring information and show us the actual happenings which supply reliable basis for control and release measures to the disaster. CBERS has played an unique important role in fighting against the slide disaster and sending relief to the area and the resulted floods. It is bond to play an active role to promote growth of Chinese national economy. Keywords: CBERS; Geological Hazards; Monimonitoring

  18. Exterior orientation of CBERS-2B imagery using multi-feature control and orbital data

    Marcato Junior, J.; Tommaselli, A. M. G.

    2013-05-01

    The major contribution of this paper relates to the practical advantages of combining Ground Control Points (GCPs), Ground Control Lines (GCLs) and orbital data to estimate the exterior orientation parameters of images collected by CBERS-2B (China-Brazil Earth Resources Satellite) HRC (High-resolution Camera) and CCD (High-resolution CCD Camera) sensors. Although the CBERS-2B is no longer operational, its images are still being used in Brazil, and the next generations of the CBERS satellite will have sensors with similar technical features, which motivates the study presented in this paper. The mathematical models that relate the object and image spaces are based on collinearity (for points) and coplanarity (for lines) conditions. These models were created in an in-house developed software package called TMS (Triangulation with Multiple Sensors) with multi-feature control (GCPs and GCLs). Experiments on a block of four CBERS-2B HRC images and on one CBERS-2B CCD image were performed using both models. It was observed that the combination of GCPs and GCLs provided better bundle block adjustment results than conventional bundle adjustment using only GCPs. The results also demonstrate the advantages of using primarily orbital data when the number of control entities is reduced.

  19. Discriminação de variedades de citros em imagens CCD/CBERS-2 Discrimination of citrus varieties using CCD/CBERS-2 satellite imagery

    Ieda Del'Arco Sanches

    2008-02-01

    Full Text Available O presente trabalho teve o objetivo de avaliar as imagens CCD/CBERS-2 quanto à possibilidade de discriminarem variedades de citros. A área de estudo localiza-se em Itirapina (SP e, para este estudo, foram utilizadas imagens CCD de três datas (30/05/2004, 16/08/2004 e 11/09/2004. Um modelo que integra os elementos componentes da cena citrícola sensoriada é proposto com o objetivo de explicar a variabilidade das respostas das parcelas de citros em imagens orbitais do tipo CCD/CBERS-2. Foram feitas classificações pelos algoritmos Isoseg e Maxver e, de acordo com o índice kappa, concluiu-se que é possível obterem-se exatidões qualificadas como muito boas, sendo que as melhores classificações foram conseguidas com imagens da estação seca.This paper was aimed at evaluating the possibility of discriminating citrus varieties in CCD imageries from CBERS-2 satellite ("China-Brazil Earth Resouces Satellite". The study area is located in Itirapina, São Paulo State. For this study, three CCD images from 2004 were acquired (May 30, August 16, and September 11. In order to acquire a better understanding and for explaining the variability of the spectral behavior of the citrus areas in orbital images (like as the CCD/CBERS-2 images a model that integrates the elements of the citrus scene is proposed and discussed. The images were classified by Isoseg and MaxVer classifiers. According to kappa index, it was possible to obtain classifications qualified as 'very good'. The best results were obtained with the images from the dry season.

  20. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    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...

  1. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  2. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  3. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  4. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  5. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  6. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    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...

  7. Deviations in CBERS-4 Satellite Direction Components From The Electromagnetic Disturbance of Communication Antennas

    Heilmann, A.; Fernandes, C.

    2017-10-01

    The CBERS-4 is a low Earth orbit satellite, with a set of antennas S-band/UHF for communication almost omni-direcional. For the electromagnetic radiation from transmission antennas, was developed a model of electromagnetic disturbance considering the antennas theory and the laws of the conservation energy-momentum. Was propagated the orbit of the CBERS-4 satellite considering your state vector from the March 14, 2016, at 11h 14m 15.23s using the equation of motion in the form of cartesian components. From the state vector of the CBERS-4 satellite was possible to propagate the orbit for different periods, without disturbance (considering just the problem of two bodies) and with a disturbance of electromagnetic origin. The model of reaction of electromagnetic acceleration on the satellite depends on only the type of antenna. Quadrifilar and parabolic propeller antennas were considered in this paper. Using the equation of motion of the satellite based on the method of Runge-Kutta of fourth and fifth degree, the effect disturber this modeling was applied on the CBERS-4 considering the mass of satellite, characteristics of antenna, power irradiated and gain maximum of antenna. The final analysis discusses the values of components in the direction (radial, cross and normal) and the coordinates X-Y-Z considering the case disturbed to both antennas.

  8. CBERS-2B Brazilian remote sensing satellite to help to monitor the Bolivia-Brazil gas pipeline

    Hernandes, Gilberto Luis Sanches [TBG Transportadora Brasileira Gasoduto Bolivia-Brasil, Rio de Janeiro, RJ (Brazil)

    2009-07-01

    This paper presents the results of CBERS-2B' Brazilian Remote Sensing Satellite to help to monitor the Bolivia-Brazil Gas Pipeline. The CBERS-2B is the third satellite launched in 2007 by the CBERS Program (China-Brazil Earth Resources Satellite) and the innovation was the HRC camera that produces high resolution images. It will be possible to obtain one complete coverage of the country every 130 days. In this study, 2 images from different parts of the Bolivia- Brazil Gas Pipeline were selected. Image processing involved the geometric registration of CBERS-2B satellite images with airborne images, contrast stretch transform and pseudo color. The analysis of satellite and airborne images in a GIS software to detect third party encroachment was effective to detect native vegetation removal, street construction, growth of urban areas, farming and residential/industrial land development. Very young, the CBERS-2B is a good promise to help to inspect the areas along the pipelines. (author)

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

    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.

  10. 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

    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

  11. 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

    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.

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

    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.

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

    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.

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

    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.

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

    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...

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

    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.

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

    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

  18. Análise de mapas de represas publicados na web usando imagens orbitais CCD/CBERS no estado de Minas Gerais Analysis of dams maps published on the web by using orbital CCD/CBERS images in Minas Gerais State, Brazil

    Elizabeth Ferreira

    2010-02-01

    Full Text Available Neste trabalho, bancos de dados públicos e gratuitos disponíveis na World Wide Web (WEB foram utilizados para avaliar as áreas das superfícies dos espelhos d'água das represas de Furnas e do Funil, no Estado de Minas Gerais. O objetivo foi comparar as informações obtidas nos bancos da WEB com os valores das áreas calculadas a partir de imagens do sensor CCD a bordo dos satélites CBERS2 e CBERS2B. A área da represa de Furnas obtida a partir das imagens CCD/CBERS2B, ano 2008, foi de 1.138 km², mas nos bancos de dados consultados esta área estava entre 1.182 e 1.503 km². A represa do Funil, construída em 2003, com superfície de espelho d'água de 29,37 km² e uma ilha com área de 1,93 km² não aparecem nos bancos Atlas, Geominas, IGAM e IBGE. Os resultados mostraram algumas discrepâncias nos bancos de dados publicados na WEB, tais como diferenças em áreas e supressão ou extrapolação de limites do espelho d'água. Concluiu-se que, até o momento, os responsáveis por algumas publicações de bancos de dados no Estado de Minas Gerais não tiveram rigor suficiente com as atualizações. As imagens CCD/CBERS, que também são dados públicos disponíveis na WEB, mostraram ser produtos adequados para verificar, atualizar e melhorar as informações publicadas.In this work some public databases from the World Wide Web (WEB were used to find the area of the Furnas and Funil Dams in Minas Gerais State. The purpose of this work was to compare the WEB public databases values and the real values obtained from the CCD camera images on board CBERS2 and CBERS2B satellites. The Furnas Dam area obtained from CCD/ CBERS2B images, in 2008, was 1.138 km², but in the consulted databases this area ranged from 1.182 to 1.503 km². The dam of the Funil, built in 2003, with a water surface of 29.37 km² and an island with 1.93 km² area, did not appear in Atlas, Geominas, IGAM and IBGE databases. The results revealed some problems in the WEB public

  19. 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

    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

  20. Redfield Energy Approval

    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

  1. 76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

    2011-03-15

    ... could facilitate patient access to information on what types of devices are available for their medical... input from the public on what they would want and need in labeling and how they would want to access it. CDRH is also interested in learning more about how patients, consumers, and caregivers acquire and use...

  2. 21 CFR 807.93 - Content and format of a 510(k) statement.

    2010-04-01

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

  3. 76 FR 50230 - Center for Devices and Radiological Health 510(k) Clearance Process; Recommendations Proposed in...

    2011-08-12

    ... develop and implement a program of continuous quality improvement to track regulatory decisions on medical devices, identify potential process improvements in the medical device regulatory framework, and address... software used in devices, software used as devices, and software used as a tool in producing devices. 8...

  4. Drugs Approved for Thyroid Cancer

    ... 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 ...

  5. Drugs Approved for Breast Cancer

    ... 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 ...

  6. Poet Marion Approval

    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

  7. Poet Portland Approval

    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

  8. Poet North Manchester Approval

    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

  9. Poet Alexandria Approval

    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

  10. Poet Laddonia Approval

    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

  11. Drugs Approved for Neuroblastoma

    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.

  12. Drugs Approved for Leukemia

    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.

  13. Drugs Approved for Retinoblastoma

    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.

  14. Premarket Approvals (PMA)

    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...

  15. Vedolizumab: first global approval.

    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.

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

    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

  17. CORN, LP Goldfield Approval

    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

  18. Poet Fostoria Approval

    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)

  19. Poet Lake Crystal Approval

    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

  20. Poet Leipsic Approval

    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

  1. Drugs Approved for Rhabdomyosarcoma

    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.

  2. Linaclotide: first global approval.

    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.

  3. Neratinib: First Global Approval.

    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.

  4. Avelumab: First Global Approval.

    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. Supercollider: Footprint approved

    Anon.

    1990-01-01

    With the 'footprint' - the precise location of the 87-kilometre US Superconducting Supercollider, SSC, and its ancillary buildings - now approved, teams of specialists commissioned by the State of Texas swing into action to procure the 17,000 acres (69 million square metres) of land covered by the project. With the SSC Laboratory in Ellis County and the US Department of Energy (DoE, the overseeing government agency) both hiring manpower for this project to collide 20 TeV (20,000 GeV) proton beams before the end of the century, the host State of Texas is providing a helping hand

  6. The Evolution of Approval Services.

    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…

  7. Electronic Approval of Invoices (AEF)

    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,...

  8. Biosimilars approval process.

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.

  9. Drugs Approved for Kidney (Renal Cell) Cancer

    ... 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 ( ...

  10. Approval plans issues and innovations

    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

  11. 48 CFR 750.7105 - Approving authorities.

    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...

  12. Drugs Approved for Esophageal Cancer

    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.

  13. Drugs Approved for Liver Cancer

    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.

  14. Drugs Approved for Kaposi Sarcoma

    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.

  15. Drugs Approved for Pancreatic Cancer

    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.

  16. Drugs Approved for Vaginal Cancer

    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.

  17. Drugs Approved for Skin Cancer

    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.

  18. Drugs Approved for Vulvar Cancer

    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.

  19. Drugs Approved for Wilms Tumor

    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.

  20. Drugs Approved for Lung Cancer

    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.

  1. Drugs Approved for Bone Cancer

    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.

  2. Drugs Approved for Malignant Mesothelioma

    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.

  3. Drugs Approved for Penile Cancer

    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.

  4. Drugs Approved for Bladder Cancer

    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.

  5. Drugs Approved for Endometrial Cancer

    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.

  6. Is It Really FDA Approved?

    ... 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 ...

  7. Electronic Voucher Approval - Financial Management

    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...

  8. Electronic Approval of Invoices (AEF)

    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

  9. Drugs Approved for Cervical Cancer

    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.

  10. Drugs Approved for Multiple Myeloma

    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.

  11. Drugs Approved for Testicular Cancer

    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.

  12. Drugs Approved for Hodgkin Lymphoma

    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.

  13. Drugs Approved for Myeloproliferative Neoplasms

    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.

  14. Immunotherapy Combination Approved for Advanced Kidney Cancer

    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.

  15. 40 CFR 145.31 - Approval process.

    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...

  16. 40 CFR 123.61 - Approval process.

    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...

  17. 7 CFR 1710.406 - Loan approval.

    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...

  18. 40 CFR 52.1772 - Approval status.

    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...

  19. 40 CFR 52.2122 - Approval status.

    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...

  20. 40 CFR 52.1323 - Approval status.

    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...

  1. 9 CFR 147.52 - Approved tests.

    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...

  2. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    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...

  3. 30 CFR 14.7 - Approval marking and distribution records.

    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...

  4. Approval of radioactive consumer goods

    Paynter, R.A.

    1992-01-01

    The 1980 Euratom Directive obliges the UK to draw up a system of prior authorization for the use of radioactive substances in a range of consumer products, and the Government intends to make regulations to fulfil the requirements of the Directive. These regulations will empower NRPB to approve such products prior to their supply to the public. In this brief article, the NRPB reviews the criteria against which to consider any proposed use of radioactive substances, considers radiological production standards for products and discusses the questions of the labelling of radioactive consumer goods. (UK)

  5. Trastuzumab emtansine: first global approval.

    Ballantyne, Anita; Dhillon, Sohita

    2013-05-01

    Genentech and ImmunoGen are collaborating on the development of trastuzumab emtansine, a HER2 antibody-drug conjugate that comprises Genentech's trastuzumab antibody linked to ImmunoGen's anti-mitotic agent, mertansine (a maytansine derivative; also known as DM1). The conjugate combines two strategies: the anti-HER2 activity of trastuzumab, and the targeted intracellular delivery of mertansine, a tubulin polymerisation inhibitor which interferes with mitosis and promotes apoptosis. The linker in trastuzumab emtansine is a non-reducible thioether linker, N-succinimidyl-4-(N-maleimidomethyl) cyclohexane-1-carboxylate (SMCC, designated MCC after conjugation). Trastuzumab emtansine (Kadcyla™) has been launched in the USA as second-line monotherapy for HER2-positive metastatic breast cancer, and has been filed for approval in the EU and Japan in this indication. Trastuzumab emtansine is in phase III development as first-line combination therapy or monotherapy for metastatic HER2-positive breast cancer, and as third-line monotherapy for metastatic HER2-positive breast cancer. Phase II development is underway for early-stage breast cancer and phase II/III development is underway in patients with HER2-positive gastric cancer. This article summarizes the milestones in the development of trastuzumab emtansine leading to this first approval for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

  6. 7 CFR 1735.90 - Preliminary approvals.

    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...

  7. Marketing Approval of Ethical Kampo Medicines.

    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.

  8. OMB Recommended vs Approved Operating Budget

    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....

  9. MNR Approvals for waterpower projects

    NONE

    2011-07-01

    On May 5, 2011, the Ontario Waterpower Association hosted the emergent hydro workshop in Peterborough. In the course of the workshop, the Ministry of Natural Resources (MNR) presented the different requirements for approval of waterpower projects. Various legislation administered by MNR applies to waterpower projects: the Public Lands Act, the Lakes and Rivers Improvement Act, the Endangered Species Act, 2007, and other legislation. The Public Lands Act provides policy and procedure for water power site release; the Lakes and Rivers Improvement Act was designed to manage, protect and preserve waters, land, fish, wildlife and other natural resources; the Endangered Species Act, 2007, is intended to protect species from extinction by protecting their habitats and promoting their recovery. MNR also administer other legislation, including the Aggregate Resources Act and the Forest Fires Prevention Act. This presentation provided an overview of the various pieces of legislation regulating waterpower projects which are administered by MNR.

  10. Polypharmacology of Approved Anticancer Drugs.

    Amelio, Ivano; Lisitsa, Andrey; Knight, Richard A; Melino, Gerry; Antonov, Alexey V

    2017-01-01

    The major drug discovery efforts in oncology have been concentrated on the development of selective molecules that are supposed to act specifically on one anticancer mechanism by modulating a single or several closely related drug targets. However, a bird's eye view on data from multiple available bioassays implies that most approved anticancer agents do, in fact, target many more proteins with different functions. Here we will review and systematize currently available information on the targets of several anticancer drugs along with revision of their potential mechanisms of action. Polypharmacology of the current antineoplastic agents suggests that drug clinical efficacy in oncology can be achieved only via modulation of multiple cellular mechanisms. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  11. Authority approvals and environmental investigations

    Olsen, F.A.; Svenson, J.

    1999-01-01

    The possible sites have been reviewed environmentally and approved in principle by the Danish authorities through 'The Offshore Wind Turbine Committee'. Therefore, environmental studies were not expected to form par of this study. However, the contacts to the authorities revealed a need for further investigations. A required Environmental Impact Study shall be performed in accordance with EC directive of June 27 1985 and March 3 1997, and more specific requirements from the Danish authorities. The possible visual impacts of the proposed large scale offshore project at Roedsand proved to be a major issue for the local acceptance of the projects. Therefore, computer aided visualisations of selected views of all 3 projects were performed and presented to the public. The visualisations were performed with dedicated computer programmes and are presented on colour photos seen from land, sea and air. As a conclusion, the possible visual impact of the proposed projects are not found to be prohibitive for a realisation of the proposed projects. (LN)

  12. The transport system approval concept

    Pettersson, B.G.

    1991-01-01

    The needs for, and merits of, a new concept for the safety assessment and approval of shipments of radioactive materials is introduced and discussed. The purpose of the new concept is to enable and encourage integration of analysis and review of transport safety with similar safety analysis and review of the handling operations involving the radioactive material at the despatching and receiving ends of a shipment. Safety contributing elements or functions of the means of transport (the Transport System) can thus readily be taken into account in the assessment. The objective is to avoid constraints -experienced or potential - introduced by the package functional provisions contained in the transport regulations, whilst maintaining safety during transport, as well as during facility handling operations, at least at the level at the level currently established. (author)

  13. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    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...

  14. E-Approval Plans in Research Libraries

    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…

  15. 48 CFR 2922.103-4 - Approvals.

    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...

  16. 38 CFR 21.7220 - Course approval.

    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...

  17. Ordinal Position, Approval Motivation, and Interpersonal Attraction

    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)

  18. 30 CFR 14.10 - Post-approval product audit.

    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...

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

    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…

  20. 30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

    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...

  1. 27 CFR 5.55 - Certificates of label approval.

    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...

  2. FDA approves efavirenz. Food and Drug Administration.

    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.

  3. Perspectives used for gaining approval of budgets.

    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.

  4. Approving of personal dosimeter services

    Bergman, K.; Malmqvist, L.

    2001-09-01

    The Swedish regulation SSI FS 98:5 requires that radiological workers of category A use dosemeters from an approved personal dosimetry service. The regulation also includes certain specific dosimeter requirements, which are based on those presented in the Technical Recommendations by the European Commission (Report EUR 14852 EN, 1994). All services have been tested for their ability to determine Hp(10) and some of them to determine Hp(0.07) at one radiation quality. The test was performed in the interval 0.2 mSv to 100 mSv at three different dose equivalents unknown to the system owner. The 11 services operating in Sweden at the moment use 5 different types of dosimeters. The five unique systems have been tested regarding the angular and energy dependence of the response of the dosimeters. The dosimeters were irradiated to a personal dose equivalent of about 1 mSv at three photon energies and at four angles (0, 20, 40 and 60 deg. resp. ) both vertically and horizontally rotated. Only 2 of the services determine Hp(0.07) for beta and gamma radiation and were tested for this quantity. The test results for Hp(10) are all except two within the trumpet curve. For the unique systems it is shown that the uncertainty related to angular response at a specified energy is within the required ±40 % except for the lowest X-ray quality at 40 kV. The response is more dependent on photon energy than on the direction of the photon radiation and the choice of radiation quality for the calibration is of great importance for the system performance

  5. 75 FR 29803 - Agency Information Collection Activity Seeking OMB Approval

    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...

  6. Drugs Approved for Stomach (Gastric) Cancer

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

  7. Drugs Approved for Gastrointestinal Stromal Tumors

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

  8. Drugs Approved for Colon and Rectal Cancer

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

  9. Drugs Approved for Soft Tissue Sarcoma

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

  10. Drugs Approved for Head and Neck Cancer

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

  11. Drugs Approved for Gestational Trophoblastic Disease

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

  12. FDA Approves First Therapeutic Cancer Vaccine

    Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

  13. 19 CFR 115.42 - Approval plates.

    2010-04-01

    ... possible methods of accomplishing this are: (1) Placing an “X” in front of the numeric portion of the... element of such number. The specific method of altering the approval number may be established by each...

  14. Page | 133 LEGISLATIVE APPROVAL OF EXECUTIVE ...

    Fr. Ikenga

    NAUJILJ 9 (2) 2018. Page | 133 ... Keywords: Executive appointments, Legislative approval, National Assembly, Constitutional duty. 1. ... Representatives is led by a Speaker.6 The election of the leadership of the senate is entirely the affair of.

  15. 40 CFR 52.2352 - Change to approved plan.

    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...

  16. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    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...

  17. 78 FR 15402 - Projects Approved for Consumptive Uses of Water

    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...

  18. 78 FR 11947 - Projects Approved for Consumptive Uses of Water

    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...

  19. 78 FR 17281 - Projects Approved for Consumptive Uses of Water

    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...

  20. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    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...

  1. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    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...

  2. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    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...

  3. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    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...

  4. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    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...

  5. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    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...

  6. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    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...

  7. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    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...

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

    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.

  9. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    2010-04-01

    ... hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES...

  10. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    2010-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY... identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of...

  11. Montana Advanced Biofuels Great Falls Approval

    This November 20, 2015 letter from EPA approves the petition from Montana Advanced Biofuels, LLC, Great Falls facility, regarding ethanol produced through a dry mill process, qualifying under the Clean Air Act for advanced biofuel (D-code 5) and renewable

  12. Reflections on the Ethics-Approval Process

    Murray, Lee; Pushor, Debbie; Renihan, Pat

    2012-01-01

    It is sometimes a difficult journey receiving ethics approval for research involving vulnerable populations, research involving our own children, or innovative research methodologies such as autoethnography. This autoethnographical account is a story about one student who wanted to write a PhD dissertation in a very different way and also the…

  13. Drugs@FDA: FDA Approved Drug Products

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  14. 15 CFR 1150.3 - Approved markings.

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Approved markings. 1150.3 Section 1150.3 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued... permanently affixed to the exterior surface of the barrel, covering the circumference of the barrel from the...

  15. The Ethics and Politics of Ethics Approval

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

    The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

  16. 7 CFR 1425.4 - Approval.

    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...

  17. 7 CFR 966.124 - Approved receiver.

    2010-01-01

    ... limited to, the following information: (1) Name, address, contact person, telephone number, and e-mail... 7 Agriculture 8 2010-01-01 2010-01-01 false Approved receiver. 966.124 Section 966.124 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements...

  18. Approval Plans in ARL Libraries. Kit 83.

    Leonhardt, Thomas W.

    Materials in this collection were submitted by respondents to a survey which sought specific data on the numbers and types of approval plans in Association of Research Libraries (ARL) libraries, whether such plans are meeting expectations, their relative importance in the library, who makes the key decisions, and the kind of thought and study that…

  19. Neratinib Approved for HER2+ Breast Cancer.

    2017-09-01

    The FDA approved the tyrosine kinase inhibitor neratinib for extended adjuvant treatment of early-stage HER2-positive breast cancer. The decision adds another treatment option to help prevent recurrence, but its relatively small potential benefit must be weighed against the risk of serious side effects. ©2017 American Association for Cancer Research.

  20. 50 CFR 223.207 - Approved TEDs.

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Approved TEDs. 223.207 Section 223.207 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE MARINE MAMMALS THREATENED MARINE AND ANADROMOUS SPECIES Restrictions Applicable to Threatened Marine and Anadromous Specie...

  1. 7 CFR 1427.10 - Approved storage.

    2010-01-01

    ... § 1427.10 Approved storage. (a) Eligible cotton may be pledged as collateral for loans only if stored at... receipt for any bale or bales of cotton pledged as collateral for a CCC loan must include the dates that... cotton pledged as collateral for a CCC loan that are stored outside, and (ii) Through their electronic...

  2. 40 CFR 52.2522 - Approval status.

    2010-07-01

    ... plant, Monongahela Power Co. (b) The Administrator hereby extends the interim limitation of 5.12 lbs. SO2 per million BTU for the Harrison power plant until a permanent emission limitation is approved. (c...-10 NAAQS. (h) EPA disapproves the portion of 45 CSR 13 subsection 1 referencing major stationary...

  3. 9 CFR 317.4 - Labeling approval.

    2010-01-01

    ... undue economic hardship; and (iv) An unfair competitive advantage would not result from the granting of... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and...

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

    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.

  5. 30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

    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...

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

    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

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

    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.

  8. Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

    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...

  9. 7 CFR 1710.105 - State regulatory approvals.

    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...

  10. 27 CFR 4.50 - Certificates of label approval.

    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...

  11. 22 CFR 96.63 - Renewal of accreditation or approval.

    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...

  12. Clone of EPA Approved Regulations in the Texas SIP

    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

  13. 75 FR 56663 - Agency Information Collection (Quarterly Report of State Approving Agency Activities); Activity...

    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...

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

    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...

  15. 19 CFR 115.55 - Termination of approval.

    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...

  16. 30 CFR 75.1108 - Approved conveyor belts.

    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...

  17. 48 CFR 52.222-16 - Approval of Wage Rates.

    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...

  18. 33 CFR 115.70 - Advance approval of bridges.

    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...

  19. 8 CFR 207.6 - Control over approved refugee numbers.

    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...

  20. 12 CFR 614.4470 - Loans subject to bank approval.

    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...

  1. 49 CFR 1522.109 - TSA review and approval.

    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...

  2. 49 CFR 1522.115 - Renewal of TSA approval.

    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...

  3. 45 CFR 1340.13 - Approval of applications.

    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...

  4. 29 CFR 1952.157 - Changes to approved plan.

    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...

  5. 46 CFR 188.10-3 - Approved container.

    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...

  6. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    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...

  7. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    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...

  8. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    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...

  9. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    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...

  10. 20 CFR 617.22 - Approval of training.

    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...

  11. 28 CFR 551.11 - Authority to approve a marriage.

    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...

  12. 7 CFR 1717.609 - RUS approval of general manager.

    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...

  13. Credit Risk Management - Loan Approval Process

    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

  14. Nuclear safety review requirements for launch approval

    Sholtis, J.A. Jr.; Winchester, R.O.

    1992-01-01

    Use of nuclear power systems in space requires approval which is preceded by extensive safety analysis and review. This careful study allows an informed risk-benefit decision at the highest level of our government. This paper describes the process as it has historically been applied to U.S. isotopic power systems. The Ulysses mission, launched in October 1990, is used to illustrate the process. Expected variations to deal with reactor-power systems are explained

  15. Academic Program Approval and Review Practices

    Don G. Creamer

    1999-08-01

    Full Text Available This report outlines general and specific processes for both program approval and program review practices found in 50 states and eight foreign countries and regions.  Models that depict these procedures are defined and the strengths and weakness of each are discussed.  Alternatives to current practice by state agencies in the U.S. are described that might provide for greater decentralization of these practices while maintaining institutional accountability.

  16. Radiation requirements for uranium project approvals

    Hondros, J.

    2014-01-01

    Uranium mining projects in Australia must receive approval under both state and national laws based on a wide ranging impact assessment of the project. The process may take a number of years and involves multiple levels and parts of government and public consultation and scrutiny. The impact assessment is broad and usually covers; environmental, social, health, public safety and economic aspects. Information provided in the approvals documentation needs to be presented in a credible and understandable manner for all audiences. This means making complex information simpler, while making sure that it maintains its technical integrity. Poorly communicated information, which is overly complex, overly simplified or incomplete, can result in significant delays to the project approval which can potentially impact on project timelines. For uranium projects, along with other projects involving radioactive materials, such as minerals sands and rare earths, radiation and its impacts usually draw a disproportionate amount of both government and public scrutiny compared to other potential impacts and risks. It is therefore of key importance that radiation assessments are properly performed and results clearly presented and communicated with sufficient detail for stakeholders to make informed decisions. It is also important to ensure that the radiation risk is presented in perspective with other risks of the project. This presentation outlines a structure for a radiation impact assessment based on experience from a number of projects in Australia. The structure aims to be clear and simple and ensure the right balance between scientific fact, digestible information and demonstrable competence. (author)

  17. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    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...

  18. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    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...

  19. Trial endpoints for drug approval in oncology: Chemoprevention.

    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.

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

    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

  1. 75 FR 50711 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Final Approval and...

    2010-08-17

    ... operations under OAC 3745-21-09(U)(2)(f). For administrative convenience, in a separate rulemaking published... conditional approval of portions of OAC rule 3745-21-09. You can learn more information about the rule... implementing a Federal Standard. National Technology Transfer Advancement Act In reviewing state submissions...

  2. 75 FR 54215 - Agency Request for Approval of a Previously Approved Information Collection(s): Uniform...

    2010-09-03

    ... about our intention to request Office of Management and Budget (OMB) approval to renew a previously... because of management and oversight responsibilities of the agency imposed by OMB Circular 2 CFR 215 (A... Department has terminated Financial Status Report (SF-269 and SF-269A) and Federal Cash Transactions Report...

  3. 78 FR 63937 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    2013-10-25

    ... Quality Plans for Designated Facilities and Pollutants, State of Iowa; Control of Emissions From Existing Hospital/ Medical/Infectious Waste Incinerator Units, Negative Declaration and 111(d) Plan Rescission... existing state air quality rules, approve an exemption from constructing permitting for engines used in...

  4. 78 FR 63887 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    2013-10-25

    ... Quality Plans for Designated Facilities and Pollutants, State of Iowa; Control of Emissions From Existing Hospital/ Medical/Infectious Waste Incinerator Units, Negative Declaration and 111(d) Plan Rescission... quality rules, approve an exemption from constructing permitting for engines used in periodic pipeline...

  5. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    2012-05-04

    ... Department of the Environment (MDE). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SO X ), and nitrogen oxides (NO X....regulations.gov or email. The www.regulations.gov Web site is an ``anonymous access'' system, which means EPA...

  6. 77 FR 26438 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    2012-05-04

    ... (MDE) pertaining to the GenOn Chalk Point Generating Station (Chalk Point). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM... www.regulations.gov or email. The www.regulations.gov Web site is an ``anonymous access'' system...

  7. 77 FR 59335 - Approval and Promulgation of Implementation Plans; North Carolina: Approval of Rocky Mount Motor...

    2012-09-27

    ... account for any future changes to the emission model, projection model and other input data. \\2\\ A safety... changes in the emissions model and vehicle miles traveled (VMT) projection model. EPA is approving this... Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal...

  8. Criteria for approving equipment for continued operation

    Narayanan, T.V.

    1993-01-01

    In May 1988, the Pressure Vessel Research Committee (PVRC) of the Welding Research Council (WRC) initiated four projects in support of ASME's efforts to develop Codes and Standards for life prediction and life extension of nuclear and fossil power plant components. These projects are: (1) Criteria for Approving Equipment for Continued Operation (2) Guidelines and Procedures for Evaluating Piping for Continued Operation (3) Nondestructive Evaluation of Material Degradation (4) Operation and Maintenance History and Life Cycle Management. The PVRC awarded a contract to Foster Wheeler Development Corporation to undertake the first of these projects. The specific objective was to develop a program plan that will lead to development of ''Criteria for Approving Equipment for Continued Operation.'' The program is divided into the following four tasks: Task 1: Literature Search; Task 2: Telephone Interview and Consultation; Task 3: Program Plan Development; Task 4: Preparation of a Summary Report. This report is in fulfillment of the above project. As part of this study, the author reviewed about 145 reports, papers and books relating to various aspects of life extension. Various experts were also consulted who are involved in EPRI, NRC, ASME, PVRC, MPC, and utility studies as well as other research projects. The conclusions and recommendations for Code-related activities are summarized

  9. Applying for ethical approval for research: the main issues.

    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.

  10. 40 CFR 256.04 - State plan approval, financial assistance.

    2010-07-01

    ... WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Purpose, General Requirements, Definitions § 256.04 State plan approval, financial assistance. (a) The...

  11. Approved Air Quality Implementation Plans in Region 10

    Landing page for information about EPA-approved air quality State Implementation Plans (SIPs), Tribal Implementation Plans (TIPs), and Federal Implementation Plans (FIPs) in Alaska, Idaho, Oregon, Washington.

  12. ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

    Hope Morgan; Richard A. Varela; Deborah LaHood; Susan Cisco; Mary Ann Benavides; Donna Burks

    2002-11-01

    The Texas Railroad Commission (RRC), working in partnership with the United States Department of Energy and the oil and gas industry it regulates, is implementing a strategy for improving efficiency in regulations and significantly reducing administrative operating costs through the Electronic Compliance and Approval Process (ECAP). The project will streamline regulatory compliance and reporting by providing the ability to electronically submit, process, and query oil and gas applications and reports through the Internet-based ECAP system. Implementation of an ECAP drilling permit pilot project began September 1999 after funding resources were secured--a $700,000 grant from the U.S. Department of Energy and an appropriation of $1.4 million from the Texas Legislature. The pilot project involves creating the ability to file, review, and approve a well's drilling permit application through a completely electronic process. The pilot project solution will ultimately provide the infrastructure, technology, and electronic modules to enable the filing of all compliance permits and performance reports through the internet from a desktop computer. The pilot project was conducted in three phases. The first phase, implemented May 2000, provided the infrastructure that allows the electronic filing and approval of simple drilling permit applications, associated fees, and attachments. The official ''roll-out'' of ECAP and the first electronically filed drilling permit application occurred on May 11, 2000 in Dallas in conjunction with an Internet Workshop sponsored by the Petroleum Technology Transfer Council. After the completion of Phase I, the ECAP team conducted an extensive review of progress to date and analyzed requirements and opportunities for future steps. The technical team identified core infrastructure modifications that would facilitate and better support future development and expansion of the ECAP system and work began on database structure

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

    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

  14. Consumer approval of irradiated meat still tentative

    Hollingsworth, P.

    1998-01-01

    Although the FDA has approved irradiation of red meat, consumers may not be so accepting of the use of this technology. Irradiation is a process used to improve food safety in food products susceptible to disease-causing microorganisms. The red meat ruling was widely praised by federal officials and food industry leaders, but consumers seem less sure. Indeed, on the night of the red meat announcement last December, CBS Evening News reported that over 70 percent of U.S. consumers would not knowingly eat irradiated food. There is hope, however, as a study by the Center for Consumer Research at the University of California, Davis, revealed that consumer interest in buying irradiated food can be substantially improved by providing consumers with information, thereby enabling them to see the benefits and to overcome the myths of irradiation

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

    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)

  16. Waste Feed Delivery Environmental Permits and Approvals Plan

    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.

  17. 14 CFR 21.8 - Approval of articles.

    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...

  18. Waste Feed Delivery Environmental Permits and Approvals Plan

    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

  19. Hyapproval : final handbook for approval of hydrogen refuelling stations

    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

  20. 75 FR 71187 - Wolverine Bank, MI; Approval of Conversion Application

    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...

  1. 12 CFR 563g.19 - Approval of the security.

    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...

  2. 5 CFR 6601.102 - Prior approval for outside employment.

    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...

  3. 38 CFR 21.9765 - Program of education approval.

    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...

  4. 47 CFR 400.5 - Approval and award.

    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...

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

    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.

  6. 5 CFR 1320.16 - Delegation of approval authority.

    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...

  7. Establishment approval in international trade of animal products

    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

  8. 32 CFR 736.7 - Approval by the Attorney General.

    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...

  9. 7 CFR 1735.62 - Approval of acquisitions and mergers.

    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...

  10. 14 CFR 21.609 - Approval for deviation.

    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...

  11. 30 CFR 75.600-1 - Approved cables; flame resistance.

    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...

  12. 50 CFR 37.22 - Approval of exploration plan.

    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...

  13. 13 CFR 302.18 - Post-approval requirements.

    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...

  14. Dabrafenib Plus Trametinib Approved for Melanoma, Thyroid Cancer

    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

  15. 45 CFR 95.611 - Prior approval conditions.

    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...

  16. 75 FR 36301 - Review and Approval of Projects

    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...

  17. 44 CFR 78.9 - Planning grant approval process.

    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...

  18. 38 CFR 21.4263 - Approval of flight training courses.

    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...

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

    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 ...

  20. 30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

    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...

  1. 34 CFR 668.144 - Application for test approval.

    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...

  2. 40 CFR 80.93 - Individual baseline submission and approval.

    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...

  3. 7 CFR 1703.121 - Approved purposes for grants.

    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...

  4. 48 CFR 1819.7203 - Mentor approval process.

    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...

  5. 5 CFR 7401.102 - Prior approval for outside employment.

    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...

  6. 42 CFR 102.73 - Approval of benefits.

    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...

  7. 24 CFR 886.107 - Approval of applications.

    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...

  8. 24 CFR 990.145 - Dwelling units with approved vacancies.

    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...

  9. 2016 in review: FDA approvals of new molecular entities.

    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.

  10. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    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...

  11. Environmental approvals in New Brunswick : economic considerations

    Marrack, C.; Maitland, R. [Suez Renewable Energy North America, Houston, TX (United States)

    2008-07-01

    This presentation provided a timeline of economic considerations related to New Brunswick's regulatory approval process for wind power developments. The economics of wind power projects require careful consideration during the initial planning phases, as it is not yet known if projects are viable. Spending in the early stages of a project should therefore be limited to items that focus on components of the environmental impact assessment (EIA) process that include establishing a relationship with First Nations groups in the area, and conducting seasonal bird studies. Economic considerations change when project viability is confirmed, and developers can then progress to conducting traditional knowledge studies and further seasonal bird studies. Baseline information studies should be reviewed, and biophysical surveys should involve the identification of any wetlands, sensitive areas, and rare plants. Archaeology studies are also required by the provincial government, as well as bat studies to determine if the site has a resident population of bats. Public and stakeholder consultations and open houses should then be held with an adequate time-frame for the submission of questions and concerns and the development of mitigation strategies. Project viability should be confirmed before power purchase agreements (PPAs) are signed. After PPAs are signed, the largest economic consideration is the schedule-related risk associated with legal and financial problems. It was concluded that noise impact, visual impact, and socioeconomic assessments and studies can be conducted after the PPA is secured. tabs., figs.

  12. Space Program Annual Report, For Approval

    TM Schaefer

    2004-01-01

    Knolls Atomic Power Laboratory (KAPL) (lead) has been requested by the Reference to create an unclassified report on the Prometheus Program's Jupiter Icy Moons Orbiter (JIMO) mission. This report is expected to be issued annually and be similar in level of content and scope to the NR Program's annual report ''The United States Naval Nuclear Propulsion Program'' (referred to as the Grey Book). The attachment to this letter provides a draft of the Prometheus Program report for NR review and approval. As stated in the Reference, a March 2005 issuance is planned following a coordinated NR Headquarter's review. The information contained in the attached report was obtained from open literature sources, NASA documents and Naval Reactors Program literature. The photographs contained in the report are drafts and their quality will be improved in the final version of the report. This report has been reviewed by the KAPL and Bettis Space Power Plant Staff and has been concurred with by the Manager of Space Power Plant (MJ Wollman) and the Manager of Bettis Reactor Engineering (C Eshelman)

  13. Guidance for package approvals in the United Kingdom

    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)

  14. Effect of Need for Approval and Situational Variables on the Viewing of Erotic Material

    Kirschner, Neil M.

    1976-01-01

    The role of social desirability on willingness to view erotic materials under conditions of implicit approval and disapproval was studied. Low need-for-approval subjects were more influenced by situational cues than high need-for-approval subjects. (NG)

  15. New Breast Cancer Treatment Approved | NIH MedlinePlus the Magazine

    ... 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 ...

  16. Project W-314 phase I environmental permits and approvals plan

    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

  17. HSE statement on the approval of dosimetry services

    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)

  18. Grandfathering of competent authority approved packages

    Osgood, N.L.

    2004-01-01

    International Atomic Energy Agency transportation regulations are reviewed and revised on a periodic basis as new technical and scientific information becomes available. The 1996 Edition of the Regulations for the Safe Transport of Radioactive Materials in TS-R-1 includes provisions for the use of package designs approved to previous editions of the regulations. This assures that there is no disruption of transport when the regulations are updated and revised. The revision of package design standards may make certain designs obsolete, though not necessarily unsafe. The U.S. Nuclear Regulatory Commission is the agency in the United States that certifies transportation packages for Type B and fissile materials. NRC regulations include grandfathering provisions that are comparable to and compatible with the IAEA standards. NRC staff is promoting a new system that would eliminate the need to grandfather package designs. Under the new method, any new or revised provision of the regulations that affects package standards would include its own transitional arrangements. In this way, each change would be evaluated for its safety importance. Changes in the package standards that are important to safety would be implemented immediately upon the regulations coming into force. Other changes, that do not significantly affect safety, would have longer implementation periods. In this way, all packages in use would be compatible with the regulations in force, and no specific grandfathering provisions for older designs would be needed. NRC staff has concluded that the package design standards are mature and have been shown to be protective over the past 40 years of shipping experience. We predict that future changes in package design standards will not be substantive in terms of resulting in significant changes in physical performance of a package in transport, including actual transportation accidents. The benefits of the new system would be a more predictable regulatory structure

  19. 75 FR 57019 - Pesticide Product Registrations; Conditional Approval

    2010-09-17

    ..., the Agency was able to make basic health and safety determinations which show that use of flutriafol... unreasonable adverse effects to man and the environment. III. Conditional Approval Form EPA issued a notice...

  20. 22 CFR 129.6 - Requirement for license/approval.

    2010-04-01

    ... LICENSING OF BROKERS § 129.6 Requirement for license/approval. (a) No person may engage in the business of... member country of that Organization, Australia, Japan, New Zealand, or South Korea, except in the case of...

  1. 40 CFR 85.1804 - Approval of Plan: Implementation.

    2010-07-01

    ... nonconformity, he will so notify the manufacturer in writing. If the remedial plan is not approved, the... nonconformity, the Administrator shall, within 60 days after the completion of such hearing, order the manufacturer to provide prompt notification of such nonconformity. ...

  2. Cognitive Properties of Approval Voting : an Experimental Approach

    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

  3. 44 CFR 78.10 - Project grant approval process.

    2010-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

  4. A guide for approval of nuclear gauging devices

    1990-01-01

    This guide has been written to assist manufacturers, distributors and users of nuclear gauging devices in the preparation of a submission to the Atomic Energy Control Board in support of a request for approval of a nuclear gauging device

  5. Uganda cabinet approves policy initiated by IDRC grantee | IDRC ...

    2016-06-28

    Jun 28, 2016 ... The Economic Policy Research Centre (EPRC), an IDRC grantee under the ... on May 4, 2016, with cabinet approval of their National Fertilizer Policy. ... that 20% of the country's population has some form of physical disability.

  6. 27 CFR 4.40 - Label approval and release.

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Withdrawal of Wine From..., denial, and revocation of certificates of label approval, as well as appeal procedures, see part 13 of...

  7. 27 CFR 7.31 - Label approval and release.

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Requirements for Withdrawal of... approval, as well as appeal procedures, see part 13 of this chapter. [T.D. ATF-66, 45 FR 40552, June 13...

  8. 27 CFR 7.41 - Certificates of label approval.

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Requirements for Approval of..., as well as appeal procedures, see part 13 of this chapter. [T.D. ATF-406, 64 FR 2129, Jan. 13, 1999...

  9. 27 CFR 5.51 - Label approval and release.

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Withdrawal..., and revocation of certificates of label approval, as well as appeal procedures, see part 13 of this...

  10. Clean Water Act Approved Total Maximum Daily Load (TMDL) Documents

    U.S. Environmental Protection Agency — Information from Approved and Established TMDL Documents as well as TMDLs that have been Withdrawn. This includes the pollutants identified in the TMDL Document, the...

  11. 12 CFR 918.5 - Approval by Finance Board.

    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...

  12. 75 FR 4081 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing...

    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...

  13. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    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...

  14. 75 FR 15645 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to the Emission...

    2010-03-30

    ... clarify EPA's role in the approval of emission quantification protocols. While the previous SIP- approved... approve severable portions of two revisions to the Texas State Implementation Plan (SIP) submitted by the... to further clarify procedures for using emission protocols and to update the approved list of...

  15. 30 CFR 285.614 - When may I begin conducting activities under my approved SAP?

    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...

  16. Miracle drug: Brazil approves never-tested cancer medicine.

    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.

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

    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.

  18. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    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

  19. Reporting ethics committee approval in public administration research.

    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.

  20. Problems of the current law concerning official plan approval

    Bluemel, W.

    1986-01-01

    The booklet presents lectures held in October 1985 at the Speyer University for Administration Science, on the subject of the law concerning official plan approval. The lectures have been selected for their common interest in the requirements of nature conservation and landscape protection. These requirements and the current practice of plan approval procedure are the main issue of the lectures which discuss aspects of environmental impact statements, consideration of ecological requirements, and the role of the landscape conservation plan accompanying official project planning documents. (HSCH) [de

  1. Defending submission-year analyses of new drug approvals.

    Carpenter, Daniel P

    2003-01-01

    In response to the critique of Mary Olsen, Daniel Carpenter, on behalf of his co-authors, addresses the issue of analysis based on the year a new drug is submitted for Food and Drug Administration (FDA) approval, not the year it is approved. Both substantive knowledge of the FDA drug review process and sound social science theory favor submission-year averaging. The history and bureaucratic mechanics of the Center for Drug Evaluation and Review (CDER) conform to the author's assumption. The statistical theory of optimal experimentation also points to the beginning of review as a locus for effects upon decisions.

  2. New technology planning and approval: critical factors for success.

    Haselkorn, Ateret; Rosenstein, Alan H; Rao, Anil K; Van Zuiden, Michele; Coye, Molly J

    2007-01-01

    The steady evolution of technology, with the associated increased costs, is a major factor affecting health care delivery. In the face of limited capital resources, it is important for hospitals to integrate technology management with the strategic plan, mission, and resource availability of the organization. Experiences in technology management have shown that having a well-organized, consistent approach to technology planning, assessment, committee membership, approval, evaluation, implementation, and monitoring are key factors necessary to ensure a successful program. We examined the results of a survey that assessed the structure, processes, and cultural support behind hospital committees for new technology planning and approval.

  3. Stakeholder cooperation: regulating a uranium mine with multiple statutory approvals

    Bush, M.

    2010-01-01

    Ranger Uranium Mine operates under an Authorisation issued by the Northern Territory Government. In addition, the site is regulated by a set of Environmental Requirements attached to the uranium export permit issued by the Australian Government Department of Resources, Energy and Tourism. A Heap Leach facility proposed for the site could result in a third approval being issued, in accordance with the Environmental Protection and Biodiversity Conservation Act 1999 (EPBC Act). Finding the correct balance to regulate the mine in light of these approvals will be a challenge for the range of stakeholders involved in regulation and oversight of this operation. (author)

  4. Number of patients studied prior to approval of new medicines

    Duijnhoven, Ruben G; Straus, Sabine M J M; Raine, June M

    2013-01-01

    length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo). CONCLUSIONS: For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy....... Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies. Please see later...

  5. Inventory information approval system certification and flexible spending account purchases.

    Shuey, Brandon; Williams, La Vonn A

    2010-01-01

    There is no question that 2009 was a year of change within the pharmacy industry. Several new requirements were implemented, including the need for an Inventory Information Approval System for accepting flexible spending or health reimbursement account cords. Some pharmacies relied on the 90% exemption rule, which is discussed within this article, or an alternative method to avoid the expense of a point of sale. However, with flexible spending or health reimbursement account card participation expected to reach 85% in 2010, now bay be the time for compounding pharmacists to weigh the pros and cons of Inventory Information Approval System certification.

  6. 7 CFR 996.22 - USDA-approved laboratory.

    2010-01-01

    ..., Agricultural Marketing Service, USDA, that chemically analyze peanuts for aflatoxin content. Quality and... 7 Agriculture 8 2010-01-01 2010-01-01 false USDA-approved laboratory. 996.22 Section 996.22 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing...

  7. 18 CFR 1304.4 - Application review and approval process.

    2010-04-01

    ... hearing is requested by the USACE pursuant to the TVA/Corps joint processing Memorandum of Understanding... the application as appropriate. (b) If a hearing is held for any of the reasons described in paragraph... contained in the hearing notice. (c) Hearings concerning approval of applications are conducted (in...

  8. Developing, Approving and Maintaining Qualifications: Selected International Approaches. Research Report

    Misko, Josie

    2015-01-01

    There are lessons for Australia in the key approaches to the development, approval, maintenance and quality assurance of qualifications adopted in countries overseas. This research takes into account a range of approaches used in selected European Union (EU) member states (Germany, Finland and Sweden), the United Kingdom (England, Northern Ireland…

  9. Bacteria-eating virus approved as food additive.

    Bren, Linda

    2007-01-01

    Not all viruses harm people. The Food and Drug Administration has approved a mixture of viruses as a food additive to protect people. The additive can be used in processing plants for spraying onto ready-to-eat meat and poultry products to protect consumers from the potentially life-threatening bacterium Listeria monocytogenes (L. monocytogenes).

  10. Aviation Maintenance Technology. Course Content Guides. FAA Approved Curriculum.

    Shrawder, Jack; And Others

    Course content guides are provided for the 30 courses in this aviation maintenance technology curriculum approved by the Federal Aviation Administration. Course titles are physics for technicians; aircraft information, regulations, and procedures; aircraft assembly; fundamentals of aircraft electronics; aircraft electrical components; aircraft…

  11. 29 CFR 1956.24 - Procedures for withdrawal of approval.

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Procedures for withdrawal of approval. 1956.24 Section 1956.24 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... do so, at least developmentally), no industrial or occupational issues may be considered a separable...

  12. 48 CFR 970.5236-1 - Government facility subcontract approval.

    2010-10-01

    ... Approval (DEC 2000) Upon request of the Contracting Officer and acceptance thereof by the Contractor, the... and wages required by law to be included in contracts for the construction, alteration, and/or repair... ENERGY AGENCY SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Solicitation Provisions...

  13. FDA-approved small-molecule kinase inhibitors

    Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig

    2015-01-01

    Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...

  14. 5 CFR 6401.103 - Prior approval for outside employment.

    2010-01-01

    .... 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior approval... her Deputy Ethics Official before engaging in outside employment, with or without compensation, that...

  15. The Cost of Delaying Approval of Golden Rice

    Wesseler, J.H.H.; Kaplan, S.; Zilberman, D.

    2014-01-01

    More than 250,000 children go blind every year because of Vitamin A deficiency. Vitamin A intake can be enhanced by consuming Golden Rice—a genetically engineered variety of rice. It was available for commercialization in 2002, but approval has been delayed. We estimate that this delay has resulted

  16. Olaparib Approved for Breast Cancers with BRCA Gene Mutations

    The Food and Drug Administration has approved olaparib (Lynparza®) to treat metastatic breast cancers that have inherited mutations in the BRCA1 or BRCA2 genes as well as a companion diagnostic test for selecting candidates for the therapy.

  17. Forecasting Housing Approvals in Australia: Do Forecasters Herd?

    Stadtmann, Georg; Pierdzioch; Rülke

    2012-01-01

    Price trends in housing markets may reflect herding of market participants. A natural question is whether such herding, to the extent that it occurred, reflects herding in forecasts of professional forecasters. Using more than 6,000 forecasts of housing approvals for Australia, we did not find...

  18. Approval Motive and Academic Behaviors: The Self Reinforcement Hypothesis

    Matell, Michael S.; Smith, Ronald E.

    1970-01-01

    Testing of college students in differing conditions as to performance being relevant to academic achievement goals revealed that under hgih relevance conditions scores on the Marlowe Crowne Social Desirability Scale were unrelated to test performance. Under low relevant conditions, the need for approval was highly related to performance in high…

  19. Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian 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.

  20. 46 CFR 160.077-6 - Approval procedures.

    2010-10-01

    ... Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS... to the particular design or that by design or construction the PFD cannot fail the test. (c) Alternative Requirements. A PFD that does not meet requirements in this subpart may still be approved if the...

  1. 46 CFR 163.002-9 - Approval procedure.

    2010-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS... designs. A pilot hoist that does not meet the materials, construction, or performance requirements of this... or in addition to the approval tests required by this subpart, show that the alternative materials...

  2. 77 FR 30327 - Approval of Information Collection Requirements; Comment Request

    2012-05-22

    ... affirmative action programs based on functional or business units. A copy of this information collection... the request for Office of Management and Budget approval of the information collection request. FOR... regardless of race, sex, color, national origin, religion, or status as a qualified individual with a...

  3. Alcohol addiction - the safety of available approved treatment options.

    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.

  4. Pharmacovigilance of biologicals : dynamics in post-approval safety learning

    Vermeer, N.S.

    2015-01-01

    Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict

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

    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. 5 CFR 7901.102 - Prior approval for outside employment.

    2010-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE TENNESSEE VALLEY AUTHORITY § 7901.102 Prior approval for outside... or designee. The written request shall be submitted through the employee's supervisor or human resource office and shall, at a minimum, identify the employer or other person for whom the services are to...

  7. 7 CFR 1735.94 - Final approval and closing procedure.

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Requirements for All Acquisitions and Mergers § 1735.94 Final approval and closing procedure. (a) Legal documents relating to the acquisition or merger, including copies of required franchises, commission orders...

  8. 18 CFR 300.10 - Application for confirmation and approval.

    2010-04-01

    ... REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS FOR FEDERAL POWER MARKETING ADMINISTRATIONS CONFIRMATION AND APPROVAL OF THE RATES OF FEDERAL POWER MARKETING ADMINISTRATIONS Filing Requirements § 300.10... with applicable laws and that it is the lowest possible rate consistent with sound business principles...

  9. 29 CFR 15.10 - Action on approved claim.

    2010-07-01

    .... (a) Payment. Payment of a claim approved under this subpart is contingent upon claimant's execution of a “Voucher for Payment Under Federal Tort Claims Act,” Standard Form 1145. When a claimant is represented by an attorney, the voucher for payment shall designate both the claimant and his or her attorney...

  10. 34 CFR 35.7 - Payment of approved claims.

    2010-07-01

    ... sign the voucher for payment, Standard Form 1145, before payment is made. (b) When the claimant is represented by an attorney, the voucher for payment (SF 1145) shall designate both the claimant and his... 34 Education 1 2010-07-01 2010-07-01 false Payment of approved claims. 35.7 Section 35.7 Education...

  11. 45 CFR 35.7 - Payment of approved claims.

    2010-10-01

    ... duly authorized agent shall sign the voucher for payment, Standard Form 1145, before payment is made. (b) When the claimant is represented by an attorney, the voucher for payment (SF 1145) shall... 45 Public Welfare 1 2010-10-01 2010-10-01 false Payment of approved claims. 35.7 Section 35.7...

  12. 40 CFR 10.7 - Payment of approved claim.

    2010-07-01

    ..., claimant or his duly authorized agent shall sign the voucher for payment, Standard Form 1145, before payment is made. (b) When the claimant is represented by an attorney, the voucher for payment (SF 1145... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Payment of approved claim. 10.7 Section...

  13. 12 CFR 793.7 - Payment of approved claims.

    2010-01-01

    ... voucher for payment, Standard Form 1145, before payment is made. (b) When the claimant is represented by an attorney, the voucher for payment (S.F. 1145) shall designate both the claimant and his attorney... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Payment of approved claims. 793.7 Section 793.7...

  14. 42 CFR 403.318 - Approval of State systems.

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Approval of State systems. 403.318 Section 403.318 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Recognition of State Reimbursement Control Systems § 403.318...

  15. Template for letter of approval by Research Supervisor

    Liliane Castets-Poupart

    a) As research supervisor of J. Smith, I confirm that I approve and support the research proposal submitted by the candidate. b) J. Smith has successfully completed the following course(s):. STAT 890: Statistics, Survey Design and Analysis INAF 540: International Affairs Dynamics. ECON 700: Qualitative Research Data.

  16. 76 FR 60774 - Review and Approval of Projects

    2011-09-30

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION: Notice of proposed rulemaking; reopening of comment period. SUMMARY: The purpose of this document is to inform the public of an extension of the comment period for...

  17. 77 FR 75915 - Review and Approval of Projects

    2012-12-26

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY... document contains proposed rules that would amend the project review regulations of the Susquehanna River... set forth in this proposed rulemaking is to make further modifications to the Commission's project...

  18. 77 FR 14272 - Review and Approval of Projects

    2012-03-09

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects CFR Correction In Title 18 of the Code of Federal Regulations, Part 400 to End, revised as of April 1, 2011, on page 118, in Sec. 806.6, (b)(1)(i) and (ii) are removed. [FR Doc. 2012-5837 Filed 3-8-12; 8:45 am] BILLING...

  19. 48 CFR 245.7305 - Sale approval and award.

    2010-10-01

    ... that the sale price is fair and reasonable, taking into consideration— (i) Knowledge or tests of the market; (ii) Current published prices for the property; (iii) The nature, condition, quantity, and...) Approve award to the responsible bidder whose bid is most advantageous to the Government, price and other...

  20. 9 CFR 355.34 - Labels, approval of, by Administrator.

    2010-01-01

    ... INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labels, approval of, by Administrator. 355.34 Section 355.34 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF...

  1. 18 CFR 806.6 - Transfer of approvals.

    2010-04-01

    ... change of ownership as a result of a corporate reorganization of the following types: (i) Where property... corporation. (ii) Where the corporation reorganization is merely a result of a change of the name, identity... and approval, to a new project sponsor upon a change of ownership of the project, subject to the...

  2. 22 CFR 64.7 - Approval of application.

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Approval of application. 64.7 Section 64.7 Foreign Relations DEPARTMENT OF STATE PUBLIC DIPLOMACY AND EXCHANGES PARTICIPATION BY FEDERAL EMPLOYEES IN... shall review the application and if satisfied that the criteria of § 516.5 are met shall inform the...

  3. 44 CFR 78.6 - Flood Mitigation Plan approval process.

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood...

  4. 28 CFR 20.23 - Documentation: Approval by OJARS.

    2010-07-01

    ... description of State policy on dissemination of criminal history record information. (c) Six months after the... Section 20.23 Judicial Administration DEPARTMENT OF JUSTICE CRIMINAL JUSTICE INFORMATION SYSTEMS State and Local Criminal History Record Information Systems § 20.23 Documentation: Approval by OJARS. Within 90...

  5. 22 CFR 3a.4 - Procedure for requesting approval.

    2010-04-01

    ... is also required by law for the applicant's acceptance of civil employment from a foreign government... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure for requesting approval. 3a.4 Section 3a.4 Foreign Relations DEPARTMENT OF STATE GENERAL ACCEPTANCE OF EMPLOYMENT FROM FOREIGN GOVERNMENTS...

  6. 75 FR 52737 - Pesticide Product Registrations; Unconditional and Conditional Approvals

    2010-08-27

    ...: Plasma Neem Oil Biological insecticide, EPA Registration Number 84185-4 for use on several food and non...) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), of registrations for pesticide... the end of the relevant registration approval summary using the instructions provided under FOR...

  7. A Document Imaging Technique for Implementing Electronic Loan Approval Process

    J. Manikandan

    2015-04-01

    Full Text Available The image processing is one of the leading technologies of computer applications. Image processing is a type of signal processing, the input for image processor is an image or video frame and the output will be an image or subset of image [1]. Computer graphics and computer vision process uses an image processing techniques. Image processing systems are used in various environments like medical fields, computer-aided design (CAD, research fields, crime investigation fields and military fields. In this paper, we proposed a document image processing technique, for establishing electronic loan approval process (E-LAP [2]. Loan approval process has been tedious process, the E-LAP system attempts to reduce the complexity of loan approval process. Customers have to login to fill the loan application form online with all details and submit the form. The loan department then processes the submitted form and then sends an acknowledgement mail via the E-LAP to the requested customer with the details about list of documents required for the loan approval process [3]. The approaching customer can upload the scanned copies of all required documents. All this interaction between customer and bank take place using an E-LAP system.

  8. Conditional approval: Japan lowers the bar for regenerative medicine products.

    Sipp, Douglas

    2015-04-02

    A new system for conditional approval of regenerative medicine products will allow products of undetermined efficacy to enter the Japanese market. The potential scientific, economic, and ethical implications of this program highlight the need for further discussion and refinement. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. 12 CFR 225.12 - Transactions not requiring Board approval.

    2010-01-01

    ... Merger Act. The merger or consolidation of a subsidiary bank of a bank holding company with another bank... application under this subpart if it determines that the merger or consolidation would have a significant adverse impact on the financial condition of the bank holding company, or otherwise requires approval...

  10. 5 CFR 6201.103 - Prior approval for outside employment.

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 6201.103 Section 6201.103 Administrative Personnel EXPORT-IMPORT BANK OF THE UNITED STATES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXPORT-IMPORT BANK OF THE UNITED STATES § 6201.103 Prior...

  11. 48 CFR 2052.215-77 - Travel approvals and reimbursement.

    2010-10-01

    ... reimbursement. 2052.215-77 Section 2052.215-77 Federal Acquisition Regulations System NUCLEAR REGULATORY....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

  12. 24 CFR 945.201 - Approval to designate housing.

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Approval to designate housing. 945.201 Section 945.201 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued) OFFICE OF ASSISTANT SECRETARY FOR PUBLIC AND INDIAN HOUSING, DEPARTMENT OF HOUSING AND...

  13. 25 CFR 1001.4 - Application review and approval.

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Application review and approval. 1001.4 Section 1001.4 Indians OFFICE OF THE ASSISTANT SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR SELF-GOVERNANCE... package and determine whether or not it is complete. Upon determination that it is complete, the name of...

  14. 29 CFR 1952.297 - Changes to approved plans.

    2010-07-01

    ... maximum authorized penalty levels. Amendments enacted in 1993 reflect the new State organizational... adapting Federal references to the State's administrative structure, was approved by the Assistant...-construction conferences with the Division of Industrial Relations for certain types of construction projects...

  15. 25 CFR 225.22 - Approval of minerals agreements.

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Approval of minerals agreements. 225.22 Section 225.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS OIL AND GAS, GEOTHERMAL... financial return to the Indian parties thereto; the extent, nature, value or disposition of the mineral...

  16. 5 CFR 6701.106 - Prior approval for outside employment.

    2010-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE GENERAL SERVICES ADMINISTRATION § 6701.106 Prior approval... to be performed; (4) The name and address of the prospective outside employer for which work will be... affects the outside employer and will disqualify himself from future participation in matters that could...

  17. 5 CFR 7101.102 - Prior approval for outside employment.

    2010-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL LABOR RELATIONS BOARD § 7101.102 Prior approval... forth, at a minimum: (i) The name of the employer; (ii) The nature of the legal activity or other work... designee may consult with the Designated Agency Ethics Official to ensure that the request for outside...

  18. Farmers' compliance with the use of approved cocoa pesticides in ...

    The survey evaluates the awareness and level of compliance in the use of approved cocoa pesticides by local farmers in selected cocoa producing states of Nigeria. Thirty farmers were randomly selected in Kwara, Ogun and Osun States. More than 70 percent of the farmers were aware of banned cocoa pesticides.

  19. Template for letter of approval by Research Supervisor

    Liliane Castets-Poupart

    a) the approval of the candidate's final version of their research proposal (not just the research topic) by the research supervisor; b) the list of courses already completed and still to be completed by the candidate in the master's/PhD program; c) confirmation that all courses will be completed, and, for PhD candidates,.

  20. 76 FR 41154 - Review and Approval of Projects

    2011-07-13

    ..., production fluids, tophole water, and unconventional natural gas development. In order to encourage the reuse... techniques. The ``gallon one'' regulatory threshold currently applicable under the regulations to gas well... rulemaking; provide for administrative approval of interbasin transfers of flowback and production fluids...

  1. 25 CFR 216.6 - Approval of exploration plan.

    2010-04-01

    ... control fire, soil erosion, pollution of surface and ground water, damage to fish and wildlife or other... 25 Indians 1 2010-04-01 2010-04-01 false Approval of exploration plan. 216.6 Section 216.6 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS SURFACE EXPLORATION, MINING, AND...

  2. 43 CFR 23.7 - Approval of exploration plan.

    2010-10-01

    ... measures to be taken to prevent or control fire, soil erosion, pollution of surface and ground water... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Approval of exploration plan. 23.7 Section 23.7 Public Lands: Interior Office of the Secretary of the Interior SURFACE EXPLORATION, MINING AND...

  3. 7 CFR 1717.608 - RUS approval of contracts.

    2010-01-01

    ... the contracts or arrangements, and regardless of whether or not a Federal power marketing agency is a party to any of them. (d) System management and maintenance contracts. RUS approval of contracts for the management and operation of a borrower's electric system or for the maintenance of the electric system is...

  4. 10 CFR 725.15 - Requirements for approval of applications.

    2010-01-01

    ... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... propulsion and is directly engaged in or proposes to engage in a substantial research and development program in such field of work; or (ii) Is engaged in or proposes to engage in a substantial study program in...

  5. 76 FR 63833 - Commission Approval of Divestiture Agreements

    2011-10-14

    ... example, ``immaterial'' may have a specific meaning under contract law that is not fully consistent with... process for approval of ministerial and other minor contract modifications that will not diminish the... competition laws and any other provisions in the order. This evaluation includes review of the purchase and...

  6. 24 CFR 245.430 - Decision on request for approval.

    2010-04-01

    ... (3) In the case of HUD's approval of a conversion of residential units in a multifamily housing... corporation or association, which residential rental units are to be converted and whether the conversion is... a conversion from project-paid utilities to tenant-paid utilities or a reduction in tenant utility...

  7. 30 CFR 906.10 - State regulatory program approval.

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false State regulatory program approval. 906.10 Section 906.10 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE COLORADO § 906.10 State...

  8. 27 CFR 4.93 - Approval of grape variety names.

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Approval of grape variety names. 4.93 Section 4.93 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.93...

  9. 27 CFR 4.91 - List of approved prime names.

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false List of approved prime names. 4.91 Section 4.91 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.91 List...

  10. 14 CFR 121.909 - Approval of Advanced Qualification Program.

    2010-01-01

    ... criteria. Each AQP must have separate curriculums for indoctrination, qualification, and continuing... the training and evaluation of CRM and technical skills and knowledge. An application for approval of... must meet all the requirements of this subpart. (2) Each indoctrination, qualification, and continuing...

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

    Dal’Asta, Ana Paula; Brigatti, Newton; Amaral, Silvana; Escada, Maria Isabel Sobral; Monteiro, Antonio Miguel Vieira

    2012-01-01

    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-...

  12. Competent authority approval of package designs in the United Kingdom

    Morgan-Warren, E.J.

    1999-01-01

    Type B packages and all packages containing fissile material, as well as special form radioactive materials, special arrangements and certain shipments, are required to be approved by the competent authority. In the United Kingdom competent authority approval is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division (RMTD) of the Department of the Environment, Transport and the Regions (DETR). Competent authority approval of a package design is given only after a detailed assessment of the design by the specialist staff of RMTD. There are three facets to the assessment procedure, namely engineering, criticality and radiation protection, and quality assurance. The engineering assessor ensures that the designer has demonstrated the integrity of the containment and shielding systems under the regulatory conditions. The criticality assessor examines criticality safety and radiation protection measures, and together with the engineering assessor, decides whether this is maintained under regulatory conditions. The quality assurance assessor verifies that the applicant has established the necessary controls to ensure that the design requirements are met. The applicant is responsible for making the case for approval, but the assessment is facilitated if the competent authority is involved with the designer at an early stage in development and during the construction of any test prototype. When a regulatory test programme is required, it is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test programme, the applicant submits a formal application, supported by a design safety report (DSR). The DSR provides a full analysis of the design and the test results, including the behaviour of the package under normal and accident conditions of transport, the manufacturing and maintenance procedures, quality assurance and the emergency provisions for the operation of the package

  13. Research ethics board approval for an international thromboprophylaxis trial.

    Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

    2012-06-01

    Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. The approval process for biosimilar erythropoiesis-stimulating agents.

    Wish, Jay B

    2014-09-05

    A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well. Copyright

  15. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    2010-01-01

    ... combat money laundering. The Board also may take into account whether the home country supervisor is developing a legal regime to address money laundering or is participating in multilateral efforts to combat money laundering. In approving an application under this paragraph (c)(1)(iii), the Board, after...

  16. 75 FR 36058 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

    2010-06-24

    ... Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and...: Extension and revision of a currently approved information collection. Abstract: Marketing order programs... / Thursday, June 24, 2010 / Notices#0;#0; [[Page 36058

  17. 76 FR 68756 - Public Information Collections Approved by the Office of Management and Budget (OMB)

    2011-11-07

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

  18. 78 FR 54626 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal...

    2013-09-05

    ...-01] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal... Commerce's approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal Identity... Information Processing Standards (FIPS). Homeland Security Presidential Directive (HSPD) 12, entitled ``Policy...

  19. When your words count: a discriminative model to predict approval of referrals

    Adol Esquivel

    2009-12-01

    Conclusions Three iterations of the model correctly predicted at least 75% of the approved referrals in the validation set. A correct prediction of whether or not a referral will be approved can be made in three out of four cases.

  20. 76 FR 39874 - Information Collection Approved by the Office of Management and Budget

    2011-07-07

    ... FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by the Office of Management and... Commission has received Office of Management and Budget (OMB) approval for the following public information... the carriers through the Automated Reporting Management Information System (ARMIS). Federal...

  1. 75 FR 52710 - Notice of Request for Extension of Approval of an Information Collection; National Management...

    2010-08-27

    ...] Notice of Request for Extension of Approval of an Information Collection; National Management Information... approval of an information collection associated with cooperative wildlife damage management programs...: For information on the national management information system for cooperative wildlife damage...

  2. 77 FR 71774 - Notice of Request for Extension of Approval of an Information Collection; National Management...

    2012-12-04

    ...] Notice of Request for Extension of Approval of an Information Collection; National Management Information... approval of an information collection associated with cooperative wildlife damage management programs... FURTHER INFORMATION CONTACT: For information on the national management information system for cooperative...

  3. 78 FR 69664 - Proposed Information Collection Request; Comment Request; Approval of State Coastal Nonpoint...

    2013-11-20

    ... Collection Request; Comment Request; Approval of State Coastal Nonpoint Pollution Control Programs AGENCY... to submit an information collection request (ICR), ``Approval of State Coastal Nonpoint Pollution... Watershed Protection Division, Office of Wetlands Oceans and Watersheds, Mail Code 4503-T, Environmental...

  4. 75 FR 57737 - Notice of Request for Approval of an Information Collection; National Veterinary Services...

    2010-09-22

    ...] Notice of Request for Approval of an Information Collection; National Veterinary Services Laboratories... Service's intention to request approval of an information collection associated with National Veterinary...' Information Collection Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: National Veterinary...

  5. 75 FR 31508 - Notice of Projects Approved for Consumptive Uses of Water

    2010-06-03

    ... County, Pa.; Approval Date: April 13, 2010. 23. Chesapeake Appalachia, LLC, Pad ID: Henry, ABR-20100423..., Susquehanna County, Pa.; Approval Date: April 14, 2010. 26. EOG Resources, Inc., Pad ID: JENKINS 1H, ABR...

  6. 21 CFR 56.113 - Suspension or termination of IRB approval of research.

    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...

  7. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    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...

  8. 42 CFR 410.142 - CMS process for approving national accreditation organizations.

    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...

  9. 75 FR 56530 - Public Information Collections Approved by Office of Management and Budget

    2010-09-16

    ... Management and Budget (OMB) approval for the following public information collections pursuant to the... Office of Management and Budget (OMB).\\2\\ On February 17, 2010, the Commission received OMB approval.\\3... Collection(s) Being Submitted for Review and Approval to the Office of Management and Budget (OMB), Comments...

  10. 77 FR 46760 - Information Collections Approved by the Office of Management and Budget

    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...

  11. 7 CFR 4290.510 - Approval of RBIC's Investment Adviser/Manager.

    2010-01-01

    ... INVESTMENT COMPANY (âRBICâ) PROGRAM Managing the Operations of a RBIC Management and Compensation § 4290.510... approval of the management contract. Approval of an Investment Adviser/Manager for one RBIC does not... 7 Agriculture 15 2010-01-01 2010-01-01 false Approval of RBIC's Investment Adviser/Manager. 4290...

  12. 46 CFR 159.005-15 - Approval of equipment or material: Suspensions, withdrawals, and terminations.

    2010-10-01

    ..., withdrawals, and terminations. 159.005-15 Section 159.005-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF..., withdrawals, and terminations. (a) The Commandant suspends an approval issued under this subchapter in...

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

    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.

  14. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    2012-10-04

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

  15. 7 CFR 1717.159 - Applications for RUS approvals of mergers.

    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...

  16. 29 CFR 1952.10 - Requirements for approval of State posters.

    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...

  17. 77 FR 48167 - Approved Tribal-State Class III Gaming Compact; Indian Gaming

    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...

  18. 49 CFR 1522.121 - Security threat assessments for personnel of TSA-approved validation firms.

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false Security threat assessments for personnel of TSA... FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation... for personnel of TSA-approved validation firms. Each of the following must successfully complete a...

  19. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    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...

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

    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.

  1. 25 CFR 1200.15 - What is the approval process for management plans?

    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...

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

    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.

  3. 75 FR 63445 - Vessel Monitoring Systems; Approved Mobile Transmitting Units and Communications Service...

    2010-10-15

    ... Monitoring Systems; Approved Mobile Transmitting Units and Communications Service Providers for Use in the... features of the VMS. ADDRESSES: To obtain copies of the list of NOAA-approved VMS mobile transmitting units and NOAA-approved VMS communications service providers, please contact the VMS Support Center at...

  4. 30 CFR 250.119 - Will MMS approve subsurface gas storage?

    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...

  5. 30 CFR 285.103 - When may MMS prescribe or approve departures from these regulations?

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false When may MMS prescribe or approve departures... CONTINENTAL SHELF General Provisions § 285.103 When may MMS prescribe or approve departures from these regulations? (a) The MMS may prescribe or approve departures from these regulations when departures are...

  6. 78 FR 28503 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter Counties...

    2013-05-15

    ...: FRL-9812-4] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter...). ACTION: Direct final rule. SUMMARY: EPA is approving Indiana's request to revise the Lake and Porter... approving new MOVES2010a-based budgets for the Lake and Porter County, Indiana 1997 8-hour ozone maintenance...

  7. 75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

    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...

  8. 75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

    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...

  9. 78 FR 29780 - Fees for Testing, Evaluation, and Approval of Mining Products

    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...

  10. 30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.

    2010-07-01

    ... District Manager and posting. 71.301 Section 71.301 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... plan; approval by District Manager and posting. (a) The District Manager will approve respirable dust control plans on a mine-by-mine basis. When approving respirable dust control plans, the District Manager...

  11. 42 CFR 8.6 - Withdrawal of approval of accreditation bodies.

    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...

  12. 7 CFR 4290.480 - Prior approval of changes to RBIC's business plan.

    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...

  13. Waste feed delivery environmental permits and approvals plan

    Papp, I.G.

    1998-01-01

    This document describes the range of environmental actions, including required permits and other agency approvals, that may affect waste feed delivery (WFD) activities in the Hanford Site's Tank Waste Remediation System (TWRS). This plan expands on the summary level information in the Tank Waste Remediation System Environmental Program Plan (HNF 1773) to address requirements that are most pertinent to WFD. This plan outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for WFD to proceed. Appendices at the end of this plan provide preliminary cost and schedule estimates for implementing the selected strategies. The rest of this section summarizes the scope of WFD activities, including important TWRS operating information, and describes in more detail the objectives, structure, and content of this plan

  14. Review of experiments for research reactors - approved 1974

    Anon.

    1977-01-01

    This standard establishes guidelines for the review and approval of experiments performed at research reactor facilities. This standard identifies the major areas that shall be reviewed for each experiment to ensure that it (a) falls within the limits delineated in the technical specifications, (b) does not present an unreviewed safety question as defined in 10 CFR Section 50.59 π2-, (c) does not constitute a threat to the health and safety of any individual or group of individuals, and (d) does not constitute a hazard to the reactor facility or other equipment. In addition, this standard recommends a system for classifying experiments to establish levels of review and approval commensurate with the level of risk inherent in the experiment

  15. THPdb: Database of FDA-approved peptide and protein therapeutics.

    Salman Sadullah Usmani

    Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.

  16. Supplements and other changes to an approved application. Final rule.

    2004-04-08

    The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

  17. Digital repositories certification: the Data Seal of Approval

    Stefano Allegrezza

    2015-09-01

    Full Text Available In recent years, it has become increasingly common to entrust records to digital repositories; this assumes an implicit confidence in the repositories reliability, and therefore is urgent to identify the criteria on which to evaluate them. The Data Seal of Approval is a set of sixteen criteria that can be used to ensure that archived data can still be found, understood and used in the future. It is a basic level of certification but it is very useful to highlight the strengths and weaknesses of the deposit; in any case, it constitutes a solid basis for further certification of compliance to ISO 16363 or DIN 31644. The aim of this article is to provide an overview of Data Seal of Approval in the wider context of digital repositories' certification.

  18. A Safety Management Model for FAR 141 Approved Flight Schools

    Mendonca, Flavio A. C.; Carney, Thomas Q

    2017-01-01

    The Safety Management Annex (Annex 19), which became applicable in November 2013, consolidates safety management provisions previously contained in six other International Civil Aviation Organization (ICAO) Annexes, and will serve as a resource for overarching state safety management responsibilities. Through Annex 19, ICAO has required that its member states develop and implement safety management systems (SMS) to improve safety. This mandate includes an approved training organization that i...

  19. Approved but non-funded vaccines: accessing individual protection.

    Scheifele, David W; Ward, Brian J; Halperin, Scott A; McNeil, Shelly A; Crowcroft, Natasha S; Bjornson, Gordean

    2014-02-07

    Funded immunization programs are best able to achieve high participation rates, optimal protection of the target population, and indirect protection of others. However, in many countries public funding of approved vaccines can be substantially delayed, limited to a portion of the at-risk population or denied altogether. In these situations, unfunded vaccines are often inaccessible to individuals at risk, allowing potentially avoidable morbidity and mortality to continue to occur. We contend that private access to approved but unfunded vaccines should be reconsidered and encouraged, with recognition that individuals have a prerogative to take advantage of a vaccine of potential benefit to them whether it is publicly funded or not. Moreover, numbers of "approved but unfunded" vaccines are likely to grow because governments will not be able to fund all future vaccines of potential benefit to some citizens. New strategies are needed to better use unfunded vaccines even though the net benefits will fall short of those of funded programs. Canada, after recent delays funding several new vaccine programs, has developed means to encourage private vaccine use. Physicians are required to inform relevant patients about risks and benefits of all recommended vaccines, publicly funded or not. Likewise, some provincial public health departments now recommend and promote both funded and unfunded vaccines. Pharmacists are key players in making unfunded vaccines locally available. Professional organizations are contributing to public and provider education about unfunded vaccines (e.g. herpes zoster, not funded in any province). Vaccine companies are gaining expertise with direct-to-consumer advertising. However, major challenges remain, such as making unfunded vaccines more available to low-income families and overcoming public expectations that all vaccines will be provided cost-free, when many other recommended personal preventive measures are user-pay. The greatest need is to

  20. Rotary mode core sampling approved checklist: 241-TX-113

    Fowler, K.D.

    1998-01-01

    The safety assessment for rotary mode core sampling was developed using certain bounding assumptions, however, those assumptions were not verified for each of the existing or potential flammable gas tanks. Therefore, a Flammable Gas/Rotary Mode Core Sampling Approved Checklist has been completed for tank 241-TX-113 prior to sampling operations. This transmittal documents the dispositions of the checklist items from the safety assessment

  1. Three Drugs Approved for Urothelial Carcinoma by FDA.

    2017-07-01

    The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.

  2. 40 CFR 52.385 - EPA-approved Connecticut regulations.

    2010-07-01

    ... a specific situation, consult the plan identified in § 52.370. To the extent that this table.../4/06 8/31/06 71 FR 51761 (c)(95) Only the automotive refinishing requirements of 22a-174-3b are...) Program. 11/1/82 6/28/83 48 FR 29689 (c) 28 Simkins Industries—approved under the State Energy Trade...

  3. Rotary mode core sampling approved checklist: 241-TX-116

    FOWLER, K.D.

    1999-01-01

    The safety assessment for rotary mode core sampling was developed using certain bounding assumptions, however, those assumptions were not verified for each of the existing or potential flammable gas tanks. Therefore, a Flammable Gas/Rotary Mode Core Sampling Approved Checklist has been completed for tank 241-TX-116 prior to sampling operations. This transmittal documents the dispositions of the checklist items from the safety assessment

  4. Biomedicines?Moving Biologic Agents into Approved Treatment Options

    Cornetta, Kenneth

    2013-01-01

    The development of biologic agents for therapeutic purposes, or biomedicines, has seen an active area of research both at the bench and in clinical trials. There is mounting evidence that biologic products can provide effective therapy for diseases that have been unresponsive to traditional pharmacologic approaches. Monoclonal antibody therapy for cancer and rheumatologic diseases has become a well accepted part of disease treatment plans. Gene therapy products have been approved in China and...

  5. Evaluating the Status Approvals about Cinema (1989 to 2009

    Elahe Dehghan Pishe

    2012-06-01

    Full Text Available The present study aimed to study and evaluate the state approvals in the field of The cabinet approval in mentioned period 1989 to 2009 in Iran. cinema from which keywords related to cinema is shown in their titles or texts will form this The method of this research is content analysis and the instrument used .research is a checklist with r= 0.91 using Scott formula. The content analysis checklist was constructed based on the model which classified arts policies into four types namely: facilitator, patron, architect and engineer. The findings revealed that in the investigated twenty-year process. the various states having come in 4-year intervals have been different in using the types of arts policies. The state in the first and second presidency of Akbar Hashemi Rafsanjani used the facilitator and engineer types; in the first presidency of Mohammad Khatami used the patron and architect types, in his second presidency the architect type; and finally in the first presidency of Mahmoud Ahmadinejad used the architect and engineer types more than the other types. Although there has been a difference between the types of arts policy in the cinema approvals in different periods of presidency. the architect and engineer types of arts policies have been used more than the facilitator and patron types.

  6. An approved personal dosimetry service based on an electronic dosimeter

    Marshall, T.O.; Bartlett, D.T.; Burgess, P.H.; Campbell, J.I.; Hill, C.E.; Pook, E.A.; Sandford, D.J.

    1991-01-01

    At the Second Conference on Radiation Protection and Dosimetry a paper was presented which, in part, announced the development of an electronic dosimeter to be undertaken in the UK by the National Radiological Protection Board (NRPB) and Siemens Plessey Controls Ltd. This dosimeter was to be of a standard suitable for use as the basis of an approved personal dosimetry service for photon and beta radiations. The project has progressed extremely well and dosimeters and readers are about to become commercially available. The system and the specification of the dosimeter are presented. The NRPB is in the process of applying for approval by the Health and Safety Executive (HSE) to operate as personal monitoring service based on this dosimeter. As part of the approval procedure the dosimeter is being type tested and is also undergoing an HSE performance test and wearer trials. The tests and the wearer trials are described and a summary of the results to date presented. The way in which the service will be organized and operated is described and a comparison is made between the running of the service and others based on passive dosimeters at NRPB

  7. Navigating the Process of Ethical Approval: A methodological note

    Eileen Carey, RNID, BSc. (hons, MSc.

    2010-12-01

    Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

  8. A viewpoint on the approval context of strategic environmental assessments

    Kontić, Branko; Kontić, Davor

    2012-01-01

    A reflection on the last report from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application and effectiveness of the Directive on Strategic Environmental Assessment (SEA) is provided. It covers the inadequacies of the approval/permitting context of SEA, which appears to be increasingly applied by a significant number of Member States in recent years. A viewpoint is provided on the main deficiencies of such praxis. As a practical defence of the planning context of SEA, the authors propose that the EC should consider a clear recommendation to Member States to cease performing SEA in the approval/permitting context until proper amendments to the SEA Directive are made and implemented. - Highlights: ► Administrative and permitting context of SEA, has ousted the primary environmental impact assessment goal. ► The approval context moves from the environmental protection to the area of political power and economy. ► SEA and EIA are misused. ► Environmental evaluations should be used for improving the projects/plans/programmes and not for permitting them.

  9. Zohydro approval by food and drug administration: controversial or frightening?

    Manchikanti, Laxmaiah; Atluri, Sairam; Candido, Kenneth D; Boswell, Mark V; Simopoulos, Thomas T; Grider, Jay S; Falco, Frank J E; Hirsch, Joshua A

    2014-01-01

    The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA's own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the U.S. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health

  10. Time to institutional review board approval with local versus central review in a multicenter pragmatic trial.

    Neuman, Mark D; Gaskins, Lakisha J; Ziolek, Tracy

    2018-02-01

    Central institutional review board (IRB) review will be required for National Institutes of Health-funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB review for multicenter studies. We compared the amount of time required for central versus local IRB review and approval for sites in one ongoing multicenter randomized trial. The REGAIN Trial (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; clinicaltrials.gov number: NCT02507505) is an ongoing randomized trial comparing standard-care spinal anesthesia to standard-care general anesthesia for patients undergoing hip fracture surgery. After approval of the protocol by the sponsor IRB, each participating US site opted either to submit the protocol for local IRB review or to designate the sponsor IRB as the IRB of record (i.e. central IRB) via an authorization agreement after a limited local review. For each US REGAIN site approved through 18 April 2017, we assessed (1) the time in calendar days from protocol receipt to IRB submission, (2) the time in calendar days from IRB submission to IRB approval, and (3) the total time in calendar days from protocol receipt to IRB approval (i.e. time from protocol receipt to IRB submission plus time from IRB submission to IRB approval). The main study protocol was submitted to the sponsor IRB on 25 May 2015 and approved on 8 July 2015 (44 days). Out of 34 sites, 9 received initial approval from the central (sponsor) IRB; 25 sought initial approval via local review. The median time from protocol receipt to IRB submission was 39 days for sites approved by the central IRB (interquartile range: 35-134) versus 58 days for sites approved via local review (interquartile range: 41-105; p = 0.711). The median time from IRB submission to IRB approval for sites approved by

  11. Ciprofloxacin Use in Hospitalized Children: Approved or Off-label?

    Faghihi, Toktam; Tekmehdash, Leila Yavari; Radfar, Mania; Gholami, Kheirollah

    2017-01-01

    Fluoroquinolones are not routinely used as the first-line antimicrobial therapy in pediatrics. The American Academy of Pediatrics (AAP) and the United States Food and Drug Administration (FDA) approved fluoroquinolones on certain indications in children. The aim of this study was to evaluate to what extent and how ciprofloxacin is used on approved indication or as off-label. Besides, dose adequacy and treatment duration were assessed. In a 10-month observational study, all children receiving systemic ciprofloxacin were assessed. We classified ciprofloxacin prescription to an AAP/FDA or off-label indication. The off-label prescriptions were further categorized to justified and unjustified therapy subgroups. The AAP/FDA category and the justified subgroup constituted the appropriate prescriptions. During the study period, 32 patients were prescribed ciprofloxacin. In general, 37% (12) of prescriptions determined to be appropriate. Of the appropriate prescriptions, 7 were AAP/FDA-approved indications. Children with Crohn's disease with abdominal abscess and children with infectious bloody diarrhea constituted the off-label; justified therapy subgroup. Unjustified prescriptions mainly occurred in the presence of a suitable alternative antibiotic for ciprofloxacin. Mean ± SD of ciprofloxacin dose (mg/kg/day) and duration (days) were 21.25 ± 6.35 and 13.56 ± 8.48, respectively. Of the appropriate prescriptions, 41% were underdosed. Underdosing was more encountered in patients with cystic fibrosis. Duration of treatment of the appropriate prescriptions was determined to be appropriate. The majority of children were receiving ciprofloxacin off-label and in an inappropriate manner. This issue emphasizes that antimicrobial stewardship program on ciprofloxacin use in pediatric hospitals should be implemented. Further studies evaluating clinical and microbiological outcomes of these programs in children are needed.

  12. How to Improve the Likelihood of CDM Approval?

    Brandt, Urs Steiner; Svendsen, Gert Tinggaard

    2014-01-01

    How can the likelihood of Clean Development Mechanism (CDM) approval be improved in the face of institutional shortcomings? To answer this question, we focus on the three institutional shortcomings of income sharing, risk sharing and corruption prevention concerning afforestation/reforestation (A....../R). Furthermore, three main stakeholders are identified, namely investors, governments and agents in a principal-agent model regarding monitoring and enforcement capacity. Developing countries such as West Africa have, despite huge potentials, not been integrated in A/R CDM projects yet. Remote sensing, however...

  13. Coastal nonpoint pollution control program: Program development and approval guidance

    1993-01-01

    The document, developed by NOAA and EPA, contains guidance for states in developing and implementing their coastal nonpoint pollutant source programs. It describes the requirements that must be met, including: the geographic scope of the program; the pollutant sources to be addressed; the types of management measures used; the establishment of critical areas; technical assistance, public participation, and administrative coordination; and, the process for program submission and Federal approval. The document also contains the criteria by which NOAA and EPA will review the states' submissions

  14. Biomedicines—Moving Biologic Agents into Approved Treatment Options

    Kenneth Cornetta

    2013-03-01

    Full Text Available The development of biologic agents for therapeutic purposes, or biomedicines, has seen an active area of research both at the bench and in clinical trials. There is mounting evidence that biologic products can provide effective therapy for diseases that have been unresponsive to traditional pharmacologic approaches. Monoclonal antibody therapy for cancer and rheumatologic diseases has become a well accepted part of disease treatment plans. Gene therapy products have been approved in China and Europe. Bioengineering of new agents capitalizing on microRNA biology, nanoparticle technology, stem cell biology, and an increasing understanding of immunology predict a rich future for product development. [...

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

    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.

  16. 14 CFR 193.17 - How must design and production approval holders handle information they receive from the FAA...

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false How must design and production approval... REGULATIONS PROTECTION OF VOLUNTARILY SUBMITTED INFORMATION § 193.17 How must design and production approval... under § 193.9(a)(2) to the holders of design approvals of production approvals issued by the FAA, the...

  17. Integration of new technology into clinical practice after FDA approval.

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  18. Observations and suggestions for improved transport/packaging approvals

    Vaughan, C.

    2004-01-01

    This paper has been developed from my personal experience as Manager, Facility Licensing with Global Nuclear Fuels in Wilmington, NC over the past four years. All of my examples involve the movement of Type A, fissile material, however, the observations and recommendations clearly have universal application to the movement of other nuclear materials. The observations are global in nature embracing the US, Canada, Japan, the European Union as well others. All of these countries openly report and ascribe to the fact that they have adopted the IAEA Regulations for the Safe Transport of Radioactive Material. The materials involved typically include UF 6 , UO 2 powder, BWR fuel assemblies and process intermediates. Many of the papers here discuss the technical details of testing and the interpretation of the test results associated with the approval of transport packages. The technical details of demonstrating safety are of course very important in the overall assurance of safety. My discussion involves, for the most part, Section VIII - Approval and Administrative Requirements of TS-R-1. I have focused on this area because significant non-productive time is spent on these administrative matters and to a degree this non-productive time spent potentially detracts from meeting the objective of safe transport of nuclear materials

  19. Proposed Changes to EPA's Transuranic Waste Characterization Approval Process

    Joglekar, R.D.; Feltcorn, E.M.; Ortiz, A.M.

    2003-01-01

    This paper describes the changes to the waste characterization (WC) approval process proposed in August 2002 by the U.S. Environmental Protection Agency (EPA or the Agency or we). EPA regulates the disposal of transuranic (TRU) waste at the Waste Isolation Pilot Plant (WIPP) repository in Carlsbad, New Mexico. EPA regulations require that waste generator/storage sites seek EPA approval of WC processes used to characterize TRU waste destined for disposal at WIPP. The regulations also require that EPA verify, through site inspections, characterization of each waste stream or group of waste streams proposed for disposal at the WIPP. As part of verification, the Agency inspects equipment, procedures, and interviews personnel to determine if the processes used by a site can adequately characterize the waste in order to meet the waste acceptance criteria for WIPP. The paper discusses EPA's mandate, current regulations, inspection experience, and proposed changes. We expect that th e proposed changes will provide equivalent or improved oversight. Also, they would give EPA greater flexibility in scheduling and conducting inspections, and should clarify the regulatory process of inspections for both Department of Energy (DOE) and the public

  20. An analysis of legal warnings after drug approval in Thailand.

    Sriphiromya, Pakawadee; Theeraroungchaisri, Anuchai

    2015-02-01

    Drug risk management has many tools for minimizing risk and black-boxed warnings (BBWs) are one of those tools. Some serious adverse drug reactions (ADRs) emerge only after a drug is marketed and used in a larger population. In Thailand, additional legal warnings after drug approval, in the form of black-boxed warnings, may be applied. Review of their characteristics can assist in the development of effective risk mitigation. This study was a cross sectional review of all legal warnings imposed in Thailand after drug approval (2003-2012). Any boxed warnings for biological products and revised warnings which were not related to safety were excluded. Nine legal warnings were evaluated. Seven related to drugs classes and two to individual drugs. The warnings involved four main types of predictable ADRs: drug-disease interactions, side effects, overdose and drug-drug interactions. The average time from first ADRs reported to legal warnings implementation was 12 years. The triggers were from both safety signals in Thailand and regulatory measures in other countries outside Thailand. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Safety review and approval process for the TFTR

    Levine, J.D.; Howe, H.J.; Howe, K.E.

    1983-01-01

    The design, construction, and operation of the Tokamak Fusion Test Reactor (TFTR) has undergone an extensive safety and enviromental analysis involving Princeton Plasma Physics Laboratory (PPPL), the U.S. Department of Energy (DOE), the Ebasco/Grumman Industrial Subcontractor Team, and other organizations. This analysis, which is continuing during the TFTR operational phase, has been facilitated by the preparation, review and approval of several documents, including an Environmental Statement (Draft and Final), a Preliminary Safety Analysis Report (PSAR), a Final Safety Analysis Report (FSAR), Operations Safety Requirements (OSRs) and Safety Requirements (SRs), and various Operating and Maintenance Manuals. Through TFTR Safety Group participation in formal system design evaluations, change control boards, and reviews of project procurement and installation documentation, the TFTR Management Configuration Control System assures that all aspects of the project, including proposed design, installation and operational changes, receive prompt and thorough safety analyses. These efforts will continue as the TFTR Program moves into the neutral beam and D-T operational phases. The safety review and approval experience that has been acquired on the TFTR Project should serve as a foundation for similar efforts on future fusion devices

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

    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.

  3. Investor Outlook: Rising from the Ashes; GSK's European Approval of Strimvelis for ADA-SCID.

    Schimmer, Joshua; Breazzano, Steven

    2016-06-01

    GlaxoSmithKline's (GSK) and partner San Raffaele Telethon Institute for Gene Therapy's recent positive European approval for Strimvelis for treatment of severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID) represents the second EU-approved gene therapy and the first γ-retrovirus and first ex vivo gene therapy. In this article we discuss the significance and implications of this historic approval for the broader gene therapy field.

  4. 30 CFR 285.706 - How do I nominate a CVA for MMS approval?

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I nominate a CVA for MMS approval? 285..., Fabrication, and Installation Certified Verification Agent § 285.706 How do I nominate a CVA for MMS approval... (§ 285.610(a)(9)) or GAP (§ 285.645(c)(5)), you must nominate a CVA for MMS approval. You must specify...

  5. 7 CFR 319.8-11 - From approved areas of Mexico.

    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...

  6. Evaluation of regulatory processes affecting nuclear power plant early site approval and standardization

    1983-12-01

    This report presents the results of a survey and evaluation of existing federal, state and local regulatory considerations affecting siting approval of power plants in the United States. Those factors that may impede early site approval of nuclear power plants are identified, and findings related to the removal of these impediments and the general improvement of the approval process are presented. A brief evaluation of standardization of nuclear plant design is also presented

  7. Vienna Agreement law 15.986 it approve Vienna Agreement for Protection ozone layer and annex

    1988-01-01

    The Agreement of Vienna is approved with respect to the protection of the Layer of Ozono, definitions,general duties, research and observations systematics, co-operation in the Spheres Scientific Juridical, and information, Technological Conference, transmission from the protocols, amends, secretariat, adoption to the agreement or the protocols, adoption and amendment of controversy, signing, ratify, approve annexes, solution or vote, relation approving, adhesion, rights between the present agreement and its protocols, entrance in vigor, reserves, retirement, deposition, exchange of information [es

  8. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Packages

    1993-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  9. 75 FR 68315 - Notice of Request for Extension of a Currently Approved Information Collection

    2010-11-05

    .... Type of Request: Extension and revision of a currently approved information collection. Abstract: The... contacts, including packers, processors, producers, brokers, and retailers. These reports are compiled on a...

  10. 7 CFR 4290.470 - Prior approval of merger, consolidation, or reorganization of RBIC.

    2010-01-01

    ... merge, consolidate, change form of organization (corporation, limited liability company, or limited partnership) or reorganize without the Secretary's prior written approval. Any such merger, consolidation, or...

  11. Application for approval of the Cold Lake Expansion Project

    1997-02-01

    Imperial Oil Resources Limited applied to the Alberta Energy and Utilities Board for approval to expand its operations at Cold Lake, Alberta and to construct and operate an electrical power plant and electrical generator substation. Imperial Oil also applied to the Alberta Environmental Protection Branch to prepare the site for a new central plant for the expansion. The company also requested a short-term groundwater withdrawal permit to provide temporary water supply for start-up. Imperial Oil claims that the project is in the public interests given the project's social, environmental and economic effects. Imperial Oil submitted this 4 volume document in support of their application. The documentation includes a project description, an environmental impact assessment, a biophysical and resource use assessment, a socio-economic assessment, and environmental baseline studies. The project is scheduled for start-up in late 1999 at a total cost of at least $440 million. refs., tabs., figs

  12. 1994 Characterization report for the state approved land disposal site

    Swanson, L.C.

    1994-01-01

    This report summarizes the results of characterization activities at the proposed state-approved land disposal site (SALDS); it updates the original characterization report with studies completed since the first characterization report. The initial characterization report discusses studies from two characterization boreholes, 699-48-77A and 699-48-77B. This revision includes data from implementation of the Groundwater Monitoring Plan and the Aquifer Test Plan. The primary sources of data are two down-gradient groundwater monitoring wells, 699-48-77C and 699-48-77D, and aquifer testing of three zones in well 699-48-77C. The SALDS is located on the Hanford Site, approximately 183 m north of the 200 West Area on the north side of the 200 Areas Plateau. The SALDS is an infiltration basin proposed for disposal of treated effluents from the 200 Areas of Hanford

  13. Factors related to drug approvals: predictors of outcome?

    Liberti, Lawrence; Breckenridge, Alasdair; Hoekman, Jarno; McAuslane, Neil; Stolk, Pieter; Leufkens, Hubert

    2017-06-01

    There is growing interest in characterising factors associated with positive regulatory outcomes for drug marketing authorisations. We assessed empirical studies published over the past 15 years seeking to identify predictive factors. Factors were classified to one of four 'factor clusters': evidentiary support; product or indication characteristics; company experience or strategy; social and regulatory factors. We observed a heterogeneous mix of technical factors (e.g., study designs, clinical evidence of efficacy) and less studied social factors (e.g., company-regulator interactions). We confirmed factors known to be of relevance to drug approval decisions (imperative) and a cohort of less understood (compensatory) social factors. Having robust supportive clinical evidence, addressing rare or serious illness, following scientific advice and prior company experience were associated with positive outcomes, which illustrated the multifactorial nature of regulatory decision making and factors need to be considered holistically while having varying, context-dependent importance. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Request for approval, vented container annual release fraction

    HILL, J.S.

    1999-01-01

    In accordance with the approval conditions for Modification to the Central Waste Complex (CWC) Radioactive Air Emissions Notice of Construction (NOC). dated August 24,1998, a new release fraction has been developed for submittal to the Washington State Department of Health (WDOH). The proposed annual release fraction of 2.50 E-14 is proposed for use in future NOCs involving the storage and handling operations associated with vented containers on the Hanford Site. The proposed annual release fraction was the largest release fraction calculated from alpha measurements of the NucFil filters from 10 vented containers consisting of nine 55-gallon drums and one burial box with dimensions of 9.3 x 5.7 x 6.4 feet. An annual release fraction of 2.0 E-09 was used in the modification to the CWC radioactive air emissions NOC. This study confirmed that the release fraction used in the CWC radioactive air emissions NOC was conservative

  15. Request for approval, vented container annual release fraction; FINAL

    HILL, J.S.

    1999-01-01

    In accordance with the approval conditions for Modification to the Central Waste Complex (CWC) Radioactive Air Emissions Notice of Construction (NOC). dated August 24,1998, a new release fraction has been developed for submittal to the Washington State Department of Health (WDOH). The proposed annual release fraction of 2.50 E-14 is proposed for use in future NOCs involving the storage and handling operations associated with vented containers on the Hanford Site. The proposed annual release fraction was the largest release fraction calculated from alpha measurements of the NucFil filters from 10 vented containers consisting of nine 55-gallon drums and one burial box with dimensions of 9.3 x 5.7 x 6.4 feet. An annual release fraction of 2.0 E-09 was used in the modification to the CWC radioactive air emissions NOC. This study confirmed that the release fraction used in the CWC radioactive air emissions NOC was conservative

  16. 15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

    2010-01-01

    ... approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations... REGULATIONS OF THE FOREIGN-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.32 Procedure for review of request for approval of manufacturing or processing. (a) Request as part of application...

  17. 76 FR 33019 - Notice of Projects Approved for Consumptive Uses of Water

    2011-06-07

    ... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(e... Wilson Drilling Pad 1, ABR-201103014, Lemon Township, Wyoming County, Pa.; Consumptive Use of up to 2.000...

  18. 77 FR 46964 - Oklahoma: Incorporation by Reference of Approved State Hazardous Waste Management Program

    2012-08-07

    ...: Incorporation by Reference of Approved State Hazardous Waste Management Program AGENCY: Environmental Protection... Agency (EPA) to authorize States to operate their hazardous waste management programs in lieu of the Federal program. The EPA uses the regulations entitled ``Approved State Hazardous Waste Management...

  19. 77 FR 59879 - Idaho: Incorporation by Reference of Approved State Hazardous Waste Management Program

    2012-10-01

    ...: Incorporation by Reference of Approved State Hazardous Waste Management Program AGENCY: Environmental Protection... ``Approved State Hazardous Waste Management Programs,'' Idaho's authorized hazardous waste program. The EPA... Federal Register, the EPA is codifying and incorporating by reference the State's hazardous waste program...

  20. 77 FR 29231 - Oklahoma: Incorporation by Reference of Approved State Hazardous Waste Management Program

    2012-05-17

    ...: Incorporation by Reference of Approved State Hazardous Waste Management Program AGENCY: Environmental Protection... Agency (EPA) to authorize States to operate their hazardous waste management programs in lieu of the Federal program. The EPA uses the regulations entitled ``Approved State Hazardous Waste Management...

  1. 76 FR 26616 - Wisconsin: Incorporation by Reference of Approved State Hazardous Waste Management Program

    2011-05-09

    ... Reference of Approved State Hazardous Waste Management Program AGENCY: Environmental Protection Agency (EPA... (RCRA) allows EPA to authorize States to operate their hazardous waste management programs in lieu of the Federal program. EPA uses the regulations entitled ``Approved State Hazardous Waste Management...

  2. Factories Act 1961, Ionizing Radiations (Unsealed Radioactive Substances) Regulations 1968, Certificate of Approval No.1 (General)

    1969-01-01

    Under the Ionising Radiations (Unsealed Radioactive Substances) Regulations No. 780 of 1968, the Chief Inspector of Factories has wide powers to ensure the protection of workers. By this Certificate he approved, for the purpose of measuring radiation doses, any radiation dosemeter, based on the phenomenon of radiation-induced thermoluminescence, supplied by an approved laboratory. (NEA) [fr

  3. 78 FR 68463 - Notice of Emergency Approval of an Information Collection: Regional Analysis of Impediments...

    2013-11-14

    ... Approval of an Information Collection: Regional Analysis of Impediments Guidance for [email protected] or telephone 202- 402-2102. This is not a toll-free number. Persons with hearing or speech... Collection: Regional Analysis of Impediments Guidance for Sustainable Communities Grantees. OMB Approval...

  4. 76 FR 30200 - Forging Machines; Extension of the Office of Management and Budget's (OMB) Approval of...

    2011-05-24

    ...] Forging Machines; Extension of the Office of Management and Budget's (OMB) Approval of Information... extend OMB approval of the information collection requirements contained in the Forging Machines Standard... to reduce employees' risk of death or serious injury by ensuring that forging machines used by them...

  5. 77 FR 64339 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

    2012-10-19

    ... complexity. The Federal Health IT Strategic Plan identifies the Fair Information Practice Principles (FIPPS... is a key principle of fair information practices. The NPP is an important component of fulfilling... Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved...

  6. 78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

    2013-03-25

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

  7. 78 FR 16601 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    2013-03-18

    ... Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule... (MAGNASTOR[supreg]) System listing within the ``List of Approved Spent Fuel Storage Casks'' to include... for the MAGNASTOR[supreg] System cask design within the list of approved spent fuel storage casks that...

  8. 78 FR 63375 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

    2013-10-24

    ... Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS[supreg] Cask System AGENCY: Nuclear...] Cask System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No..., Inc. Standardized NUHOMS[supreg] Cask System listing within the ``List of Approved Spent Fuel Storage...

  9. 75 FR 25120 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

    2010-05-07

    ...] RIN 3150-AI75 List of Approved Spent Fuel Storage Casks: NUHOMS[supreg] HD System Revision 1 AGENCY...), NUHOMS[supreg] HD System listing within the ``List of Approved Spent Fuel Storage Casks'' to include... Modular Storage System for Irradiated Nuclear Fuel. Docket Number: 72-1030. Certificate Expiration Date...

  10. 75 FR 42339 - List of Approved Spent Fuel Storage Casks: NAC-MPC System, Revision 6

    2010-07-21

    ...-2010-0183] RIN 3150--AI88 List of Approved Spent Fuel Storage Casks: NAC-MPC System, Revision 6 AGENCY.... (NAC), NAC-MPC System listing within the ``List of Approved Spent Fuel Storage Casks'' to include... changes to the configuration of the NAC-MPC storage system as noted in Appendix B of the Technical...

  11. 78 FR 32077 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    2013-05-29

    ... Fuel Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear Regulatory Commission. ACTION: Direct... All-purpose Storage (MAGNASTOR[supreg]) System listing within the ``List of Approved Spent Fuel... CoC No. 1031, MAGNASTOR[supreg] System listing within the ``List of Approved Spent Fuel Storage Casks...

  12. 78 FR 45 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

    2013-01-02

    ... fermentation processes; CO 2 from combustion of the biological fraction of municipal solid waste or biosolids... approve portions of a revision to the Georgia State Implementation Plan (SIP) submitted by the State of... are not required by the Act as part of an approvable SIP program. EPA believes that most states are...

  13. 24 CFR 1000.112 - How will HUD determine whether to approve model housing activities?

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false How will HUD determine whether to approve model housing activities? 1000.112 Section 1000.112 Housing and Urban Development Regulations... Activities § 1000.112 How will HUD determine whether to approve model housing activities? HUD will review all...

  14. 77 FR 56241 - Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000

    2012-09-12

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0131] Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000 By letter dated December 10, 2010, Westinghouse Electric... final design approval (FDA) for the Advanced Passive 1000 (AP1000) design upon the completion of...

  15. 75 FR 31510 - Fox Chase Bancorp, Inc., Hatboro, PA; Approval of Conversion

    2010-06-03

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-43: OTS No. H-4707] Fox Chase Bancorp, Inc., Hatboro, PA; Approval of Conversion Application Notice is hereby given that on May 14, 2010, the Office of Thrift Supervision approved the application of Fox Chase MHC and Fox Chase Bank, Hatboro...

  16. 38 CFR 21.258 - Cost limitations on approval of self-employment plans.

    2010-07-01

    ... approval of self-employment plans. 21.258 Section 21.258 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... Employment Under 38 U.S.C. Chapter 31 Employment Services § 21.258 Cost limitations on approval of self-employment plans. A self-employment plan with an estimated or actual cost of less than $25,000 may be...

  17. 77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

    2012-03-06

    ...-02] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure... approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS... Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS). FIPS 180-4...

  18. 78 FR 43145 - Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard

    2013-07-19

    ...-01] Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard.... SUMMARY: This notice announces the Secretary of Commerce's approval of Federal Information Processing... changes are effective on July 19, 2013. FOR FURTHER INFORMATION CONTACT: Elaine Barker (301) 975-2911...

  19. Project W-521, waste feed delivery systems environmental permits and approvals plan

    TOLLEFSON, K.S.

    1999-01-01

    This document has been prepared to define the specific environmental requirements applicable to Project W-521. The document describes the permits and approvals necessary for the project to design, construct, and install planned upgrades, and provides a schedule of activities and provides cost estimates to complete the required permitting and approval activities

  20. 75 FR 52065 - SharePlus Federal Bank, Plano, TX; Approval of Conversion Application

    2010-08-24

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-50: OTS Nos. 17972 and H4743] SharePlus Federal Bank, Plano, TX; Approval of Conversion Application Notice is hereby given that on August 12, 2010, the Office of Thrift Supervision approved the application of SharePlus Federal Bank, Piano...

  1. 75 FR 51333 - Madison Square Federal Savings Bank, Baltimore, MD; Approval of Conversion Application

    2010-08-19

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-49: OTS Nos. 08156 and H4736] Madison Square Federal Savings Bank, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on August 12, 2010, the Office of Thrift Supervision approved the application of Madison Square...

  2. 75 FR 24774 - Fairmount Bank, Baltimore, MD; Approval of Conversion Application

    2010-05-05

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-36 OTS Nos. 08193 and H4677] Fairmount Bank, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on April 15, 2010, the Office of Thrift Supervision approved the application of Fairmount Bank, Baltimore, Maryland, to...

  3. 76 FR 27753 - American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application

    2011-05-12

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-61: OTS Nos. 07212] American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application Notice is hereby given that on May 3, 2011, the Office of Thrift Supervision approved the application of American Eagle Savings Bank, Boothwyn...

  4. 75 FR 31511 - Ideal Federal Savings Bank, Baltimore, MD; Approval of Conversion Application

    2010-06-03

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-46: OTS No. 08283] Ideal Federal Savings Bank, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on May 24, 2010, the Office of Thrift Supervision approved the application of Ideal Federal Savings Bank...

  5. 25 CFR 225.28 - Approval of amendments to minerals agreements.

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Approval of amendments to minerals agreements. 225.28 Section 225.28 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS OIL AND GAS, GEOTHERMAL, AND SOLID MINERALS AGREEMENTS Minerals Agreements § 225.28 Approval of amendments to...

  6. 13 CFR 108.140 - SBA approval of initial Management Expenses.

    2010-01-01

    ... VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Organizing A Nmvc Company § 108.140 SBA approval of initial Management Expenses. A NMVC Company must have its Management Expenses approved by SBA at the time of designation as a NMVC Company. (See § 108.520 for the definition of Management...

  7. 48 CFR 301.106 - Office of Management and Budget approval under the Paperwork Reduction Act.

    2010-10-01

    ... Issuance 301.106 Office of Management and Budget approval under the Paperwork Reduction Act. (a) The... approval from the Office of Management and Budget (OMB) before collecting the same information from 10 or... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Office of Management and...

  8. 76 FR 32321 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the...

    2011-06-06

    ...) Program--Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties AGENCY... approve revisions to the Pennsylvania State Implementation Plan (SIP). The revision consists of a change... prior SIP-approved I/M program to change the duration of the timing of quality assurance audits...

  9. 24 CFR 982.612 - Group home: State approval of group home.

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Group home: State approval of group... Types Group Home § 982.612 Group home: State approval of group home. A group home must be licensed..., Retardation, or Social Services) as a group home for elderly persons or persons with disabilities. ...

  10. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    2010-04-01

    ... comply with all applicable provisions of the corporate charter, bylaws, and applicable State law prescribing the method and degree of stockholder approval required for the issuance of corporate stock or options. If the applicable State law does not prescribe a method and degree of stockholder approval in...

  11. 23 CFR 420.209 - What are the conditions for approval?

    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...

  12. 21 CFR 500.84 - Conditions for approval of the sponsored compound.

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Conditions for approval of the sponsored compound. 500.84 Section 500.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Used in Food-Producing Animals § 500.84 Conditions for approval of the sponsored compound. (a) On the...

  13. 77 FR 52233 - Approval and Promulgation of Implementation Plans and Operating Permits Program; Commonwealth of...

    2012-08-29

    ...: EPA is approving revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution... Regulations for the Control of Atmospheric Pollution (PRRCAP). In the context of the Clean Air Act (CAA or Act... that approved the revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution...

  14. 77 FR 31292 - Notice of Request for Extension of Approval of an Information Collection; National Poultry...

    2012-05-25

    ...] Notice of Request for Extension of Approval of an Information Collection; National Poultry Improvement... approval of an information collection associated with regulations for the National Poultry Improvement Plan... INFORMATION CONTACT: For information on regulations for the National Poultry Improvement Plan, contact Dr...

  15. 77 FR 41981 - Information Collection Approved by the Office of Management and Budget (OMB)

    2012-07-17

    ... FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by the Office of Management and... Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for the following... of TRS offered, including documentary and other evidence, and in the case of VRS, such documentary...

  16. Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved packages

    1987-11-01

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1). This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volume 1

  17. 76 FR 68699 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of the...

    2011-11-07

    ... formed in the atmosphere as a result of various chemical reactions from precursor emissions of nitrogen... is proposing to conditionally approve the air quality modeling submitted to demonstrate attainment of the 1997 PM 2.5 NAAQS. In order for EPA to fully approve the modeling analysis, PADEP must update the...

  18. 24 CFR 28.20 - Request for approval by the Department of Justice.

    2010-04-01

    ... Department of Justice. 28.20 Section 28.20 Housing and Urban Development Office of the Secretary, Department....20 Request for approval by the Department of Justice. (a) If the General Counsel or designee... written request to the Department of Justice for approval to issue a complaint under § 28.25. (b) The...

  19. 75 FR 53269 - Federal Acquisition Regulation; Tribal Consultation; Justification and Approval of Sole-Source 8...

    2010-08-31

    ... and approval of sole-source contracts over $20 million under the 8(a) small business development... valuable component of its deliberations in preparing to implement this law, which includes contracting with... Regulation; Tribal Consultation; Justification and Approval of Sole-Source 8(a) Contracts AGENCIES...

  20. 49 CFR 381.515 - May the FMCSA remove approved participants from a pilot program?

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false May the FMCSA remove approved participants from a... § 381.515 May the FMCSA remove approved participants from a pilot program? The Administrator will... with the terms and conditions of the pilot program, or if continued participation is inconsistent with...

  1. 6 CFR 27.245 - Review and approval of site security plans.

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Review and approval of site security plans. 27.245 Section 27.245 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY CHEMICAL FACILITY ANTI-TERRORISM STANDARDS Chemical Facility Security Program § 27.245 Review and approval of site...

  2. 6 CFR 27.240 - Review and approval of security vulnerability assessments.

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Review and approval of security vulnerability assessments. 27.240 Section 27.240 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY CHEMICAL FACILITY ANTI-TERRORISM STANDARDS Chemical Facility Security Program § 27.240 Review and approval...

  3. 76 FR 40908 - Information Collection Approved by the Office of Management and Budget

    2011-07-12

    ... FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by the Office of Management and... Commission has received Office of Management and Budget (OMB) approval for the following public information... conduct or sponsor a collection of information unless it displays a currently valid OMB control number...

  4. 77 FR 74185 - Information Collection Approved by Office of Management and Budget

    2012-12-13

    ... FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by Office of Management and... Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). An agency may...

  5. 76 FR 68757 - Information Collection Approved by the Office of Management and Budget

    2011-11-07

    ... FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by the Office of Management and... Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). An agency may...

  6. 42 CFR 423.171 - Procedures for approval of accreditation as a basis for deeming compliance.

    2010-10-01

    ... BENEFIT Cost Control and Quality Improvement Requirements § 423.171 Procedures for approval of... 42 Public Health 3 2010-10-01 2010-10-01 false Procedures for approval of accreditation as a basis for deeming compliance. 423.171 Section 423.171 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES...

  7. 76 FR 56001 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    2011-09-09

    ...: Regional intermodal transportation center. Determination: Partially approved. The FAA determined that... Approved for Collection and Use at a $3.00 PFC Level: Public information display kiosks. Wildlife hazard assessment study. Interactive employee training module. Blast fence extension--taxiway D. Aircraft rescue and...

  8. 78 FR 2878 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

    2013-01-14

    ... incorrect version of the proposed rulemaking. DATES: The proposed rule published January 2, 2013, is... Deterioration'' to approve changes to Georgia's SIP-approved regulations entitled ``Air Quality Control Rule 391-3-.1.'' The proposed rule version published in the Federal Register on January 2, 2013, was an...

  9. 76 FR 9407 - Fraternity Federal Savings & Loan Association, Baltimore, MD; Approval of Conversion Application

    2011-02-17

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-58 OTS No. 01292 and H 4762] Fraternity Federal Savings & Loan Association, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on February 10, 2011, the Office of Thrift Supervision approved the application of...

  10. 78 FR 40270 - Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New York; Approval of...

    2013-07-03

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency [OCC Charter Number 702397] Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New York; Approval of Conversion...) approved the application of Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New...

  11. 75 FR 2535 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    2010-01-15

    ...; Comment Request; Approval of State Coastal Nonpoint Pollution Control Programs (Renewal) AGENCY..., Assessment and Watershed Protection Division, Office of Wetlands Oceans and Watersheds, Mail Code 4503-T... docket, go to http://www.regulations.gov . Title: Approval of State Coastal Nonpoint Pollution Control...

  12. 32 CFR 644.67 - Approval of Title by the Attorney General.

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Approval of Title by the Attorney General. 644.67... § 644.67 Approval of Title by the Attorney General. (a) General. Section 355 of the Revised Statutes of... delegated to the Department of the Army, subject to the supervision and review of the Attorney General...

  13. 7 CFR 1717.611 - RUS approval of expenditures for legal, accounting, engineering, and supervisory services.

    2010-01-01

    ..., supervisory (other than for the management and operation of the borrower's electric system, see § 1717.608(d... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of expenditures for legal, accounting... COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Operational Controls § 1717.611 RUS approval of...

  14. 19 CFR 210.69 - Approval of complainant's temporary relief bond.

    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...

  15. 78 FR 68464 - Notice of Emergency Approval of an Information Collection: Record of Employee Interview

    2013-11-14

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5683-N-101] Notice of Emergency Approval of an Information Collection: Record of Employee Interview AGENCY: Office of the Chief Information... Collection Title of Information Collection: Record of Employee Interview. OMB Approval Number: 2501-0009...

  16. 7 CFR 1948.82 - Plan and State Investment Strategy approval procedure.

    2010-01-01

    ... the State Investment Strategy for Energy Impacted Areas. (c) Appropriate growth management and/or... 7 Agriculture 13 2010-01-01 2009-01-01 true Plan and State Investment Strategy approval procedure... Impacted Area Development Assistance Program § 1948.82 Plan and State Investment Strategy approval...

  17. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    2010-04-01

    ... based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Approval based on evidence of effectiveness from... the effectiveness of these products only when: (1) There is a reasonably well-understood...

  18. 75 FR 9276 - Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion Application

    2010-03-01

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-35: OTS No. H-4649] Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion Application Notice is hereby given that on February 12, 2010, the Office of Thrift Supervision approved the application of Harvard Savings Bank...

  19. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve or...

  20. 76 FR 49433 - Notice To Request an Extension and Revision of Currently Approved Information Collection and...

    2011-08-10

    ... information will help NRCS to match the skills of individuals who are applying for volunteer work that will... Previously Approved Information Collection'' for volunteer workers (73 FR 62949). In accordance with the... request an extension for currently approved information collection, Volunteer Program-Earth Team. This...