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

Science.gov (United States)

2010-01-26

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

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

Directory of Open Access Journals (Sweden)

José C. Rosatti

2006-12-01

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

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

Science.gov (United States)

2012-12-17

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

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

Science.gov (United States)

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

2017-11-01

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

Vad är den främst avgörande faktorn vid privatkundens val av marginalbank? : en studie om hur demografiska skillnader påverkar privatkunders val av marginalbank samt se hur deras val kan användas vid segmentering

OpenAIRE

Lindh, Jenni; Persson, Frida

2012-01-01

Syfte: Syftet med detta examensarbete är att förklara vad som är den främst avgörande faktorn vid privatkundens val av marginalbank, genom att jämföra med demografiska variabler samt hur deras val kan användas vid segmentering. Dessutom vill vi titta på vilka typer av banker privatkunder har. Metod: För att nå fram till resultat för analysen har ett positivistiskt angreppssätt och en deduktiv ansats använts. Det empiriska materialet är baserat på en enkätundersökning gjord på personer i Hässl...

Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

Science.gov (United States)

Asano, K; Tanaka, A; Sato, T; Uyama, Y

2013-08-01

Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

Improving Fraudster Detection in Online Auctions by Using Neighbor-Driven Attributes

Directory of Open Access Journals (Sweden)

Jun-Lin Lin

2015-12-01

Full Text Available Online auction websites use a simple reputation system to help their users to evaluate the trustworthiness of sellers and buyers. However, to improve their reputation in the reputation system, fraudulent users can easily deceive the reputation system by creating fake transactions. This inflated-reputation fraud poses a major problem for online auction websites because it can lead legitimate users into scams. Numerous approaches have been proposed in the literature to address this problem, most of which involve using social network analysis (SNA to derive critical features (e.g., k-core, center weight, and neighbor diversity for distinguishing fraudsters from legitimate users. This paper discusses the limitations of these SNA features and proposes a class of SNA features referred to as neighbor-driven attributes (NDAs. The NDAs of users are calculated from the features of their neighbors. Because fraudsters require collusive neighbors to provide them with positive ratings in the reputation system, using NDAs can be helpful for detecting fraudsters. Although the idea of NDAs is not entirely new, experimental results on a real-world dataset showed that using NDAs improves classification accuracy compared with state-of-the-art methods that use the k-core, center weight, and neighbor diversity.

Central site monitoring: results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection.

Science.gov (United States)

Lindblad, Anne S; Manukyan, Zorayr; Purohit-Sheth, Tejashri; Gensler, Gary; Okwesili, Paul; Meeker-O'Connell, Ann; Ball, Leslie; Marler, John R

2014-04-01

Site monitoring and source document verification account for 15%-30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification. To determine whether a central review by statisticians using data submitted to the Food and Drug Administration (FDA) by clinical trial sponsors can identify problem sites and trials that failed FDA site inspections. An independent Analysis Center (AC) analyzed data from four anonymous new drug applications (NDAs) where FDA had performed site inspections overseen by FDA's Office of Scientific Investigations (OSI). FDA team members in the OSI chose the four NDAs from among all NDAs with data in Study Data Tabulation Model (SDTM) format. Two of the NDAs had data that OSI had deemed unreliable in support of the application after FDA site inspections identified serious data integrity problems. The other two NDAs had clinical data that OSI deemed reliable after site inspections. At the outset, the AC knew only that the experimental design specified two NDAs with significant problems. FDA gave the AC no information about which NDAs had problems, how many sites were inspected, or how many were found to have problems until after the AC analysis was complete. The AC evaluated randomization balance, enrollment patterns, study visit scheduling, variability of reported data, and last digit reference. The AC classified sites as 'High Concern', 'Moderate Concern', 'Mild Concern', or 'No Concern'. The AC correctly identified the two NDAs with data deemed unreliable by OSI. In addition, central data analysis correctly identified 5 of 6 (83%) sites for which FDA recommended rejection of data and 13 of 15 sites (87%) for which any regulatory deviations were

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

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

Science.gov (United States)

2012-09-01

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

NASA Data Acquisition System Software Development for Rocket Propulsion Test Facilities

Science.gov (United States)

Herbert, Phillip W., Sr.; Elliot, Alex C.; Graves, Andrew R.

2015-01-01

Current NASA propulsion test facilities include Stennis Space Center in Mississippi, Marshall Space Flight Center in Alabama, Plum Brook Station in Ohio, and White Sands Test Facility in New Mexico. Within and across these centers, a diverse set of data acquisition systems exist with different hardware and software platforms. The NASA Data Acquisition System (NDAS) is a software suite designed to operate and control many critical aspects of rocket engine testing. The software suite combines real-time data visualization, data recording to a variety formats, short-term and long-term acquisition system calibration capabilities, test stand configuration control, and a variety of data post-processing capabilities. Additionally, data stream conversion functions exist to translate test facility data streams to and from downstream systems, including engine customer systems. The primary design goals for NDAS are flexibility, extensibility, and modularity. Providing a common user interface for a variety of hardware platforms helps drive consistency and error reduction during testing. In addition, with an understanding that test facilities have different requirements and setups, the software is designed to be modular. One engine program may require real-time displays and data recording; others may require more complex data stream conversion, measurement filtering, or test stand configuration management. The NDAS suite allows test facilities to choose which components to use based on their specific needs. The NDAS code is primarily written in LabVIEW, a graphical, data-flow driven language. Although LabVIEW is a general-purpose programming language; large-scale software development in the language is relatively rare compared to more commonly used languages. The NDAS software suite also makes extensive use of a new, advanced development framework called the Actor Framework. The Actor Framework provides a level of code reuse and extensibility that has previously been difficult

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

Directory of Open Access Journals (Sweden)

Marina de Fátima Vilela

2005-08-01

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

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

Science.gov (United States)

Cotten, J H

1994-01-01

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

Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: a systematic review.

Science.gov (United States)

Yu, Jingjing; Ritchie, Tasha K; Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle

2014-12-01

The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition. Copyright © 2014 by The American Society for Pharmacology and Experimental Therapeutics.

Risk evaluation and mitigation strategies (REMS): educating the prescriber.

Science.gov (United States)

Nicholson, Susan C; Peterson, Janet; Yektashenas, Behin

2012-02-01

The US FDA Amendments Act of 2007 was signed into law on 27 September 2007. A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question exists as to whether the benefits of a drug outweigh its risks. REMS constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients. This applies to existing drugs on the market, new drug applications (NDAs), abbreviated NDAs (generics) and biologics licence applications. REMS represent an 'upgrade' from previously required risk minimization action plans, based on the strengthening of FDA powers of authority and enforceability to incur monetary penalties against individuals representing the pharmaceutical industry who fail to comply. For illustrative purposes, we chose the drug romiplostim (Nplate®) to present an REMS, as all components were utilized to help assuage risks associated with the drug. Romiplostim is an FDA-approved drug used to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura that has a significant adverse safety profile based on the risk of changes in bone marrow reticulin formation and bone marrow fibroses, and other associated risks. This review of current REMS policy is intended to provide the prescriber with a better understanding of current modalities in FDA-mandated drug safety programmes, which will impact day-to-day healthcare provider practices.

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

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

2010-04-01

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

Redfield Energy Approval

Science.gov (United States)

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

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

Science.gov (United States)

DiMasi, Joseph A

2013-06-01

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

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

Science.gov (United States)

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

2017-01-01

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

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

Science.gov (United States)

2010-07-01

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

Drugs Approved for Breast Cancer

Science.gov (United States)

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

Drugs Approved for Thyroid Cancer

Science.gov (United States)

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

Network data analysis server (NDAS) prototype development

International Nuclear Information System (INIS)

Marka, Szabolcs; Mours, Benoit; Williams, Roy

2002-01-01

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

Implications of the Food, Drug, and Cosmetic Act on the quality assurance of radiopharmaceuticals used in the United States

International Nuclear Information System (INIS)

Kishore, R.; Sheinin, E.B.

1990-01-01

The drug sections of the Federal Food, Drug, and Cosmetic Act (Title 21 U.S.C.) are intended to assure the consumer that drugs are safe and effective for their intended use. The Act requires that new drugs be approved by the FDA before they go on the market. The regulations for the new drug review process, are contained in the Code of Federal Regulations (CFR) Title 21, sections 312 for Investigational New Drugs (INDs), 314 for New Drug Applications (NDAs). Section 361 deals with radioactive drugs for certain research (RDR) uses. The regulations require that sufficient information be provided on the acceptable limits and the analytical methods used for the assurance of the identity, strength, quality, purity and the stability of the new drug as well as the raw materials used in the preparation of the new drug. The impact of the Act on the control of radiopharmaceutical products will be discussed

Easy encryption for CERN laptops

CERN Multimedia

Computer Security Team

2014-01-01

The number of laptops stolen from or lost by CERN staff and users is not negligible. On average, four to five devices are reported lost or stolen to the CERN Fire Brigade every month.   The real number might be even higher as not everyone is aware that such thefts/losses should be reported in this way. Along with each laptop, private e-mails and personal documents, as well as MARS forms, contracts, NDAs, etc. are also lost. Fortunately, CERN has not lost any sensitive data so far (unlike other companies). In parallel with the approval by the Enlarged Directorate at its latest session of the development of a CERN-wide Data Protection Policy, the IT Department has prepared measures allowing you to protect the data on your laptop using full hard-disk encryption. While the word “encryption” might sounds complicated, the IT Department has fully automated the encryption process. For centrally managed Windows PCs, you just have to install the corresponding CMF package (“M...

Electronic Approval of Invoices (AEF)

CERN Document Server

2004-01-01

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

Marketing Approval of Ethical Kampo Medicines.

Science.gov (United States)

Hakamatsuka, Takashi

2017-01-01

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

40 CFR 145.31 - Approval process.

Science.gov (United States)

2010-07-01

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

40 CFR 52.2122 - Approval status.

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

2010-08-10

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

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

Science.gov (United States)

2013-09-05

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

40 CFR 52.1772 - Approval status.

Science.gov (United States)

2010-07-01

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

Jalgpallisõjal polnud jalgpalliga mingit seost / Allan Espenberg

Index Scriptorium Estoniae

Espenberg, Allan

2005-01-01

14. juulil 1969 ründas El Salvador riigipea Fidel Sanchez Hernandeze korraldusel naaberriiki Hondurast. Rahulepinguni jõuti pärast ülikeerukaid ja mitmel korral katkenud läbirääkimisi alles 1980. aastal

9 CFR 147.52 - Approved tests.

Science.gov (United States)

2010-01-01

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

30 CFR 14.10 - Post-approval product audit.

Science.gov (United States)

2010-07-01

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

7 CFR 1710.406 - Loan approval.

Science.gov (United States)

2010-01-01

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

40 CFR 123.61 - Approval process.

Science.gov (United States)

2010-07-01

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

Merekultuuriaasta haridusprogramm pälvis suurt huvi / Jane Niit

Index Scriptorium Estoniae

Niit, Jane

2016-01-01

Märtsist maini rändas TTÜ Eesti mereakadeemia koordineeritav mereteemaline haridusprogramm mööda Eesti kõiki maakondi ning vabatahtlikud külalisõpetajad pidasid kokku 330 külalistundi 147 koolis ja 18 asutuses

An Orientation Sensor-Based Head Tracking System for Driver Behaviour Monitoring

Directory of Open Access Journals (Sweden)

Yifan Zhao

2017-11-01

Full Text Available Although at present legislation does not allow drivers in a Level 3 autonomous vehicle to engage in a secondary task, there may become a time when it does. Monitoring the behaviour of drivers engaging in various non-driving activities (NDAs is crucial to decide how well the driver will be able to take over control of the vehicle. One limitation of the commonly used face-based head tracking system, using cameras, is that sufficient features of the face must be visible, which limits the detectable angle of head movement and thereby measurable NDAs, unless multiple cameras are used. This paper proposes a novel orientation sensor based head tracking system that includes twin devices, one of which measures the movement of the vehicle while the other measures the absolute movement of the head. Measurement error in the shaking and nodding axes were less than 0.4°, while error in the rolling axis was less than 2°. Comparison with a camera-based system, through in-house tests and on-road tests, showed that the main advantage of the proposed system is the ability to detect angles larger than 20° in the shaking and nodding axes. Finally, a case study demonstrated that the measurement of the shaking and nodding angles, produced from the proposed system, can effectively characterise the drivers’ behaviour while engaged in the NDAs of chatting to a passenger and playing on a smartphone.

40 CFR 52.1323 - Approval status.

Science.gov (United States)

2010-07-01

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

30 CFR 14.7 - Approval marking and distribution records.

Science.gov (United States)

2010-07-01

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

Drugs Approved for Kidney (Renal Cell) Cancer

Science.gov (United States)

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

Russia warns NATO on presence in Eastern Europe / Lorne Cook

Index Scriptorium Estoniae

Cook, Lorne

2004-01-01

Vene kaitseminister Sergei Ivanov kutsus Müncheni rahvusvahelisel julgeolekufoorumil NATO-t hoiduma kohaloleku laiendamisest Poolasse ja Balti riikidesse. USA senaator John McCain ründas Venemaad reageeringute eest, mis esitavad väljakutse naabrite demokraatlikule ja territoriaalsele terviklikkusele

Trial endpoints for drug approval in oncology: Chemoprevention.

Science.gov (United States)

Beitz, J

2001-04-01

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

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

Science.gov (United States)

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

2015-01-01

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

40 CFR 52.2352 - Change to approved plan.

Science.gov (United States)

2010-07-01

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

The Evolution of Approval Services.

Science.gov (United States)

Warzala, Martin

1994-01-01

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

Approval plans issues and innovations

CERN Document Server

Katz, Linda S

2013-01-01

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

48 CFR 750.7105 - Approving authorities.

Science.gov (United States)

2010-10-01

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

Vedolizumab: first global approval.

Science.gov (United States)

Poole, Raewyn M

2014-07-01

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

19 CFR 115.55 - Termination of approval.

Science.gov (United States)

2010-04-01

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

20 CFR 617.22 - Approval of training.

Science.gov (United States)

2010-04-01

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

Vene politoloog ründas presidenti / Alo Raun

Index Scriptorium Estoniae

Raun, Alo, 1981-

2005-01-01

Vene politoloogi, Kaukaasia demokraatiainstituudi direktori Valeri Tursunovi hinnangul peaks Euroopa Nõukogu Parlamentaarne Assamblee teiste seas hukka mõistma ka Eesti presidendi Arnold Rüütli, kuna ta töötas aastaid ENSV Ülemnõukogu presiidiumi esimehena. Ilmunud ka Sakala, (2005/Dec/28), lk. 8 ; Postimees : na russkom jazõke (2005/Dec/28), lk. 2 ; Pärnu Postimees (2005/Dec/29) lk. 6

76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Science.gov (United States)

2011-12-02

... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

30 CFR 75.1108 - Approved conveyor belts.

Science.gov (United States)

2010-07-01

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

45 CFR 1340.13 - Approval of applications.

Science.gov (United States)

2010-10-01

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

27 CFR 5.55 - Certificates of label approval.

Science.gov (United States)

2010-04-01

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

46 CFR 188.10-3 - Approved container.

Science.gov (United States)

2010-10-01

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

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

76 FR 54473 - Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

Science.gov (United States)

2011-09-01

... (formerly Docket No. 00D-0892)] Guidance on Positron Emission Tomography Drug Applications-- Content and... the availability of a guidance for industry entitled ``PET Drug Applications--Content and Format for... guidance for industry entitled ``PET Drug Applications--Content and Format for NDAs and ANDAs.'' The...

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

Science.gov (United States)

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

2015-01-01

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

76 FR 76168 - Regulatory Site Visit Training Program

Science.gov (United States)

2011-12-06

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

76 FR 4919 - Regulatory Site Visit Training Program

Science.gov (United States)

2011-01-27

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2007-05-15

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

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

Science.gov (United States)

Fountaine, Charles A.; And Others

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

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

Science.gov (United States)

2013-11-07

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

Eestimaa aadlimehest seikleja reis Egiptusesse ja Nuubiasse / Sergei Stadnikov

Index Scriptorium Estoniae

Stadnikov, Sergei, 1956-

2012-01-01

Alexander von Uexküll rändas koos prantsuse oreintalisti Théodore-Antoine-Lopez de la SaiteTrinité de Lessepsiga. Nad jõudsid üsna kaugele Alam-Nuubia sügavusse. Esimese eestimaalasena nägi Alexander von Uexküll Abu Simbeli templeid

76 FR 6144 - Positron Emission Tomography; Notice of Public Meeting; Request for Comments

Science.gov (United States)

2011-02-03

... Administration (FDA) is announcing a public meeting to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose (FDG) 18 injection, ammonia N 13... ammonia N 13 injection can be considered safe and effective for the indications noted previously, although...

Finite-Time Stabilization for a Class of Nonlinear Differential-Algebraic Systems Subject to Disturbance

Directory of Open Access Journals (Sweden)

Xiaohui Mo

2017-01-01

Full Text Available In this paper, finite-time stabilization problem for a class of nonlinear differential-algebraic systems (NDASs subject to external disturbance is investigated via a composite control manner. A composite finite-time controller (CFTC is proposed with a three-stage design procedure. Firstly, based on the adding a power integrator technique, a finite-time control (FTC law is explicitly designed for the nominal NDAS by only using differential variables. Then, by using homogeneous system theory, a continuous finite-time disturbance observer (CFTDO is constructed to estimate the disturbance generated by an exogenous system. Finally, a composite controller which consists of a feedforward compensation part based on CFTDO and the obtained FTC law is proposed. Rigorous analysis demonstrates that not only the proposed composite controller can stabilize the NDAS in finite time, but also the proposed control scheme exhibits nominal performance recovery property. Simulation examples are provided to illustrate the effectiveness of the proposed control approach.

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

Science.gov (United States)

Mattingly, T Joseph; Simoni-Wastila, Linda

2017-10-01

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

49 CFR 1522.109 - TSA review and approval.

Science.gov (United States)

2010-10-01

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

49 CFR 1522.115 - Renewal of TSA approval.

Science.gov (United States)

2010-10-01

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

29 CFR 1952.157 - Changes to approved plan.

Science.gov (United States)

2010-07-01

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

48 CFR 2922.103-4 - Approvals.

Science.gov (United States)

2010-10-01

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

38 CFR 21.7220 - Course approval.

Science.gov (United States)

2010-07-01

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

33 CFR 115.70 - Advance approval of bridges.

Science.gov (United States)

2010-07-01

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

E-Approval Plans in Research Libraries

Science.gov (United States)

Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

2014-01-01

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

Premarket Approvals (PMA)

Data.gov (United States)

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

Magnetic Properties of Nd-Group V Compounds

DEFF Research Database (Denmark)

Bak, Poul Erik; Lindgård, Per-Anker

1973-01-01

The Nd monopnictides NdP, NdAs and NdSb are simple cubic type I antiferromagnets in which the crystal-field splitting is larger than the exchange energy. The magnetic properties are calculated by means of a mean-field theory including crystal-field and magnetoelastic effects. The calculations are...

76 FR 56201 - Prescription Drug User Fee Act; Public Meeting

Science.gov (United States)

2011-09-12

... safety and effectiveness of new drug applications (NDAs) and biologics license applications (BLAs) to be... public health, often targeted at severe illnesses where few or no therapeutic options exist. PDUFA funds... uncertainty for patients and health professionals. To do this, FDA must work quickly to conduct its own meta...

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

Science.gov (United States)

2010-05-24

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

7 CFR 1710.105 - State regulatory approvals.

Science.gov (United States)

2010-01-01

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

Perspectives used for gaining approval of budgets.

Science.gov (United States)

Franks-Joiner, G L

1990-01-01

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

78 FR 2315 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-01-10

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

78 FR 15402 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-11

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

78 FR 11947 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-02-20

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

78 FR 17281 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-20

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

77 FR 16317 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-03-20

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

77 FR 66909 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-11-07

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

77 FR 21143 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-09

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

77 FR 25010 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-26

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

77 FR 34455 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-06-11

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

77 FR 55891 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

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

77 FR 55892 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

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

77 FR 59239 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-26

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

Applying for ethical approval for research: the main issues.

Science.gov (United States)

Gelling, Leslie

2016-01-13

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

Poet Marion Approval

Science.gov (United States)

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

Poet Portland Approval

Science.gov (United States)

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

Poet Alexandria Approval

Science.gov (United States)

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

Poet Laddonia Approval

Science.gov (United States)

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

Poet Fostoria Approval

Science.gov (United States)

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

Immunotherapy Combination Approved for Advanced Kidney Cancer

Science.gov (United States)

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

Poet Leipsic Approval

Science.gov (United States)

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

Guidance for package approvals in the United Kingdom

International Nuclear Information System (INIS)

Morgan-Warren, E.J.

2004-01-01

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

Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

Science.gov (United States)

Banerjee, Tannista; Nayak, Arnab

2017-01-01

This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

45 CFR 95.611 - Prior approval conditions.

Science.gov (United States)

2010-10-01

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

8 CFR 207.6 - Control over approved refugee numbers.

Science.gov (United States)

2010-01-01

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

47 CFR 400.5 - Approval and award.

Science.gov (United States)

2010-10-01

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

13 CFR 302.18 - Post-approval requirements.

Science.gov (United States)

2010-01-01

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

12 CFR 614.4470 - Loans subject to bank approval.

Science.gov (United States)

2010-01-01

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

NDAS NASA Data Acquisition Software Suite- Version 2.0

Data.gov (United States)

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

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

48 CFR 52.222-16 - Approval of Wage Rates.

Science.gov (United States)

2010-10-01

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

7 CFR 1717.609 - RUS approval of general manager.

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... general manager of the borrower's system, such approval is hereby granted provided that the borrower is in...

28 CFR 551.11 - Authority to approve a marriage.

Science.gov (United States)

2010-07-01

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

2016 in review: FDA approvals of new molecular entities.

Science.gov (United States)

Griesenauer, Rebekah H; Kinch, Michael S

2017-11-01

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

24 CFR 886.107 - Approval of applications.

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2013-12-04

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

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

Science.gov (United States)

2010-05-14

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

New Breast Cancer Treatment Approved | NIH MedlinePlus the Magazine

Science.gov (United States)

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

FDA approves efavirenz. Food and Drug Administration.

Science.gov (United States)

Highleyman, L

1998-10-01

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

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

Science.gov (United States)

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

2011-04-20

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

14 CFR 21.8 - Approval of articles.

Science.gov (United States)

2010-01-01

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

48 CFR 1819.7203 - Mentor approval process.

Science.gov (United States)

2010-10-01

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

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

Science.gov (United States)

Zenz, Michael; Zenz, Julia; Grieger, Maximilian

2018-06-05

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

27 CFR 4.50 - Certificates of label approval.

Science.gov (United States)

2010-04-01

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

14 CFR 21.609 - Approval for deviation.

Science.gov (United States)

2010-01-01

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

Ordinal Position, Approval Motivation, and Interpersonal Attraction

Science.gov (United States)

Nowicki, Stephen, Jr.

1971-01-01

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

Drugs Approved for Neuroblastoma

Science.gov (United States)

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

42 CFR 102.73 - Approval of benefits.

Science.gov (United States)

2010-10-01

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

76 FR 66117 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2011-10-25

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

76 FR 53526 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2011-08-26

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

76 FR 42159 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2011-07-18

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

77 FR 4859 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-01-31

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

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.

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

OpenAIRE

Tatsuyoshi Saijo; Yoshitaka Okano; Takafumi Yamakawa

2015-01-01

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

REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

International Nuclear Information System (INIS)

Markman, D.W.

1999-01-01

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

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

Science.gov (United States)

2012-11-29

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

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

Science.gov (United States)

2011-05-06

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

42 CFR 8.6 - Withdrawal of approval of accreditation bodies.

Science.gov (United States)

2010-10-01

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

Establishment approval in international trade of animal products

NARCIS (Netherlands)

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

2012-01-01

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

Poet North Manchester Approval

Science.gov (United States)

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

Cognitive Properties of Approval Voting : an Experimental Approach

Directory of Open Access Journals (Sweden)

Krzysztof Przybyszewski

2011-01-01

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

7 CFR 1717.159 - Applications for RUS approvals of mergers.

Science.gov (United States)

2010-01-01

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

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

Science.gov (United States)

2010-01-01

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

30 CFR 250.119 - Will MMS approve subsurface gas storage?

Science.gov (United States)

2010-07-01

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

75 FR 36301 - Review and Approval of Projects

Science.gov (United States)

2010-06-25

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

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

African Journals Online (AJOL)

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

29 CFR 1952.10 - Requirements for approval of State posters.

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

2010-10-01

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

Linaclotide: first global approval.

Science.gov (United States)

McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

2012-11-12

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

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

Science.gov (United States)

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

2013-10-01

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

Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

Data.gov (United States)

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

44 CFR 78.9 - Planning grant approval process.

Science.gov (United States)

2010-10-01

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

7 CFR 1703.121 - Approved purposes for grants.

Science.gov (United States)

2010-01-01

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

Dabrafenib Plus Trametinib Approved for Melanoma, Thyroid Cancer

Science.gov (United States)

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

Drugs Approved for Leukemia

Science.gov (United States)

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

Poet Lake Crystal Approval

Science.gov (United States)

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

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

Science.gov (United States)

2011-01-25

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

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

Science.gov (United States)

2010-09-07

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

22 CFR 96.63 - Renewal of accreditation or approval.

Science.gov (United States)

2010-04-01

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

Clone of EPA Approved Regulations in the Texas SIP

Science.gov (United States)

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

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Directory of Open Access Journals (Sweden)

Lin-Chau Chang

Full Text Available Standardised MedDRA Queries (SMQs have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA and Biologics License Application (BLA submissions to the United States Food and Drug Administration (USFDA.We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed.A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59% of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18% of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated. Most searches (75% of 227 searches with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process.SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Science.gov (United States)

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

2017-01-01

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

CORN, LP Goldfield Approval

Science.gov (United States)

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

HSE statement on the approval of dosimetry services

International Nuclear Information System (INIS)

1992-09-01

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

Avelumab: First Global Approval.

Science.gov (United States)

Kim, Esther S

2017-05-01

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

5 CFR 1320.16 - Delegation of approval authority.

Science.gov (United States)

2010-01-01

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

Waste Feed Delivery Environmental Permits and Approvals Plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

2000-01-01

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

34 CFR 668.144 - Application for test approval.

Science.gov (United States)

2010-07-01

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

50 CFR 37.22 - Approval of exploration plan.

Science.gov (United States)

2010-10-01

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

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

Science.gov (United States)

2010-01-01

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

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

Science.gov (United States)

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

38 CFR 21.9765 - Program of education approval.

Science.gov (United States)

2010-07-01

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

Waste Feed Delivery Environmental Permits and Approvals Plan

Energy Technology Data Exchange (ETDEWEB)

TOLLEFSON, K.S.

2000-01-18

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

Drugs Approved for Rhabdomyosarcoma

Science.gov (United States)

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

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

Science.gov (United States)

Newson, Ainsley J; Lipworth, Wendy

2015-12-01

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

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

Science.gov (United States)

2011-04-01

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

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

Science.gov (United States)

2010-06-22

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

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

Science.gov (United States)

2010-10-01

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

Neratinib: First Global Approval.

Science.gov (United States)

Deeks, Emma D

2017-10-01

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

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

Science.gov (United States)

2010-07-01

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

Miracle drug: Brazil approves never-tested cancer medicine.

Science.gov (United States)

Kuchenbecker, Ricardo S; Mota, Daniel M

2017-07-01

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

75 FR 29803 - Agency Information Collection Activity Seeking OMB Approval

Science.gov (United States)

2010-05-27

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

Drugs Approved for Pancreatic Cancer

Science.gov (United States)

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

Drugs Approved for Lung Cancer

Science.gov (United States)

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

Drugs Approved for Bladder Cancer

Science.gov (United States)

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

Electronic Voucher Approval - Financial Management

Data.gov (United States)

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

30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

Science.gov (United States)

2010-07-01

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

12 CFR 918.5 - Approval by Finance Board.

Science.gov (United States)

2010-01-01

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

Drugs Approved for Esophageal Cancer

Science.gov (United States)

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

Drugs Approved for Kaposi Sarcoma

Science.gov (United States)

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

Drugs Approved for Skin Cancer

Science.gov (United States)

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

Drugs Approved for Vulvar Cancer

Science.gov (United States)

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

Drugs Approved for Bone Cancer

Science.gov (United States)

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

Drugs Approved for Malignant Mesothelioma

Science.gov (United States)

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

Drugs Approved for Endometrial Cancer

Science.gov (United States)

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

Is It Really FDA Approved?

Science.gov (United States)

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

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

Science.gov (United States)

2013-11-25

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

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

Science.gov (United States)

2010-06-22

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

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

Science.gov (United States)

2013-08-14

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

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

Science.gov (United States)

2010-06-09

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

Drugs Approved for Liver Cancer

Science.gov (United States)

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

Drugs Approved for Penile Cancer

Science.gov (United States)

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

Hyapproval : final handbook for approval of hydrogen refuelling stations

NARCIS (Netherlands)

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

2006-01-01

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

38 CFR 21.4263 - Approval of flight training courses.

Science.gov (United States)

2010-07-01

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

Drugs Approved for Vaginal Cancer

Science.gov (United States)

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

7 CFR 1735.62 - Approval of acquisitions and mergers.

Science.gov (United States)

2010-01-01

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

5 CFR 7401.102 - Prior approval for outside employment.

Science.gov (United States)

2010-01-01

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

Reporting ethics committee approval in public administration research.

Science.gov (United States)

Jordan, Sara R; Gray, Phillip W

2014-03-01

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

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

Science.gov (United States)

2012-08-13

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

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

Science.gov (United States)

2010-11-22

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

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

Science.gov (United States)

2010-07-01

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

40 CFR 80.93 - Individual baseline submission and approval.

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

2012-02-29

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

75 FR 15639 - Revision of the Requirements for Constituent Materials

Science.gov (United States)

2010-03-30

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

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

Science.gov (United States)

2013-04-08

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

Drugs Approved for Wilms Tumor

Science.gov (United States)

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

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

Science.gov (United States)

2010-05-04

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

7 CFR 1735.90 - Preliminary approvals.

Science.gov (United States)

2010-01-01

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

32 CFR 736.7 - Approval by the Attorney General.

Science.gov (United States)

2010-07-01

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

5 CFR 6601.102 - Prior approval for outside employment.

Science.gov (United States)

2010-01-01

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

24 CFR 990.145 - Dwelling units with approved vacancies.

Science.gov (United States)

2010-04-01

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

OMB Recommended vs Approved Operating Budget

Data.gov (United States)

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

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

Directory of Open Access Journals (Sweden)

Bhaven C. Kataria

2013-01-01

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

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

Science.gov (United States)

2010-01-01

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

Project W-314 phase I environmental permits and approvals plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

1999-01-01

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

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2013-05-21

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

Alcohol addiction - the safety of available approved treatment options.

Science.gov (United States)

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

2018-02-01

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

Drugs Approved for Cervical Cancer

Science.gov (United States)

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

Drugs Approved for Testicular Cancer

Science.gov (United States)

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

Drugs Approved for Hodgkin Lymphoma

Science.gov (United States)

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

Drugs Approved for Myeloproliferative Neoplasms

Science.gov (United States)

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

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

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

2010-01-01

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

21 CFR 610.53 - Dating periods for licensed biological products.

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-04-01

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

Credit Risk Management - Loan Approval Process

Directory of Open Access Journals (Sweden)

Lulzim Rashiti

2016-03-01

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

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

Science.gov (United States)

2012-08-06

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

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

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

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

2010-01-01

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

7 CFR 1425.4 - Approval.

Science.gov (United States)

2010-01-01

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

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

Science.gov (United States)

Decter-Frain, Ari; Frimer, Jeremy A

2016-01-01

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

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

Directory of Open Access Journals (Sweden)

Ari eDecter-Frain

2016-02-01

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

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

Science.gov (United States)

2010-09-16

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

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

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

Greene, Louise Eleanor; Bearn, David R

2013-06-01

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

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

Directory of Open Access Journals (Sweden)

Laura M McNamee

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

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

Science.gov (United States)

2010-01-01

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

23 CFR 420.209 - What are the conditions for approval?

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-11-22

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

Drugs Approved for Multiple Myeloma

Science.gov (United States)

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

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

Science.gov (United States)

2010-10-15

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

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

Science.gov (United States)

2010-09-16

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

Drugs Approved for Stomach (Gastric) Cancer

Science.gov (United States)

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

Drugs Approved for Soft Tissue Sarcoma

Science.gov (United States)

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

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.

25 CFR 225.28 - Approval of amendments to minerals agreements.

Science.gov (United States)

2010-04-01

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

28 CFR 2.206 - Travel approval and transfers of supervision.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval and transfers of supervision. 2.206 Section 2.206 Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION AND RECOMMITMENT OF PRISONERS, YOUTH OFFENDERS, AND JUVENILE DELINQUENTS District of Columbia Supervised Releasees § 2.206 Travel approval and...

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

Science.gov (United States)

Decter-Frain, Ari; Frimer, Jeremy A.

2016-01-01

What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a “big data” approach—the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition. PMID:26941691

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

Science.gov (United States)

2010-08-17

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

Drugs Approved for Gastrointestinal Stromal Tumors

Science.gov (United States)

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

19 CFR 115.42 - Approval plates.

Science.gov (United States)

2010-04-01

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

Page | 133 LEGISLATIVE APPROVAL OF EXECUTIVE ...

African Journals Online (AJOL)

Fr. Ikenga

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

13 CFR 108.140 - SBA approval of initial Management Expenses.

Science.gov (United States)

2010-01-01

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

13 CFR 108.380 - Final approval as a NMVC Company.

Science.gov (United States)

2010-01-01

... VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.380 Final approval as a... amount of Regulatory Capital set forth in its application, pursuant to § 108.310(a)(1); and (B) The... at least 30 percent of its Regulatory Capital if the Conditionally Approved NMVC Company— (i) Already...

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

Science.gov (United States)

2013-10-25

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

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

Science.gov (United States)

2013-10-25

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

FDA Approves First Therapeutic Cancer Vaccine

Science.gov (United States)

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

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

Science.gov (United States)

2010-09-03

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

Research ethics board approval for an international thromboprophylaxis trial.

Science.gov (United States)

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

2012-06-01

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

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)

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

Science.gov (United States)

2010-10-01

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

Drugs@FDA: FDA Approved Drug Products

Science.gov (United States)

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

In-use vs. type-approval fuel consumption of current passenger cars in Europe

International Nuclear Information System (INIS)

Ntziachristos, L.; Mellios, G.; Tsokolis, D.; Keller, M.; Hausberger, S.; Ligterink, N.E.; Dilara, P.

2014-01-01

In-use fuel consumption data of 924 passenger cars (611 petrol, 313 diesel) were collected from various European sources and were evaluated in comparison to their corresponding type-approval values. The analysis indicated that the average in-use fuel consumption was higher than the type-approval one by 11% for petrol cars and 16% for diesel cars. Comparison of this dataset with the Travelcard database in the Netherlands showed that the deviation increased for late model years and in particular for cars with low type-approval values. The deviation was higher than 60% for vehicles registered in 2012 within the 90–100 gCO 2 /km bin. Unrealistic vehicle resistances used in type-approval were identified as one of the prime reasons of the difference. A simplified linear model developed in the study may be used to predict in-use fuel consumption based on data publicly available. The model utilizes the fuel consumption measured in type-approval, the mass, and the engine capacity to provide in-use fuel consumption. This may be either used to correct fuel consumption factors currently utilized by emission models (e.g. COPERT, HBEFA, VERSIT+, and others) or could be used independently to make projections on how fuel consumption may develop on the basis of changing future passenger cars characteristics. - Highlights: • In-use fuel consumption of petrol and diesel passenger cars is 11% and 16% higher than type-approval, respectively. • The relative difference between in-use and type-approval increases for late model and vehicles with low consumption. • Unrealistically low vehicle resistances are identified as a prime reason of low type-approval fuel consumption. • A model developed predicts in-use consumption on the basis of type-approval consumption, vehicle mass, and engine capacity

The approval process for biosimilar erythropoiesis-stimulating agents.

Science.gov (United States)

Wish, Jay B

2014-09-05

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

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

Science.gov (United States)

2010-10-01

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

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

Science.gov (United States)

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

2018-02-01

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

Report on Contractual Flow Down Provisions in the Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS)

Science.gov (United States)

2017-11-01

Each subcontract required non- disclosure agreements (NDAs) with the prime. 5 2. Flow-Down Clauses FAR/DFARS flow-down clauses derive from the...unusual for the prime contractor to only account for 10–20 percent of the total MDAP cost. Subcontractors—inclusive of basic parts and material suppliers...that feed the upper tiers of the supply chain— account for the bulk of the defense industrial base.7 MDAP prime contractors are often viewed as

Montana Advanced Biofuels Great Falls Approval

Science.gov (United States)

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

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

Science.gov (United States)

2010-01-01

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

42 CFR 8.3 - Application for approval as an accreditation body.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Application for approval as an accreditation body... accreditation body. (a) Eligibility. Private nonprofit organizations or State governmental entities, or... an accreditation body. (b) Application for initial approval. Three copies of an accreditation body...

14 CFR 21.305 - Approval of materials, parts, processes, and appliances.

Science.gov (United States)

2010-01-01

..., and appliances. 21.305 Section 21.305 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION..., Parts, Processes, and Appliances § 21.305 Approval of materials, parts, processes, and appliances. Whenever a material, part, process, or appliance is required to be approved under this chapter, it may be...

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

Science.gov (United States)

2010-01-01

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

Supercollider: Footprint approved

International Nuclear Information System (INIS)

Anon.

1990-01-01

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

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

Science.gov (United States)

2012-10-04

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

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

Science.gov (United States)

2010-07-01

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

9 CFR 317.4 - Labeling approval.

Science.gov (United States)

2010-01-01

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

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

Science.gov (United States)

2010-10-01

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

Defending submission-year analyses of new drug approvals.

Science.gov (United States)

Carpenter, Daniel P

2003-01-01

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

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

Science.gov (United States)

2010-05-05

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

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

African Journals Online (AJOL)

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

Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

Science.gov (United States)

KuKanich, Butch; Warner, Matt; Hahn, Kevin

2017-02-01

OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

Analysis of research ethics board approval times in an academic department of medicine.

Science.gov (United States)

Tsang, Teresa S M; Jones, Meaghan; Meneilly, Graydon S

2015-04-01

As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols. © The Author(s) 2015.

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

Science.gov (United States)

2010-03-30

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

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

Science.gov (United States)

2012-05-04

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

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

Science.gov (United States)

2010-06-03

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

Radiation requirements for uranium project approvals

International Nuclear Information System (INIS)

Hondros, J.

2014-01-01

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

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

Science.gov (United States)

2010-07-01

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

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 Manager...

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.

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

Science.gov (United States)

2010-01-01

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

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

African Journals Online (AJOL)

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

21 CFR 515.20 - Approval of medicated feed mill license applications.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Approval of medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.20 Approval of medicated feed mill license applications. Within 90 days after an...

46 CFR 167.45-30 - Use of approved fire-fighting equipment.

Science.gov (United States)

2010-10-01

... PUBLIC NAUTICAL SCHOOL SHIPS Special Firefighting and Fire Prevention Requirements § 167.45-30 Use of approved fire-fighting equipment. Portable fire extinguishers or fire-extinguishing systems which conform... 46 Shipping 7 2010-10-01 2010-10-01 false Use of approved fire-fighting equipment. 167.45-30...

42 CFR 8.13 - Revocation of accreditation and accreditation body approval.

Science.gov (United States)

2010-10-01

... GENERAL PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Certification and Treatment Standards § 8.13... period of 1 year after the date of withdrawal of approval of the accreditation body, unless SAMHSA.... (2) Within 1 year from the date of withdrawal of approval of an accreditation body, or within any...

Ethics approval: responsibilities of journal editors, authors and research ethics committees.

Science.gov (United States)

Bain, Luchuo Engelbert

2017-01-01

Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

7 CFR 966.124 - Approved receiver.

Science.gov (United States)

2010-01-01

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

FDA-approved small-molecule kinase inhibitors

DEFF Research Database (Denmark)

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

2015-01-01

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

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

Science.gov (United States)

2012-09-27

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

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

Science.gov (United States)

2010-01-01

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

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

Science.gov (United States)

2010-01-01

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

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

Science.gov (United States)

Lawrence, Dana J

2011-11-01

To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-01-01

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

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. ...

Problems of the current law concerning official plan approval

International Nuclear Information System (INIS)

Bluemel, W.

1986-01-01

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

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

Science.gov (United States)

2012-05-04

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

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.

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

International Nuclear Information System (INIS)

1983-12-01

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

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

Science.gov (United States)

2010-04-01

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

15 CFR 1150.3 - Approved markings.

Science.gov (United States)

2010-01-01

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

50 CFR 223.207 - Approved TEDs.

Science.gov (United States)

2010-10-01

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

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

Science.gov (United States)

2011-09-09

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

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

Science.gov (United States)

2013-05-29

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

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

Science.gov (United States)

2012-01-05

... 173 [Docket No. PHMSA-2011-0315; Notice No. 11-13] Clarification and Further Guidance on the Fireworks... fireworks approvals applications from fireworks manufacturers or their designated agents and grant approvals only to manufacturers of fireworks devices. This clarification and additional guidance follows the...

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

Science.gov (United States)

2010-07-01

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

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…

40 CFR 52.2522 - Approval status.

Science.gov (United States)

2010-07-01

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

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

Science.gov (United States)

2012-12-13

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

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

Science.gov (United States)

2013-03-18

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

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

Science.gov (United States)

2011-04-13

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

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

Science.gov (United States)

2011-08-15

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

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.

Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC approved packages

International Nuclear Information System (INIS)

1988-12-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make 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 front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages, Report of NRC approved packages

International Nuclear Information System (INIS)

1990-10-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make 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 front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Drugs Approved for Colon and Rectal Cancer

Science.gov (United States)

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

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

International Nuclear Information System (INIS)

1993-10-01

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

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

Science.gov (United States)

2010-07-01

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

77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

Science.gov (United States)

2012-12-13

... proposal to extend Office of Management and Budget (OMB) approval of the Information Collection: Work-Study... reporting requirements that include a Work Study Program application and written participation agreement. In... private school system to file with the Wage and Hour Division Administrator an application for approval of...

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

Science.gov (United States)

2010-04-01

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

Approved Air Quality Implementation Plans in Region 10

Science.gov (United States)

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

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 § 75...

9 CFR 130.11 - User fees for inspecting and approving import/export facilities and establishments.

Science.gov (United States)

2010-01-01

... hourly user fee rate in § 130.30(2) applies to biosecurity level two laboratories. (b) [Reserved] [65 FR... approval) Per year $537.00 $553.00 $570.00 $587.00 $604.00 Inspection for approval of biosecurity level three labs (all inspections related to approving the laboratory for handling one defined set of...

Revised guideline for the approval procedure of package designs in Germany

International Nuclear Information System (INIS)

Nitsche, F.; Roedel, R.

2004-01-01

The IAEA Regulations for the Safe Transport of Radioactive Material, TS-R-1 are applied in Germany through the implementation of the Dangerous Goods Transport Regulations for class 7 of the International Modal Organisations (ADR, RID, IMDG-Code, ICAO-TI). Based on this the approval procedures for packages designs applied in Germany are in compliance with the provisions of TS-R-1. The Guideline R 003 issued by the Ministry of Transport, Building and Housing (BMVBW) in 1991 is the basis for the package design approval procedures in Germany. This Guideline has been reviewed and revised to reflect latest developments in the regulations as well as in the regulatory practice. In particular it has been extended to the approval procedures of Type C packages, packages subject to transitional arrangements, special form and low dispersible radioactive material and provides more detailed information to the applicant about the requested documentation. Publication of this revised guideline has been delayed but it is expected to take place in October 2004. The paper gives an overview about the main parts and provisions of this revised Guideline R 003 with the focus on package design approval procedures

New technology planning and approval: critical factors for success.

Science.gov (United States)

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

2007-01-01

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

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

Science.gov (United States)

Schimmer, Joshua; Breazzano, Steven

2016-06-01

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

44 CFR 78.10 - Project grant approval process.

Science.gov (United States)

2010-10-01

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

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

Science.gov (United States)

2011-06-07

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

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

Science.gov (United States)

2010-06-03

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

30 CFR 250.290 - What operations require approval of the Conceptual Plan?

Science.gov (United States)

2010-07-01

... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information Deepwater Operations Plans (dwop) § 250.290 What operations require approval of the Conceptual Plan? You may... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What operations require approval of the...

Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

Directory of Open Access Journals (Sweden)

Bate R

2012-07-01

Full Text Available Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA or the World Health Organization (WHO prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50% than Indian cities (26.57%, but they also experienced a higher failure rate (14.21% than Indian cities (7.83%. The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high

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

Science.gov (United States)

2011-07-07

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

Advances of orbital gas tungsten arc welding for Brazilian space applications – experimental setup

Directory of Open Access Journals (Sweden)

José A. Orlowski de Garcia

2010-08-01

Full Text Available The present work describes details of the several steps of the technology involved for the orbital Gas Tungsten Arc Welding (GTAW process of pure commercially titanium tubes. These pieces will be used to connect the several components of the propulsion system of the China-Brazilian Satellite CBERS, and is part of the Brazilian aerospace industry development. The implantation involved the steps of environment control; cut and facing of the base metal; cleaning procedures; piece alignment; choice of the type, geometry and installation of the tungsten electrode; system for the pressure of the purge gas; manual tack welding; choice of the welding parameters; and, finally, the qualification of welding procedures. Three distinct welding programs were studied, using pulsed current with increasing speed, continuous current and pulsed current with decreasing amperage levels. The results showed that the high quality criteria required to the aerospace segment is such that usual welding operations must be carefully designed and executed. The three welding developed programs generated welds free of defects and with adequate morphology, allowing to select the condition that better fits the Brazilian aerospace segment, and to be implanted in the welding of the CBERS Satellite Propulsion System.

7 CFR 996.22 - USDA-approved laboratory.

Science.gov (United States)

2010-01-01

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

46 CFR 163.002-9 - Approval procedure.

Science.gov (United States)

2010-10-01

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

7 CFR 1427.10 - Approved storage.

Science.gov (United States)

2010-01-01

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

Crystalline Electric Field Levels in the Neodymium Monopnictides Determined by Neutron Spectroscopy

DEFF Research Database (Denmark)

Furrer, A.; Kjems, Jørgen; Vogt, O.

1972-01-01

Neutron inelastic scattering experiments have been carried out to determine the energies and widths of the crystalline electric field levels in the neodymium monopnictides NdP, NdAs, and NdSb. The energy level sequence is derived from the observed crystal field transition peak intensities, which...... are in good agreement with calculations based on elementary crystal field theory. The energy level widths are qualitatively discussed. It is found that the point-charge model cannot reproduce the crystal field levels satisfactorily....

Review of experiments for research reactors - approved 1974

International Nuclear Information System (INIS)

Anon.

1977-01-01

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

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

Science.gov (United States)

2010-04-01

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

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

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

1999-01-01

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

27 CFR 5.51 - Label approval and release.

Science.gov (United States)

2010-04-01

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

Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.

Science.gov (United States)

Wang, Bo; Kesselheim, Aaron S

2015-09-23

To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs' originally approved indications. Systematic review. Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs' supplemental and original indication approvals. The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (Pindications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. © Wang et al 2015.

U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

Science.gov (United States)

Wing, Deborah A; Powers, Barbara; Hickok, Durlin

2010-04-01

The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical-legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.

A planning support system to optimize approval of private housing development projects

Science.gov (United States)

Hussnain, M. Q.; Wakil, K.; Waheed, A.; Tahir, A.

2016-06-01

Out of 182 million population of Pakistan, 38% reside in urban areas having an average growth rate of 1.6%, raising the urban housing demand significantly. Poor state response to fulfil the housing needs has resulted in a mushroom growth of private housing schemes (PHS) over the years. Consequently, only in five major cities of Punjab, there are 383 legal and 150 illegal private housing development projects against 120 public sector housing schemes. A major factor behind the cancerous growth of unapproved PHS is the prolonged and delayed approval process in concerned approval authorities requiring 13 months on average. Currently, manual and paper-based approaches are used for vetting and for granting the permission which is highly subjective and non-transparent. This study aims to design a flexible planning support system (PSS) to optimize the vetting process of PHS projects under any development authority in Pakistan by reducing time and cost required for site and documents investigations. Relying on the review of regulatory documents and interviews with professional planners and land developers, this study describes the structure of a PSS developed using open- source geo-spatial tools such as OpenGeo Suite, PHP, and PostgreSQL. It highlights the development of a Knowledge Module (based on regulatory documents) containing equations related to scheme type, size (area), location, access road, components of layout plan, planning standards and other related approval checks. Furthermore, it presents the architecture of the database module and system data requirements categorized as base datasets (built-in part of PSS) and input datasets (related to the housing project under approval). It is practically demonstrated that developing a customized PSS to optimize PHS approval process in Pakistan is achievable with geospatial technology. With the provision of such a system, the approval process for private housing schemes not only becomes quicker and user-friendly but also

Small-molecule kinase inhibitors: an analysis of FDA-approved drugs

DEFF Research Database (Denmark)

Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig

2016-01-01

Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...

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

Science.gov (United States)

2010-07-01

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

14 CFR 414.35 - Public notification of the criteria by which a safety approval was issued.

Science.gov (United States)

2010-01-01

... issued. For each grant of a safety approval, the FAA will publish in the Federal Register a notice of the... which a safety approval was issued. 414.35 Section 414.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety...

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.

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

Science.gov (United States)

2011-07-12

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

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

Science.gov (United States)

2011-10-03

... marriages, a change in course of instruction and termination of school attendance. Affected Public... (Approval of School Attendance) Activity: Comment Request AGENCY: Veterans Benefits Administration... techniques or the use of other forms of information technology. Titles: a. Request for Approval of School...

75 FR 57019 - Pesticide Product Registrations; Conditional Approval

Science.gov (United States)

2010-09-17

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

27 CFR 4.40 - Label approval and release.

Science.gov (United States)

2010-04-01

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

24 CFR 1710.29 - Use of property report-misstatements, omissions or representation of HUD approval prohibited.

Science.gov (United States)

2010-04-01

...-misstatements, omissions or representation of HUD approval prohibited. 1710.29 Section 1710.29 Housing and Urban...—misstatements, omissions or representation of HUD approval prohibited. Nothing is these regulations shall be construed to authorize or approve the use of a property report containing any untrue statement of a material...

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

Science.gov (United States)

2010-01-01

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

Approved but non-funded vaccines: accessing individual protection.

Science.gov (United States)

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

2014-02-07

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

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

Science.gov (United States)

2010-03-01

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

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

Science.gov (United States)

2010-06-03

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

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

Science.gov (United States)

2010-07-01

..., by the owner-coal mine operator of such machines including any associated electrical equipment... 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...

78 FR 69168 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Science.gov (United States)

2013-11-18

... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70848; File No. SR-NSCC-2013-10] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To...

46 CFR 160.077-6 - Approval procedures.

Science.gov (United States)

2010-10-01

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

A guide for approval of x-ray fluorescence analysis devices

International Nuclear Information System (INIS)

1990-01-01

This guide has been written to assist manufacturers, distributors and users of x-ray fluorescence analysis devices in the preparation of a submission to the Atomic Energy Control Board (AECB) in support of a request for approval of an x-ray fluorescence analysis device. Prior to the issuance of a Radioisotope licence authorizing the use or possession of an x-ray fluorescence analysis device in Canada, the design and construction of the device must be approved by the AECB. The AECB assessment is limited to the radiation safety aspects of use and packaging for transportation

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

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

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

Science.gov (United States)

2013-05-15

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

Perceived social approval and condom use with casual partners among youth in urban Cameroon

Directory of Open Access Journals (Sweden)

Meekers Dominique

2011-08-01

Full Text Available Abstract Background HIV prevention programs targeting youth often emphasize the role of peers, and assume that youths will model their behavior after their peers'. We challenge this view; we argue that adopting a given behavior requires social approval, and that youths do not necessarily turn to peers for such approval. This study analyzes survey data on youths in urban Cameroon to 1 identify which type of persons youths look to for social approval, and 2 establish how important social approval by these persons is for condom use among youths. Methods We analyzed data from three survey waves (2000, 2002, and 2003 of a reproductive health survey conducted among urban Cameroonian youth (aged 15-24. Only respondents who reported having at least one casual partner in the past year were retained for the analysis. Bivariate analyses and structural equation modeling were used to examine relationships among perceived social approval, attitudes towards condoms and condom use. Results The data show that only 3% of youths named their friends as people whose opinion they valued, while 93% mentioned family members. The perceived approval of condom use by these persons had a significant positive effect on the frequency of condom use among youths. The frequency of condom use was also affected by the respondents' attitudes toward condom use, the range of persons with whom they discussed reproductive health matters, whether they were enrolled in school, socioeconomic status, their self-efficacy, perceived severity of AIDS, risk perception and sexual risk behavior. The perceived social approval of condom use and the respondents' own condom attitudes were correlated. Conclusions Our analysis demonstrates that perceived social approval facilitates the adoption of condom use among urban Cameroonian youth. However, youths tend to value the opinions of family members much more than the opinions of their peers. These results suggest that interventions targeting youths

Waste feed delivery environmental permits and approvals plan

International Nuclear Information System (INIS)

Papp, I.G.

1998-01-01

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

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.

Trastuzumab emtansine: first global approval.

Science.gov (United States)

Ballantyne, Anita; Dhillon, Sohita

2013-05-01

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

Competent authority approval of package designs in the United Kingdom

International Nuclear Information System (INIS)

Morgan-Warren, E.J.

1999-01-01

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

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

Science.gov (United States)

2011-11-07

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

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

Science.gov (United States)

2011-05-12

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

First approval procedure of the TL dosimetric service of the NPP in Slovenia

International Nuclear Information System (INIS)

Janzekovic, H.; Krizman, M.; Pucelj, B.; Stuhec, M.; Zdesar, U.

2001-01-01

The individual dosimetry of exposed workers in a NPP is one of the essential parts which demonstrates the radiation protection standards achieved in a facility. According to the current legislation the Ministry of Health of the Republic of Slovenia has the authority to grant approvals to personal dosimetric services which perform the dosimetric monitoring of workers in Slovenia. Due to the fact that the detailed approval procedure is not given in national regulations, the Ministry of Health in 2000 established a group of experts with the task to prepare technical and organising requirements for such approval. Based on international documents [1,2,3] the Approval procedure for the thermoluminescence dosimetric (TL) services was created. Following this procedure the assessment of the TL dosimetric service in the NPP was performed. The problems related to the technical and organising requirements with the emphasise on the QA/QC criteria of the TL dosimetric service will be discussed.(author)

Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved packages

International Nuclear Information System (INIS)

1983-01-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make 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 Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

22 CFR 129.6 - Requirement for license/approval.

Science.gov (United States)

2010-04-01

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

27 CFR 7.31 - Label approval and release.

Science.gov (United States)

2010-04-01

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

27 CFR 7.41 - Certificates of label approval.

Science.gov (United States)

2010-04-01

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

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

Science.gov (United States)

Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

2015-01-01

Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

Directory of Open Access Journals (Sweden)

Jing Hao

Full Text Available Fixed-dose combinations (FDC contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed.Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients.New molecular entities (NMEs, new therapeutic biologics license applications (BLAs and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC and only already marketed drugs (Non-NMEs-FDC. Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed.During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31 after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39 before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24 years to the patent and exclusivity life of the single active ingredients in the combination.FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

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

Science.gov (United States)

2010-08-24

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

77 FR 63311 - Acacia Natural Gas Corporation; Notice of Petition for Rate Approval

Science.gov (United States)

2012-10-16

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR13-1-000] Acacia Natural Gas Corporation; Notice of Petition for Rate Approval Take notice that on October 9, 2012, Acacia Natural Gas Corporation (Acacia) filed a Petition for Rate Approval pursuant to 284.123(b)(2) of the...

75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products

Science.gov (United States)

2010-12-29

..., and Approval of Mining Products AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION..., evaluating, and approving mining products as provided by 30 CFR part 5. MSHA charges applicants a fee to... materials manufactured for use in the mining industry. The new fee schedule, effective January 1, 2011, is...

30 CFR 906.25 - Approval of Colorado abandoned mine land reclamation plan amendments.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Colorado abandoned mine land reclamation plan amendments. 906.25 Section 906.25 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND... STATE COLORADO § 906.25 Approval of Colorado abandoned mine land reclamation plan amendments. The...

14 CFR 21.617 - Issue of letters of TSO design approval: import appliances.

Science.gov (United States)

2010-01-01

...: import appliances. 21.617 Section 21.617 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... Order Authorizations § 21.617 Issue of letters of TSO design approval: import appliances. (a) A letter of TSO design approval may be issued for an appliance that is manufactured in a foreign country with...

40 CFR 256.04 - State plan approval, financial assistance.

Science.gov (United States)

2010-07-01

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

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

23 CFR 661.31 - Do IRRBP projects have to be listed on an approved IRR TIP?

Science.gov (United States)

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Do IRRBP projects have to be listed on an approved IRR... ENGINEERING AND TRAFFIC OPERATIONS INDIAN RESERVATION ROAD BRIDGE PROGRAM § 661.31 Do IRRBP projects have to be listed on an approved IRR TIP? Yes. All IRRBP projects must be listed on an approved IRR TIP. The...

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.

Uudised : Neoandertals müristas Euroopas. Kontsert paavstile

Index Scriptorium Estoniae

2007-01-01

Lõuna-Eestist pärit ülibrutaalse death metal'i duo Neoandertals rändas 5.-14. okt. koos läti death metal'i bändiga Flaying Kesk-Euroopas, esinedes ja tutvustades oma albumit "Neanderthals Were Master Butchers"underground-klubides Austrias, Tšehhis, Poolas ja Slovakkias. Baieri Ringhäälingu Sümfooniaorkester lätlasest peadirigendi Mariss Jansonsi juhtimisel sai Baierist pärit paavsti Benedictus XVI kutse esineda 27. okt. Vatikanis, kontserdil esitatakse L. van Beethoveni 9. sümfoonia

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) The...

On the question of a site plan approval procedure for large-scale power stations

International Nuclear Information System (INIS)

Roemermann, K.

1982-01-01

The author discusses the question whether a plan approval procedure for large-sclae power plants might contribute to shortening the period of time currently used for the licensing of such plants. On the basis of current practice which includes a planning and building permission by virtue of section 35 of the building law (BBauG) together with an approval of plans within the framework of regional planning, the author explains and discusses various models of site plan approval procedures, (a.o. section 38 of the Federal building law). (HP) [de

Stakeholder cooperation: regulating a uranium mine with multiple statutory approvals

International Nuclear Information System (INIS)

Bush, M.

2010-01-01

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

Inventory information approval system certification and flexible spending account purchases.

Science.gov (United States)

Shuey, Brandon; Williams, La Vonn A

2010-01-01

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

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

Science.gov (United States)

2013-11-20

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

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

Science.gov (United States)

2012-10-01

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

A guide for approval of nuclear gauging devices

International Nuclear Information System (INIS)

1990-01-01

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

Neratinib Approved for HER2+ Breast Cancer.

Science.gov (United States)

2017-09-01

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

22 CFR 64.7 - Approval of application.

Science.gov (United States)

2010-04-01

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

18 CFR 806.6 - Transfer of approvals.

Science.gov (United States)

2010-04-01

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

40 CFR 85.1804 - Approval of Plan: Implementation.

Science.gov (United States)

2010-07-01

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

29 CFR 1952.297 - Changes to approved plans.

Science.gov (United States)

2010-07-01

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

Technical architecture of ONC-approved plans for statewide health information exchange.

Science.gov (United States)

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 advancements in standards and technology of HIE, etc. Review of 28 state plans shows virtually all include a direct messaging component, but for participating entities at state-specific levels of granularity (RHIO, enterprise, organization/provider). About ½ of reviewed plans describe a federated architecture, and ¼ of plans utilize a single-vendor "hybrid-federated" architecture. About 1/3 of states plan to leverage new federal and open exchange technologies (DIRECT, CONNECT, etc.). Only one plan describes a centralized architecture for statewide HIE, but others combine central and federated architectural approaches.

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

Science.gov (United States)

2012-08-07

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

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

Science.gov (United States)

2012-05-17

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

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

Science.gov (United States)

2011-05-09

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

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

Science.gov (United States)

2012-07-17

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

75 FR 17332 - Idaho: Incorporation by Reference of Approved State Hazardous Waste Management Program

Science.gov (United States)

2010-04-06

...: Incorporation by Reference of Approved State Hazardous Waste Management Program AGENCY: Environmental Protection... ``Approved State Hazardous Waste Management Programs,'' Idaho's authorized hazardous waste program. The EPA... regulations that are authorized and that the EPA will enforce under the Solid Waste Disposal Act, commonly...

Directory of certificates of compliance for radioactive materials packages; Summary Report of NRC Approved Packages

International Nuclear Information System (INIS)

1980-12-01

This directory contains a Summary Report of NRC approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. To assist in identifying packaging, and index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material using these packagings must be in accordance with the provisions of 49 CFR 173.393a and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure them--that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

Bacteria-eating virus approved as food additive.

Science.gov (United States)

Bren, Linda

2007-01-01

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

Approval Plans in ARL Libraries. Kit 83.

Science.gov (United States)

Leonhardt, Thomas W.

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

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…

APPROVAL OF WASTE TREATMENT AND IMMOBILIZATION PLANT CONTRACTOR-INITIATED AUTHORIZATION BASIS AMENDMENT REQUESTS (ABAR)

International Nuclear Information System (INIS)

JONES GL

2008-01-01

The objective is to describe the process used by the Office of River Protection (ORP) for evaluating and implementing Contractor-initiated changes to the Waste Treatment and Immobilization Plant (WTP) Authorization Basis (AB). The WTP Project's history has provided a unique challenge for establishing and maintaining an ORP-approved AB during design and construction. Until operations begin, the project cannot implement the classic Unreviewed Safety Question (USQ) process to determine when ORP approval of Contractor-initiated changes is required. A 'quasiUSQ' process has been implemented that defines when AB changes could occur. The three types of AB changes are (1) Limited Scope Changes, (2) Authorization Basis Deviations, and (3) Authorization Basis Amendment Request (ABAR). DOE RL/REG 97-13, 'Office of River Protection Position on Contractor-Initiated Changes to the Authorization Basis', describes the process the WTP Contractor must follow to make changes to the AB, with and without ORP approval. The process uses a 'safety evaluation' process that is similar to the USQ process but at a more qualitative level. The maturation of the WTP Contractor's facility design and activities, and other changing conditions, resulted in a process that allows the Contractor to make changes to the AB without ORP approval; however, those changes that may significantly affect nuclear safety do require ORP approval. This process balances the WTP regulatory principle of efficiency with assurance that adequate safety will not be compromised. The process has reduced the number of ABARs requiring ORP approval and reduced the potential for delays in design and procurement activities

Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule

Directory of Open Access Journals (Sweden)

Chia-Wei eTsai

2015-12-01

Full Text Available On December 14, 2012, the FDA approved raxibacumab, the first product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or Animal Rule. Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues.

Approval of radioactive consumer goods

International Nuclear Information System (INIS)

Paynter, R.A.

1992-01-01

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

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

Science.gov (United States)

2011-02-17

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

75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

Science.gov (United States)

2010-12-16

...; Securities Exchange Act of 1934 Release No. 63526/December 10, 2010] Order Approving Public Company... Company Accounting Oversight Board (the ``PCAOB'') to oversee the audits of companies and related matters..., subject to approval by the Commission, auditing and related attestation, quality control, ethics, and...

75 FR 39619 - Proposed Information Collection (Quarterly Report of State Approving Agency) Activities Activity...

Science.gov (United States)

2010-07-09

... information needed to accurately reimburse State Approving Agencies (SAAs) for expenses incurred in the... reimburses SAAs for expenses incurred in the approval and supervision of education and training programs. SAAs are required to report their activities to VA quarterly and provide notices regarding which...

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

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines assembled with certified... ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Machines Assembled With Certified or Explosion-Proof Components, Field...

78 FR 28267 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Science.gov (United States)

2013-05-14

... Trust Company (``DTC'') and maintain accounts to facilitate Delivery Orders (``DOs'') to approved... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... securities transactions and foster cooperation and coordination with persons engaged in the clearance and...

76 FR 41154 - Review and Approval of Projects

Science.gov (United States)

2011-07-13

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

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

International Nuclear Information System (INIS)

1988-01-01

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

An approved personal dosimetry service based on an electronic dosimeter

International Nuclear Information System (INIS)

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

1991-01-01

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

A viewpoint on the approval context of strategic environmental assessments

International Nuclear Information System (INIS)

Kontić, Branko; Kontić, Davor

2012-01-01

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

Approaches to facilitate institutional review board approval of multicenter research studies.

Science.gov (United States)

Marsolo, Keith

2012-07-01

Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks. A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned. Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects. Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.

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

Science.gov (United States)

2010-08-19

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

75 FR 32355 - Notice of Request for Revision of a Currently Approved Information Collection

Science.gov (United States)

2010-06-08

.... Expiration Date of Approval: November 30, 2010. Type of Request: Revision of a currently approved information... retailers to market product. The Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), section 203(g... ornamental trade, which includes packers, processors, brokers, retailers, producers, and associated...

77 FR 74722 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule...

Science.gov (United States)

2012-12-17

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68401; File No. SR-CME-2012-42] Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule Change Regarding the Valuation of... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

77 FR 40394 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Science.gov (United States)

2012-07-09

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67333; File No. SR-OCC-2012-07] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Adjustment... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

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.

Evaluating the Status Approvals about Cinema (1989 to 2009

Directory of Open Access Journals (Sweden)

Elahe Dehghan Pishe

2012-06-01

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

77 FR 75915 - Review and Approval of Projects

Science.gov (United States)

2012-12-26

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

28 CFR 20.23 - Documentation: Approval by OJARS.

Science.gov (United States)

2010-07-01

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

Approval of devices and facilities using ionizing radiations for medical purposes

International Nuclear Information System (INIS)

1977-01-01

This Order made by the Ministers of Health and Social Security, Agriculture and Labour amends a previous Decree of 23 April 1969 in particular concerning the classification of medical or dental radiodiagnostic devices subject to approval. The technical conditions to be complied with for such devices and facilities have also been amended. Finally, it is provided that, as regards facilities with heavy equipment subject to licensing (Act of 31 December 1970), approval is subject to compliance with the licensing conditions and is requested together with the application for a licence. (NEA) [fr

40 CFR 1043.50 - Approval of methods to meet Tier 1 retrofit NOX standards.

Science.gov (United States)

2010-07-01

... retrofit NOX standards. 1043.50 Section 1043.50 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... SUBJECT TO THE MARPOL PROTOCOL § 1043.50 Approval of methods to meet Tier 1 retrofit NOX standards. Regulation 13 of Annex VI provides for certification of Approved Methods, which are retrofit procedures that...

76 FR 68811 - Notice of Request for the Revision of Currently Approved Information Collection

Science.gov (United States)

2011-11-07

... operating information from the nation's public transportation systems. Congress created the NTD to be the... request the Office of Management and Budget (OMB) to approve the revision of the currently approved information collection: 49 U.S.C. 5335(a) and (b) National Transit Database (NTD). DATES: Comments must be...

77 FR 41278 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Reasonably Available...

Science.gov (United States)

2012-07-13

... control technology (RACT) for oxides of nitrogen (NO X ) and volatile organic compounds (VOCs) for the... certification that previously adopted RACT controls in Maryland's SIP, which were approved by EPA under the 1... through (1) certification that previously adopted RACT controls in Maryland's SIP that were approved by...

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

Science.gov (United States)

2013-02-19

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

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

Science.gov (United States)

2012-05-30

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

78 FR 33726 - Approval and Promulgation of Implementation Plans; Kentucky: Kentucky Portion of Cincinnati...

Science.gov (United States)

2013-06-05

... the Regional Office's normal hours of operation. The Regional Office's official hours of business are... model which was the latest approved emissions model at that time. That plan satisfied the CAA... plan included MVEBs that were derived with the MOVES model--the latest approved emissions model at that...

Arkitekturer i operativsystem : en fallstudie i monolitisk och micro kernel

OpenAIRE

Hjortsberg, Andreas; Frederiksen, Kristofer

2001-01-01

Den tekniska utvecklingen driver fram allt mer avancerade datorsystem. Samtidigt ställs allt större krav på stabilitet och flexibilitet i de operativsystem som ska användas på dessa system. De senaste årtiondena har micro kernel arkitekturen varit föremål för intensiv forskning och det finns idag ett flertal operativsystem på marknaden som använder denna arkitektur. Traditionella monolitiska operativsystem är relativt resurskrävande system som ofta anklagats för att sakna struktur. Micro kern...

Djur som en del i omvårdnad : En litteraturstudie

OpenAIRE

Jirback, Fia; Olsson, Malin

2011-01-01

Bakgrund: Äldre på boende idag kan känna att de saknar sociala interaktioner med vårdpersonal, familj eller vänner. För att uppleva god livskvalitet krävs bland annat trygghet, sociala interaktioner och aktiviteter. Djur kan användas som behandlingsmetod i vården i form av Animal-Assisted Activity (AAA) och Animal-Assisted Therapy (AAT). Syfte: Syftet med litteraturstudien var att belysa sällskapsdjurs betydelse för äldres livskvalitet på äldreboende. Metod: Studien har genomförts som en allm...

Vilken underbar värld vi förstörde... : Historiebruk i postapokalyptisk fiktion, exemplet Metro 2033

OpenAIRE

Almroth, Klas

2014-01-01

Uppsatsen ämnar utforska hur den postapokalyptiska genren brukar historia. Detta görs genom en läsning av Dimitrij Gluchovskijs Metro 2033 (2009), utifrån Espmarks syn på dialogicitet och Aronssons historiebruksteoretiska tankar, där historiskt meningsskapande med olika syften blir till genom berättelser i former som större narrativ, metaforer, metonymier och symboler.Bakhtins kronotop används också, men med Aronssons fokus på dess spatiala sida. Uppsatsen föreslår att figuren kan användas fö...

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

Science.gov (United States)

2013-09-05

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

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

Science.gov (United States)

2010-09-22

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

Multi-criteria approval for evaluating landscape management strategies (Case study: Fruška Gora National Park)

OpenAIRE

Lakićević Milena D.; Srđević Bojan M.; Srđević Zorica B.

2015-01-01

This paper deals with the problem of multi-criteria evaluation of four management strategies for Fruška Gora National Park. The criteria set was defined in ac­cordance with the IUCN guidelines for management of national parks. Four strategies were evaluated by testing preference intensities for each alternative with the respect to each cri­terion. Alternatives with preference above the approval threshold were approved, and a multi-criteria approval matrix w...

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...

76 FR 60774 - Review and Approval of Projects

Science.gov (United States)

2011-09-30

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

24 CFR 945.201 - Approval to designate housing.

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

2010-10-01

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

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

Science.gov (United States)

2010-04-01

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

14 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 § 121.409...

76 FR 36875 - Approval and Promulgation of Implementation Plans; South Carolina: Prevention of Significant...

Science.gov (United States)

2011-06-23

... requirements pertaining to NO X as an ozone precursor into the South Carolina SIP. b. NSR PM2.5 Rule With...-0958-201119; FRL-9322- 6] Approval and Promulgation of Implementation Plans; South Carolina: Prevention.... SUMMARY: EPA is taking final action to approve three revisions to the South Carolina State Implementation...

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

Science.gov (United States)

2011-11-07

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

77 FR 18804 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2012-03-28

... Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR... and without change, unless the comment contains copyrighted material, confidential business... attitudes, beliefs, motivations and feelings regarding specific issues and will provide invaluable...

Sustainable Forest Management in Cameroon Needs More than Approved Forest Management Plans

Directory of Open Access Journals (Sweden)

Paolo Omar. Cerutti

2008-12-01

Full Text Available One of the main objectives of the 1994 Cameroonian forestry law is to improve the management of production forests by including minimum safeguards for sustainability into compulsory forest management plans. As of 2007, about 3.5 million hectares (60% of the productive forests are harvested following the prescriptions of 49 approved management plans. The development and implementation of these forest management plans has been interpreted by several international organizations as long awaited evidence that sustainable management is applied to production forests in Cameroon. Recent reviews of some plans have concluded, however, that their quality was inadequate. This paper aims at taking these few analyses further by assessing the actual impacts that approved management plans have had on sustainability and harvesting of commercial species. We carry out an assessment of the legal framework, highlighting a fundamental flaw, and a thorough comparison between data from approved management plans and timber production data. Contrary to the principles adhered to by the 1994 law, we find that the government has not yet succeeded in implementing effective minimum sustainability safeguards and that, in 2006, 68% of the timber production was still carried out as though no improved management rules were in place. The existence of a number of approved management plans cannot be used a proxy for proof of improved forest management.

Approving cancer treatments based on endpoints other than overall survival: an analysis of historical data using the PACE Continuous Innovation Indicators™ (CII).

Science.gov (United States)

Brooks, Neon; Campone, Mario; Paddock, Silvia; Shortenhaus, Scott; Grainger, David; Zummo, Jacqueline; Thomas, Samuel; Li, Rose

2017-01-01

There is an active debate about the role that endpoints other than overall survival (OS) should play in the drug approval process. Yet the term 'surrogate endpoint' implies that OS is the only critical metric for regulatory approval of cancer treatments. We systematically analyzed the relationship between U.S. Food and Drug Administration (FDA) approval and publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available. Using the PACE Continuous Innovation Indicators (CII) platform, we analyzed the effects of cancer type, treatment goal, and year of approval on the lag time between FDA approval and publication of first significant OS finding for 53 treatments approved between 1952 and 2016 for 10 cancer types (n = 71 approved indications). Greater than 59% of treatments were approved before significant OS data for the approved indication were published. Of the drugs in the sample, 31% had lags between approval and first published OS evidence of 4 years or longer. The average number of years between approval and first OS evidence varied by cancer type and did not reliably predict the eventual amount of OS evidence accumulated. Striking the right balance between early access and minimizing risk is a central challenge for regulators worldwide. We illustrate that endpoints other than OS have long helped to provide timely access to new medicines, including many current standards of care. We found that many critical drugs are approved many years before OS data are published, and that OS may not be the most appropriate endpoint in some treatment contexts. Our examination of approved treatments without significant OS data suggests contexts where OS may not be the most relevant endpoint and highlights the importance of using a wide variety of fit-for-purpose evidence types in the approval process.

30 CFR 285.615 - What other reports or notices must I submit to MMS under my approved SAP?

Science.gov (United States)

2010-07-01

... MMS under my approved SAP? 285.615 Section 285.615 Mineral Resources MINERALS MANAGEMENT SERVICE... CONTINENTAL SHELF Plans and Information Requirements Activities Under An Approved Sap § 285.615 What other reports or notices must I submit to MMS under my approved SAP? (a) You must notify MMS in writing within...