WorldWideScience

Sample records for cber approved ndas

  1. NDAS Hardware Translation Layer Development

    Science.gov (United States)

    Nazaretian, Ryan N.; Holladay, Wendy T.

    2011-01-01

    The NASA Data Acquisition System (NDAS) project is aimed to replace all DAS software for NASA s Rocket Testing Facilities. There must be a software-hardware translation layer so the software can properly talk to the hardware. Since the hardware from each test stand varies, drivers for each stand have to be made. These drivers will act more like plugins for the software. If the software is being used in E3, then the software should point to the E3 driver package. If the software is being used at B2, then the software should point to the B2 driver package. The driver packages should also be filled with hardware drivers that are universal to the DAS system. For example, since A1, A2, and B2 all use the Preston 8300AU signal conditioners, then the driver for those three stands should be the same and updated collectively.

  2. Center for Biologics Evaluation and Research (CBER)

    Data.gov (United States)

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  5. First in-Flight Radiometric Calibration of MUX and WFI on-Board CBERS-4

    Directory of Open Access Journals (Sweden)

    Cibele Pinto

    2016-05-01

    Full Text Available Brazil and China have a long-term joint space based sensor program called China-Brazil Earth Resources Satellite (CBERS. The most recent satellite of this program (CBERS-4 was successfully launched on 7 December 2014. This work describes a complete procedure, along with the associated uncertainties, used to calculate the in-flight absolute calibration coefficients for the sensors Multispectral Camera (MUX and Wide-Field Imager (WFI on-board CBERS-4. Two absolute radiometric calibration techniques were applied: (i reflectance-based approach and (ii cross-calibration method. A specific site at Algodones Dunes region located in the southwestern portion of the United States of America was used as a reference surface. Radiometric ground and atmospheric measurements were carried out on 9 March 2015, when CBERS-4 passed over the region. In addition, a cross-calibration between both MUX and WFI on-board CBERS-4 and the Operational Land Imager (OLI on-board Landsat-8 was performed using the Libya-4 Pseudo Invariant Calibration Site. The gain coefficients are now available: 1.68, 1.62, 1.59 and 1.42 for MUX and 0.379, 0.498, 0.360 and 0.351 for WFI spectral bands blue, green, red and NIR, respectively, in units of (W/(m2·sr·μm/DN. These coefficients were determined with uncertainties lower than 3.5%. As a validation of these radiometric coefficients, cross-calibration was also undertaken. An evaluation of radiometric consistency was performed between the two instruments (MUX and WFI on-board CBERS-4 and with the well calibrated Landsat-7 ETM+. Results show that the reflectance values match in all the analogous spectral bands within the specified calibration uncertainties.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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. Evaluation of land use classification accuracy based upon TM and CBERS-02B HR data fusion

    Science.gov (United States)

    Liu, Guifang; Lu, Heli

    2010-11-01

    Data fusions from SAR and TM, SPOT and TM, ASTER and TM, MODIS and ETM, etc are the common methods. But that from TM and CBERS-02B is rare. With HR camera working in September 19th 2007, Chinese-Brazil Earth Resources Satellite 02B (CBERS-02B) became the first civilian high-resolution satellite in China. It could provide 2.36m panchromatic image which is better to Landsat TM. Meanwhile the spectral resolution of TM is better than CBERS-02B. So it's a good idea to take advantage of benefits from CBERS-02B HR and TM through data fusion. In this study, images of TM and CBERS-02B HR in 2007 were used as data sources. After image registration and noiseremoval process, data fusion methods of IHS and PCA were adopted. Then unsupervised classification and supervised classification were used for land use classification. Finally, classification accuracy between original image and fusion image was compared and evaluated. The result shows: (1) Compared with original TM or CBERS-02B HR image, the fusion image not only retains abundance spectrum but also enhances the object details. Residential texture, lake morphological, the relative position between roads, industrial and mining sites, etc, was identified easily. (2) Results from IHS and PCA are different. IHS image had higher spatial resolution but more spectral distortion. Spectral differences between some objects became smaller and classification accuracy was lower. Supervised classification accuracy assessment shows that overall Kappa index and overall land use classification accuracy decreased by 0.237 and 11% respectively. Meanwhile PCA image not only had high spatial resolution, but also smaller spectral distortion. Different land use / cover types can be better distinguished. (3) Disadvantages of low spatial resolution in TM and single color in CBERS-02B HR image are overcome in PCA fusion image to a certain extent. In this research under supervised classification in PCA image Kappa index of farm land, forest land and

  9. 76 FR 33310 - Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97...

    Science.gov (United States)

    2011-06-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0411] Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New... Administration (FDA) is withdrawing approval of 70 new drug applications (NDAs) and 97 abbreviated new drug...

  10. 76 FR 79701 - Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97...

    Science.gov (United States)

    2011-12-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0411] Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New... applications (NDAs) and 97 abbreviated new drug applications (ANDAs) from multiple applicants, effective July 8...

  11. Analysis of new drugs whose clinical development and regulatory approval were hampered during their introduction in Japan.

    Science.gov (United States)

    Asada, R; Shimizu, S; Ono, S; Ito, T; Shimizu, A; Yamaguchi, T

    2013-08-01

    Many drugs fail during development. However, detailed reasons for failure during drug development are almost never disclosed. We focused on the drugs whose clinical development and registration were initially hampered, but which were finally approved to identify reasons that delayed their marketing approval in Japan. We analysed 727 new drug applications (NDAs) approved in Japan between 2001 and 2011. Fifty-three NDAs had serious and identifiable problems during drug development. Of these, 43 NDAs had 'problem related to clinical data'. We found that the problems for withdrawal of these NDAs could be ascribed largely to inappropriate clinical data package and study design for supporting the intended indications and usage and to unclear clinical results for defining dosage regimen or efficacy of the drugs. Our results indicate the importance of careful determination of the optimal dosage regimen and the choice of objective endpoints in clinical trials. Further, it is important to establish a clear strategy for generating the clinical data package, to include careful design of clinical trials on the basis of the nature of the target disease and target population. For drugs marketed in Japan, there is a need to include sufficient numbers of Japanese patients in the trials. © 2013 John Wiley & Sons Ltd.

  12. STRIPING NOISE REMOVAL OF IMAGES ACQUIRED BY CBERS 2 CCD CAMERA SENSOR

    Directory of Open Access Journals (Sweden)

    E. Amraei

    2014-10-01

    Full Text Available CCD Camera is a multi-spectral sensor that is carried by CBERS 2 satellite. Imaging technique in this sensor is push broom. In images acquired by the CCD Camera, some vertical striping noise can be seen. This is due to the detectors mismatch, inter detector variability, improper calibration of detectors and low signal-to-noise ratio. These noises are more profound in images acquired from the homogeneous surfaces, which are processed at level 2. However, the existence of these noises render the interpretation of the data and extracting information from these images difficult. In this work, spatial moment matching method is proposed to modify these images. In this method, the statistical moments such as mean and standard deviation of columns in each band are used to balance the statistical specifications of the detector array to those of reference values. After the removal of the noise, some periodic diagonal stripes remain in the image where their removal by using the aforementioned method seems impossible. Therefore, to omit them, frequency domain Butterworth notch filter was applied. Finally to evaluate the results, the image statistical moments such as the mean and standard deviation were deployed. The study proves the effectiveness of the method in noise removal.

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

    Directory of Open Access Journals (Sweden)

    José Marcato Junior

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

  14. AVALIAÇÃO DAS IMAGENS CBERS/CCD PARA O MAPEAMENTO DE AREAIS NO SUDOESTE DE GOIÁS

    Directory of Open Access Journals (Sweden)

    Marluce Silva Sousa

    2007-06-01

    Full Text Available O objetivo deste trabalho foi o de aplicar diferentes técnicasde transformação em duas imagens CBERS, dosperíodos seco e chuvoso, que permitissem realçar emapear as manchas de Neossolos Quartzarênicos, semcobertura vegetal (areais, da bacia do Ribeirão Sujo,município de Serranópolis/GO. Revisaram-se bibliografiassobre comportamento espectral de solos arenosose trabalhos relacionados à avaliação de áreas degradadas.Utilizaram-se três métodos de transformaçãode imagens para os dois períodos com a finalidade demapear os areais: o modelo linear de mistura espectral,o índice de vegetação da diferença normalizada (NDVI ea análise por componentes principais. Verificou-se queas imagens do período chuvoso ressaltaram melhor osareais em relação aos vários tipos de cobertura da terrae que a técnica que apresentou o melhor resultado para omapeamento dos areais foi a classificação supervisionadadas bandas 2, 3 e 4 do sensor CDD/CBERS.

  15. CCD CBERS and ASTER data in dasometric characterization of Pinus radiata D. Don (north-western Spain

    Directory of Open Access Journals (Sweden)

    Eva Sevillano-Marco

    2013-03-01

    Full Text Available A Chinese-Brazilian Earth Resources Satellite (CBERS and an Advanced Spaceborne Thermal Emission and Reflection Radiometer (ASTER scenes coupled with ancillary georeferenced data and field survey were employed to examine the potential of the remote sensing data in stand basal area, volume and aboveground biomass assessment over large areas of Pinus radiata D. Don plantations in Northwestern Spain. Statistical analysis proved that the near infrared band and the shade fraction image showed significant correlation coefficients with all stand variables considered. Predictive models were accordingly selected and utilized to undertake the spatial distribution of stand variables in radiata stands delimited by the National Forestry Map. The study reinforces the potentiality of remote sensing techniques in a cost-effective assessment of forest systems.

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

    Directory of Open Access Journals (Sweden)

    Maria Isabel Sobral Escada

    2012-01-01

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

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

    Science.gov (United States)

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

    2012-12-01

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

  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

    Directory of Open Access Journals (Sweden)

    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. The use of CBERS (China-Brazil Earth Resources Satellite to trace the dynamics of total suspended matter at an urbanized coastal area

    Directory of Open Access Journals (Sweden)

    Maria Fernanda Colo Giannini

    Full Text Available ABSTRACT The distribution of organic and inorganic particles in the water column, or the total suspended matter (TSM, responds to local and remote oceanographic and meteorological processes, potentially impacting biogeochemical cycles. In shallow coastal areas, where particles have distinct origins and compositions and vary in different time scales, the use of remote sensing tools for monitoring and tracing this material is highly encouraged due to the high temporal and spatial data resolution. The objective of this work was to understand the variability of in situ TSM at Santos Bay (Southeastern Brazil and its response to oceanographic and meteorological conditions. We also aimed to verify the applicability of the satellite data from CBERS-2 sensor in order to map the dynamics of TSM in this region. Our results have shown that the distribution of TSM in Santos Bay varied consistently with winds, currents and tidal cycles, with significant relationships emphasizing the role of south-western winds and spring tides. Neap tides and eastern winds, along with rainfall, play an important role in the input of organic matter into the bay. In conclusion, our analyses showed that the main patterns observed in situ regarding the responses of TSM to the ocean-meteorological processes could be reproduced in the CBERS-2 satellite data, after simple and standard methods of images processing. TSM data retrieval from CBERS-2 or other satellite sensors were shown to be feasible, becoming an essential tool for synoptic observations of the composition and quality of water, especially at urbanized and impacted coastal areas.

  20. New drug approval process for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Sheinin, E.B.; Kishore, R.

    1990-01-01

    The Federal Food, Drug, and Cosmetic Act requires that new drugs by approved by the FDA before they can be marketed. The Drug Amendments of 1962 provided for the investigation of new drugs by the submission of Investigational New Drug Applications (INDs). The format for the submission of INDs and New Drug Applications (NDAs) are contained in the Code of Federal Regulations (CFR) Title 21, Sections 312 and 314, respectively. A series of guidelines pertaining to the chemistry, manufacturing and control sections of the application are available. The applicant must provide satisfactory information on the composition, manufacturing and control of the drug substance (active ingredient) as well as on the final drug product to satisfy the FDA requirements that the new drug is safe and effective. Areas of the submissions where deficiencies are typically seen will be discussed

  1. Focus adjustment method for CBERS 3 and 4 satellites Mux camera to be performed in air condition and its experimental verification for best performance in orbital vacuum condition

    Science.gov (United States)

    Scaduto, Lucimara C. N.; Malavolta, Alexandre T.; Modugno, Rodrigo G.; Vales, Luiz F.; Carvalho, Erica G.; Evangelista, Sérgio; Stefani, Mario A.; de Castro Neto, Jarbas C.

    2017-11-01

    The first Brazilian remote sensing multispectral camera (MUX) is currently under development at Opto Eletronica S.A. It consists of a four-spectral-band sensor covering a 450nm to 890nm wavelength range. This camera will provide images within a 20m ground resolution at nadir. The MUX camera is part of the payload of the upcoming Sino-Brazilian satellites CBERS 3&4 (China-Brazil Earth Resource Satellite). The preliminary alignment between the optical system and the CCD sensor, which is located at the focal plane assembly, was obtained in air condition, clean room environment. A collimator was used for the performance evaluation of the camera. The preliminary performance evaluation of the optical channel was registered by compensating the collimator focus position due to changes in the test environment, as an air-to-vacuum environment transition leads to a defocus process in this camera. Therefore, it is necessary to confirm that the alignment of the camera must always be attained ensuring that its best performance is reached for an orbital vacuum condition. For this reason and as a further step on the development process, the MUX camera Qualification Model was tested and evaluated inside a thermo-vacuum chamber and submitted to an as-orbit vacuum environment. In this study, the influence of temperature fields was neglected. This paper reports on the performance evaluation and discusses the results for this camera when operating within those mentioned test conditions. The overall optical tests and results show that the "in air" adjustment method was suitable to be performed, as a critical activity, to guarantee the equipment according to its design requirements.

  2. Nord Stream "ründas" Gotlandil Eestit / Tuuli Koch

    Index Scriptorium Estoniae

    Koch, Tuuli

    2010-01-01

    Vene- Saksa gaasijuhtme ehituse sõlmpunktiks muutuval Gotlandil jäi Slite sadamasse Nord Streami raha eest ehitatud kaile ette mälestusmärk eestlastele ja lätlastele, kes 1944. aastal punavõimu eest põgenedes Gotlandile jõudsid. Kaart

  3. Putin ründas kriisikohtumisel Eestit / Aadu Hiietamm

    Index Scriptorium Estoniae

    Hiietamm, Aadu, 1954-

    2007-01-01

    Euroopa Liidu ja Venemaa tippkohtumisel Samaras süüdistas president Putin Eestit ja Lätit venekeelsete elanike inimõiguste rikkumises, tippkohtumine tõi välja pinged ja eriarvamused Venemaa ning Euroopa Liidu vahel

  4. NDAS NASA Data Acquisition Software Suite- Version 2.0

    Data.gov (United States)

    National Aeronautics and Space Administration — Current NASA propulsion test facilities include Stennis Space Center in Mississippi, Marshall Space Flight Center in Alabama, Plum Brook Station in Ohio, and White...

  5. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

    Science.gov (United States)

    Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

    2017-12-05

    To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

  6. Post-Approval Studies

    Data.gov (United States)

    U.S. Department of Health & Human Services — The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a...

  7. Drugs Approved for Leukemia

    Science.gov (United States)

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs ... used in leukemia that are not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) ...

  8. Drugs Approved for Breast Cancer

    Science.gov (United States)

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

  9. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Bladder Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bladder Cancer Atezolizumab Avelumab Bavencio (Avelumab) Cisplatin Doxorubicin Hydrochloride Durvalumab ...

  10. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    ... about Your Treatment Research Drugs Approved for Malignant Mesothelioma This page lists cancer drugs approved by the ... are not listed here. Drugs Approved for Malignant Mesothelioma Alimta (Pemetrexed Disodium) Pemetrexed Disodium Drug Combinations Used ...

  11. The effect size, study design, and development experience in commercially sponsored studies for new drug applications in approved drugs.

    Science.gov (United States)

    Fukunaga, Satoshi; Kusama, Makiko; Ono, Shunsuke

    2014-01-01

    Pharmaceutical companies incorporate different features into the trials for new drug applications (NDAs) to render them efficient, making use of their experience. The objective of this analysis was to examine the associations between outcome and features related to study design and clinical development experience in commercially sponsored clinical trials. We collected data of phase 2 and phase 3 trials of all the drugs that obtained approval for depression, schizophrenia, asthma, hypertension, and diabetes in Japan from 1970 to 2011. In total, 145 trials from 90 test drugs were eligible for our study. We calculated the effect size, the standard mean of differences between test drug and comparator therapeutic effects, as the objective variable for use in our analysis. A linear mixed effect model with nested and crossed random effects was used in the analysis including variety of therapeutic area, test drugs and clinical trials. The analysis showed that trial features including sample size, subjective endpoints and active comparator of the same mode of action were negatively associated with effect size. In addition, sponsors' domestic clinical development experience with similar drugs seemed to have a positive association, but prior development experience in foreign countries did not. The accumulation of skills and knowledge within sponsors, and accumulated experience in domestic professionals who implement clinical trials under study contracts with sponsors would be of great importance for yielding clear outcomes. This study provides additional evidence with respect to possible sizes and directions of the influence of study design features that must be considered when planning and implementing trials for new drug applications, and when retrospectively comparing outcomes from trials with different designs and environments.

  12. Drugs Approved for Neuroblastoma

    Science.gov (United States)

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

  13. Drugs Approved for Retinoblastoma

    Science.gov (United States)

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

  14. Premarket Approvals (PMA)

    Data.gov (United States)

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

  15. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ... drug applications (NDAs) and biologics license applications (BLAs). This document defines several types... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm... applications (BLAs). Similar approaches could be used in clinical trials in earlier phases of drug development...

  16. FDA Approval for Imiquimod

    Science.gov (United States)

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  17. CORN, LP Goldfield Approval

    Science.gov (United States)

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

  18. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

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

  19. FDA Approvals - Cancer Currents Blog

    Science.gov (United States)

    Blog posts on cancer drugs and devices approved by the Food and Drug Administration—including summaries of the evidence to support the approvals and what they mean for patients—from NCI Cancer Currents.

  20. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Lung Cancer Lymphoma Pancreatic Cancer Prostate Cancer Skin Cancer Thyroid Cancer Uterine Cancer All Cancer Types A to ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ...

  1. Panobinostat: first global approval.

    Science.gov (United States)

    Garnock-Jones, Karly P

    2015-04-01

    Novartis has developed oral and intravenous formulations of panobinostat (Farydak(®)), a histone deacetylase (HDAC) inhibitor, for the treatment of cancer. HDACs have important roles in maintaining chromatin structure and in regulating gene expression, including that of tumour suppressor genes, and thus represent valid targets in the search for cancer therapeutics. Oral panobinostat is approved in the US, as combination therapy with bortezomib and dexamethasone in patients with recurrent multiple myeloma who have received at least two prior treatment regimens, including bortezomib and an immunomodulatory agent. Regulatory submissions have been made for the use of combination therapy with panobinostat in patients with recurrent multiple myeloma in the EU and Japan. Panobinostat is in various stages of clinical development worldwide for a range of haematological and solid tumours. This article summarizes the milestones in the development of panobinostat leading to this first approval for multiple myeloma.

  2. NAS council approves reorganization

    Science.gov (United States)

    Richman, Barbara T.

    A proposed reorganization at the National Academy of Sciences (NAS) would fold the Commission on Natural Resources into the Assembly of Mathematical and Physical Sciences (AMPS) to form what would be called the Commission on Mathematics, Physical Sciences, and Resources. Spurred by NAS President Frank Press, past president of AGU, the merger is part of a reorganization that aims to clarify the division of labor within the National Research Council (NRC). The NAS council approved the general structure of the reorganization; the National Academy of Engineering's council was scheduled to review the matter at its March 12 meeting. Administrative details of the restructuring will not be finalized until the April 3 meeting of the NRC governing board.

  3. The Evolution of Approval Services.

    Science.gov (United States)

    Warzala, Martin

    1994-01-01

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

  4. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    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,...

  5. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

    ... about Your Treatment Research Drugs Approved for Non-Hodgkin Lymphoma This page lists cancer drugs approved by the ... are not listed here. Drugs Approved for Non-Hodgkin Lymphoma Abitrexate (Methotrexate) Acalabrutinib Adcetris (Brentuximab Vedotin) Aliqopa (Copanlisib ...

  6. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

    ... Your Treatment Research Drugs Approved for Soft Tissue Sarcoma This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Soft Tissue Sarcoma Cosmegen (Dactinomycin) Dactinomycin Doxorubicin Hydrochloride Eribulin Mesylate Gleevec ( ...

  7. Approval plans issues and innovations

    CERN Document Server

    Katz, Linda S

    2013-01-01

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

  8. 48 CFR 750.7105 - Approving authorities.

    Science.gov (United States)

    2010-10-01

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

  9. Electronic Voucher Approval - Financial Management

    Data.gov (United States)

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

  10. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

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

  11. Drugs Approved for Skin Cancer

    Science.gov (United States)

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

  12. Drugs Approved for Bone Cancer

    Science.gov (United States)

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

  13. Drugs Approved for Penile Cancer

    Science.gov (United States)

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

  14. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

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

  15. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

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

  16. Drugs Approved for Lung Cancer

    Science.gov (United States)

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

  17. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

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

  18. Drugs Approved for Liver Cancer

    Science.gov (United States)

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

  19. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

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

  20. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

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

  1. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

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

  2. Drugs Approved for Cervical Cancer

    Science.gov (United States)

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

  3. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  4. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

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

  5. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

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

  6. Drugs Approved for Testicular Cancer

    Science.gov (United States)

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

  7. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

    ... Common Cancer Types Bladder Cancer Breast Cancer Colorectal Cancer Kidney (Renal Cell) Cancer Leukemia Liver Cancer Lung Cancer ... Ask about Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs approved by the ...

  8. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  9. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  10. 30 CFR 7.311 - Approval checklist.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval checklist. 7.311 Section 7.311 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Electric Motor Assemblies § 7.311 Approval checklist...

  11. 30 CFR 7.71 - Approval checklist.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval checklist. 7.71 Section 7.71 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... checklist. Each blasting unit bearing an MSHA approval marking shall be accompanied by a description of what...

  12. 30 CFR 7.51 - Approval checklist.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval checklist. 7.51 Section 7.51 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.51 Approval checklist. Each...

  13. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

    ... course of education, including the class schedules of a resident course not leading to a standard college degree, offered by an educational institution must be approved by— (i) The State approving agency for the...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C...

  14. Trastuzumab emtansine: first global approval.

    Science.gov (United States)

    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.

  15. Post-approval fate of pharmaceutical companies.

    Science.gov (United States)

    Kinch, Michael S

    2015-02-01

    For a fortunate subset of pharmaceutical companies, a regulatory approval is the culmination of massive investment in time, work and money. What happens next? Some companies proceed to build a pipeline and obtain additional approvals. Others do not. In this present report, post-approval fate is evaluated and it was found that most companies are ultimately acquired. A subset achieved a second approval six-to-eight years after the first approval, whereas a shrinking subset, designated as 'singlets', remains active in drug discovery with only a single approval. The likelihood that a company will remain a singlet or be acquired relates to therapeutic indication, with oncology associated with increased acquisition potential and infectious-disease-based companies being less commonly acquired. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. OMB Recommended vs Approved Operating Budget

    Data.gov (United States)

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

  17. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

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

  18. 33 CFR 67.10-35 - Notice of approval and withdrawal of approval.

    Science.gov (United States)

    2010-07-01

    ... HOMELAND SECURITY AIDS TO NAVIGATION AIDS TO NAVIGATION ON ARTIFICIAL ISLANDS AND FIXED STRUCTURES General... publishes a notice of the approval or withdrawal of approval of a sound signal in the Local Notice to...

  19. 77 FR 47544 - Approval of Classification Societies

    Science.gov (United States)

    2012-08-09

    ... referenced in Sec. 2.45-15(a)(4). We amended Sec. 2.45-15(a)(5)(ii) by rewording the language of the proposed... Kyokai NK Yes. Registro Italiano Navale......... RINA Yes. Russian Maritime Register of RS No. Shipping... for approval. (a) An application for approval must be made in writing and in the English language to U...

  20. FDA Expands Abiraterone Approval for Prostate Cancer

    Science.gov (United States)

    The FDA has expanded the approval of abiraterone (Zytiga) to treat men with metastatic prostate cancer. The agency approved abiraterone, in combination with prednisone, for men whose cancer that is responsive to hormone-blocking treatments (also known as castration-sensitive) and is at high risk of progressing.

  1. 46 CFR 154.1005 - Equipment approval.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 5 2010-10-01 2010-10-01 false Equipment approval. 154.1005 Section 154.1005 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) CERTAIN BULK DANGEROUS CARGOES SAFETY STANDARDS... safe or explosion proof by an independent laboratory that is specially approved by the Commandant (CG...

  2. 8 CFR 207.4 - Approved application.

    Science.gov (United States)

    2010-01-01

    ... conditionally as a refugee upon arrival at the port within four months of the date the Form I-590 was approved... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Approved application. 207.4 Section 207.4 Aliens and Nationality DEPARTMENT OF HOMELAND SECURITY IMMIGRATION REGULATIONS ADMISSION OF REFUGEES...

  3. FDA Approves Lutathera for Neuroendocrine Tumors

    Science.gov (United States)

    FDA has approved Lutathera® for some people with neuroendocrine tumors (NETs) that affect the digestive tract. On January 29, FDA approved Lutathera® for adult patients with advanced NETs that affect the pancreas or gastrointestinal tract, known as GEP-NETs.

  4. 7 CFR 1427.10 - Approved storage.

    Science.gov (United States)

    2010-01-01

    ... § 1427.10 Approved storage. (a) Eligible cotton may be pledged as collateral for loans only if stored at... warehouse. (c) An approved cotton storage warehouse may temporarily store cotton pledged as collateral for a... individual application, all-risk insurance for the loan value of the cotton with CCC as loss payee, and use...

  5. Perspectives used for gaining approval of budgets.

    Science.gov (United States)

    Franks-Joiner, G L

    1990-01-01

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

  6. Approving of personal dosimeter services

    International Nuclear Information System (INIS)

    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

  7. FDA Approves Apalutamide for Prostate Cancer

    Science.gov (United States)

    Apalutamide (Erleada) is a hormone therapy that counteracts resistance to androgen deprivation therapy. Learn more about the FDA approval of apalutamide for men with castration-resistant nonmetastatic prostate cancer in this Cancer Currents blog post.

  8. FDA Approves First Therapeutic Cancer Vaccine

    Science.gov (United States)

    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.

  9. 32 CFR 552.77 - Suspension approval.

    Science.gov (United States)

    2010-07-01

    ... solicitation privileges have been denied or suspended for cause. This includes agents, companies, or other... designee. Exception to this time frame must be approved by The Adjutant General (DAAG-PSI) or by the...

  10. 7 CFR 550.27 - Prior approvals.

    Science.gov (United States)

    2010-01-01

    ... accordance with OMB Circular A-21, “Cost Principles for Educational Institutions,” (2 CFR part 220), OMB... the approved budget. The budget shall be related to performance for program evaluation purposes. (b...

  11. Drugs Approved for Gestational Trophoblastic Disease

    Science.gov (United States)

    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. Drugs Approved for Gastrointestinal Stromal Tumors

    Science.gov (United States)

    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.

  13. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    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.

  14. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

    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.

  15. Drugs Approved for Head and Neck Cancer

    Science.gov (United States)

    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.

  16. Drug updates and approvals: 2017 in review.

    Science.gov (United States)

    Mospan, Geoffrey; Mospan, Cortney; Vance, Shayna; Bradshaw, Alyssa; Meosky, Kalyn; Bowles, Kirklin

    2017-12-15

    In 2017, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: brodalumab (Siliq), dapagliflozin and saxagliptin (Qtern), dupilumab (Dupixent), oxymetazoline (Rhofade), safinamide (Xadago), and sarilumab (Kevzara).

  17. 30 CFR 7.105 - Approval marking.

    Science.gov (United States)

    2010-07-01

    ... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Power Packages Intended for Use in Areas of Underground Coal Mines Where Permissible Electric Equipment is Required § 7.105 Approval marking. Each...

  18. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

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

  19. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

  20. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

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

  1. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

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

    Science.gov (United States)

    2012-04-09

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

  3. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

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

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

    Science.gov (United States)

    2012-06-11

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

  5. 78 FR 15402 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-11

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

  6. 78 FR 17281 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-20

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

  7. 78 FR 27470 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-05-10

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process..., Bradford County, Pa.; Consumptive Use of Up to 2.000 mgd; Approval Date: March 12, 2013. 2. Carrizo...

  8. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...; Approval Date: October 3, 2012. 6. Chief Oil & Gas LLC, Pad ID: T. Brown Drilling Pad, ABR-201210006, Lemon...

  9. 42 CFR 84.1103 - Approval labels and markings; approval of contents; use.

    Science.gov (United States)

    2010-10-01

    ... DEVICES Dust, Fume, and Mist; Pesticide; Paint Spray; Powered Air-Purifying High Efficiency Respirators and Combination Gas Masks § 84.1103 Approval labels and markings; approval of contents; use. (a) Full... pesticide gas mask Entire Mask and container. Dust, fume, and mist respirators Entire Respirator container...

  10. 30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines constructed of components... Electrically Operated Mining Equipment § 18.95 Approval of machines constructed of components approved, accepted or certified under Bureau of Mines Schedule 2D, 2E, 2F, or 2G. Machines for which field approval...

  11. 7 CFR 322.4 - Approved regions.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Approved regions. 322.4 Section 322.4 Agriculture Regulations of the Department of Agriculture (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS, AND BEEKEEPING EQUIPMENT Importation of Adult...

  12. Montana Advanced Biofuels Great Falls Approval

    Science.gov (United States)

    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

  13. 7 CFR 1425.4 - Approval.

    Science.gov (United States)

    2010-01-01

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

  14. Family Structure Variables and Need Approval

    Science.gov (United States)

    Masterson, Michael L.

    1971-01-01

    The results indicated that significant main effects for family size and sex indicated that Ss with smaller families showed lower need for approval and that females showed higher n App. Ordinal position was not a significant source of variance, however; these three family structure variables were found to be interacting. (Author)

  15. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

    ... 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 ...

  16. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    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…

  17. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

    ... SERVICES Plastic Surgery § 549.51 Approval procedures. The Clinical Director shall consider individually any request from an inmate or a BOP medical consultant. (a) In circumstances where plastic surgery is... the Clinical Director recommends plastic surgery for the good order and security of the institution...

  18. 133 LEGISLATIVE APPROVAL OF EXECUTIVE APPOINTMENTS ...

    African Journals Online (AJOL)

    Fr. Ikenga

    that peace, order and good governance shall be promoted both at the Federal and State levels. Keywords: Executive appointments, Legislative approval, National Assembly, Constitutional duty. 1. Introduction. The National Assembly is the highest law making and representative body in Nigeria. It is the. Constitutional ...

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  1. AOA Approval of ACGME Internship and Residency Training.

    Science.gov (United States)

    Duffy, Thomas; Martinez, Bulmaro

    2011-04-01

    Since the 1970s, the American Osteopathic Association (AOA) has provided a means for osteopathic physicians to apply for approval of their postdoctoral training in programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). Osteopathic physicians who trained in ACGME programs need this approval to meet AOA licensure and board certification requirements. The AOA approves ACGME residency training with several different approval processes. Approval of the first year of postdoctoral training occurs through Resolution 42, specialty approval (for specialties in which the first year of training is part of the residency), or federal or military training approval. For residency training, the AOA verifies successful completion of an ACGME training program before approving the training. The AOA is using customer surveys and online applications to improve the review process for applicants.

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

    Data.gov (United States)

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

  3. Drugs Approved for Wilms Tumor and Other Childhood Kidney Cancers

    Science.gov (United States)

    ... Common Cancer Types Bladder Cancer Breast Cancer Colorectal Cancer Kidney (Renal Cell) Cancer Leukemia Liver Cancer Lung Cancer ... Drugs Approved for Wilms Tumor and Other Childhood Kidney Cancers This page lists cancer drugs approved by the ...

  4. Clone of EPA Approved Regulations in the Texas SIP

    Science.gov (United States)

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

  5. 38 CFR 21.4258 - Notice of approval.

    Science.gov (United States)

    2010-07-01

    ... (2) Furnish VA an official copy of the letter, any attachments, and any subsequent amendments. In...) Organization's or entity's candidate handbook. (b) Contents of letter of approval. The letter of approval will...

  6. 27 CFR 4.93 - Approval of grape variety names.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Approval of grape variety..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.93 Approval of grape variety names. (a) Any interested person may petition the Administrator for the approval...

  7. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    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...

  8. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    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...

  9. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    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...

  10. 33 CFR 115.70 - Advance approval of bridges.

    Science.gov (United States)

    2010-07-01

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

  11. 33 CFR 67.10-15 - Approval of sound signals.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Approval of sound signals. 67.10... Sound signals § 67.10-15 Approval of sound signals. (a) The Coast Guard approves a sound signal if: (1) It meets the requirements for sound signals in § 67.10-1 (a), (b), (c), (d), and (e) when tested...

  12. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-26

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process.... 24. Chief Oil & Gas LLC, Pad ID: Tague East Drilling Pad, ABR- 201208024, Lemon Township, Wyoming...

  13. 78 FR 11947 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-02-20

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process..., 2012. 15. Chief Oil & Gas LLC, Pad ID: Harvey Drilling Pad, ABR- 201212015, Lemon Township, Wyoming...

  14. 40 CFR 85.1804 - Approval of Plan: Implementation.

    Science.gov (United States)

    2010-07-01

    ... manufacturer shall commence implementation of the approved plan. Notification of vehicle or engine owners shall... 40 Protection of Environment 18 2010-07-01 2010-07-01 false Approval of Plan: Implementation. 85... (CONTINUED) CONTROL OF AIR POLLUTION FROM MOBILE SOURCES Recall Regulations § 85.1804 Approval of Plan...

  15. 29 CFR 4221.14 - PBGC-approved arbitration procedures.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false PBGC-approved arbitration procedures. 4221.14 Section 4221... LIABILITY FOR MULTIEMPLOYER PLANS ARBITRATION OF DISPUTES IN MULTIEMPLOYER PLANS § 4221.14 PBGC-approved arbitration procedures. (a) Use of PBGC-approved arbitration procedures. In lieu of the procedures prescribed...

  16. 31 CFR 50.82 - Advance approval of settlements.

    Science.gov (United States)

    2010-07-01

    ... of action for property damage, personal injury, or death, asserted by a third-party or parties... INSURANCE PROGRAM Federal Cause of Action; Approval of Settlements § 50.82 Advance approval of settlements... advance approval any proposed agreement to settle or compromise any Federal cause of action for property...

  17. 8 CFR 207.6 - Control over approved refugee numbers.

    Science.gov (United States)

    2010-01-01

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

  18. 30 CFR 77.703-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved methods of grounding. 77.703-1 Section... COAL MINES Grounding § 77.703-1 Approved methods of grounding. The methods of grounding stated in § 77.701-1 will be approved with respect to the grounding of frames of high-voltage equipment referred to...

  19. 30 CFR 77.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved methods of grounding. 77.700-1 Section... COAL MINES Grounding § 77.700-1 Approved methods of grounding. Metallic sheaths, armors, and conduits... methods of grounding will be approved: (a) A solid connection to metal waterlines having low resistance to...

  20. 30 CFR 75.704-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved methods of grounding. 75.704-1 Section... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Grounding § 75.704-1 Approved methods of grounding. The methods of grounding stated in § 75.701-1 will also be approved with respect to the...

  1. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

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

  2. 19 CFR 115.55 - Termination of approval.

    Science.gov (United States)

    2010-04-01

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

  3. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    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...

  4. IPP plant owned by Mitsubishi subsidiary approved

    International Nuclear Information System (INIS)

    Anon.

    1990-01-01

    The Federal Energy Regulatory Commission has approved wholesale rates based on avoided cost for a $400 million plant to be built in central Virginia by Doswell Limited Partnership, a subsidiary of Diamond Energy Inc., which is a wholly owned subsidiary of the Mitsubishi Corporation. In granting the order accepting wholesale power rates filed by Doswell, the commission found that Doswell lacked market power over Virginia Power, to which it will sell power

  5. Academic Program Approval and Review Practices

    Directory of Open Access Journals (Sweden)

    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.

  6. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2013-09-05

    ...] Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval for... account approval for reimbursable services. DATES: We will consider all comments that we receive on or... (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit account...

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

    Science.gov (United States)

    DiMasi, Joseph A

    2013-06-01

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

  8. 78 FR 63937 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    Science.gov (United States)

    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...

  9. 78 FR 63887 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    Science.gov (United States)

    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...

  10. 75 FR 54215 - Agency Request for Approval of a Previously Approved Information Collection(s): Uniform...

    Science.gov (United States)

    2010-09-03

    ... Application for Federal Assistance (SF-424), Federal Financial Report (SF-425), Request for Advance or... Department has terminated Financial Status Report (SF-269 and SF-269A) and Federal Cash Transactions Report... 2105-0531. The Department's request for approval of the Federal Financial Report (FFR) (SF-425) is...

  11. Approved Air Quality Implementation Plans in Region 10

    Science.gov (United States)

    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)

    Energy Technology Data Exchange (ETDEWEB)

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

    Science.gov (United States)

    2010-07-01

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

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

    DEFF Research Database (Denmark)

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

    2013-01-01

    . 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...

  15. 7 CFR 1735.62 - Approval of acquisitions and mergers.

    Science.gov (United States)

    2010-01-01

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

  16. For the approval process of GMOs: The Japanese case

    NARCIS (Netherlands)

    Ebata, A.; Punt, M.J.; Wesseler, J.H.H.

    2013-01-01

    This article reviews the approval process of genetically modified organisms (GMOs) in Japan. The purpose of this review is to explain the Japanese safety approval procedures for food, feed, and imported GMOs and place it in an international context through a comparison with the United States and the

  17. 14 CFR 21.8 - Approval of articles.

    Science.gov (United States)

    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. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

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

  19. 25 CFR 225.22 - Approval of minerals agreements.

    Science.gov (United States)

    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, AND SOLID MINERALS AGREEMENTS Minerals Agreements § 225.22 Approval of minerals agreements. (a) A...

  20. 12 CFR 918.5 - Approval by Finance Board.

    Science.gov (United States)

    2010-01-01

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

  1. 22 CFR 64.9 - Termination of approval.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Termination of approval. 64.9 Section 64.9 Foreign Relations DEPARTMENT OF STATE PUBLIC DIPLOMACY AND EXCHANGES PARTICIPATION BY FEDERAL EMPLOYEES IN CULTURAL EXCHANGE PROGRAMS OF FOREIGN COUNTRIES § 64.9 Termination of approval. If at any time it appears...

  2. 22 CFR 64.7 - Approval of application.

    Science.gov (United States)

    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 CULTURAL EXCHANGE PROGRAMS OF FOREIGN COUNTRIES § 64.7 Approval of application. The Secretary of State...

  3. 22 CFR 64.5 - Criteria for approval of program.

    Science.gov (United States)

    2010-04-01

    ... 64.5 Foreign Relations DEPARTMENT OF STATE PUBLIC DIPLOMACY AND EXCHANGES PARTICIPATION BY FEDERAL EMPLOYEES IN CULTURAL EXCHANGE PROGRAMS OF FOREIGN COUNTRIES § 64.5 Criteria for approval of program. To obtain approval of its program of cultural exchanges, a foreign government is required to show that: (a...

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

    African Journals Online (AJOL)

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

  5. 78 FR 37848 - ASME Code Cases Not Approved for Use

    Science.gov (United States)

    2013-06-24

    ... COMMISSION ASME Code Cases Not Approved for Use AGENCY: Nuclear Regulatory Commission. ACTION: Draft... public comment draft regulatory guide (DG), DG-1233, ``ASME Code Cases not Approved for Use.'' This regulatory guide lists the American Society of Mechanical Engineers (ASME) Code Cases that the NRC has...

  6. 21 CFR 1240.83 - Approval of watering points.

    Science.gov (United States)

    2010-04-01

    ... DISEASES Source and Use of Potable Water § 1240.83 Approval of watering points. (a) The Commissioner of Food and Drugs shall approve any watering point if (1) the water supply thereat meets the standards....83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

  7. 21 CFR 1240.90 - Approval of treatment aboard conveyances.

    Science.gov (United States)

    2010-04-01

    ... COMMUNICABLE DISEASES Source and Use of Potable Water § 1240.90 Approval of treatment aboard conveyances. (a... produce, potable water. (b) The Commissioner of Food and Drugs may base his approval or disapproval of the... Section 1240.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  8. 40 CFR 307.40 - Payment of approved claims.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 27 2010-07-01 2010-07-01 false Payment of approved claims. 307.40 Section 307.40 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY... LIABILITY ACT (CERCLA) CLAIMS PROCEDURES Payments and Subrogation § 307.40 Payment of approved claims. (a...

  9. 10 CFR 61.73 - Commission approval of proposals.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Commission approval of proposals. 61.73 Section 61.73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Participation by State Governments and Indian Tribes § 61.73 Commission approval of proposals. (a...

  10. 7 CFR 621.33 - Conditions for approval.

    Science.gov (United States)

    2010-01-01

    ... Reports With the Department of the Army § 621.33 Conditions for approval. A joint investigation and report is authorized by a resolution of the Committee on Environment and Public Works of the U.S. Senate or... 7 Agriculture 6 2010-01-01 2010-01-01 false Conditions for approval. 621.33 Section 621.33...

  11. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY... lists the projects, described below, receiving approval for the consumptive use of water pursuant to the... Appalachia, LLC, Pad ID: Karp, ABR-201105027, Lemon Township, Wyoming County, Pa.; Consumptive Use of up to 7...

  12. 28 CFR 512.17 - Monitoring approved research projects.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Monitoring approved research projects... MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.17 Monitoring approved research projects. The BRRB shall monitor all research projects for compliance with Bureau policies. At a minimum, yearly reviews...

  13. 75 FR 60617 - Review and Approval of Projects

    Science.gov (United States)

    2010-10-01

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY... the project review regulations of the Susquehanna River Basin Commission (Commission) to include... approval; improve notice procedures for all project applications; clarify requirements for grandfathered...

  14. 77 FR 8095 - Review and Approval of Projects

    Science.gov (United States)

    2012-02-14

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY... amend the project review regulations of the Susquehanna River Basin Commission (Commission) to include... fluids from a Commission approved hydrocarbon development project to an out-of- basin treatment or...

  15. 75 FR 36301 - Review and Approval of Projects

    Science.gov (United States)

    2010-06-25

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

  16. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    2000-01-01

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

  17. 18 CFR 12.34 - Approval of independent consultant.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Approval of independent... COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS AND PROJECT WORKS Inspection by Independent Consultant § 12.34 Approval of independent consultant. At least 60...

  18. 18 CFR 154.6 - Acceptance for filing not approval.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Acceptance for filing... Provisions and Conditions § 154.6 Acceptance for filing not approval. The acceptance for filing of any tariff, contract or part thereof does not constitute approval by the Commission. Any filing which does not comply...

  19. 38 CFR 17.804 - Loan approval criteria.

    Science.gov (United States)

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Loan approval criteria. 17.804 Section 17.804 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL... package, loan approval will be based on the following: (a) Favorable financial history and status, (1) A...

  20. 7 CFR 714.45 - Approval by Deputy Administrator.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 7 2010-01-01 2010-01-01 false Approval by Deputy Administrator. 714.45 Section 714... PENALTIES ERRONEOUSLY, ILLEGALLY, OR WRONGFULLY COLLECTED § 714.45 Approval by Deputy Administrator. The Deputy Administrator shall review each claim forwarded to him by the State committee to determine whether...

  1. 27 CFR 27.206 - Bottles not constituting approved containers.

    Science.gov (United States)

    2010-04-01

    ... approved containers. 27.206 Section 27.206 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS IMPORTATION OF DISTILLED SPIRITS, WINES, AND BEER Requirements for Liquor Bottles § 27.206 Bottles not constituting approved containers. The appropriate TTB...

  2. 10 CFR 61.8 - Information collection requirements: OMB approval.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 61.8 Section 61.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE General Provisions § 61.8 Information collection requirements: OMB approval. (a) The Nuclear...

  3. 5 CFR 8301.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF AGRICULTURE § 8301.102 Prior approval for outside... an alternative form of reporting approved by the Office of Government Ethics, shall, before engaging... consultative or professional services, a statement indicating whether the client, employer, or other person on...

  4. 5 CFR 7401.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

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

  5. 7 CFR 272.9 - Approval of homeless meal providers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 4 2010-01-01 2010-01-01 false Approval of homeless meal providers. 272.9 Section 272... AGENCIES § 272.9 Approval of homeless meal providers. The State food stamp agency, or another appropriate... does in fact serve meals to homeless persons. Where the State food stamp agency identifies another...

  6. 33 CFR 157.12e - Certificate of approval.

    Science.gov (United States)

    2010-07-01

    ...) POLLUTION RULES FOR THE PROTECTION OF THE MARINE ENVIRONMENT RELATING TO TANK VESSELS CARRYING OIL IN BULK Design, Equipment, and Installation § 157.12e Certificate of approval. (a) A copy of the certificate of approval for the oil content meters must be carried aboard an oil tanker fitted with such equipment at all...

  7. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ... change to the scope of the project; (E) A change to the approved cost allocation methodology. The State... Management Information System (FAMIS)-type projects, in accordance with section 402(e)(2)(C) of the Social... obtain written approval of the Department prior to the initiation of project activity. (1) For regular...

  8. 17 CFR 250.63 - Approval of reorganization fees.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Approval of reorganization... Reorganizations § 250.63 Approval of reorganization fees. All fees, expenses and remuneration, whether interim or final, to whomsoever paid for services rendered or to be rendered in connection with any reorganization...

  9. 30 CFR 75.703-2 - Approved grounding mediums.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved grounding mediums. 75.703-2 Section 75... AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Grounding § 75.703-2 Approved grounding mediums. For purposes of grounding offtrack direct-current machines, the following grounding mediums are...

  10. 30 CFR 75.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved methods of grounding. 75.700-1 Section... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Grounding § 75.700-1 Approved methods of grounding. Metallic sheaths, armors and conduits in resistance grounded systems where the enclosed...

  11. 30 CFR 75.703-1 - Approved method of grounding.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved method of grounding. 75.703-1 Section... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Grounding § 75.703-1 Approved method of grounding. In instances where the metal frames both of an offtrack direct-current machine and of...

  12. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

    ..., the air cock on the test rig is opened and, if necessary, the oil and water supply valves are closed... period, the air cock on the test rig is opened and, if necessary, the oil and water supply valves are...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Pollution Prevention Equipment § 162.050-23 Separator: Approval...

  13. 75 FR 36464 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-06-25

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) approval of a new information... collection of information was published on March 18, 2010, vol. 75, no. 52, page 13204. This research is...

  14. 46 CFR 113.10-1 - Approved equipment.

    Science.gov (United States)

    2010-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT Fire and Smoke Detecting and Alarm Systems § 113.10-1 Approved equipment. Each alarm annunciator, fire detector, test station, manual station, and vibrating bell must be approved under Subpart...

  15. 47 CFR 400.5 - Approval and award.

    Science.gov (United States)

    2010-10-01

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

  16. Establishment approval in international trade of animal products

    NARCIS (Netherlands)

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

    2012-01-01

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

  17. 24 CFR 990.145 - Dwelling units with approved vacancies.

    Science.gov (United States)

    2010-04-01

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

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

    NARCIS (Netherlands)

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

    2006-01-01

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

  19. 17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

    Science.gov (United States)

    2010-04-01

    ... products for Commission review and approval. 40.3 Section 40.3 Commodity and Securities Exchanges COMMODITY... products for Commission review and approval. (a) Request for approval. Pursuant to Section 5c(c) of the Act... review. All products submitted for Commission approval under this paragraph shall be deemed approved by...

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

    Science.gov (United States)

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

    2016-06-01

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

  1. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Science.gov (United States)

    2010-05-24

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

  2. Daptomycin: the first approved lipopeptide antimicrobial.

    Science.gov (United States)

    Guay, David R P

    2004-07-01

    To review the literature concerning the first Food and Drug Administration-approved lipopeptide antimicrobial, daptomycin. A PUBMED search was conducted to identify pertinent English-language journal articles between 1985 and November 2003, and additional references were obtained from the bibliographies of these articles. Abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy meetings from 1985 through 2003 also were reviewed. All studies evaluating any aspect of daptomycin. Daptomycin is a semisynthetic lipopeptide, the first such antimicrobial agent to reach the marketplace. Its mechanism of action differs from that of the related agent vancomycin in that much of its effect is not because of inhibition of peptidoglycan biosynthesis, but instead is a result of alterations in cell-membrane electrical charge and transport. It exhibits a broad spectrum of activity against gram-positive aerobes and anaerobes, including methicillin-, penicillin-, aminoglycoside-, and vancomycin-resistant strains. In subjects with normal renal function, the terminal disposition half-life is about 7 to 10 hours. It is principally eliminated as unchanged drug in the urine. Available clinical trial data demonstrate efficacy in complicated skin and skin-structure infections resulting from susceptible gram-positive pathogens, but not in pneumonia. The principal adverse event of concern, although rare, is myotoxicity, manifested by muscle pain and/or weakness and elevated serum creatine phosphokinase (CPK) concentrations. The approved dosage regimen is 4 mg/kg intravenously over 30 minutes once daily for 7 days to 14 days. Studies are underway evaluating doses of up to 8 mg/kg once daily. Daptomycin, the first lipopeptide antimicrobial to be marketed, exhibits activity against multiresistant gram-positive pathogens, including linezolid- and quinupristindalfopristin-resistant strains. As such, it is a potentially valuable agent to treat infections resulting from

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

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

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

  4. 78 FR 32681 - Notice of Proposed Information Collection: Comment Request; Condominium Project Approval Document...

    Science.gov (United States)

    2013-05-31

    ... Approval Document Collection AGENCY: Office of the Assistant Secretary for Housing, HUD. ACTION: Notice... information: Title of Proposal: Condominium Project Approval Document Collection. OMB Control Number, if...

  5. Grandfathering of competent authority approved packages

    International Nuclear Information System (INIS)

    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

  6. Approval Letter for an Alternative Renewable Biomass Tracking Program

    Science.gov (United States)

    This January 27, 2015 letter and decision document from EPA approves the Argentine Chamber of Biofuel's (CARBIO) Alternate Biomass Traking Program meeting all the requirements outlined in 40 CFR § 80.1454, including elements determined necessary to achieve

  7. 22 CFR 129.6 - Requirement for license/approval.

    Science.gov (United States)

    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...

  8. 30 CFR 7.106 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

    ..., AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Power Packages Intended for Use in Areas of Underground Coal Mines Where Permissible Electric Equipment is Required § 7.106 Post...

  9. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    Science.gov (United States)

    2010-06-11

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

  10. 30 CFR 285.614 - When may I begin conducting activities under my approved SAP?

    Science.gov (United States)

    2010-07-01

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

  11. 30 CFR 14.1 - Purpose, effective date for approval holders.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Purpose, effective date for approval holders... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.1 Purpose, effective date for approval holders. This Part...

  12. 7 CFR 1427.1086 - Approval of warehouse, requests for reconsideration.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Approval of warehouse, requests for reconsideration... Standards for Approval of Warehouses for Cotton and Cotton Linters § 1427.1086 Approval of warehouse, requests for reconsideration. (a) CCC will approve a warehouse if it determines that the warehouse meets...

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

    Science.gov (United States)

    Kuchenbecker, Ricardo S; Mota, Daniel M

    2017-07-01

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

  14. 25 CFR 293.15 - When does an approved or considered-to-have-been-approved compact or amendment take effect?

    Science.gov (United States)

    2010-04-01

    ... compact or amendment take effect? 293.15 Section 293.15 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ECONOMIC ENTERPRISES CLASS III TRIBAL STATE GAMING COMPACT PROCESS § 293.15 When does an approved or considered-to-have-been-approved compact or amendment take effect? (a) An approved or...

  15. Steps for winning state approval of integration transactions.

    Science.gov (United States)

    O'Hare, P K

    1997-01-01

    The powers attorneys general have to regulate integration transactions between for-profit and not-for-profit organizations may differ from state to state, but regardless of location, health-care executives planning integration transactions should take steps to help ensure that such transactions receive state approval. Executives should familiarize themselves with the attorney general's approval process in their state, be prepared to defend the valuation of any not-for-profit assets to be transferred as part of an integration transaction, review articles of incorporation and state statutes to make certain that the proposed transfer of assets is permissible, and ensure that the process for securing board approval to proceed with the integration is free from conflicts of interest.

  16. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

    Markman, D.W.

    1999-01-01

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

  17. Reporting ethics committee approval in public administration research.

    Science.gov (United States)

    Jordan, Sara R; Gray, Phillip W

    2014-03-01

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

  18. Real Time Maintenance Approval and Required IMMT Coordination

    Science.gov (United States)

    Burchell, S.

    2016-01-01

    Payloads are assessed for nominal operations. Payload Developers have the option of performing a maintenance hazard assessment (MHA) for potential maintenance activities. When POIC (Payload Operations and Integration Center) Safety reviews an OCR calling for a maintenance procedure, we cannot approve it without a MHA. If no MHA exists, we contact MER (Mission Evaluation Room) Safety. Depending on the nature of the problem, MER Safety has the option to: Analyze and grant approval themselves; Direct the payload back to the ISRP (Integrated Safety Review Panel); Direct the payload to the IMMT (Increment Mission Management Team).

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

    Science.gov (United States)

    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.

  20. 2014 in review: FDA approval of new drugs.

    Science.gov (United States)

    Kinch, Michael S

    2017-04-01

    The year 2014 witnessed the approval by the US Food and Drug Administration (FDA) of 42 new molecular entities (NMEs), which is well above recent averages. These molecules targeted a range of molecular pathways and clinical indications, although the latter was skewed toward hepatitis C virus (HCV) infection and diabetes. By contrast, a single drug was approved for cardiovascular diseases and none for neurological indications (excepting sleeping disorders). Of note is a continued trend toward consolidation because the net number of biotechnology companies has reached its lowest point in over 25 years, raising questions about sustainability. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    International Nuclear Information System (INIS)

    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)

  2. Ethics approval: a challenge for public health researchers in India.

    Science.gov (United States)

    Nagaraja, Sharath Burugina; Menezes, Ritesh G; Zachariah, Rony; Wilson, Nevin

    2015-01-01

    There is increasing impetus, interest and opportunity for people working in public health programmes in India to carry out operational research (OR) around relevant programme issues and then publish that in peer-reviewed publications. These published researches are valuable in analysing, documenting and advocating for locally generated evidence to inform policy and practice. Ethics review and approval is an essential step in the process of OR but is often viewed as a barrier rather than a prerequisite of good practice in OR. Journals and peer reviewers are also increasingly requiring approvals from local institutional ethics committees (IECs).

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

    Energy Technology Data Exchange (ETDEWEB)

    Bush, M., E-mail: Michelle.Bush@environment.gov.au [Dept. of the Environment, Water, Heritage and the Arts, Supervising Scientist Division, Darwin, NT (Australia)

    2010-07-01

    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. 9 CFR 317.5 - Generically approved labeling.

    Science.gov (United States)

    2010-01-01

    ... claims, negative claims, geographical origin claims (except as provided by paragraph (b)(9)(xxv) of this... origin claims (except as provided by paragraph (b)(9)(xxv) of this section), or guarantees, or which is... of animals, fireworks, etc. are used with approved labeling (the use of such designs will not make...

  5. 9 CFR 381.133 - Generically approved labeling.

    Science.gov (United States)

    2010-01-01

    ... claims, health claims, negative claims, geographical origin claims (except as provided by paragraph (b)(9... claims, geographical origin claims (except as provided by paragraph (b)(9)(xxviii) of this section), or... of animals, fireworks, etc. are used with approved labeling (the use of such designs will not make...

  6. 42 CFR 410.143 - Requirements for approved accreditation organizations.

    Science.gov (United States)

    2010-10-01

    ... accreditation program. (2) If an organization does not use the NSDSMEP quality standards described in § 410.144... the organization's accreditation program. (3) If CMS notifies an organization that uses the CMS... organization reapplies to CMS for continuation of its approval and recognition by CMS of its program to...

  7. FDA-approved small-molecule kinase inhibitors

    DEFF Research Database (Denmark)

    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...

  8. 46 CFR 162.050-7 - Approval procedures.

    Science.gov (United States)

    2010-10-01

    ... observed at the separated water outlet of the separator; (4) During Test No. 5A its operation is continuous... this chapter as an article of ships' stores or supplies has been certified. (i) An oil content meter is... article of ships' stores or supplies has been certified. (j) A bilge alarm is approved under this subpart...

  9. 44 CFR 78.6 - Flood Mitigation Plan approval process.

    Science.gov (United States)

    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...

  10. 18 CFR 300.10 - Application for confirmation and approval.

    Science.gov (United States)

    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...

  11. 7 CFR 622.32 - Reviews and approvals.

    Science.gov (United States)

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Planning § 622.32 Reviews and approvals. (a) The watershed plan-environmental impact statement (or assessment) will be subject to internal technical reviews..., and a final review as stated in NRCS's National Watersheds Manual. (b) After thorough review by NRCS...

  12. 29 CFR 15.10 - Action on approved claim.

    Science.gov (United States)

    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...

  13. 34 CFR 35.7 - Payment of approved claims.

    Science.gov (United States)

    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...

  14. 45 CFR 35.7 - Payment of approved claims.

    Science.gov (United States)

    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...

  15. 40 CFR 10.7 - Payment of approved claim.

    Science.gov (United States)

    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...

  16. 12 CFR 793.7 - Payment of approved claims.

    Science.gov (United States)

    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...

  17. 40 CFR 35.940-3 - Costs allowable, if approved.

    Science.gov (United States)

    2010-07-01

    ... ASSISTANCE STATE AND LOCAL ASSISTANCE Grants for Construction of Treatment Works-Clean Water Act § 35.940-3 Costs allowable, if approved. Certain direct costs are sometimes necessary for the construction of a... the treatment process, or that will be used for ultimate disposal of residues resulting from such...

  18. FDA Expands Approval of Brentuximab for Hodgkin Lymphoma

    Science.gov (United States)

    The FDA has expanded the approved uses of brentuximab (Adcetris) in people with Hodgkin lymphoma. As this Cancer Currents post explains, it can now be used in combination with three chemotherapy drugs as an initial treatment in patients with advanced disease.

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

    Directory of Open Access Journals (Sweden)

    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.

  20. 22 CFR 3a.4 - Procedure for requesting approval.

    Science.gov (United States)

    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...

  1. Senate approves global warming bill; House bill introduced

    International Nuclear Information System (INIS)

    Yates, M.

    1990-01-01

    This article examines the Senate approved global warming bill and its impact to the Department of Energy (DOE) and the power industry. The bill requires stabilization or reduction of the greenhouse gases produced by the United States by the year 2005. DOE is required to develop a least-cost national energy strategy. A similar bill has been introduced into the House

  2. 33 CFR 104.410 - Submission and approval.

    Science.gov (United States)

    2010-07-01

    ... operations or by December 31, 2003, whichever is later. (c) The Commanding Officer, Marine Safety Center (MSC... Section 104.410 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY MARITIME SECURITY MARITIME SECURITY: VESSELS Vessel Security Plan (VSP) § 104.410 Submission and approval. (a) In...

  3. 48 CFR 970.5236-1 - Government facility subcontract approval.

    Science.gov (United States)

    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...

  4. Overview of FDA approval paths optical surgical navigation

    Science.gov (United States)

    Jacobs, Paula M.

    2017-02-01

    The development of drugs and devices to guide surgical resection of tumors in the United States requires the approval of the US Food and Drug Administration. Because these combine a drug and a device, the regulatory pathways can be confusing, particularly to academics or small companies. This paper discusses some of the issues and provides some guidance in this area.

  5. 7 CFR 1781.19 - Approval, closing, and cancellation.

    Science.gov (United States)

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE (CONTINUED) RESOURCE CONSERVATION AND DEVELOPMENT (RCD) LOANS AND WATERSHED (WS... requirements have been met: (1) The WS or RCD plan has been approved for operations by NRCS and the applicant... or WS advance, or RCD loan. In making this determination, consideration will be given to the relative...

  6. 38 CFR 21.4267 - Approval of independent study.

    Science.gov (United States)

    2010-07-01

    ... in absentia) necessary for the preparation of the student's— (i) Master's thesis, (ii) Doctoral... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Administration of Educational Assistance Programs Courses § 21.4267 Approval of independent study. (a) Overview. Except as provided in §§ 21.4252(g), 21.7120(d...

  7. 76 FR 60774 - Review and Approval of Projects

    Science.gov (United States)

    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...

  8. 77 FR 75915 - Review and Approval of Projects

    Science.gov (United States)

    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...

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

    NARCIS (Netherlands)

    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

  10. 48 CFR 245.7305 - Sale approval and award.

    Science.gov (United States)

    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...

  11. 76 FR 41154 - Review and Approval of Projects

    Science.gov (United States)

    2011-07-13

    ... 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... development project to an out-of-basin treatment or disposal facility; insert language authorizing ``renewal...

  12. 77 FR 14272 - Review and Approval of Projects

    Science.gov (United States)

    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...

  13. Olaparib Approved for Breast Cancers with BRCA Gene Mutations

    Science.gov (United States)

    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.

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

    International Development Research Centre (IDRC) Digital Library (Canada)

    2016-06-28

    Jun 28, 2016 ... The strong case for the use of fertilizers attracted the Alliance for a Green Revolution in Africa (AGRA) to finance a project supporting the Uganda Ministry of Agriculture, Animal Industry, and Fisheries (MAAIF) in the process of formulation and approval of the national fertilizer regulations, strategy, and policy.

  15. 50 CFR 15.26 - Approval of cooperative breeding programs.

    Science.gov (United States)

    2010-10-01

    ... WILDLIFE AND PLANTS WILD BIRD CONSERVATION ACT Permits and Approval of Cooperative Breeding Programs § 15... program requested for the exotic bird species, including: (i) A breeding protocol, including a genetic... resources available to the program appear adequate to successfully accomplish the objectives stated in the...

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

    Science.gov (United States)

    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…

  17. The Cost of Delaying Approval of Golden Rice

    NARCIS (Netherlands)

    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

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

    Science.gov (United States)

    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.

  19. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    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...

  20. 46 CFR 160.077-6 - Approval procedures.

    Science.gov (United States)

    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.

    Science.gov (United States)

    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. Forecasting Housing Approvals in Australia: Do Forecasters Herd?

    DEFF Research Database (Denmark)

    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...

  3. 10 CFR 60.8 - Information collection requirements: Approval.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: Approval. 60.8 Section 60.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN... Nuclear Regulatory Commission has submitted the information collection requirements contained in this part...

  4. 5 CFR 6701.106 - Prior approval for outside employment.

    Science.gov (United States)

    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...

  5. 5 CFR 7901.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... ETHICAL CONDUCT FOR EMPLOYEES OF THE TENNESSEE VALLEY AUTHORITY § 7901.102 Prior approval for outside... resource office and shall, at a minimum, identify the employer or other person for whom the services are to... Designated Agency Ethics Official, exempt specified classes of employees from this section based upon a...

  6. 5 CFR 7101.102 - Prior approval for outside employment.

    Science.gov (United States)

    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...

  7. 76 FR 63833 - Commission Approval of Divestiture Agreements

    Science.gov (United States)

    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...

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

    African Journals Online (AJOL)

    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.

  9. 33 CFR 157.12g - Plan approval requirements.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) POLLUTION RULES FOR THE PROTECTION OF THE MARINE ENVIRONMENT RELATING TO TANK VESSELS CARRYING OIL IN BULK Design, Equipment, and Installation § 157.12g Plan approval requirements. Adequate...-tank area and compatible with the operational requirements set out in the oil tanker's cargo and...

  10. 5 CFR 6401.103 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... an organization for which a different Deputy Ethics Official has responsibility, the employee must... five years unless the employee's Deputy Ethics Official specifies a longer time period. (e) Definition... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior approval...

  11. 16 CFR 802.6 - Federal agency approval.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Federal agency approval. 802.6 Section 802.6 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENTS AND INTERPRETATIONS UNDER THE... Bank “B”, which owns a financial subsidiary engaged in securities underwriting. “A”'s acquisition of “B...

  12. Template for letter of approval by Research Supervisor

    International Development Research Centre (IDRC) Digital Library (Canada)

    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.

  13. Template for letter of approval by Research Supervisor

    International Development Research Centre (IDRC) Digital Library (Canada)

    Liliane Castets-Poupart

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

  14. 25 CFR 216.6 - Approval of exploration plan.

    Science.gov (United States)

    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...

  15. 43 CFR 23.7 - Approval of exploration plan.

    Science.gov (United States)

    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...

  16. 75 FR 8426 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-02-24

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on October 16, 2009, vol. 74, no. 199, pages 53316-53317. Title 49...

  17. 75 FR 36466 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-06-25

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on April 13, 2010, vol. 75, no. 70, page 18940. Enplanement data...

  18. 75 FR 20874 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-04-21

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on November 13, 2009, vol. 74, no. 218, page 58676-58677. This...

  19. 75 FR 36465 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-06-25

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on April 13, 2010, vol. 75, no. 70, pages 18940-18941. 14 CFR part 61...

  20. 75 FR 29804 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-05-27

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on March 8, 2010, vol. 75, no. 44, page 10549. Title 49 U.S.C. 44703...

  1. 75 FR 13806 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-03-23

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on November 13, 2009, vol. 74, no. 218, page 58676. This information...

  2. 75 FR 882 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-01-06

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on Information collected to provide services to aircraft inflight and...

  3. 75 FR 3954 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-01-25

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on October 16, 2009, vol. 74, no. 199, page 53312. 49 U.S.C. 40117...

  4. 75 FR 8425 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-02-24

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on November 13, 2009, vol. 74, no. 218, page 58677. The FAA Office of...

  5. 75 FR 883 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-01-06

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on October 16, 2009, vol. 74, no. 199, pages 53311-53312. The FAA...

  6. 75 FR 5843 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-02-04

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on October 16, 2009, vol. 74, no. 199, page 53317. 49 CFR part 44707...

  7. 75 FR 7304 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-02-18

    ... Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... our intention to request the Office of Management and Budget's (OMB) revision of a current information... collection of information was published on October 16, 2009, vol. 74, no. 199, page 53316. FAR Part 157...

  8. Ensuring Effective Curriculum Approval Processes: A Guide for Local Senates

    Science.gov (United States)

    Academic Senate for California Community Colleges, 2016

    2016-01-01

    Curriculum is the heart of the mission of every college. College curriculum approval processes have been established to ensure that rigorous, high quality curriculum is offered that meets the needs of students. While some concerns may exist regarding the effectiveness and efficiency of local curriculum processes, all participants in the process…

  9. 28 CFR 20.23 - Documentation: Approval by OJARS.

    Science.gov (United States)

    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...

  10. 16 CFR 453.5 - Services provided without prior approval.

    Science.gov (United States)

    2010-01-01

    ... or deceptive act or practice for any provider to embalm a deceased human body for a fee unless: (1) State or local law or regulation requires embalming in the particular circumstances regardless of any funeral choice which the family might make; or (2) Prior approval for embalming (expressly so described...

  11. Legislative approval of executive appointments by the national ...

    African Journals Online (AJOL)

    ... in a patriotic manner in order to engender good governance? The paper concludes that the power should be exercised in a way that peace, order and good governance shall be promoted both at the Federal and State levels. Keywords: Executive appointments, Legislative approval, National Assembly, Constitutional duty ...

  12. 33 CFR 100.30 - Approval required for holding event.

    Science.gov (United States)

    2010-07-01

    ... event. 100.30 Section 100.30 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND... holding event. (a) An event for which application is required under § 100.15(a) shall be held only after approval of such event by the District Commander, except that applications referred to a State under § 100...

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

    International Nuclear Information System (INIS)

    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

  14. Experience with directional coronary atherectomy since pre-market approval.

    Science.gov (United States)

    Cowley, M J; DiSciascio, G

    1993-10-18

    Directional coronary atherectomy (DCA) received Food and Drug Administration (FDA) Pre-Market Approval in September 1990 and was then released through formal training certification of physicians at each new site. Procedure volume has increased dramatically since approval, with > 17,000 DCA procedures performed in 1991 and a cumulative total of > 33,000 procedures by mid-1992, at > 670 centers in the United States. Clinical application and results since approval have generally been similar to preapproval multicenter investigational results. Comparison of pre- and postapproval usage at the Medical College of Virginia shows similar baseline characteristics and indications, although recent patients show a higher proportion of "salvage" DCA for failed or suboptimal angioplasty (6% vs 14%) or DCA in combination with multidevice multiple vessel intervention (30% vs 38%). Overall results in 300 patients and 345 procedures included procedural success in 95%, clinical success in 94%, with major complications in 4.6% (including urgent bypass surgery in 3.8%, Q wave myocardial infarction in 1.7%, and hospital mortality in 0.3%). Results before and after FDA approval were similar for procedural success (94% vs 96%), clinical success rate (94% vs 94%), and major complications (5.5% vs 4.4%). There was a trend toward lower urgent surgery rate (5.4% vs 3.3%) in the more recent experience. In addition to its established efficacy for highly eccentric lesions, newer applications for which DCA is being used following FDA approval include treatment of saphenous vein grafts, thrombus-associated lesions, aorto-ostial lesions, failed or suboptimal percutaneous transluminal coronary angioplasty result, bifurcation lesions, and use as part of multivessel intervention.(ABSTRACT TRUNCATED AT 250 WORDS)

  15. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2010-08-10

    ... services, contact Mrs. Kris Caraher, User Fees Section Head, Financial Management Division, MRBBS, APHIS... services are repeat customers who request that we bill them. We need to collect certain information to... Inspection Service [Docket No. APHIS-2010-0071] Notice of Request for Extension of Approval of an Information...

  16. 21 CFR 530.13 - Extralabel use from compounding of approved new animal and approved human drugs.

    Science.gov (United States)

    2010-04-01

    ... of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a veterinarian within the practice of veterinary medicine. Nothing in this part shall be construed as permitting... pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes...

  17. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Science.gov (United States)

    2010-10-01

    ... organ transplant centers. 488.61 Section 488.61 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... kidney transplant centers or the pertinent national coverage decisions (NCDs) for extra-renal organ... CMS approves an extra-renal organ transplant center under the conditions of participation, the NCDs no...

  18. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    Science.gov (United States)

    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...

  19. 77 FR 7162 - Agency Information Collection Activities; Renewal of a Currently Approved Collection; Prohibition...

    Science.gov (United States)

    2012-02-10

    ... Collection Activities; Renewal of a Currently Approved Collection; Prohibition on Funding of Unlawful... currently approved information collection: Title: Prohibition on Funding of Unlawful Internet Gambling. OMB... implementing certain provisions of the Act's prohibition on the funding of unlawful Internet gambling...

  20. 75 FR 18472 - Notice of Intent to Seek Approval To Collect Information

    Science.gov (United States)

    2010-04-12

    ... of approval. Type of Request: Approval for data collection from individuals working in the areas of... food safety education (e.g. DVDs, posters, curriculum, kits) for inclusion in NAL's Food Safety...

  1. 78 FR 44923 - Notice of Intent to Seek Approval To Collect Information

    Science.gov (United States)

    2013-07-25

    .... Expiration Date: Three years from the date of approval. Type of Request: Approval for data collection from... materials developed to support food safety education (e.g. DVDs, posters, curriculum, kits) for inclusion in...

  2. 77 FR 46760 - Information Collections Approved by the Office of Management and Budget

    Science.gov (United States)

    2012-08-06

    ... Budget AGENCY: Federal Communications Commission. ACTION: Notice of public information collection 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...

  3. 76 FR 39874 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    2011-07-07

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

  4. 78 FR 51686 - Approval and Promulgation of Implementation Plans; Oklahoma; Regional Haze and Interstate...

    Science.gov (United States)

    2013-08-21

    ... require us to revisit our earlier approval of the State's NO X BART determination for these units, but... intention of replacing a FIP, EPA must approve the SIP revision so long as the SIP revision does not...

  5. 7 CFR 4290.480 - Prior approval of changes to RBIC's business plan.

    Science.gov (United States)

    2010-01-01

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

  6. 49 CFR 1544.231 - Airport-approved and exclusive area personnel identification systems.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false Airport-approved and exclusive area personnel... AIRCRAFT OPERATOR SECURITY: AIR CARRIERS AND COMMERCIAL OPERATORS Operations § 1544.231 Airport-approved... carry out a personnel identification system for identification media that are airport-approved, or...

  7. 75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-05-04

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

  8. 75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-11-22

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

  9. 7 CFR 1717.159 - Applications for RUS approvals of mergers.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

    Greene, Louise Eleanor; Bearn, David R

    2013-06-01

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

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

    Science.gov (United States)

    Newson, Ainsley J; Lipworth, Wendy

    2015-12-01

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

  12. 75 FR 66824 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-10-29

    ... 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...-201009108, Hazleton City, Luzerne County, Pa.; Consumptive Use of up to 0.055 mgd; Approval Date: September...

  13. 75 FR 31508 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-06-03

    ... 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 and 18 CFR 806.22...

  14. 75 FR 38591 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-07-02

    ... 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 and 18 CFR 806.22...

  15. 30 CFR 18.80 - Approval of machines assembled with certified or explosion-proof components.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines assembled with certified... MINE EQUIPMENT AND ACCESSORIES Machines Assembled With Certified or Explosion-Proof Components, Field Modifications of Approved Machines, and Permits To Use Experimental Equipment § 18.80 Approval of machines...

  16. 77 FR 53210 - Notice of Proposed Information Collection: Comment Request; Request for Approval of Advance of...

    Science.gov (United States)

    2012-08-31

    ... Information Collection: Comment Request; Request for Approval of Advance of Escrow Funds AGENCY: Office of the... information: Title of Proposal: Request for Approval of Advance of Escrow Funds. OMB Control Number, if... collected on the ``Request for Approval of Advance of Escrow Funds'' form is to ensure that escrowed funds...

  17. 76 FR 70807 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-11-15

    ... construction). Runway 18U36R structural joint rehabilitation. Closed circuit television improvements (design... notice of PFC approvals and disapprovals. In October 2011, there were six applications approved. This notice also includes information on one application, approved in September 2011, inadvertently left off...

  18. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    Science.gov (United States)

    2010-10-01

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

  19. 40 CFR 63.91 - Criteria for straight delegation and criteria common to all approval options.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 9 2010-07-01 2010-07-01 false Criteria for straight delegation and... Criteria for straight delegation and criteria common to all approval options. (a) Applicable approval... following paragraphs. (1) Unchanged Federal section 112 rules (“straight delegation”). To obtain approval of...

  20. 23 CFR 810.106 - Approval of fringe and transportation corridor parking facilities.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Approval of fringe and transportation corridor parking... Projects and Special Use Highway Facilities § 810.106 Approval of fringe and transportation corridor parking facilities. (a) In approving fringe and transportation corridor parking facilities, the Federal...

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

    Science.gov (United States)

    2010-04-01

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

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

    Science.gov (United States)

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

  3. 48 CFR 1371.114 - Government review, comment, acceptance, and approval.

    Science.gov (United States)

    2010-10-01

    ... Provisions and Clauses 1371.114 Government review, comment, acceptance, and approval. Insert clause 1352.271-83, Government Review, Comment, Acceptance and Approval, in all solicitations and contracts for ship..., acceptance, and approval. 1371.114 Section 1371.114 Federal Acquisition Regulations System DEPARTMENT OF...

  4. 7 CFR 1717.613 - RUS approval of data processing and system control equipment.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of data processing and system control... system control equipment. If a borrower's mortgage or loan contract requires the borrower to obtain approval from RUS before purchasing data processing equipment or system control equipment, such approval is...

  5. 13 CFR 108.140 - SBA approval of initial Management Expenses.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false SBA approval of initial Management Expenses. 108.140 Section 108.140 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS... SBA approval of initial Management Expenses. A NMVC Company must have its Management Expenses approved...

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

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Review and approval of security vulnerability... of security vulnerability assessments. (a) Review and Approval. The Department will review and approve in writing all Security Vulnerability Assessments that satisfy the requirements of § 27.215...

  7. 30 CFR 250.119 - Will MMS approve subsurface gas storage?

    Science.gov (United States)

    2010-07-01

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

  8. 30 CFR 285.103 - When may MMS prescribe or approve departures from these regulations?

    Science.gov (United States)

    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...

  9. 47 CFR 1.10004 - What am I allowed to do if I am approved?

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false What am I allowed to do if I am approved? 1.10004 Section 1.10004 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE International Bureau Filing System § 1.10004 What am I allowed to do if I am approved? If you are approved and...

  10. 77 FR 48167 - Approved Tribal-State Class III Gaming Compact; Indian Gaming

    Science.gov (United States)

    2012-08-13

    ... 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 the Eastern Band of Cherokee Indians...

  11. 34 CFR 97.111 - Criteria for IRB approval of research.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Criteria for IRB approval of research. 97.111 Section 97.111 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS... Subjects) § 97.111 Criteria for IRB approval of research. (a) In order to approve research covered by this...

  12. 30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests... means approved by the Secretary, and tests for methane shall be made with a methane detector approved by...

  13. 78 FR 28503 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter Counties...

    Science.gov (United States)

    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...

  14. 17 CFR 250.64 - Scope of applications for approval of reorganization plans.

    Science.gov (United States)

    2010-04-01

    ... approval of reorganization plans. 250.64 Section 250.64 Commodity and Securities Exchanges SECURITIES AND... Solicitations and Reorganizations § 250.64 Scope of applications for approval of reorganization plans. Any application for approval of a plan of reorganization under section 11 (49 Stat. 820; 15 U.S.C. 79k), or...

  15. 28 CFR 2.206 - Travel approval and transfers of supervision.

    Science.gov (United States)

    2010-07-01

    ... supervision. 2.206 Section 2.206 Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION... Supervised Releasees § 2.206 Travel approval and transfers of supervision. (a) A releasee's supervision officer may approve travel outside the district of supervision without approval of the Commission in the...

  16. 21 CFR 56.113 - Suspension or termination of IRB approval of research.

    Science.gov (United States)

    2010-04-01

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

  17. 78 FR 29780 - Fees for Testing, Evaluation, and Approval of Mining Products

    Science.gov (United States)

    2013-05-21

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

  18. 76 FR 5270 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Particulate Matter...

    Science.gov (United States)

    2011-01-31

    ... Wisconsin Paper Council (WPC) adverse to the proposed approval. Therefore, EPA withdrew the direct final rule on June 2, 2010 (75 FR 30710). In its May 7, 2010 letter, the WPC opposed approval of the rule on five grounds. First, WPC asserts, ``EPA's stated basis for approving WDNR's SIP submittal is not...

  19. 42 CFR 8.6 - Withdrawal of approval of accreditation bodies.

    Science.gov (United States)

    2010-10-01

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

  20. 75 FR 56530 - Public Information Collections Approved by Office of Management and Budget

    Science.gov (United States)

    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...

  1. Review of experiments for research reactors - approved 1974

    International Nuclear Information System (INIS)

    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

  2. Waste feed delivery environmental permits and approvals plan

    International Nuclear Information System (INIS)

    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

  3. Digital repositories certification: the Data Seal of Approval

    Directory of Open Access Journals (Sweden)

    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.

  4. Assisted Death: The Risks and Benefits of Tribunal Approval.

    Science.gov (United States)

    Handelman, Mark

    2016-02-01

    Should every request for physician-assisted death require approval from some kind of independent tribunal? The benefits include consistent interpretation of statutory or judge-created guidelines from hospital to hospital, accurate reporting of assisted deaths, a process that protects vulnerable patients and health practitioners, and assurance to the public that the process has sufficient safeguards. On the other hand, such a process might cause delays for persons suffering intolerably. Accessibility might be a problem, and there is the risk that the patient's personal health information becomes fodder for media sensationalism. The author weighs these risks and benefits and concludes that a tribunal approval process is a transparent system capable of helping the law clearly gel in a way that provides guidelines, encourages trust in the healthcare process generally and the assisted death process specifically. I

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

    International Nuclear Information System (INIS)

    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

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

    Science.gov (United States)

    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

  7. The Gold Standard as a `Good Housekeeping Seal of Approval'

    OpenAIRE

    Michael D. Bordo

    1995-01-01

    In this paper we argue that adherence to the gold standard rule of convertibility of national currencies into a fixed weight of gold served as a `good housekeeping seal of approval' which facilitated access by peripheral countries to foreign capital from the core countries of western Europe. We survey the historical background of gold standard adherence in the period 1870-1914 by nine important peripheral countries. The sample includes the full range of commitment to the gold standard from co...

  8. The Gold Standard as a "Good Housekeeping Seal of Approval"

    OpenAIRE

    Hugh Rockoff; Michael D. Bordo

    1996-01-01

    In this paper we argue that adherence to the gold standard rule of convertibility of national currencies into a fixed weight of gold served as `a good housekeeping seal of approval' which facilitated access by peripheral countries to foreign capital from the core countries of western Europe. We survey the historical background of gold standard adherence in the period 1870-1914 by nine important peripheral countries. The sample includes the full range of commitment to the gold standard from co...

  9. 40 CFR 52.385 - EPA-approved Connecticut regulations.

    Science.gov (United States)

    2010-07-01

    ..., manufacture of vegetable oil, pneumatic rubber tire categories. Other VOC rules. 10/10/80 6/7/82 47 FR 24452...) Program. 11/1/82 6/28/83 48 FR 29689 (c) 28 Simkins Industries—approved under the State Energy Trade... 5104 (c) 37 VOC RACT for King Industries. 8/8/87 12/17/87 52 FR 47925 (c) 39 VOC RACT for Belding...

  10. Biomedicines?Moving Biologic Agents into Approved Treatment Options

    OpenAIRE

    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...

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  14. Functional neural correlates of social approval in schizophrenia.

    Science.gov (United States)

    Makowski, Carolina S; Lepage, Martin; Harvey, Philippe-Olivier

    2016-03-01

    Social approval is a reward that uses abstract social reinforcers to guide interpersonal interactions. Few studies have specifically explored social reward processing and its related neural substrates in schizophrenia. Fifteen patients with schizophrenia and fifteen healthy controls participated in a two-part study to explore the functional neural correlates of social approval. In the first session, participants were led to believe their personality would be assessed based on their results from various questionnaires and an interview. Participants were then presented with the results of their supposed evaluation in the scanner, while engaging in a relevant fMRI social approval task. Subjects provided subjective reports of pleasure associated with receiving self-directed positive or negative feedback. Higher activation of the right parietal lobe was found in controls compared with individuals with schizophrenia. Both groups rated traits from the high social reward condition as more pleasurable than the low social reward condition, while intergroup differences emerged in the low social reward condition. Positive correlations were found in patients only between subjective ratings of positive feedback and right insula activation, and a relevant behavioural measure. Evidence suggests potential neural substrates underlying the cognitive representation of social reputation in schizophrenia. © The Author (2015). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

  15. Prodrugs - Recent approvals and a glimpse of the pipeline.

    Science.gov (United States)

    Rautio, Jarkko; Kärkkäinen, Jussi; Sloan, Kenneth B

    2017-11-15

    Prodrugs offer a versatile strategy to overcome flaws of viable drug candidates or clinically approved drugs. However, the strategic importance of prodrugs in the pharmaceutical industry has often been challenged, and prodrugs are often considered as the last option after lead optimization and when the selected drug candidate has faced significant pharmaceutical and pharmacokinetic limitations. Based on recent success in marketed drugs, prodrug strategy should clearly be considered already in early stages of lead optimization. During the past five years or so, prodrugs have accounted for about 10% of all small molecular weight drugs that have come to the market. In 2015 alone, the FDA approved seven prodrugs, which gives a prodrug prevalence of over 20% among the small molecules or over 15% among the total amount of the FDA approved drugs that year. A great number of various prodrugs are also undergoing late stage clinical trials. The pharmaceutical industry will therefore continue to depend on prodrugs for the foreseeable future. In this review, we will present the state of the art in the design of the prodrugs launched by the FDA since 2015. We will also provide an overview of some interesting late stage clinical prodrug candidates. We hope this review will demonstrate potential of prodrug strategies and facilitates the use of prodrugs in drug discovery projects. Copyright © 2017 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

    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

  17. Seeking approval: Present and future therapies for pemphigus vulgaris

    Science.gov (United States)

    Mao, Xuming; Payne, Aimee S

    2014-01-01

    Pemphigus vulgaris is an autoimmune blistering disease of the skin and mucous membranes. Despite the potentially fatal prognosis, there are currently no FDA-approved treatments specifically for pemphigus. In 2006, the FDA designated orphan drug status to mycophenolate mofetil for the treatment of pemphigus vulgaris indicating both federal and commercial interest in developing therapies for this devastating disease. This review focuses on pemphigus therapies that are currently in preclinical or clinical trials, as well as potential novel therapies based on recent advances in the understanding of the pathophysiology of this disease. PMID:18465660

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

    International Nuclear Information System (INIS)

    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

  19. The French procedure for granting new drug approval for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Verain, A.

    1986-01-01

    The pharmaceutical file which has to be prepared by the pharmaceutical manufacturers for obtaining new drug approval for radiopharmaceuticals in France is described. It consists of the scientific file, a technical file and an analytical appraisal. The text of the scientific file containing a detailed study of the raw material, a detailed galenical study and a detailed study of the final product is discussed. A brief outline of the technical file is given and finally details of the clinical file are presented including the required conditions, the phases of the clinical study and the clinical test protocols. (UK)

  20. Minister approves first exports from Beverley Uranium project

    International Nuclear Information System (INIS)

    Anon

    2000-01-01

    The Minister for Industry, Science and Resources, Senator Nick Minchin, approved the first uranium exports from the Beverley uranium project in March 2001. Beverley, a sandstone-hosted uranium deposit located near Lake Frome in South Australia, is the first new uranium mine to come into production following a change in Australian uranium mining policy in 1996 allowing for the construction of new mines. Beverley is expected to generate ∼ $424 million in export revenue over its project life and provide a further boost to Australia's uranium mining sector

  1. ANSI / FM Approvals 2510 flood abatement equipment test standard

    Directory of Open Access Journals (Sweden)

    Kravetz Frédéric

    2016-01-01

    Full Text Available Natural hazards, including flooding, continue to be the leading cause of commercial and industrial property damage worldwide. Until recently, there has been a limited amount of readily available guidance on choosing flood abatement protection. FM Approvals, a division of FM Global, one of the world’s largest business property insurers, working together with the Association of State Floodplain Managers and the US Army Corps of Engineers have developed a National Flood Barrier Test Program after recognizing the urgent demand for reliable flood abatement products to mitigate potential losses. This lead to the ANSI/ FM2510 flood abatement equipment standard.

  2. Biomedicines—Moving Biologic Agents into Approved Treatment Options

    Directory of Open Access Journals (Sweden)

    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. [...

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

    Science.gov (United States)

    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.

  4. Observations and suggestions for improved transport/packaging approvals

    International Nuclear Information System (INIS)

    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

  5. Safety review and approval process for the TFTR

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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

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

    Science.gov (United States)

    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.

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

    International Nuclear Information System (INIS)

    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

  9. 7 CFR 319.8-11 - From approved areas of Mexico.

    Science.gov (United States)

    2010-01-01

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

  10. 30 CFR 285.706 - How do I nominate a CVA for MMS approval?

    Science.gov (United States)

    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...

  11. 38 CFR 17.63 - Approval of community residential care facilities.

    Science.gov (United States)

    2010-07-01

    ... State and local regulations including construction, maintenance, and sanitation regulations; (2) Meet... must be approved by the appropriate Veterans Health Administration Veterans Integrated Service Networks...

  12. 75 FR 67388 - Credit Watch Termination Initiative; Termination of Direct Endorsement (DE) Approval

    Science.gov (United States)

    2010-11-02

    ... Approval terminated. FOR FURTHER INFORMATION CONTACT: The Quality Assurance Division, Office of Housing... Auditing Standards as provided by the Government Accountability Office. The mortgagee must also submit a...

  13. 76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Science.gov (United States)

    2011-08-30

    ... Approval for Cardiovascular Permanent Pacemaker Electrode; Correction AGENCY: Food and Drug Administration... development protocol for the class III preamendments device: Cardiovascular permanent pacemaker electrode. The...

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

    International Nuclear Information System (INIS)

    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

  15. 76 FR 27169 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-05-10

    ... surface markings. Fire alarm system replacement. Brief Description of Project Partially Approved for... building. Improve runway safety area. Conduct aeronautical survey for wide area augmentation system...

  16. Repurposing FDA-approved drugs for anti-aging therapies.

    Science.gov (United States)

    Snell, Terry W; Johnston, Rachel K; Srinivasan, Bharath; Zhou, Hongyi; Gao, Mu; Skolnick, Jeffrey

    2016-11-01

    There is great interest in drugs that are capable of modulating multiple aging pathways, thereby delaying the onset and progression of aging. Effective strategies for drug development include the repurposing of existing drugs already approved by the FDA for human therapy. FDA approved drugs have known mechanisms of action and have been thoroughly screened for safety. Although there has been extensive scientific activity in repurposing drugs for disease therapy, there has been little testing of these drugs for their effects on aging. The pool of FDA approved drugs therefore represents a large reservoir of drug candidates with substantial potential for anti-aging therapy. In this paper we employ FINDSITE comb , a powerful ligand homology modeling program, to identify binding partners for proteins produced by temperature sensing genes that have been implicated in aging. This list of drugs with potential to modulate aging rates was then tested experimentally for lifespan and healthspan extension using a small invertebrate model. Three protein targets of the rotifer Brachionus manjavacas corresponding to products of the transient receptor potential gene 7, ribosomal protein S6 polypeptide 2 gene, or forkhead box C gene, were screened against a compound library consisting of DrugBank drugs including 1347 FDA approved, non-nutraceutical molecules. Twenty nine drugs ranked in the top 1 % for binding to each target were subsequently included in our experimental analysis. Continuous exposure of rotifers to 1 µM naproxen significantly extended rotifer mean lifespan by 14 %. We used three endpoints to estimate rotifer health: swimming speed (mobility proxy), reproduction (overall vitality), and mitochondria activity (cellular senescence proxy). The natural decline in swimming speed with aging was more gradual when rotifers were exposed to three drugs, so that on day 6, mean swimming speed of females was 1.19 mm/s for naproxen (P = 0.038), 1.20 for fludarabine (P = 0

  17. The LEP collider, from design to approval and commissioning

    International Nuclear Information System (INIS)

    Myers, S.

    1991-01-01

    A description is given of the design, approval, construction, and commissioning of the Large Electron-Positron storage ring (LEP) collider. The contribution of John Adams is highlighted both during his years as CERN's Director General and later as an active member of the LEP Machine Advisory Committee. The first injection into LEP took place in July 1989, first collisions for physics being about a month later. After one year of operation the LEP luminosity has reached more than half of the design value, and more than 900,000 Z 0 particles have been generated, detected, and analysed. The major factors relating to each significant improvement in performance are described. The present-day limitations to performance are analysed, and the foreseen improvements aimed at raising the performance are discussed. In addition, the time schedule and performance estimates for the planned upgrade in LEP energy to allow study of W pair production are reported. (orig.)

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

    Science.gov (United States)

    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.

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

    International Nuclear Information System (INIS)

    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

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

    Science.gov (United States)

    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...

  1. 30 CFR 75.1107-2 - Approved fire-resistant hydraulic fluids; minimum requirements.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved fire-resistant hydraulic fluids... Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-2 Approved fire-resistant hydraulic fluids; minimum requirements. Fire-resistant hydraulic fluids and...

  2. 78 FR 43145 - Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard

    Science.gov (United States)

    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...

  3. 77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

    Science.gov (United States)

    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...

  4. 25 CFR 87.12 - Insuring the proper performance of approved plans.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Insuring the proper performance of approved plans. 87.12... DISTRIBUTION OF INDIAN JUDGMENT FUNDS § 87.12 Insuring the proper performance of approved plans. A timetable... regarding the maintenance of the timetable, a full accounting of any per capita distribution, and the...

  5. 22 CFR 204.33 - A.I.D. approval of acceleration of notes.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false A.I.D. approval of acceleration of notes. 204.33 Section 204.33 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT HOUSING GUARANTY STANDARD TERMS AND CONDITIONS Covenants § 204.33 A.I.D. approval of acceleration of notes. Without the prior...

  6. 76 FR 33192 - Notice of Request for Extension of Approval of an Information Collection; Phytosanitary Export...

    Science.gov (United States)

    2011-06-08

    ... Animal and Plant Health Inspection Service Notice of Request for Extension of Approval of an Information Collection; Phytosanitary Export Certification AGENCY: Animal and Plant Health Inspection Service, USDA... approval of an information collection. Abstract: The Animal and Plant Health Inspection Service (APHIS...

  7. State Approval Policies and Procedures for Postsecondary Career and Technical Education

    Science.gov (United States)

    Merkley, Rodney J.; Johnston, George H.

    2007-01-01

    This study examined the final program approval for new postsecondary Career and Technical Education (CTE) programs and program review policies and procedures for existing programs based on publicly available Web sites and on follow-up interviews with representatives in the final state approving agency. The purpose of the study was to inventory the…

  8. State Approval Policies and Procedures for Postsecondary CTE Programs. In Brief

    Science.gov (United States)

    Merkley, Rodney J.; Johnston, George H.

    2007-01-01

    This brief presents the results of a national study designed to inventory state agency approval policies and procedures for postsecondary Career and Technical Education (CTE) programs (Merkley & Johnston, forthcoming). The study was limited to the states' approval of CTE programs implemented by public, two-year degree-granting institutions and did…

  9. 78 FR 37777 - Notice of Request for Extension of Approval of an Information Collection; Cooperative...

    Science.gov (United States)

    2013-06-24

    ...] Notice of Request for Extension of Approval of an Information Collection; Cooperative Agricultural Pest... approval of an information collection associated with the Cooperative Agricultural Pest Survey. DATES: We... INFORMATION CONTACT: For information on the Cooperative Agricultural Pest Survey, contact Dr. John Bowers...

  10. 78 FR 3453 - Notice of Intent To Seek Approval To Establish an Information Collection System

    Science.gov (United States)

    2013-01-16

    ... functions of the Foundation, including whether the information will have practical utility; (b) the accuracy.... Expiration Date of Approval: Not applicable. Type of Request: Intent to seek approval to establish an... outreach programs that help stir the imagination of K-12 students, often with a focus on groups...

  11. 78 FR 59360 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

    Science.gov (United States)

    2013-09-26

    ... Greater Risk Program. Burden Statement: Burden in this context means the time expended by persons to... Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved...: Girls at Greater Risk for Juvenile Delinquency and HIV Prevention Program. OMB No.: 0990-0360. Abstract...

  12. 13 CFR 115.62 - Prohibition on participation in Prior Approval program.

    Science.gov (United States)

    2010-01-01

    ... Prior Approval program. 115.62 Section 115.62 Business Credit and Assistance SMALL BUSINESS... in Prior Approval program. A PSB Surety is not eligible to submit applications under subpart B of this part. This prohibition does not extend to an Affiliate, as defined in 13 CFR § 121.103, of a PSB...

  13. 46 CFR 164.009-3 - Noncombustible materials not requiring specific approval.

    Science.gov (United States)

    2010-10-01

    ...) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Noncombustible Materials for... noncombustible materials may be used in merchant vessel construction though not specifically approved under this subpart: (a) Sheet glass, block glass, clay, ceramics, and uncoated fibers. (b) All metals, except...

  14. 78 FR 11639 - Houston Pipe Line Company LP; Notice of Petition for Rate Approval

    Science.gov (United States)

    2013-02-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR13-31-000] Houston Pipe Line Company LP; Notice of Petition for Rate Approval Take notice that on February 1, 2013, Houston Pipe Line Company LP (HPL) filed for approval of rates for transportation service pursuant to section...

  15. 25 CFR 225.28 - Approval of amendments to minerals agreements.

    Science.gov (United States)

    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...

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

    International Nuclear Information System (INIS)

    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

  17. 77 FR 9865 - Clarification on the Division 1.1 Fireworks Approvals Policy

    Science.gov (United States)

    2012-02-21

    ... APA Standard 87-1 (IBR, see Sec. 171.7), and the device passes the thermal stability test. Additionally, the applicant must certify that the firework device conforms to the APA Standard 87-1 and that... approval. While APA Standard 87-1 contains two instances where Division 1.1 fireworks may be approved under...

  18. 77 FR 429 - Clarification and Further Guidance on the Fireworks Approvals Policy

    Science.gov (United States)

    2012-01-05

    ...) and the American Pyrotechnic Association (APA) Standard 87-1. PHMSA understands that it is a common... approval is requested conforms to the APA Standard 87-1, and the descriptions and technical information... manufacturer must sign and certify that the device for which the approval is requested conforms to the APA...

  19. 76 FR 50536 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-15

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

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

    International Nuclear Information System (INIS)

    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

  1. 42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

    Science.gov (United States)

    2010-10-01

    ...; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY... 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg...

  2. 29 CFR 1952.240 - Description of the plan as initially approved.

    Science.gov (United States)

    2010-07-01

    ... of the standards beginning with the effective date of the grant approved under section 23(g) of the Act. The timetable requires from 6 to 36 months for completion of the standard-setting process with... ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Alaska...

  3. 28 CFR 58.26 - Procedures for inclusion on the approved provider list.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Procedures for inclusion on the approved... RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994 § 58.26 Procedures for inclusion on the approved provider list. (a) As used in this section the term “provider” means a provider of a personal financial...

  4. Analysis of time to regulatory and ethical approval of SATVI TB ...

    African Journals Online (AJOL)

    Background. Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product. Aim. Our aim was to ...

  5. 78 FR 19729 - Wild Bird Conservation Act; Receipt of Application for Approval

    Science.gov (United States)

    2013-04-02

    ...-FF09A30000] Wild Bird Conservation Act; Receipt of Application for Approval AGENCY: Fish and Wildlife Service... birds that are protected in accordance with the Wild Bird Conservation Act of 1992. DATES: Written data... invited to comment on the following application for approval to conduct certain activities with bird...

  6. 76 FR 50479 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-08-15

    ... Activities; Submission to OMB for Review and Approval; Comment Request; Lead-Based Paint Pre-Renovation... nature of the information collection activity and its expected burden and costs. DATES: Additional... (OMB) for review and approval: Lead-Based Paint Pre- Renovation Information Dissemination--TSCA Sec...

  7. 25 CFR 273.17 - Programs approved by Indian Education Committee.

    Science.gov (United States)

    2010-04-01

    ... pursuant to this part shall be changed from the time of its original approval by the Indian Education... 25 Indians 1 2010-04-01 2010-04-01 false Programs approved by Indian Education Committee. 273.17... EDUCATION ASSISTANCE ACT PROGRAM EDUCATION CONTRACTS UNDER JOHNSON-O'MALLEY ACT Application Process § 273.17...

  8. 47 CFR 69.119 - Basic service element expedited approval process.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Basic service element expedited approval... CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element... approval of new basic service elements are those indicated in § 1.45 of the rules, except as specified...

  9. 16 CFR 1028.111 - Criteria for IRB approval of research.

    Science.gov (United States)

    2010-01-01

    ... HUMAN SUBJECTS § 1028.111 Criteria for IRB approval of research. (a) In order to approve research... subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant...) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design...

  10. 75 FR 22172 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-04-27

    ... 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(f... (PA), Inc., Pad ID: Roba, ABR-20100101, Scott Township, Lackawanna County, Pa.; Consumptive Use of up...

  11. 75 FR 51155 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-08-18

    ... 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(f... Appalachia, LLC; Pad ID: Duane, ABR-20100601, Leroy Township, Bradford County, Pa.; Consumptive Use of up to...

  12. 75 FR 52049 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-08-24

    ... 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..., Salisbury Township, Lancaster County and West Sadsbury Township, Chester County, Pa.; Consumptive Use of up...

  13. 15 CFR 27.111 - Criteria for IRB approval of research.

    Science.gov (United States)

    2010-01-01

    ... HUMAN SUBJECTS § 27.111 Criteria for IRB approval of research. (a) In order to approve research covered... subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant...) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design...

  14. 14 CFR 1230.111 - Criteria for IRB approval of research.

    Science.gov (United States)

    2010-01-01

    ... HUMAN SUBJECTS § 1230.111 Criteria for IRB approval of research. (a) In order to approve research... subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant...) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design...

  15. The influence of husbands' approval on women's use of prenatal care

    African Journals Online (AJOL)

    Administrator

    pregnancy wantedness and other factors. Results: It was found out that a husband's approval has a greater effect on prenatal care utilization than whether a wife wanted the pregnancy or a wife's level of education. It was also found that the impact of a husband's approval on prenatal care is greatest among women under the ...

  16. 77 FR 29231 - Oklahoma: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Science.gov (United States)

    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...

  17. 77 FR 46964 - Oklahoma: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Science.gov (United States)

    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...

  18. 76 FR 26616 - Wisconsin: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Science.gov (United States)

    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...

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

    Science.gov (United States)

    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. 46 CFR 11.309 - Coast Guard-accepted training other than approved courses.

    Science.gov (United States)

    2010-10-01

    ... first aid, nor a person with at least 3 years of service as a member of the Armed Forces of the United... 46 Shipping 1 2010-10-01 2010-10-01 false Coast Guard-accepted training other than approved... OFFICERS AND SEAMEN REQUIREMENTS FOR OFFICER ENDORSEMENTS Training Schools with Approved Courses § 11.309...

  1. 46 CFR 12.03-1 - Coast Guard-accepted training other than approved courses.

    Science.gov (United States)

    2010-10-01

    ... field of non-maritime education, such as mathematics or first aid, nor a person with at least 3 years of... 46 Shipping 1 2010-10-01 2010-10-01 false Coast Guard-accepted training other than approved... OFFICERS AND SEAMEN REQUIREMENTS FOR RATING ENDORSEMENTS Approved and Accepted Training § 12.03-1 Coast...

  2. 76 FR 30200 - Forging Machines; Extension of the Office of Management and Budget's (OMB) Approval of...

    Science.gov (United States)

    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...

  3. 75 FR 51437 - Notice of Request for Extension of a Currently Approved Information Collection (Advanced Meat...

    Science.gov (United States)

    2010-08-20

    ... Request for Extension of a Currently Approved Information Collection (Advanced Meat Recovery) AGENCY: Food... information collection regarding the regulatory requirements associated with the production of meat from Advanced Meat Recovery systems because the OMB approval will expire on January 31, 2011. DATES: Comments on...

  4. 7 CFR 1717.611 - RUS approval of expenditures for legal, accounting, engineering, and supervisory services.

    Science.gov (United States)

    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...

  5. 76 FR 20802 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-04-13

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved or Rescinded for Consumptive Uses of Water... the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR..., Pad ID: Garrison Drilling Pad 1, ABR-201102032, Lemon Township, Wyoming County, Pa.; Consumptive Use...

  6. 76 FR 33019 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    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...

  7. 9 CFR 354.34 - Application for inspection service in official plants; approval.

    Science.gov (United States)

    2010-01-01

    ... according to the following procedure: (a) Initial survey. When application has been filed for inspection... insects. (6) Finish of floors—concrete, brick, mastic material, etc. (7) Drainage—indicate the amount of... of the originally approved drawing or blueprint. (g) Final survey and plant approval. Prior to the...

  8. 77 FR 3928 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Consumer and Commercial...

    Science.gov (United States)

    2012-01-26

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Virginia; Consumer...: EPA is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia... industrial (AIM) coatings, adhesives and sealants, and asphalt paving operations within the Northern Virginia...

  9. 76 FR 69214 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Consumer and Commercial...

    Science.gov (United States)

    2011-11-08

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Virginia; Consumer...: EPA is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth..., architectural and industrial (AIM) coatings, adhesives and sealants, and asphalt paving operations within the...

  10. 76 FR 63574 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Miscellaneous Metal and...

    Science.gov (United States)

    2011-10-13

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2010-1001; FRL-9478-5] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Miscellaneous Metal and Plastic Parts Surface... Indiana's miscellaneous metal and plastic parts surface coating rules. These rules are approvable because...

  11. 25 CFR 162.107 - What are BIA's objectives in granting or approving leases?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false What are BIA's objectives in granting or approving leases... LEASES AND PERMITS General Provisions § 162.107 What are BIA's objectives in granting or approving leases... land under the tribe's jurisdiction, through contracts and self-governance compacts entered into under...

  12. 36 CFR 1200.10 - What are NARA's criteria for approval?

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false What are NARA's criteria for... § 1200.10 What are NARA's criteria for approval? NARA's criteria for approval are as follows: (a) NARA..., commercial products or services, or a requestor's policies or activities. [67 FR 72101, Dec. 4, 2002, as...

  13. 75 FR 35122 - Approval of Noise Compatibility Program for Buckeye Municipal Airport, Town of Buckeye, AZ

    Science.gov (United States)

    2010-06-21

    ... approval of such program. The submitted program contained five proposed actions for noise abatement, noise... Federal Aviation Administration Approval of Noise Compatibility Program for Buckeye Municipal Airport... Aviation Administration (FAA) announces its findings on the noise compatibility program submitted by the...

  14. 75 FR 75959 - Notice of Intent: To Request a Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-12-07

    ... mitigate risk through production diversification or resource conservation practices, including soil erosion... Date of Approval: May 31, 2012. Type of Request: To revise a currently approved information collection... and practices to conserve, develop, and use the soil, water, and related natural resources on private...

  15. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    Science.gov (United States)

    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...

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

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 13 2010-01-01 2009-01-01 true Plan and State Investment Strategy approval procedure... HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY... Impacted Area Development Assistance Program § 1948.82 Plan and State Investment Strategy approval...

  17. 77 FR 66547 - Approval and Promulgation of Implementation Plans; Michigan; Detroit-Ann Arbor Nonattainment Area...

    Science.gov (United States)

    2012-11-06

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Michigan; Detroit-Ann Arbor... the state's Detroit-Ann Arbor (Livingston, Macomb, Monroe, Oakland, St. Clair, Washtenaw, and Wayne... rulemaking to approve Michigan's PM 2.5 2005 base year emissions inventory for the Detroit-Ann Arbor area...

  18. 30 CFR 950.30 - Approval of Wyoming abandoned mine land reclamation plan.

    Science.gov (United States)

    2010-07-01

    ..., Department of Environmental Quality, Abandoned Mine Lands Division, Herschler Building, Third Floor West, 122... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Wyoming abandoned mine land... § 950.30 Approval of Wyoming abandoned mine land reclamation plan. The Wyoming Abandoned Mine Land...

  19. 78 FR 55290 - Approved Recovery Plan for the Dwarf Lake Iris

    Science.gov (United States)

    2013-09-10

    ...-FF03E00000] Approved Recovery Plan for the Dwarf Lake Iris AGENCY: Fish and Wildlife Service, Interior...), announce the availability of the approved recovery plan for the dwarf lake iris (Iris lacustris), a species... draft dwarf lake iris recovery plan to the public and solicited comments from May 30, 2012, through June...

  20. 75 FR 9103 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; NOX

    Science.gov (United States)

    2010-03-01

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2009-0964; FRL-9116-8] Approval and Promulgation of Air Quality Implementation Plans; Illinois; NOX Budget Trading Program AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving a revision to the Illinois...

  1. 75 FR 9146 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; NOX

    Science.gov (United States)

    2010-03-01

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2009-0964; FRL-9116-9] Approval and Promulgation of Air Quality Implementation Plans; Illinois; NOX Budget Trading Program AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a revision to the...

  2. 75 FR 6336 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Removal of NOX

    Science.gov (United States)

    2010-02-09

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2009-0706; FRL-9111-6] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Removal of NOX SIP Call Rules AGENCY... oxides (NOx) SIP Call rules. In the Final Rules section of this Federal Register, EPA is approving the...

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

    International Nuclear Information System (INIS)

    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

  4. Adolescent Perceptions of Maternal Approval of Birth Control and Sexual Risk Behavior.

    Science.gov (United States)

    Jaccard, James; Dittus, Patricia J.

    2000-01-01

    Used data from the Longitudinal Study of Adolescent health to examine the relationship between adolescent perception of maternal approval of the use of birth control and sexual outcomes over 12 months. Overall, adolescents' perceptions of maternal approval related to an increased likelihood of sexual intercourse in the next year and an increase in…

  5. 76 FR 28121 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-05-13

    .... Programming, design, and construction of replacement aircraft rescue and firefighting building, including... of Projects Approved for Collection and Use: Procurement and installation of aircraft loading bridge...: Aircraft rescue and firefighting facility. Determination: The approval of this project is limited to the...

  6. 49 CFR 178.273 - Approval of Specification UN portable tanks.

    Science.gov (United States)

    2010-10-01

    ...) All applicable provisions of the design and construction have been met to the satisfaction of the... approval agency must: (i) Apply its name, identifying mark or identifying number, and the date upon which... approvals for UN portable tanks authorizing design or construction alternatives (Alternate Arrangements...

  7. 75 FR 71135 - Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug Application

    Science.gov (United States)

    2010-11-22

    ... HUMAN SERVICES Food and Drug Administration Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug... held by Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110- 1199. Hoffmann-La Roche Inc... INFORMATION: Hoffmann-La Roche Inc. has requested that FDA withdraw approval of NDA 18-662, ACCUTANE...

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

    Science.gov (United States)

    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...

  9. Structure and problems of the project approval procedure in the context of the atomic energy act

    International Nuclear Information System (INIS)

    Witt, S. de

    2005-01-01

    The paper is focussed on the following topics: project approval in the context of sectoral planning laws, project approval for the final disposal of radioactive wastes, atomic energy law in relation to the mining law, missing disposession laws, and consequences for the site selection procedure

  10. 75 FR 41855 - ONEOK Field Services Company, LLC; Notice of Petition for Rate Approval

    Science.gov (United States)

    2010-07-19

    ... Energy Regulatory Commission ONEOK Field Services Company, LLC; Notice of Petition for Rate Approval July 13, 2010. Take notice that on July 1, 2010, ONEOK Field Services Company, LLC ] (OFS) filed a... is filing for approval for a new maximum rate for interruptible transportation service provided...

  11. 5 CFR 7301.102 - Prior approval for outside teaching, speaking and writing.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside teaching... approval for outside teaching, speaking and writing. (a) Before engaging in outside teaching, speaking or... that the outside teaching, speaking or writing is not expected to involve conduct prohibited by statute...

  12. 76 FR 8628 - Safe, Efficient Use and Preservation of the Navigable Airspace; OMB Approval of Information...

    Science.gov (United States)

    2011-02-15

    ...-25002; Amendment No. 77-13] RIN 2120-AH31 Safe, Efficient Use and Preservation of the Navigable Airspace; OMB Approval of Information Collection AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule; OMB approval of information collection. SUMMARY: This document announces the Office of Management...

  13. 78 FR 76383 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-12-17

    ... Airport Authority, Mobile, Alabama. Application Number: 13-06-C-00-MOB. Application Type: Impose and use a... Regional Airport (MOB). Determination: Approved. Based on information submitted in the public agency's... annual enplanements at MOB. Brief Description of Projects Approved for Collection and Use: Wildlife...

  14. 78 FR 19128 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards

    Science.gov (United States)

    2013-03-29

    ... Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards AGENCY: Environmental... conditional approval of specified provisions of the Ohio state implementation plan (SIP) to a full approval... emission limitation exemption for jet engine testing. Pursuant to a state commitment underlying a previous...

  15. 34 CFR 668.143 - Approval of State tests or assessments.

    Science.gov (United States)

    2010-07-01

    ... Secretary approves passing scores or other methods of evaluation established by the State for each test or... attend eligible institutions located in that State. (d) If a State wishes to have the Secretary approve... and assessments, its passing scores on those tests and assessments, and the educational standards...

  16. 28 CFR 901.3 - Approval of delayed fingerprint submission requests.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Approval of delayed fingerprint... COMPACT COUNCIL FINGERPRINT SUBMISSION REQUIREMENTS § 901.3 Approval of delayed fingerprint submission requests. (a) A state may, based upon exigent circumstances, apply for delayed submission of fingerprints...

  17. 5 CFR 2471.6 - Investigation of request; Panel procedures; approval of binding arbitration.

    Science.gov (United States)

    2010-01-01

    ... procedures; approval of binding arbitration. 2471.6 Section 2471.6 Administrative Personnel FEDERAL LABOR... procedures; approval of binding arbitration. (a) Upon receipt of a request for consideration of an impasse... arbitration or mediation-arbitration (by a Panel designee or a private arbitrator). Following procedures used...

  18. 5 CFR 2471.1 - Request for Panel consideration; request for Panel approval of binding arbitration.

    Science.gov (United States)

    2010-01-01

    ... for Panel approval of binding arbitration. 2471.1 Section 2471.1 Administrative Personnel FEDERAL... consideration; request for Panel approval of binding arbitration. If voluntary arrangements, including the... procedure, which they have agreed to adopt, for binding arbitration of the negotiation impasse by filing a...

  19. 48 CFR 1352.271-83 - Government review, comment, acceptance and approval.

    Science.gov (United States)

    2010-10-01

    ..., acceptance or approval by the Government as required under this contract and applicable specifications shall..., acceptance and approval. 1352.271-83 Section 1352.271-83 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 1352...

  20. 78 FR 13661 - Energy Transfer Fuel, LP; Notice of Petition for Rate Approval

    Science.gov (United States)

    2013-02-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Energy Transfer Fuel, LP; Notice of Petition for Rate Approval Take notice that on February 15, 2013, Energy Transfer Fuel, LP filed for approval of rates for transportation...

  1. 77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Science.gov (United States)

    2012-06-22

    ... Approval for a Pacemaker Programmer AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY... approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker... for the pacemaker programmer (the August 2011 proposed rule). In accordance with section 515(b)(2)(A...

  2. 24 CFR 28.20 - Request for approval by the Department of Justice.

    Science.gov (United States)

    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...

  3. 24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

    Science.gov (United States)

    2010-04-01

    ... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

  4. 75 FR 12251 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2010-03-15

    ... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  5. 78 FR 17937 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2013-03-25

    ... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  6. 78 FR 36560 - 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal, Periodic...

    Science.gov (United States)

    2013-06-18

    ... 92001-C Non-compliances on Title I Lenders Description of the need for the information and proposed use... Information Collection: FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY...

  7. 77 FR 63323 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2012-10-16

    ... Lenders OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  8. 40 CFR 131.21 - EPA review and approval of water quality standards.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.21 EPA review and approval of water quality standards. (a) After the State submits its... analysis. (b) The Regional Administrator's approval or disapproval of a State water quality standard shall...

  9. 78 FR 37885 - Approval of American Society of Mechanical Engineers' Code Cases

    Science.gov (United States)

    2013-06-24

    ... Approval of American Society of Mechanical Engineers' Code Cases; Proposed Rule #0;#0;Federal Register... COMMISSION 10 CFR Part 50 [NRC-2009-0359] RIN 3150-AI72 Approval of American Society of Mechanical Engineers... Society of Mechanical Engineers (ASME). This proposed action would allow nuclear power plant licensees...

  10. 13 CFR 120.427 - Will SBA approve a securitization application from a capital impaired Securitizer?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Will SBA approve a securitization... securitization application from a capital impaired Securitizer? If a securitizer does not maintain the level of capital required by this subpart, SBA will not approve a securitization application from that securitizer. ...

  11. 45 CFR 73.735-708 - Administrative approval of certain outside activities.

    Science.gov (United States)

    2010-10-01

    ... administrative approval to engage in the following outside activities: (1) Certain writing or editing activities... the grantee or contractor and the Government. (See § 73.735-704(a)(2)) (c) The Department Ethics..., deputy ethics counselors, and Schedule C employees in the Office of the Secretary. (d) Granting Approval...

  12. 76 FR 27332 - Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing

    Science.gov (United States)

    2011-05-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0621] Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing AGENCY: Food and...) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the...

  13. 7 CFR 322.12 - Risk assessment procedures for approving countries.

    Science.gov (United States)

    2010-01-01

    ... consequences of establishment, including economic, environmental, and perceived social and political effects... 7 Agriculture 5 2010-01-01 2010-01-01 false Risk assessment procedures for approving countries... Regions § 322.12 Risk assessment procedures for approving countries. (a) The national government of the...

  14. 14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

    Science.gov (United States)

    2010-01-01

    ... the pilot flight training requirements prescribed in the certificate holder's approved low-altitude... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Training program: Approval of airplane simulators and other training devices. 121.407 Section 121.407 Aeronautics and Space FEDERAL AVIATION...

  15. 22 CFR 201.85 - Legal effect of USAID approvals and decisions.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Legal effect of USAID approvals and decisions... APPLICABLE TO COMMODITY TRANSACTIONS FINANCED BY USAID Rights and Remedies of USAID, and Waiver Authority § 201.85 Legal effect of USAID approvals and decisions. In any transaction subject to this part 201...

  16. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  17. Auditing the process of ethics approval for Master's degrees at a ...

    African Journals Online (AJOL)

    Objective. This study audited the process of ethics approval for Master's research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa. Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master's proposal for the year 2010 was reviewed.

  18. 77 FR 35862 - Approval and Promulgation of Implementation Plans; State of Florida: New Source; Review...

    Science.gov (United States)

    2012-06-15

    ...: Final rule. SUMMARY: EPA is taking final action to approve changes to the Florida State Implementation... taking final action to approve changes to the Florida SIP such that it is consistent with federal.... EPA notes that Florida's October 19, 2007, SIP submission makes clarifying changes to rule 62-212.400...

  19. 75 FR 52065 - SharePlus Federal Bank, Plano, TX; Approval of Conversion Application

    Science.gov (United States)

    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...

  20. 76 FR 60961 - Approval of Noise Compatibility Program; Kissimmee Gateway Airport, Kissimmee, FL

    Science.gov (United States)

    2011-09-30

    ... Program; Kissimmee Gateway Airport, Kissimmee, FL AGENCY: Federal Aviation Administration, DOT. ACTION... 23, 2011, the FAA approved the Kissimmee Gateway Airport Noise Compatibility Program Update. Some of...'s approval of the Kissimmee Gateway Airport Noise Compatibility Program Update is September 23, 2011...

  1. 76 FR 61148 - Proposed Information Collection (Approval of School Attendance) Activity: Comment Request

    Science.gov (United States)

    2011-10-03

    ... AFFAIRS Proposed Information Collection (Approval of School Attendance) Activity: Comment Request AGENCY... information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4.... Request for Approval of School Attendance, VA Form 21-674 and 21-674c. b. School Attendance Report, VA...

  2. 34 CFR 97.113 - Suspension or termination of IRB approval of research.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Suspension or termination of IRB approval of research. 97.113 Section 97.113 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN... Research Subjects) § 97.113 Suspension or termination of IRB approval of research. An IRB shall have...

  3. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

    Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

  4. 38 CFR 21.4250 - Course and licensing and certification test approval; jurisdiction and notices.

    Science.gov (United States)

    2010-07-01

    ... (other than a flight course) not leading to a standard college degree, it must also approve the class... chooses to approve a resident course (other than a flight course) not leading to a standard college degree... the test for VA payment. (6)(i) If an organization or entity offers a licensing or certification test...

  5. 77 FR 71145 - Approval and Promulgation of Implementation Plans; New Mexico; New Source Review (NSR...

    Science.gov (United States)

    2012-11-29

    .... EPA's policy is that all comments received will be included in the public docket without change and... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; New Mexico; New Source Review...) State Implementation Plan (SIP) for New Mexico. Among the changes, EPA is proposing to approve are the...

  6. 76 FR 59600 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of Lake and...

    Science.gov (United States)

    2011-09-27

    ...] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of Lake and Porter... redesignation of the Lake and Porter Counties, Indiana portion (Lake and Porter Counties) of the Chicago-Gary... or standard). EPA is proposing to approve the redesignation request for Lake and Porter Counties...

  7. 76 FR 76302 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of Lake and...

    Science.gov (United States)

    2011-12-07

    ...] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of Lake and Porter...). ACTION: Final rule. SUMMARY: EPA is taking several related actions affecting Lake and Porter Counties and... redesignation of Lake and Porter Counties to attainment of the 1997 annual PM 2.5 standard. EPA is approving, as...

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

    Science.gov (United States)

    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. 13 CFR 107.470 - SBA approval of merger, consolidation, or reorganization of Licensee.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false SBA approval of merger, consolidation, or reorganization of Licensee. 107.470 Section 107.470 Business Credit and Assistance SMALL..., consolidation, or reorganization of Licensee. (a) Prior approval requirements. You may not merge, consolidate...

  10. 25 CFR 141.6 - Approval or denial of license application.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Approval or denial of license application. 141.6 Section 141.6 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR FINANCIAL ACTIVITIES BUSINESS PRACTICES ON THE NAVAJO, HOPI AND ZUNI RESERVATIONS Licensing Requirements and Procedures § 141.6 Approval...

  11. 13 CFR 107.140 - SBA approval of initial Management Expenses.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false SBA approval of initial Management Expenses. 107.140 Section 107.140 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Qualifying for an SBIC License Organizing An Sbic § 107.140 SBA approval of...

  12. 76 FR 68757 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    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...

  13. 77 FR 74185 - Information Collection Approved by Office of Management and Budget

    Science.gov (United States)

    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...

  14. 76 FR 40908 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    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...

  15. 77 FR 31727 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container...

    Science.gov (United States)

    2012-05-30

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2012-0073; FRL 9677-3] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container Exemption From VOC Coating Rules...), direct final rule approving a revision to the Illinois SIP that added a ``small container exemption'' for...

  16. 76 FR 63549 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Miscellaneous Metal and...

    Science.gov (United States)

    2011-10-13

    ... otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov website is... authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. Subpart P...) * * * EPA-Approved Indiana Regulations Indiana Indiana citation Subject effective date EPA approval date...

  17. 28 CFR 0.152 - Approval of funds for attendance at meetings.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Approval of funds for attendance at... Approval of funds for attendance at meetings. The Director of the Federal Bureau of Investigation, the... Explosives, and the Director of the Office of Justice Assistance, Research and Statistics, as to their...

  18. 40 CFR 125.99 - What are approved design and construction technologies?

    Science.gov (United States)

    2010-07-01

    ... construction technologies? 125.99 Section 125.99 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...) of the Act § 125.99 What are approved design and construction technologies? (a) The following technologies constitute approved design and construction technologies for purposes of § 125.94(a)(4): (1...

  19. 45 CFR 400.8 - Approval of State plans and plan amendments.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 2 2010-10-01 2010-10-01 false Approval of State plans and plan amendments. 400.8 Section 400.8 Public Welfare Regulations Relating to Public Welfare OFFICE OF REFUGEE RESETTLEMENT... Grants to States for Refugee Resettlement The State Plan § 400.8 Approval of State plans and plan...

  20. Post-Approval Safety Issues with Innovative Drugs : A European Cohort Study

    NARCIS (Netherlands)

    Mol, Peter G. M.; Arnardottir, Arna H.; Motola, Domenico; Vrijlandt, Patrick J.; Duijnhoven, Ruben G.; Haaijer-Ruskamp, Flora M.; de Graeff, Pieter A.; Denig, Petra; Straus, Sabine M. J. M.

    2013-01-01

    Background At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety