WorldWideScience

Sample records for cber approved ndas

  1. CBERS-02 Application Assessment

    Institute of Scientific and Technical Information of China (English)

    GUO Jianning; YU Jin; MIN Xiangjun; LI Xingchao; HOU Minghui

    2004-01-01

    As the successor of CBERS-01, CBERS-02 was launched successfully on 21October 2003 and transmitted its first downlink data the next day. According to the OBT (On Board Test) outline, CRESDA cooperated with CAST and many remote sensing organizations in China in implementing the test of the satellite payloads, ground processing system and data application. In this paper, the test is briefly illustrated in three parts: Ⅰ. Satellite Parameters Test (especially the test for payloads), Ⅱ. Payload Image Quality Assessment, and Ⅲ. Data Application Assessment. The results of the test show that the image quality of CBERS-02 is much improved over CBERS-01 and will continue to play a more important role in the society and economic development of China.

  2. 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.

  3. NASA Data Acquisitions System (NDAS) Software Architecture

    Science.gov (United States)

    Davis, Dawn; Duncan, Michael; Franzl, Richard; Holladay, Wendy; Marshall, Peggi; Morris, Jon; Turowski, Mark

    2012-01-01

    The NDAS Software Project is for the development of common low speed data acquisition system software to support NASA's rocket propulsion testing facilities at John C. Stennis Space Center (SSC), White Sands Test Facility (WSTF), Plum Brook Station (PBS), and Marshall Space Flight Center (MSFC).

  4. The Prototype Development for The Second Generation CBERS Initiates

    Institute of Scientific and Technical Information of China (English)

    SunQing

    2005-01-01

    It's reported that the concept for the second generation CBERS-CBERS-03 & 04 to be jointly developed by China Academy of Space Technology (CAST) and INPE went through the assessment by China Aerospace Science and Technology Corporation (CASC) at the beginning of the year. It means that the prototype development of CBERS-03 & 04 has been initiated.

  5. Applications Of CBERS Data In Oceanic Research

    Institute of Scientific and Technical Information of China (English)

    Li Xiaomin; Zhang Jie; Ma Yi; Song Pingjian

    2009-01-01

    @@ The CBERS series satellite data has been widely used by the First Institute of Oceanography, State Oceanic Administration (SOA) for the studies related to the monitoring of coral islands, land use changes of islands and coastal zone, green tide,implementation of ocean functional zoning, suspended particulate matter,sea ice, rafts cultivation and so on.The data covers the range of islands,coastal zone and inshore sea areas.

  6. The Application Achievements And Perspective Of CBERS Series Satellite Imagery

    Institute of Scientific and Technical Information of China (English)

    Li Xingchao; Qi Xueyong; Lu Yilin

    2009-01-01

    @@ Since the first China-Brazil Earth Resources Satellite (CBERS-1),launched in 1999,the CBERS data has been applied in many fields extensively.Remarkable social and economic benefits have been achieved.This article presents the application achievements during the past nine years,and gives a perspective for the future.All these applications demonstrate that the CBERS data has been an important data source for resources investigation and monitoring.

  7. Atmospheric correction of CBERS CCD images with MODIS data

    Institute of Scientific and Technical Information of China (English)

    LI Junsheng; ZHANG Bing; CHEN Zhengchao; SHEN Qian

    2006-01-01

    China Brazil Earth Resource Satellite (CBERS) CCD images have much potential for inland water environmental monitoring. However, their atmospheric accuracy correction can affect their quantitative applications. This paper contains an atmospheric correction algorithm for CBERS CCD images with MODIS data from the same day, the use of which improves the atmospheric correction algorithm of ocean color remote sensing developed by Gordon (1993, 1994) and makes it applicable to inland waters. The improved algorithm retrieves atmospheric parameters from MODIS data and uses them to perform the atmospheric correction of CBERS CCD images. Experimental results show that the atmospheric correction algorithm of CBERS CCD images assisted by MODIS data is reliable. Furthermore, MODIS data can be freely obtained on a daily basis, making the algorithm developed in this paper useful for environmental monitoring of inland waters.

  8. A tasseled cap transformation for CBERS-02B CCD data

    Institute of Scientific and Technical Information of China (English)

    Li SHENG; Jing-feng HUANG; Xiao-lu TANG

    2011-01-01

    The tasseled cap transformation of remote sensing data has been widely used in agriculture,forest,ecology,and landscape.In this paper,tasseled cap transformation coefficients appropriate for data from a new sensor (China & Brazil Earth Resource Satellite (CBERS-02B)) are presented.The first three components after transformation captured 98% of the four-band variance,and represent the physical characteristics of brightness (coefficients:0.509,0.431,0.330,and 0.668),greenness (coefficients:-0.494,-0.318,-0.324,and 0.741),and blueness (coefficients:0.581,-0.070,-0.811,and 0.003),respectively.We hope these results will enhance the application of CBERS-02B charge-coupled device (CCD) data in the areas of agriculture,forest,ecology,and landscape.

  9. The NIM alanine-EPR dosimetry system: its application in NDAS programme and others

    International Nuclear Information System (INIS)

    In 1983, National Institute of Metrology (NIM) began to study alanine-EPR dosimetry system. From 1988 on, the system has been used as a transfer standard to launch into the National Dose Assurance Service (NDAS) programme for cobalt-60 facilities in China. In this paper, the eleven years implementation of NDAS programme are presented by statistics. In 1991, under an IAEA coordinated research programme, NIM had studied to extend the range of the system to therapy level. In recent years, the NIM in cooperation with other institutes has been developing film-alanine dosimeter for electron beam dosimetry. (author)

  10. Topographic correction realization based on the CBERS-02B image

    Science.gov (United States)

    Qin, Hui-ping; Yi, Wei-ning; Fang, Yong-hua

    2011-08-01

    The special topography of mountain terrain will induce the retrieval distortion in same species and surface spectral lines. In order to improve the research accuracy of topographic surface characteristic, many researchers have focused on topographic correction. Topographic correction methods can be statistical-empirical model or physical model, in which the methods based on the digital elevation model data are most popular. Restricted by spatial resolution, previous model mostly corrected topographic effect based on Landsat TM image, whose spatial resolution is 30 meter that can be easily achieved from internet or calculated from digital map. Some researchers have also done topographic correction based on high spatial resolution images, such as Quickbird and Ikonos, but there is little correlative research on the topographic correction of CBERS-02B image. In this study, liao-ning mountain terrain was taken as the objective. The digital elevation model data was interpolated to 2.36 meter by 15 meter original digital elevation model one meter by one meter. The C correction, SCS+C correction, Minnaert correction and Ekstrand-r were executed to correct the topographic effect. Then the corrected results were achieved and compared. The images corrected with C correction, SCS+C correction, Minnaert correction and Ekstrand-r were compared, and the scatter diagrams between image digital number and cosine of solar incidence angel with respect to surface normal were shown. The mean value, standard variance, slope of scatter diagram, and separation factor were statistically calculated. The analysed result shows that the shadow is weakened in corrected images than the original images, and the three-dimensional affect is removed. The absolute slope of fitting lines in scatter diagram is minished. Minnaert correction method has the most effective result. These demonstrate that the former correction methods can be successfully adapted to CBERS-02B images. The DEM data can be

  11. CRESDA APPLICATION SYSTEM OF CBERS-1, RESULTS AND TYPICAL EXAMPLES OF APPLICATIONS

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    CRESDA Application System of CBERS-1 was established in 1999. During the operation of the system for more than two years, about 240 000 scenes of CBERS-1 Level 0 data have been archived and more than 13 000 scenes of Level 2 products have been ordered by end users from different application fields.In this paper, the typical examples of applications in crop yield estimation,calamity alleviation, resources survey and protection, environment monitoring and continuable development, and urban planning are mainly described.

  12. 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.

  13. Energetic particle radiations measured by particle detector on board CBERS-1 satellite

    Institute of Scientific and Technical Information of China (English)

    HAO YongQiang; XIAO Zuo; ZOU Hong; ZHANG DongHe

    2007-01-01

    Using the data measured by energetic particle detector on board CBERS-01 and -02 for the past five years, statistics was made to show the general features of MeV electrons and protons along a solar synchronous orbit at an altitude of 780 km. This height is in the bottom region of the Earth's radiation belts. Detectors are inside the satellite cabinet and such continuous monitoring of particle radiation environment inside a satellite has seldom conducted so far. After a proper and careful treatment, it is indicated that the data inside satellite are well correlated with the radiation environment outside. Besides the agreement of the general distribution characteristics of energetic electrons and protons with similar observations from other satellites, attention is particularly paid to the disturbed conditions. Variations of particle fluxes are closely related with solar proton events, in general, electron fluxes of outer belt are well correlated with Dst index after three days' delay while the electron injection occurred almost at the same day during great magnetic storms. It is confirmed that both energetic electrons and protons appear in the Polar Cap region only after the solar proton events.

  14. 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.

  15. Land use mapping from CBERS-2 images with open source tools by applying different classification algorithms

    Science.gov (United States)

    Sanhouse-García, Antonio J.; Rangel-Peraza, Jesús Gabriel; Bustos-Terrones, Yaneth; García-Ferrer, Alfonso; Mesas-Carrascosa, Francisco J.

    2016-02-01

    Land cover classification is often based on different characteristics between their classes, but with great homogeneity within each one of them. This cover is obtained through field work or by mean of processing satellite images. Field work involves high costs; therefore, digital image processing techniques have become an important alternative to perform this task. However, in some developing countries and particularly in Casacoima municipality in Venezuela, there is a lack of geographic information systems due to the lack of updated information and high costs in software license acquisition. This research proposes a low cost methodology to develop thematic mapping of local land use and types of coverage in areas with scarce resources. Thematic mapping was developed from CBERS-2 images and spatial information available on the network using open source tools. The supervised classification method per pixel and per region was applied using different classification algorithms and comparing them among themselves. Classification method per pixel was based on Maxver algorithms (maximum likelihood) and Euclidean distance (minimum distance), while per region classification was based on the Bhattacharya algorithm. Satisfactory results were obtained from per region classification, where overall reliability of 83.93% and kappa index of 0.81% were observed. Maxver algorithm showed a reliability value of 73.36% and kappa index 0.69%, while Euclidean distance obtained values of 67.17% and 0.61% for reliability and kappa index, respectively. It was demonstrated that the proposed methodology was very useful in cartographic processing and updating, which in turn serve as a support to develop management plans and land management. Hence, open source tools showed to be an economically viable alternative not only for forestry organizations, but for the general public, allowing them to develop projects in economically depressed and/or environmentally threatened areas.

  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. Remote Sensing of the EnviSat and Cbers-2B satellites rotation around the centre of mass by photometry

    Science.gov (United States)

    Koshkin, N.; Korobeynikova, E.; Shakun, L.; Strakhova, S.; Tang, Z. H.

    2016-08-01

    During 2013-2015 the photometric observations of the EnviSat satellite, which became space debris after the failure in April 2012 in low Earth orbit, were performed. The rotation pole position and slow change in sidereal rotation period were updated on the basis of analysis of specular glints observed in 222 light curves using reduction of synodic periods. Apparently, there are minor oscillations of the rotation pole near the normal to the orbital plane. The sense of the EnviSat's spinning is opposite to the sense of its orbital rotation. The sidereal period is best approximated by the second-order polynomial: Psid (sec) = 0.000021534 ·T2 + 0.04936003 · T + 121.18195 where T is measured in days from the beginning of 2013. This method being applied to another representative of space debris, namely the Cbers-2B satellite, has shown a similar result: there is not precise solution for the rotation pole either as it undergoes oscillations with various time scale from several hours to several months. In 2014, the spin axis made the 10 ° angle with the normal to the orbital plane while the sense of spinning is direct in this case, i.e. coincides with the sense of orbital rotation. The sidereal period is best approximated by the following expression: Psid (sec) = 0.000029543 ·T2 + 0.08094931 · T + 81.31775 where T is measured in days starting from March 10, 2014. This method allows of controlling slow changes in the spatial orientation of the rotation axis of the satellites in which specular reflection of light from flat faces of the surface is inherent.

  19. 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

  20. Concentration of chlorhophyll-a and the limit of the photic zone in the Third River reservoir (Córdoba-Argentina, using images from CBERS-2B satellite

    Directory of Open Access Journals (Sweden)

    Claudia Maria Rodriguez

    2012-12-01

    Full Text Available The satellite images provided by remote sensors represent an important tool for monitoring, controlling and administering water resources. The aim of this work was to model the spatial distribution of the concentration of chlorhophyll-a and the limit of the photic zone in the Rio Tercero reservoir (Córdoba-Argentina, using images from CBERS-2B satellite and a geographical information system (SIG. We selected 15 samples places wherefrom we measured physical, chemical and biological parameters during the fall of 2008. By using a georeferenced image from sensor CBERS-2B and performing an analysis of the principal components (ACP, we were able to identify associations between variables and reflectance values of the satellite bands. Based on these associations and with simple regression models, we were able to know the spatial distribution of the variables: concentration of chlorophyll-a (R2 = 0, 73 and the limit of the photic zone (R2 = 0, 78 in the reservoir as a whole. We may conclude thata there exists a negative correlation between the concentration of chlorophyll-a and the water transparency in reservoir Rio Tercero, as well as that the sensor used allows us to evaluate the quality of the water in a relative short time.

  1. Network data analysis server (NDAS) prototype development

    International Nuclear Information System (INIS)

    We have developed a simple and robust system based on standard UNIX tools and frame library code to transfer and merge data from multiple gravitational wave detectors distributed worldwide. The transfer and merger take place with less than 20 minute delay and the output frames are available for all participants. Presently VIRGO and LIGO participate in the exchange and only environmental data are shared. The system is modular to allow future improvements and the use of new tools like Grid

  2. Drugs Approved for Leukemia

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) Arranon (Nelarabine) Asparaginase Erwinia chrysanthemi ...

  3. 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...

  4. More New Medication Approvals.

    Science.gov (United States)

    Turkoski, Beatrice B

    2016-01-01

    In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures. PMID:27441881

  5. 76 FR 58398 - Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New...

    Science.gov (United States)

    2011-09-21

    ... Drugs; Compliance Policy Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs... ``Marketed Unapproved Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs... ``Marketed Unapproved Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved...

  6. Drugs Approved for Brain Tumors

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) Becenum ( ...

  7. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Hodgkin Lymphoma This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Hodgkin Lymphoma Adcetris (Brentuximab Vedotin) Ambochlorin (Chlorambucil) Amboclorin (Chlorambucil) Becenum ( ...

  8. Drugs Approved for Prostate Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Prostate Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Prostate Cancer Abiraterone Acetate Bicalutamide Cabazitaxel Casodex (Bicalutamide) Degarelix Docetaxel ...

  9. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Pancreatic Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Pancreatic Cancer Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation) Afinitor (Everolimus) ...

  10. 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...

  11. 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.

  12. Drugs Approved for Melanoma

    Science.gov (United States)

    ... are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome (Dacarbazine) IL-2 (Aldesleukin) Imlygic (Talimogene Laherparepvec) Interleukin-2 (Aldesleukin) Intron A ( ...

  13. 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.

  14. FWS Approved Acquisition Boundaries

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This data layer depicts the external boundaries of lands and waters that are approved for acquisition by the U.S. Fish and Wildlife Service (USFWS) in North...

  15. 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

  16. Brodalumab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-09-01

    Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis. PMID:27577550

  17. Venetoclax: First Global Approval.

    Science.gov (United States)

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL. PMID:27260335

  18. FDA approved radiopharmaceuticals

    International Nuclear Information System (INIS)

    FDA is the abbreviation of American Food and Drug Administration. It s main job is assuring the safety and reliability of the food, cosmetics, medicines, medical devices and radiation emitting products such as microwave oven, the food and medicine for animals. Radiopharmaceuticals are also under its management. The basic information of FDA and FDA approved radiopharmaceuticals are introduced

  19. Drugs Approved for Skin Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Skin Cancer This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer, including drugs for basal cell carcinoma and melanoma. ...

  20. Cariprazine: First Global Approval.

    Science.gov (United States)

    McCormack, Paul L

    2015-11-01

    Cariprazine (Vraylar) is an oral atypical antipsychotic originated by Gedeon Richter. It is a potent dopamine D3 and D2 receptor partial agonist, which preferentially binds to the D3 receptor. Cariprazine also has partial agonist activity at serotonin 5-HT1A receptors. In September 2015, cariprazine received its first global approval in the USA for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. It is also in development in a variety of countries for the treatment of schizophrenia with predominant negative symptoms (phase III), as adjunctive therapy for major depressive disorder (phase II/III) and for the treatment of bipolar depression (phase II). This article summarizes the milestones in the development of cariprazine leading to this first approval for schizophrenia and manic or mixed episodes associated with bipolar I disorder. PMID:26510944

  1. Obiltoxaximab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-05-01

    Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. PMID:27085536

  2. Osimertinib: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-02-01

    Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC. PMID:26729184

  3. Necitumumab: First Global Approval.

    Science.gov (United States)

    Garnock-Jones, Karly P

    2016-02-01

    Eli Lilly is developing necitumumab (Portrazza™), an intravenously administered fully human IgG monoclonal antibody directed against the epidermal growth factor receptor (EGFR), which is expressed in a variety of solid tumours and has been implicated in promoting oncogenesis and tumour progression. Necitumumab is approved as a part of combination therapy (with gemcitabine and cisplatin) in the USA for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), and regulatory submissions have been made in the EU for this same indication. Necitumumab was derived from the proprietary phage display library of Dyax Corp, and originated with ImClone Systems, which was acquired by Eli Lilly in November 2008. Necitumumab was also under phase II development for colorectal cancer in Belgium and Spain; however, no recent development has been reported for this indication. This article summarizes the milestones in the development of necitumumab leading to this first approval for the first-line treatment of metastatic squamous NSCLC, in combination with gemcitabine and cisplatin. PMID:26729188

  4. Multinational design approval programme

    International Nuclear Information System (INIS)

    The licensing of new nuclear power facilities is likely to pose many challenges to national regulatory organizations. The majority of nuclear power plants to be built around the world in the next 15 years will likely be limited to a small number of relatively standardized designs, purchased from a limited number of multinational corporations. Such standardization creates an opportunity to leverage the resources and knowledge of the national regulatory authorities who will be tasked with the review of the new reactor power plant designs. The Nuclear Regulatory Commission has developed an innovative proposal for a multinational design approval programme (MDAP). This paper describes the stages of the MDAP and the benefits that could be derived from its implementation. (author)

  5. Drugs Approved for Lung Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic and brand names. This page also lists common drug combinations used in lung ...

  6. 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,...

  7. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Stomach (Gastric) Cancer This page lists cancer drugs approved ... that are not listed here. Drugs Approved for Stomach (Gastric) Cancer Cyramza (Ramucirumab) Docetaxel Doxorubicin Hydrochloride 5- ...

  8. 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) Adcetris (Brentuximab Vedotin) Ambochlorin (Chlorambucil) Amboclorin ( ...

  9. 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

  10. 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.

  11. 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...

  12. Is It Really FDA Approved?

    Science.gov (United States)

    ... medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the ... Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic ...

  13. FDA-Approved HIV Medicines

    Science.gov (United States)

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  14. 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.

  15. 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.

  16. Drugs Approved for Bladder Cancer

    Science.gov (United States)

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

  17. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

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

  18. 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.

  19. 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.

  20. Drugs Approved for Breast Cancer

    Science.gov (United States)

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

  1. Drugs Approved for Wilms Tumor

    Science.gov (United States)

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

  2. 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.

  3. 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.

  4. 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.

  5. 28 CFR 2.41 - Travel approval.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  6. 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

  7. 76 FR 75809 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2011-12-05

    ... the type of packaging material on which the label is printed; n. Brand name changes, provided that... poultry products will take effect January 1, 2012 (75 FR 82148, Dec. 29, 2010). These mandatory features..., location, and indication of final color. To obtain sketch label approval, domestic meat and...

  8. 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.

  9. 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.

  10. 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.

  11. Alkylbenzene Project in Xinjiang Approved

    Institute of Scientific and Technical Information of China (English)

    Zhou Weiyong

    1996-01-01

    @@ The feasibility study on alkylbenzene project in Dushanzi, Xinjiang Uygur Autonomous Region, submitted jointly by the government of Xinjiang UygurAutonomous Region and China National Petroleum Corporation (CNPC), has been approved by State Council recently,after pass appraisa l by China International Engineering Consulting Corporation entrusted by State Planning Committee.

  12. 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.

  13. Unilateral approval - Is it working?

    International Nuclear Information System (INIS)

    MDS Nordion, owned by Canadian based MDS Inc., designs, manufactures and uses transport packages for the distribution of radioactive materials used in the medical, research and sterilisation industries. Each of these packages must be proven to meet the International Atomic Energy Agency (IAEA) transport regulations. This paper will explore the unilateral approval concept as well as provide examples of its implementation. The IAEA transport regulations are recognised and implemented across the world. They include the unilateral approval concept of a single competent authority approval of the package design. Although the performance standards set by the IAEA regulations for Type B(U) packages have been accepted and implemented in national legislation, national authorities tend to require additional reviews of the safety analysis report. Case studies will be presented to demonstrate that the concept of unilateral approval is not applied consistently between all IAEA member states, and that this has impeded the efficient transport of radioactive material. The studies also show that these additional reviews have not resulted in changes to the design of a transport package. The lack of recognition of the IAEA unilateral approval for transport packages is a barrier to the effective transport of packages. These additional reviews require allocation of resources for both the company and the regulatory agency. As a responsible partner in a very unique industry, MDS Nordion encourages all IAEA member states to accept Type B(U) transport certificate from other jurisdictions without requiring additional review or endorsement. In this respect, the collaboration of the competent authorities is important to reduce this regulatory impediment and allowing the effective transport of radioactive material. (author)

  14. Epclusa Approved for Chronic Hepatitis C

    Science.gov (United States)

    ... news/fullstory_159609.html Epclusa Approved for Chronic Hepatitis C Combination drug treats six major forms of ... to treat the six major strains of chronic hepatitis C virus (HCV). Epclusa combines sofosbuvir, FDA-approved ...

  15. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Colon and Rectal Cancer This page ... and rectal cancer that are not listed here. Drugs Approved for Colon Cancer Avastin (Bevacizumab) Bevacizumab Camptosar ( ...

  16. 28 CFR 2.93 - Travel approval.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the...

  17. 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...

  18. 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....

  19. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... testing known negative samples, as determined by the official NPIP procedures found in this part. If... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry... kits) may be approved through the following procedure: (1) The sensitivity of the kit will be...

  20. 12 CFR 611.510 - Approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Approval procedures. 611.510 Section 611.510 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Transfer of Authorities § 611.510 Approval procedures. (a) Upon receipt of approval of a resolution by the Farm...

  1. 30 CFR 746.14 - Approval, disapproval or conditional approval, of mining plan.

    Science.gov (United States)

    2010-07-01

    ..., of mining plan. 746.14 Section 746.14 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR FEDERAL LANDS PROGRAM REVIEW AND APPROVAL OF MINING PLANS § 746.14 Approval, disapproval or conditional approval, of mining plan. The Secretary shall approve, disapprove...

  2. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2010-08-10

    ... Approval of an Information Collection; Credit Account Approval for Reimbursable Services AGENCY: Animal and... information collection associated with credit account approval for reimbursable services. DATES: We will... account approval for reimbursable services, contact Mrs. Kris Caraher, User Fees Section Head,...

  3. Approval of radioactive consumer goods

    International Nuclear Information System (INIS)

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

  4. Mipomersen sodium: first global approval.

    Science.gov (United States)

    Hair, Philip; Cameron, Fiona; McKeage, Kate

    2013-04-01

    Mipomersen sodium (Kynamro™) (henceforth mipomersen) is a second-generation antisense oligonucleotide inhibitor of apolipoprotein B-100, which is the main structural component of atherogenic lipid particles. Mipomersen is administered via subcutaneous injection and is indicated as adjunctive treatment for homozygous familial hypercholesterolaemia (HoFH). The drug was developed by Isis Pharmaceuticals, which now collaborates with Genzyme Corporation for on-going development and product marketing. Multinational phase III trials of mipomersen as adjunctive therapy were completed in patients with HoFH, severe FH, heterozygous FH (HeFH) with coronary artery disease (CAD), and in those with hypercholesterolaemia at high risk of CAD. Mipomersen 200 mg once weekly has been approved in the USA as an adjunct to lipid-lowering medications and diet in HoFH patients and is undergoing regulatory review in the EU for the same indication. Genzyme is also conducting a multinational phase III, open-label extension study to evaluate long-term treatment in HoFH and HeFH patients, as well as a multinational trial to evaluate a three-times-per-week mipomersen regimen in patients with severe FH. This article summarises the milestones in the development of once-weekly, subcutaneous mipomersen leading to this first approval. PMID:23564617

  5. 7 CFR 959.123 - Approval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Approval. 959.123 Section 959.123 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... consideration to each application for a Certificate of Privilege. Approval of an application, based upon...

  6. 7 CFR 948.123 - Approval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Approval. 948.123 Section 948.123 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... give prompt consideration to each application for a Certificate of Privilege. Approval of...

  7. 7 CFR 1735.90 - Preliminary approvals.

    Science.gov (United States)

    2010-01-01

    ... preliminary approval to the acquisition or merger. However, the borrower may not obtain additional loan funds...) Before RUS will grant preliminary approval, the borrower shall submit: (1) Merger or acquisition documents required by state law; (2) Acquisition agreements covering the transaction; (3) Any...

  8. 77 FR 6560 - Pesticide Product Registration Approval

    Science.gov (United States)

    2012-02-08

    ... the Federal Register of June 10, 2009 (74 FR 27541) (FRL-8413-2), which announced that Lubrizol, 29400... AGENCY Pesticide Product Registration Approval AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces Agency approval of an application to register the...

  9. 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... forward the surgery request to the Office of Medical Designations and Transportation for approval. (b)...

  10. 30 CFR 28.2 - Approved fuses.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved fuses. 28.2 Section 28.2 Mineral... MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES General Provisions § 28.2 Approved fuses. (a) On and after the effective date...

  11. 13 CFR 108.370 - Conditional approval.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Conditional approval. 108.370 Section 108.370 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.370 Conditional approval....

  12. Ordinal Position, Approval Motivation, and Interpersonal Attraction

    Science.gov (United States)

    Nowicki, Stephen, Jr.

    1971-01-01

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

  13. 46 CFR 249.7 - Approval.

    Science.gov (United States)

    2010-10-01

    ... UNDERWRITERS FOR MARINE HULL INSURANCE § 249.7 Approval. (a) Approval of the applicant will be based upon an.... hull insurance market, if U.S. insurers are denied similar access to the hull insurance market in the... to MARAD's attention any discriminatory laws or practices relating to the placement of marine...

  14. E-Approval Plans in Research Libraries

    Science.gov (United States)

    Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

    2014-01-01

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

  15. 18 CFR 1304.7 - Conditions of approvals.

    Science.gov (United States)

    2010-04-01

    ... CONSTRUCTION IN THE TENNESSEE RIVER SYSTEM AND REGULATION OF STRUCTURES AND OTHER ALTERATIONS Procedures for Approval of Construction § 1304.7 Conditions of approvals. Approvals of applications shall contain...

  16. 5 CFR 7601.102 - Prior approval of outside employment.

    Science.gov (United States)

    2010-01-01

    ... prohibited by statute or Federal regulation, including 5 CFR part 2635. (c) Scope of approval. Approval will... employee's NARA position, the employee shall submit a revised request for approval. (d) Definition...

  17. The dilemma of approving antidotes.

    Science.gov (United States)

    Steffen, Christian

    2007-04-20

    Clinical trials with antidotes are difficult to perform for a variety of practical, ethical, and financial reasons. As acute poisoning is a rare event, the commercial interest in basic and clinical research is low. Poisoned patients are usually not available for normal clinical trial procedures and, if they are, they cannot give informed consent. This situation results in a dilemma: antidotes are essential drugs. A resolution of the Council of Europe requests to guarantee the optimal availability of antidotes and the improvement of their use. As comprehensive data on the efficacy of antidotes are often missing, a marketing authorisation under exceptional circumstances according to Article 14(8) of Regulation (EC) No. 276/2004, will often be the only way to get an approval, as: (1) the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence ("orphan drug"), (2) in the present state of scientific knowledge, comprehensive information cannot be provided, or (3) it would be contrary to generally accepted principles of medical ethics to collect such data. Typically, data on antidotes are obtained from a patchwork of studies with animals, human tissue and a few observations from human poisoning corroborated with data from clinical observations and biochemistry. Generalisations from chemical and mechanistic similarities between groups of poisons are usual, but often lack scientific evidence. Current standards of good clinical practice can rarely be observed. Therefore, public funding and other financial support are necessary incentives to initiate trials in this important area. PMID:17207900

  18. Approving of personal dosimeter services

    International Nuclear Information System (INIS)

    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

  19. 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.

  20. FDA Approves Eye Implant for Aging Boomers

    Science.gov (United States)

    ... medlineplus/news/fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to ... 2016 THURSDAY, June 30, 2016 (HealthDay News) -- An implant that helps the aging eye focus on small ...

  1. FDA Approves Implant to Battle Opioid Addiction

    Science.gov (United States)

    ... gov/medlineplus/news/fullstory_159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing ... 26, 2016 (HealthDay News) -- A new long-acting implant that can help treat people addicted to heroin ...

  2. 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.

  3. 27 CFR 40.394 - Notice of approval of bond.

    Science.gov (United States)

    2010-04-01

    ... manufacturer, in writing, of the bond approval, in order that the manufacturer may commence operations. (72... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Notice of approval of bond... Manufacturers § 40.394 Notice of approval of bond. If the bond required under this subpart is approved by...

  4. 45 CFR 2400.42 - Approval of Plan of Study.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Approval of Plan of Study. 2400.42 Section 2400.42... FOUNDATION FELLOWSHIP PROGRAM REQUIREMENTS Graduate Study § 2400.42 Approval of Plan of Study. The Foundation must approve each Fellow's Plan of Study. To be approved, the plan must: (a) On a part-time or...

  5. 46 CFR 160.023-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.023-4 Section 160.023... Signals § 160.023-4 Approval and production tests. (a) Approval tests. The approval tests are those tests... independent laboratory accepted by the Commandant under § 159.010 of this chapter. (b) Production...

  6. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

    ... to audit for cause at any time MSHA believes the approval holder product is not in compliance with... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject...

  7. 7 CFR 1726.36 - Documents subject to RUS approval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Documents subject to RUS approval. 1726.36 Section... subject to RUS approval. Unless otherwise indicated, the borrower shall make all contracts and amendments that are subject to RUS approval effective only upon RUS approval....

  8. 30 CFR 28.25 - Changes or modifications of approved fuses; issuance of modification of certificate of approval.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Changes or modifications of approved fuses... HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR... Approval and Disapproval § 28.25 Changes or modifications of approved fuses; issuance of modification...

  9. Recent New Drug Approvals. Part 1: Drugs with Pediatric Indications

    OpenAIRE

    Shelton, Chasity M.; Chhim, Rebecca F.; Christensen, Michael L.

    2012-01-01

    This two-part review provides information about drugs that have been recently approved by the Food and Drug Administration and focuses on drugs approved with pediatric indications or approved in adults with active pediatric studies. Information was obtained from the product labeling and selected published studies. Part 1 reviews recently approved drugs with labeled pediatric indications, and Part 2 will review recent drug approvals in adults that have potential use in pediatrics and have acti...

  10. Review of non-FDA-approved fillers.

    Science.gov (United States)

    Ellis, David A F; Segall, Lorne

    2007-05-01

    The number of commercially available injectable soft tissue fillers has increased dramatically worldwide over the past decade. In the United States, a variety of temporary non-collagen-based fillers have been approved. However, no permanent soft tissue injectable fillers are currently approved by the US Food and Drug Administration. This article discusses some of the more popular soft tissue fillers, such as Restylane Fine Line, Restylane SQ, Perlane, Artecoll, Dermalive, Dermadeep, Bioalcamid, Bioplastique, Evolution, Outline, Argiform, and Aquamid, which are all available outside of the United States. PMID:17544940

  11. 40 CFR 52.722 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... Air Act, as amended in 1977. (c) The Administrator finds that the carbon monoxide control strategy... National Ambient Air Quality Standards under section 110 of the Clean Air Act. Furthermore, the... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL...

  12. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... provisions do not meet the requirements of 40 CFR 51.160 for scope. EPA also disapproves 45 CSR 13 section 9... the West Virginia SIP. These provisions do not meet the requirements of 40 CFR 51.161 for public... attainment of the primary SO2 NAAQS. The Administrator does not approve the State's control strategy...

  13. 7 CFR 1735.61 - Approval criteria.

    Science.gov (United States)

    2010-01-01

    ... of its mortgage or loan contract to obtain RUS approval of a merger or acquisition, the borrower...) Whether the merger or acquisition may result in any relinquishment, impairment, or waiver of a right or power of the Government; (3) Whether the proposed merger or acquisition is in the best interests of...

  14. 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…

  15. 23 CFR 645.215 - Approvals.

    Science.gov (United States)

    2010-04-01

    .... 109, 111, and 116, and 23 CFR 1.23 and 1.27, and meet the requirements of this regulation, the FHWA... Accommodation of Utilities § 645.215 Approvals. (a) Each State transportation department shall submit a... the FHWA for prior concurrence, except when the proposed installation is not in accordance with...

  16. 77 FR 16544 - Pesticide Product Registration Approvals

    Science.gov (United States)

    2012-03-21

    ... of receipt published on April 14, 2010 (75 FR 19388; FRL- 8808-5). One comment was received during... AGENCY Pesticide Product Registration Approvals AGENCY: Environmental Protection Agency (EPA). ACTION... pesticide products and amended registrations for currently existing pesticide products. FOR...

  17. Side effects of cytokines approved for therapy.

    Science.gov (United States)

    Baldo, Brian A

    2014-11-01

    Cytokines, currently known to be more than 130 in number, are small MW (aldesleukin (rhIL-2), oprelvekin (rhIL-11), filgrastim and tbo-filgrastim (rhG-CSF), sargramostim (rhGM-CSF), metreleptin (rh-leptin) and the rh-erythropoietins, epoetin and darbepoietin alfa. Anakinra, a recombinant receptor antagonist for IL-1, is in the IL-1 family; recombinant interferons alfa-1, alfa-2, beta-1 and gamma-1 make up the interferon family; palifermin (rhKGF) and becaplermin (rhPDGF) are in the PDGF family; and rhBMP-2 and rhBMP-7 represent the TGFβ family. The main physicochemical features, FDA-approved indications, modes of action and side effects of these approved cytokines are presented. Underlying each adverse events profile is their pleiotropism, potency and capacity to release other cytokines producing cytokine 'cocktails'. Side effects, some serious, occur despite cytokines being endogenous proteins, and this therefore demands caution in attempts to introduce individual members into the clinic. This caution is reflected in the relatively small number of cytokines currently approved by regulatory agencies and by the fact that 14 of the FDA-approved preparations carry warnings, with 10 being black box warnings. PMID:25270293

  18. Reflections on the Ethics-Approval Process

    Science.gov (United States)

    Murray, Lee; Pushor, Debbie; Renihan, Pat

    2012-01-01

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

  19. 46 CFR 58.16-10 - Approvals.

    Science.gov (United States)

    2010-10-01

    ... been involved in a fire. (c) Safety-relief devices. All required safety-relief devices must be approved... in accordance with 49 CFR part 178. (2) All liquefied petroleum gas cylinders in service shall bear a... with 49 CFR part 178. (d) Valves, regulators, and vaporizers. All component parts of the system,...

  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. PMID:26039675

  1. 30 CFR 28.20 - Certificates of approval; scope of approval.

    Science.gov (United States)

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT... only for individual, completely fabricated fuses which have been examined, inspected, and tested...

  2. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

    ... Maryland Department of the Environment (MDE). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SO X ), and...

  3. 76 FR 30189 - Receipt of Application for Approval

    Science.gov (United States)

    2011-05-24

    ... program for the Swift Parrot (Lathamus discolor). The approval would be for the cooperative breeding program and all its members, including the applicant. If approved, the program will be overseen by...

  4. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... distribution of test scores for each edition, form, level, sub-test, or partial battery, for which approval is... submitted to the Secretary for review and approval, documentation of periodic reviews of the content...

  5. 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...

  6. Doctors Often Overestimate Promise of Newly Approved Drugs

    Science.gov (United States)

    ... nlm.nih.gov/medlineplus/news/fullstory_158267.html Doctors Often Overestimate Promise of Newly Approved Drugs Many ... and Drug Administration's expedited approval process could mislead doctors about the new drugs' actual benefits, researchers warn. ...

  7. 46 CFR 164.007-3 - Conditions of approval.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Conditions of approval. 164.007-3 Section 164.007-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-3 Conditions of approval. (a)...

  8. 50 CFR 15.26 - Approval of cooperative breeding programs.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 1 2010-10-01 2010-10-01 false Approval of cooperative breeding programs... WILDLIFE AND PLANTS WILD BIRD CONSERVATION ACT Permits and Approval of Cooperative Breeding Programs § 15.26 Approval of cooperative breeding programs. Upon receipt of a complete application, the...

  9. 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...

  10. 46 CFR 160.036-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.036-4 Section 160.036... Distress Signals § 160.036-4 Approval and production tests. (a) Approval tests. The manufacturer must... Commandant under § 159.010 of this chapter. (b) Production inspections and tests. Production inspections...

  11. 46 CFR 160.040-5 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.040-5 Section 160.040... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... performance tests in paragraph (c) of this section. (b) Production inspections and tests....

  12. 46 CFR 160.037-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.037-4 Section 160.037... Approval and production tests. (a) Approval tests. The manufacturer must produce a lot of at least 100... chapter. (b) Production inspections and tests. Production inspections and tests of each lot of...

  13. 46 CFR 160.031-5 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.031-5 Section 160.031... Equipment) § 160.031-5 Approval and production tests. (a) Approval test. An independent laboratory accepted... operational test in paragraph (c) of this section. (b) Production inspections and tests....

  14. 46 CFR 160.022-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.022-4 Section 160.022... Minutes) § 160.022-4 Approval and production tests. (a) Approval tests. The manufacturer must produce a... Commandant under § 159.010 of this chapter. (b) Production inspections and tests. Production inspections...

  15. 46 CFR 160.024-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.024-4 Section 160.024... Signals § 160.024-4 Approval and production tests. (a) Approval tests. The manufacturer must produce a lot... under § 159.010 of this chapter. (b) Production inspections and tests. Production inspections and...

  16. 46 CFR 160.021-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.021-4 Section 160.021... Approval and production tests. (a) Approval tests. The manufacturer must produce a lot of at least 100... Chapter. (b) Production inspections and tests. Production inspections and tests of each lot of...

  17. 46 CFR 160.028-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.028-4 Section 160.028... § 160.028-4 Approval and production tests. (a) Approval test. An independent laboratory accepted by the... paragraph (c) of this section. (b) Production inspections and tests. Production inspections and tests...

  18. 46 CFR 160.057-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.057-4 Section 160.057... Minutes) § 160.057-4 Approval and production tests. (a) Approval tests. The manufacturer must produce a... under § 159.010 of this chapter. (b) Production inspections and tests. Production inspections and...

  19. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    2010-01-01

    ... 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... laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology...

  20. 14 CFR 21.269 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.269 Section 21.269 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION....269 Export airworthiness approvals. The manufacturer may issue export airworthiness approvals....

  1. 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... PROJECT WORKS Inspection by Independent Consultant § 12.34 Approval of independent consultant. At least 60... Director of the Office of Energy Projects Licensing for approval, with a copy to the Regional Engineer,...

  2. 46 CFR 8.530 - Plan development and approval.

    Science.gov (United States)

    2010-10-01

    ... develop the CAP and VAP with guidance from the Coast Guard SIP Advisor for OCMI approval. (a) Company Action Plan. The CAP shall include at least the following: (1) A copy of the OCMI CAP approval letter (once the CAP is approved). (2) An organization commitment statement. (3) A company organization...

  3. 48 CFR 2806.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... justification. 2806.304 Section 2806.304 Federal Acquisition Regulations System DEPARTMENT OF JUSTICE... Approval of the justification. (a) All justifications for contract actions over the contracting officer's... contracting activity competition advocate for approval. Justifications requiring approval by the PE shall...

  4. 48 CFR 570.502-1 - Justification and approval requirements.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Justification and approval... Contracting for Lease Alterations 570.502-1 Justification and approval requirements. If the proposed... competition, the following justification and approval requirements apply: (a) If the alteration project...

  5. 48 CFR 606.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... justification. 606.304 Section 606.304 Federal Acquisition Regulations System DEPARTMENT OF STATE COMPETITION... Approval of the justification. (a)(2) The approval authority for a proposed contract over $550,000 but not... determining the approval level of a justification....

  6. 48 CFR 1406.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... justification. 1406.304 Section 1406.304 Federal Acquisition Regulations System DEPARTMENT OF THE INTERIOR... Approval of the justification. A class justification shall be approved in accordance with bureau procedures. Copies of approved class justifications shall be promptly transmitted to PAM....

  7. 48 CFR 1306.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Approval of the justification. 1306.304 Section 1306.304 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE... Approval of the justification. The designee authorized to approve justifications for other than full...

  8. 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... Transitional Housing Loan Program § 17.804 Loan approval criteria. Upon consideration of the application package, loan approval will be based on the following: (a) Favorable financial history and status, (1)...

  9. 46 CFR 162.018-8 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Safety Relief Valves, Liquefied Compressed Gas § 162.018-8 Procedure for approval. (a) General. Safety relief valves for use on pressure vessels containing...

  10. 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...

  11. 46 CFR 131.710 - Approved work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Approved work vests. 131.710 Section 131.710 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS OPERATIONS Work Vests § 131.710 Approved work vests. Each buoyant work vest carried aboard must be approved under subpart...

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

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of general manager. 1717.609 Section... Operational Controls § 1717.609 RUS approval of general manager. (a) If a borrower's mortgage or loan contract grants RUS the unconditioned right to approve the employment and/or the employment contract of...

  13. 7 CFR 1717.308 - RUS approval of nonconforming rates.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of nonconforming rates. 1717.308 Section... Federal Pre-emption in Rate Making in Connection With Power Supply Borrowers § 1717.308 RUS approval of nonconforming rates. Borrowers may request and RUS may approve rates which do not conform with the...

  14. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Separator: Approval tests. 162.050-23 Section 162.050-23...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Pollution Prevention Equipment § 162.050-23 Separator: Approval... and influent pressure equal to the maximum throughput and pressure at which the separator being...

  15. Three Newly Approved Analgesics: An Update

    OpenAIRE

    Saraghi, Mana; Hersh, Elliot V.

    2013-01-01

    Since 2008, three new analgesic entities, tapentadol immediate release (Nucynta) diclofenac potassium soft gelatin capsules (Zipsor), and bupivacaine liposome injectable suspension (EXPAREL) were granted US Food and Drug Administration (FDA) approval to treat acute pain. Tapentadol immediate-release is a both a mu-opioid agonist and a norepinephrine reuptake inhibitor, and is indicated for the treatment of moderate to severe pain. Diclofenac potassium soft gelatin capsules are a novel formula...

  16. Credit Risk Management - Loan Approval Process

    OpenAIRE

    Lulzim Rashiti; Branimir Kalas; Lazar Drec; Nino Stameski

    2016-01-01

    The aim of this study is on understanding the international regulations issued by Basel I, Basel II and Basel III to best supervise and manage credit risk management policies. Part of paper will focus on the description and impacts of the regulations and the pivotal importance they play in providing a sound banking system. Credit risk represents another important element that will be analysed considering that it lays the foundation during the loan consideration and approval process. The paper...

  17. Social desirability, approval and public good contribution

    OpenAIRE

    Daniel John Zizzo; Piers Fleming

    2009-01-01

    Behaviour in public good experiments is usually attributed partly to rational self-interest and partly to social norms and preferences. This paper examines if sensitivity to social desirability affects public good contribution and in what way. A pre-experimental measure of social desirability (SDS17) was used to match partners in a two-person public good game. Half the participants received experimenter approval based upon their investment. Contrary to predictions, the highest public good inv...

  18. 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.

  19. Drug updates and approvals: 2015 in review.

    Science.gov (United States)

    Klibanov, Olga M; Phan, Diep; Ferguson, Kelli

    2015-12-12

    This article highlights important prescribing information for some drugs that received FDA approval within the past year. These include: atazanavir and cobicistat (Evotaz®), ceftazidime and avibactam (Avycaz®), edoxaban (Savaysa®), ivabradine (Corlanor®), liraglutide (rDNA origin) injection (Saxenda®), perindopril arginine and amlodipine besylate (Prestalia®), and secukinumab (Cosentyx®) subcutaneous injection. PMID:26545091

  20. Shanghai-Nanjing Intercity Railway Approved

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    @@ The feasibility study on Shanghai-Nanjing and Shanghai-Hangzhou Intercity Railways were approved officially by the National Reform and Development Commission (NRDC). The Shanghai-Nanjing Intercity Railway will be located briefly in parallel with the existing Shanghai-Nanjing Railway, starting from Shanghai and ending at Nanjing via Kunshan, Suzhou,Wuxi, Changzhou, Danyang and Zhenjiang, with a total length of 300 km for the main line, among which 32km will be in Shanghai and 268 km in Jiangsu Province.

  1. Shareholders, creditors approve utility reorganization plan

    International Nuclear Information System (INIS)

    Shareholders and all classes of secured creditors of Public Service Company of New Hampshire voted overwhelmingly last month to approve Northeast Utilities' Chapter 11 reorganization plan for PSNH, the utility announced. PSNH filed for bankruptcy protection in January 1988. Under the reorganization plan, Connecticut-based NU would acquire the utility for $2.3 billion. While PSNH's preferred and common stockholders voted to accept the proposal, holders of warrants to purchase PSNH common stock rejected the plan. Except for the votes of a group of independent power producers, PSNH's unsecured creditors also voted to accept the plan

  2. Levomilnacipran extended release: first global approval.

    Science.gov (United States)

    Hair, Philip; Cameron, Fiona; Garnock-Jones, Karly P

    2013-09-01

    Pierre Fabre and Forest Laboratories are developing levomilnacipran extended release (ER) [FETZIMA™], an enantiomer of milnacipran, for the treatment of major depressive disorder (MDD). In addition, Pierre Fabre (the originator of the compound) is developing the drug to improve recovery in patients with ischaemic stroke. Levomilnacipran ER exerts its effects by selectively inhibiting the reuptake of norepinephrine and serotonin (two neurotransmitters known to play an essential role in regulating mood) without directly affecting the uptake of dopamine or other neurotransmitters. The agent is being developed as an extended-release capsule formulation for once-daily dosing. Levomilnacipran ER is approved and launched in the US for the treatment of MDD; phase III development in this indication was completed in the US and Canada. In Europe, a phase II trial for MDD was completed, and development is in progress for improving functional recovery of patients with ischaemic stroke. A completed phase II trial in the US investigated levomilnacipran ER for the treatment of fatigue associated with MDD. This article summarizes the milestones in the development of levomilnacipran ER leading to the first approval for major depressive disorder. PMID:24000002

  3. 14 CFR 171.25 - Minimum requirements for approval.

    Science.gov (United States)

    2010-01-01

    ... (CONTINUED) NAVIGATIONAL FACILITIES NON-FEDERAL NAVIGATION FACILITIES Nondirectional Radio Beacon Facilities... met before the FAA will approve an IFR procedure for a non-Federal, nondirectional radio...

  4. 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

  5. Council approves statement on natural hazards

    Science.gov (United States)

    As a scientific society, AGU may adopt positions of advocacy on geophysical science isues based on their intrinsic merits and needs. On December 18, 1996, the AGU Council approved a Union position statement regarding scientific research and education in natural hazards. The complete position statement follows and also is posted at the Union Web Site, http://www.agu.org. Other Union position statements and information about proposing a position statement are in the AGU Handbook and at the Union Web Site.Few locations on Earth are immune from droughts, storms, floods, fires, earthquakes, landslides, tsunamis, volcanic eruptions, sea level changes, water course changes, atmospheric electrical storms, and impacts from comets and asteroids. Humans and technological systems are also threatened by natural hazards that occur in space. The effects of space weather, for example, can wreak havoc with the satellites we use to provide communications, weather forecasts, and defense and positioning information.

  6. Consumer approval of irradiated meat still tentative

    International Nuclear Information System (INIS)

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

  7. 28 CFR 551.31 - Approval of an organization.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Approval of an organization. 551.31 Section 551.31 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MISCELLANEOUS Inmate Organizations § 551.31 Approval of an organization. (a) An inmate must submit a request...

  8. 30 CFR 75.800-2 - Approved circuit schemes.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved circuit schemes. 75.800-2 Section 75... § 75.800-2 Approved circuit schemes. The following circuit schemes will be regarded as providing the necessary protection to the circuits required by § 75.800: (a) Ground check relays may be used...

  9. 40 CFR 1065.12 - Approval of alternate procedures.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Approval of alternate procedures. 1065.12 Section 1065.12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS ENGINE-TESTING PROCEDURES Applicability and General Provisions § 1065.12 Approval...

  10. 34 CFR 668.156 - Approved State process.

    Science.gov (United States)

    2010-07-01

    ... teachers and counselors regarding the student's classroom performance and satisfactory progress toward... student's eligibility for Title IV, HEA program funds must apply to the Secretary for approval of that... approves a State's process if— (1) The State administering the process can demonstrate that the students...

  11. 25 CFR 216.7 - Approval of mining plan.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Approval of mining plan. 216.7 Section 216.7 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS SURFACE EXPLORATION, MINING, AND RECLAMATION OF LANDS General Provisions § 216.7 Approval of mining plan. (a) Before surface mining...

  12. 43 CFR 23.8 - Approval of mining plan.

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Approval of mining plan. 23.8 Section 23.8 Public Lands: Interior Office of the Secretary of the Interior SURFACE EXPLORATION, MINING AND RECLAMATION OF LANDS § 23.8 Approval of mining plan. (a) Before surface mining operations may commence...

  13. Need for Approval and Children's Well-Being

    Science.gov (United States)

    Rudolph, Karen D.; Caldwell, Melissa S.; Conley, Colleen S.

    2005-01-01

    This research examined the hypothesis that a tendency to base one's self-worth on peer approval is associated with positive and negative aspects of children's well-being. A sample of 153 fourth through eighth graders (9.0 to 14.8 years) reported on need for approval, global self-worth, social-evaluative concerns, anxiety and depression, and…

  14. 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...

  15. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

    ... Production Company, Pad ID: FLICKS RUN, ABR-201201011, Cogan House Township, Lycoming County, Pa...-201201014, Cummings Township, Lycoming County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date... Township, Lycoming County, Pa.; Consumptive Use of Up to 8.000 mgd; Approval Date: January 11, 2012....

  16. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-10-25

    ..., Lycoming County, Pa.; Consumptive Use of up to 4.000 mgd; Approval Date: August 10, 2011. 20. Chief Oil.... 38. Seneca Resources Corporation, Pad ID: DCNR 100 Pad G, ABR- 201108032, McIntyre Township, Lycoming...; Approval Date: September 6, 2011. 61. Anadarko E&P Company, LP, Pad ID: Lycoming H&FC Pad C, ABR-...

  17. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ..., Penn Township, Lycoming County, Pa.; Consumptive Use of Up to 8.000 mgd; Approval Date: May 7, 2012. 4... Corporation, Pad ID: DCNR 100 Pad P, ABR- 201205011, Lewis Township, Lycoming County, Pa.; Consumptive Use of..., Penn Township, Lycoming County, Pa.; Consumptive Use of Up to 8.000 mgd; Approval Date: May 25,...

  18. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-26

    .... Seneca Resources Corporation, Pad ID: DCNR 100 Pad D 85V, ABR- 201107007, McIntyre Township, Lycoming...-20100205.1, Penn Township, Lycoming County, Pa.; Consumptive Use of up to 8.000 mgd; Approval Date: July 5..., Penn Township, Lycoming County, Pa.; Consumptive Use of up to 8.000 mgd; Approval Date: July 8,...

  19. 76 FR 63833 - Commission Approval of Divestiture Agreements

    Science.gov (United States)

    2011-10-14

    ... divestiture with an ``up-front buyer''). If the order requires the respondent to divest within some deadline... Commission must approve both the acquirer of the divested assets and all agreements relating to the... perform as required in that agreement fails to divest in the approved manner, and thereby, ] fails...

  20. 14 CFR 21.609 - Approval for deviation.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval for deviation. 21.609 Section 21.609 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT... deviation. (a) Each manufacturer who requests approval to deviate from any performance standard of a...

  1. 28 CFR 20.23 - Documentation: Approval by OJARS.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Documentation: Approval by OJARS. 20.23 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...

  2. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

    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

  3. 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...

  4. 19 CFR 115.63 - Application for approval.

    Science.gov (United States)

    2010-04-01

    ...) Particulars of construction; (ii) Dimensions; (iii) Construction materials; and (iv) Marks and numbers... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each...

  5. 48 CFR 206.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Approval of the justification. 206.304 Section 206.304 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS... Competition 206.304 Approval of the justification. (a)(4) The Under Secretary of Defense...

  6. 48 CFR 2406.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Approval of the justification. 2406.304 Section 2406.304 Federal Acquisition Regulations System DEPARTMENT OF HOUSING AND URBAN... 2406.304 Approval of the justification. (c) A class justification for other than full and...

  7. 48 CFR 806.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... justification. 806.304 Section 806.304 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS... Approval of the justification. (a) For a justification other than a class justification specified in FAR 6.304(c), Table 806.304-1 provides the authorities who may approve a justification: Table...

  8. 48 CFR 306.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... justification. 306.304 Section 306.304 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Approval of the justification. Certification, concurrence, and approval requirements. The Project Officer... Contracting Officer shall certify that the justification is accurate and complete by signing the JOFOC....

  9. Waste Feed Delivery Environmental Permits and Approvals Plan

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    2000-01-18

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

  10. 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...

  11. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

    ... Section 614.4470 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS Loan Approval Requirements § 614.4470 Loans subject to bank approval. (a) The following loans... supervising the association in which the loan application originates: (1) Loans to a director of...

  12. 42 CFR 37.42 - Approval of roentgenographic facilities.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Approval of roentgenographic facilities. 37.42 Section 37.42 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE... Roentgenographic Examinations Specifications for Performing Chest Roentgenographic Examinations § 37.42 Approval...

  13. 27 CFR 4.50 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Certificates of label approval. 4.50 Section 4.50 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Approval of Labels...

  14. 46 CFR 160.076-25 - Approval testing.

    Science.gov (United States)

    2010-10-01

    ... constructed in accordance with the plans and specifications submitted with the application for approval. (b... 46 Shipping 6 2010-10-01 2010-10-01 false Approval testing. 160.076-25 Section 160.076-25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND...

  15. 21 CFR 900.6 - Withdrawal of approval.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Withdrawal of approval. 900.6 Section 900.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... committed fraud, or has submitted material false statements to the agency, FDA may withdraw its approval...

  16. 75 FR 13204 - Notice of Petition for Approval

    Science.gov (United States)

    2010-03-18

    ... (PSP) submitted pursuant to 49 CFR Part 236, subpart H. The individual petition is described below... approval of a revised version (version 3.0) of their already approved PSP for the Electronic Train Management System (ETMS). BNSF asserts that the revised PSP demonstrates that ETMS has been designed...

  17. 46 CFR 162.017-6 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ... design or type of pressure-vacuum relief valve shall submit drawings in quadruplicate showing the design... representative sample of the pressure-vacuum relief valve in each size for which approval is desired. Test...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Valves, Pressure-Vacuum Relief, for Tank Vessels §...

  18. 40 CFR 57.603 - Criteria for approval.

    Science.gov (United States)

    2010-07-01

    ...) PRIMARY NONFERROUS SMELTER ORDERS Research and Development Requirements § 57.603 Criteria for approval. The approvability of any proposed research and development program shall be judged primarily according... technology can be implemented at the smelter in question, should the smelter be placed on a SIP...

  19. Approved forest stands for seed collection; 1 : 1 000 000

    International Nuclear Information System (INIS)

    This map of The Atlas represents the approved forest stands for seed collection of the Slovak Republic. The approved stands rank among the best quality ones of the wood species used for seed collection and they are the result of the previous massive selection expressed by the phenotype value in the forest economic plan. (authors)

  20. 49 CFR 238.21 - Special approval procedure.

    Science.gov (United States)

    2010-10-01

    ..., DEPARTMENT OF TRANSPORTATION PASSENGER EQUIPMENT SAFETY STANDARDS General § 238.21 Special approval procedure.... (Requests for approval of programs for the inspection, testing, and maintenance of Tier II passenger... designated representatives of its employees, together with a list of the names and addresses of the...

  1. 14 CFR 414.29 - Safety approval transfer.

    Science.gov (United States)

    2010-01-01

    ... 414.29 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... safety approval or the prospective transferee may request a safety approval transfer. (c) Both the holder and prospective transferee must agree to the transfer. (d) The person requesting the transfer...

  2. 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

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

    Science.gov (United States)

    2012-04-26

    ... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the time period specified above: Approvals by Rule Issued Under 18 CFR 806.22(f) 1. EXCO Resources (PA), LLC, Pad... 27, 2012. 28. Range Resources--Appalachia, LLC, Pad ID: Porter, Stephen, ABR- 201203028, Cogan...

  4. 38 CFR 21.4263 - Approval of flight training courses.

    Science.gov (United States)

    2010-07-01

    ..., may seek an administrative review of their approval by the Director, Education Service. Requests for... number of hours should be approved. (ii) The Director, Education Service shall base her or his decision... AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Administration of Educational...

  5. 5 CFR 1305.2 - Production prohibited unless approved.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Production prohibited unless approved. 1305.2 Section 1305.2 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET ADMINISTRATIVE....2 Production prohibited unless approved. No employee or former employee of OMB shall, in response...

  6. 7 CFR 987.157 - Approved date product manufacturers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Approved date product manufacturers. 987.157 Section... DATES PRODUCED OR PACKED IN RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Qualification to Regulation § 987.157 Approved date product manufacturers. Any person, including date handlers,...

  7. 7 CFR 1717.608 - RUS approval of contracts.

    Science.gov (United States)

    2010-01-01

    ... requirements regarding RUS approval of such contracts are set forth in 7 CFR part 1724 for architectural and engineering services, and in 7 CFR part 1726 for construction and procurement. (b) Large retail power... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of contracts. 1717.608 Section...

  8. Thirty-seven NSFC-KOSEF Cooperative Projects Approved

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    @@ Thrity seven bilateral projects (including 25 joint research projects and 12 joint seminars) between NSFC and KOSEF for FY 2008 were approved by the 12th Meeting of China-Korea Joint Committee for Basic Scientific Research held in Xiamen,China from May 21 to 24,2008.The approved joint research projects and seminars are listed below.

  9. 32 CFR 644.135 - Lease authorization and approvals.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Lease authorization and approvals. 644.135... PROPERTY REAL ESTATE HANDBOOK Acquisition Acquisition by Leasing § 644.135 Lease authorization and approvals. (a) Title 10 Reports. Under the provisions of 10 U.S.C. 2662, a lease proposal or renewal with...

  10. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2013-09-05

    ... Collection; Credit Account Approval for Reimbursable Services AGENCY: Animal and Plant Health Inspection... with ] credit account approval for reimbursable services. DATES: We will consider all comments that we... call (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit...

  11. Modelling seasonality in Australian building approvals

    Directory of Open Access Journals (Sweden)

    Harry M Karamujic

    2012-02-01

    Full Text Available The paper examines the impact of seasonal influences on Australian housing approvals, represented by the State of Victoria[1] building approvals for new houses (BANHs. The prime objective of BANHs is to provide timely estimates of future residential building work. Due to the relevance of the residential property sector to the property sector as whole, BANHs are viewed by economic analysts and commentators as a leading indicator of property sector investment and as such the general level of economic activity and employment. The generic objective of the study is to enhance the practice of modelling housing variables. In particular, the study seeks to cast some additional light on modelling the seasonal behaviour of BANHs by: (i establishing the presence, or otherwise, of seasonality in Victorian BANHs; (ii if present, ascertaining is it deterministic or stochastic; (iii determining out of sample forecasting capabilities of the considered modelling specifications; and (iv speculating on possible interpretation of the results. To do so the study utilises a structural time series model of Harwey (1989. The modelling results confirm that the modelling specification allowing for stochastic trend and deterministic seasonality performs best in terms of diagnostic tests and goodness of fit measures. This is corroborated with the analysis of out of sample forecasting capabilities of the considered modelling specifications, which showed that the models with deterministic seasonal specification exhibit superior forecasting capabilities. The paper also demonstrates that if time series are characterized by either stochastic trend or seasonality, the conventional modelling approach[2] is bound to be mis-specified i.e. would not be able to identify statistically significant seasonality in time series.According to the selected modeling specification, factors corresponding to June, April, December and November are found to be significant at five per cent level

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

    Science.gov (United States)

    Kirschner, Neil M.

    1976-01-01

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

  13. Environmental approvals in New Brunswick : economic considerations

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-07-01

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

  14. Guidance for package approvals in the United Kingdom

    International Nuclear Information System (INIS)

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

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

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    1999-02-24

    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.

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

    International Nuclear Information System (INIS)

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

  17. Grandfathering of competent authority approved packages

    International Nuclear Information System (INIS)

    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

  18. FDA Approves New Drug to Treat Bladder Cancer

    Science.gov (United States)

    ... in its class of drugs, called PD-1/PD-L1 inhibitors, approved to treat this type of cancer. " ... these patients with a new therapy targeting the PD-L1 pathway," Dr. Richard Pazdur, director of the office ...

  19. 78 FR 27470 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-05-10

    ... Township, Lycoming County, Pa.; Consumptive Use of Up to 2.100 mgd; Approval Date: March 15, 2013. 3. Carrizo Marcellus, LLC, Pad ID: Hanlon, ABR-201303003, McNett Township, Lycoming County, Pa.;...

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

    Data.gov (United States)

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

  1. 40 CFR 82.38 - Approved independent standards testing organizations.

    Science.gov (United States)

    2010-07-01

    ... equipment testing and the technical experience of the organization's personnel; (iii) Thorough knowledge of... Approved independent standards testing organizations. (a) Any independent standards testing organization... following: (1) That the organization has the capacity to accurately test whether refrigerant...

  2. 75 FR 60617 - Review and Approval of Projects

    Science.gov (United States)

    2010-10-01

    ... fracking water. Also, people farther than a half mile may experience impacts to their water, air, and soil... fracking activity. Response: The Commission can find no evidence linking its approval of water...

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

    Science.gov (United States)

    2010-07-01

    ... the level of Acting Warden. (b) The appropriate Community Corrections Manager may approve the request... inmate who is in a community corrections center, in home confinement, in state custody, or in a...

  4. Living with Fibromyalgia, Drugs Approved to Manage Pain

    Science.gov (United States)

    ... Consumers Home For Consumers Consumer Updates Living with Fibromyalgia, Drugs Approved to Manage Pain Share Tweet Linkedin ... syndrome, and depression. back to top What Causes Fibromyalgia? Scientists believe that the condition may be due ...

  5. Xalkori Approved for Rare Genetic Form of Lung Cancer

    Science.gov (United States)

    ... html Xalkori Approved For Rare Genetic Form of Lung Cancer ROS-1 positive NSCLC To use the sharing ... Drug Administration to treat advanced non-small cell lung cancer (NSCLC) with tumors that have a rare ROS- ...

  6. 7 CFR 1786.56 - Approval of applications.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE (CONTINUED) PREPAYMENT OF RUS GUARANTEED AND INSURED LOANS TO ELECTRIC AND TELEPHONE BORROWERS Special Discounted Prepayments on RUS Direct/Insured Loans § 1786.56 Approval of applications....

  7. [Approval of predator management activities in North Dakota, 2005

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — Request from U.S. Fish and Wildlife Service and approval from North Dakota Game & Fish Department for predator management activities outside of the state...

  8. Possible FDA-approved drugs to treat Ebola virus infection

    OpenAIRE

    Yuan, Shu

    2015-01-01

    There is currently no effective treatment for the Ebola virus (EBOV) thus far. Most drugs and vaccines developed to date have not yet been approved for human trials. Two FDA-approved c-AbI1 tyrosine kinase inhibitors Gleevec and Tasigna block the release of viral particles; however, their clinical dosages are much lower than the dosages required for effective EBOV suppression. An α-1,2-glucosidase inhibitor Miglustat has been shown to inhibit EBOV particle assembly and secretion. Additionally...

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

    OpenAIRE

    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 European Union (EU). While the regulatory regime in the United States and EU is often discussed, little is understood about the Japanese regulations. However, Japan plays an important role in term...

  10. Catching Up on New Medications: New FDA Approvals.

    Science.gov (United States)

    Turkoski, Beatrice B

    2016-01-01

    Despite all efforts of the Federal Drug Administration to release timely and accurate information about new drug approvals, marketing and media announcements about new drugs may be incomplete, misinterpreted, or misunderstood. Informed and knowledgeable nurses are able to educate patients about new medications: they can clarify misunderstandings or misconceptions and significantly reduce the potential for harm. In this article, selected examples of new brand name drugs and first-time generics approved this year are discussed. PMID:26814007

  11. Testing (HIV). Quick test receives Singapore approval.

    Science.gov (United States)

    1996-04-22

    Hema-Strip HIV 1/2 is a rapid HIV antibody immunoassay developed by Saliva Diagnostic Systems, Inc. (SDS) which can be used by anyone who can read the product insert. The test kit is comprised of a small lancet for a finger stick, a cylindrical tube with a capillary tip and a SDS diagnostic strip inside, and a vial of buffer. Once blood is drawn by the lancet, the capillary tip is placed upon the blood droplet and the blood is automatically drawn into the tube. The tube is then inserted tip first into the vial of buffer. The buffer and blood migrate over the diagnostic strip inside, yielding stable results within 15 minutes. Studies have found Hema-Strip HIV 1/2 to have a sensitivity and specificity greater than 99.4%, as accurate as most conventional HIV tests which require the use of laboratory equipment and trained staff, and possibly hours to produce results. Moreover, the test kit requires neither refrigeration nor special storage. Hema-Strip HIV 1/2 has received a certificate of free sale from the Ministry of Health in Singapore and is now being submitted for regulatory approval in Brazil, China, Russia, India, Malaysia, Thailand, and the UK. SDS products in production include Sero-Strip HIV 1/2, a rapid serum-based HIV antibody test; Omni-SAL, a saliva collector which is the principal sample collection device used by British insurance companies for HIV testing with other confirmatory tests; Omni-Swab, a serrated swab which collects body fluids or cells; Saliva-Sampler, a saliva collection device used for general testing purposes; and Saliva Check, a test which checks the composition of saliva samples. SDS is in the final stages of developing Saliva-Strip HIV-1/2, a rapid saliva-based HIV antibody test. The company also intends to complete development in 1996 of a rapid blood-based antibody test for the Helicobacter pylori bacteria, a pathogen linked to 80% of peptic ulcers and gastric cancers. PMID:12290908

  12. Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-04-01

    Conclusions: This study confirms that India lag behind the US and EU regions in terms of total number of new drug approvals for antineoplastic and immunomodulating agents. There is a substantial approval delay in India compared to the US and EU regions. Further detailed analyses are necessary to find the reasons and impacts of drug lag for new antineoplastic and immunomodulating agents in India. [Int J Basic Clin Pharmacol 2016; 5(2.000: 335-340

  13. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    OpenAIRE

    Hatswell, Anthony J.; Baio, Gianluca; Berlin, Jesse A.; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from ...

  14. 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. PMID:27159747

  15. 12 CFR 516.280 - How will I know if my application has been approved?

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false How will I know if my application has been approved? 516.280 Section 516.280 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE... application has been approved? (a) OTS approval or denial. (1) OTS will approve or deny your...

  16. 38 CFR 21.4155 - Evaluations of State approving agency performance.

    Science.gov (United States)

    2010-07-01

    ... approving agency performance. 21.4155 Section 21.4155 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF... Assistance Programs State Approving Agencies § 21.4155 Evaluations of State approving agency performance. (a... evaluation of each State approving agency. The evaluation shall be based on standards developed by VA...

  17. 7 CFR 4290.510 - Approval of RBIC's Investment Adviser/Manager.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Approval of RBIC's Investment Adviser/Manager. 4290... Approval of RBIC's Investment Adviser/Manager. (a) General. You may employ an Investment Adviser/Manager... approval of the management contract. Approval of an Investment Adviser/Manager for one RBIC does...

  18. 21 CFR 316.31 - Scope of orphan-drug exclusive approval.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Scope of orphan-drug exclusive approval. 316.31... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.31 Scope of orphan-drug exclusive approval. (a) After approval of a sponsor's marketing application for a designated...

  19. 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... AND GUARANTEED ELECTRIC LOANS Operational Controls § 1717.613 RUS approval of data processing and... approval from RUS before purchasing data processing equipment or system control equipment, such approval...

  20. Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis

    Science.gov (United States)

    Wang, Bo; Franklin, Jessica M.; Eddings, Wesley; Landon, Joan; Kesselheim, Aaron S.

    2016-01-01

    Background Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved (“off-label”) uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children. Methods Retrospective, segmented time-series analysis using new prescription claims during 2003–2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone). FDA approved the sNDAs for pediatric use of olanzapine and quetiapine in December 2009, but did not approve the sNDA for pediatric use of ziprasidone. Results During the months before FDA approval of its pediatric sNDA, new prescriptions of olanzapine decreased for both children and adults. After FDA approval, the increase in prescribing trends was similar for both age groups (P = 0.47 for schizophrenia and bipolar disorder; P = 0.37 for other indications). Comparable decreases in use of quetiapine were observed between pediatrics and adults following FDA approval of its pediatric sNDA (P = 0.88; P = 0.63). Prescribing of ziprasidone decreased similarly for pediatric and adult patients after FDA non-approval of its pediatric sNDA (P = 0.61; P = 0.79). Conclusions The FDA’s sNDA determinations relating to use of antipsychotics in children did not result in changes in use that favored the approved sNDAs and disfavored the unapproved sNDA. Improved communication may help translate the agency’s expert judgments to clinical practice. PMID:27032095

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

    International Nuclear Information System (INIS)

    Type B packages and all packages containing fissile material, as well as special form materials, special arrangements and certain shipments, are required to be approved by the Competent Authority. In the United Kingdom, this function is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division of the Department of the Environment, Transport and the Regions (RMTD). Competent Authority approval 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 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 the test prototype. Central to the approval process is the regulatory test program, which is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test program, the applicant submit a formal application, supported by the Design Safety Report, which 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. RMTD produces a comprehensive Guide to Applications, which details the information required in all types of application for Competent Authority approval in the United Kingdom. (authors)

  2. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    D.W. Markman

    1999-09-17

    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

  3. Duchenne muscular dystrophy drugs face tough path to approval.

    Science.gov (United States)

    Hodgkinson, L; Sorbera, L; Graul, A I

    2016-03-01

    Highly anticipated as new disease-modifying treatments for Duchenne muscular dystrophy (DMD), therapeutics by BioMarin Pharmaceutical (Kyndrisa™; drisapersen) and Sarepta Therapeutics (eteplirsen; AVI-4658) both recently received negative FDA reviews and are now facing battles for approval in the U.S. At present, BioMarin is committed to working with the FDA to forge a pathway to approval following the failure of its NDA, while Sarepta awaits the formal decision on its NDA, which is expected by late May 2016. Despite the critical nature of both reviews, analysts consider that there is still a narrow possibility of approval of both drugs. According to Consensus forecasts from Thomson Reuters Cortellis for Competitive Intelligence, Kyndrisa is forecast to achieve sales of USD 533.71 million in 2021. PMID:27186594

  4. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

    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

  5. 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

    Harmonisation's E1 guideline recommendations. METHODS AND FINDINGS: All medicines containing new molecular entities approved between 2000 and 2010 were included in the study, including orphan medicines as a separate category. The total number of patients studied before approval was extracted (main outcome). In...... addition, the number of patients with long-term use (6 or 12 mo) was determined for chronic medication. 200 unique new medicines were identified: 161 standard and 39 orphan medicines. The median total number of patients studied before approval was 1,708 (interquartile range [IQR] 968-3,195) for standard...... medicines and 438 (IQR 132-915) for orphan medicines. On average, chronic medication was studied in a larger number of patients (median 2,338, IQR 1,462-4,135) than medication for intermediate (878, IQR 513-1,559) or short-term use (1,315, IQR 609-2,420). Safety and efficacy of chronic use was studied in...

  6. Need for Approval and Children's Well-Being

    OpenAIRE

    Rudolph, Karen D.; Caldwell, Melissa S.; Conley, Colleen S.

    2005-01-01

    This research examined the hypothesis that a tendency to base one's self-worth on peer approval is associated with positive and negative aspects of children's well-being. 153 4th - 8th graders (9.0 to 14.8 years) reported on need for approval (NFA), global self-worth, social-evaluative concerns, anxiety and depression, and exposure to victimization. Teachers reported on social behavior. Results confirmed that NFA is a two-dimensional construct composed of positive (enhanced self-worth in the ...

  7. 2015 in review: FDA approval of new drugs.

    Science.gov (United States)

    Kinch, Michael S

    2016-07-01

    The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise. PMID:27109618

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

    Science.gov (United States)

    Shrawder, Jack; And Others

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

  9. 24 CFR 945.201 - Approval to designate housing.

    Science.gov (United States)

    2010-04-01

    ... part. The PHA is required to meet the requirements of 24 CFR part 960, subpart D. (2) A PHA that... existing or planned mixed population projects, reserved under 24 CFR part 960, subpart B, as additional... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Approval to designate housing....

  10. 77 FR 8095 - Review and Approval of Projects

    Science.gov (United States)

    2012-02-14

    ... post- hydrofracture and pre-production is defined as flowback. Comment: The word ``siting'' in the... requiring review and approval. (a) * * * (3) Diversions. Except with respect to agricultural water use... also strengthening their laws and regulations. At this stage, there appears to be no justification...

  11. 30 CFR 918.10 - State regulatory program approval.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false State regulatory program approval. 918.10... INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE LOUISIANA § 918.10 State... and Mining Division, 625 N. 4th Street, P.O. Box 94275, Baton Rouge, LA 70804-9275. (b) Office...

  12. 19 CFR 151.13 - Approval of commercial gaugers.

    Science.gov (United States)

    2010-04-01

    ... requirements: (1) To comply with the requirements of part 151, Customs Regulations (19 CFR part 151), and to... approval to execute a bond in accordance with part 113, Customs Regulations (19 CFR part 113), and submit... Executive Director will determine the applicant's overall competence, independence, and character...

  13. 34 CFR 668.146 - Criteria for approving tests.

    Science.gov (United States)

    2010-07-01

    ... reference of this document has been approved by the Director of the Office of the Federal Register pursuant to the Director's authority under 5 U.S.C. 552(a) and 1 CFR part 51. The incorporated document is on... Independence Avenue, S.W., Washington, D.C. 20202 and at the National Archives and Records Administration...

  14. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ... Township, Lycoming County, Pa.; Consumptive Use of Up to 4.500 mgd; Approval Date: October 12, 2012. ] 9... LP, Pad ID: Terry D. Litzelman Pad A, ABR- 201211005, Cogan House Township, Lycoming County, Pa...: Larry's Creek F&G Pad F, ABR- 201211006, Cummings Township, Lycoming County, Pa.; Consumptive Use of...

  15. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

    ..., Cummings Township, Lycoming County, Pa.; Consumptive Use of up to 3.000 mgd; Approval Date: May 6, 2011. 2... Company LP, Pad ID: COP Tract 728 Pad H, ABR- 201105006, Watson Township, Lycoming County, Pa... 728 Pad G, ABR- 201105007, Watson Township, Lycoming County, Pa.; Consumptive Use of up to 4.000...

  16. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-26

    ... LP, Pad ID: Salt Run HC Pad A, ABR- 201208007, Cascade Township, Lycoming County, Pa.; Consumptive... Martin Pad A, ABR- 201208008, Cogan House Township, Lycoming County, Pa.; Consumptive Use of Up to 4.000...- 201208009, Cogan House Township, Lycoming County, Pa.; Consumptive Use of Up to 4.000 mgd; Approval...

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

    Science.gov (United States)

    2013-03-11

    .... Moxie Energy, LLC, Moxie Patriot, LLC Facility, ABR-201301006, Clinton Township, Lycoming County, Pa..., Lycoming County, Pa.; Consumptive Use of Up to 3.500 mgd; Approval Date: January 11, 2013. 5. Pennsylvania General Energy Company, LLC, Pad ID: COP Tract 322 Pad B, ABR-201301005, Cummings Township,...

  18. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ..., Lycoming County, Pa.; Consumptive Use of Up to 3.500 mgd; Approval Date: June 18, 2012. 7. Anadarko E&P Company, LP, Pad ID: Elbow F&G Pad B, ABR- 201206007, Cogan House Township, Lycoming County, Pa.... Inflection Energy LLC, Pad ID: Eck, ABR-201206011, Fairfield Township, Lycoming County, Pa.; Consumptive...

  19. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

    ... (PA), LLC, Pad ID: Warner North Unit Pad, ABR- 201202001, Penn Township, Lycoming County, Pa...-201202003, Mifflin Township, Lycoming County, Pa.; Consumptive Use of Up to 8.000 mgd; Approval Date...: Dale Bower East Unit Pad, ABR- 201202009, Penn Township, Lycoming County, Pa.; Consumptive Use of Up...

  20. 38 CFR 21.4267 - Approval of independent study.

    Science.gov (United States)

    2010-07-01

    ... study. 21.4267 Section 21.4267 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... § 21.4267 Approval of independent study. (a) Overview. Except as provided in §§ 21.4252(g), 21.7120(d... whole or in part by independent study. Hence, it is necessary to differentiate independent study...

  1. 31 CFR 3.23 - Approval of claims.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Approval of claims. 3.23 Section 3.23 Money and Finance: Treasury Office of the Secretary of the Treasury CLAIMS REGULATIONS AND..., taking into consideration the recommendation of the legal division....

  2. 10 CFR 72.234 - Conditions of approval.

    Science.gov (United States)

    2010-01-01

    ... Spent Fuel Storage Casks § 72.234 Conditions of approval. (a) The certificate holder and applicant for a CoC shall ensure that the design, fabrication, testing, and maintenance of a spent fuel storage cask... that the design, fabrication, testing, and maintenance of spent fuel storage casks are conducted...

  3. 40 CFR 82.160 - Approved equipment testing organizations.

    Science.gov (United States)

    2010-07-01

    ... list of equipment present at the organization that will be used for equipment testing. (2) Expertise in equipment testing and the technical experience of the organization's personnel. (3) Thorough knowledge of... equipment testing organizations. (a) Any equipment testing organization may apply for approval by...

  4. 46 CFR 160.176-5 - Approval procedures.

    Science.gov (United States)

    2010-10-01

    ... by design or construction the lifejacket can not fail the test. (e) Alternative requirements. A... and 159.005-7 may be omitted if a similar design has already been approved. (2) The information...) that the lifejacket is designed to provide. (ii) Any special purpose(s) for which the lifejacket...

  5. 77 FR 42002 - Revision of Approved Information Collection

    Science.gov (United States)

    2012-07-17

    ...), the BLM published a 60-day notice in the Federal Register on May 20, 2011 (76 FR 26263), and the... previously approved under the control number 1004- 0114. DATES: The OMB is required to respond to this... directly to the Desk Officer for the Department of the Interior (OMB 1004-0114), Office of Management...

  6. 78 FR 1718 - Approved Tests for Bovine Tuberculosis in Cervids

    Science.gov (United States)

    2013-01-09

    ... Animal and Plant Health Inspection Service 9 CFR Part 77 Approved Tests for Bovine Tuberculosis in... of antibodies to bovine tuberculosis in certain species of captive cervids. This action is necessary..., CO 80526-8117; (970) 494-7378. SUPPLEMENTARY INFORMATION: Background Bovine tuberculosis is...

  7. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

    ... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... propulsion and is directly engaged in or proposes to engage in a substantial research and development program... the field of nuclear reactors for rocket propulsion preparatory to the submission of a research...

  8. 14 CFR 21.500 - Approval of engines and propellers.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of engines and propellers. 21.500 Section 21.500 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... been subjected by the manufacturer to a final operational check....

  9. 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, DEPARTMENT OF AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Mortgage Controls on Acquisitions...

  10. 12 CFR 303.62 - Transactions requiring prior approval.

    Science.gov (United States)

    2010-01-01

    ... merger transaction that consists of the acquisition by an out of state bank of a branch without... must provide certification of assumption of deposit liability to the FDIC in accordance with 12 CFR... FILING PROCEDURES Merger Transactions § 303.62 Transactions requiring prior approval. (a)...

  11. 48 CFR 906.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

    ... justification. 906.304 Section 906.304 Federal Acquisition Regulations System DEPARTMENT OF ENERGY COMPETITION... justification. (c) Class justifications within the delegated authority of a Head of the Contracting Activity may... institutions. Class justifications for classes of actions that may exceed $10,000,000 require the approval...

  12. 10 CFR 903.22 - Final rate approval.

    Science.gov (United States)

    2010-01-01

    ... would result in total revenues in excess of those required by law, the rate last previously confirmed... 10 Energy 4 2010-01-01 2010-01-01 false Final rate approval. 903.22 Section 903.22 Energy... Transmission Rate Adjustments and Extensions for the Alaska, Southeastern, Southwestern, and Western Area...

  13. 75 FR 5844 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-02-04

    ... TRANSPORTATION Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... safety and oversight rules for a broad variety of sightseeing and commercial air tour flights. DATES... hours annually. Abstract: This rule set safety and oversight rules for a broad variety of...

  14. 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.

  15. 75 FR 17758 - Approved Recovery Plan for the Scaleshell Mussel

    Science.gov (United States)

    2010-04-07

    ... and solicited comments from August 6, 2004, through September 7, 2004 (69 FR 47949). We considered... plan. We listed the scaleshell as endangered on October 9, 2001 (66 FR 51322). The current distribution... Fish and Wildlife Service Approved Recovery Plan for the Scaleshell Mussel AGENCY: Fish and...

  16. 9 CFR 590.435 - Wholesomeness and approval of materials.

    Science.gov (United States)

    2010-01-01

    ... materials. 590.435 Section 590.435 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... additive approved. (d) Containers and packing or packaging materials in which shell eggs are received into... of use as human food shall be clean, wholesome, and unadulterated. (b) The use of chemical...

  17. 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...

  18. 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 names. 4.93 Section 4.93 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names §...

  19. 27 CFR 5.51 - Label approval and release.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Label approval and release. 5.51 Section 5.51 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for...

  20. 27 CFR 4.91 - List of approved prime names.

    Science.gov (United States)

    2010-04-01

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

  1. 27 CFR 4.40 - Label approval and release.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Label approval and release. 4.40 Section 4.40 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Withdrawal of Wine...

  2. 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... required, with section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C))...

  3. 78 FR 53474 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-08-29

    ... Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval..., development, production, and utilization of geothermal resources on BLM-managed public lands, and on lands... the Paperwork Reduction Act, 44 U.S.C. 3501- 3521, require that interested members of the public...

  4. 77 FR 26037 - Renewal of Approved Information Collection

    Science.gov (United States)

    2012-05-02

    ... on January 24, 2012 (77 FR 3496), and the comment period ended March 26, 2012. The BLM received no... for oil and gas or geothermal resources. The Office of Management and Budget (OMB) previously approved... . SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act (44 U.S.C. 3501- 3521) and OMB regulations at 5 ]...

  5. 77 FR 29747 - Notice of Request for Information Collection Approval

    Science.gov (United States)

    2012-05-18

    ... published on April 11, 2000 (65 FR 19477) or you may visit http://DocketsInfo.dot.gov . Docket: For Internet.... Abstract: DOT will utilize the form to collect information necessary to process EEO discrimination... Office of the Secretary Notice of Request for Information Collection Approval AGENCY: Office of...

  6. 46 CFR 160.053-6 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ... independent laboratory accepted by the Coast Guard under 46 CFR 159.010. (c) If the work vest is of a non...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-6 Procedure for... § 159.010-7 of this subchapter covering the in-water testing of personal flotation devices,...

  7. 27 CFR 24.258 - Certificates of approval or exemption.

    Science.gov (United States)

    2010-04-01

    ... AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS WINE Storage, Treatment and Finishing of Wine Bottling, Packing, and Labeling of Wine § 24.258 Certificates of approval or exemption. The proprietor... required by 27 CFR part 4. (August 29, 1935, ch. 814, Sec. 5, 49 Stat. 981, as amended (27 U.S.C. 205))...

  8. 48 CFR 32.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... payments and (2) potential Government benefits from the contract performance. (e) Proposed advance payment... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Recommendation for approval. 32.409-1 Section 32.409-1 Federal Acquisition Regulations System FEDERAL ACQUISITION...

  9. 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...

  10. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ... Management Information System (FAMIS)-type projects, in accordance with section 402(e)(2)(C) of the Social... activities beyond that approved in the APD; (D) A change in system concept or scope of the project; (E) A... the project changes to be reported in the “As Needed APDU”. (3) Failure to submit any of the above...

  11. 45 CFR 1355.53 - Conditions for approval of funding.

    Science.gov (United States)

    2010-10-01

    ... these enhancements on a phased basis. (g) The system must perform Quality Assurance functions to provide... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON CHILDREN, YOUTH AND..., developed (or an existing system enhanced), and installed in accordance with an approved advance...

  12. 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.

  13. 29 CFR 1952.246 - Changes to approved plans.

    Science.gov (United States)

    2010-07-01

    ... (29 CFR 1928.110) and temporary labor camps (29 CFR 1910.142) in agriculture (except for agricultural... personal sampling, ex parte warrants, petition to modify abatement dates, withdrawal of contest...) Temporary labor camps/field sanitation. Effective February 3, 1997, the Assistant Secretary approved...

  14. 50 CFR Appendix B to Part 404 - Approved VMS

    Science.gov (United States)

    2010-10-01

    ... OF COMMERCE); ENDANGERED SPECIES COMMITTEE REGULATIONS SUBCHAPTER A NORTHWESTERN HAWAIIAN ISLANDS MARINE NATIONAL MONUMENT Pt. 404, App. B Appendix B to Part 404—Approved VMS I. VMS Mobile Transceiver... supports the security and privacy of vessel accounts and messages with the following: (a)...

  15. NCI Community Oncology Research Program Approved | Division of Cancer Prevention

    Science.gov (United States)

    On June 24, 2013, the National Cancer Institute (NCI) Board of Scientific Advisors approved the creation of the NCI Community Oncology Research Program (NCORP). NCORP will bring state-of-the art cancer prevention, control, treatment and imaging clinical trials, cancer care delivery research, and disparities studies to individuals in their own communities. |

  16. 19 CFR 134.45 - Approved markings of country name.

    Science.gov (United States)

    2010-04-01

    ... OF THE TREASURY COUNTRY OF ORIGIN MARKING Method and Location of Marking Imported Articles § 134.45 Approved markings of country name. (a) Language. (1) Except as otherwise provided in paragraph (a)(2) of... origin, unless another marking to indicate the English name of the country of origin is...

  17. Senate approves global warming bill; House bill introduced

    International Nuclear Information System (INIS)

    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

  18. 22 CFR 129.6 - Requirement for license/approval.

    Science.gov (United States)

    2010-04-01

    ...) Brokering activities undertaken by or for an agency of the United States Government— (i) For use by an agency of the United States Government; or (ii) For carrying out any foreign assistance or sales program... LICENSING OF BROKERS § 129.6 Requirement for license/approval. (a) No person may engage in the business...

  19. 21 CFR 601.12 - Changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... 601.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... the approved application; (ii) Changes requiring completion of an appropriate human study to... analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal...

  20. 76 FR 59863 - Application and Approval Process for New Programs

    Science.gov (United States)

    2011-09-27

    ... under the Higher Education Act of 1965, as amended (HEA), to streamline the application and approval... 600 Institutional Eligibility Under the Higher Education Act of 1965, as Amended We discuss... provides for the eligibility of institutions of higher education (20 U.S.C. 1099c). Current...

  1. The Cost of Delaying Approval of Golden Rice

    OpenAIRE

    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 in 600,000 to 1.2 million additional cases of blindness.

  2. 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

  3. 20 CFR 656.32 - Revocation of approved labor certifications.

    Science.gov (United States)

    2010-04-01

    ... Officer in consultation with the Chief, Division of Foreign Labor Certification may take steps to revoke... Intent to Revoke an approved labor certification which contains a detailed statement of the grounds for... relevant evidence presented in deciding whether to revoke the labor certification. (2) If rebuttal...

  4. 78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

    Science.gov (United States)

    2013-07-10

    ... limited aspect of Indiana's infrastructure SIP in our October 29, 2012, final rulemaking (see 77 FR 65478... Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian... on Region 5 states' submissions (see 77 FR 45992). Notably, we proposed to find that Indiana had...

  5. 78 FR 65030 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Approval of...

    Science.gov (United States)

    2013-10-30

    ... of Marine Hull Insurance AGENCY: Maritime Administration. ACTION: Notice and request for comments....gov . FOR FURTHER INFORMATION CONTACT: Michael Yarrington, Chief, Office of Marine Insurance, Maritime...: 2133-0517. Title: Approval of Underwriters of Marine Hull Insurance. Form Numbers: None. Type of...

  6. 75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-05-04

    ... ID: Kepner 8503H, ABR-20100209, Shrewsbury Township, Lycoming County, Pa.; Approval Date: February 11...-20100211, Shrewsbury Township, Lycoming County, Pa.; Approval Date: February 12, 2010. 14. Fortuna...

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

    Directory of Open Access Journals (Sweden)

    Adol Esquivel

    2009-12-01

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

  8. 78 FR 18336 - Public Water System Supervision Program Approval for the State of Michigan

    Science.gov (United States)

    2013-03-26

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Michigan AGENCY: Environmental... has tentatively approved five revisions to the State of Michigan's public water system...

  9. 78 FR 14791 - Public Water System Supervision Program Approval for the State of Indiana

    Science.gov (United States)

    2013-03-07

    ... AGENCY Public Water System Supervision Program Approval for the State of Indiana AGENCY: Environmental... has tentatively approved three revisions to the State of Indiana's public water system supervision... the State of Indiana's public water system supervision program, thereby giving IDEM...

  10. 77 FR 76034 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-12-26

    ... AGENCY Public Water System Supervision Program Approval for the State of Ohio AGENCY: Environmental... has tentatively approved revisions to the State of Ohio's public water system supervision program... public water system supervision program, thereby giving Ohio EPA primary enforcement responsibility...

  11. 77 FR 21099 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-04-09

    ... AGENCY Public Water System Supervision Program Approval for the State of Ohio AGENCY: Environmental... has tentatively approved three revisions to the State of Ohio's public water system supervision... of Ohio's public water system supervision program, thereby giving Ohio EPA primary...

  12. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Science.gov (United States)

    2010-04-01

    ... labeling prior to marketing. (c) FDA will approve an application after it determines that the drug meets... not be introduced or delivered for introduction into interstate commerce until approval of...

  13. 76 FR 75523 - Vessel Monitoring Systems; Approved Mobile Transmitting Units and Communications Service...

    Science.gov (United States)

    2011-12-02

    ... National Oceanic and Atmospheric Administration RIN 0648-XA844 Vessel Monitoring Systems; Approved Mobile... (NOAA), Commerce. ACTION: Notice of vessel monitoring systems; type approval. SUMMARY: This document provides notice that three mobile transmitting unit (MTU) vessel monitoring systems (VMS) that...

  14. 5 CFR 7301.102 - Prior approval for outside teaching, speaking and writing.

    Science.gov (United States)

    2010-01-01

    ... or Federal regulation, including 5 CFR part 2635. ... 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...

  15. 7 CFR 1710.209 - Approval requirements for load forecast work plans.

    Science.gov (United States)

    2010-01-01

    ... approved work plan represents a commitment by a power supply borrower and its members, or by a large... the majority of the members that are borrowers. (j) The borrower's board of directors must approve...

  16. 13 CFR 107.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Science.gov (United States)

    2010-01-01

    ... prior SBA approval for a proposed transfer of Control. SBA approval is contingent upon full disclosure... assume, in writing, personal liability for your Leverage, effective only in the event of their direct...

  17. An overview of drugs approved in India from 1999 through 2015

    Directory of Open Access Journals (Sweden)

    Vihang S. Chawan

    2015-08-01

    Conclusions: Thus, the present study highlights the changing scenario of drug approval, with few drugs being approved for clinical practice in the last 3 years. [Int J Basic Clin Pharmacol 2015; 4(4.000: 697-700

  18. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    Science.gov (United States)

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  19. Contemplation on new drug approvals by U.S. FDA, 2011-2015

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-02-01

    Conclusions: For new drugs approved between 2011 and 2015, the U.S. FDA was first to approve majority of new drugs. There was upward trend of new drug approvals in antineoplastic therapeutic area. [Int J Basic Clin Pharmacol 2016; 5(1.000: 55-59

  20. Comparison of new drug approval by regulatory agencies of US, EU and India

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-02-01

    Conclusions: For new drugs approved between 2011 and 2015, India has lagged behind the US and the EU in approval of new drugs. There was no difference in the patterns of new drug approvals with respect to the therapeutic areas. [Int J Basic Clin Pharmacol 2016; 5(1.000: 112-115

  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...

  2. 75 FR 38591 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-07-02

    ... Mountain 736, ABR- 20100502, McIntyre Township, Lycoming County, Pa.; Approval Date: May 3, 2010. 3. East..., ABR-20100505, Mifflin Township, Lycoming County, Pa.; Approval Date: May 5, 2010. 6. Chief Oil & Gas...- 20100532, McIntyre Township, Lycoming County, Pa.; Approval Date: May 18, 2010. 33. EOG Resources,...

  3. 75 FR 51155 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-08-18

    ..., Moreland Township, Lycoming County, Pa.; Consumptive Use of up to 4.000 mgd; Approval Date: June 2, 2010. 5... Township, Lycoming County, Pa.; Consumptive Use of up to 2.000 mgd; Approval Date: June 6, 2010. 17..., Watson Township, Lycoming County, Pa.; Consumptive Use of up to 3.000 mgd; Approval Date: June 10,...

  4. 75 FR 41369 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD Revision 1; Withdrawal

    Science.gov (United States)

    2010-07-16

    ... COMMISSION 10 CFR Part 72 RIN 3150-AI75 List of Approved Spent Fuel Storage Casks: NUHOMS HD Revision 1... HD cask system listing within the list of approved spent fuel storage casks to include Amendment No... ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1 to the CoC. Amendment No....

  5. 75 FR 41404 - List of Approved Spent Fuel Storage Casks: NUHOMS®

    Science.gov (United States)

    2010-07-16

    ... COMMISSION 10 CFR Part 72 RIN 3150-AI75 List of Approved Spent Fuel Storage Casks: NUHOMS HD Revision 1... cask system listing within the list of approved spent fuel storage casks to include Amendment No. 1 to... within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1 to the CoC....

  6. 14 CFR 91.1077 - Training program and revision: Initial and final approval.

    Science.gov (United States)

    2010-01-01

    ... to an approved training program, each program manager must submit to the Administrator— (1) An... final approval of the proposed training program or revision if the program manager shows that the..., the Administrator grants initial approval in writing after which the program manager may conduct...

  7. 43 CFR 45.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Has OMB approved the information... the Interior CONDITIONS AND PRESCRIPTIONS IN FERC HYDROPOWER LICENSES Alternatives Process § 45.74 Has... indicates OMB approval. OMB has reviewed the information collection in this rule and approved it under...

  8. 13 CFR 106.303 - Who has authority to approve and sign a Fee Based Record?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Who has authority to approve and... Activities § 106.303 Who has authority to approve and sign a Fee Based Record? The Administrator, or upon his... consultation with the General Counsel (or designee), has the authority to approve and sign each Fee...

  9. 50 CFR 221.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Has OMB approved the information... PRESCRIPTIONS IN FERC HYDROPOWER LICENSES Alternatives Process § 221.74 Has OMB approved the information... it displays a currently valid OMB control number that indicates OMB approval. OMB has reviewed...

  10. 13 CFR 106.204 - Who has the authority to approve and sign a Cosponsorship Agreement?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Who has the authority to approve... Cosponsored Activities § 106.204 Who has the authority to approve and sign a Cosponsorship Agreement? The... administrator, after consultation with the General Counsel (or designee), has the authority to approve...

  11. 75 FR 65567 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards

    Science.gov (United States)

    2010-10-26

    ... revisions are being evaluated in separate rulemaking; see the June 27, 2005 proposed rule at 70 FR 36901... requirements for major sources, found at OAC 3745-31 (approved by EPA on January 10, 2003, 68 FR 1366), to... to Rule 9 since it was approved by EPA on May 27, 1994, 59 FR 27464. Ohio requested approval of...

  12. 25 CFR 290.5 - Who approves tribal revenue allocation plans?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Who approves tribal revenue allocation plans? 290.5... REVENUE ALLOCATION PLANS § 290.5 Who approves tribal revenue allocation plans? The ABO will review and approve tribal revenue allocation plans for compliance with IGRA....

  13. 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...

  14. 30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.

    Science.gov (United States)

    2010-07-01

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

  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... § 201.85 Legal effect of USAID approvals and decisions. In any transaction subject to this part 201... funds. Any decision by USAID to exercise or refrain from exercising these approval rights shall be...

  16. 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...

  17. 13 CFR 108.380 - Final approval as a NMVC Company.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Final approval as a NMVC Company... VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.380 Final approval as a NMVC Company. (a) General rule. With respect to each Conditionally Approved NMVC Company, SBA...

  18. 30 CFR 18.91 - Electric equipment for which field approvals will be issued.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Electric equipment for which field approvals... OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.91 Electric...

  19. 30 CFR 28.3 - Installation, use, and maintenance of approved fuses.

    Science.gov (United States)

    2010-07-01

    ... fuses. 28.3 Section 28.3 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT... maintenance of approved fuses. Approved fuses shall be installed and maintained in accordance with...

  20. 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...

  1. 7 CFR 1427.1086 - Approval of warehouse, requests for reconsideration.

    Science.gov (United States)

    2010-01-01

    ... CFR part 780. When appealing under such regulations, the warehouseman shall be considered as a... 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...

  2. 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...

  3. Recent New Drug Approvals, Part 2: Drugs Undergoing Active Clinical Studies in Children

    OpenAIRE

    Chhim, Rebecca F.; Shelton, Chasity M.; Christensen, Michael L.

    2013-01-01

    The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children.

  4. 78 FR 47253 - Approval and Promulgation of Air Quality Implementation Plans; Maine; Oxides of Nitrogen...

    Science.gov (United States)

    2013-08-05

    ... the applicable requirements. On December 26, 1995 (60 FR 66748), EPA approved the State of Maine's... effect as approved by EPA in 1995. In addition, on February 3, 2006 (71 FR 5791), EPA approved a section... (69 FR 23951) requires areas to request a separate section 182(f) NO X exemption request under...

  5. 13 CFR 302.8 - Pre-approval Investment Assistance costs.

    Science.gov (United States)

    2010-01-01

    ..., DEPARTMENT OF COMMERCE GENERAL TERMS AND CONDITIONS FOR INVESTMENT ASSISTANCE § 302.8 Pre-approval Investment Assistance costs. Project activities carried out before approval of Investment Assistance shall be carried... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Pre-approval Investment...

  6. 40 CFR 63.95 - Additional approval criteria for accidental release prevention programs.

    Science.gov (United States)

    2010-07-01

    ... accidental release prevention programs. 63.95 Section 63.95 Protection of Environment ENVIRONMENTAL... Additional approval criteria for accidental release prevention programs. (a) A State submission for approval... (“federally-listed chemicals”) that an approvable State Accidental Release Prevention program is...

  7. 46 CFR 160.171-19 - Approval testing for child size immersion suit.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval testing for child size immersion suit. 160.171..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Immersion Suits § 160.171-19 Approval testing for child size immersion suit. A child size suit must pass the following tests: (a)...

  8. 46 CFR 160.171-17 - Approval testing for adult size immersion suit.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval testing for adult size immersion suit. 160.171..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Immersion Suits § 160.171-17 Approval testing for adult size immersion suit. Caution: During each of the in-water tests prescribed...

  9. 17 CFR 240.14a-20 - Shareholder approval of executive compensation of TARP recipients.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Shareholder approval of... § 240.14a-20 Shareholder approval of executive compensation of TARP recipients. If a solicitation is... shareholder vote to approve the compensation of executives, as disclosed pursuant to Item 402 of Regulation...

  10. 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...

  11. 7 CFR 1751.104 - Obtaining RUS approval of a proposed Modernization Plan.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Obtaining RUS approval of a proposed Modernization... CRITERIA, AND PROCEDURES State Telecommunications Modernization Plan § 1751.104 Obtaining RUS approval of a proposed Modernization Plan. (a) To obtain RUS approval of a proposed Modernization Plan, the...

  12. 7 CFR 1717.611 - RUS approval of expenditures for legal, accounting, engineering, and supervisory services.

    Science.gov (United States)

    2010-01-01

    ... 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... contract requires the borrower to obtain approval from RUS before incurring expenses for legal,...

  13. 7 CFR 1717.612 - RUS approval of borrower's bank or other depository.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of borrower's bank or other depository... GUARANTEED ELECTRIC LOANS Operational Controls § 1717.612 RUS approval of borrower's bank or other depository. If a borrower's mortgage or loan contract gives RUS the authority to approve the bank or...

  14. 75 FR 42672 - Approval and Promulgation of Implementation Plans; New Jersey; 8-hour Ozone Control Measures

    Science.gov (United States)

    2010-07-22

    ... conditionally approved. See 74 FR 22837 (May 15, 2009). If EPA approves this proposed SIP revision, the RACT... Subchapter 24 occurred on January 25, 2006 (71 FR 4045). EPA had previously approved Subchapter 24 provisions... addition, any contact adhesive, electronic cleaner, footwear or leather care product, general...

  15. The Effect of Perceived Parental Approval of Drinking on Alcohol Use and Problems

    Science.gov (United States)

    Messler, Erick C.; Quevillon, Randal P.; Simons, Jeffrey S.

    2014-01-01

    The relationship between perceived parental approval of drinking and alcohol use and problems was explored with undergraduate students in a small midwestern university. Participants completed a survey measuring demographic information, perceived approval of drinking, and alcohol use and problems. Results indicated perceived parental approval of…

  16. 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...

  17. 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.

  18. Implications of Recent Drug Approvals for Older Adults

    Science.gov (United States)

    Eisenhower, Christine; Koronkowski, Michael; Marcum, Zachary

    2016-01-01

    More than 100 medications were approved by the US Food and Drug Administration as new drugs or for new indications in 2014 and 2015. Several of the new drugs may benefit older adults, but adverse events and pharmacokinetic changes due to aging must be considered. This article will focus on three recently approved drugs that are marketed for chronic conditions that can affect older adults: suvorexant, for treatment of insomnia; edoxaban, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of venous thromboembolism; and droxidopa, for treatment of symptomatic neurogenic orthostatic hypotension. Information about indications, mechanisms of action, dosing, efficacy, and safety are reviewed. The place of each agent in therapy for older adults is also discussed.

  19. Burial of small quantities of radionuclides without prior NRC approval

    International Nuclear Information System (INIS)

    The US Nuclear Regulatory Commission has proposed to delete a regulation (10 CFR 20.304) which allows licensees to bury specified small quantities of radionuclides anywhere without notification or approval of NRC, subject to certain conditions. In developing this proposed deletion, the NRC staff contacted licensees, state officials, inspectors, and others to obtain information on disposal practices. The Commission and its staff tentatively concluded that burials pursuant to 10 CFR Section 20.304 should stop, and that the impact of the proposed deletion would be small. If review of public comments does not change this evaluation, 10 CFR Section 20.304 will be deleted, and burials will have to be specifically approved in advance by NRC

  20. Waste feed delivery environmental permits and approvals plan

    International Nuclear Information System (INIS)

    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

  1. Chinese Government Approves Nanhai Oil Refinery Project of CNOOC

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ The Nanhai Oil Refinery Project independently funded by CNOOC was approved by the related governmental departments in late July. The offshore oil giant builds the 12 million ton-per-year oil refinery in Guangdong Province in the next three years to tap the lucrative South China oil market.The investment in the project will total at least 16 billion yuan (US$1.93 billion).

  2. Should local research ethics committees monitor research they have approved?

    OpenAIRE

    Cave (née Pickworth), E.

    2000-01-01

    The function of local research ethics committees is to consider the ethics of research proposals using human participants. After approval has been given, there is no comprehensive system in place to monitor research and ensure that recommendations are carried out. Some suggest that research ethics committees are ideally placed to fulfil this function by carrying out random monitoring of research they have reviewed. The health service guideline creating local research ethics committees is unde...

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

    Energy Technology Data Exchange (ETDEWEB)

    Fowler, K.D.

    1998-08-03

    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.

  4. Ethical considerations in orphan drug approval and use.

    Science.gov (United States)

    Kesselheim, A S

    2012-08-01

    The Orphan Drug Act seeks to meet a utilitarian goal of advancing therapeutic options for patients with rare diseases. However, data show that orphan drugs are often approved with more limited premarket testing than that carried out for nonorphan drugs and consequently expose patients to more risk and less certain efficacy. Therefore, the ethical principles of justice and beneficence may require attention to informed consent among patients receiving the drugs and greater investment in postmarket surveillance and confirmational testing. PMID:22814660

  5. Sex offender grouping within a probation approved premises

    OpenAIRE

    Reeves, Carla

    2008-01-01

    This presentation explores how convicted or charged sexual offenders within a Probation Approved Premises (probation hostel) experience life within the hostel in terms of group structures. The presentation considers the findings of an ethnographic case study of a probation hostel which drew upon the work of Sykes and Matza, Goffman and Foucault. The hostel accommodated medium-high and high risk offenders, and was mixed in terms of the offences that residents had committed and also by gen...

  6. Possible FDA-approved drugs to treat Ebola virus infection.

    Science.gov (United States)

    Yuan, Shu

    2015-01-01

    There is currently no effective treatment for the Ebola virus (EBOV) thus far. Most drugs and vaccines developed to date have not yet been approved for human trials. Two FDA-approved c-AbI1 tyrosine kinase inhibitors Gleevec and Tasigna block the release of viral particles; however, their clinical dosages are much lower than the dosages required for effective EBOV suppression. An α-1,2-glucosidase inhibitor Miglustat has been shown to inhibit EBOV particle assembly and secretion. Additionally, the estrogen receptor modulators Clomiphene and Toremifene prevent membrane fusion of EBOV and 50-90% of treated mice survived after Clomiphene/Toremifene treatments. However, the uptake efficiency of Clomiphene by oral administration is very low. Thus, I propose a hypothetical treatment protocol to treat Ebola virus infection with a cumulative use of both Miglustat and Toremifene to inhibit the virus effectively and synergistically. EBOV infection induces massive apoptosis of peripheral lymphocytes. Also, cytolysis of endothelial cells triggers disseminated intravascular coagulation (DIC) and subsequent multiple organ failures. Therefore, blood transfusions and active treatments with FDA-approved drugs to treat DIC are also recommended. PMID:25984303

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

    Directory of Open Access Journals (Sweden)

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

    2010-12-01

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

  8. Approved Antiviral Drugs over the Past 50 Years.

    Science.gov (United States)

    De Clercq, Erik; Li, Guangdi

    2016-07-01

    Since the first antiviral drug, idoxuridine, was approved in 1963, 90 antiviral drugs categorized into 13 functional groups have been formally approved for the treatment of the following 9 human infectious diseases: (i) HIV infections (protease inhibitors, integrase inhibitors, entry inhibitors, nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, and acyclic nucleoside phosphonate analogues), (ii) hepatitis B virus (HBV) infections (lamivudine, interferons, nucleoside analogues, and acyclic nucleoside phosphonate analogues), (iii) hepatitis C virus (HCV) infections (ribavirin, interferons, NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors), (iv) herpesvirus infections (5-substituted 2'-deoxyuridine analogues, entry inhibitors, nucleoside analogues, pyrophosphate analogues, and acyclic guanosine analogues), (v) influenza virus infections (ribavirin, matrix 2 protein inhibitors, RNA polymerase inhibitors, and neuraminidase inhibitors), (vi) human cytomegalovirus infections (acyclic guanosine analogues, acyclic nucleoside phosphonate analogues, pyrophosphate analogues, and oligonucleotides), (vii) varicella-zoster virus infections (acyclic guanosine analogues, nucleoside analogues, 5-substituted 2'-deoxyuridine analogues, and antibodies), (viii) respiratory syncytial virus infections (ribavirin and antibodies), and (ix) external anogenital warts caused by human papillomavirus infections (imiquimod, sinecatechins, and podofilox). Here, we present for the first time a comprehensive overview of antiviral drugs approved over the past 50 years, shedding light on the development of effective antiviral treatments against current and emerging infectious diseases worldwide. PMID:27281742

  9. Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait

    Directory of Open Access Journals (Sweden)

    Maurizio Bendandi

    2010-03-01

    Full Text Available Hybridoma-derived idiotype vaccines have been used for the experimental treatment of human lymphoma over the last twenty years, providing evidence of biological efficacy, clinical efficacy and clinical benefit. However, the product that has come closer to regulatory approval is unlikely to clear that hurdle due to the insufficiently robust data obtained in a recently closed clinical trial. This review aims at discussing the reasons for hybridoma-derived idiotype vaccines, more difficult to produce but also more successful than recombinant idiotype vaccines so far, are unlikely to gain regulatory approval. In particular, it is necessary to examine the many peculiar features of this therapeutic approach in a broader context, with special attention to concepts like customized active immunotherapy and randomization. Most published trials based on hybridoma-derived idiotype vaccines are being analyzed, together with the yet non-peer reviewed data from the only randomized study conducted so far with this product, and with the main trials on recombinant idiotype vaccines for thorough comparison. All in all, the sole randomized trial ever conducted on hybridoma-derived idiotype vaccines failed to achieve its primary clinical end point because of an insufficient accrual and because the statistical significance achieved was not as stringent as required for regulatory approval.

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

    International Nuclear Information System (INIS)

    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

  11. Procedures for the approval of oil spill treatment products

    International Nuclear Information System (INIS)

    The final report of the Government Review on the Testing, Approval and Use of Oil Dispersants (MAFF, 1996) made a number of recommendations affecting approval of oil dispersants. In addition toxicity testing protocols have recently been developed to assess new types of oil treatment products such as sorbents and bioremediation agents. This document reflects these changes. It supersedes Fisheries Research Technical Report No. 39 - New procedures for the toxicity testing of oil slick dispersants (Blackman et al., 1977). Until April 1996 all toxicity assessments were carried out by the MAFF, Directorate of Fisheries Research (DFR). However, from that date appropriate toxicity testing can be carried out by suitably accredited or recognised laboratories, as an alternative to DFR, and results submitted to MAFF for consideration. This document is designed as an aid to manufacturers and potential testing laboratories. Under the scheme there is a need to assess and approve all types of oil treatment products. At present four different groups are recognised; dispersants, sorbents, bioremediation agents and miscellaneous. (author)

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

    International Nuclear Information System (INIS)

    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. Contents specification criteria for package design approvals in Germany

    International Nuclear Information System (INIS)

    Requirements for a package design for the transport of radioactive and fissile material are established in the Regulations for the Safe Transport of Radioactive Material - 1996 Edition (TS-R-1). Beginning with the first edition in 1961 the Regulations for the Safe Transport of Radioactive Material were developed consequently to a high standard to protect persons, property and the environment from the effects of radiation during the transport of radioactive material by placing the primary reliance on the package design. One important part of the package design approval procedure is to show that all dose rate limits and other requirements relating to radiation shielding are fulfilled when the maximum radioactive contents is considered. The applicant has to find covering parameters for the contents description which will be fixed in the package design approval certificate as maximum permissible parameters. This paper describes the contents description for spent fuel elements and vitrified high level radioactive waste (HAW) from the reprocessing which are acceptable to the Federal Office for Radiation Protection (BfS) as the competent authority for package design approval. Such parameters for spent fuel elements are i.e. enrichment, burn-up, cooling time, or the description by source strengths for gamma and neutron emitters. It is also shown which specific evidences, i.e. for weak areas of the shielding, are requested by BfS. (author)

  14. Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals

    OpenAIRE

    Bhaven C. Kataria; Ashna S. Pandya; Ashwin K. Panchasara; Pavan J. Panchal; Mitul R. Parmar

    2016-01-01

    Background: There is a tremendous amount of research being conducted on development of new drugs for cancer therapies. The drug development of cancer therapies has dramatically increased over the past few decades. The present study was undertaken to assess the drug lag for new antineoplastic and immunomodulating agents in India compared with that in the United States (US) or European Union (EU). Methods: The new drugs approved in the US, EU and India between 2011 and 2015 were identified a...

  15. The TOUCH program and natalizumab: Fundamental flaw in patient protection [version 3; referees: 2 approved, 1 approved with reservations

    OpenAIRE

    Jagannadha Avasarala

    2016-01-01

    Many drugs have been approved by the Food and Drug Administration (FDA) since 1993 for treatment of relapsing forms of multiple sclerosis (MS). One such drug is natalizumab (Tysabri, Biogen Idec and Elan pharmaceuticals) which has enjoyed great success in the management of MS since its re-introduction in 2006. One of the complications of using natalizumab is the risk of development of progressive multifocal leukoencephalopathy (PML). To mitigate the risk of PML development, Biogen Idec initia...

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

    Science.gov (United States)

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

    2014-01-01

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

  17. 基于CBERS-02B高分辨率遥感影像分割的最优尺度选取%Optimal scale selection base on CBERS-02B high-resolution remote sensing images

    Institute of Scientific and Technical Information of China (English)

    况润元; 袁秀华; 罗卫; 张萌; 王聪颖

    2013-01-01

    高分辨遥感影像的信息提取对矿山的监测有着重要意义,影像分割是高分辨率遥感影像信息提取关键的一步.文中以赣州稀土矿山的高分辨率遥感影像为源数据,采用分形网络演化多尺度分割算法对高分辨率遥感影像进行分割,通过Robert算子的边缘提取结果计算分割参数获取分割尺度,并在此基础上设置不同分割尺度对影像进行分割,对比分析分割结果表明,沉淀池的最优分割尺度为35.最后利用分割质量值对分割结果进行评价分析,验证了试验结果的正确性.%It has important significance for high resolution remote sensing image information extraction to monitor rare earth mine. Image segmentation is a key step in the high resolution remote sensing image information extraction. In order to obtain the optimal segmentation results, this paper chooses high-resolution remote sensing image of Ganzhou rare earth mines, uses Fractal Net Evolution Approach algorithm to segment high resolution remote sensing image, and computes segmentation parameter to obtain segmentation scale by edge extraction results of Robert operator, and sets different segmentation scale to segment image base on it, after comparing and analyzing segmentation results, it shows that optimal segmentation scale of sedimentation tank was 35. At last Segmentation results were evaluated by segmentation quality value, it verifies the accuracy of experimental result.

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

    OpenAIRE

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

    2012-01-01

    Every spatial unit of human occupation is part of a network structuring an extensive process of urbanization in the Amazon territory. Multi-resolution remote sensing data were used to identify and map human presence and activities in the Sustainable Forest District of Cuiabá-Santarém highway (BR-163), west of Pará, Brazil. The limits of spatial units of human occupation were mapped based on digital classification of Landsat-TM5 (Thematic Mapper 5) image (30m spatial resolution). High-spatial-...

  19. Analysis of the observation of particle detector inside ‘CBERS-1’ satellite under solar quiet conditions

    Institute of Scientific and Technical Information of China (English)

    ZOU; Hong; XIAO; Zuo; HAO; Yongqiang; ZOU; Jiqing; ZHU; Wenming; WU; Zhongxiang

    2006-01-01

    Based on the knowledge and related theory of earth's radiation belt, the data chronous orbit were analyzed. It is proved that the observational results are in agreement with the theoretical description of the radiation belt structures. Analysis of more than 3years' data showed clearly that under quiet solar conditions, at a height of about 800 km the energetic particles were mainly located in three regions: northern auroral belt (40°-80°), southern auroral belt (-40°- -80°) and South Atlantic Geomagnetic Anomaly Region (SAA). Actually, this is for the global distribution, at each longitude the latitudinal coverage is much narrower and particles are along the geomagnetic latitude of about ±60°.The species of particles in different regions and their counting rates are different. In SAA,usually both electrons and protons are observed, which should come from inner radiation belt; in polar regions only energetic electrons are observed under the quiet condition,which belongs to the outer radiation belt. The distribution of outer radiation electrons is asymmetrical for longitudes as well as northern and southern polar regions. These asymmetries can be explained with the reflecting altitudes of the mirror points of charged particles at the same L shell.

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

    International Nuclear Information System (INIS)

    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

  1. STS safety approval process for small self-contained payloads

    Science.gov (United States)

    Gum, Mary A.

    1988-01-01

    The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

  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. Observations and suggestions for improved transport/packaging approvals

    International Nuclear Information System (INIS)

    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 UF6, UO2 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

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

    International Nuclear Information System (INIS)

    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

  5. Technical Architecture of ONC-Approved Plans For Statewide Health Information Exchange

    OpenAIRE

    Barrows, Randolph C.; Ezzard, John

    2011-01-01

    ONC-approved state plans for HIE were reviewed for descriptions and depictions of statewide HIE technical architecture. Review was complicated by non-standard organizational elements and technical terminology across state plans. Findings were mapped to industry standard, referenced, and defined HIE architecture descriptions and characteristics. Results are preliminary due to the initial subset of ONC-approved plans available, the rapid pace of new ONC-plan approvals, and continuing advancemen...

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

    OpenAIRE

    Siriwardhana Chesmal; Athukorale Manjula; Lekamwattage Manura; Hewege Suwin; Siribaddana Sisira; Sumathipala Athula; Murray Joanna; Prince Martin

    2008-01-01

    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 L...

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

    International Nuclear Information System (INIS)

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

  8. Translating Social Motivation into Action: Contributions of Need for Approval to Children’s Social Engagement

    OpenAIRE

    Rudolph, Karen D.; Bohn, Lauren E.

    2013-01-01

    This research examined how children’s need for approval (NFA) from peers predicted social behavior (prosocial behavior, aggression, social helplessness) and peer responses (acceptance, victimization, exclusion). Children (N = 526, M age = 7.95, SD = .33) reported on need for approval and teachers reported on social engagement. Approach NFA (motivation to gain approval) predicted more positive engagement and less conflictual engagement and disengagement. Conversely, avoidance NFA (motivation t...

  9. 75 FR 4901 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-01-29

    ...; Approval Date: December 21, 2009. 55. XTO Energy Incorporated, Pad ID: King Unit, ABR-20091225, Shrewsbury.... XTO Energy Incorporated, Pad ID: Booth, ABR-20091226, Shrewsbury Township, Lycoming County,...

  10. 76 FR 52917 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

    Science.gov (United States)

    2011-08-24

    ...; Adoption of Control Techniques Guidelines for Large Appliance and Metal Furniture Coatings AGENCY... same title, ``Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption...

  11. 75 FR 45007 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2010-07-30

    ... of Renewed Approval of Information Collection(s): Verification of Authenticity of Foreign License...: Verification of Authenticity of Foreign License, Rating and Medical Certification. Form Numbers: FAA form...

  12. 78 FR 7778 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request...

    Science.gov (United States)

    2013-02-04

    ... Utilities. 2211 Electric Power Generation, Transmission and Distribution. 5617 Services to Buildings and... approval of a new collection. Public comments were previously requested via the Federal Register (75...

  13. A practical guide to attaining research ethics approval in the U.K.

    Science.gov (United States)

    Tod, Angela Mary; Allmark, Peter; Alison, Althea

    This article examines the permissions and approvals required for nurses and other health professionals to conduct research in the NHS in the U.K. today. A fictitious example of a research study conducted by a nurse who did not obtain NHS research ethics committee (REC) approval is provided. The current position regarding the REC approval process, including the role of ethics in research governance, is explored. The differences between research, audit and service evaluation are explained. Finally, the main ethical issues to be addressed in an application for REC approval are summarised. PMID:19323124

  14. Announcement of Newly Approved National Standards of P. R. China 2007 No.4 (total No. 104)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 114 national standards and publicize now.

  15. Announcement of Newly Approved National Standards of P. R. China 2006 No.13 (total No. 100)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 371 national standards and publicize now.

  16. Announcement of Newly Approved National Standards of P. R. China 2006 No.11 (total No.98)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 220 national standards and publicize now.

  17. 78 FR 76389 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-12-17

    ... operating at Southwest Florida International Airport (RSW). Determination: Approved. Based on information... vehicles and equipment. Extend and rehabilitate apron (airline). Demolish old passenger terminal...

  18. 76 FR 11751 - Notice of Request for Extension of Approval of an Information Collection; Environmental...

    Science.gov (United States)

    2011-03-03

    ... Plant Health Inspection Service's intention to request an extension of approval of an information... Inspection Service (APHIS) of the United States Department of Agriculture is to provide leadership...

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

    International Nuclear Information System (INIS)

    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

  20. 78 FR 58598 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2013-09-24

    ... of Renewed Approval of Information Collection: Verification of Authenticity of Foreign License... INFORMATION: OMB Control Number: 2120-0724. Title: Verification of Authenticity of Foreign License,...

  1. 78 FR 64209 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Engine...

    Science.gov (United States)

    2013-10-28

    ... approval of a new collection. Public comments were previously requested via the Federal Register (78 FR..., unless the comment includes profanity, threats, information claimed to be Confidential...

  2. 78 FR 75342 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP...

    Science.gov (United States)

    2013-12-11

    ... approved through March 31, 2014. Public comments were previously requested via the Federal Register (78 FR..., unless the comment includes profanity, threats, information claimed to be Confidential...

  3. 1994 Characterization report for the state approved land disposal site

    Energy Technology Data Exchange (ETDEWEB)

    Swanson, L.C.

    1994-09-19

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

  4. The support of human genetic evidence for approved drug indications.

    Science.gov (United States)

    Nelson, Matthew R; Tipney, Hannah; Painter, Jeffery L; Shen, Judong; Nicoletti, Paola; Shen, Yufeng; Floratos, Aris; Sham, Pak Chung; Li, Mulin Jun; Wang, Junwen; Cardon, Lon R; Whittaker, John C; Sanseau, Philippe

    2015-08-01

    Over a quarter of drugs that enter clinical development fail because they are ineffective. Growing insight into genes that influence human disease may affect how drug targets and indications are selected. However, there is little guidance about how much weight should be given to genetic evidence in making these key decisions. To answer this question, we investigated how well the current archive of genetic evidence predicts drug mechanisms. We found that, among well-studied indications, the proportion of drug mechanisms with direct genetic support increases significantly across the drug development pipeline, from 2.0% at the preclinical stage to 8.2% among mechanisms for approved drugs, and varies dramatically among disease areas. We estimate that selecting genetically supported targets could double the success rate in clinical development. Therefore, using the growing wealth of human genetic data to select the best targets and indications should have a measurable impact on the successful development of new drugs. PMID:26121088

  5. Safety aspects and approvals of the first JET tritium experiment

    International Nuclear Information System (INIS)

    The first tritium experiment was carried out successfully in the JET machine in November 1991. A new gas introduction system was constructed and an existing cryogenic pumping system was modified to permit collection of tritium in the exhaust gas. The total amount of tritium used was 0.12 g, out of a total available on-site inventory of 0.24 g. This paper describes the essential safety features of the modifications to the machine and how the safety and other approvals were obtained. The standards which were required to be met are discussed, and it is shown that the risk to employees and members of the public arising from the experiment was negligible. In addition, the measures taken to identify potential operational problems and to respond to incidents which might have occurred are described. (orig.)

  6. Application for approval of the Cold Lake Expansion Project

    International Nuclear Information System (INIS)

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

  7. Performance and approval procedures for active personal dosemeters

    International Nuclear Information System (INIS)

    Active personal dosemeters (APDs) are well accepted as useful and reliable instruments for individual dosimetry measurements. The increasing concern about studying the behaviour of APDs in pulsed fields is illustrated through revision of the results of the most representative studies on the performance of APDs in the last 5 y. The deficiencies of APDs in pulsed fields are discussed together with proposals to overcome them. Although there are no legal constraints or technical limitations for recognising APDs for legal dosimetry in facilities with continuous radiation fields, APDs continue to be mainly used as operational dosemeters. The approval procedures applicable to APDs, especially the approach undertaken by Germany, are presented. Finally, some trends in the developments and use of APDs are summarised. (authors)

  8. The Complexity of Manipulating $k$-Approval Elections

    CERN Document Server

    Lin, Andrew

    2010-01-01

    An important problem in computational social choice theory is the computability and complexity of undesirable behavior among agents, such as control, manipulation, and bribery in election systems. These kind of voting strategies are often tempting at the individual level but disasterous for the agents as a whole. Creating election systems where the determination of such strategies is difficult is thus an important goal. Previous work in this area has demonstrated the complexity of misuse in cases involving a fixed number of candidates, and of specific election systems on unbounded number of candidates such as Borda. In contrast, we take the first step in generalizing the results of computational complexity of election misuse to cases of infinitely many systems on an unbounded number of candidates. Interesting families of systems include $k$-approval and $k$-veto elections, in which voters distinguish $k$ candidates from the candidate set. We also demonstrate a surprising connection between manipulation in ele...

  9. 1994 Characterization report for the state approved land disposal site

    International Nuclear Information System (INIS)

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

  10. 77 FR 50611 - Approval and Promulgation of Implementation Plans; State of Oregon; Regional Haze State...

    Science.gov (United States)

    2012-08-22

    ... approved certain provisions in Oregon's Regional Haze SIP submission. 76 FR 38997. This previous action... developing a LTS. 76 FR 38997. A detailed explanation of the Regional Haze Rule including the requirements... retrofit technology (BART). 76 FR 38997. On May 23, 2012, EPA proposed approving the remaining portion...

  11. 78 FR 58992 - Notice of Request for Extension of Approval of an Information Collection; Citrus Canker...

    Science.gov (United States)

    2013-09-25

    ... Animal and Plant Health Inspection Service Notice of Request for Extension of Approval of an Information Collection; Citrus Canker; Interstate Movement of Regulated Nursery Stock and Fruit From Quarantined Areas AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Extension of approval of an...

  12. 21 CFR 314.170 - Adulteration and misbranding of an approved drug.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Adulteration and misbranding of an approved drug... Applications and Abbreviated Applications § 314.170 Adulteration and misbranding of an approved drug. All drugs... subject to the adulteration and misbranding provisions in sections 501, 502, and 503 of the act. FDA...

  13. 77 FR 39983 - Migratory Bird Hunting; Application for Approval of Fluoropolymeric Shot Coatings as Nontoxic for...

    Science.gov (United States)

    2012-07-06

    ... of Fluoropolymeric Shot Coatings as Nontoxic for Waterfowl Hunting AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of application for nontoxic shot approval. SUMMARY: We, the U.S. Fish and Wildlife Service, announce that Spectra Shot, LLC, of Lafayette, Louisiana, has applied for approval of steel...

  14. 23 CFR 810.308 - Approval of urban system nonhighway public mass transit projects.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Approval of urban system nonhighway public mass transit... PUBLIC TRANSPORTATION MASS TRANSIT AND SPECIAL USE HIGHWAY PROJECTS Federal-Aid Urban System Nonhighway Public Mass Transit Projects § 810.308 Approval of urban system nonhighway public mass transit...

  15. 77 FR 11483 - Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2012-02-27

    ... AGENCY: Risk Management Agency, USDA. ACTION: Extension of approval of an information collection; comment request. Note: With this renewal submission of 0563-0067--Risk Management and Crop Insurance Education... approved information collection for Risk Management and Crop Insurance Education; Request for...

  16. 29 CFR 1956.80 - Description of the plan as initially approved.

    Science.gov (United States)

    2010-07-01

    ... with 29 CFR 1953.5. Any emergency temporary standards will be adopted within 30 days of Federal... procedures at 29 CFR 1905 within two years of plan approval. (d) Employee notice and discrimination... and the independence of the adjudicatory process within one year of plan approval. The Director...

  17. 76 FR 50536 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-15

    ... Township, Lycoming County, Pa.; Consumptive Use of up to 4.000 mgd; Approval Date: June 21, 2011. 18...&G Pad H, ABR- 201106019, Cummings Township, Lycoming County, Pa.; Consumptive Use of up to 4.000 mgd..., Cogan House Township, Lycoming County, Pa.; Consumptive Use of up to 4.000 mgd; Approval Date: June...

  18. 76 FR 33019 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-06-07

    ...., Pad ID: Lundy Well Pad, ABR-201103010, Gamble Township, Lycoming County, Pa.; Consumptive Use of up to... Township, Lycoming County, Pa.; Consumptive Use of up to 8.000 mgd; Approval Date: March 17, 2011. 19... Township, Lycoming County, Pa.; Consumptive Use of up to 5.000 mgd; Approval Date: March 22, 2011. 32....

  19. 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...

  20. 7 CFR 400.707 - Presentation to the Board for approval or disapproval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Presentation to the Board for approval or disapproval. 400.707 Section 400.707 Agriculture Regulations of the Department of Agriculture (Continued) FEDERAL... Policies, Provisions of Policies and Rates of Premium § 400.707 Presentation to the Board for approval...

  1. 76 FR 2277 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

    Science.gov (United States)

    2011-01-13

    ... COMMISSION 10 CFR Part 72 RIN 3150--AI89 List of Approved Spent Fuel Storage Casks: NUHOMS HD System Revision... Commission (NRC or the Commission) is proposing to amend its spent fuel storage cask regulations by revising the Transnuclear, Inc. (TN) NUHOMS HD System listing within the ``List of Approved Spent Fuel...

  2. 78 FR 16619 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-03-18

    ...; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 RIN 3150-AJ22 List of Approved Spent Fuel Storage Casks... Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the NAC... within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 3 to Certificate...

  3. 76 FR 2243 - List of Approved Spent Fuel Storage Casks: NUHOMS ® HD System Revision 1

    Science.gov (United States)

    2011-01-13

    ... 3150-AI89 List of Approved Spent Fuel Storage Casks: NUHOMS HD System Revision 1 AGENCY: Nuclear... Commission) is amending its spent fuel storage regulations by revising the Transnuclear, Inc. (TN) NUHOMS HD System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1...

  4. 75 FR 25120 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

    Science.gov (United States)

    2010-05-07

    ... REGULATORY COMMISSION 10 CFR Part 72 RIN 3150-AI75 List of Approved Spent Fuel Storage Casks: NUHOMS HD... Regulatory Commission (NRC) is proposing to amend its spent fuel storage cask regulations by revising the Transnuclear, Inc. (TN), NUHOMS HD System listing within the ``List of Approved Spent Fuel Storage Casks''...

  5. 78 FR 78693 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

    Science.gov (United States)

    2013-12-27

    ... RIN 3150-AJ10 List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS Cask... final rule amended the NRC's spent fuel storage regulations by revising the Transnuclear, Inc. Standardized NUHOMS Cask System listing within the ``List of Approved Spent Fuel Storage Casks'' to...

  6. 75 FR 33678 - List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 1

    Science.gov (United States)

    2010-06-15

    ... COMMISSION 10 CFR Part 72 RIN 3150-AI86 List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision... Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the NAC International Inc. (NAC) MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks''...

  7. 10 CFR 72.236 - Specific requirements for spent fuel storage cask approval and fabrication.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Specific requirements for spent fuel storage cask approval... REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Approval of Spent Fuel Storage Casks § 72.236 Specific requirements...

  8. 10 CFR 72.214 - List of approved spent fuel storage casks.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false List of approved spent fuel storage casks. 72.214 Section... STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE General License for Storage of Spent Fuel at Power Reactor Sites § 72.214 List of approved...

  9. 75 FR 33736 - List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 1

    Science.gov (United States)

    2010-06-15

    ... COMMISSION 10 CFR Part 72 RIN 3150--AI86 List of Approved Spent Fuel Storage Casks: MAGNASTOR System... Regulatory Commission (NRC) is proposing to amend its spent fuel storage cask regulations by revising the NAC International, Inc. (NAC), MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks''...

  10. 78 FR 63408 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

    Science.gov (United States)

    2013-10-24

    ... COMMISSION 10 CFR Part 72 RIN 3150-AJ10 List of Approved Spent Fuel Storage Casks: Transnuclear, Inc.... Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the Transnuclear, Inc. Standardized NUHOMS Cask System listing within the ``List of Approved Spent Fuel...

  11. 77 FR 4203 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System, Revision 2

    Science.gov (United States)

    2012-01-27

    ... 3150-AI91 List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 2 AGENCY: Nuclear... amended the NRC's spent fuel storage regulations by revising the NAC International, Inc. (NAC) MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 2...

  12. 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...

  13. 14 CFR 91.1087 - Approval of aircraft simulators and other training devices.

    Science.gov (United States)

    2010-01-01

    ... included in the program manager's training program if approved by the Administrator. (b) Each aircraft... device may be used by more than one program manager. (d) In granting initial and final approval of... procedures listed in the program manager's curriculum under § 91.1079....

  14. 76 FR 28123 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-05-13

    .... Additionally, five approved amendments to previously approved applications are listed. SUMMARY: The FAA... requirements of Sec. 158.15(b). Decision Date: March 11, 2011. For Further Information Contact: Irene Porter... training upgrade. Pre-conditioned air hose upgrade (five boarding bridges). Brief Description of...

  15. 78 FR 30385 - Approval of Noise Compatibility Program for Tweed-New Haven Regional Airport

    Science.gov (United States)

    2013-05-22

    ... Federal Aviation Administration Approval of Noise Compatibility Program for Tweed-New Haven Regional... Administration (FAA) announces its findings on the noise compatibility program submitted by the Tweed-New Haven... FAA's approval of the Tweed-New Haven Regional Airport noise compatibility program is May 9, 2013....

  16. 45 CFR 2540.540 - Who has authority to approve use of national service insignia?

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Who has authority to approve use of national service insignia? 2540.540 Section 2540.540 Public Welfare Regulations Relating to Public Welfare... Use of National Service Insignia § 2540.540 Who has authority to approve use of national...

  17. 76 FR 4710 - Accreditation and Approval of Laboratory Service, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2011-01-26

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Laboratory Service, Inc., as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of accreditation and approval of Laboratory Service, Inc., as a commercial gauger...

  18. 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....

  19. 7 CFR 1710.205 - Minimum approval requirements for all load forecasts.

    Science.gov (United States)

    2010-01-01

    ... format acceptable to RUS. (d) Document retention. The borrower must retain its latest approved load... per consumer projections from the load forecast to develop system design criteria. The assumptions and... forecast work plan must be retained as part of the approved load forecast. (e) Consultation with RUS....

  20. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Refusal to approve a medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.21 Refusal to approve a medicated feed mill license application. (a)...

  1. 78 FR 56225 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...

    Science.gov (United States)

    2013-09-12

    ... activities as described in this ICR (77 FR 39699, July 5, 2012). EPA did not receive any public comments... AGENCY Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...) for review and approval in accordance with the Paperwork Reduction Act: ``Soil Fumigant...

  2. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Procedures for certification of approved products for Homeland Security. 25.9 Section 25.9 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY REGULATIONS TO SUPPORT ANTI-TERRORISM BY FOSTERING EFFECTIVE TECHNOLOGIES § 25.9 Procedures for certification of approved...

  3. 77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Science.gov (United States)

    2012-06-22

    ... subject to the requirements of premarket approval. In the Federal Register of May 6, 1994 (59 FR 23731... premarket approval. ] In the Federal Register of July 27, 2011 (76 FR 44872) (the July 27, 2011, proposed... submitted in response to the 515(i) Order, (April 9, 2009 (74 FR 16214)), and any additional...

  4. 75 FR 58340 - Airworthiness Directives; Koito Industries, Ltd., Seats and Seating Systems Approved Under...

    Science.gov (United States)

    2010-09-24

    ... rule'' under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), and 3. Will..., Ltd., Seats and Seating Systems Approved Under Technical Standard Order (TSO) TSO-C39b, TSO-C39c, or..., Ltd., seats and seating systems approved under TSO-C39b, TSO-C39c, or TSO-C127a. This proposed...

  5. 46 CFR 8.570 - Interim approval of prototype SIP company or vessel plans.

    Science.gov (United States)

    2010-10-01

    ... of 46 CFR part 2, subpart 2.01 of this chapter. ... 46 Shipping 1 2010-10-01 2010-10-01 false Interim approval of prototype SIP company or vessel... of prototype SIP company or vessel plans. (a) A company operating under an approved prototype...

  6. 14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. (a) Each airplane simulator and other training device that is used in a training course permitted under §...

  7. 48 CFR 8.405-6 - Limited sources justification and approval.

    Science.gov (United States)

    2010-10-01

    ... justification and approval. 8.405-6 Section 8.405-6 Federal Acquisition Regulations System FEDERAL ACQUISITION... Limited sources justification and approval. (a) Orders placed under Federal Supply Schedules are exempt... threshold, the justification required by paragraph (g) of this subsection. (e) The posting requirement...

  8. 76 FR 14559 - Federal Acquisition Regulation; Justification and Approval of Sole-Source 8(a) Contracts

    Science.gov (United States)

    2011-03-16

    ... the meeting notice that was published in the Federal Register on August 31, 2010 at 75 FR 53269... Acquisition Regulation; Justification and Approval of Sole-Source 8(a) Contracts AGENCIES: Department of... by making certain that the proper Justification and Approval (J&A) is obtained prior to award of...

  9. 48 CFR 5.406 - Public disclosure of justification and approval documents for noncompetitive contracts.

    Science.gov (United States)

    2010-10-01

    ... justification and approval documents for noncompetitive contracts. 5.406 Section 5.406 Federal Acquisition... Information 5.406 Public disclosure of justification and approval documents for noncompetitive contracts. Justifications for other than full and open competition must be posted in accordance with 6.305....

  10. 75 FR 53269 - Federal Acquisition Regulation; Tribal Consultation; Justification and Approval of Sole-Source 8...

    Science.gov (United States)

    2010-08-31

    ... Federal Acquisition Regulation; Tribal Consultation; Justification and Approval of Sole-Source 8(a... justification and approval of sole-source contracts over $20 million under the 8(a) small business development... agency. Section 811 states that a sole-source justification must include the following information: (1)...

  11. 48 CFR 308.405-6 - Limited source justification and approval.

    Science.gov (United States)

    2010-10-01

    ... justification and approval. 308.405-6 Section 308.405-6 Federal Acquisition Regulations System HEALTH AND HUMAN... Schedules 308.405-6 Limited source justification and approval. (g)(1) As required by FAR 8.405-1 or 8.405-2, the responsible program office must provide a written justification whenever it requests...

  12. 48 CFR 2406.304-70 - Approval of the justification-field procurements.

    Science.gov (United States)

    2010-10-01

    ... justification-field procurements. 2406.304-70 Section 2406.304-70 Federal Acquisition Regulations System... Other Than Full and Open Competition 2406.304-70 Approval of the justification—field procurements. (a) The justification for other than full and open competition for field procurements shall be approved...

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

    Science.gov (United States)

    2010-01-01

    ... action. (d) We will publish a notice of availability of all completed risk assessments for public comment... 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...

  14. 30 CFR 75.1103-2 - Automatic fire sensors; approved components; installation requirements.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic fire sensors; approved components... Protection § 75.1103-2 Automatic fire sensors; approved components; installation requirements. (a) The components of each automatic fire sensor required to be installed in accordance with the provisions of §...

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

    International Nuclear Information System (INIS)

    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

  16. 77 FR 71145 - Approval and Promulgation of Implementation Plans; New Mexico; New Source Review (NSR...

    Science.gov (United States)

    2012-11-29

    ... at the State Air Agency listed below during official business hours by appointment: New Mexico.... EPA's Evaluation The current New Mexico SIP includes EPA-approved Part 72 provisions (see 62 FR 50514... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; New Mexico; New Source...

  17. 77 FR 18923 - Approval and Promulgation of Implementation Plans; New Mexico; Construction Permit Fees

    Science.gov (United States)

    2012-03-29

    ... at the State Air Agency listed below during official business hours by appointment: New Mexico... September 26, 1997 (62 FR 50518). Therefore, a direct comparison to the approved New Mexico SIP is... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; New Mexico; Construction...

  18. 77 FR 65821 - Approval and Promulgation of Implementation Plans; New Mexico; Albuquerque/Bernalillo County...

    Science.gov (United States)

    2012-10-31

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; New Mexico; Albuquerque.... SUMMARY: EPA is finalizing approval of revisions from the Governor of New Mexico to the State... publicly available, e.g., Confidential Business Information or other information the disclosure of which...

  19. 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.

  20. 7 CFR 1948.82 - Plan and State Investment Strategy approval procedure.

    Science.gov (United States)

    2010-01-01

    ... hired in coal or uranium development activities in each of the next three years within the approved... Impacted Area Development Assistance Program § 1948.82 Plan and State Investment Strategy approval... production, processing, or transportation in each of the next three calendar years within the area covered...

  1. 77 FR 42306 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-07-18

    ... Human Health or the Environment AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY... approval according to the procedures prescribed in 5 CFR 1320.12. On October 25, 2011 (76 FR 66061), EPA... AGENCY Agency Information Collection Activities; Submission to OMB for Review and Approval;...

  2. 78 FR 38714 - Public Water System Supervision Program Approval for the State of Illinois

    Science.gov (United States)

    2013-06-27

    ... AGENCY Public Water System Supervision Program Approval for the State of Illinois AGENCY: Environmental... of Illinois is revising its approved public water system supervision program for the Ground Water Rule, the Arsenic Rule and the ] new Public Water System Definition. EPA has determined that...

  3. First Delisting Approval by the US EPA for a Vitrified Mixed Waste

    International Nuclear Information System (INIS)

    Delisting of a vitrified hazardous and radioactive (mixed) waste stored at the Savannah River Site has been approved by Environmental Protection Agency, Region 4. This is the first approval of a delisting petition for a vitrified waste, listed or mixed, in the United States

  4. 7 CFR 4290.503 - RBIC's adoption of an approved valuation policy.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false RBIC's adoption of an approved valuation policy. 4290... adoption of an approved valuation policy. (a) Valuation guidelines. You must prepare, document and report the valuations of your Loans and Investments in accordance with the Valuation Guidelines for...

  5. 13 CFR 108.503 - NMVC Company's adoption of an approved valuation policy.

    Science.gov (United States)

    2010-01-01

    ... approved valuation policy. 108.503 Section 108.503 Business Credit and Assistance SMALL BUSINESS... Requirements § 108.503 NMVC Company's adoption of an approved valuation policy. (a) Valuation guidelines. You must prepare, document and report the valuations of your Loans and Investments in accordance with...

  6. 42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Proposed quality control plans; approval by the Institute. 84.42 Section 84.42 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Quality Control § 84.42 Proposed quality control plans; approval by the Institute. (a) Each...

  7. 42 CFR 413.85 - Cost of approved nursing and allied health education activities.

    Science.gov (United States)

    2010-10-01

    ... courses relating to the theory and practice of the nursing or allied health profession involved that are... 42 Public Health 2 2010-10-01 2010-10-01 false Cost of approved nursing and allied health... NURSING FACILITIES Specific Categories of Costs § 413.85 Cost of approved nursing and allied...

  8. 30 CFR 75.601-2 - Short circuit protection; use of fuses; approval by the Secretary.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Short circuit protection; use of fuses; approval by the Secretary. 75.601-2 Section 75.601-2 Mineral Resources MINE SAFETY AND HEALTH... Trailing Cables § 75.601-2 Short circuit protection; use of fuses; approval by the Secretary. Fuses...

  9. 12 CFR 708a.3 - Board of directors' approval and members' opportunity to comment.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Board of directors' approval and members... REGULATIONS AFFECTING CREDIT UNIONS CONVERSION OF INSURED CREDIT UNIONS TO MUTUAL SAVINGS BANKS § 708a.3 Board of directors' approval and members' opportunity to comment. (a) A credit union's board of...

  10. 77 FR 51465 - Federal Housing Administration: Strengthening Risk Management Through Responsible FHA-Approved...

    Science.gov (United States)

    2012-08-24

    ... Management Through Responsible FHA-Approved ] Lenders'' (75 FR 20718). The April 20, 2010, final rule... Administration: Strengthening Risk Management Through Responsible FHA-Approved Lenders AGENCY: Office of the... correction. SUMMARY: As part of HUD's efforts to strengthen the risk management practices of the...

  11. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Science.gov (United States)

    2010-10-01

    ... constructed in accordance with the plans and specifications in the application for approval. In each test only... 46 Shipping 6 2010-10-01 2010-10-01 false Approval Testing-Recreational Hybrid PFD's. 160.077-19 Section 160.077-19 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED)...

  12. 75 FR 80061 - Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA

    Science.gov (United States)

    2010-12-21

    ... HUMAN SERVICES Food and Drug Administration Abbott Laboratories, Inc.; Withdrawal of Approval of a New... (sibutramine hydrochloride (HCl)) oral capsules held by Abbott Laboratories, Inc. (Abbott), 100 Abbott Park Rd., Abbott Park, IL 60064. Abbott has voluntarily requested that approval of this application be...

  13. 77 FR 1892 - Approval and Promulgation of Air Quality Implementation Plans; State of Colorado; Motor Vehicle...

    Science.gov (United States)

    2012-01-12

    ... affect the approved maintenance plans for Metro-Denver and Longmont for carbon monoxide (see 72 FR 46148... of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide... monoxide (see 70 FR 48650), or the approved attainment plan for Metro-Denver/NFR for the 1997 8-hour...

  14. 24 CFR 982.612 - Group home: State approval of group home.

    Science.gov (United States)

    2010-04-01

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

  15. 78 FR 18364 - Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process

    Science.gov (United States)

    2013-03-26

    ... FR 16236-16319, and became effective on June 1, 2010. Update Certifying Organizations With a... posted on DEA's Web site. 75 FR 16243 (March 31, 2010). On January 18, 2013, DEA approved the... biometrics subsystem, including its interfaces. 77 FR 45688 (August 1, 2012). This approval for...

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

    International Nuclear Information System (INIS)

    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. 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...

  18. 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...

  19. 78 FR 56648 - Notice of a Request for a Reinstatement of a Currently Approved Information Collection

    Science.gov (United States)

    2013-09-13

    ... Foreign Agricultural Service Notice of a Request for a Reinstatement of a Currently Approved Information... Service (FAS) intends to reinstate a currently approved information collection procedure for the Trade... at the mail address listed above between 8:00 a.m. and 4:30 p.m., Monday through Friday,...

  20. 78 FR 14352 - Notice of Approved Class III Tribal Gaming Ordinances

    Science.gov (United States)

    2013-03-05

    ... National Indian Gaming Commission Notice of Approved Class III Tribal Gaming Ordinances AGENCY: National Indian Gaming Commission. ACTION: Notice. SUMMARY: The purpose of this notice is to inform the public of the approved Class III tribal gaming ordinances. DATES: Effective Date: This notice is effective...

  1. 30 CFR 902.20 - Approval of Alaska abandoned mine land reclamation plan.

    Science.gov (United States)

    2010-07-01

    ... available at: (a) Department of Natural Resources, Division of Mining and Water Management, 3601 C Street... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Alaska abandoned mine land... § 902.20 Approval of Alaska abandoned mine land reclamation plan. The Alaska Reclamation Plan,...

  2. 75 FR 75957 - Notice of Revision and Request for Extension of Approval of an Information Collection...

    Science.gov (United States)

    2010-12-07

    ... quarantine facilities; States approved to conduct contagious equine metritis testing; State animal health... Animal and Plant Health Inspection Service Notice of Revision and Request for Extension of Approval of an Information Collection; Importation of Equines Into the United States AGENCY: Animal and Plant...

  3. 76 FR 9281 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts; Revised Carbon...

    Science.gov (United States)

    2011-02-17

    ... for the Lowell CO nonattainment area were approved by EPA on February 19, 2002 (67 FR 7272).) The... requirements, which was codified in 40 CFR part 58. (See 71 FR 61236.) That rule explicitly recognized that, in... replaced. (See 71 FR 61250 and 71 FR 61301.) As described above, this action is proposing to approve...

  4. 76 FR 80410 - Pendency of Request for Approval of Special Withdrawal Liability Rules; the Cultural Institutions...

    Science.gov (United States)

    2011-12-23

    ... CORPORATION Pendency of Request for Approval of Special Withdrawal Liability Rules; the Cultural Institutions... received a request from The Cultural Institutions Pension Plan for approval of a plan amendment providing... Request PBGC received a request, dated January 11, 2011, from The Cultural Institutions Pension...

  5. 30 CFR 885.16 - After OSM approves my grant, what responsibilities do I have?

    Science.gov (United States)

    2010-07-01

    ... TRIBES § 885.16 After OSM approves my grant, what responsibilities do I have? (a) When we award your grant, we send you a written grant agreement stating the terms of the grant. (b) After you are awarded a... 30 Mineral Resources 3 2010-07-01 2010-07-01 false After OSM approves my grant,...

  6. 30 CFR 886.16 - After OSM approves my grant, what responsibilities do I have?

    Science.gov (United States)

    2010-07-01

    ... STATES AND INDIAN TRIBES § 886.16 After OSM approves my grant, what responsibilities do I have? (a) When we award your grant, we send you a written grant agreement stating the terms of the grant. (b) After... 30 Mineral Resources 3 2010-07-01 2010-07-01 false After OSM approves my grant,...

  7. 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)...

  8. 75 FR 64155 - Approval of Implementation Plans of Wisconsin: Nitrogen Oxides Reasonably Available Control...

    Science.gov (United States)

    2010-10-19

    ...EPA is approving revisions to the Wisconsin State Implementation Plan (SIP) submitted on June 12, 2007 and on September 14, 2009. These revisions incorporate provisions related to the implementation of nitrogen oxides (NOX) Reasonably Available Control Technology (RACT) for major sources in the Milwaukee-Racine and Sheboygan County ozone nonattainment areas. EPA is approving SIP......

  9. 15 CFR Schedule I to Part 700 - Approved Programs and Delegate Agencies

    Science.gov (United States)

    2010-01-01

    ... Agencies I Schedule I to Part 700 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign... BASE REGULATIONS DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM Pt. 700, Sched. I Schedule I to Part 700—Approved Programs and Delegate Agencies The programs listed in this schedule have been approved...

  10. 13 CFR 107.510 - SBA approval of Licensee's Investment Adviser/Manager.

    Science.gov (United States)

    2010-01-01

    ... Portfolio; and (2) Indicate the basis for computing Management Expenses. (b) Material change to approved... ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Managing the Operations of a Licensee Management and... management contract. SBA's approval of an Investment Adviser/Manager for one Licensee does not...

  11. 77 FR 52708 - Request to Revise a Currently-Approved Data Collection

    Science.gov (United States)

    2012-08-30

    .... Energy Information Administration Request to Revise a Currently-Approved Data Collection AGENCY: U.S... and comment. SUMMARY: EIA has submitted a request to revise a currently-approved data collection under...). EIA proposes changes to the data collection requirements for the Forms EIA-861, ``Annual...

  12. 50 CFR 403.03 - Review and approval of State request for management authority.

    Science.gov (United States)

    2010-10-01

    ... management authority will not be approved unless it contains the following: (1) The scientific and common... management authority. 403.03 Section 403.03 Wildlife and Fisheries JOINT REGULATIONS (UNITED STATES FISH AND... TRANSFER OF MARINE MAMMAL MANAGEMENT AUTHORITY TO STATES § 403.03 Review and approval of State request...

  13. 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):...

  14. 7 CFR 319.56-4 - Approval of certain fruits and vegetables for importation.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Approval of certain fruits and vegetables for importation. 319.56-4 Section 319.56-4 Agriculture Regulations of the Department of Agriculture (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOREIGN QUARANTINE NOTICES Fruits and Vegetables § 319.56-4 Approval of...

  15. 75 FR 2915 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2010-01-19

    ... COMMISSION Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...), 74 FR 64783 (``Notice''). II. Description of Proposal The Exchange proposes to amend its Schedule of... No. 56254 (August 15, 2007), 72 FR 47104 (August 22, 2007) (approving SR-ISE-2007-70). \\5\\...

  16. 76 FR 51123 - Agency Information Collection Activities; Submission for OMB Review and Approval; Joint Comment...

    Science.gov (United States)

    2011-08-17

    ... maintain thorough documentation of ICAAP. Section 43 specifies that boards of directors must approve the bank's ICAAP, review it on a regular basis, and approve any changes. Boards of ] directors also are... screening in order to inspect and photocopy comments. Board: You may submit comments, identified by FR...

  17. 46 CFR 35.03-5 - Approved types of work vests-TB/ALL.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Approved types of work vests-TB/ALL. 35.03-5 Section 35.03-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY TANK VESSELS OPERATIONS Work Vests § 35.03-5 Approved types of work vests—TB/ALL. (a) Each buoyant work vest carried under the...

  18. 46 CFR 196.34-5 - Approved types of work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Approved types of work vests. 196.34-5 Section 196.34-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OCEANOGRAPHIC RESEARCH VESSELS OPERATIONS Work Vests § 196.34-5 Approved types of work vests. (a) Each buoyant work vest carried under...

  19. 46 CFR 78.36-5 - Approved types of work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 3 2010-10-01 2010-10-01 false Approved types of work vests. 78.36-5 Section 78.36-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PASSENGER VESSELS OPERATIONS Work Vests § 78.36-5 Approved types of work vests. (a) Each buoyant work vest carried under the...

  20. 46 CFR 97.34-5 - Approved types of work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Approved types of work vests. 97.34-5 Section 97.34-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) CARGO AND MISCELLANEOUS VESSELS OPERATIONS Work Vests § 97.34-5 Approved types of work vests. (a) Each buoyant work vest carried under...