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

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

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Science.gov (United States)

2010-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product... products by the Food and Drug Administration. Any representation in labeling or advertising that creates an...

Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.

Directory of Open Access Journals (Sweden)

Derek So

Full Text Available Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR, which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

7 CFR 1755.901 - Incorporation by Reference.

Science.gov (United States)

2010-01-01

...”), incorporation by reference approved for § 1755.902(h). (e) The following Telecommunications Industry Association... AGRICULTURE TELECOMMUNICATIONS POLICIES ON SPECIFICATIONS, ACCEPTABLE MATERIALS, AND STANDARD CONTRACT FORMS... Performance Properties of Insulations and Jackets for Telecommunications Wire and Cable, approved March 10...

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.

[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.

Standard Reference Development of nuclear material for Tensile and Hardness Test Properties

International Nuclear Information System (INIS)

Choo, Y. S.; Kim, D. S.; Yoo, B. O.; Ahn, S. B.; Baik, S. J.; Chun, Y. B.; Kim, K. H.; Hong, K. P.; Ryu, W. S.

2007-12-01

Standard reference is a official approved data such a coefficient of physics, approved material properties, and etc., which should be analyzed and evaluated by scientific method to acquire official approval for accuracy and credibility of measured data and information. So it could be used broadly and continuously by various fields of nation and society. It is classified to effective standard reference, verified standard reference, and certified standard reference. There are sixteen fields in designated standard references such a physical chemistry field, material field, metal field, and the others. The standard reference of neutron irradiated nuclear structural material is classified to metal field. This report summarized the whole processes about data collection, data production, data evaluation and the suggestion of details evaluation technical standard for tensile and hardness properties, which were achieved by carry out the project 'nuclear material standard reference development' as a result

Standard Reference Development of nuclear material for Tensile and Hardness Test Properties

Energy Technology Data Exchange (ETDEWEB)

Choo, Y. S.; Kim, D. S.; Yoo, B. O.; Ahn, S. B.; Baik, S. J.; Chun, Y. B.; Kim, K. H.; Hong, K. P.; Ryu, W. S

2007-12-15

Standard reference is a official approved data such a coefficient of physics, approved material properties, and etc., which should be analyzed and evaluated by scientific method to acquire official approval for accuracy and credibility of measured data and information. So it could be used broadly and continuously by various fields of nation and society. It is classified to effective standard reference, verified standard reference, and certified standard reference. There are sixteen fields in designated standard references such a physical chemistry field, material field, metal field, and the others. The standard reference of neutron irradiated nuclear structural material is classified to metal field. This report summarized the whole processes about data collection, data production, data evaluation and the suggestion of details evaluation technical standard for tensile and hardness properties, which were achieved by carry out the project 'nuclear material standard reference development' as a result.

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

A novel SNP analysis method to detect copy number alterations with an unbiased reference signal directly from tumor samples

Directory of Open Access Journals (Sweden)

LaFramboise William A

2011-01-01

Full Text Available Abstract Background Genomic instability in cancer leads to abnormal genome copy number alterations (CNA as a mechanism underlying tumorigenesis. Using microarrays and other technologies, tumor CNA are detected by comparing tumor sample CN to normal reference sample CN. While advances in microarray technology have improved detection of copy number alterations, the increase in the number of measured signals, noise from array probes, variations in signal-to-noise ratio across batches and disparity across laboratories leads to significant limitations for the accurate identification of CNA regions when comparing tumor and normal samples. Methods To address these limitations, we designed a novel "Virtual Normal" algorithm (VN, which allowed for construction of an unbiased reference signal directly from test samples within an experiment using any publicly available normal reference set as a baseline thus eliminating the need for an in-lab normal reference set. Results The algorithm was tested using an optimal, paired tumor/normal data set as well as previously uncharacterized pediatric malignant gliomas for which a normal reference set was not available. Using Affymetrix 250K Sty microarrays, we demonstrated improved signal-to-noise ratio and detected significant copy number alterations using the VN algorithm that were validated by independent PCR analysis of the target CNA regions. Conclusions We developed and validated an algorithm to provide a virtual normal reference signal directly from tumor samples and minimize noise in the derivation of the raw CN signal. The algorithm reduces the variability of assays performed across different reagent and array batches, methods of sample preservation, multiple personnel, and among different laboratories. This approach may be valuable when matched normal samples are unavailable or the paired normal specimens have been subjected to variations in methods of preservation.

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.

20 CFR 416.1720 - Whom we refer.

Science.gov (United States)

2010-04-01

... Treatment of Alcoholism Or Drug Addiction § 416.1720 Whom we refer. We will refer you to an approved facility for treatment of your alcoholism or drug addiction if— (a) You are disabled; (b) You are not blind; (c) You are not 65 years old or older; and (d) Alcoholism or drug addiction is a contributing factor...

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...

21 CFR 660.25 - Potency tests without reference preparations.

Science.gov (United States)

2010-04-01

... recommended for slide tests or microplate techniques. Blood Grouping Reagent recommended for slide test... Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood Grouping Reagents are not available shall be tested for potency by a method approved by the Director...

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...

Some Numbers behind Canada's Decision to Adopt an Orphan Drug Policy: US Orphan Drug Approvals in Canada, 1997-2012.

Science.gov (United States)

Herder, Matthew; Krahn, Timothy Mark

2016-05-01

We examined whether access to US-approved orphan drugs in Canada has changed between 1997 (when Canada chose not to adopt an orphan drug policy) and 2012 (when Canada reversed its policy decision). Specifically, we looked at two dimensions of access to US-approved orphan drugs in Canada: (1) regulatory access; and (2) temporal access. Whereas only 63% of US-approved orphan drugs were granted regulatory approval in 1997, we found that regulatory access to US-approved orphan drugs in Canada increased to 74% between 1997 and 2012. However, temporal access to orphan drugs is slower in Canada: in a head-on comparison of 40 matched drugs, only two were submitted and four were approved first in Canada; moreover, the mean review time in Canada (423 days) was longer than that in the US (mean = 341 days), a statistically significant difference (t[39] = 2.04, p = 0.048). These results raise questions about what motivated Canada's apparent shift in orphan drug policy. Copyright © 2016 Longwoods Publishing.

Practical reference - radiation standards in Canada

International Nuclear Information System (INIS)

1983-07-01

In developing a policy that will require licensees to calibrate their radiation dose measuring devices and trace such calibrations to approved reference standards, the AECB has consulted recognized experts. This document presents the experts' reports and recommendations which will be considered in finalizing the policy

46 CFR 160.047-1 - Incorporation by reference.

Science.gov (United States)

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Vest, Kapok or Fibrous Glass, Adult... reference to the following documents: (1) Federal Specification: L-P-375C—Plastic Film, Flexible, Vinyl...

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...

77 FR 58309 - Approval and Promulgation of Implementation Plans; State of Missouri

Science.gov (United States)

2012-09-20

... . SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or ``our'' refer to EPA. Outline I. What is.... What action is EPA taking? I. What is being addressed in this document? EPA is approving revisions to....040 Reference Methods, and 10 CSR 10-6.130 Controlling Emissions During Episodes of High Air Pollution...

75 FR 5624 - Extension of Approval of Information Collection, OMB Control Number 1004-0137

Science.gov (United States)

2010-02-03

...: The currently approved annual burden for this collection is 2,631,120 hours. The following chart... 18,800 5(d)(1), Schematic/Facility Diagrams 43 CFR 3162.4-1(b), Well 3,000 8 24,000 Completion or...

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...

40 CFR 59.412 - Incorporations by reference.

Science.gov (United States)

2010-07-01

... Test Method for Chemical Resistance of Coatings Used in Light-Water Nuclear Power Plants, incorporation by reference approved for § 59.401, Nuclear coating. (5) ASTM Method D 4082-89, Standard Test Method for Effects of Gamma Radiation on Coatings for Use in Light-Water Nuclear Power Plants, incorporation...

7 CFR 300.4 - Reference Manual B.

Science.gov (United States)

2010-01-01

..., 2001, by the National Seed Health System (NSHS), has been approved for incorporation by reference in 7... inspection at the APHIS Library, U.S. Department of Agriculture, 4700 River Road, Riverdale, MD or at the... the APHIS Web site at http://www.aphis.usda.gov/ppq/pim/accreditation. ...

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 ...

46 CFR 160.005-1 - Incorporation by reference.

Science.gov (United States)

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, Fibrous Glass, Adult and Child (Jacket Type... makes reference to the following documents: (1) Federal Specification: L-P-375C—Plastic Film, Flexible....005-1: (Sheet 1) Cutting Pattern and General Arrangement (Adult). (Sheet 2) Alternate Stitching of...

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 2002 ed

International Nuclear Information System (INIS)

2002-08-01

The current edition of the transport Regulations was published in 1996 and is more commonly referred to as 'ST-1'. Earlier Editions were known as Safety Series No. 6. The latest English reprint (2000) is now identified as TS-R-1 (ST-1, Revised). The transport Regulations elaborate requirements for the design, fabrication and maintenance of packaging as well as those for preparation, consigning, handling, carriage, storage in transit and receipt of the packages at final destination. Approval issued in the form of certificates is required for the design or shipment of packages. This report supersedes IAEA-TECDOC-1237 Directory of National Competent Authorities' Approval Certificates for Package Design, Special Form Material and Shipment of Radioactive Material, 2001 Edition. It is distributed worldwide to the IAEA Member States' competent authorities for transport, and other entities who have requested copies. Electronic copies of the main data file are provided to registered users of the PACKTRAM database. The information contained in this report is given in six tables. In each of these, information is presented in alphabetical order based on the certificate number. Tables 1 to 4 present administrative data including issue and expiry dates, package identification, package serial numbers, modes for which the package/shipment is approved and the edition of the IAEA Transport Safety Regulations on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table 5. Table 6 shows the certificates reported to the Secretariat by each participating Member State

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 2001 edition

International Nuclear Information System (INIS)

2001-08-01

The current edition of the transport Regulations was published in 1996 and is more commonly referred to as 'ST-1'. Earlier Editions were known as Safety Series No. 6. The latest English reprint (2000) is now identified as TS-R-1 (ST-1, Revised). The transport Regulations elaborate requirements for the design, fabrication and maintenance of packaging as well as those for preparation, consigning, handling, carriage, storage in transit and receipt of the packages at final destination. Approval issued in the form of certificates is required for the design or shipment of packages. This report supersedes IAEA-TECDOC-1171 D irectory of National Competent Authorities' Approval Certificates for Package Design, Special Form Material and Shipment of Radioactive Material, 2000 Edition . It is distributed worldwide to the IAEA Member States' competent authorities for transport, and other entities who have requested copies. Electronic copies of the main data file are provided to registered users of the PACKTRAM database. The information contained in this report is given in six tables. In each of these, information is presented in alphabetical order based on the certificate number. Tables 1 to 4 present administrative data including issue and expiry dates, package identification, package serial numbers, modes for which the package/shipment is approved and the edition of the IAEA Transport Safety Regulations on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table 5. Table 6 shows the certificates reported to the Secretariat by each participating Member State

49 CFR 393.7 - Matter incorporated by reference.

Science.gov (United States)

2010-10-01

... § 393.104(e). (20) Recommended Standard Specification for Synthetic Web Tiedowns, Web Sling and Tiedown..., 2nd Edition, Wire Rope Technical Board November 1985, incorporation by reference approved for § 393... Composite Rope Specifications, Three-Strand and Eight-Strand Standard Construction, May 1979; (iv) NRS-1...

40 CFR 194.5 - Publications incorporated by reference.

Science.gov (United States)

2010-07-01

.... Nuclear Regulatory Commission, NUREG-1297 “Peer Review for High-Level Nuclear Waste Repositories... Characterization of High-Level Nuclear Waste Repositories” (excluding section 2.1 (b) and (c)); IBR approved for... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Publications incorporated by reference...

Technical Note: Modification of the standard gain correction algorithm to compensate for the number of used reference flat frames in detector performance studies

International Nuclear Information System (INIS)

Konstantinidis, Anastasios C.; Olivo, Alessandro; Speller, Robert D.

2011-01-01

Purpose: The x-ray performance evaluation of digital x-ray detectors is based on the calculation of the modulation transfer function (MTF), the noise power spectrum (NPS), and the resultant detective quantum efficiency (DQE). The flat images used for the extraction of the NPS should not contain any fixed pattern noise (FPN) to avoid contamination from nonstochastic processes. The ''gold standard'' method used for the reduction of the FPN (i.e., the different gain between pixels) in linear x-ray detectors is based on normalization with an average reference flat-field. However, the noise in the corrected image depends on the number of flat frames used for the average flat image. The aim of this study is to modify the standard gain correction algorithm to make it independent on the used reference flat frames. Methods: Many publications suggest the use of 10-16 reference flat frames, while other studies use higher numbers (e.g., 48 frames) to reduce the propagated noise from the average flat image. This study quantifies experimentally the effect of the number of used reference flat frames on the NPS and DQE values and appropriately modifies the gain correction algorithm to compensate for this effect. Results: It is shown that using the suggested gain correction algorithm a minimum number of reference flat frames (i.e., down to one frame) can be used to eliminate the FPN from the raw flat image. This saves computer memory and time during the x-ray performance evaluation. Conclusions: The authors show that the method presented in the study (a) leads to the maximum DQE value that one would have by using the conventional method and very large number of frames and (b) has been compared to an independent gain correction method based on the subtraction of flat-field images, leading to identical DQE values. They believe this provides robust validation of the proposed method.

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...

75 FR 8496 - Approval and Promulgation of Implementation Plans; Ohio New Source Review Rules

Science.gov (United States)

2010-02-25

... Skinner. This letter, included as Additional material in paragraph (145)(ii)(B) below, removes references... Regional Administrator Thomas Skinner, titled Request for Approval of Ohio Administrative Code (``OAC...

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.

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

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

Space Program Annual Report, For Approval

International Nuclear Information System (INIS)

TM Schaefer

2004-01-01

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

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...

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

International Nuclear Information System (INIS)

1987-11-01

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

Roaming Reference: Reinvigorating Reference through Point of Need Service

Directory of Open Access Journals (Sweden)

Kealin M. McCabe

2011-11-01

Full Text Available Roaming reference service was pursued as a way to address declining reference statistics. The service was staffed by librarians armed with iPads over a period of six months during the 2010-2011 academic year. Transactional statistics were collected in relation to query type (Research, Facilitative or Technology, location and approach (librarian to patron, patron to librarian or via chat widget. Overall, roaming reference resulted in an additional 228 reference questions, 67% (n=153 of which were research related. Two iterations of the service were implemented, roaming reference as a standalone service (Fall 2010 and roaming reference integrated with traditional reference desk duties (Winter 2011. The results demonstrate that although the Weller Library’s reference transactions are declining annually, they are not disappearing. For a roaming reference service to succeed, it must be a standalone service provided in addition to traditional reference services. The integration of the two reference models (roaming reference and reference desk resulted in a 56% decline in the total number of roaming reference questions from the previous term. The simple act of roaming has the potential to reinvigorate reference services as a whole, forcing librarians outside their comfort zones, allowing them to reach patrons at their point of need.

Biosimilars approval process.

Science.gov (United States)

Zuñiga, Leyre; Calvo, Begoña

2010-04-01

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

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

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)

Equine Science. Instructor Guide [and] Student Reference. Volume 27, Number 4 [and] Volume 27, Number 5.

Science.gov (United States)

Leffert, Kenneth L.; And Others

This instructor guide and the corresponding student reference contain 10 lessons to enhance an Agricultural Science I course for grade 9. The lessons cover the following topics: introduction, psychology and handling, conformation and selection, genetics and reproduction, herd health, hoof care, nutrition, equipment and facilities, handling horses,…

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...

76 FR 59769 - Clarification on the Division 1.1 Fireworks Approvals Policy

Science.gov (United States)

2011-09-27

... issuing the EX approval. While APA Standard 87-1 references two instances where Division 1.1 fireworks may... test laboratory if the firework device is manufactured in accordance with APA Standard 87-1 (IBR, see... certify that the firework device conforms to the APA Standard 87-1 and that the descriptions and technical...

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

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…

77 FR 36442 - Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD Regulations

Science.gov (United States)

2012-06-19

... pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile... 2.5 , EPA will defer action on this matter. EPA is also proposing to approve the removal of R. 336...

Simulating HCCI Blending Octane Number of Primary Reference Fuel with Ethanol

KAUST Repository

Singh, Eshan

2017-03-28

The blending of ethanol with primary reference fuel (PRF) mixtures comprising n-heptane and iso-octane is known to exhibit a non-linear octane response; however, the underlying chemistry and intermolecular interactions are poorly understood. Well-designed experiments and numerical simulations are required to understand these blending effects and the chemical kinetic phenomenon responsible for them. To this end, HCCI engine experiments were previously performed at four different conditions of intake temperature and engine speed for various PRF/ethanol mixtures. Transfer functions were developed in the HCCI engine to relate PRF mixture composition to autoignition tendency at various compression ratios. The HCCI blending octane number (BON) was determined for mixtures of 2-20 vol % ethanol with PRF70. In the present work, the experimental conditions were considered to perform zero-dimensional HCCI engine simulations with detailed chemical kinetics for ethanol/PRF blends. The simulations used the actual engine geometry and estimated intake valve closure conditions to replicate the experimentally measured start of combustion (SOC) for various PRF mixtures. The simulated HCCI heat release profiles were shown to reproduce the experimentally observed trends, specifically on the effectiveness of ethanol as a low temperature chemistry inhibitor at various concentrations. Detailed analysis of simulated heat release profiles and the evolution of important radical intermediates (e.g., OH and HO) were used to show the effect of ethanol blending on controlling reactivity. A strong coupling between the low temperature oxidation reactions of ethanol and those of n-heptane and iso-octane is shown to be responsible for the observed blending effects of ethanol/PRF mixtures.

Simulating HCCI Blending Octane Number of Primary Reference Fuel with Ethanol

KAUST Repository

Singh, Eshan; Waqas, Muhammad; Johansson, Bengt; Sarathy, Mani

2017-01-01

The blending of ethanol with primary reference fuel (PRF) mixtures comprising n-heptane and iso-octane is known to exhibit a non-linear octane response; however, the underlying chemistry and intermolecular interactions are poorly understood. Well-designed experiments and numerical simulations are required to understand these blending effects and the chemical kinetic phenomenon responsible for them. To this end, HCCI engine experiments were previously performed at four different conditions of intake temperature and engine speed for various PRF/ethanol mixtures. Transfer functions were developed in the HCCI engine to relate PRF mixture composition to autoignition tendency at various compression ratios. The HCCI blending octane number (BON) was determined for mixtures of 2-20 vol % ethanol with PRF70. In the present work, the experimental conditions were considered to perform zero-dimensional HCCI engine simulations with detailed chemical kinetics for ethanol/PRF blends. The simulations used the actual engine geometry and estimated intake valve closure conditions to replicate the experimentally measured start of combustion (SOC) for various PRF mixtures. The simulated HCCI heat release profiles were shown to reproduce the experimentally observed trends, specifically on the effectiveness of ethanol as a low temperature chemistry inhibitor at various concentrations. Detailed analysis of simulated heat release profiles and the evolution of important radical intermediates (e.g., OH and HO) were used to show the effect of ethanol blending on controlling reactivity. A strong coupling between the low temperature oxidation reactions of ethanol and those of n-heptane and iso-octane is shown to be responsible for the observed blending effects of ethanol/PRF mixtures.

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

Science.gov (United States)

2013-11-14

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

Self-Handicapping and Irrational Beliefs about Approval in a Sample of Teacher Candidates

Science.gov (United States)

Kaya, Çinar; Ugur, Erol; Sar, Ali Haydar; Ercengiz, Mustafa

2017-01-01

The main objective of the current study is to examine the relationships between self-handicapping, and irrational beliefs about approval, irrational beliefs about interpersonal relationships, irrational beliefs about self and the overall level of irrational beliefs by reference to the " ABC " framework. Participants of the study were 263…

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

Science.gov (United States)

2013-11-14

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

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-10-01

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 Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date.

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

International Nuclear Information System (INIS)

1995-10-01

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 Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

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...

19 CFR 176.22 - Deletion of protest or entry number.

Science.gov (United States)

2010-04-01

... 19 Customs Duties 2 2010-04-01 2010-04-01 false Deletion of protest or entry number. 176.22... Facts § 176.22 Deletion of protest or entry number. If any protest number or entry number is to be... authorized official making and approving the deletion. [T.D. 70-181, 35 FR 13433, Aug. 22, 1970] ...

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

Science.gov (United States)

2010-05-07

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

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

Science.gov (United States)

2013-07-03

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

77 FR 29275 - Oklahoma: Incorporation by Reference of State Hazardous Waste Management Program

Science.gov (United States)

2012-05-17

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

77 FR 46994 - Oklahoma: Incorporation by Reference of State Hazardous Waste Management Program

Science.gov (United States)

2012-08-07

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

75 FR 36609 - Oklahoma: Incorporation by Reference of State Hazardous Waste Management Program

Science.gov (United States)

2010-06-28

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

7 CFR 1942.350 - OMB control number.

Science.gov (United States)

2010-01-01

...) PROGRAM REGULATIONS (CONTINUED) ASSOCIATIONS Rural Business Enterprise Grants and Television Demonstration... Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... been approved by the Office of Management and Budget and have been assigned OMB control number 0575...

A 'Global Reference' Comparator for Biosimilar Development.

Science.gov (United States)

Webster, Christopher J; Woollett, Gillian R

2017-08-01

Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multiplier effect of required repetition by each biosimilar sponsor, their collective costs are substantial. Yet versions of biologics licensed in different jurisdictions usually share the same development data, and any manufacturing changes between versions have been justified by a rigorous comparability process. The fact that a biosimilar is usually expected to be licensed in multiple jurisdictions, in each case as similar to the local reference product, confirms that minor analytical differences between versions of reference biologics are typically inconsequential for clinical outcomes and licensing. A greatly simplified basis for selecting a reference comparator, that does not require conducting new bridging studies, is proposed and justified based on the shared data of the reference product versions as well as the proof offered where biosimilars have already been approved. The relevance of this proposal to the interchangeability designation available in the US is discussed.

Photon number projection using non-number-resolving detectors

International Nuclear Information System (INIS)

Rohde, Peter P; Webb, James G; Huntington, Elanor H; Ralph, Timothy C

2007-01-01

Number-resolving photo-detection is necessary for many quantum optics experiments, especially in the application of entangled state preparation. Several schemes have been proposed for approximating number-resolving photo-detection using non-number-resolving detectors. Such techniques include multi-port detection and time-division multiplexing. We provide a detailed analysis and comparison of different number-resolving detection schemes, with a view to creating a useful reference for experimentalists. We show that the ideal architecture for projective measurements is a function of the detector's dark count and efficiency parameters. We also describe a process for selecting an appropriate topology given actual experimental component parameters

Descriptions of reference LWR facilities for analysis of nuclear fuel cycles

Energy Technology Data Exchange (ETDEWEB)

Schneider, K.J.; Kabele, T.J.

1979-09-01

To contribute to the Department of Energy's identification of needs for improved environmental controls in nuclear fuel cycles, a study was made of a light water reactor system. A reference LWR fuel cycle was defined, and each step in this cycle was characterized by facility description and mainline and effluent treatment process performance. The reference fuel cycle uses fresh uranium in light water reactors. Final treatment and ultimate disposition of waste from the fuel cycle steps were not included, and the waste is assumed to be disposed of by approved but currently undefined means. The characterization of the reference fuel cycle system is intended as basic information for further evaluation of alternative effluent control systems.

Descriptions of reference LWR facilities for analysis of nuclear fuel cycles

International Nuclear Information System (INIS)

Schneider, K.J.; Kabele, T.J.

1979-09-01

To contribute to the Department of Energy's identification of needs for improved environmental controls in nuclear fuel cycles, a study was made of a light water reactor system. A reference LWR fuel cycle was defined, and each step in this cycle was characterized by facility description and mainline and effluent treatment process performance. The reference fuel cycle uses fresh uranium in light water reactors. Final treatment and ultimate disposition of waste from the fuel cycle steps were not included, and the waste is assumed to be disposed of by approved but currently undefined means. The characterization of the reference fuel cycle system is intended as basic information for further evaluation of alternative effluent control systems

76 FR 24372 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Update to Materials...

Science.gov (United States)

2011-05-02

... revised the procedures for incorporating by reference Federally- approved SIPs, as a result of... document, IBR procedures and ``Identification of plan'' format are discussed in further detail in the May...) of the Administrative Procedures Act (APA) which, upon finding ``good cause,'' authorizes agencies to...

Pharmacovigilance of biologicals : dynamics in post-approval safety learning

NARCIS (Netherlands)

Vermeer, N.S.

2015-01-01

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

7 CFR 1956.100 - OMB control number.

Science.gov (United States)

2010-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS...) PROGRAM REGULATIONS (CONTINUED) DEBT SETTLEMENT Debt Settlement-Farm Loan Programs and Multi-Family... been approved by the Office of Management and Budget and assigned OMB control number 0575-0118. Public...

29 CFR 4010.15 - OMB control number.

Science.gov (United States)

2010-07-01

... Regulations Relating to Labor (Continued) PENSION BENEFIT GUARANTY CORPORATION CERTAIN REPORTING AND DISCLOSURE REQUIREMENTS ANNUAL FINANCIAL AND ACTUARIAL INFORMATION REPORTING § 4010.15 OMB control number. The collection of information requirements contained in this part have been approved by the Office of...

75 FR 45583 - New York: Incorporation by Reference of State Hazardous Waste Management Program

Science.gov (United States)

2010-08-03

...: Incorporation by Reference of State Hazardous Waste Management Program AGENCY: Environmental Protection Agency... authorized hazardous waste program which is set forth in the regulations entitled ``Approved State Hazardous Waste Management Programs'', New York's authorized hazardous waste program. EPA will incorporate by...

77 FR 3224 - New Mexico: Incorporation by Reference of State Hazardous Waste Management Program

Science.gov (United States)

2012-01-23

... Mexico: Incorporation by Reference of State Hazardous Waste Management Program AGENCY: Environmental... entitled ``Approved State Hazardous Waste Management Programs,'' New Mexico's authorized hazardous waste... of the State regulations that are authorized and that the EPA will enforce under the Solid Waste...

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

Science.gov (United States)

2010-03-15

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

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

Science.gov (United States)

2013-03-25

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

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

Science.gov (United States)

2012-10-16

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

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

International Nuclear Information System (INIS)

1979-10-01

This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. 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 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

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

Energy Technology Data Exchange (ETDEWEB)

None

1979-10-01

This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. 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 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.

76 FR 28727 - Child Nutrition (CN) Labeling Program; Request for Extension and Revision of a Currently Approved...

Science.gov (United States)

2011-05-18

... (CN) Labeling Program; Request for Extension and Revision of a Currently Approved Information... INFORMATION: Title: Child Nutrition Labeling Program. OMB Number: 0581-0261 . Expiration Date of Approval: 3... collection. Abstract: The Child Nutrition (CN) Labeling Program is a voluntary technical assistance service...

Preferred Formats for References | Editor | Ghana Journal of ...

African Journals Online (AJOL)

Preferred Formats for References. References made in the notes or in the text should include author's last name, the date of publication and the relevant page number(s), e.g. (Chomsky 1972: 63-4). There should be a separate list of references at the end of the paper, but before any appendices, in which all and only items ...

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

Locus Reference Genomic sequences: An improved basis for describing human DNA variants

KAUST Repository

Dalgleish, Raymond; Flicek, Paul; Cunningham, Fiona; Astashyn, Alex; Tully, Raymond E; Proctor, Glenn; Chen, Yuan; McLaren, William M; Larsson, Pontus; Vaughan, Brendan W; Bé roud, Christophe; Dobson, Glen; Lehvä slaiho, Heikki; Taschner, Peter EM; den Dunnen, Johan T; Devereau, Andrew; Birney, Ewan; Brookes, Anthony J; Maglott, Donna R

2010-01-01

As our knowledge of the complexity of gene architecture grows, and we increase our understanding of the subtleties of gene expression, the process of accurately describing disease-causing gene variants has become increasingly problematic. In part, this is due to current reference DNA sequence formats that do not fully meet present needs. Here we present the Locus Reference Genomic (LRG) sequence format, which has been designed for the specifi c purpose of gene variant reporting. The format builds on the successful National Center for Biotechnology Information (NCBI) RefSeqGene project and provides a single-fi le record containing a uniquely stable reference DNA sequence along with all relevant transcript and protein sequences essential to the description of gene variants. In principle, LRGs can be created for any organism, not just human. In addition, we recognize the need to respect legacy numbering systems for exons and amino acids and the LRG format takes account of these. We hope that widespread adoption of LRGs - which will be created and maintained by the NCBI and the European Bioinformatics Institute (EBI) - along with consistent use of the Human Genome Variation Society (HGVS)- approved variant nomenclature will reduce errors in the reporting of variants in the literature and improve communication about variants aff ecting human health. Further information can be found on the LRG web site (http://www.lrg-sequence.org). 2010 Dalgleish et al.; licensee BioMed Central Ltd.

Locus Reference Genomic sequences: An improved basis for describing human DNA variants

KAUST Repository

Dalgleish, Raymond

2010-04-15

As our knowledge of the complexity of gene architecture grows, and we increase our understanding of the subtleties of gene expression, the process of accurately describing disease-causing gene variants has become increasingly problematic. In part, this is due to current reference DNA sequence formats that do not fully meet present needs. Here we present the Locus Reference Genomic (LRG) sequence format, which has been designed for the specifi c purpose of gene variant reporting. The format builds on the successful National Center for Biotechnology Information (NCBI) RefSeqGene project and provides a single-fi le record containing a uniquely stable reference DNA sequence along with all relevant transcript and protein sequences essential to the description of gene variants. In principle, LRGs can be created for any organism, not just human. In addition, we recognize the need to respect legacy numbering systems for exons and amino acids and the LRG format takes account of these. We hope that widespread adoption of LRGs - which will be created and maintained by the NCBI and the European Bioinformatics Institute (EBI) - along with consistent use of the Human Genome Variation Society (HGVS)- approved variant nomenclature will reduce errors in the reporting of variants in the literature and improve communication about variants aff ecting human health. Further information can be found on the LRG web site (http://www.lrg-sequence.org). 2010 Dalgleish et al.; licensee BioMed Central Ltd.

Hg0 and HgCl2 Reference Gas Standards: ?NIST Traceability ...

Science.gov (United States)

EPA and NIST have collaborated to establish the necessary procedures for establishing the required NIST traceability of commercially-provided Hg0 and HgCl2 reference generators. This presentation will discuss the approach of a joint EPA/NIST study to accurately quantify the true concentrations of Hg0 and HgCl2 reference gases produced from high quality, NIST-traceable, commercial Hg0 and HgCl2 generators. This presentation will also discuss the availability of HCl and Hg0 compressed reference gas standards as a result of EPA's recently approved Alternative Methods 114 and 118. Gaseous elemental mercury (Hg0) and oxidized mercury (HgCl2) reference standards are integral to the use of mercury continuous emissions monitoring systems (Hg CEMS) for regulatory compliance emissions monitoring. However, a quantitative disparity of approximately 7-10% has been observed between commercial Hg0 and HgCl2 reference gases which currently limits the use of (HgCl2) reference gas standards. Resolving this disparity would enable the expanded use of (HgCl2) reference gas standards for regulatory compliance purposes.

75 FR 45489 - New York: Incorporation by Reference of State Hazardous Waste Management Program

Science.gov (United States)

2010-08-03

...: Incorporation by Reference of 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. EPA uses the regulations entitled ``Approved State Hazardous Waste Management Programs'' to...

Introduction to Animal Nutrition. Instructor Guide [and] Student Reference. Volume 28, Number 7 [and] Volume 28, Number 8.

Science.gov (United States)

Peiter, Andrea; And Others

This instructor guide and the corresponding student reference contain five lessons about animal science for inclusion in Vocational Instructional Management System (VIMS) agricultural education courses. The lessons cover these topics: the monogastric digestive system, the ruminant digestive system, the importance of meeting nutritional needs, how…

Introduction to Animal Reproduction. Instructor Guide [and] Student Reference. Volume 28, Number 5 [and] Volume 28, Number 6.

Science.gov (United States)

Peiter, Andrea; And Others

This instructor guide and the corresponding student reference contain seven lessons about animal reproduction for inclusion in Vocational Instructional Management System (VIMS) agricultural education courses. The lessons cover the following topics: the male and female reproductive systems, puberty and the estrous cycle, conception and gestation,…

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

Science.gov (United States)

2012-01-26

... Incorporated by Reference, in order to make administrative changes for clarity, style, format, renumbering, and... follows: PART 52--[AMENDED] 0 1. The authority citation for 40 CFR part 52 continues to read as follows... Statutes State State citation Title/subject effective EPA approval date Explanation [former date SIP...

78 FR 46516 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update to Materials...

Science.gov (United States)

2013-08-01

... for incorporating by reference Federally- approved SIPs, as a result of consultations between EPA and... and ``Identification of plan'' format are discussed in further detail in the May 22, 1997 Federal... ``good cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon...

78 FR 58465 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Update to Materials...

Science.gov (United States)

2013-09-24

... for incorporating by reference Federally- approved SIPs, as a result of consultations between EPA and... and ``Identification of plan'' format are discussed in further detail in the May 22, 1997 Federal... the ``good cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which...

78 FR 11984 - Approval and Promulgation of Implementation Plans; State of Hawaii; Update to Materials...

Science.gov (United States)

2013-02-21

... procedures for incorporating by reference federally-approved SIPs, as a result of consultations between EPA... procedures and ``Identification of plan'' format are discussed in further detail in the May 22, 1997 Federal... cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding...

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...

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive material 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

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

Science.gov (United States)

2010-08-27

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

77 FR 64510 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2012-10-22

... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Metal Furniture Surface... Furniture Surface Coating (Renewal). ICR Numbers: EPA ICR Number 1952.05, OMB Control Number 2060-0518. ICR... instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting...

Neutrino number of the universe

International Nuclear Information System (INIS)

Kolb, E.W.

1981-01-01

The influence of grand unified theories on the lepton number of the universe is reviewed. A scenario is presented for the generation of a large (>> 1) lepton number and a small (<< 1) baryon number. 15 references

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.

76 FR 19771 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2011-04-08

... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Vinyl Chloride (Renewal... . Title: NESHAP for Vinyl Chloride (Renewal). ICR Numbers: EPA ICR Number 0186.12, OMB Control Number 2060... performance tests, and periodic reports and results. Owners or operators are also required to maintain records...

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 ...

24 CFR 200.1101 - Cross-reference.

Science.gov (United States)

2010-04-01

... URBAN DEVELOPMENT GENERAL INTRODUCTION TO FHA PROGRAMS Social Security Numbers and Employer Identification Numbers; Applicants in Unassisted Programs § 200.1101 Cross-reference. The provisions in subpart B of part 5 of this title apply to Social Security Numbers and Employer Identification Numbers for...

24 CFR 200.1001 - Cross-reference.

Science.gov (United States)

2010-04-01

... URBAN DEVELOPMENT GENERAL INTRODUCTION TO FHA PROGRAMS Social Security Numbers and Employer Identification Numbers; Assistance Applicants and Participants § 200.1001 Cross-reference. The provisions in subpart B of part 5 of this title apply to Social Security Numbers and Employer Identification Numbers for...

75 FR 54654 - Agency Information Collection Activities; Proposals, Submissions, and Approvals

Science.gov (United States)

2010-09-08

... appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of.... Type of Review: Extension without change of a previously approved collection. Title of Collection.... Affected Public: Businesses or other for-profits, Federal Government. Total Estimated Number of Responses...

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 ...

Judicial problems in connection with preliminary decision and construction design approval in nuclear licensing procedures

International Nuclear Information System (INIS)

Schmieder, K.

1977-01-01

Standardization in nuclear engineering makes two demands on a legal instrument which is to make this standardization possible and which is to promote standardization in the nuclear licensing practice: On the basis of just one licence for a constructional part or a component, its applicability in any number of subsequent facility licensing procedures has to be warranted, and by virtue of its binding effect, standardization has to create a sufficiently big confidence protection with manufacturers, constructioneers and operators to offer sufficiently effective incentives for standardization. The nuclear preliminary decision pursuant to section 7 a of the Atomic Energy Act in the form of the component preliminary decision appears to be unsuitable as a legal instrument for standardization, as the preliminary decision refers exclusively to the construction of a concrete facility. For standardization in reactor engineering, the construction design approval appears to be basically the proper legal instrument on account of its legal structure as well as its economic effect. Its binding effect encouters a limitation with regard to third parties in so far that this limitation could question again the binding effect in a subsequent site-dependent nuclear licence procedure. The legal structure of the extent of the binding effect, which is decisive for the suitability of the construction design approval, lies with the legislator. The following questions have to be regulated: Ought the applicant to have a legal claim on the granting of a construction design approval, or ought it to be at the discretion of the authorities, and secondly, the extent of the binding effect in terms of time on the basis of the fixation of a time limit, or on the basis of the possibility of subsequent conditions to be imposed, or the revocation. (orig./HP) [de

Three Drugs Approved for Urothelial Carcinoma by FDA.

Science.gov (United States)

2017-07-01

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

Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

Science.gov (United States)

Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

2015-01-01

Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

Recent references

International Nuclear Information System (INIS)

Ramavataram, S.

1991-01-01

In support of a continuing program of systematic evaluation of nuclear structure data, the National Nuclear Data Center maintains a complete computer file of references to the nuclear physics literature. Each reference is tagged by a keyword string, which indicates the kinds of data contained in the article. This master file of Nuclear Structure References (NSR) contains complete keyword indexes to literature published since 1969, with partial indexing of older references. Any reader who finds errors in the keyword descriptions is urged to report them to the National Nuclear Data Center so that the master NSR file can be corrected. In 1966, the first collection of Recent References was published as a separate issue of Nuclear Data Sheets. Every four months since 1970, a similar indexed bibliography to new nuclear experiments has been prepared from additions to the NSR file and published. Beginning in 1978, Recent References was cumulated annually, with the third issue completely superseding the two issues previously published during a given year. Due to publication policy changes, cumulation of Recent Reference was discontinued in 1986. The volume and issue number of all the cumulative issues published to date are given. NNDC will continue to respond to individual requests for special bibliographies on nuclear physics topics, in addition to those easily obtained from Recent References. If the required information is available from the keyword string, a reference list can be prepared automatically from the computer files. This service can be provided on request, in exchange for the timely communication of new nuclear physics results (e.g., preprints). A current copy of the NSR file may also be obtained in a standard format on magnetic tape from NNDC. Requests for special searches of the NSR file may also be directed to the National Nuclear Data Center

Development of a certified reference materials for composition of citric acid

Directory of Open Access Journals (Sweden)

D. H. Kulev

2014-01-01

Full Text Available The paper presents a summary of analyzing Technical Regulations of the Customs Union TR TC 029/2012 "Safety Requirements for Food Additives, Flavorings and Technological Processing Aids". Information on certified reference materials (RMs for composition of citric acid is provided. Certified characteristics of the RM are, on the one hand, mass fraction of the base substance and, on the other hand, mass fraction of impurities - toxic elements (lead, arsenic, cadmium, mercury. The first batches of the given RMs are produced, which are registered in the State Register of the approved types of certified reference materials GS010300-2013 and GS010143-2012.

Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product

Directory of Open Access Journals (Sweden)

Abdalla A

2017-03-01

Full Text Available Abuelmagd Abdalla, Niamh Byrne, Richard Conway, Thomas Walsh, Geraldine Mannion, Michael Hanly, Miriam O’Sullivan, Ann Maria Curran, John J Carey Department of Rheumatology, Galway University Hospitals, Galway, Ireland Purpose: To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. Patients and methods: In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. Results: Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9, mean disease duration 14.79 years (9.7, median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3 months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively. There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7% patients discontinued the biosimilar infliximab. Conclusion: Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost. Keywords: biologic therapy, rheumatic diseases, biosimilar exchange, infliximab, adult

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages

International Nuclear Information System (INIS)

1990-10-01

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 quality assurance programs for radioactive materials packages

International Nuclear Information System (INIS)

1989-10-01

The purpose of this directory is to make available a convenient source of information on packaging 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

78 FR 44884 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Update to Materials...

Science.gov (United States)

2013-07-25

... reference Federally- approved SIPs, as a result of consultations between EPA and the Office of the Federal...'' format are discussed in further detail in the May 22, 1997 Federal Register document. On February 10... under the ``good cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA...

78 FR 22020 - Agency Information Collection Activities: Requests for Comments; Clearance of New Approval of...

Science.gov (United States)

2013-04-12

... Control Number: 2120-XXXX. Title: Safety Awareness, Feedback, and Evaluation (SAFE) Program. Form Numbers: No FAA forms are associated with this collection. Type of Review: Clearance of a new information... Activities: Requests for Comments; Clearance of New Approval of Information Collection: Safety Awareness...

24 CFR 3285.4 - Incorporation by reference (IBR).

Science.gov (United States)

2010-04-01

..., Virginia 22206. (1) ACCA Manual J, Residential Load Calculation, 8th Edition, IBR approved for § 3285.503(a)(1)(i)(A). (2) [Reserved] (c) The materials listed below are available for purchase from APA—The...-6600, fax number (253) 565-7265. (1) PS1-95, Construction and Industrial Plywood (with typical APA...

Learn every day about numbers 100 best ideas from teachers

CERN Document Server

Charner, Kathy

2009-01-01

Classroom-tested and teacher approved, these activities help children ages three to six learn all about numbers. With one hundred engaging and fun activities, Learn Every Day About Numbers offers everything a teacher needs to build a foundation for future math learning. Children will love becoming a Number Detective, a Flashlight Writer, or a Number Hero as they investigate the wonderful world of numbers. Each activity offers learning objectives to meet standards, a materials list, related children's books, and an assessment component to measure children's learning. Learning about numbers has never been so much fun!.

Recent references May through August 1992

International Nuclear Information System (INIS)

Ramavataram, S.

1992-01-01

In support of a continuing program of systematic evaluation of nuclear structure data, the National Nuclear Data Center maintains a complete computer file of references to the nuclear physics literature. Each reference is tagged by a keyword string, which indicates the kinds of data contained in the article. This master file of Nuclear Structure References (NSR) contains complete keyword indexes to literature published since 1969, with partial indexing of older references. Listed are Key Numbers and Keywords, a reaction index, and references and secondary sources for the data

Reference Ranges in [(99m)Tc]Mercaptoacetyltriglycerine Renography

DEFF Research Database (Denmark)

Rewers, Kate I; Hvidsten, Svend; Gerke, Oke

2015-01-01

PURPOSE: The purpose of the study was to define reference ranges for quantitative parameters in [(99m)Tc]mercaptoacetyltriglycerine ([(99m)Tc]MAG3) renography to assist interpretation in a semi-automated (Xeleris, GE) compared to a manual (Picker, Odyssey) software package. PROCEDURES: Forty......-eight subjects approved for renal donation were evaluated with [(99m)Tc]MAG3 renography using both the Xeleris and the Picker software. RESULTS: Reference ranges for the two software were comparable regarding the relative function of the two kidneys (the split function, SF) and the residual activities (RA......). The time to peak whole-kidney activities (T max whole-kidney) was more dependent on the type of software. Using Bland-Altman limits, we found good and acceptable agreement between the two methods. CONCLUSIONS: We found good correlation between renography results using the Xeleris and Picker software...

Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved quality assurance programs for radioactive material 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

77 FR 69844 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Science.gov (United States)

2012-11-21

... Reserve expects to use the Statement in reviewing the internal controls and risk management systems of.... Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of... control number. [[Page 69845

49 CFR 107.705 - Registrations, reports, and applications for approval.

Science.gov (United States)

2010-10-01

... format may be filed by facsimile (fax) to: (202) 366-3753 or (202) 366-3308 or by electronic mail (e-mail... mailing addresses, e-mail address optional, and telephone number of the person on whose behalf the... proposed duration of the approval; (3) The transport mode or modes affected, as applicable; (4) Any...

Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.

Science.gov (United States)

Beck, Alain; Reichert, Janice M

2013-01-01

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product's (Remicade®) patent in the EU.

[Errors in Peruvian medical journals references].

Science.gov (United States)

Huamaní, Charles; Pacheco-Romero, José

2009-01-01

References are fundamental in our studies; an adequate selection is asimportant as an adequate description. To determine the number of errors in a sample of references found in Peruvian medical journals. We reviewed 515 scientific papers references selected by systematic randomized sampling and corroborated reference information with the original document or its citation in Pubmed, LILACS or SciELO-Peru. We found errors in 47,6% (245) of the references, identifying 372 types of errors; the most frequent were errors in presentation style (120), authorship (100) and title (100), mainly due to spelling mistakes (91). References error percentage was high, varied and multiple. We suggest systematic revision of references in the editorial process as well as to extend the discussion on this theme. references, periodicals, research, bibliometrics.

46 CFR 162.050-4 - Incorporation by reference: Where can I get a copy of the publications mentioned in this part?

Science.gov (United States)

2010-10-01

... ENGINEERING EQUIPMENT Pollution Prevention Equipment § 162.050-4 Incorporation by reference: Where can I get a....org): (1) International Standard ISO 8217 Third edition 2005-11-01, Petroleum products—Fuels (class F)—Specifications of marine fuels (“ISO 8217”), incorporation by reference approved for § 162.050-20. (2...

Fast IMRT by increasing the beam number and reducing the number of segments

International Nuclear Information System (INIS)

Bratengeier, Klaus; Gainey, Mark B; Flentje, Michael

2011-01-01

The purpose of this work is to develop fast deliverable step and shoot IMRT technique. A reduction in the number of segments should theoretically be possible, whilst simultaneously maintaining plan quality, provided that the reduction is accompanied by an increased number of gantry angles. A benefit of this method is that the segment shaping could be performed during gantry motion, thereby reducing the delivery time. The aim was to find classes of such solutions whose plan quality can compete with conventional IMRT. A planning study was performed. Step and shoot IMRT plans were created using direct machine parameter optimization (DMPO) as a reference. DMPO plans were compared to an IMRT variant having only one segment per angle ('2-Step Fast'). 2-Step Fast is based on a geometrical analysis of the topology of the planning target volume (PTV) and the organs at risk (OAR). A prostate/rectum case, spine metastasis/spinal cord, breast/lung and an artificial PTV/OAR combination of the ESTRO-Quasimodo phantom were used for the study. The composite objective value (COV), a quality score, and plan delivery time were compared. The delivery time for the DMPO reference plan and the 2-Step Fast IMRT technique was measured and calculated for two different linacs, a twelve year old Siemens Primus™ ('old' linac) and two Elekta Synergy™ 'S' linacs ('new' linacs). 2-Step Fast had comparable or better quality than the reference DMPO plan. The number of segments was smaller than for the reference plan, the number of gantry angles was between 23 and 34. For the modern linac the delivery time was always smaller than that for the reference plan. The calculated (measured) values showed a mean delivery time reduction of 21% (21%) for the new linac, and of 7% (3%) for the old linac compared to the respective DMPO reference plans. For the old linac, the data handling time per beam was the limiting factor for the treatment time reduction. 2-Step

Fast IMRT by increasing the beam number and reducing the number of segments

Directory of Open Access Journals (Sweden)

Bratengeier Klaus

2011-12-01

Full Text Available Abstract Purpose The purpose of this work is to develop fast deliverable step and shoot IMRT technique. A reduction in the number of segments should theoretically be possible, whilst simultaneously maintaining plan quality, provided that the reduction is accompanied by an increased number of gantry angles. A benefit of this method is that the segment shaping could be performed during gantry motion, thereby reducing the delivery time. The aim was to find classes of such solutions whose plan quality can compete with conventional IMRT. Materials/Methods A planning study was performed. Step and shoot IMRT plans were created using direct machine parameter optimization (DMPO as a reference. DMPO plans were compared to an IMRT variant having only one segment per angle ("2-Step Fast". 2-Step Fast is based on a geometrical analysis of the topology of the planning target volume (PTV and the organs at risk (OAR. A prostate/rectum case, spine metastasis/spinal cord, breast/lung and an artificial PTV/OAR combination of the ESTRO-Quasimodo phantom were used for the study. The composite objective value (COV, a quality score, and plan delivery time were compared. The delivery time for the DMPO reference plan and the 2-Step Fast IMRT technique was measured and calculated for two different linacs, a twelve year old Siemens Primus™ ("old" linac and two Elekta Synergy™ "S" linacs ("new" linacs. Results 2-Step Fast had comparable or better quality than the reference DMPO plan. The number of segments was smaller than for the reference plan, the number of gantry angles was between 23 and 34. For the modern linac the delivery time was always smaller than that for the reference plan. The calculated (measured values showed a mean delivery time reduction of 21% (21% for the new linac, and of 7% (3% for the old linac compared to the respective DMPO reference plans. For the old linac, the data handling time per beam was the limiting factor for the treatment time

78 FR 13243 - Updates to Standards Incorporated by Reference; Reapproved ASTM Standards; Technical Amendment

Science.gov (United States)

2013-02-27

... Characteristics of Plastic Film 2009)[egr]1. and Sheeting. Standard Specification for F682-82a F682-82a 46 56.01-2... (Reapproved Standard Test Method for Determining Gas 2009)[egr]1. Permeability Characteristics of Plastic Film... Permeability Characteristics of Plastic Film and Sheeting (approved May 1, 2009), incorporation by reference...

77 FR 37904 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2012-06-25

... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Reinforced Plastic... compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an...: NESHAP for Reinforced Plastic Composites Production (Renewal) ICR Numbers: EPA ICR Number 1976.05, OMB...

77 FR 64512 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2012-10-22

... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Metal Furniture Coating... Furniture Coating (40 CFR Part 60, Subpart EE) (Renewal) ICR Numbers: EPA ICR Number 0649.11, OMB Control... needed to review instructions; develop, acquire, install, and utilize technology and systems for the...

78 FR 77203 - Agency Requests for Renewal of a Previously Approved Information Collection(s): War Risk...

Science.gov (United States)

2013-12-20

... Previously Approved Information Collection(s): War Risk Insurance, Applications and Related Information... determine the eligibility of the applicant and the vessel(s) for participation in the war risk insurance... Control Number: 2133-0011. Title: War Risk Insurance, Applications and Related Information. Form Numbers...

75 FR 16458 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2010-04-01

... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Plastic Parts and Products... Protection Agency (EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C... . Title: NESHAP for Plastic Parts and Products Surface Coating (Renewal). ICR Numbers: EPA ICR Number 2044...

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages. Volume 3, Revision 15

International Nuclear Information System (INIS)

1995-10-01

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 Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPI.

Science.gov (United States)

Yoshida, Shimon; Matsui, Rie; Kikuchi, Chikara

2018-01-01

Pharmaceutical labeling describes the safe and effective use of an approved product. Such information may be provided to consumers and/or health care physicians, and available online or in the pack in a variety of different formats according to local or regional regulations. Depending on the Health Authority (HA), content within a nationally approved label is generally reliant on two primary sources, a Company Core Data Sheet (CCDS), and the text approved by the Health Authority. Content in the nationally approved label may differ from the CCDS for a variety of reasons. In some countries, HAs require the Marketing Authorization Holder (MAH) to base their national label on an already approved label in a "major market" economy, only approving changes to the label when there is evidence that the major market has already approved. In this paper, we examine recent steps taken by the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to change labeling regulation in Japan in the context of the recently communicated national strategy, and assess whether this may impact on uptake of the J-PI as a reference label. Decreases in approval times by PMDA for new products, development of basic principles on multiregional clinical trials, greater transparency of content on the PMDA website, and increasing outreach to other Asian Agencies in recent years are highlighted. Labeling harmonization across regions, particularly of safety-related information, represents a key factor in promoting patient safety and risk communication, and is a worthy topic for future ICH consideration.

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,...

7 CFR 1940.350 - Office of Management and Budget (OMB) control number.

Science.gov (United States)

2010-01-01

... 7 Agriculture 13 2010-01-01 2009-01-01 true Office of Management and Budget (OMB) control number....350 Office of Management and Budget (OMB) control number. The collection of information requirements in this regulation has been approved by the Office of Management and Budget and has been assigned OMB...

Virtual Reference Services.

Science.gov (United States)

Brewer, Sally

2003-01-01

As the need to access information increases, school librarians must create virtual libraries. Linked to reliable reference resources, the virtual library extends the physical collection and library hours and lets students learn to use Web-based resources in a protected learning environment. The growing number of virtual schools increases the need…

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.

Distribution theory of algebraic numbers

CERN Document Server

Yang, Chung-Chun

2008-01-01

The book timely surveys new research results and related developments in Diophantine approximation, a division of number theory which deals with the approximation of real numbers by rational numbers. The book is appended with a list of challenging open problems and a comprehensive list of references. From the contents: Field extensions Algebraic numbers Algebraic geometry Height functions The abc-conjecture Roth''s theorem Subspace theorems Vojta''s conjectures L-functions.

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...

Entomology for Agricultural Science II Core Curriculum. Instructor Guide, Volume 23, Number 2, and Student Reference, Volume 23, Number 3.

Science.gov (United States)

DeFelice, Karen L.

This unit is a basic introduction to entomology. The instructor guide and the corresponding student reference contain seven lessons: (1) introduction to entomology; (2) insect collection; (3) insect identification; (4) methods of control; (5) chemical control measures; (6) safe use of insecticides; and (7) integrated pest management. Students…

77 FR 56212 - Federal Acquisition Regulation; Information Collection; Use of Data Universal Numbering System...

Science.gov (United States)

2012-09-12

...; Information Collection; Use of Data Universal Numbering System (DUNS) as Primary Contractor Identification... ``Information Collection 9000-0145, Use of Data Universal Numbering System (DUNS) as Primary Contractor... extension of a previously approved information collection requirement concerning use of the Data Universal...

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...

78 FR 34151 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Science.gov (United States)

2013-06-06

... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2013-0050] Notice... of a signal system. FRA assigned the petition Docket Number FRA-2013-0050. Applicant: Wisconsin... Railway (CN), seeks approval of the proposed discontinuance and removal of a traffic control system (TCS...

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...

Medical Surveillance Monthly Report (MSMR). Volume 14, Number 2, May 2007

Science.gov (United States)

2007-05-01

portable insulated food containers. Desserts and green salads were prepackaged in individual and large serving sizes, respectively. Soldiers could...MONITOR’S ACRONYM(S) 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 12. DISTRIBUTION/AVAILABILITY STATEMENT Approved for public release ; distribution unlimited...which includes post-traumatic stress disorder) (Table 2). Among these cohorts, service members who redeployed between January and June 2003

The theory of algebraic numbers

CERN Document Server

Pollard, Harry

1998-01-01

An excellent introduction to the basics of algebraic number theory, this concise, well-written volume examines Gaussian primes; polynomials over a field; algebraic number fields; and algebraic integers and integral bases. After establishing a firm introductory foundation, the text explores the uses of arithmetic in algebraic number fields; the fundamental theorem of ideal theory and its consequences; ideal classes and class numbers; and the Fermat conjecture. 1975 edition. References. List of Symbols. Index.

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...

Writing More Informative Letters of Reference

OpenAIRE

Wright, Scott M; Ziegelstein, Roy C

2004-01-01

Writing a meaningful and valuable letter of reference is not an easy task. Several factors influence the quality of any letter of reference. First, the accuracy and reliability of the writer's impressions and judgment depend on how well he knows the individual being described. Second, the writer's frame of reference, which is determined by the number of persons at the same level that he has worked with, will impact the context and significance of his beliefs and estimations. Third, the letter...

Sequence Factorization with Multiple References.

Directory of Open Access Journals (Sweden)

Sebastian Wandelt

Full Text Available The success of high-throughput sequencing has lead to an increasing number of projects which sequence large populations of a species. Storage and analysis of sequence data is a key challenge in these projects, because of the sheer size of the datasets. Compression is one simple technology to deal with this challenge. Referential factorization and compression schemes, which store only the differences between input sequence and a reference sequence, gained lots of interest in this field. Highly-similar sequences, e.g., Human genomes, can be compressed with a compression ratio of 1,000:1 and more, up to two orders of magnitude better than with standard compression techniques. Recently, it was shown that the compression against multiple references from the same species can boost the compression ratio up to 4,000:1. However, a detailed analysis of using multiple references is lacking, e.g., for main memory consumption and optimality. In this paper, we describe one key technique for the referential compression against multiple references: The factorization of sequences. Based on the notion of an optimal factorization, we propose optimization heuristics and identify parameter settings which greatly influence 1 the size of the factorization, 2 the time for factorization, and 3 the required amount of main memory. We evaluate a total of 30 setups with a varying number of references on data from three different species. Our results show a wide range of factorization sizes (optimal to an overhead of up to 300%, factorization speed (0.01 MB/s to more than 600 MB/s, and main memory usage (few dozen MB to dozens of GB. Based on our evaluation, we identify the best configurations for common use cases. Our evaluation shows that multi-reference factorization is much better than single-reference factorization.

Reference satellite selection method for GNSS high-precision relative positioning

Directory of Open Access Journals (Sweden)

Xiao Gao

2017-03-01

Full Text Available Selecting the optimal reference satellite is an important component of high-precision relative positioning because the reference satellite directly influences the strength of the normal equation. The reference satellite selection methods based on elevation and positional dilution of precision (PDOP value were compared. Results show that all the above methods cannot select the optimal reference satellite. We introduce condition number of the design matrix in the reference satellite selection method to improve structure of the normal equation, because condition number can indicate the ill condition of the normal equation. The experimental results show that the new method can improve positioning accuracy and reliability in precise relative positioning.

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.

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

Directory of Open Access Journals (Sweden)

Salman Sadullah Usmani

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

References from Brazilian medical journals in national publications.

Science.gov (United States)

Teixeira, Renan Kleber Costa; Botelho, Nara Macedo; Petroianu, Andy

2013-01-01

To assess whether there is a preference for international journal citation to the detriment of national ones in ten Brazilian medical journals, in two different periods. All references in the articles published in Arquivos Brasileiros de Oftalmologia, Revista Brasileira de Cirurgia Cardiovascular, Revista da Associação Médica Brasileira, São Paulo Medical Journal, Arquivos Brasileiros de Endocrinologia e Metabologia, Clinics, Jornal Brasileiro de Pneumologia, Revista da Sociedade Brasileira de Medicina Tropical, Revista Brasileira de Psiquiatria e Acta Ortopédica Brasileira in the years 2011 and 2007 were analyzed, assessing the number of articles published in national and international journals. A total of 36,125 references from 1,462 articles published in the 10 aforementioned journals were analyzed. Of the total number, 4.242 (11.74%) were from Brazilian journals. There was no significant difference between the two analyzed periods. A total of 453 (30,98%) of the articles studied non-cited brazilian papers,and 81 (5.54%) articles had more Brazilian than international references. Of total references analyzed, 11.74% were related to articles published in Brazilian journals. This number, when compared to the percentage of Brazilian articles published in the medical area, demonstrates a good number of citations of national articles. Copyright © 2012 Elsevier Editora Ltda. All rights reserved.

77 FR 15755 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Science.gov (United States)

2012-03-16

... Reports Report title: Consolidated Financial Statements for Bank Holding Companies. Agency form number: FR... operations. The FR Y-9C consists of standardized financial statements similar to the Federal Financial..., supporting statements and approved collection of information instruments are placed into OMB's public docket...

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...

Crop Science. Instructor Guide [and] Student Reference. Volume 24, Numbers 5 and 6.

Science.gov (United States)

Humphrey, John Kevin

This document consists of two separately published guides for a course on crop science: an instructor's guide and a student's reference manual. Each part contains nine lessons on the following topics: (1) economic importance of crops; (2) crop uses (products and byproducts); (3) plant and seed identification; (4) certified seed and variety…

Plant Science. Instructor Guide [and] Student Reference. Volume 24, Numbers 3 and 4.

Science.gov (United States)

Humphrey, John Kevin

This document consists of two separately published guides for a course on plant science: an instructor's guide and a student's reference manual. Each part consists of eight lessons and cover the following topics: (1) importance of plants; (2) classification of plants; (3) plant growth factors; (4) weeds, diseases, insects; (5) germination; (6)…

12 CFR 27.1 - Scope and OMB control number.

Science.gov (United States)

2010-01-01

... Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY FAIR HOUSING HOME LOAN DATA SYSTEM § 27.1 Scope and OMB control number. (a) Scope. This part applies to the activities of national... information requirements contained in this part were approved by the Office of Management and Budget under OMB...

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...

Reference Design of the Mu2e Detector Solenoid

CERN Document Server

Feher, S; Brandt,, J; Cheban, S; Coleman, R; Dhanaraj, N; Fang, I; Lamm, M; Lombardo, V; Lopes, M; Miller, J; Ostojic, R ,; Orris, D; Page, T; Peterson, T; Tang, Z; Wands, R

2014-01-01

The Mu2e experiment at Fermilab has been approved by the Department of Energy to proceed developing the preliminary design. Integral to the success of Mu2e is the superconducting solenoid system. One of the three major solenoids is the Detector Solenoid that houses the stopping target and the detectors. The goal of the Detector Solenoid team is to produce detailed design specifications that are sufficient for vendors to produce the final design drawings, tooling and fabrication procedures and proceed to production. In this paper we summarize the Reference Design of the Detector Solenoid.

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 ( ...

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.

With Reference to Reference Genes: A Systematic Review of Endogenous Controls in Gene Expression Studies.

Science.gov (United States)

Chapman, Joanne R; Waldenström, Jonas

2015-01-01

The choice of reference genes that are stably expressed amongst treatment groups is a crucial step in real-time quantitative PCR gene expression studies. Recent guidelines have specified that a minimum of two validated reference genes should be used for normalisation. However, a quantitative review of the literature showed that the average number of reference genes used across all studies was 1.2. Thus, the vast majority of studies continue to use a single gene, with β-actin (ACTB) and/or glyceraldehyde 3-phosphate dehydrogenase (GAPDH) being commonly selected in studies of vertebrate gene expression. Few studies (15%) tested a panel of potential reference genes for stability of expression before using them to normalise data. Amongst studies specifically testing reference gene stability, few found ACTB or GAPDH to be optimal, whereby these genes were significantly less likely to be chosen when larger panels of potential reference genes were screened. Fewer reference genes were tested for stability in non-model organisms, presumably owing to a dearth of available primers in less well characterised species. Furthermore, the experimental conditions under which real-time quantitative PCR analyses were conducted had a large influence on the choice of reference genes, whereby different studies of rat brain tissue showed different reference genes to be the most stable. These results highlight the importance of validating the choice of normalising reference genes before conducting gene expression studies.

Directory of Certificates of Compliance for Radioactive Materials Packages. Summary report of NRC approved packages. Volume 1, Revision 8

International Nuclear Information System (INIS)

1985-10-01

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 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 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 utilizing these packagings must be in accordance with the provisions of 49 CFR 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 them that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages. Volume 1. Revision 9

International Nuclear Information System (INIS)

1986-10-01

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 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 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 utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Sections 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. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages. Volume 1, Revision 7

International Nuclear Information System (INIS)

1984-11-01

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 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 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 utilizing these packagings must be in accordance with the provisions of 49 CFR 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 that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

Supplement to the approved requirements for the packaging, labelling and carriage of radioactive material by rail. Packaging, Labelling and Carriage of Radioactive Material by Rail Regulations 1996

International Nuclear Information System (INIS)

1999-01-01

The ADR and RID Framework Directives require EC member states' arrangements for the carriage of dangerous goods on domestic road and rail journeys to align with the existing ADR and RID agreements which cover international journeys by road and rail. Because ADR and RID are updated every two years in line with technical and scientific developments, the ADR/RID Framework Directives are also revised on a two-year cycle, to require member states to amend their implementing legislation accordingly. In Great Britain, these two Directives were initially implemented on 1 September 1996 via regulations (usually referred to as the 'carriage regulations'), containing the general legal duties, supported by approved documents, and an Approved Code of Practice containing the detailed technical requirements. The following approved documents have been updated: (a) Approved Vehicle Requirements (AVR) - L89; (b) Approved Requirements and test methods for the classification and packaging of dangerous goods for carriage (ARTM) - L88; (c) Approved Requirements for the packaging, labelling and carriage of radioactive material by rail (ARCRR) - L94; (d) Approved Requirements for the construction of vehicles intended for the carriage of explosives by road (AEVR) - L92; and (e) Approved Carriage List (ACL) - L90

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...

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

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

77 FR 3490 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval...

Science.gov (United States)

2012-01-24

...] Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Mourning Dove...: Mourning Dove Call Count Survey. Service Form Number(s): 3-159. Type of Request: Extension of currently... migratory bird populations. The Mourning Dove Call Count Survey is an essential part of the migratory bird...

Digital reference service: trends in academic health science libraries.

Science.gov (United States)

Dee, Cheryl R

2005-01-01

Two years after the initial 2002 study, a greater number of academic health science libraries are offering digital reference chat services, and this number appears poised to grow in the coming years. This 2004 follow-up study found that 36 (27%) of the academic health science libraries examined provide digital chat reference services; this was an approximately 6% increase over the 25 libraries (21%) located in 2002. Trends in digital reference services in academic health science libraries were derived from the exploration of academic health science library Web sites and from digital correspondence with academic health science library personnel using e-mail and chat. This article presents an overview of the current state of digital reference service in academic health science libraries.

Directory of certificates of compliance for radioactive materials packages. Volume 3, revision 1. Summary report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1981-12-01

The 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

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...

78 FR 13375 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval...

Science.gov (United States)

2013-02-27

... enjoyable visitor experience at a reasonable rate. Organizational structure and history. Experience with... Opportunities, 36 CFR 51. Service Form Number: None. Type of Request: Extension of a currently approved...

Minutes of the third annual meeting of the Panel on Reference Nuclear Data

International Nuclear Information System (INIS)

Burrows, T.W.; Stewart, L.; Coyne, J.J.

1979-05-01

The major activities of the meeting were as follows: welcome; organization, approval of minutes of the second meeting, and approval of agenda; review of nuclear data compilation and evaluation efforts (national and international efforts, master data files, publications); summary of 1977 panel meeting; definition of reference nuclear data; discussion of specific data needs and possible data center contributions (reactor physics, medicine and biology, controlled thermonuclear reactors and astrophysics); establishment of current interest and future direction of the panel; adjournment. Recommendations and action items are listed. Tables on nuclear data needs in applied physics, medicine and biology, and controlled thermonuclear reactors and astrophysics are presented. Appendixes include membership lists of various committees, summaries of publication activities, survey results, correspondence, and portions of the documents Proceedings of the Magnetic Fusion Energy Blanket and Shield Workshop and National Needs for Critically Evaluated Physical and Chemical Data

A comprehensive profile of DNA copy number variations in a Korean population: identification of copy number invariant regions among Koreans.

Science.gov (United States)

Jeon, Jae Pil; Shim, Sung Mi; Jung, Jong Sun; Nam, Hye Young; Lee, Hye Jin; Oh, Berm Seok; Kim, Kuchan; Kim, Hyung Lae; Han, Bok Ghee

2009-09-30

To examine copy number variations among the Korean population, we compared individual genomes with the Korean reference genome assembly using the publicly available Korean HapMap SNP 50 k chip data from 90 individuals. Korean individuals exhibited 123 copy number variation regions (CNVRs) covering 27.2 mb, equivalent to 1.0% of the genome in the copy number variation (CNV) analysis using the combined criteria of P value (Por= 0.25) among study subjects. In contrast, when compared to the Affymetrix reference genome assembly from multiple ethnic groups, considerably more CNVRs (n=643) were detected in larger proportions (5.0%) of the genome covering 135.1 mb even by more stringent criteria (Por=0.25), reflecting ethnic diversity of structural variations between Korean and other populations. Some CNVRs were validated by the quantitative multiplex PCR of short fluorescent fragment (QMPSF) method, and then copy number invariant regions were detected among the study subjects. These copy number invariant regions would be used as good internal controls for further CNV studies. Lastly, we demonstrated that the CNV information could stratify even a single ethnic population with a proper reference genome assembly from multiple heterogeneous populations.

76 FR 2151 - Notice of Intent To Seek Approval To Renew an Information Collection

Science.gov (United States)

2011-01-12

... Measure Customer Service Satisfaction. OMB Number: 3145-0157. Expiration Date of Approval: August 31, 2011...: On September 11, 1993, President Clinton issued Executive Order 12862, ``Setting Customer Service... determine the kind and quality of services they want and their level of satisfaction with existing services...

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.

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1991 edition

International Nuclear Information System (INIS)

1991-08-01

The format of this report is a result of recommendations made by the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM) at its 6th meeting in November 1987. The database was at that time maintained on the main frame and it was felt that adapting it for use on a personal computer would allow more flexibility in data processing and reporting. This document supersedes TECDOC-552 ''Directory of National Competent Authorities' Approval Certificates for Package Design and Shipment of Radioactive Material 1990 Edition''. Since publication of TECDOC-552, some modifications affecting the structure of the database and reporting formats were undertaken. These are fully described in ''Working Material: The PACKTRAM Database National Competent Authority Package Approval Certificates, User Guide Rev. 1'', which was released in early 1991. The present report is contained in five tables. In each of these, information is presented in alphabetical order based on the certificate number. This is composed of the issuing Member State's VRI code, followed by a slash, then a three- or four-digit number, another slash and finally a code identifying the type of package involved. ''-85'' is appended to those certificates that were approved on the basis of the 1985 Edition of Safety Series No. 6. Tables 1 to 4 present administrative data including issue and expire, dates, package identification, package serial numbers, modes for which the package/shipment is approved and the edition of Safety Series No. 6 on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table. 5

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.

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...

Unsolved problems in number theory

CERN Document Server

Guy, Richard K

1994-01-01

Unsolved Problems in Number Theory contains discussions of hundreds of open questions, organized into 185 different topics. They represent numerous aspects of number theory and are organized into six categories: prime numbers, divisibility, additive number theory, Diophantine equations, sequences of integers, and miscellaneous. To prevent repetition of earlier efforts or duplication of previously known results, an extensive and up-to-date collection of references follows each problem. In the second edition, not only extensive new material has been added, but corrections and additions have been included throughout the book.

Writing more informative letters of reference.

Science.gov (United States)

Wright, Scott M; Ziegelstein, Roy C

2004-05-01

Writing a meaningful and valuable letter of reference is not an easy task. Several factors influence the quality of any letter of reference. First, the accuracy and reliability of the writer's impressions and judgment depend on how well he knows the individual being described. Second, the writer's frame of reference, which is determined by the number of persons at the same level that he has worked with, will impact the context and significance of his beliefs and estimations. Third, the letter-writing skills of the person composing the letter will naturally affect the letter. To support the other components of a candidate's application, a letter of reference should provide specific examples of how an individual's behavior or attitude compares to a reference group and should assess "intangibles" that are hard to glean from a curriculum vitae or from test scores. This report offers suggestions that should help physicians write more informative letters of reference.

Resampling methods in Microsoft Excel® for estimating reference intervals.

Science.gov (United States)

Theodorsson, Elvar

2015-01-01

Computer-intensive resampling/bootstrap methods are feasible when calculating reference intervals from non-Gaussian or small reference samples. Microsoft Excel® in version 2010 or later includes natural functions, which lend themselves well to this purpose including recommended interpolation procedures for estimating 2.5 and 97.5 percentiles. 
The purpose of this paper is to introduce the reader to resampling estimation techniques in general and in using Microsoft Excel® 2010 for the purpose of estimating reference intervals in particular.
 Parametric methods are preferable to resampling methods when the distributions of observations in the reference samples is Gaussian or can transformed to that distribution even when the number of reference samples is less than 120. Resampling methods are appropriate when the distribution of data from the reference samples is non-Gaussian and in case the number of reference individuals and corresponding samples are in the order of 40. At least 500-1000 random samples with replacement should be taken from the results of measurement of the reference samples.

40 CFR 260.11 - References.

Science.gov (United States)

2010-07-01

... Chromatography,” IBR approved for § 264.1063. (4) ASTM D 2382-83, “Standard Test Method for Heat of Combustion of Hydrocarbon Fuels by Bomb Calorimeter (High-Precision Method),” IBR approved for §§ 264.1033, 265.1033. (5..., “Standard Test Methods for Flash Point for Liquids by Setaflash Closed Tester,” IBR approved for § 261.21(a...

Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan.

Science.gov (United States)

Nakayama, Hiroki; Tsukamoto, Katsura

2018-04-17

The approval of orphan anticancer drugs has increased, with the number exceeding that of non-orphan drugs in Japan in recent years. Although orphan anticancer drugs may have unique characteristics due to their rarity, these have not been fully characterized. We investigated anticancer drugs approved in Japan between April 2004 and November 2017 to reveal the characteristics of regulatory approval and pivotal studies on orphan anticancer drugs compared to non-orphan drugs. The median regulatory review time and number of patients in pivotal studies on orphan anticancer drugs (281.0 days [interquartile range, 263.3-336.0]; 222.5 patients [66.0-454.3]) were significantly lower than those on non-orphan drugs (353.0 days [277.0-535.5]; 521.0 patients [303.5-814.5], respectively) (P < 0.001). Phase II, non-randomized and non-controlled designs were more frequently used in pivotal studies on orphan anticancer drugs (45.9%, 41.9% and 43.2%) than non-orphan drugs (17.2%, 14.1% and 14.1%, respectively). Response rate was more commonly used as a primary endpoint in pivotal studies on orphan anticancer drugs (48.6%) than non-orphan drugs (17.2%). Indications limited by molecular features, second or later treatment line, and accelerated approval in the United States were associated with the use of response rate in orphan anticancer drug studies. In conclusion, we demonstrated that orphan anticancer drugs in Japan have unique characteristics compared to non-orphan drugs: shorter regulatory review and pivotal studies frequently using phase II, non-randomized, or non-controlled designs and response rate as a primary endpoint, with fewer patients.

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...

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.

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

Longitudinal evaluation of a World Wide Web-based antimicrobial stewardship program: assessing factors associated with approval patterns and trends over time.

Science.gov (United States)

Venugopal, Vidya; Lehmann, Christoph U; Diener-West, Marie; Agwu, Allison L

2014-02-01

The Johns Hopkins Children's Medical and Surgery Center developed a Web-based Antimicrobial Stewardship Program (ASP) in 2005. The present study aimed to assess longitudinal antimicrobial request and approval patterns for this ASP. We analyzed a total of 16,229 antimicrobial requests for 3,542 patients between June 1, 2005, and June 30, 2009. Antimicrobial approval was the outcome of interest. We assessed gaming by studying trends in automatically approved requests. Nonparametric tests for trend were performed to detect changes in approval patterns. Multiple logistic regression was used to identify factors associated with approval. The vast majority (91.3%) of antimicrobial requests were approved, with an increase of 6.1% over time (P Web-based ASP allows management of a large number of antimicrobial requests, without apparent gaming. Observed differences in approval patterns based on patient, requestor, and antimicrobial factors may inform the development of ASPs and evaluation of provider education and training. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

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...

Analysis of android random number generator

OpenAIRE

Sarıtaş, Serkan

2013-01-01

Ankara : The Department of Computer Engineering and the Graduate School of Engineering and Science of Bilkent University, 2013. Thesis (Master's) -- Bilkent University, 2013. Includes bibliographical references leaves 61-65. Randomness is a crucial resource for cryptography, and random number generators are critical building blocks of almost all cryptographic systems. Therefore, random number generation is one of the key parts of secure communication. Random number generatio...

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...

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1992 ed

International Nuclear Information System (INIS)

1992-08-01

Being in a unique position to facilitate information exchange, the Secretariat of the International Atomic Energy Agency was requested by its Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM) to collate package approval data and publish periodical reports thereon. A database was implemented on the mainframe computer in the mid-1980s but this was soon adapted for use on a personal computer. A fully menu-driven system programme was designed that allows both contributing Member States and the Secretariat more flexibility in data processing and reporting. Complete documentation is available in the form of a user guide. The cut-off date used for this report is 31 August 1992. This report supersedes IAEA-TECDOC-617 ''Directory of National Competent Authorities' Approval Certificates for Package Design, Special Form Material and Shipment of Radioactive Material, 1991 Edition''. The information contained in this report is given in six tables. In each of these, information is presented in alphabetical order based on the certificate number. The certificate number is identical with the competent authority identification mark. It is composed of the issuing Member State's international vehicle registration identification (VRI) code, followed by a slash, then a unique number specific to a particular design or shipment that is assigned by the competent authority, another slash and finally a code identifying the type of package involved. ''-85'' is appended to those certificates that were approved on the basis of the 1985 Edition of Safety Series No. 6. Tables 1 to 4 present administrative data including issue and expiry dates, package identification, package serial numbers, modes for which the package/shipment is approved and the edition of Safety Series No. 6 on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table 5. Table 6

Getting DNA copy numbers without control samples.

Science.gov (United States)

Ortiz-Estevez, Maria; Aramburu, Ander; Rubio, Angel

2012-08-16

The selection of the reference to scale the data in a copy number analysis has paramount importance to achieve accurate estimates. Usually this reference is generated using control samples included in the study. However, these control samples are not always available and in these cases, an artificial reference must be created. A proper generation of this signal is crucial in terms of both noise and bias.We propose NSA (Normality Search Algorithm), a scaling method that works with and without control samples. It is based on the assumption that genomic regions enriched in SNPs with identical copy numbers in both alleles are likely to be normal. These normal regions are predicted for each sample individually and used to calculate the final reference signal. NSA can be applied to any CN data regardless the microarray technology and preprocessing method. It also finds an optimal weighting of the samples minimizing possible batch effects. Five human datasets (a subset of HapMap samples, Glioblastoma Multiforme (GBM), Ovarian, Prostate and Lung Cancer experiments) have been analyzed. It is shown that using only tumoral samples, NSA is able to remove the bias in the copy number estimation, to reduce the noise and therefore, to increase the ability to detect copy number aberrations (CNAs). These improvements allow NSA to also detect recurrent aberrations more accurately than other state of the art methods. NSA provides a robust and accurate reference for scaling probe signals data to CN values without the need of control samples. It minimizes the problems of bias, noise and batch effects in the estimation of CNs. Therefore, NSA scaling approach helps to better detect recurrent CNAs than current methods. The automatic selection of references makes it useful to perform bulk analysis of many GEO or ArrayExpress experiments without the need of developing a parser to find the normal samples or possible batches within the data. The method is available in the open-source R package

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

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 16802 - Extension of Approval of Information Collection, OMB Control Number 1004-0196

Science.gov (United States)

2011-03-25

... paperwork requirements for operators and operating rights owners in the National Petroleum Reserve--Alaska... is provided for the information collection: Title: Oil and Gas Leasing: National Petroleum Reserve... Control Number: 1004-0196. Abstract: This control number covers paperwork requirements for operators and...

A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

Science.gov (United States)

DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

2015-11-01

We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. © 2015 American Society for Clinical Pharmacology and Therapeutics.

78 FR 755 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval...

Science.gov (United States)

2013-01-04

...-FF09W23000; FVWF511009000007B-XXX-FF09W23000] Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Annual Certification of Hunting and Sport Fishing Licenses Issued... Hunting and Sport Fishing Licenses Issued, 50 CFR 80, Subpart D. Service Form Number(s): 3-154a and 3-154b...

Orthorad - the online reference database of skeletal plain film radiography

International Nuclear Information System (INIS)

Hinkmann, F.M.; Heberlein, C.; Greess, H.; Ketelsen, D.; Klose, K.J.; Grunewald, M.

2006-01-01

Purpose: it is evident that there is a growing need for internet-based reference databases for reasons of practicability and due to the increasing use of reporting on digital workstations. The main advantages of online databases are expected with respect to plain film radiography and cross-sectional imaging. A reference database of skeletal plain film radiography was to be created using the Orthorad program. Materials and methods: the most important standard settings and special images of young and healthy adults in plain film radiography were collected over one year. All samples were approved for the Orthorad database by a board qualified radiologist. Based on the workflows of radiographers and radiologists, the records were organized by body part (http://www.idr.med.uni-erlangen.de/orthorad/orthorad.htm). This logical data structure will ensure that the tool serves as a source of information in two ways: On the one hand, the radiographer can access information on positioning, tube voltage and cassette format. On the other hand, the radiologist receives important knowledge regarding X-ray anatomy, reference data regarding the human skeleton, and information about the correct reporting for an image. (orig.)

The generation and management of references with the Online Mechanism for References - MORE

Directory of Open Access Journals (Sweden)

Proxério Manoel Felisberto

2015-04-01

Full Text Available The scientific production and the development of academic papers have their own formalities. In this paper, is sought seek from these formalities for the ones that refers to the way of granting merits to the authors of the works used in the theoretical basis, through quotations and references. The goal is to help users of libraries to generate and manage references using a web tool developed for this purpose. There are many applications, in desktop and web platforms, that could be used to do this task. However, some of them require the payment of an expensive license to be fully functional. Others offers free versions, but they are very limited and often do not generate references specified by ABNT. There are others that do not store the generate references for later use. In order to fill this gap, the Online Mechanism for References (MORE was developed and made available to the general public in the web. Even so, the fast technological advances combined with a high number of users demanded an update to the application, done recently. It is important to state that all the work was developed exclusively with proven and free to use technologies. Initially, sought up identified the main tools available to generate and manage references and which free technologies could be used to build interactive web applications. This paper briefly describes the reengineering process that MORE was submitted, its new structure, new requirements met and its expanded portfolio of features. Finally, the results achieved after the reengineering are compared to indicators of its previous version.

Nuclear model parameter testing for nuclear data evaluation (Reference Input Parameter Library: Phase II). Summary report of the third research co-ordination meeting

International Nuclear Information System (INIS)

Herman, M.

2002-04-01

This report summarises the results and recommendations of the third Research Co-ordination Meeting on improving and testing the Reference Input Parameter Library: Phase II. A primary aim of the meeting was to review the achievements of the CRP, to assess the testing of the library and to approve the final contents. Actions were approved that will result in completion of the file and a draft report by the end of February 2002. Full release of the library is scheduled for July 2002. (author)

77 FR 15432 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Science.gov (United States)

2012-03-15

... corporate governance structure of OCC by: (i) Increasing the number of public directors on OCC's Board of... directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds... Directors, OCC stated that the changes would enhance the corporate governance structure at OCC. As such, the...

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)

A Numbers Game

DEFF Research Database (Denmark)

Levin, Bruce R; McCall, Ingrid C.; Perrot, Veronique

2017-01-01

We postulate that the inhibition of growth and low rates of mortality of bacteria exposed to ribosome-binding antibiotics deemed bacteriostatic can be attributed almost uniquely to these drugs reducing the number of ribosomes contributing to protein synthesis, i.e., the number of effective......-targeting bacteriostatic antibiotics, the time before these bacteria start to grow again when the drugs are removed, referred to as the post-antibiotic effect (PAE), is markedly greater for constructs with fewer rrn operons than for those with more rrn operons. We interpret the results of these other experiments reported...... here as support for the hypothesis that the reduction in the effective number of ribosomes due to binding to these structures provides a sufficient explanation for the action of bacteriostatic antibiotics that target these structures....

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…

A general number-to-space mapping deficit in developmental dyscalculia.

Science.gov (United States)

Huber, S; Sury, D; Moeller, K; Rubinsten, O; Nuerk, H-C

2015-01-01

Previous research on developmental dyscalculia (DD) suggested that deficits in the number line estimation task are related to a failure to represent number magnitude linearly. This conclusion was derived from the observation of logarithmically shaped estimation patterns. However, recent research questioned this idea of an isomorphic relationship between estimation patterns and number magnitude representation. In the present study, we evaluated an alternative hypothesis: impairments in the number line estimation task are due to a general deficit in mapping numbers onto space. Adults with DD and a matched control group had to learn linear and non-linear layouts of the number line via feedback. Afterwards, we assessed their performance how well they learnt the new number-space mappings. We found irrespective of the layouts worse performance of adults with DD. Additionally, in case of the linear layout, we observed that their performance did not differ from controls near reference points, but that differences between groups increased as the distance to reference point increased. We conclude that worse performance of adults with DD in the number line task might be due a deficit in mapping numbers onto space which can be partly overcome relying on reference points. Copyright © 2015 Elsevier Ltd. All rights reserved.

Models of Reference Services in Australian Academic Libraries

Science.gov (United States)

Burke, Liz

2008-01-01

This article reports on a project which was undertaken in 2006 to investigate the current modes and methods for delivering reference services in Australian academic libraries. The project included a literature review to assist in providing a definition of reference services as well as a snapshot of statistics showing staff and patron numbers from…

Excipients and their role in approved injectable products: current usage and future directions.

Science.gov (United States)

Nema, Sandeep; Brendel, Ronald J

2011-01-01

This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper published more than a decade ago (reference 11). Since then many new products have been approved. Safety concerning excipients has evolved as the scientific community continues to learn about their usage. New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications. Excipients are added to parenteral dosage forms to serve a variety of functions including stabilization and as vehicles. This review article is a survey of excipients used in approved injectable products. Information provided includes excipient concentrations, functional roles, and frequency of use. This article is an update of an article originally published over a decade ago. Since then new products have been approved and safety concerns have evolved as the scientific community has learned about the usage of excipients. In addition, new excipients are being used in early phases of clinical trials to support novel therapeutic entities such as RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving

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

H.J. Bhabha: A case study of synchronous references

International Nuclear Information System (INIS)

Swarna, T.; Kalyane, V.L.; Prakasan, E.R.; Kumar, V.

2006-01-01

Quantitative analysis of the events of synchronous references in the research papers followed throughout the publishing career of an individual scientist revealed interesting highlights on the knowledge-generating-system. In the case study of Homi Jehangir Bhabha, the first quinquennium and fifth quinquennium of his research career had low self-references; the third quinquennium and the fourth quinquennium had moderate self-references; whereas the second quinquennium had the highest number of self-references. The two major clusters of self-references occurring during the second and third quinquenniums were indicators of active periods of knowledge-generating and faster communications. (author)

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...

Adaptive testing with equated number-correct scoring

NARCIS (Netherlands)

van der Linden, Willem J.

1999-01-01

A constrained CAT algorithm is presented that automatically equates the number-correct scores on adaptive tests. The algorithm can be used to equate number-correct scores across different administrations of the same adaptive test as well as to an external reference test. The constraints are derived

Some types of parent number talk count more than others: relations between parents' input and children's cardinal-number knowledge.

Science.gov (United States)

Gunderson, Elizabeth A; Levine, Susan C

2011-09-01

Before they enter preschool, children vary greatly in their numerical and mathematical knowledge, and this knowledge predicts their achievement throughout elementary school (e.g. Duncan et al., 2007; Ginsburg & Russell, 1981). Therefore, it is critical that we look to the home environment for parental inputs that may lead to these early variations. Recent work has shown that the amount of number talk that parents engage in with their children is robustly related to a critical aspect of mathematical development - cardinal-number knowledge (e.g. knowing that the word 'three' refers to sets of three entities; Levine, Suriyakham, Rowe, Huttenlocher & Gunderson, 2010). The present study characterizes the different types of number talk that parents produce and investigates which types are most predictive of children's later cardinal-number knowledge. We find that parents' number talk involving counting or labeling sets of present, visible objects is related to children's later cardinal-number knowledge, whereas other types of parent number talk are not. In addition, number talk that refers to large sets of present objects (i.e. sets of size 4 to 10 that fall outside children's ability to track individual objects) is more robustly predictive of children's later cardinal-number knowledge than talk about smaller sets. The relation between parents' number talk about large sets of present objects and children's cardinal-number knowledge remains significant even when controlling for factors such as parents' socioeconomic status and other measures of parents' number and non-number talk. © 2011 Blackwell Publishing Ltd.

78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

Science.gov (United States)

2013-12-27

... FDA's review of the change. The proposed rule published without a reference or a link to the... comments received, go to http://www.regulations.gov and insert the docket number(s), found in brackets in... rulemaking. The proposed rule published without reference or a link to the accompanying Regulatory Impact...

78 FR 36725 - Numbering Policies for Modern Communications; IP-Enabled Services; Telephone Number Requirements...

Science.gov (United States)

2013-06-19

... help speed the delivery of innovative services to consumers and businesses, while preserving the... available for public inspection during regular business hours in the FCC Reference Information Center... already broken the historical tie between a number and a specific device. For example, Skype permits users...

Getting DNA copy numbers without control samples

Directory of Open Access Journals (Sweden)

Ortiz-Estevez Maria

2012-08-01

Full Text Available Abstract Background The selection of the reference to scale the data in a copy number analysis has paramount importance to achieve accurate estimates. Usually this reference is generated using control samples included in the study. However, these control samples are not always available and in these cases, an artificial reference must be created. A proper generation of this signal is crucial in terms of both noise and bias. We propose NSA (Normality Search Algorithm, a scaling method that works with and without control samples. It is based on the assumption that genomic regions enriched in SNPs with identical copy numbers in both alleles are likely to be normal. These normal regions are predicted for each sample individually and used to calculate the final reference signal. NSA can be applied to any CN data regardless the microarray technology and preprocessing method. It also finds an optimal weighting of the samples minimizing possible batch effects. Results Five human datasets (a subset of HapMap samples, Glioblastoma Multiforme (GBM, Ovarian, Prostate and Lung Cancer experiments have been analyzed. It is shown that using only tumoral samples, NSA is able to remove the bias in the copy number estimation, to reduce the noise and therefore, to increase the ability to detect copy number aberrations (CNAs. These improvements allow NSA to also detect recurrent aberrations more accurately than other state of the art methods. Conclusions NSA provides a robust and accurate reference for scaling probe signals data to CN values without the need of control samples. It minimizes the problems of bias, noise and batch effects in the estimation of CNs. Therefore, NSA scaling approach helps to better detect recurrent CNAs than current methods. The automatic selection of references makes it useful to perform bulk analysis of many GEO or ArrayExpress experiments without the need of developing a parser to find the normal samples or possible batches within the

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.

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...

Desired Numbers of Children, Fertility Preferences and Related Factors among Couples Who Referred to Pre-Marriage Counseling in Alborz Province, Iran.

Science.gov (United States)

Lotfi, Razieh; Rajabi Naeeni, Masoumeh Rajabi Naeeni; Rezaei, Nasrin; Farid, Malihe; Tizvir, Afsoon

2017-10-01

The Islamic Republic of Iran has experienced a dramatic decrease in fertility rates in the past three decades. One of the main issues in the field of fertility is the couple's preferences and the desire to bear children. This study aimed to determine desired number of children, fertility preference, and related factors among people referring pre-marriage counseling to clarify their presumed behavior in case of fertility. This study was a descriptive analytic cross-sectional survey, conducted during 8 months. The participants were 300 couples came to pre-marriage counseling centers of two health centers of Karaj and asked to complete a 22 items questionnaire about of demographic characteristics, participants' interest, preference about fertility, and economic situation. Majority of the males were between the ages of 20-30 years (66.6%) while majority of the females were below 25 years of age (57%). About 17 percent of men and 22.3 percent of women stated that they want to have 1 child and equally 52.7 percent of men and 52.7 percent of women wanted to have 2 children. The only factor that contributed to the female participant's decision for a desirable number of children was the number of siblings that they have. In male participants with an increasing age at marriage and aspiration for higher educational level, the time interval between marriage and the birth of the first child has increased. There was a convergence in desired number of children in male and female participants. Majority of the participants express their desire to have only one or two children in future but in considering the fact that what one desires does not always come into reality, the risk of reduced fertility is generally present in the community. Appropriate policies should be implemented in order to create a favorable environment for children. Copyright© by Royan Institute. All rights reserved.

76 FR 78230 - Notice of Request for Extension of Approval of an Information Collection; Requirements for...

Science.gov (United States)

2011-12-16

...: Extension of approval of an information collection. Abstract: The Plant Protection Act (PPA, 7 U.S.C. 7701... plant protection organizations, and producers. Estimated annual number of respondents: 37. Estimated... DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2011-0112...

77 FR 16805 - Notice of Request for Extension and Revision of a Currently Approved Information Collection...

Science.gov (United States)

2012-03-22

... Monitoring System and the Food Safety Mobile Questionnaire) AGENCY: Food Safety and Inspection Service, USDA... Safety Mobile questionnaire. The approval for this information collection is due to expire. FSIS is... post their personal contact information--mailing address, email address, and telephone number-- on the...

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…

Application for approval to construct the Waste Receiving And Processing facility

International Nuclear Information System (INIS)

1993-02-01

The following Application For Approval Of Construction is being submitted by the US Department of Energy, Richland Field Office pursuant to 40 CFR 61.07, ''Application for Approval of Construction or Modification,'' for the Waste Receiving and Processing (WRAP) Module 1 facility (also referred to as WRAP 1). The WRAP 1 facility will be a new source of radioactive emissions to the atmosphere. The WRAP 1 facility will be housed in the new 2336-W Building, which will be located in the 200 West Area south of 23rd Street and west of Dayton Avenue. The 200 West Area is located within the boundary of the Hanford Site. The mission of the WRAP 1 facility is to examine, assay, characterize, treat, and repackage solid radioactive and mixed waste to enable permanent disposal of the waste in accordance with all applicable regulations. The solid wastes to be handled in the WRAP 1 facility include low-level waste (LLW), Transuranic (TRU) waste, TRU mixed waste, and low-level mixed waste (LLMW). The WRAP 1 facility will only accept contact handled (CH) waste containers. CH waste is a waste category whose external surface dose rate does not exceed 200 mrem/h. These containers have a surface dose rate of less than 200 mrem/h

Premarket Approvals (PMA)

Data.gov (United States)

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

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

Science.gov (United States)

2010-05-24

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

7 CFR 1710.105 - State regulatory approvals.

Science.gov (United States)

2010-01-01

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

Perspectives used for gaining approval of budgets.

Science.gov (United States)

Franks-Joiner, G L

1990-01-01

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

78 FR 2315 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-01-10

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

78 FR 15402 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-11

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

78 FR 11947 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-02-20

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

78 FR 17281 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-20

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

77 FR 16317 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-03-20

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

77 FR 66909 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-11-07

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

77 FR 21143 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-09

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

77 FR 25010 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-26

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

77 FR 34455 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-06-11

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

77 FR 55891 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

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

77 FR 55892 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

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

77 FR 59239 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-26

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

Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study.

Science.gov (United States)

Larochelle, Matthieu; Downing, Nicholas S; Ross, Joseph S; David, Frank S

2017-02-08

To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. A cohort study. New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. Characteristics of new therapeutics approved by the EMA and/or Health Canada before the FDA, including mechanistic novelty, likely clinical impact, size of the affected population and FDA review outcome. From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval-of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons-including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns. If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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

Reference Frame Fields based on Quantum Theory Representations of Real and Complex Numbers

OpenAIRE

Benioff, Paul

2007-01-01

A quantum theory representations of real (R) and complex (C) numbers is given that is based on states of single, finite strings of qukits for any base k > 1. Both unary representations and the possibility that qukits with k a prime number are elementary and the rest composite are discussed. Cauchy sequences of qukit string states are defined from the arithmetic properties. The representations of R and C, as equivalence classes of these sequences, differ from classical kit string state represe...

Accuracy of references and quotations in veterinary journals.

Science.gov (United States)

Hinchcliff, K W; Bruce, N J; Powers, J D; Kipp, M L

1993-02-01

The accuracy of references and quotations used to substantiate statements of fact in articles published in 6 frequently cited veterinary journals was examined. Three hundred references were randomly selected, and the accuracy of each citation was examined. A subset of 100 references was examined for quotational accuracy; ie, the accuracy with which authors represented the work or assertions of the author being cited. Of the 300 references selected, 295 were located, and 125 major errors were found in 88 (29.8%) of them. Sixty-seven (53.6%) major errors were found involving authors, 12 (9.6%) involved the article title, 14 (11.2%) involved the book or journal title, and 32 (25.6%) involved the volume number, date, or page numbers. Sixty-eight minor errors were detected. The accuracy of 111 quotations from 95 citations in 65 articles was examined. Nine quotations were technical and not classified, 86 (84.3%) were classified as correct, 2 (1.9%) contained minor misquotations, and 14 (13.7%) contained major misquotations. We concluded that misquotations and errors in citations occur frequently in veterinary journals, but at a rate similar to that reported for other biomedical journals.

Instrumentation reference book

CERN Document Server

Boyes, Walt

2002-01-01

Instrumentation is not a clearly defined subject, having a 'fuzzy' boundary with a number of other disciplines. Often categorized as either 'techniques' or 'applications' this book addresses the various applications that may be needed with reference to the practical techniques that are available for the instrumentation or measurement of a specific physical quantity or quality. This makes it of direct interest to anyone working in the process, control and instrumentation fields where these measurements are essential.* Comprehensive and authoritative collection of technical information* Writte

Establishing a Business Process Reference Model for Universities

KAUST Repository

Svensson, Carsten

2012-09-01

Modern universities are by any standard complex organizations that, from an IT perspective, present a number of unique challenges. This paper will propose establishing a business process reference framework. The benefit to the users would be a better understanding of the system landscape, business process enablement, collection of performance data and systematic reuse of existing community experience and knowledge. For these reasons reference models such as the SCOR (Supply Chain Operations Reference), DCOR (Design Chain Operations Reference) and ITIL (Information Technology Infrastructure Library) have gained popularity among organizations in both the private and public sectors. We speculate that this success can be replicated in a university setting. Furthermore the paper will outline how the research group suggests moving ahead with the research which will lead to a reference model.

Quality assurance of approved out of programme psychiatry training and research over the past 5 years

Science.gov (United States)

Osman-Hicks, Victoria; Graham, Hannah; Leadbetter, Peter; Brittlebank, Andrew

2015-01-01

Aims and method This paper intends to analyse the number of applications, trainee demographic and approval rate of those applying for out of programme training (OOPT) or out of programme research (OOPR) between January 2008 and April 2013 using the committee’s anonymised database. We also describe the process of application and approval by the Quality Assurance Committee. Results There were 90 applications, including 10 resubmissions during the 64-month period. Most applicants (77%) were higher trainees; 53% of applicants were from the London deanery; 60% of applications were for research posts and higher degrees (OOPR). Overall, 64% were approved by the committee: 70% for OOPRs and 53% for OOPTs. Clinical implications This paper shows with transparency the breakdown of applications to the Quality Assurance Committee. Around two-thirds of applications to the committee are supported (64%). Relatively few psychiatry trainees (2.5%) have applied for an OOPT or an OOPR over the past 5 years. PMID:26191450

Reference Intervals of Common Clinical Chemistry Analytes for Adults in Hong Kong.

Science.gov (United States)

Lo, Y C; Armbruster, David A

2012-04-01

Defining reference intervals is a major challenge because of the difficulty in recruiting volunteers to participate and testing samples from a significant number of healthy reference individuals. Historical literature citation intervals are often suboptimal because they're be based on obsolete methods and/or only a small number of poorly defined reference samples. Blood donors in Hong Kong gave permission for additional blood to be collected for reference interval testing. The samples were tested for twenty-five routine analytes on the Abbott ARCHITECT clinical chemistry system. Results were analyzed using the Rhoads EP evaluator software program, which is based on the CLSI/IFCC C28-A guideline, and defines the reference interval as the 95% central range. Method specific reference intervals were established for twenty-five common clinical chemistry analytes for a Chinese ethnic population. The intervals were defined for each gender separately and for genders combined. Gender specific or combined gender intervals were adapted as appropriate for each analyte. A large number of healthy, apparently normal blood donors from a local ethnic population were tested to provide current reference intervals for a new clinical chemistry system. Intervals were determined following an accepted international guideline. Laboratories using the same or similar methodologies may adapt these intervals if deemed validated and deemed suitable for their patient population. Laboratories using different methodologies may be able to successfully adapt the intervals for their facilities using the reference interval transference technique based on a method comparison study.

78 FR 77449 - GSA Approves Renewal of North American Numbering Council Charter Through September 20, 2015

Science.gov (United States)

2013-12-23

... on issues related to North American Numbering Plan (NANP) administration. The NANP is the telephone numbering plan for the United States and its territories, Canada, Bermuda, and 17 Caribbean nations. The... annual evaluations of the current North American Numbering Plan Administrator, the Pooling Administrator...

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)

77 FR 38650 - Agency Information Collection Activities: Refugee/Asylee Adjusting Status, OMB Control Number...

Science.gov (United States)

2012-06-28

... Collection Activities: Refugee/Asylee Adjusting Status, OMB Control Number 1615-0070; Extension, Without...: Form I- 643, Health and Human Services Statistical Data for Refugee/Asylee Adjusting Status; OMB... currently approved collection. (2) Title of the Form/Collection: Refugee/Asylee Adjusting Status. (3) Agency...

Directory of Certificates of Compliance for Radioactive Materials Packages. Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages. Volume 3. Revision 5

International Nuclear Information System (INIS)

1985-10-01

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 October 1, 1985. 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. Shipments of radioactive material utilizing these packages 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 a Nuclear Regulatory Commission approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR Section 71.12 does not authorize the receipt, possession, use or transfer of byproduct, source or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, or 70

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved quality assurance programs for radioactive material packages. Volume 3, Revision 4

International Nuclear Information System (INIS)

1984-11-01

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 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 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 utilizing these packagings must be in accordance with the provisions of 49 CFR 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 they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

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

76 FR 64299 - Notice of Intent to Request Revision and Extension of a Currently Approved Information Collection

Science.gov (United States)

2011-10-18

..., cotton, potatoes, soybeans, and wheat. Sample fields are randomly selected for these crops, plots are... (NASS) to request revision and extension of a currently approved information collection, the Field Crops... Agriculture, (202) 720-4333. SUPPLEMENTARY INFORMATION: Title: Field Crops Objective Yield. OMB Control Number...

Strategic Self-Presentation or Authentic Communication? Predicting Adolescents' Alcohol References on Social Media.

Science.gov (United States)

Geusens, Femke; Beullens, Kathleen

2017-01-01

The current study is one of the first to examine how self-reported alcohol consumption, friends' perceived alcohol consumption, and the perceived number of friends sharing alcohol references on social networking sites (SNS) is associated with adolescents' sharing of alcohol references on SNS. A cross-sectional paper-and-pencil survey was administered among 3,172 adolescents (n = 3,133 used for analyses, mean age = 17.16 years, SD = 0.93; 50.7% male). Structural equation modeling was used to test the hypotheses. First, the results indicated that both self-reported drinking behavior and the perceived number of friends sharing alcohol references were related to sharing alcohol references on SNS, but the perceived number of friends sharing alcohol references was a stronger predictor than self-reported drinking behavior. Friends' perceived drinking behavior was not a significant predictor. In the second place, self-reported drinking behavior was a stronger predictor for girls than for boys, whereas the perceived number of friends sharing alcohol references was a stronger predictor for boys than for girls. Adolescents' alcohol-related self-representation is in line with their alcohol consumption and is also strongly related to what their friends are sharing. Thus, adolescents appear to communicate authentically about their drinking experiences, but the decision to do so is heavily influenced by the prevailing social norm regarding alcohol-related communication.

Ten Years Back, Five Years Forward: The Data Seal of Approval

Directory of Open Access Journals (Sweden)

Ingrid Dillo

2015-02-01

Full Text Available If we want to share data, the long-term storage of those data in a trustworthy digital archive is an essential condition. Trust is the basis of storing and sharing data. That trust must be present in the various stakeholders involved. Certification of digital archives can make an important contribution to the confidence of these stakeholders in the digital archives.Ten years ago DANS was assigned the task of developing a Seal of Approval for digital data to ensure that archived data can still be found, understood and used in the future. In 2009 this Data Seal of Approval (DSA was transferred to an international body, the DSA Board, which has managed and further developed the guidelines and the peer review process ever since.The objectives of the DSA are to safeguard data, ensure high quality and guide reliable management of data for the future without requiring implementation of new standards, regulations or heavy investments. The DSA contains 16 guidelines for applying and verifying quality aspects concerning the creation, storage, use and reuse of digital data.Based on feedback from data archives that applied for a DSA and different case studies we have gained some insight into the benefits of DSA. Still, the impact of having the Seal is not easy to measure. Seal holders usually refer to qualitative benefits in the form of increased awareness of the value of their repositories to their communities, funders and publishers.Ten years down the line we can safely state that the Data Seal of Approval has proven its added value. If we try to look five years into the future, what can we expect? There are different developments: a growing interest in DSA among European research infrastructures, the collaboration between DSA and the ISCU World Data System under the umbrella of the RDA (Research Data Alliance and the European Commission is showing a growing interest in certification services.The success of DSA also provides the challenge to further

29 CFR 1915.5 - Incorporation by reference.

Science.gov (United States)

2010-07-01

... Protective Ensemble for Structural Fire Fighting, IBR approved for § 1915.505(e)(4)(ii). (iii) NFPA 1976-2000, Standard on Protective Ensemble for Proximity Fire Fighting, IBR approved for § 1915.505(e)(5). (iv) NFPA...) NFPA 1983-2001, Standard on Fire Service Life Safety Rope and System Components, IBR approved for...

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...

77 FR 49774 - Notice of Request for Extension of a Currently Approved Information Collection; USDA Registration...

Science.gov (United States)

2012-08-17

...Authentication Service (eAuth), located at http://www.eauth.egov.usda.gov . The USDA eAuth service provides the... Electronic Access Code. OMB Number: 0503-0014. Expiration Date of Approval: August 31, 2013. Type of Request... eAuth as a management and technical process that addresses user authentication and authorization...

ANSI/ASHRAE/IES Standard 90.1-2010 Performance Rating Method Reference Manual

Energy Technology Data Exchange (ETDEWEB)

Goel, Supriya [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Rosenberg, Michael I. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

2016-05-01

This document is intended to be a reference manual for the Appendix G Performance Rating Method (PRM) of ANSI/ASHRAE/IES Standard 90.1- 2010 (Standard 90.1-2010).The PRM is used for rating the energy efficiency of commercial and high-rise residential buildings with designs that exceed the requirements of Standard 90.1. The procedures and processes described in this manual are designed to provide consistency and accuracy by filling in gaps and providing additional details needed by users of the PRM. It should be noted that this document is created independently from ASHRAE and SSPC 90.1 and is not sanctioned nor approved by either of those entities . Potential users of this manual include energy modelers, software developers and implementers of “beyond code” energy programs. Energy modelers using ASHRAE Standard 90.1-2010 for beyond code programs can use this document as a reference manual for interpreting requirements of the Performance Rating method. Software developers, developing tools for automated creation of the baseline model can use this reference manual as a guideline for developing the rules for the baseline model.

45 CFR 205.52 - Furnishing of social security numbers.

Science.gov (United States)

2010-10-01

... 45 Public Welfare 2 2010-10-01 2010-10-01 false Furnishing of social security numbers. 205.52... GENERAL ADMINISTRATION-PUBLIC ASSISTANCE PROGRAMS § 205.52 Furnishing of social security numbers. The... furnish to the State or local agency a social security account number, hereinafter referred to as the SSN...

ALA Library Schools and Subject Reference Coursework: A Short Communication

Science.gov (United States)

Condic, Kristine

2016-01-01

Reference librarians are exposed to the literature of different disciplines in a number of ways including advanced degrees, on the job training, and intellectual inquisitiveness. As students, many reference librarians were also exposed to library science programs offering coursework specializing in information sources and research within other…

3 July 1985: Convention signed in Brussels on 31 January 1963, supplementary to the Paris Convention of 29 July 1960 on Third Party Liability in the Field of Nuclear Energy and Act approving the Protocols to amend the Paris Convention and the Brussels Supplementary Convention

International Nuclear Information System (INIS)

1985-01-01

This Act refers to the Brussels Supplementary Convention approved by Belgium in 1966 and ratified on 20 August 1985 and approves ratification of the Protocols of 16 November 1982 to amend the Paris Convention and the Brussels Supplementary Convention respectively. The Protocols are reproduced in French, Dutch and German. (NEA) [fr

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...

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1998 edition

International Nuclear Information System (INIS)

1998-08-01

The information contained in this report is given in six tables. Tables 1 to 4 present administrative data including issue and expiration dates, package identification, package serial numbers, modes for which the package/shipments approved and the edition of Safety Series No. 6 on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table 5. Table 6 shows the certificates reported to the IAEA Secretariat by each participating Member State

76 FR 13970 - Notice of Request for Extension of Approval of an Information Collection; Black Stem Rust...

Science.gov (United States)

2011-03-15

... Requirements for Addition of Rust-Resistant Varieties AGENCY: Animal and Plant Health Inspection Service, USDA... Rust-Resistant Varieties. OMB Number: 0579-0186. Type of Request: Extension of approval of an... products to prevent the introduction of plant pests into the United States or their dissemination within...

77 FR 1071 - Information Collection Being Submitted for Review and Approval to the Office of Management and...

Science.gov (United States)

2012-01-09

... currently approved collection. Respondents: Business or other for-profit, Federal Government, and State... reduce the possibility of both carriers and PSAPs investing money before the PSAP is actually E911...: Business or other for-profit. Number of Respondents: 2,000 respondents; 2,000 responses. Estimated Time per...

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...

Desired Numbers of Children, Fertility Preferences and Related Factors among Couples Who Referred to Pre-Marriage Counseling in Alborz Province, Iran

Directory of Open Access Journals (Sweden)

Razieh Lotfi

2017-09-01

Full Text Available Background The Islamic Republic of Iran has experienced a dramatic decrease in fertility rates in the past three decades. One of the main issues in the field of fertility is the couple’s preferences and the desire to bear children. This study aimed to determine desired number of children, fertility preference, and related factors among people referring pre-marriage counseling to clarify their presumed behavior in case of fertility. Materials and Methods This study was a descriptive analytic cross-sectional survey, conducted during 8 months. The participants were 300 couples came to pre-marriage counseling centers of two health centers of Karaj and asked to complete a 22 items questionnaire about of demographic characteristics, participants’ interest, preference about fertility, and economic situation. Results Majority of the males were between the ages of 20-30 years (66.6% while majority of the females were below 25 years of age (57%. About 17 percent of men and 22.3 percent of women stated that they want to have 1 child and equally 52.7 percent of men and 52.7 percent of women wanted to have 2 children. The only factor that contributed to the female participant’s decision for a desirable number of children was the number of siblings that they have. In male participants with an increasing age at marriage and aspiration for higher educational level, the time interval between marriage and the birth of the first child has increased. There was a convergence in desired number of children in male and female participants. Conclusion Majority of the participants express their desire to have only one or two children in future but in considering the fact that what one desires does not always come into reality, the risk of reduced fertility is generally present in the community. Appropriate policies should be implemented in order to create a favorable environment for children.

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

consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain - the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future.

Eliminating traditional reference services in an academic health sciences library: a case study

Science.gov (United States)

Schulte, Stephanie J

2011-01-01

Question: How were traditional librarian reference desk services successfully eliminated at one health sciences library? Setting: The analysis was done at an academic health sciences library at a major research university. Method: A gap analysis was performed, evaluating changes in the first eleven months through analysis of reference transaction and instructional session data. Main Results: Substantial increases were seen in the overall number of specialized reference transactions and those conducted by librarians lasting more than thirty minutes. The number of reference transactions overall increased after implementing the new model. Several new small-scale instructional initiatives began, though perhaps not directly related to the new model. Conclusion: Traditional reference desk services were eliminated at one academic health sciences library without negative impact on reference and instructional statistics. Eliminating ties to the confines of the physical library due to staffing reference desk hours removed one significant barrier to a more proactive liaison program. PMID:22022221

Muon number nonconservation in gauge theories

International Nuclear Information System (INIS)

Cheng, T.P.; Li, L.F.

1977-01-01

The question of separate conservation of muon and electron number is considered in the context of unified gauge theories of weak and electromagnetic interactions. Theories with heavy neutral leptons, Higgs scalars, and doubly charged heavy leptons are discussed. 28 references

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...

75 FR 28231 - Cotton Classing, Testing and Standards: Notice of Request for an Extension and Revision to a...

Science.gov (United States)

2010-05-20

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [AMS-CN-10-0038, CN-10-002] Cotton... comments should reference the docket number and page number of this issue of the Federal Register. All... Standards. OMB Number: 0581-0008. Expiration Date of Approval: December 30, 2010. Type of Request: Extension...

76 FR 68780 - Renewal of Approved Information Collection, OMB Control Number 1004-0201

Science.gov (United States)

2011-11-07

...: Mavis Love at (307) 775-6258. Persons who use a telecommunication device for the deaf (TDD) may call the Federal Information Relay Service at 1-(800) 877-8339, to contact Ms. Love. You may also review the... of this information collection request: B. Number of C. Hours per D. Total hours A. Type of response...

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...

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved quality assurance programs for radioactive material packages. Volume 3, Revision 6

International Nuclear Information System (INIS)

1986-10-01

This directory contains a Summary Report of NRC Approved Packages (Volumes 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 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 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 utilizing these packagings must be in accordance with the provisions of 49 CFR 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 them that have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use of transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

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 ...

A data-driven approach to estimating the number of clusters in hierarchical clustering [version 1; referees: 2 approved, 1 approved with reservations

Directory of Open Access Journals (Sweden)

Antoine E. Zambelli

2016-12-01

Full Text Available DNA microarray and gene expression problems often require a researcher to perform clustering on their data in a bid to better understand its structure. In cases where the number of clusters is not known, one can resort to hierarchical clustering methods. However, there currently exist very few automated algorithms for determining the true number of clusters in the data. We propose two new methods (mode and maximum difference for estimating the number of clusters in a hierarchical clustering framework to create a fully automated process with no human intervention. These methods are compared to the established elbow and gap statistic algorithms using simulated datasets and the Biobase Gene ExpressionSet. We also explore a data mixing procedure inspired by cross validation techniques. We find that the overall performance of the maximum difference method is comparable or greater to that of the gap statistic in multi-cluster scenarios, and achieves that performance at a fraction of the computational cost. This method also responds well to our mixing procedure, which opens the door to future research. We conclude that both the mode and maximum difference methods warrant further study related to their mixing and cross-validation potential. We particularly recommend the use of the maximum difference method in multi-cluster scenarios given its accuracy and execution times, and present it as an alternative to existing algorithms.

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...

A Hybrid Approach to Proving Memory Reference Monotonicity

KAUST Repository

Oancea, Cosmin E.

2013-01-01

Array references indexed by non-linear expressions or subscript arrays represent a major obstacle to compiler analysis and to automatic parallelization. Most previous proposed solutions either enhance the static analysis repertoire to recognize more patterns, to infer array-value properties, and to refine the mathematical support, or apply expensive run time analysis of memory reference traces to disambiguate these accesses. This paper presents an automated solution based on static construction of access summaries, in which the reference non-linearity problem can be solved for a large number of reference patterns by extracting arbitrarily-shaped predicates that can (in)validate the reference monotonicity property and thus (dis)prove loop independence. Experiments on six benchmarks show that our general technique for dynamic validation of the monotonicity property can cover a large class of codes, incurs minimal run-time overhead and obtains good speedups. © 2013 Springer-Verlag.

Preparation and certification of a reference uranium

International Nuclear Information System (INIS)

Anon.

1979-06-01

The CEA Analysis Coordination has produced a reference uranium metal of guaranteed minimum uranium content. The metal was purified by electro-refining in fused salt baths and the dendrites obtained were cast in the form of an ingot by electron bombardment. The ingot was rolled and cut into pieces of mass between 0.5 g and 1.5 g, and each piece conditioned in a glass ampoule under primary vacuum. The total number of reference samples is about 4500. The uranium content was inferred from the impurity concentration determined by spark mass spectrometry and atomic or molecular adsorption spectrophotometry and from the gas concentration determined by specific methods. A certificate of guarantee gives instructions for the use of these reference samples [fr

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...

Assessment of international reference materials for isotope-ratio analysis (IUPAC Technical Report)

Science.gov (United States)

Brand, Willi A.; Coplen, Tyler B.; Vogl, Jochen; Rosner, Martin; Prohaska, Thomas

2014-01-01

Since the early 1950s, the number of international measurement standards for anchoring stable isotope delta scales has mushroomed from 3 to more than 30, expanding to more than 25 chemical elements. With the development of new instrumentation, along with new and improved measurement procedures for studying naturally occurring isotopic abundance variations in natural and technical samples, the number of internationally distributed, secondary isotopic reference materials with a specified delta value has blossomed in the last six decades to more than 150 materials. More than half of these isotopic reference materials were produced for isotope-delta measurements of seven elements: H, Li, B, C, N, O, and S. The number of isotopic reference materials for other, heavier elements has grown considerably over the last decade. Nevertheless, even primary international measurement standards for isotope-delta measurements are still needed for some elements, including Mg, Fe, Te, Sb, Mo, and Ge. It is recommended that authors publish the delta values of internationally distributed, secondary isotopic reference materials that were used for anchoring their measurement results to the respective primary stable isotope scale.

Classification of nervous system withdrawn and approved drugs with ToxPrint features via machine learning strategies.

Science.gov (United States)

Onay, Aytun; Onay, Melih; Abul, Osman

2017-04-01

Early-phase virtual screening of candidate drug molecules plays a key role in pharmaceutical industry from data mining and machine learning to prevent adverse effects of the drugs. Computational classification methods can distinguish approved drugs from withdrawn ones. We focused on 6 data sets including maximum 110 approved and 110 withdrawn drugs for all and nervous system diseases to distinguish approved drugs from withdrawn ones. In this study, we used support vector machines (SVMs) and ensemble methods (EMs) such as boosted and bagged trees to classify drugs into approved and withdrawn categories. Also, we used CORINA Symphony program to identify Toxprint chemotypes including over 700 predefined chemotypes for determination of risk and safety assesment of candidate drug molecules. In addition, we studied nervous system withdrawn drugs to determine the key fragments with The ParMol package including gSpan algorithm. According to our results, the descriptors named as the number of total chemotypes and bond CN_amine_aliphatic_generic were more significant descriptors. The developed Medium Gaussian SVM model reached 78% prediction accuracy on test set for drug data set including all disease. Here, bagged tree and linear SVM models showed 89% of accuracies for phycholeptics and psychoanaleptics drugs. A set of discriminative fragments in nervous system withdrawn drug (NSWD) data sets was obtained. These fragments responsible for the drugs removed from market were benzene, toluene, N,N-dimethylethylamine, crotylamine, 5-methyl-2,4-heptadiene, octatriene and carbonyl group. This paper covers the development of computational classification methods to distinguish approved drugs from withdrawn ones. In addition, the results of this study indicated the identification of discriminative fragments is of significance to design a new nervous system approved drugs with interpretation of the structures of the NSWDs. Copyright © 2017 Elsevier B.V. All rights reserved.

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)

Fibonacci and Lucas numbers with applications

CERN Document Server

Koshy, Thomas

2011-01-01

[Koshy's] book is without doubt the most comprehensive and scholarly work on Fibonacci numbers to date and I am sure that it will quickly signal its presence and impose itself as an authoritative reference manual on Fibonacci numbers. -Napoleon Gauthier, Royal Military College of Canada, Kingston, ON What a gem this is! [...] My only regrest about the book is that it wasn't around years ago. It fills such a void. -Monte Zerger, Adams State College, Alamosa, CO

77 FR 33764 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval...

Science.gov (United States)

2012-06-07

...-FF09W11000/ FVWF51100900000-XXX-FF09W11000] Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Wildlife and Sport Fish Grants and Cooperative Agreements AGENCY: Fish...: OMB Control Number: 1018-0109. Title: Wildlife and Sport Fish Grants and Cooperative Agreements, 80...

75 FR 28231 - Cotton Classification and Market News Service: Notice of Request for an Extension and Revision of...

Science.gov (United States)

2010-05-20

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [AMS-CN-10-0037; CN-10-003] Cotton....regulations.gov. All comments should reference the docket number and page number of this issue of the Federal... and Market News Service. OMB Number: 0581-0009. Expiration Date of Approval: December 30, 2010. Type...

How do reference montage and electrodes setup affect the measured scalp EEG potentials?

Science.gov (United States)

Hu, Shiang; Lai, Yongxiu; Valdes-Sosa, Pedro A.; Bringas-Vega, Maria L.; Yao, Dezhong

2018-04-01

Objective. Human scalp electroencephalogram (EEG) is widely applied in cognitive neuroscience and clinical studies due to its non-invasiveness and ultra-high time resolution. However, the representativeness of the measured EEG potentials for the underneath neural activities is still a problem under debate. This study aims to investigate systematically how both reference montage and electrodes setup affect the accuracy of EEG potentials. Approach. First, the standard EEG potentials are generated by the forward calculation with a single dipole in the neural source space, for eleven channel numbers (10, 16, 21, 32, 64, 85, 96, 128, 129, 257, 335). Here, the reference is the ideal infinity implicitly determined by forward theory. Then, the standard EEG potentials are transformed to recordings with different references including five mono-polar references (Left earlobe, Fz, Pz, Oz, Cz), and three re-references (linked mastoids (LM), average reference (AR) and reference electrode standardization technique (REST)). Finally, the relative errors between the standard EEG potentials and the transformed ones are evaluated in terms of channel number, scalp regions, electrodes layout, dipole source position and orientation, as well as sensor noise and head model. Main results. Mono-polar reference recordings are usually of large distortions; thus, a re-reference after online mono-polar recording should be adopted in general to mitigate this effect. Among the three re-references, REST is generally superior to AR for all factors compared, and LM performs worst. REST is insensitive to head model perturbation. AR is subject to electrodes coverage and dipole orientation but no close relation with channel number. Significance. These results indicate that REST would be the first choice of re-reference and AR may be an alternative option for high level sensor noise case. Our findings may provide the helpful suggestions on how to obtain the EEG potentials as accurately as possible for

A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial.

Science.gov (United States)

Blackwell, Kimberly; Donskih, Roman; Jones, C Michael; Nixon, Allen; Vidal, Maria J; Nakov, Roumen; Singh, Pritibha; Schaffar, Gregor; Gascón, Pere; Harbeck, Nadia

2016-07-01

Pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. In highly regulated markets, there are currently no approved biosimilars of pegfilgrastim. Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare proposed biosimilar LA-EP2006 with reference pegfilgrastim (Neulasta, Amgen) in early-stage breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy. A total of 308 patients were randomized to LA-EP2006 or reference pegfilgrastim. Each patient received TAC (intravenous docetaxel 75 mg/m(2), doxorubicin 50 mg/m(2), and cyclophosphamide 500 mg/m(2)) on day 1 of each cycle, for six or more cycles. Pegfilgrastim (LA-EP2006 or reference) was given subcutaneously (6 mg in 0.6 mL) on day 2 of each cycle. The primary endpoint was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with an absolute neutrophil count prevention of neutropenia in patients with early-stage breast cancer receiving TAC. The granulocyte colony-stimulating factor pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. Biosimilars are biologics with similar quality, safety, and efficacy to a reference product that may increase the affordability of treatment compared with their reference compounds. There are currently no approved biosimilars of pegfilgrastim in highly regulated markets. No previous phase III studies have been performed with LA-EP2006. PROTECT-2 was conducted to confirm the similarity of the proposed biosimilar LA-EP2006 to pegfilgrastim. Biosimilar pegfilgrastim (LA-EP2006) may benefit oncology patients by offering increased access to biological treatments that may improve clinical outcomes. This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred. ©AlphaMed Press.

Effect of endogenous reference genes on digital PCR assessment of genetically engineered canola events

Directory of Open Access Journals (Sweden)

Tigst Demeke

2018-05-01

Full Text Available Droplet digital PCR (ddPCR has been used for absolute quantification of genetically engineered (GE events. Absolute quantification of GE events by duplex ddPCR requires the use of appropriate primers and probes for target and reference gene sequences in order to accurately determine the amount of GE materials. Single copy reference genes are generally preferred for absolute quantification of GE events by ddPCR. Study has not been conducted on a comparison of reference genes for absolute quantification of GE canola events by ddPCR. The suitability of four endogenous reference sequences (HMG-I/Y, FatA(A, CruA and Ccf for absolute quantification of GE canola events by ddPCR was investigated. The effect of DNA extraction methods and DNA quality on the assessment of reference gene copy numbers was also investigated. ddPCR results were affected by the use of single vs. two copy reference genes. The single copy, FatA(A, reference gene was found to be stable and suitable for absolute quantification of GE canola events by ddPCR. For the copy numbers measured, the HMG-I/Y reference gene was less consistent than FatA(A reference gene. The expected ddPCR values were underestimated when CruA and Ccf (two copy endogenous Cruciferin sequences were used because of high number of copies. It is important to make an adjustment if two copy reference genes are used for ddPCR in order to obtain accurate results. On the other hand, real-time quantitative PCR results were not affected by the use of single vs. two copy reference genes. Keywords: Canola, Digital PCR, DNA extraction, GMO, Reference genes

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.

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1994 ed

International Nuclear Information System (INIS)

1994-08-01

This is the fifth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM). The reporting format was established at consecutive meetings of SAGSTRAM, whose membership consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA's transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last two complete calendar years. The 1985 Edition of IAEA Safety Series No. 6, the ''Regulations for the Safe Transport of Radioactive Material'' highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1995 edition

International Nuclear Information System (INIS)

1995-09-01

This is the sixth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM). The reporting format was established at consecutive meetings of SAGSTRAM, whose membership consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA's transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last complete calendar year. The 1985 Edition of IAEA Safety Series No. 6, the ''Regulations for the Safe Transport of Radioactive Material'' highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material. 6 tabs

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...

76 FR 16772 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Science.gov (United States)

2011-03-25

.... Respondents: Business or other for-profit entities and State, local or tribal government. Number of... the technical standards set forth in Sec. 76.605(a)(11). 47 CFR 76.601 the local franchising authority... currently approved collection. Respondents: Not-for-profit institutions; State, local or tribal government...

Long term file migration. Part I: file reference patterns

International Nuclear Information System (INIS)

Smith, A.J.

1978-08-01

In most large computer installations, files are moved between on-line disk and mass storage (tape, integrated mass storage device) either automatically by the system or specifically at the direction of the user. This is the first of two papers which study the selection of algorithms for the automatic migration of files between mass storage and disk. The use of the text editor data sets at the Stanford Linear Accelerator Center (SLAC) computer installation is examined through the analysis of thirteen months of file reference data. Most files are used very few times. Of those that are used sufficiently frequently that their reference patterns may be examined, about a third show declining rates of reference during their lifetime; of the remainder, very few (about 5%) show correlated interreference intervals, and interreference intervals (in days) appear to be more skewed than would occur with the Bernoulli process. Thus, about two-thirds of all sufficiently active files appear to be referenced as a renewal process with a skewed interreference distribution. A large number of other file reference statistics (file lifetimes, interference distributions, moments, means, number of uses/file, file sizes, file rates of reference, etc.) are computed and presented. The results are applied in the following paper to the development and comparative evaluation of file migration algorithms. 17 figures, 13 tables

77 FR 33394 - Notice of Intent To Request an Extension of a Currently Approved Information Collection

Science.gov (United States)

2012-06-06

... information collection in support of authorizations to use the 4-H Club Name and/or Emblem. DATES: Written... Emblem. OMB Number: 0524-0034. Expiration Date of Current Approval: August 31, 2012. Type of Request.... Abstract: Use of the 4-H Club Name and/or Emblem is authorized by an Act of Congress (18 U.S.C. 707). Use...

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.

Sophisticated approval voting, ignorance priors, and plurality heuristics: a behavioral social choice analysis in a Thurstonian framework.

Science.gov (United States)

Regenwetter, Michel; Ho, Moon-Ho R; Tsetlin, Ilia

2007-10-01

This project reconciles historically distinct paradigms at the interface between individual and social choice theory, as well as between rational and behavioral decision theory. The authors combine a utility-maximizing prescriptive rule for sophisticated approval voting with the ignorance prior heuristic from behavioral decision research and two types of plurality heuristics to model approval voting behavior. When using a sincere plurality heuristic, voters simplify their decision process by voting for their single favorite candidate. When using a strategic plurality heuristic, voters strategically focus their attention on the 2 front-runners and vote for their preferred candidate among these 2. Using a hierarchy of Thurstonian random utility models, the authors implemented these different decision rules and tested them statistically on 7 real world approval voting elections. They cross-validated their key findings via a psychological Internet experiment. Although a substantial number of voters used the plurality heuristic in the real elections, they did so sincerely, not strategically. Moreover, even though Thurstonian models do not force such agreement, the results show, in contrast to common wisdom about social choice rules, that the sincere social orders by Condorcet, Borda, plurality, and approval voting are identical in all 7 elections and in the Internet experiment. PsycINFO Database Record (c) 2007 APA, all rights reserved.

Defense Acquisition Research Journal. Volume 22, Number 1, Issue 72.

Science.gov (United States)

2015-01-01

references in APA format (author-date-page number form of citation) as outlined in the Publication Manual of the American Psychological Association [ 6th ... Edition ]). For all other style questions, please refer to the Chicago Manual of Style (16th Edition ). Contributors are encouraged to seek the advice of...reference to government works. Helpful guidance is also available in The Complete Guide to Citing Government Documents (Revised Edition ): A Manual

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...

78 FR 69812 - Approval and Promulgation of Implementation Plans; Texas; Control of Air Pollution by Permits for...

Science.gov (United States)

2013-11-21

...EPA is proposing to approve portions of two revisions to the Texas State Implementation Plan (SIP) concerning the Permits for Specific Designated Facilities Program, also referred to as the FutureGen Program. EPA has determined that the portions of these SIP revisions specific to the FutureGen Program submitted on March 9, 2006 and July 2, 2010, comply with the Clean Air Act and EPA regulations and are consistent with EPA policies. This action is being taken under section 110 and parts C and D of the Act.

78 FR 69773 - Approval and Promulgation of Implementation Plans; Texas; Control of Air Pollution by Permits for...

Science.gov (United States)

2013-11-21

...EPA is taking a direct final action to approve portions of two revisions to the Texas State Implementation Plan (SIP) concerning the Permits for Specific Designated Facilities Program, also referred to as the FutureGen Program. EPA has determined that the portions of these SIP revisions specific to the FutureGen Program submitted on March 9, 2006 and July 2, 2010, comply with the Clean Air Act and EPA regulations and are consistent with EPA policies. This action is being taken under section 110 and parts C and D of the Act.

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

Effect of endogenous reference genes on digital PCR assessment of genetically engineered canola events.

Science.gov (United States)

Demeke, Tigst; Eng, Monika

2018-05-01

Droplet digital PCR (ddPCR) has been used for absolute quantification of genetically engineered (GE) events. Absolute quantification of GE events by duplex ddPCR requires the use of appropriate primers and probes for target and reference gene sequences in order to accurately determine the amount of GE materials. Single copy reference genes are generally preferred for absolute quantification of GE events by ddPCR. Study has not been conducted on a comparison of reference genes for absolute quantification of GE canola events by ddPCR. The suitability of four endogenous reference sequences ( HMG-I/Y , FatA(A), CruA and Ccf) for absolute quantification of GE canola events by ddPCR was investigated. The effect of DNA extraction methods and DNA quality on the assessment of reference gene copy numbers was also investigated. ddPCR results were affected by the use of single vs. two copy reference genes. The single copy, FatA(A), reference gene was found to be stable and suitable for absolute quantification of GE canola events by ddPCR. For the copy numbers measured, the HMG-I/Y reference gene was less consistent than FatA(A) reference gene. The expected ddPCR values were underestimated when CruA and Ccf (two copy endogenous Cruciferin sequences) were used because of high number of copies. It is important to make an adjustment if two copy reference genes are used for ddPCR in order to obtain accurate results. On the other hand, real-time quantitative PCR results were not affected by the use of single vs. two copy reference genes.

76 FR 44003 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Science.gov (United States)

2011-07-22

... common to both types of roaming. Using the same process allows, but does not require, a party to bring a... Complaints. Form Number: FCC Form 485. Type of Review: Revision of a currently approved collection... documents will cover the collection, maintenance, use, and disposal of all personally identifiable...

Directory of certificates of compliance for radioactive materials packages: summary report of NRC approved quality-assurance programs for radioactive-material packages. Volume 3, Revision 3

International Nuclear Information System (INIS)

1983-09-01

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 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 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 utilizing these packagings must be in accordance with the provisions of 49 CFR 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 them in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

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...

76 FR 68759 - GSA Approves Renewal of North American Numbering Council Charter Through September 23, 2013

Science.gov (United States)

2011-11-07

... telecommunications industry. In October 1995, the Commission established the NANC, a Federal advisory committee... telecommunications industry and to the American public cannot be overstated. Telephone numbers are the means by which..., and will ensure that numbering resources are available to all telecommunications service providers on...

Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs

Science.gov (United States)

McGettigan, Patricia; Roderick, Peter; Mahajan, Rushikesh; Kadam, Abhay; Pollock, Allyson M.

2015-01-01

Background In 2012, an Indian parliamentary committee reported that manufacturing licenses for large numbers of fixed dose combination (FDC) drugs had been issued by state authorities without prior approval of the Central Drugs Standard Control Organization (CDSCO) in violation of rules, and considered that some ambiguity until 1 May 2002 about states’ powers might have contributed. To our knowledge, no systematic enquiry has been undertaken to determine if evidence existed to support these findings. We investigated CDSCO approvals for and availability of oral FDC drugs in four therapeutic areas: analgesia (non-steroidal anti-inflammatory drugs [NSAIDs]), diabetes (metformin), depression/anxiety (anti-depressants/benzodiazepines), and psychosis (anti-psychotics). Methods and Findings This was an ecologic study with a time-trend analysis of FDC sales volumes (2007–2012) and a cross-sectional examination of 2011–2012 data to establish the numbers of formulations on the market with and without a record of CDSCO approval (“approved” and “unapproved”), their branded products, and sales volumes. Data from the CDSCO on approved FDC formulations were compared with sales data from PharmaTrac, a database of national drug sales. We determined the proportions of FDC sales volumes (2011–2012) arising from centrally approved and unapproved formulations and from formulations including drugs banned/restricted internationally. We also determined the proportions of centrally approved and unapproved formulations marketed before and after 1 May 2002, when amendments were made to the drug rules. FDC approvals in India, the United Kingdom (UK), and United States of America (US) were compared. For NSAID FDCs, 124 formulations were marketed, of which 34 (27%) were centrally approved and 90 (73%) were unapproved; metformin: 25 formulations, 20 (80%) approved, five (20%) unapproved; anti-depressants/benzodiazepines: 16 formulations, three (19%) approved, 13 (81%) unapproved

Low Reynolds Number Vehicles

Science.gov (United States)

1985-02-01

of the blade. The Darrieus VAWT has more complex aerodynamics. This type of wind turbine produces power as a result of the tangential thrust as...Horizontal Axis Propeller-Type b) Verticle Axis Darrieus -Type Figure 78. Wind Turbine Configurations 0 6 Q K [_ 2 -, C 4 UJ UJ...Sailplanes 23 5.2 Wind Turbines 23 6. CONCLUDING REMARKS 24 7. RECOMMENDATIONS FOR FUTURE RESEARCH 24 REFERENCES 25 FIGURES 32 yv/ LOW REYNOLDS NUMBER

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

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...

Decline in Reference Transactions with Few Questions Referred to Librarian when the Reference Desk is Staffed by a Paraprofessional. A Review of: Dinkins, D., & Ryan, S. M. (2010. Measuring referrals: The use of paraprofessionals at the reference desk. The Journal of Academic Librarianship, 36(4, 279-286.

Directory of Open Access Journals (Sweden)

Diana K. Wakimoto

2011-03-01

.5% decrease in the number of reference desk transactions during the paraprofessional's hours on the desk compared to the previous year when the desk was staffed by professional librarians. Overall, reference desk transactions for all hours decreased 4.1% compared to the previous year. The results from the questionnaire on his experiences at the reference desk showed that the paraprofessional was satisfied with his training, comfortable with referring questions to the librarians, did not use the print reference collection extensively, thought the "interface for searching the library's catalogue/databases is dated at best" (p. 285, and felt that being close in age to many of the students was a disadvantage while working at the reference desk.Conclusion — The authors concluded that staffing the reference desk with a paraprofessional was a success and that the "referrals to librarians had been made appropriately and when necessary" (p. 285. The results corroborated previous studies that showed only a "small percentage of reference desk transactions would need to be referred to a librarian" (p. 285. In part, because of the success of staffing the desk with a paraprofessional, the authors suggest that reference desk staffing configurations at academic libraries should be reevaluated. Librarians freed from duties at the physical reference desk could use this time to "develop virtual reference services" and expand information literacy programs (p. 286.To explain the decrease in number of transactions during the paraprofessional's time on the reference desk, the authors surmised four possibilities: patrons' reluctance to ask questions of someone new on the desk, their dissatisfaction with the paraprofessional's answers, the similarity in age between the paraprofessional and the "age of the student population" (p. 284, or the librarians being more conscientious in tallying every transaction. However, the authors doubted that users perceived the paraprofessional's answers as "less

Quantum frames of reference

International Nuclear Information System (INIS)

Kaufherr, T.

1981-01-01

The idea that only relative variables have physical meaning came to be known as Mach's principle. Carrying over this idea to quantum theory, has led to the consideration of finite mass, macroscopic reference frames, relative to which all physical quantities are measured. During the process of measurement, a finite mass observer receives a kickback, and this reaction of the measuring device is not negligible in quantum theory because of the quantization of the action. Hence, the observer himself has to be included in the system that is being considered. Using this as the starting point, a number of thought experiments involving finite mass observers is discussed which have quantum uncertainties in their time or in their position. These thought experiments serve to elucidate in a qualitative way some of the difficulties involved, as well as pointing out a direction to take in seeking solutions to them. When the discussion is extended to include more than one observer, the question of the covariance of the theory immediately arises. Because none of the frames of reference should be preferred, the theory should be covariant. This demand expresses an equivalence principle which here is extended to include reference frames which are in quantum uncertainties relative to each other. Formulating the problem in terms of canonical variables, the ensueing free Hamiltonian contains vector and scalar potentials which represent the kick that the reference frame receives during measurement. These are essentially gravitational type potentials, resulting, as it were, from the extension of the equivalence principle into the quantum domain

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

Science.gov (United States)

Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

2017-08-15

High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were

Standard and reference materials for environmental science. Part 1. Technical memo

Energy Technology Data Exchange (ETDEWEB)

Cantillo, A.Y.

1995-11-01

This is the fourth edition of the catalog of reference materials suited for use in environmental science, originally compiled in 1986 for NOAA, IOC, and UNEP. The catalog lists more than 1200 reference materials from 28 producers and contains information about their proper use, sources, availability, and analyte concentrations. Indices are included for elements, isotopes, and organic compounds, as are cross references to CAS registry numbers, alternate names, and chemical structures of selected organic compounds.

Standard and reference materials for environmental science. Part 2. Technical memo

Energy Technology Data Exchange (ETDEWEB)

Cantillo, A.Y.

1995-11-01

This is the fourth edition of the catalog of reference materials suited for use in environmental science, originally compiled in 1986 for NOAA, IOC, and UNEP. The catalog lists more than 1200 reference materials from 28 producers and contains information about their proper use, sources, availability, and analyte concentrations. Indices are included for elements, isotopes, and organic compounds, as are cross references to CAS registry numbers, alternate names, and chemical structures of selected organic compounds.

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 ...

Properties of gravi-inertial systems of reference

International Nuclear Information System (INIS)

Dozmorov, I.M.

1977-01-01

A number of papers of the author have been summarized devoted to gravi-inertial systems of reference in which the following problems are solved: a) analogs of inertial systems of reference (ISR), gravi-ISR, have been introduced into the general relativity the ory (GRT); b) using transformations between such ISR as symmetry transformation, obtained by variational methods are values with clear physical sense; c) using the gravi-ISR basis as the zero level of the deformation reading, the theory of elasticity in GRT has been constructed and someof its applications considered. The results are compared with those of other authors

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.

Rare muon decays and lepton-family number conservation

International Nuclear Information System (INIS)

Hoffman, C.M.

1984-04-01

A brief historical survey of the discovery of the muon, interest in neutrinoless processes, and lepton-number conservation laws is given. The present view of lepton-number conservation laws and the search for μ → eγ are described. Other experiments are discussed including μ + → e + e + e - decay, μ - Z → e - Z reactions, μ → e γγ decay, other rare muon processes, strangeness-changing muon-number-nonconserving decays, and tau decays. 52 references

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.

An associative model of adaptive inference for learning word-referent mappings.

Science.gov (United States)

Kachergis, George; Yu, Chen; Shiffrin, Richard M

2012-04-01

People can learn word-referent pairs over a short series of individually ambiguous situations containing multiple words and referents (Yu & Smith, 2007, Cognition 106: 1558-1568). Cross-situational statistical learning relies on the repeated co-occurrence of words with their intended referents, but simple co-occurrence counts cannot explain the findings. Mutual exclusivity (ME: an assumption of one-to-one mappings) can reduce ambiguity by leveraging prior experience to restrict the number of word-referent pairings considered but can also block learning of non-one-to-one mappings. The present study first trained learners on one-to-one mappings with varying numbers of repetitions. In late training, a new set of word-referent pairs were introduced alongside pretrained pairs; each pretrained pair consistently appeared with a new pair. Results indicate that (1) learners quickly infer new pairs in late training on the basis of their knowledge of pretrained pairs, exhibiting ME; and (2) learners also adaptively relax the ME bias and learn two-to-two mappings involving both pretrained and new words and objects. We present an associative model that accounts for both results using competing familiarity and uncertainty biases.

Analytical characterization of recombinant hCG and comparative studies with reference product.

Science.gov (United States)

Thennati, Rajamannar; Singh, Sanjay Kumar; Nage, Nitin; Patel, Yena; Bose, Sandip Kumar; Burade, Vinod; Ranbhor, Ranjit Sudhakar

2018-01-01

Regulatory agencies recommend a stepwise approach for demonstrating biosimilarity between a proposed biosimilar and reference biological product emphasizing for functional and structural characterization to trace if there is any difference which may impact safety and efficacy. We studied the comparative structural and biological attributes of recombinant human chorionic gonadotropin (rhCG), SB005, with reference product, Ovidrel ® and Ovitrelle ® . Recombiant hCG was approved in 2000 by the US Food and Drug Administration for the induction of final follicular maturation, early luteinization in infertile women as part of assisted reproductive technology program. It is also indicated for the induction of ovulation and pregnancy in ovulatory infertile patients whose cause of infertility is not due to ovarian failure. Primary structure was studied by intact mass analysis, peptide fingerprinting, peptide mass fingerprinting and sequence coverage analysis. Higher order structure was studied by circular dichroism, ultraviolet-visible spectroscopy, fluorescence spectroscopy, and disulfide bridge analysis. Different isoforms of reference product and SB005 were identified using capillary isoelectric focusing and capillary zone electrophoresis. Glycosylation was studied by N-glycan mapping using LC-ESI-MS, point of glycosylation, released glycan analysis using ultra performance liquid chromatography and sialic acid analysis. Product related impurities such as oligomer content analysis and oxidized impurities were studied using size exclusion chromatography and reverse phase high performance liquid chromatography, respectively. Biological activity in term of potency of reference product and SB005 was studied by in vivo analysis. In this study we have compared analytical similarity of recombinant rhCG (SB005) produced at Sun Pharmaceuticals with the reference product with respect to its primary, higher order structure, isoforms, charge variants, glycosylation, sialyation

Considerations for reference pump curves

International Nuclear Information System (INIS)

Stockton, N.B.

1992-01-01

This paper examines problems associated with inservice testing (IST) of pumps to assess their hydraulic performance using reference pump curves to establish acceptance criteria. Safety-related pumps at nuclear power plants are tested under the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (the Code), Section 11. The Code requires testing pumps at specific reference points of differential pressure or flow rate that can be readily duplicated during subsequent tests. There are many cases where test conditions cannot be duplicated. For some pumps, such as service water or component cooling pumps, the flow rate at any time depends on plant conditions and the arrangement of multiple independent and constantly changing loads. System conditions cannot be controlled to duplicate a specific reference value. In these cases, utilities frequently request to use pump curves for comparison of test data for acceptance. There is no prescribed method for developing a pump reference curve. The methods vary and may yield substantially different results. Some results are conservative when compared to the Code requirements; some are not. The errors associated with different curve testing techniques should be understood and controlled within reasonable bounds. Manufacturer's pump curves, in general, are not sufficiently accurate to use as reference pump curves for IST. Testing using reference curves generated with polynomial least squares fits over limited ranges of pump operation, cubic spline interpolation, or cubic spline least squares fits can provide a measure of pump hydraulic performance that is at least as accurate as the Code required method. Regardless of the test method, error can be reduced by using more accurate instruments, by correcting for systematic errors, by increasing the number of data points, and by taking repetitive measurements at each data point

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

75 FR 6677 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0086

Science.gov (United States)

2010-02-10

... Office of Management and Budget; OMB Control Number: 1625-0086 AGENCY: Coast Guard, DHS. ACTION: Sixty... Management and Budget (OMB) requesting an extension of its approval for the following collection of... following means: (1) Online: http://www.regulations.gov . [[Page 6678

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

探思參考服務的畸形發展 Rethinking of the Development of Reference Service

Directory of Open Access Journals (Sweden)

Sheue-fang Song

1997-03-01

Full Text Available 無This article explains what's wrong with reference service. Users often have low inspections of what the reference librarian have to offer. Perhaps limited to a belief that librarians know where things are. Perhaps limited to a understanding what can the reference librarian do. But be a reference librarian, she (he has a lot of stuffs need to do, has a lot of plains try to design. She doesn't have any break. Everytime we talk about the number of increasing reference services, increasing the number of reference books. But we seldom talk about the increasing depression on the reference librarian. this paper talks about coping with success and failure on reference service in Taiwan.

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

40 CFR 86.1 - Reference materials.

Science.gov (United States)

2010-07-01

... Chromatography, 1994 SAE Handbook—SAE International Cooperative Engineering Program, Volume 1: Materials, Fuels... Method for Analysis of Natural Gas by Gas Chromatography, IBR approved for §§ 86.113-94, 86.513-94, 86...) Gases and Propane Concentrates by Gas Chromatography, IBR approved for §§ 86.113-94, 86.1213-94, 86.1313...

Advantage of using allele-specific copy numbers when testing for association in regions with common copy number variants.

Directory of Open Access Journals (Sweden)

Gaëlle Marenne

Full Text Available Copy number variants (CNV can be called from SNP-arrays; however, few studies have attempted to combine both CNV and SNP calls to test for association with complex diseases. Even when SNPs are located within CNVs, two separate association analyses are necessary, to compare the distribution of bi-allelic genotypes in cases and controls (referred to as SNP-only strategy and the number of copies of a region (referred to as CNV-only strategy. However, when disease susceptibility is actually associated with allele specific copy-number states, the two strategies may not yield comparable results, raising a series of questions about the optimal analytical approach. We performed simulations of the performance of association testing under different scenarios that varied genotype frequencies and inheritance models. We show that the SNP-only strategy lacks power under most scenarios when the SNP is located within a CNV; frequently it is excluded from analysis as it does not pass quality control metrics either because of an increased rate of missing calls or a departure from fitness for Hardy-Weinberg proportion. The CNV-only strategy also lacks power because the association testing depends on the allele which copy number varies. The combined strategy performs well in most of the scenarios. Hence, we advocate the use of this combined strategy when testing for association with SNPs located within CNVs.

Thermal radiation transfer calculations in combustion fields using the SLW model coupled with a modified reference approach

Science.gov (United States)

Darbandi, Masoud; Abrar, Bagher

2018-01-01

The spectral-line weighted-sum-of-gray-gases (SLW) model is considered as a modern global model, which can be used in predicting the thermal radiation heat transfer within the combustion fields. The past SLW model users have mostly employed the reference approach to calculate the local values of gray gases' absorption coefficient. This classical reference approach assumes that the absorption spectra of gases at different thermodynamic conditions are scalable with the absorption spectrum of gas at a reference thermodynamic state in the domain. However, this assumption cannot be reasonable in combustion fields, where the gas temperature is very different from the reference temperature. Consequently, the results of SLW model incorporated with the classical reference approach, say the classical SLW method, are highly sensitive to the reference temperature magnitude in non-isothermal combustion fields. To lessen this sensitivity, the current work combines the SLW model with a modified reference approach, which is a particular one among the eight possible reference approach forms reported recently by Solovjov, et al. [DOI: 10.1016/j.jqsrt.2017.01.034, 2017]. The combination is called "modified SLW method". This work shows that the modified reference approach can provide more accurate total emissivity calculation than the classical reference approach if it is coupled with the SLW method. This would be particularly helpful for more accurate calculation of radiation transfer in highly non-isothermal combustion fields. To approve this, we use both the classical and modified SLW methods and calculate the radiation transfer in such fields. It is shown that the modified SLW method can almost eliminate the sensitivity of achieved results to the chosen reference temperature in treating highly non-isothermal combustion fields.

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

Quantum reference frames and their applications to thermodynamics.

Science.gov (United States)

Popescu, Sandu; Sainz, Ana Belén; Short, Anthony J; Winter, Andreas

2018-07-13

We construct a quantum reference frame, which can be used to approximately implement arbitrary unitary transformations on a system in the presence of any number of extensive conserved quantities, by absorbing any back action provided by the conservation laws. Thus, the reference frame at the same time acts as a battery for the conserved quantities. Our construction features a physically intuitive, clear and implementation-friendly realization. Indeed, the reference system is composed of the same types of subsystems as the original system and is finite for any desired accuracy. In addition, the interaction with the reference frame can be broken down into two-body terms coupling the system to one of the reference frame subsystems at a time. We apply this construction to quantum thermodynamic set-ups with multiple, possibly non-commuting conserved quantities, which allows for the definition of explicit batteries in such cases.This article is part of a discussion meeting issue 'Foundations of quantum mechanics and their impact on contemporary society'. © 2018 The Author(s).

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)

Measurement uncertainty of ester number, acid number and patchouli alcohol of patchouli oil produced in Yogyakarta

Science.gov (United States)

Istiningrum, Reni Banowati; Saepuloh, Azis; Jannah, Wirdatul; Aji, Didit Waskito

2017-03-01

Yogyakarta is one of patchouli oil distillation center in Indonesia. The quality of patchouli oil greatly affect its market price. Therefore, testing quality of patchouli oil parameters is an important concern, one through determination of the measurement uncertainty. This study will determine the measurement uncertainty of ester number, acid number and content of patchouli alcohol through a bottom up approach. Source contributor to measurement uncertainty of ester number is a mass of the sample, a blank and sample titration volume, the molar mass of KOH, HCl normality, and replication. While the source contributor of the measurement uncertainty of acid number is the mass of the sample, the sample titration volume, the relative mass and normality of KOH, and repetition. Determination of patchouli alcohol by Gas Chromatography considers the sources of measurement uncertainty only from repeatability because reference materials are not available.

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...

77 FR 56847 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic...

Science.gov (United States)

2012-09-14

... Number 0910-0645)--Revision The SRP (formerly referred to as the MedWatch\\Plus\\ Portal and Rational Questionnaire) and the ESG are the Agency's electronic systems for collecting, submitting, and processing... ESG, approved under OMB control number 0910-0645. III. The FDA Safety Reporting Portal Rational...

27 CFR 44.142 - Records.

Science.gov (United States)

2010-04-01

... cigarettes); (d) Name of manufacturer and brand; and, (e) Quantity of tobacco products, cigarette papers and... appropriate TTB officer upon request. (Approved by the Office of Management and Budget under control number... papers and tubes”, and by revising the Office of Management and Budget control number reference...

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...

29 CFR 1910.6 - Incorporation by reference.

Science.gov (United States)

2010-07-01

... Test for Distillation of Petroleum Products, IBR approved for §§ 1910.106(a)(5) and 1910.119(b... of Pulverized Sugar and Cocoa, IBR approved for § 1910.263(k)(2)(i). (15) NFPA 68-1954 Guide for...

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.

Establishing a business process reference model for Universities

DEFF Research Database (Denmark)

Svensson, Carsten; Hvolby, Hans-Henrik

2012-01-01

Modern universities are by any standard complex organizations that, from an IT perspective, present a number of unique challenges. This paper will propose establishing a business process reference framework. The benefit to the users would be a better understanding of the system landscape, business......) have gained popularity among organizations in both the private and public sectors. We speculate that this success can be replicated in a university setting. Furthermore the paper will outline how the research group suggests moving ahead with the research which will lead to a reference model....

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.

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1993 ed

International Nuclear Information System (INIS)

1993-10-01

This is the fourth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM). The reporting format was established at consecutive meetings of SAGSTRAM, whose memberships consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA's transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last two complete calendar years. The 1985 Edition of IAEA Safety Series No. 6, the 'Regulations for the Safe Transport of Radioactive Material'' highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material. 6 tabs

Directory of national competent authorities` approval certificates for package design, special form material and shipment of radioactive material. 1995 edition

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-09-01

This is the sixth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM). The reporting format was established at consecutive meetings of SAGSTRAM, whose membership consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA`s transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last complete calendar year. The 1985 Edition of IAEA Safety Series No. 6, the ``Regulations for the Safe Transport of Radioactive Material`` highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material. 6 tabs.

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1999 Edition

International Nuclear Information System (INIS)

1999-08-01

This is the tenth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Transport Safety Standards Advisory Committee (TRANSSAC), formerly known as the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM). The reporting format was established at consecutive meetings of SAGSTRAM and endorsed by TRANSSAC, whose membership consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA's transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last complete calendar year. The 1985 Edition of IAEA Safety Series No. 6, the 'Regulations for the Safe Transport of Radioactive Material' highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material

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.

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

Science.gov (United States)

Kondo, Hideyuki; Saint-Raymond, Agnès; Yasuda, Naoyuki

2018-03-01

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.

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.

Xyce parallel electronic simulator : reference guide.

Energy Technology Data Exchange (ETDEWEB)

Mei, Ting; Rankin, Eric Lamont; Thornquist, Heidi K.; Santarelli, Keith R.; Fixel, Deborah A.; Coffey, Todd Stirling; Russo, Thomas V.; Schiek, Richard Louis; Warrender, Christina E.; Keiter, Eric Richard; Pawlowski, Roger Patrick

2011-05-01

This document is a reference guide to the Xyce Parallel Electronic Simulator, and is a companion document to the Xyce Users Guide. The focus of this document is (to the extent possible) exhaustively list device parameters, solver options, parser options, and other usage details of Xyce. This document is not intended to be a tutorial. Users who are new to circuit simulation are better served by the Xyce Users Guide. The Xyce Parallel Electronic Simulator has been written to support, in a rigorous manner, the simulation needs of the Sandia National Laboratories electrical designers. It is targeted specifically to run on large-scale parallel computing platforms but also runs well on a variety of architectures including single processor workstations. It also aims to support a variety of devices and models specific to Sandia needs. This document is intended to complement the Xyce Users Guide. It contains comprehensive, detailed information about a number of topics pertinent to the usage of Xyce. Included in this document is a netlist reference for the input-file commands and elements supported within Xyce; a command line reference, which describes the available command line arguments for Xyce; and quick-references for users of other circuit codes, such as Orcad's PSpice and Sandia's ChileSPICE.

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...

75 FR 39700 - Information Collection Request to Office of Management and Budget; OMB; Control Number: 1625-New

Science.gov (United States)

2010-07-12

... Office of Management and Budget; OMB; Control Number: 1625-New AGENCY: Coast Guard, DHS. ACTION: Sixty... of Management and Budget (OMB) requesting an approval for the following collection of information... the following means: (1) Online: http://www.regulations.gov . (2) Mail: Docket Management Facility...

The use of medications approved for Alzheimer’s disease in autism spectrum disorder: a systematic review

Directory of Open Access Journals (Sweden)

Daniel eRossignol

2014-08-01

Full Text Available Autism spectrum disorder (ASD is a neurodevelopmental disorder that affects 1 in 68 children in the United States. Even though it is a common disorder, only two medications (Risperidone and Aripiprazole are approved by the U.S. Food and Drug Administration (FDA to treat symptoms associated with ASD. However these medications are approved to treat irritability, which is not a core symptom of ASD. A number of novel medications which have not been approved by the FDA to treat ASD have been used off-label in some studies to treat ASD symptoms, including medications approved for Alzheimer’s disease. Interestingly, some of these studies are high quality, double-blind, placebo-controlled (DBPC studies. This article systematically reviews studies published through April, 2014 which examined the use of Alzheimer’s medications in ASD, including donepezil (7 studies, 2 were DBPC, 5/7 reported improvements, galantamine (4 studies, 2 were DBPC, all reported improvements, rivastigmine (1 study reporting improvements, tacrine (1 study reporting improvements and memantine (9 studies, 1 was DBPC, 8 reported improvements. An evidence-based scale was used to rank each medication. Collectively, these studies reported improvements in expressive language and communication, receptive language, social interaction, irritability, hyperactivity, attention, eye contact, emotional lability, repetitive or self-stimulatory behaviors, motor planning, disruptive behaviors, obsessive-compulsive symptoms, lethargy, overall ASD behaviors and increased REM sleep. Reported side effects are reviewed and include irritability, gastrointestinal problems, verbal or behavioral regression, headaches, irritability, rash, tremor, sedation, vomiting, and speech problems. Both galantamine and memantine had sufficient evidence ranking for improving both core and associated symptoms of ASD. Given the lack of medications approved to treat ASD, further studies on novel medications, including

Reference Priors For Non-Normal Two-Sample Problems

NARCIS (Netherlands)

Fernández, C.; Steel, M.F.J.

1997-01-01

The reference prior algorithm (Berger and Bernardo, 1992) is applied to locationscale models with any regular sampling density. A number of two-sample problems is analyzed in this general context, extending the dierence, ratio and product of Normal means problems outside Normality, while explicitly

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...

Metric propositional neighborhood logics on natural numbers

DEFF Research Database (Denmark)

Bresolin, Davide; Della Monica, Dario; Goranko, Valentin

2013-01-01

Metric Propositional Neighborhood Logic (MPNL) over natural numbers. MPNL features two modalities referring, respectively, to an interval that is “met by” the current one and to an interval that “meets” the current one, plus an infinite set of length constraints, regarded as atomic propositions...

Staffing an Academic Reference Desk with Librarians is not Cost-effective. A Review of: Ryan, Susan M. “Reference Transactions Analysis: The Cost-effectiveness of Staffing a Traditional Academic Reference Desk.” Journal of Academic Librarianship 34.5 (2008: 389-99.

Directory of Open Access Journals (Sweden)

Cari Merkley

2009-06-01

categories derived by the researcher: look-up (a search for a known item, directional (library-specific orientation to the space and collections, technology (assistance with using library technology and electronic resources, and reference. The category of reference was further subdivided into eight additional categories: catalogue search, citation help, database help, “guide to correct databases,” “personal knowledge or referral,” “quick internet search,” research, and Serials Solutions (392. “Guide to correct databases” referred to advice on the appropriate database to answer a question and serials solutions included questions that could be answered using the Serials Solutions product, such as the availability of a particular journal or article in the collection (392. Questions were assigned to the single most appropriate category by the researcher. Question categories were then mapped to “suggested staffing levels” (396. This determination was made by the researcher, and no details were given as to how the decision was made for each category. The three levels of staffing discussed were librarian, “trained student or staff,” and “well-trained staff/occasional librarian referral” (396. The cost of staffing the reference desk during the eight months captured in this study was calculated by multiplying the hours worked by each librarian by his/her individual average rate of pay across the four data collection periods. Indirect staff costs such as benefits were not included in this calculation. The average cost per reference transaction was determined by dividing the total salary costs by the total number of reference queries during the periods of study. Costs for those categories of questions best addressed by a librarian could then be determined. The actual number of librarians who participated in the study is unclear. The methodology refers to four full-time and two part-time librarians (391. However, later in the article there is reference to

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...

40 CFR 60.17 - Incorporations by reference.

Science.gov (United States)

2010-07-01

..., Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, IBR approved... Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter (Precision Method), IBR approved for..., Standard Test Method for Gross Calorific Value of Solid Fuel by the Adiabatic Bomb Calorimeter, IBR...

PVWatts Version 1 Technical Reference

Energy Technology Data Exchange (ETDEWEB)

Dobos, A. P.

2013-10-01

The NREL PVWatts(TM) calculator is a web application developed by the National Renewable Energy Laboratory (NREL) that estimates the electricity production of a grid-connected photovoltaic system based on a few simple inputs. PVWatts combines a number of sub-models to predict overall system performance, and makes several hidden assumptions about performance parameters. This technical reference details the individual sub-models, documents assumptions and hidden parameters, and explains the sequence of calculations that yield the final system performance estimation.

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...

10 CFR 431.443 - Materials incorporated by reference.

Science.gov (United States)

2010-01-01

... Renewable Energy, Building Technologies Program, Sixth Floor, 950 L'Enfant Plaza, SW., Washington, DC 20024... Procedure for Polyphase Induction Motors and Generators, approved February 9, 2004, IBR approved for § 431...

75 FR 10297 - Information Collection Request to Office of Management and Budget; OMB Control Numbers: 1625-0056

Science.gov (United States)

2010-03-05

... Office of Management and Budget; OMB Control Numbers: 1625-0056 AGENCY: Coast Guard, DHS. ACTION: Sixty... of Management and Budget (OMB) requesting an extension of its approval for the following collection... . (2) Mail: Docket Management Facility (DMF) (M-30), U.S. Department of Transportation (DOT), West...

75 FR 1068 - Information Collection Request to Office of Management and Budget; OMB Control Numbers: 1625-0087

Science.gov (United States)

2010-01-08

... Office of Management and Budget; OMB Control Numbers: 1625-0087 AGENCY: Coast Guard, DHS. ACTION: Sixty... Management and Budget (OMB) requesting an extension of its approval for the following collection of...: Docket Management Facility (DMF) (M-30), U.S. Department of Transportation (DOT), West Building Ground...

75 FR 70938 - Information Collection Request to Office of Management and Budget; OMB Control numbers: 1625-0108.

Science.gov (United States)

2010-11-19

... Office of Management and Budget; OMB Control numbers: 1625-0108. AGENCY: Coast Guard, DHS. ACTION: Sixty... of Management and Budget (OMB) requesting an extension of its approval for the following collection.... (2) Mail: Docket Management Facility (DMF) (M-30), U.S. Department of Transportation (DOT), West...

[The references in articles published in biomedical journals].

Science.gov (United States)

Reyes, H

2001-04-01

Bibliographic citations or "references" are an important component of all scientific manuscripts. The authors are responsible for their accuracy and they should follow the format and style requested by the journal where they are submitting their paper. Revista Médica de Chile adheres to the "Uniform Requirements" established by the Vancouver Group of Medical Editors. Equally important is a correct choice of references, including those original articles strictly connected to the content of the manuscript. The number of citations usually vary according to the specific character of the study: research article, or case reports, review article, etc. Common mistakes are due to an excessive number of repetitive or irrelevant citations, or the omission of important articles sometimes not found in bibliographic indexes, or an erroneous claim of priority in reporting an observation. Finally, in developing countries the authors should include previous reports appeared in their own local journals, therefore improving their opportunities of achieving international visibility.

Development of a certified reference material for composition of high-purity copper as a transfer standard within GET 176-2013

Directory of Open Access Journals (Sweden)

Veniamin M. Zyskin

2017-01-01

Full Text Available Introduction. The paper gives information on the development of a certified reference material (CRM for composition of high-purity copper (Cu CRM UNIIM. The CRM is included as the transfer standard into the State primary standard of the mass (molar fraction and mass (molar concentration of the component in liquid and solid substances and materials based on coulometry GET 176-2013.Materials and methods. The CRM represents pieces of oxygen-free copper wire rod, brand KMB, produced according to GOST R 53803-2010, weighing from 0.5 to 1g. The CRM is packed in plastic vials with the capacity of 30 or 50 cm3. The certified characteristic of the CRM is copper mass fraction in copper wire rod, expressed in percentages. The certified value for copper mass fraction was established by the primary method of controlled-potential coulometry using the State primary standard GET 176-2013.Results. The permitted interval of the certified value for copper mass fraction in the CRM is from 99,950 % to 100,000 %. The relative expanded uncertainty (k=2 of the certified value for copper mass fraction does not exceed 0,030 %; the relative standard uncertainty due to inhomogeneity does not exceed 0.010 %; the relative standard uncertainty due to instability does not exceed 0.010 %. The shelf life of the developed CRM is 10 years provided that standard storage conditions are ensured.Discussion and conclusions. The developed CRM is included into the State register of type approved RMs under the number GSO 10800-2016. The CRM of high-purity copper (Cu CRM UNIIM as a transfer standard is intended for reproduction, storage and transfer of the copper mass fraction unit to other reference materials and chemical reagents by the method of comparison using a comparator and by conducting direct measurements. This CRM may also be used:– for verification of measuring instruments (MIs according to the state verification schedule described in GOST R 8.735.0-2014,– for calibration

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 ...

Food and Drug Administration Drug Approval Process: A History and Overview.

Science.gov (United States)

Williams, Christopher Ty

2016-03-01

In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluating college students’ displayed alcohol references on Facebook and Twitter

Science.gov (United States)

Moreno, Megan A.; Arseniev-Koehler, Alina; Litt, Dana; Christakis, Dimitri

2018-01-01

Purpose Current trends suggest adolescents and young adults typically maintain a social media “portfolio” of several sites including Facebook and Twitter, but little is known regarding how an individual chooses to display risk behaviors across these different sites. The purpose of this study was to investigate college students’ displayed alcohol references on both Facebook and Twitter. Methods Among a larger sample of college students from two universities, we identified participants who maintained both Facebook and Twitter profiles. Data collection included evaluation of 5 months of participants’ Facebook and Twitter posts for alcohol references, number of social connections (i.e. friends or followers) and number of posts. Phone interviews assessed participants’ frequency of Facebook and Twitter use and self-reported alcohol use. Analyses included Fisher’s exact test, Wilcoxon matched pair sign test, Freidman rank-sum tests and logistic regression. Results Of 112 eligible participants, 94 (RR=84.8%) completed the study. Participants were more likely to display alcohol references on Facebook compared to Twitter (76% versus 34%, p=0.02). Participants reported more social connections on Facebook versus Twitter (average 801.2 friends versus 189.4 followers, pTwitter (94.6% versus 50%, pTwitter displayed alcohol references, but mediators differed in each model. Discussion College students were more likely to display alcohol references on Facebook compared to Twitter. Understanding these patterns and predictors may inform prevention and intervention efforts directed at particular social media sites. PMID:26995291

Recommended conservation of the names Streptococcus sanguis, Streptococcus rattus, Streptococcus cricetus, and seven other names included in the Approved Lists of Bacterial Names. Request for an opinion

DEFF Research Database (Denmark)

Kilian, Mogens

2001-01-01

With reference to the first Principle of the International Code of Nomenclature of Bacteria, which emphasizes stability of names, it is proposed that the original names Streptococcus sanguis, Streptococcus rattus, Streptococcus cricetus, Erwinia ananas, Eubacterium tarantellus, Lactobacillus sake......, Nitrosococcus oceanus, Pseudomonas betle, Rickettsia canada and Streptomyces rangoon, all included in the Approved Lists of Bacterial Names, be conserved. Request for an Opinion...

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.

VMware vSphere 5 Administration Instant Reference

CERN Document Server

Kusek, Christopher; Daniel, Andy

2011-01-01

Compact and portable reference guide for quick answers to VMware vSphere If you're looking to migrate to the newest version of VMware vSphere, this concise guide will get you up to speed and down to business in no time. If you're new to VMware vSphere, this book is for you too! The compact size of this quick reference makes it easy for you to have by your side—whether you're in the field, server room, or at your desk. Helpful elements for finding information such as thumb tabs, tables of contents with page numbers at the beginning of each chapter, and special headers puts what you need a

7 CFR 46.21 - Returns, rejections, or credit memorandums on sales.

Science.gov (United States)

2010-01-01

..., a credit memorandum showing the buyer's name, sales ticket number, lot number, date of the granting... notation shall be made on the original sales ticket referring to the adjustment and showing where the... sales ticket or invoice properly completed to show the facts and shall be approved by a duly authorized...

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

Selection of References in Wind Turbine Model Predictive Control Design

DEFF Research Database (Denmark)

Odgaard, Peter Fogh; Hovgaard, Tobias

2015-01-01

a model predictive controller for a wind turbine. One of the important aspects for a tracking control problem is how to setup the optimal reference tracking problem, as it might be relevant to track, e.g., the three concurrent references: optimal pitch angle, optimal rotational speed, and optimal power......Lowering the cost of energy is one of the major focus areas in the wind turbine industry. Recent research has indicated that wind turbine controllers based on model predictive control methods can be useful in obtaining this objective. A number of design considerations have to be made when designing....... The importance if the individual references differ depending in particular on the wind speed. In this paper we investigate the performance of a reference tracking model predictive controller with two different setups of the used optimal reference signals. The controllers are evaluated using an industrial high...

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.

75 FR 57809 - Information Collection Request to Office of Management and Budget; OMB Control Numbers: 1625-0002...

Science.gov (United States)

2010-09-22

... Office of Management and Budget; OMB Control Numbers: 1625-0002, 1625-0017, 1625-0019, and 1625- 0030... (ICRs) and Analyses to the Office of Management and Budget (OMB) requesting an extension of its approval...://www.regulations.gov . (2) Mail: Docket Management Facility (DMF) (M-30), U.S. Department of...

75 FR 19413 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0089.

Science.gov (United States)

2010-04-14

... Office of Management and Budget; OMB Control Number: 1625-0089. AGENCY: Coast Guard, DHS. ACTION: Sixty... of Management and Budget (OMB) requesting an approval for re-instatement with change of the following... Management Facility (DMF) (M-30), U.S. Department of Transportation (DOT), West Building Ground Floor, Room...

ON A NEW CRITERIA OF THE REFERRING WASTE TO RADIOACTIVE CATEGORIES AND ON THE AMENDMENTS INTRODUCED IN BSRRSP-99/2010 AND SRRWT-2002

Directory of Open Access Journals (Sweden)

I. K. Romanovich

2014-01-01

Full Text Available A new criteria of the referring solid, liquid and gaseous waste to radioactive categories are analyzed, which  were  approved  by  Russian  Federation  Government  Resolution  №  1069,  October  19,  2012.  Following amendments  introduced  in  BSRRSP-99/2010  (Supplement  №  1,  2013  and  SRRWT-2002  (Supplements  № 2, 2013 are analyzed as well. Brief analysis is given of the difference of new criteria of the reference waste to radioactive categories in comparison with BSRRSP-99/2010.

Perceptual quality estimation of H.264/AVC videos using reduced-reference and no-reference models

Science.gov (United States)

Shahid, Muhammad; Pandremmenou, Katerina; Kondi, Lisimachos P.; Rossholm, Andreas; Lövström, Benny

2016-09-01

Reduced-reference (RR) and no-reference (NR) models for video quality estimation, using features that account for the impact of coding artifacts, spatio-temporal complexity, and packet losses, are proposed. The purpose of this study is to analyze a number of potentially quality-relevant features in order to select the most suitable set of features for building the desired models. The proposed sets of features have not been used in the literature and some of the features are used for the first time in this study. The features are employed by the least absolute shrinkage and selection operator (LASSO), which selects only the most influential of them toward perceptual quality. For comparison, we apply feature selection in the complete feature sets and ridge regression on the reduced sets. The models are validated using a database of H.264/AVC encoded videos that were subjectively assessed for quality in an ITU-T compliant laboratory. We infer that just two features selected by RR LASSO and two bitstream-based features selected by NR LASSO are able to estimate perceptual quality with high accuracy, higher than that of ridge, which uses more features. The comparisons with competing works and two full-reference metrics also verify the superiority of our models.

The Influence of Reference Corpus Size on Wordsmith Tools Keywords Extraction

Directory of Open Access Journals (Sweden)

Tony Berber Sardinha

2012-05-01

Full Text Available A KeyWords analysis (using WordSmith Tools enables the discovery of lexical items which reveal the main lexical sets in a text or corpus. Such an analysis requires that a reference corpus be compared to the corpus the researcher intends to describe (the study corpus. This paper presents a mathematical method for finding out the influence of reference corpus size on the number of key words extracted by the program. The results reveal that a reference corpus that is at least five times as large as the study corpus allows for drawing an amount of key words that is statistically equivalent to larger reference corpora, thus suggesting five times (as larger as the study corpora as the minimum order of magnitude for reference corpora.

Defense Acquisition Research Journal. Volume 21, Number 2, Issue 69

Science.gov (United States)

2014-04-01

Manual of the American Psychological Association ( 6th Edition ). For all other style questions, please refer to the Chicago Manual of Style (15th...Graphic Designer Technical Editor Editorial Assistant Proofreader Multimedia Assistant Editing , Design, and Layout A Publication of the Defense...language. Format Please submit your manuscript with references in APA format (author-date-page number form of citation) as outlined in the Publication

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...

Estimating the number of cases of podoconiosis in Ethiopia using geostatistical methods [version 2; referees: 3 approved, 1 approved with reservations

Directory of Open Access Journals (Sweden)

Kebede Deribe

2017-12-01

Full Text Available Background: In 2011, the World Health Organization recognized podoconiosis as one of the neglected tropical diseases. Nonetheless, the  magnitude of podoconiosis and the geographical distribution of the disease is poorly understood. Based on a nationwide mapping survey and geostatistical modelling, we predict the prevalence of podoconiosis and estimate the number of cases across Ethiopia. Methods: We used nationwide data collected in Ethiopia between 2008 and 2013. Data were available for 141,238 individuals from 1,442 communities in 775 districts from all nine regional states and two city administrations. We developed a geostatistical model of podoconiosis prevalence among adults (individuals aged 15 years or above, by combining environmental factors. The number of people with podoconiosis was then estimated using a gridded map of adult population density for 2015. Results: Podoconiosis is endemic in 345 districts in Ethiopia: 144 in Oromia, 128 in Southern Nations, Nationalities and People’s [SNNP], 64 in Amhara, 4 in Benishangul Gumuz, 4 in Tigray and 1 in Somali Regional State. Nationally, our estimates suggest that 1,537,963 adults (95% confidence intervals, 290,923-4,577,031 adults were living with podoconiosis in 2015. Three regions (SNNP, Oromia and Amhara contributed 99% of the cases. The highest proportion of individuals with podoconiosis resided in the SNNP (39%, while 32% and 29% of people with podoconiosis resided in Oromia and Amhara Regional States, respectively. Tigray and Benishangul Gumuz Regional States bore lower burdens, and in the remaining regions, podoconiosis was almost non-existent.  Conclusions: The estimates of podoconiosis cases presented here based upon the combination of currently available epidemiological data and a robust modelling approach clearly show that podoconiosis is highly endemic in Ethiopia. Given the presence of low cost prevention, and morbidity management and disability prevention services, it is

Establishing Local Reference Dose Values and Optimisation Strategies

International Nuclear Information System (INIS)

Connolly, P.; Moores, B.M.

2000-01-01

The revised EC Patient Directive 97/43 EURATOM introduces the concepts of clinical audit, diagnostic reference levels and optimisation of radiation protection in diagnostic radiology. The application of reference dose levels in practice involves the establishment of reference dose values as actual measurable operational quantities. These values should then form part of an ongoing optimisation and audit programme against which routine performance can be compared. The CEC Quality Criteria for Radiographic Images provides guidance reference dose values against which local performance can be compared. In many cases these values can be improved upon quite considerably. This paper presents the results of a local initiative in the North West of the UK aimed at establishing local reference dose values for a number of major hospital sites. The purpose of this initiative is to establish a foundation for both optimisation strategies and clinical audit as an ongoing and routine practice. The paper presents results from an ongoing trial involving patient dose measurements for several radiological examinations upon the sites. The results of an attempt to establish local reference dose values from measured dose values and to employ them in optimisation strategies are presented. In particular emphasis is placed on the routine quality control programmes necessary to underpin this strategy including the effective data management of results from such programmes and how they can be employed to optimisation practices. (author)

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...

Directory of national competent authorities' approval certificates for package design, special form material and shipment of radioactive material. 1996 edition

International Nuclear Information System (INIS)

1996-09-01

This is the seventh annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificated (PACKTRAM) at the recommendation of the then Standing Advisory Group on the Sate Transport of Radioactive Material (SAGSTRAM). The functions of SAGSTRAM were taken over in 1996 by the Transport Safety Standards Advisory Committee (TRANSSAC). The reporting format was established at consecutive meetings of SAGSTRAM, whose membership consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA's transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last complete calendar year. The 1985 Edition of IAEA Safety Series No. 6, the ''Regulations for the Safe Transport of Radioactive Material'', highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material. 6 tabs

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.

Psychiatric Morbidity Patterns in Referred Inpatients of Other Specialties

Directory of Open Access Journals (Sweden)

Ajay Risal

2013-03-01

Conclusions: Psychiatric consultation was sought mostly by medical ward that had maximum number of patients presenting with self-poisoning. The commonest diagnosis seen in the referred in-patients was depression and anxiety disorder. Keywords: consultation-liaison psychiatry; in-patient referral; psychiatric morbidity.

75 FR 59278 - Information Collection Request to Office of Management and Budget; OMB Control Numbers: 1625-0062...

Science.gov (United States)

2010-09-27

... Office of Management and Budget; OMB Control Numbers: 1625-0062, 1625-0078, and 1625-0082 AGENCY: Coast... Analyses to the Office of Management and Budget (OMB) requesting a revision of its approval for the...: (1) Online: http://www.regulations.gov . (2) Mail: Docket Management Facility (DMF) (M-30), U.S...

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...

40 CFR 61.18 - Incorporations by reference.

Science.gov (United States)

2010-07-01

... D2382-76, 88, Heat of Combustion of Hydrocarbon Fuels by Bomb Calorimeter (High-Precision Method), IBR..., IBR approved September 14, 1989 for § 61.270(a). (13) ASTM D4809-95, Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter (Precision Method), IBR approved for § 61.245(e)(3...

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...

Embedded systems design with special arithmetic and number systems

CERN Document Server

Sousa, Leonel; Chang, Chip-Hong

2017-01-01

This book introduces readers to alternative approaches to designing efficient embedded systems using unconventional number systems. The authors describe various systems that can be used for designing efficient embedded and application-specific processors, such as Residue Number System, Logarithmic Number System, Redundant Binary Number System Double-Base Number System, Decimal Floating Point Number System and Continuous Valued Number System. Readers will learn the strategies and trade-offs of using unconventional number systems in application-specific processors and be able to apply and design appropriate arithmetic operations from these number systems to boost the performance of digital systems. • Serves as a single-source reference to designing embedded systems with unconventional number systems • Covers theory as well as implementation on application-specific processors • Explains mathematical concepts in a manner accessible to readers with diverse backgrounds.

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...

Reference samples for the earth sciences

Science.gov (United States)

Flanagan, F.J.

1974-01-01

A revised list of reference samples of interest to geoscientists has been extended to include samples for the agronomist, the archaeologist and the environmentalist. In addition to the source from which standard samples may be obtained, references or pertinent notes for some samples are included. The number of rock reference samples is now almost adequate, and the variety of ore samples will soon be sufficient. There are very few samples for microprobe work. Oil shales will become more important because of the outlook for world petroleum resources. The dryland equivalent of a submarine basalt might be useful in studies of sea-floor spreading and of the geochemistry of basalts. The Na- and K-feldspars of BCS (British Chemical Standards-Bureau of Analysed Samples), NBS (National Bureau of Standards), and ANRT (Association Kationale de la Recherche Technique) could serve as trace-element standards if such data were available. Similarly, the present NBS flint and plastic clays, as well as their predecessors, might be useful for archaeological pottery studies. The International Decade for Ocean Exploration may stimulate the preparation of ocean-water standards for trace elements or pollutants and a standard for manganese nodules. ?? 1974.