WorldWideScience

Sample records for nonpostable terms approved

  1. Quality assurance terms and definitions - approved 1973

    International Nuclear Information System (INIS)

    Anon.

    1975-01-01

    Standards for certain terms and their definitions that are important to the uniform understanding of the intent of required quality assurance practices for the construction of nuclear power plants are presented

  2. Standard definitions of terms relating to dosimetry - approved standard 1973

    International Nuclear Information System (INIS)

    Anon.

    1975-01-01

    Definitions are presented for terms related to radiation dosimetry. These definitions are the same as, or similar to, those recommended by the International Commission on Radiological Units and Measurements (ICRU) as presented in the National Bureau of Sandards Handbook 62, but attempt has been made to define some of the terms more exactly

  3. 78 FR 32001 - Public Notice for a Change in Use of Aeronautical Property and Long-Term Lease Approval at...

    Science.gov (United States)

    2013-05-28

    ... International Airport approved Airport Layout Plan (ALP). There is to be no sale or transfer of property rights... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Public Notice for a Change in Use of Aeronautical Property and Long-Term Lease Approval at Harrisburg International Airport (MDT), Middletown, PA...

  4. Subjective and objective peer approval evaluations and self-esteem development: A test of reciprocal, prospective, and long-term effects.

    Science.gov (United States)

    Gruenenfelder-Steiger, Andrea E; Harris, Michelle A; Fend, Helmut A

    2016-10-01

    A large body of literature suggests a clear, concurrent association between peer approval and self-esteem in adolescence. However, little empirical work exists on either the prospective or reciprocal relation between peer approval and self-esteem during this age period. Moreover, it is unclear from past research whether both subjectively perceived peer approval and objectively measured peer approval are related to subsequent self-esteem over time (and vice versa) and whether these paths have long-term associations into adulthood. Using data from a large longitudinal study that covers a time span of 2 decades, we examined reciprocal, prospective relations between self-esteem and peer approval during ages 12-16 in addition to long-term relations between these variables and later social constructs at age 35. Cross-lagged regression analyses revealed small but persistent effect sizes from both types of peer approval to subsequent self-esteem in adolescence, controlling for prior self-esteem. However, effects in the reverse direction were not confirmed. These findings support the notion that peer relationships serve an important function for later self-esteem, consistent with many theoretical tenets of the importance of peers for building a strong identity. Finally, we found long-term relations between adult social constructs and adolescent objective and subjective peer approval as well as self-esteem. Therefore, not only do peer relationships play a role in self-esteem development across adolescence, but they remain impactful throughout adulthood. In sum, the current findings highlight the lasting, yet small link between peer relationships and self-esteem development and call for investigations of further influential factors for self-esteem over time. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  5. Approved CAR T cell therapies : Ice bucket challenges on glaring safety risks and long-term impacts

    NARCIS (Netherlands)

    P.P. Zheng (Pingpin); J.M. Kros (Johan); J. Li (Jin)

    2018-01-01

    textabstractTwo autologous chimeric antigen receptor (CAR) T cell therapies (Kymriah™ and Yescarta™) were recently approved by the FDA. Kymriah™ is for the treatment of pediatric patients and young adults with refractory or relapse (R/R) B cell precursor acute lymphoblastic leukemia and Yescarta™ is

  6. Aiming for long-term, objective-driven science communication in the UK [version 2; referees: 1 approved, 2 approved with reservations

    Directory of Open Access Journals (Sweden)

    Andreas Prokop

    2016-12-01

    Full Text Available Communicating science to wider lay audiences is an increasingly important part of a scientist's remit, and is something that many scientists are keen to embrace. However, based on surveys carried out amongst the UK public, as well as our own experiences in developing and delivering such activities, we believe that they are not always as effective at engaging members of the general public as they could be. In this opinion article we argue that in order to achieve more effective science communication, we need more objective-driven and long-term initiatives. As well as being implemented by the scientists themselves, funding organisations can play an important role in helping to drive such initiatives, and we suggest a list of actionable items that might allow for some of these ideas to be implemented.

  7. Case Report: Postpartum hemorrhage associated with Dengue with warning signs in a term pregnancy and delivery [version 1; referees: 2 approved, 1 not approved

    Directory of Open Access Journals (Sweden)

    Le Phi Hung

    2015-12-01

    Full Text Available Background: Dengue infection during peripartum period, although rare in endemic regions, has challenged clinicians regarding its management, especially if a parturient woman experiences postpartum hemorrhage due to a classical risk factor of maternal bleeding. Case: A full-term pregnant Vietnamese woman was diagnosed with polyhydramnios and Dengue with warning signs (DWS. She was administered platelet transfusion prior to delivery and then gave birth to a healthy newborn. After active management of the third stage of labor, the patient suffered a postpartum hemorrhage which was caused by uterine atony and accompanied with thrombocytopenia. Therefore, we decided to administer uterotonic drugs and additionally transfuse platelets. Conclusion: We describe a case of postpartum hemorrhage caused by uterine atony and coinciding with Dengue infection during delivery period, which is a rare clinical entity. With timely detection and management, the patient was finally discharged without complications.

  8. Subjective and Objective Peer Approval Evaluations and Self-Esteem Development: A Test of Reciprocal, Prospective, and Long-Term Effects

    Science.gov (United States)

    Gruenenfelder-Steiger, Andrea E.; Harris, Michelle A.; Fend, Helmut A.

    2016-01-01

    A large body of literature suggests a clear, concurrent association between peer approval and self-esteem in adolescence. However, little empirical work exists on either the prospective or reciprocal relation between peer approval and self-esteem during this age period. Moreover, it is unclear from past research whether both "subjectively…

  9. 75 FR 27375 - Review of Nonpostal Services Language

    Science.gov (United States)

    2010-05-14

    ... Accountability and Enhancement Act, January 14, 2010, at 31, 39 (Order No. 392); appeals docketed, Le Page's 2000..., February 12, 2010). The decision in Phase II regarding the Warranty Repair Program was not appealed and is..., Leasing, Licensing or Other Non-Sale Disposition of Tangible Property; Advertising; Mail Services...

  10. Application for approval of derived authorized limits for the release of the 190-C trenches and 105-C process water tunnels at the Hanford Site: Volume 2 - source term development

    International Nuclear Information System (INIS)

    Denham, D.H.; Winslow, S.L.; Moeller, M.P.; Kennedy, W.E. Jr.

    1997-03-01

    As part of environmental restoration activities at the Hanford Site, Bechtel Hanford, Inc. is conducting a series of evaluations to determine appropriate release conditions for specific facilities following the completion of decontamination and decommissioning projects. The release conditions, with respect to the residual volumetric radioactive contamination, are termed authorized limits. This report presents the summary of the supporting information and the final application for approval of derived authorized limits for the release of the 190-C trenches and the 105-C process water tunnels. This document contains two volumes; this volume (Vol. 2) contains the radiological characterization data, spreadsheet analyses, and radiological source terms

  11. 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...

  12. Patterns of database citation in articles and patents indicate long-term scientific and industry value of biological data resources [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    David Bousfield

    2016-02-01

    Full Text Available Data from open access biomolecular data resources, such as the European Nucleotide Archive and the Protein Data Bank are extensively reused within life science research for comparative studies, method development and to derive new scientific insights. Indicators that estimate the extent and utility of such secondary use of research data need to reflect this complex and highly variable data usage. By linking open access scientific literature, via Europe PubMedCentral, to the metadata in biological data resources we separate data citations associated with a deposition statement from citations that capture the subsequent, long-term, reuse of data in academia and industry.  We extend this analysis to begin to investigate citations of biomolecular resources in patent documents. We find citations in more than 8,000 patents from 2014, demonstrating substantial use and an important role for data resources in defining biological concepts in granted patents to both academic and industrial innovators. Combined together our results indicate that the citation patterns in biomedical literature and patents vary, not only due to citation practice but also according to the data resource cited. The results guard against the use of simple metrics such as citation counts and show that indicators of data use must not only take into account citations within the biomedical literature but also include reuse of data in industry and other parts of society by including patents and other scientific and technical documents such as guidelines, reports and grant applications.

  13. 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

  14. Comparison of Iran’s and World’s Leading Faculties Approved Curriculum in the Field of Pharmacy, in terms of Pharmaceutical Care Education

    Directory of Open Access Journals (Sweden)

    Kaveh Eslami

    2018-02-01

    Full Text Available Background: Following the changes in the basic concepts of pharmaceutical science, the main opinion in pharmacy practice changed from “drug-oriented pharmacy” to “patient-oriented pharmacy”, leading to changes in the pharmacy education in many aspects.Methods: In the presented study, we compare Iran’s Pharm.D education system and the four of high ranking systems available in the world in term of pharmaceutical care related educations and how much is the portion of this type educations in the curriculum. The University of California, San Francisco (UCSF with a rank of 2, The University of Michigan with a rank of 7, and the Universities of Pittsburgh and Purdue with ranks of almost under 50 in the world ranking have been selected.Results: The results showed, in the United States (US colleges about 60.5% of educational program was related to the pharmaceutical care concept. This calculation for the University of Waterloo was about 74%. The Saudi University compared, had about 47% related units. Regarding the Iranian program, when the specialized units after basic science were considered as the professional course, about 24% of them had a relationship with the pharmaceutical care. However, this was in the case that a student chooses the hospital internship instead of industry internship in the final year; otherwise, the percentage would reduce to 22.7%.Conclusion: Based on the results of this study, and regarding internationally accepted standards, we strongly recommend to change the structure of pharmacy curriculum in Iran to improve the ability of students for patient-oriented services.

  15. 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.

  16. 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 ...

  17. 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 ...

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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...

  7. 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.

  8. 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

  9. 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)

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Supercollider: Footprint approved

    International Nuclear Information System (INIS)

    Anon.

    1990-01-01

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

  18. 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…

  19. 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,...

  20. 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 ( ...

  1. 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

  2. 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...

  3. 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.

  4. Drugs Approved for Liver Cancer

    Science.gov (United States)

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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Drugs Approved for Bone Cancer

    Science.gov (United States)

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

  13. Drugs Approved for 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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 ...

  18. 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...

  19. 49 CFR 381.515 - May the FMCSA remove approved participants from a pilot program?

    Science.gov (United States)

    2010-10-01

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

  20. 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

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

  2. Drugs Approved for Cervical Cancer

    Science.gov (United States)

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

  3. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

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

  4. Drugs Approved for Testicular Cancer

    Science.gov (United States)

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

  5. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  6. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

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

  7. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-04-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

  8. 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.

  9. 78 FR 1276 - FY 2012 Annual Compliance Report

    Science.gov (United States)

    2013-01-08

    ...); (3) worksharing-related cost studies; and (4) billing determinant information for both domestic and... future price increases for Standard Mail Flats. Id. at 15-19. \\2\\ Docket No. ACR2010, Order No. 1427... Classification Schedule (MCS) descriptions and prices for nonpostal service products. The approved MCS includes...

  10. 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.

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    Science.gov (United States)

    2010-07-01

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

  19. 7 CFR 1717.853 - Loan terms and conditions.

    Science.gov (United States)

    2010-01-01

    ... Accommodations and Subordinations for 100 Percent Private Financing § 1717.853 Loan terms and conditions. (a) Terms and conditions. A loan, bond or other financing instrument, for which a lien accommodation or... also waive its right of approval in other cases. RUS's decision to waive its right of approval will...

  20. 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...

  1. Approval of radioactive consumer goods

    International Nuclear Information System (INIS)

    Paynter, R.A.

    1992-01-01

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

  2. Trastuzumab emtansine: first global approval.

    Science.gov (United States)

    Ballantyne, Anita; Dhillon, Sohita

    2013-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

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

  4. Teaching and Learning Science in Authoritative Classrooms: Teachers' Power and Students' Approval in Korean Elementary Classrooms

    Science.gov (United States)

    Lee, Jeong-A.; Kim, Chan-Jong

    2017-09-01

    This study aims to understand interactions in Korean elementary science classrooms, which are heavily influenced by Confucianism. Ethnographic observations of two elementary science teachers' classrooms in Korea are provided. Their classes are fairly traditional teaching, which mean teacher-centered interactions are dominant. To understand the power and approval in science classroom discourse, we have adopted Critical Discourse Analysis (CDA). Based on CDA, form and function analysis was adopted. After the form and function analysis, all episodes were analyzed in terms of social distance. The results showed that both teachers exercised their power while teaching. However, their classes were quite different in terms of getting approval by students. When a teacher got students' approval, he could conduct the science lesson more effectively. This study highlights the importance of getting approval by students in Korean science classrooms.

  5. 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...

  6. 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.

  7. OMB Recommended vs Approved Operating Budget

    Data.gov (United States)

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

  8. 76 FR 10598 - Medicare and Medicaid Programs; Approval of the Joint Commission for Deeming Authority for...

    Science.gov (United States)

    2011-02-25

    ... corporal punishment. To meet the requirements at Sec. 482.24(b)(2), the Joint Commission revised its... include both short-term and long-range patient goals. To meet the requirements at Sec. 482.61(c)(1)(iv.... B. Term of Approval Based on the review and observations described in section III. of this final...

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

    Science.gov (United States)

    Wish, Jay B

    2014-09-05

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

  10. MNR Approvals for waterpower projects

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

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

  11. Polypharmacology of Approved Anticancer Drugs.

    Science.gov (United States)

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

    2017-01-01

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

  12. Authority approvals and environmental investigations

    International Nuclear Information System (INIS)

    Olsen, F.A.; Svenson, J.

    1999-01-01

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

  13. The transport system approval concept

    International Nuclear Information System (INIS)

    Pettersson, B.G.

    1991-01-01

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

  14. 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...

  15. 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…

  16. 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...

  17. 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...

  18. 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)

  19. 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...

  20. 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…

  1. 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...

  2. 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...

  3. 27 CFR 17.11 - Meaning of terms.

    Science.gov (United States)

    2010-04-01

    ... OF THE TREASURY LIQUORS DRAWBACK ON TAXPAID DISTILLED SPIRITS USED IN MANUFACTURING NONBEVERAGE... versa, and words indicating the masculine gender include the feminine. The terms “includes” and... Spirits Used in Manufacturing Nonbeverage Products. Approved, or approved for drawback. When used with...

  4. 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.

  5. Perspectives used for gaining approval of budgets.

    Science.gov (United States)

    Franks-Joiner, G L

    1990-01-01

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

  6. Approving of personal dosimeter services

    International Nuclear Information System (INIS)

    Bergman, K.; Malmqvist, L.

    2001-09-01

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

  7. 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...

  8. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

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

  9. Drugs Approved for Gastrointestinal Stromal Tumors

    Science.gov (United States)

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

  10. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

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

  11. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

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

  12. Drugs Approved for Head and Neck Cancer

    Science.gov (United States)

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

  13. Drugs Approved for Gestational Trophoblastic Disease

    Science.gov (United States)

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

  14. FDA Approves First Therapeutic Cancer Vaccine

    Science.gov (United States)

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

  15. 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...

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

    African Journals Online (AJOL)

    Fr. Ikenga

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

  17. Grandfathering of competent authority approved packages

    International Nuclear Information System (INIS)

    Osgood, N.L.

    2004-01-01

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

  18. 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.

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 77 FR 55168 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Permits for Major...

    Science.gov (United States)

    2012-09-07

    ... Pollution Control Board or by the permittee. Actions to combine permit terms and conditions must include a... submitted by VADEQ for approval into the SIP were adopted by the State Air Pollution Control Board on June 8... prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment...

  13. 78 FR 18336 - Public Water System Supervision Program Approval for the State of Michigan

    Science.gov (United States)

    2013-03-26

    ... and Copper Rule Short Term Revisions, and the Lead and Copper Rule Minor Revisions. These rules better... defined in 18 U.S.C. 1151. By approving these rules, EPA does not intend to affect the rights of federally recognized Indian Tribes in Michigan, nor does it intend to limit existing rights of the State of Michigan...

  14. 75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

  15. 28 CFR 58.26 - Procedures for inclusion on the approved provider list.

    Science.gov (United States)

    2010-07-01

    ... provider list. (a) As used in this section the term “provider” means a provider of a personal financial... of a Personal Financial Management Course” (application), including all appendices, and submit it at... directors; and a merger or consolidation with another entity; (2) The provider shall request approval by...

  16. 78 FR 41059 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request...

    Science.gov (United States)

    2013-07-09

    ... fuels. Tier 2 requires short-term inhalation exposures of laboratory animals to emissions to screen for... Submitted to OMB for Review and Approval; Comment Request; Registration of Fuels and Fuel Additives: Health... request (ICR), Registration of Fuels and Fuel Additives: Health-Effects Research Requirements for...

  17. 78 FR 23492 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Particulate Matter Air...

    Science.gov (United States)

    2013-04-19

    ... addressing the NAAQS for nitrogen dioxide (NO 2 ), sulfur dioxide (SO 2 ), PM 10 and PM 2.5 . EPA will be... IDEM's requested removal of the annual PM 10 NAAQS is approvable. Indiana also requests in its... into the SIP, specifically at 326 IAC 1-4-1. These terms include ``SO 2 '', ``CO'' (carbon monoxide...

  18. 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.

  19. Montana Advanced Biofuels Great Falls Approval

    Science.gov (United States)

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

  20. Reflections on the Ethics-Approval Process

    Science.gov (United States)

    Murray, Lee; Pushor, Debbie; Renihan, Pat

    2012-01-01

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

  1. 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 ...

  2. 15 CFR 1150.3 - Approved markings.

    Science.gov (United States)

    2010-01-01

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

  3. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

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

  4. 7 CFR 1425.4 - Approval.

    Science.gov (United States)

    2010-01-01

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

  5. 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...

  6. 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…

  7. Neratinib Approved for HER2+ Breast Cancer.

    Science.gov (United States)

    2017-09-01

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

  8. 50 CFR 223.207 - Approved TEDs.

    Science.gov (United States)

    2010-10-01

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

  9. 7 CFR 1427.10 - Approved storage.

    Science.gov (United States)

    2010-01-01

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

  10. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  11. 9 CFR 317.4 - Labeling approval.

    Science.gov (United States)

    2010-01-01

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

  12. Half term report

    CERN Multimedia

    2011-01-01

    This week marks the mid-point of my mandate as Director General, so what better time to take stock of the last two and a half years and look forward to the next?    On the surface, the report is good. The LHC is performing well, Council has just approved our medium term plan, and the there seem to be few clouds on CERN’s long-term horizon. It’s precisely at times like this, however, that complacency would be most dangerous. The world is still in the grip of an economic crisis, and recovery in our Member States is slow. CERN is still in debt, as are our social security systems. We are working on this, but these factors need constant and careful attention. While we need to remain vigilant, I’d like to focus on the positives for my mid term message. Let’s start with the LHC. The machine’s performance this year has been fantastic. We achieved our target luminosity for the year in June, which augurs well for the summer conferences. I don&r...

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

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2013-01-01

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

  14. 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...

  15. 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

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

    Science.gov (United States)

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

    2015-01-01

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

  17. Application for approval of the Cold Lake Expansion Project

    International Nuclear Information System (INIS)

    1997-02-01

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

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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

  3. 75 FR 56663 - Agency Information Collection (Quarterly Report of State Approving Agency Activities); Activity...

    Science.gov (United States)

    2010-09-16

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

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 8 CFR 207.6 - Control over approved refugee numbers.

    Science.gov (United States)

    2010-01-01

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

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. Credit Risk Management - Loan Approval Process

    Directory of Open Access Journals (Sweden)

    Lulzim Rashiti

    2016-03-01

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

  3. Nuclear safety review requirements for launch approval

    International Nuclear Information System (INIS)

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

    1992-01-01

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

  4. Academic Program Approval and Review Practices

    Directory of Open Access Journals (Sweden)

    Don G. Creamer

    1999-08-01

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

  5. 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)

  6. 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...

  7. 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...

  8. 24 CFR 891.525 - Amount and terms of financing.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Amount and terms of financing. 891... Handicapped-Section 8 Assistance § 891.525 Amount and terms of financing. (a) The amount of financing approved... financing provided shall not exceed the lesser of: (1) The dollar amounts stated in paragraphs (b) through...

  9. 32 CFR 701.101 - Privacy program terms and definitions.

    Science.gov (United States)

    2010-07-01

    ... from a project on privacy issues, identifying and resolving the privacy risks, and approval by a... 32 National Defense 5 2010-07-01 2010-07-01 false Privacy program terms and definitions. 701.101... DEPARTMENT OF THE NAVY DOCUMENTS AFFECTING THE PUBLIC DON Privacy Program § 701.101 Privacy program terms and...

  10. 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.

  11. 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

  12. 30 CFR 285.803 - How must I conduct my approved activities to protect essential fish habitats identified and...

    Science.gov (United States)

    2010-07-01

    ... protect essential fish habitats identified and described under the Magnuson-Stevens Fishery Conservation... Act? (a) If, during the conduct of your approved activities, MMS finds that essential fish habitat or... adverse affects on Essential Fish Habitat will be incorporated as terms and conditions in the lease and...

  13. 78 FR 75437 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2013-12-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71004; File No. SR-Phlx-2013-101] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Regarding the Short Term Options Program December 6, 2013. I. Introduction On October 3, 2013, NASDAQ OMX PHLX LLC...

  14. 76 FR 8793 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2011-02-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63875; File No. SR-Phlx-2010-183] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Expanding Its Short Term Option Program February 9, 2011. I. Introduction On December 15, 2010, NASDAQ OMX PHLX LLC...

  15. 75 FR 50711 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Final Approval and...

    Science.gov (United States)

    2010-08-17

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

  16. 75 FR 54215 - Agency Request for Approval of a Previously Approved Information Collection(s): Uniform...

    Science.gov (United States)

    2010-09-03

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

  17. 78 FR 63937 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    Science.gov (United States)

    2013-10-25

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

  18. 78 FR 63887 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    Science.gov (United States)

    2013-10-25

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

  19. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

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

  20. 77 FR 26438 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

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

  1. 77 FR 59335 - Approval and Promulgation of Implementation Plans; North Carolina: Approval of Rocky Mount Motor...

    Science.gov (United States)

    2012-09-27

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

  2. Criteria for approving equipment for continued operation

    International Nuclear Information System (INIS)

    Narayanan, T.V.

    1993-01-01

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

  3. 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.

  4. 40 CFR 256.04 - State plan approval, financial assistance.

    Science.gov (United States)

    2010-07-01

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

  5. Approved Air Quality Implementation Plans in Region 10

    Science.gov (United States)

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

  6. ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

    Energy Technology Data Exchange (ETDEWEB)

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

    2002-11-01

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

  7. Investigating Long-Term Monitoring Protocols in support of Quivira NWR Habitat Objectives

    Data.gov (United States)

    Department of the Interior — The project purpose is to investigate long-term monitoring protocols in support of Quivira NWR habitat objectives as described in the Refuge’s recently approved CCP...

  8. 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

  9. Consumer approval of irradiated meat still tentative

    International Nuclear Information System (INIS)

    Hollingsworth, P.

    1998-01-01

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

  10. Term Croatian considered in russian context

    Directory of Open Access Journals (Sweden)

    Željka Čelić

    2008-01-01

    Full Text Available Term Croatian is considered in Russian context, i. e. context of Russian scientific material (which is comparable to the unwritten situation in universities. Russian scientific texts connect term Croatian, almost without an exception, with the term Serbian in words such as Serbo-Croatian. This point of view is politically approved in the period untill 1990’s, but it exists in the 21st century’s scientific material. The nature of the problem lays, at the same time, in politics, language and society; thus, the question is: what is the reason of such a context in which Croatian language is placed now? There are no arguments for it, especially if it is for Slovak language politically based and language approved to be an entity – in comparison to the Czech language; for Ukrainian (once Littlerussian – at least in principle, in comparison to the Russian, or, more convincable, Belorussian to Russian (the standard Belorussian language exists from 1905. The term Croatian is independently, even in new books, connected with terms of soil, state, nation, but not language. And though today, because of political reasons, exists an awareness of Croatian language without its Serbian mirror reflexion, the term Serbo-Croatian stays. Thus, this paper looks through the history concerning Croatian language in 19, 20 and 21st century’s Russian philology, including Juraj Križanić and Vatroslav Jagić – innovators of the Croatian word in Russia.

  11. Women's approval of domestic physical violence against wives: analysis of the Ghana demographic and health survey.

    Science.gov (United States)

    Doku, David Teye; Asante, Kwaku Oppong

    2015-12-21

    Intimate partner violence (IPV) has serious consequences for the physical, psychological, and reproductive and sexual health of women. However, the factors that make women to justify domestic violence against wives in many sub-Saharan African countries have not been explored. This study investigates factors that influence women approval of domestic physical violence among Ghanaian women aged 15-49. A nationally representative sampled data (N = 10,607) collected in the 2003 and 2008 Ghana Demographic and Health Survey were used. Multivariate logistic regression was used to study the associations between women's economic and socio-demographic characteristics and their approval of domestic physical violence against wives. Women aged 25-34 and 15-24 were 1.5 and 1.3 times, respectively, more likely to approve domestic physical violence against wives compared to those aged 35 years and above. Furthermore, women with no education (OR = 3.1, CI = 2.4-3.9), primary education (OR = 2.6, CI = 2.1-3.3) and junior secondary education (OR = 1.8, CI = 1.4-2.2) had higher probability of approving domestic physical violence compared to a woman who had secondary education or higher. Compared to women with Christian belief, Moslems (OR = 1.5, CI = 1.3-1.8) and Traditional believer (OR = 1.7, CI = 1.2-2.4) were more likely to approve domestic physical violence of wives. Women who were in the richest, rich and middle wealth index categories were less likely to approve domestic physical violence of wives compared to the poorest. These findings fill a gap in understanding economic and socio-demographic factors associated with approval of domestic physical violence of wives. Interventions and policies should be geared at contextualizing intimate partner violence in terms of the justification of this behaviour, as this can play an important role in perpetration and victimization.

  12. Price, performance, and the FDA approval process: the example of home HIV testing.

    Science.gov (United States)

    Paltiel, A David; Pollack, Harold A

    2010-01-01

    The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.

  13. 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)

  14. 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.

  15. 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...

  16. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    2000-01-01

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

  17. 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

  18. 75 FR 71187 - Wolverine Bank, MI; Approval of Conversion Application

    Science.gov (United States)

    2010-11-22

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

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

    Science.gov (United States)

    2010-01-01

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

  20. 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...

  1. 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...

  2. 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...

  3. [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.

  4. 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...

  5. 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

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

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

  12. 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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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 ...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. Environmental approvals in New Brunswick : economic considerations

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-07-01

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

  9. 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)

  10. 77 FR 32170 - Notice of Request for Renewal of Previously Approved Collection; Short Term Lending Program...

    Science.gov (United States)

    2012-05-31

    ..., Manager Financial Assistance Division, Office of Small and Disadvantaged Business Utilization, Office of... (8a, women-owned, small disadvantaged, HUBZone, veteran owned, and service disabled veteran [[Page... Businesses (8a, women-owned, small disadvantaged, HUBZone, veteran owned, and service disabled veteran owned...

  11. Guidance for package approvals in the United Kingdom

    International Nuclear Information System (INIS)

    Morgan-Warren, E.J.

    2004-01-01

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

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

    Science.gov (United States)

    Kirschner, Neil M.

    1976-01-01

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

  13. 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 ...

  14. 22 CFR 201.71 - Terms of letters of credit.

    Science.gov (United States)

    2010-04-01

    ... shall not be inconsistent with or contrary to the terms of the letter of commitment. Any such letter of credit or agreement may be modified or extended at any time in such a manner and to such extent as is acceptable to the approved applicant and the bank: Provided, That such modification or extension may not be...

  15. Assessing long-term and rare adverse effects of medicines

    NARCIS (Netherlands)

    Duijnhoven, R.G.|info:eu-repo/dai/nl/357218574

    2016-01-01

    Clinical studies in the development of new medicines are primarily designed to investigate efficacy. Knowledge of adverse effects is therefore limited at the time of approval of new medicines. In this thesis several studies were conducted to investigate long-term and rare adverse effects of

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

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

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

  17. 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)

  18. 7 CFR 1735.61 - Approval criteria.

    Science.gov (United States)

    2010-01-01

    ...) Whether the merger or acquisition may result in any relinquishment, impairment, or waiver of a right or... Government as note holder; and (4) Whether the proposed purchase price and terms of an acquisition are... price unreasonable if, in RUS's opinion, it will endanger financial feasibility. ...

  19. Behaviour therapy for obesity treatment considering approved drug therapy

    Directory of Open Access Journals (Sweden)

    Wasem, Jürgen

    2008-05-01

    Full Text Available Introduction: Obesity is a worldwide health problem whose prevalence is on the increase. Many obesity-associated diseases require intensive medical treatment and are the cause of a large proportion of health-related expenditures in Germany. Treatment of obesity includes nutritional, exercise and behaviour therapy, usually in combination. The goal of behaviour therapy for obesity is to bring about a long-term alteration in the eating and exercise habits of overweight and obese individuals. Under certain circumstances, drug treatment may be indicated. Objectives: What is the effectiveness of behaviour therapy for obesity considering approved drugs reduce weight under medical, economic, ethical-social and legal aspects? Methods: A systematic review was conducted using relevant electronic literature databases. Publications chosen according to predefined criteria are evaluated by approved methodical standards of the evidence-based medicine systematically and qualitatively. Results: In total 18 studies, included one HTA and one meta-analysis could be identified according to the predefined inclusion criteria. Three studies compare behaviour therapy to other therapy forms (advice or instruction on nutritional changes, physical activity or a combination of the two, six studies evaluate different forms of behaviour therapy, four studies and four studies compare behaviour therapies mediated by Internet or telephone. Three studies could be identified examining the effect of the combination of behaviour and drug therapy. Furthermore one HTA and one meta-analysis could be included in the evaluation. The behaviour therapy in comparison with other therapy forms reveals a higher effectiveness. In comparison of the different therapeutic approaches of the behaviour therapy intensive behaviour therapy forms and group therapy show a higher effectiveness. Studies related to behaviour therapy based on media support demonstrate a weight reduction both through the

  20. 75 FR 57019 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-09-17

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

  1. 22 CFR 129.6 - Requirement for license/approval.

    Science.gov (United States)

    2010-04-01

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

  2. 40 CFR 85.1804 - Approval of Plan: Implementation.

    Science.gov (United States)

    2010-07-01

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

  3. 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

  4. 44 CFR 78.10 - Project grant approval process.

    Science.gov (United States)

    2010-10-01

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

  5. A guide for approval of nuclear gauging devices

    International Nuclear Information System (INIS)

    1990-01-01

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

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

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

    2016-06-28

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

  7. 27 CFR 4.40 - Label approval and release.

    Science.gov (United States)

    2010-04-01

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

  8. 27 CFR 7.31 - Label approval and release.

    Science.gov (United States)

    2010-04-01

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

  9. 27 CFR 7.41 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

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

  10. 27 CFR 5.51 - Label approval and release.

    Science.gov (United States)

    2010-04-01

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

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

    Data.gov (United States)

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

  12. 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...

  13. Nephrotoxicities [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Stuart L. Goldstein

    2017-01-01

    Full Text Available Nephrotoxic medication exposure is nearly ubiquitous in hospitalized patients and represents one of the most common causes of acute kidney injury (AKI in the hospitalized setting. Although provision of medications that are nephrotoxic has led to improved outcomes in terms of treatment of underlying illness, unnecessary nephrotoxic medication exposure can be viewed as a potentially modifiable adverse safety event if AKI can be prevented. The advancements in electronic health record development, standardization of AKI definitions, and the ability to identify AKI risk and development in near real time provide opportunities to reduce harm from nephrotoxicity.

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

    Science.gov (United States)

    2010-03-30

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

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

    Science.gov (United States)

    2010-07-01

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

  16. 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.

  17. 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.

  18. 42 CFR 137.35 - What is the term of a self-governance compact?

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false What is the term of a self-governance compact? 137... HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES TRIBAL SELF-GOVERNANCE Self-Governance compact § 137.35 What is the term of a self-governance compact? Upon approval and execution of a self-governance...

  19. 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

  20. 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.

  1. Problems of the current law concerning official plan approval

    International Nuclear Information System (INIS)

    Bluemel, W.

    1986-01-01

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

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

    Science.gov (United States)

    Carpenter, Daniel P

    2003-01-01

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

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

    Science.gov (United States)

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

    2007-01-01

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

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

    International Nuclear Information System (INIS)

    Bush, M.

    2010-01-01

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

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

    Science.gov (United States)

    Shuey, Brandon; Williams, La Vonn A

    2010-01-01

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

  6. Approaches to safety, environment and regulatory approval for the International Thermonuclear Experimental Reactor

    International Nuclear Information System (INIS)

    Saji, G.; Bartels, H.W.; Chuyanov, V.; Holland, D.; Kashirski, A.V.; Morozov, S.I.; Piet, S.J.; Poucet, A.; Raeder, J.; Rebut, P.H.; Topilski, L.N.

    1995-01-01

    International Thermonuclear Experimental Reactor (ITER) Engineering Design Activities (EDA) in safety and environment are approaching the point where conceptual safety design, topic studies and research will give way to project oriented engineering design activities. The Joint Central Team (JCT) is promoting safety design and analysis necessary for siting and regulatory approval. Scoping studies are underway at the general level, in terms of laying out the safety and environmental design framework for ITER. ITER must follow the nuclear regulations of the host country as the future construction site of ITER. That is, regulatory approval is required before construction of ITER. Thus, during the EDA, some preparations are necessary for the future application for regulatory approval. Notwithstanding the future host country's jurisdictional framework of nuclear regulations, the primary responsibility for safety and reliability of ITER rests with the legally responsible body which will operate ITER. Since scientific utilization of ITER and protection of the large investment depends on safe and reliable operation of ITER, we are highly motivated to achieve maximum levels of operability, maintainability, and safety. ITER will be the first fusion facility in which overall 'nuclear safety' provisions need to be integrated into the facility. For example, it will be the first fusion facility with significant decay heat and structural radiational damage. Since ITER is an experimental facility, it is also important that necessary experiments can be performed within some safety design limits without requiring extensive regulatory procedures. ITER will be designed with such a robust safety envelope compatible with the fusion power and the energy inventories. The basic approach to safety will be realized by 'defense-in-depth'. (orig.)

  7. 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

  8. Short-term treatment with flumazenil restores long-term object memory in a mouse model of Down syndrome.

    Science.gov (United States)

    Colas, Damien; Chuluun, Bayarsaikhan; Garner, Craig C; Heller, H Craig

    2017-04-01

    Down syndrome (DS) is a common genetic cause of intellectual disability yet no pro-cognitive drug therapies are approved for human use. Mechanistic studies in a mouse model of DS (Ts65Dn mice) demonstrate that impaired cognitive function is due to excessive neuronal inhibitory tone. These deficits are normalized by chronic, short-term low doses of GABA A receptor (GABA A R) antagonists in adult animals, but none of the compounds investigated are approved for human use. We explored the therapeutic potential of flumazenil (FLUM), a GABA A R antagonist working at the benzodiazepine binding site that has FDA approval. Long-term memory was assessed by the Novel Object Recognition (NOR) testing in Ts65Dn mice after acute or short-term chronic treatment with FLUM. Short-term, low, chronic dose regimens of FLUM elicit long-lasting (>1week) normalization of cognitive function in both young and aged mice. FLUM at low dosages produces long lasting cognitive improvements and has the potential of fulfilling an unmet therapeutic need in DS. Copyright © 2017. Published by Elsevier Inc.

  9. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    2010-01-01

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

  10. 18 CFR 1304.4 - Application review and approval process.

    Science.gov (United States)

    2010-04-01

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

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

    Science.gov (United States)

    Misko, Josie

    2015-01-01

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

  12. Bacteria-eating virus approved as food additive.

    Science.gov (United States)

    Bren, Linda

    2007-01-01

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

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

    Science.gov (United States)

    Shrawder, Jack; And Others

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

  14. 29 CFR 1956.24 - Procedures for withdrawal of approval.

    Science.gov (United States)

    2010-07-01

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

  15. 48 CFR 970.5236-1 - Government facility subcontract approval.

    Science.gov (United States)

    2010-10-01

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

  16. FDA-approved small-molecule kinase inhibitors

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  17. 5 CFR 6401.103 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

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

  18. The Cost of Delaying Approval of Golden Rice

    NARCIS (Netherlands)

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

    2014-01-01

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

  19. Olaparib Approved for Breast Cancers with BRCA Gene Mutations

    Science.gov (United States)

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

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

    DEFF Research Database (Denmark)

    Stadtmann, Georg; Pierdzioch; Rülke

    2012-01-01

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

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

    Science.gov (United States)

    Matell, Michael S.; Smith, Ronald E.

    1970-01-01

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

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

    Science.gov (United States)

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

  3. 46 CFR 160.077-6 - Approval procedures.

    Science.gov (United States)

    2010-10-01

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

  4. 46 CFR 163.002-9 - Approval procedure.

    Science.gov (United States)

    2010-10-01

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

  5. 77 FR 30327 - Approval of Information Collection Requirements; Comment Request

    Science.gov (United States)

    2012-05-22

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

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

    Science.gov (United States)

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

    2018-02-01

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

  7. 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

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

    Directory of Open Access Journals (Sweden)

    Laura M McNamee

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

  9. 5 CFR 7901.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

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

  10. 7 CFR 1735.94 - Final approval and closing procedure.

    Science.gov (United States)

    2010-01-01

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

  11. 18 CFR 300.10 - Application for confirmation and approval.

    Science.gov (United States)

    2010-04-01

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

  12. 29 CFR 15.10 - Action on approved claim.

    Science.gov (United States)

    2010-07-01

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

  13. 34 CFR 35.7 - Payment of approved claims.

    Science.gov (United States)

    2010-07-01

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

  14. 45 CFR 35.7 - Payment of approved claims.

    Science.gov (United States)

    2010-10-01

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

  15. 40 CFR 10.7 - Payment of approved claim.

    Science.gov (United States)

    2010-07-01

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

  16. 12 CFR 793.7 - Payment of approved claims.

    Science.gov (United States)

    2010-01-01

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

  17. 42 CFR 403.318 - Approval of State systems.

    Science.gov (United States)

    2010-10-01

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

  18. Template for letter of approval by Research Supervisor

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

    Liliane Castets-Poupart

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

  19. 76 FR 60774 - Review and Approval of Projects

    Science.gov (United States)

    2011-09-30

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

  20. 77 FR 75915 - Review and Approval of Projects

    Science.gov (United States)

    2012-12-26

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

  1. 77 FR 14272 - Review and Approval of Projects

    Science.gov (United States)

    2012-03-09

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

  2. 48 CFR 245.7305 - Sale approval and award.

    Science.gov (United States)

    2010-10-01

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

  3. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Science.gov (United States)

    2010-01-01

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

  4. 18 CFR 806.6 - Transfer of approvals.

    Science.gov (United States)

    2010-04-01

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

  5. 22 CFR 64.7 - Approval of application.

    Science.gov (United States)

    2010-04-01

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

  6. 44 CFR 78.6 - Flood Mitigation Plan approval process.

    Science.gov (United States)

    2010-10-01

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

  7. 28 CFR 20.23 - Documentation: Approval by OJARS.

    Science.gov (United States)

    2010-07-01

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

  8. 22 CFR 3a.4 - Procedure for requesting approval.

    Science.gov (United States)

    2010-04-01

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

  9. 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...

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

    Directory of Open Access Journals (Sweden)

    J. Manikandan

    2015-04-01

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

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

    Science.gov (United States)

    Sipp, Douglas

    2015-04-02

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

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

    Science.gov (United States)

    2010-01-01

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

  13. 5 CFR 6201.103 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

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

  14. 48 CFR 2052.215-77 - Travel approvals and reimbursement.

    Science.gov (United States)

    2010-10-01

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

  15. 24 CFR 945.201 - Approval to designate housing.

    Science.gov (United States)

    2010-04-01

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

  16. 25 CFR 1001.4 - Application review and approval.

    Science.gov (United States)

    2010-04-01

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

  17. 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...

  18. 25 CFR 225.22 - Approval of minerals agreements.

    Science.gov (United States)

    2010-04-01

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

  19. 5 CFR 6701.106 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

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

  20. 5 CFR 7101.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

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

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

    African Journals Online (AJOL)

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

  2. Template for letter of approval by Research Supervisor

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

    Liliane Castets-Poupart

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

  3. 76 FR 41154 - Review and Approval of Projects

    Science.gov (United States)

    2011-07-13

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

  4. 25 CFR 216.6 - Approval of exploration plan.

    Science.gov (United States)

    2010-04-01

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

  5. 43 CFR 23.7 - Approval of exploration plan.

    Science.gov (United States)

    2010-10-01

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

  6. 7 CFR 1717.608 - RUS approval of contracts.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

    2010-01-01

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

  8. 76 FR 63833 - Commission Approval of Divestiture Agreements

    Science.gov (United States)

    2011-10-14

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

  9. 24 CFR 245.430 - Decision on request for approval.

    Science.gov (United States)

    2010-04-01

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

  10. 30 CFR 906.10 - State regulatory program approval.

    Science.gov (United States)

    2010-07-01

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

  11. 27 CFR 4.93 - Approval of grape variety names.

    Science.gov (United States)

    2010-04-01

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

  12. 27 CFR 4.91 - List of approved prime names.

    Science.gov (United States)

    2010-04-01

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

  13. 14 CFR 121.909 - Approval of Advanced Qualification Program.

    Science.gov (United States)

    2010-01-01

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

  14. A nuclear source term analysis for spacecraft power systems

    International Nuclear Information System (INIS)

    McCulloch, W.H.

    1998-01-01

    All US space missions involving on board nuclear material must be approved by the Office of the President. To be approved the mission and the hardware systems must undergo evaluations of the associated nuclear health and safety risk. One part of these evaluations is the characterization of the source terms, i.e., the estimate of the amount, physical form, and location of nuclear material, which might be released into the environment in the event of credible accidents. This paper presents a brief overview of the source term analysis by the Interagency Nuclear Safety Review Panel for the NASA Cassini Space Mission launched in October 1997. Included is a description of the Energy Interaction Model, an innovative approach to the analysis of potential releases from high velocity impacts resulting from launch aborts and reentries

  15. Approved and Experimental Small-Molecule Oncology Kinase Inhibitor Drugs: A Mid-2016 Overview.

    Science.gov (United States)

    Fischer, Peter M

    2017-03-01

    Kinase inhibitor research is a comparatively recent branch of medicinal chemistry and pharmacology and the first small-molecule kinase inhibitor, imatinib, was approved for clinical use only 15 years ago. Since then, 33 more kinase inhibitor drugs have received regulatory approval for the treatment of a variety of cancers and the volume of reports on the discovery and development of kinase inhibitors has increased to an extent where it is now difficult-even for those working in the field-easily to keep an overview of the compounds that are being developed, as currently there are 231 such compounds, targeting 38 different protein and lipid kinases (not counting isoforms), in clinical use or under clinical investigation. The purpose of this review is thus to provide an overview of the biomedical rationales for the kinases being targeted on the one hand, and the design principles, as well as chemical, pharmacological, pharmaceutical, and toxicological kinase inhibitor properties, on the other hand. Two issues that are especially important in kinase inhibitor research, target selectivity and drug resistance, as well as the underlying structural concepts, are discussed in general terms and in the context of relevant kinases and their inhibitors. © 2016 Wiley Periodicals, Inc.

  16. General Technical Approvals for Decentralised Sustainable Urban Drainage Systems (SUDS—The Current Situation in Germany

    Directory of Open Access Journals (Sweden)

    Carsten Dierkes

    2015-03-01

    Full Text Available The use of decentralised, sustainable urban drainage systems (SUDS for the treatment of stormwater runoff is becoming increasingly prevalent in Germany. Decentralised SUDS can offer a viable and attractive alternative to end of pipe treatment systems for stormwater runoff from urban areas. However, there is still some uncertainty regarding the long-term performance of SUDS, and the general legislative requirements for SUDS approval and testing. Whilst the allowable pollution levels in stormwater runoff that infiltrate into ground and/or water table are regulated across Germany by the Federal Soil Protection Law, there is presently no federal law addressing the discharge requirements for surface water runoff. The lack of clear guidance can make it difficult for planners and designers to implement these innovative and sustainable stormwater treatment systems. This study clarifies the current understanding of urban stormwater treatment requirements and new technical approval guidelines for decentralised SUDS devices in Germany. The study findings should assist researchers, designers and asset managers to better anticipate and understand the performance, effective life-spans, and the planning and maintenance requirements for decentralised SUDS systems. This should help promote even greater use of these systems in the future.

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

    International Nuclear Information System (INIS)

    Morgan-Warren, E.J.

    1999-01-01

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

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

    Science.gov (United States)

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

    2012-06-01

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

  19. 77 FR 8865 - Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval

    Science.gov (United States)

    2012-02-15

    ... Enhanced Surface Water Treatment Rule. Illinois is also applying its Stage 2 Disinfectants and Disinfection... for Long-Term 2 Enhanced Surface Water Treatment and Stage 2 Disinfectants and Disinfection By-product..., Ground Water and Drinking Water Branch (WG-15J), 77 West Jackson Boulevard, Chicago, Illinois 60604. FOR...

  20. 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

  1. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    Science.gov (United States)

    2010-01-01

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

  2. Dictionary of machine terms

    International Nuclear Information System (INIS)

    1990-06-01

    This book has introduction of dictionary of machine terms, and a compilation committee and introductory remarks. It gives descriptions of the machine terms in alphabetical order from a to Z and also includes abbreviation of machine terms and symbol table, way to read mathematical symbols and abbreviation and terms of drawings.

  3. 75 FR 36058 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-06-24

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

  4. 76 FR 68756 - Public Information Collections Approved by the Office of Management and Budget (OMB)

    Science.gov (United States)

    2011-11-07

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

  5. 78 FR 54626 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal...

    Science.gov (United States)

    2013-09-05

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

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

    Directory of Open Access Journals (Sweden)

    Adol Esquivel

    2009-12-01

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

  7. 76 FR 39874 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    2011-07-07

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

  8. 75 FR 52710 - Notice of Request for Extension of Approval of an Information Collection; National Management...

    Science.gov (United States)

    2010-08-27

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

  9. 77 FR 71774 - Notice of Request for Extension of Approval of an Information Collection; National Management...

    Science.gov (United States)

    2012-12-04

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

  10. 78 FR 69664 - Proposed Information Collection Request; Comment Request; Approval of State Coastal Nonpoint...

    Science.gov (United States)

    2013-11-20

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

  11. 75 FR 57737 - Notice of Request for Approval of an Information Collection; National Veterinary Services...

    Science.gov (United States)

    2010-09-22

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

  12. 75 FR 31508 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-06-03

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

  13. Is suvorexant a better choice than alternative hypnotics? [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Daniel F. Kripke

    2015-08-01

    Full Text Available Suvorexant is a novel dual orexin receptor antagonist (DORA newly introduced in the U.S. as a hypnotic, but no claim of superiority over other hypnotics has been offered.  The manufacturer argued that the 5 and 10 mg starting doses recommended by the FDA might be ineffective.  The manufacturer's main Phase III trials had not even included the 10 mg dosage, and the 5 mg dosage had not been tested at all in registered clinical trials at the time of approval.  Popular alternative hypnotics may be similarly ineffective, since the FDA has also reduced the recommended doses for zolpidem and eszopiclone.  The "not to exceed" suvorexant dosage of 20 mg does slightly increase sleep.  Because of slow absorption, suvorexant has little effect on latency to sleep onset but some small effect in suppressing wakening after sleep onset and in improving sleep efficiency. The FDA would not approve the manufacturer's preferred 40 mg suvorexant dosage, because of concern with daytime somnolence, driving impairment, and possible narcolepsy-like symptoms.  In its immediate benefits-to-risks ratio, suvorexant is unlikely to prove superior to currently available hypnotics—possibly worse—so there is little reason to prefer over the alternatives this likely more expensive hypnotic less-tested in practice.  Associations are being increasingly documented relating hypnotic usage with incident cancer, with dementia risks, and with premature death.  There is some basis to speculate that suvorexant might be safer than alternative hypnotics in terms of cancer, dementia, infections, and mortality.  These safety considerations will remain unproven speculations unless adequate long-term trials can be done that demonstrate suvorexant advantages.

  14. 21 CFR 56.113 - Suspension or termination of IRB approval of research.

    Science.gov (United States)

    2010-04-01

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

  15. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    Science.gov (United States)

    2010-01-01

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

  16. 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...

  17. 75 FR 56530 - Public Information Collections Approved by Office of Management and Budget

    Science.gov (United States)

    2010-09-16

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

  18. 77 FR 46760 - Information Collections Approved by the Office of Management and Budget

    Science.gov (United States)

    2012-08-06

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

  19. 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...

  20. 46 CFR 159.005-15 - Approval of equipment or material: Suspensions, withdrawals, and terminations.

    Science.gov (United States)

    2010-10-01

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

  1. 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.

  2. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-10-04

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

  3. 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...

  4. 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...

  5. 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...

  6. 49 CFR 1522.121 - Security threat assessments for personnel of TSA-approved validation firms.

    Science.gov (United States)

    2010-10-01

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

  7. 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...

  8. 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.

  9. 25 CFR 1200.15 - What is the approval process for management plans?

    Science.gov (United States)

    2010-04-01

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

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

    Science.gov (United States)

    Greene, Louise Eleanor; Bearn, David R

    2013-06-01

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

  11. 75 FR 63445 - Vessel Monitoring Systems; Approved Mobile Transmitting Units and Communications Service...

    Science.gov (United States)

    2010-10-15

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

  12. 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...

  13. 30 CFR 285.103 - When may MMS prescribe or approve departures from these regulations?

    Science.gov (United States)

    2010-07-01

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

  14. 78 FR 28503 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter Counties...

    Science.gov (United States)

    2013-05-15

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

  15. 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...

  16. 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...

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

    Science.gov (United States)

    2013-05-21

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

  18. 30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.

    Science.gov (United States)

    2010-07-01

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

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

    Science.gov (United States)

    2010-10-01

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

  20. 7 CFR 4290.480 - Prior approval of changes to RBIC's business plan.

    Science.gov (United States)

    2010-01-01

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

  1. Waste feed delivery environmental permits and approvals plan

    International Nuclear Information System (INIS)

    Papp, I.G.

    1998-01-01

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

  2. Review of experiments for research reactors - approved 1974

    International Nuclear Information System (INIS)

    Anon.

    1977-01-01

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

  3. 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.

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

    Science.gov (United States)

    2004-04-08

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

  5. Digital repositories certification: the Data Seal of Approval

    Directory of Open Access Journals (Sweden)

    Stefano Allegrezza

    2015-09-01

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

  6. SWEETLEAD: an in silico database of approved drugs, regulated chemicals, and herbal isolates for computer-aided drug discovery.

    Directory of Open Access Journals (Sweden)

    Paul A Novick

    Full Text Available In the face of drastically rising drug discovery costs, strategies promising to reduce development timelines and expenditures are being pursued. Computer-aided virtual screening and repurposing approved drugs are two such strategies that have shown recent success. Herein, we report the creation of a highly-curated in silico database of chemical structures representing approved drugs, chemical isolates from traditional medicinal herbs, and regulated chemicals, termed the SWEETLEAD database. The motivation for SWEETLEAD stems from the observance of conflicting information in publicly available chemical databases and the lack of a highly curated database of chemical structures for the globally approved drugs. A consensus building scheme surveying information from several publicly accessible databases was employed to identify the correct structure for each chemical. Resulting structures are filtered for the active pharmaceutical ingredient, standardized, and differing formulations of the same drug were combined in the final database. The publically available release of SWEETLEAD (https://simtk.org/home/sweetlead provides an important tool to enable the successful completion of computer-aided repurposing and drug discovery campaigns.

  7. Decree of the 28 August 2017 bearing approval of the decision nr 2017-DC-0592 of the Authority for Nuclear Safety of the 13 June 2017 related to obligations of operators of basic nuclear installations in terms of preparation and of management of emergency situations, and to the content of the internal emergency plan. Decision nr 2017-DC-0592 of the Authority for Nuclear Safety of 13 June 2017 related to obligations of operators of basic nuclear installations in terms of preparation and of management of emergency situations, and to the content of the internal emergency plan

    International Nuclear Information System (INIS)

    Mortureux, M.

    2017-01-01

    The decree formalises the implementation of decision made by the ASN regarding the preparation and management of emergency situations, and the content of the internal emergency plan for basic nuclear installations (some aspects concern installations others than nuclear power plants). Delays of elaboration and publication of the internal emergency plan are indicated for nuclear installations, and depend on the fact the installation is being dismantled or to be dismantled, or is being operated or to be created. An appendix contains a set of definitions of relevant terms related to the installation organisation, a specification of some general measures regarding the organisation to be implemented, procedures related to the alert and coordination with authorities and external bodies and departments, involved human resources, crisis exercises and real-life simulations to be performed, material resources to be used for the management of emergency situations, and aspects related to the protection of people present within the installation

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

    OpenAIRE

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

    2017-01-01

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

  9. 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

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

    International Nuclear Information System (INIS)

    Fowler, K.D.

    1998-01-01

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

  11. 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.

  12. 40 CFR 52.385 - EPA-approved Connecticut regulations.

    Science.gov (United States)

    2010-07-01

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

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

    International Nuclear Information System (INIS)

    FOWLER, K.D.

    1999-01-01

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

  14. Biomedicines?Moving Biologic Agents into Approved Treatment Options

    OpenAIRE

    Cornetta, Kenneth

    2013-01-01

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

  15. ITER Safety Task NID-5A, Subtask 1-1: Source terms and energies - initial tritium source terms. Final report

    International Nuclear Information System (INIS)

    Fong, C.; Kalyanam, K.M.; Tanaka, M.R.; Sood, S.; Natalizio, A.; Delisle, M.

    1995-02-01

    The overall objective of the Early Safety and Environmental Characterization Study (ESECS) is to assess the environmental impact of tritium using appropriate assumptions on a hypothetical site for ITER, having the r eference s ite characteristics as proposed by the JCT. The objective of this work under the above subtask 1-1, NID-5a, is to determine environmental source terms (i.e., process source term x containment release fraction) for the fuel cycle and cooling systems. The work is based on inventories and process source terms (i.e., inventory x mobilization fraction), provided by others (under Task NID 3b). The results of this work form the basis for the determination, by others, of the off-site dose (i.e., environmental source term x dose/release ratio). For the determination of the environmental source terms, the TMAP4 code has been utilized (ref 1). This code is approved by ITER for safety assessment. 6 refs

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

    Directory of Open Access Journals (Sweden)

    Elahe Dehghan Pishe

    2012-06-01

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

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

    International Nuclear Information System (INIS)

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

    1991-01-01

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

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

    Directory of Open Access Journals (Sweden)

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

    2010-12-01

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

  19. 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.

  20. English-Japanese terms in nondestructive testing specifications

    International Nuclear Information System (INIS)

    1991-01-01

    For technical development, it is the prerequisite to clarify the terms to be used in various fields and their definition, therefore, in various foreign countries, there are some standards on terms in respective fields, and also as international standards, ISO/TC 135 (Non-destructive testing) organized the SC on terms from the beginning of foundation. In JIS, there is the column for corresponding English (for reference), but there is the problem of English and American English. The English used in ISO, BS or EN and ASTM standards in relation to nondestructive testing were collected in every technical field and put in order, and the corresponding English terms were selected. Moreover at this opportunity, the terms having the definition in these international, national and semi-national standards were classified into eight fields, that is, common (approval, quality assurance, defects and others), radiography, ultrasonic flaw detection, acoustic emission, eddy current flaw detection, magnetic flaw detection, liquid penetrant testing and leak test, and the Japanese translation was stipulated. The draft of this standard was approved by the standardization committee on January 17, 1991. (K.I.)

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

    Science.gov (United States)

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

    2014-01-01

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

  2. A novel data storage logic in the cloud [version 3; referees: 2 approved, 1 not approved

    Directory of Open Access Journals (Sweden)

    Bence Mátyás

    2017-08-01

    Full Text Available Databases which store and manage long-term scientific information related to life science are used to store huge amount of quantitative attributes. Introduction of a new entity attribute requires modification of the existing data tables and the programs that use these data tables. A feasible solution is increasing the virtual data tables while the number of screens remains the same. The main objective of the present study was to introduce a logic called Joker Tao (JT which provides universal data storage for cloud-based databases. It means all types of input data can be interpreted as an entity and attribute at the same time, in the same data table.

  3. 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

  4. Two Classification Methods for Grouping Common Environmental Sounds in Terms of Perceived Pleasantness

    Science.gov (United States)

    2016-02-01

    NUMBER OF PAGES 24 19a. NAME OF RESPONSIBLE PERSON Kelly Dickerson a. REPORT Unclassified b. ABSTRACT Unclassified c . THIS...ARL-TR-7960 ● FEB 2016 US Army Research Laboratory Two Classification Methods for Grouping Common Environmental Sounds in Terms...of Perceived Pleasantness by Kelly Dickerson, Brandon S Perelman, Laura Sherry, and Jeremy R Gaston Approved for public

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

    Science.gov (United States)

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

    2017-01-01

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

  6. QUADrATiC: scalable gene expression connectivity mapping for repurposing FDA-approved therapeutics.

    Science.gov (United States)

    O'Reilly, Paul G; Wen, Qing; Bankhead, Peter; Dunne, Philip D; McArt, Darragh G; McPherson, Suzanne; Hamilton, Peter W; Mills, Ken I; Zhang, Shu-Dong

    2016-05-04

    Gene expression connectivity mapping has proven to be a powerful and flexible tool for research. Its application has been shown in a broad range of research topics, most commonly as a means of identifying potential small molecule compounds, which may be further investigated as candidates for repurposing to treat diseases. The public release of voluminous data from the Library of Integrated Cellular Signatures (LINCS) programme further enhanced the utilities and potentials of gene expression connectivity mapping in biomedicine. We describe QUADrATiC ( http://go.qub.ac.uk/QUADrATiC ), a user-friendly tool for the exploration of gene expression connectivity on the subset of the LINCS data set corresponding to FDA-approved small molecule compounds. It enables the identification of compounds for repurposing therapeutic potentials. The software is designed to cope with the increased volume of data over existing tools, by taking advantage of multicore computing architectures to provide a scalable solution, which may be installed and operated on a range of computers, from laptops to servers. This scalability is provided by the use of the modern concurrent programming paradigm provided by the Akka framework. The QUADrATiC Graphical User Interface (GUI) has been developed using advanced Javascript frameworks, providing novel visualization capabilities for further analysis of connections. There is also a web services interface, allowing integration with other programs or scripts. QUADrATiC has been shown to provide an improvement over existing connectivity map software, in terms of scope (based on the LINCS data set), applicability (using FDA-approved compounds), usability and speed. It offers potential to biological researchers to analyze transcriptional data and generate potential therapeutics for focussed study in the lab. QUADrATiC represents a step change in the process of investigating gene expression connectivity and provides more biologically-relevant results than

  7. Glossary of atomic terms

    International Nuclear Information System (INIS)

    1982-04-01

    This glossary, containing almost 400 terms, has been compiled to help people outside the atomic energy industry to understand what those inside it are saying. It is not intended to be a definitive dictionary of scientific or technical terms, nor does it aim to cover terms that are in general use in science and technology. A list of about 100 initials and acronyms will be found at the end. (author)

  8. Glossary of atomic terms

    International Nuclear Information System (INIS)

    1980-01-01

    This glossary (of about 400 terms) has been compiled to help people outside the atomic energy industry to understand what those inside it are saying. It is not intended to be a definitive dictionary of scientific or technical terms, nor does it aim to cover terms that are in general use in science and technology. A list of some initials and acronyms is appended. (author)

  9. How to Improve the Likelihood of CDM Approval?

    DEFF Research Database (Denmark)

    Brandt, Urs Steiner; Svendsen, Gert Tinggaard

    2014-01-01

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

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

    International Nuclear Information System (INIS)

    1993-01-01

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

  11. Biomedicines—Moving Biologic Agents into Approved Treatment Options

    Directory of Open Access Journals (Sweden)

    Kenneth Cornetta

    2013-03-01

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

  12. METHOD OF RARE TERM CONTRASTIVE EXTRACTION FROM NATURAL LANGUAGE TEXTS

    Directory of Open Access Journals (Sweden)

    I. A. Bessmertny

    2017-01-01

    Full Text Available The paper considers a problem of automatic domain term extraction from documents corpus by means of a contrast collection. Existing contrastive methods successfully extract often used terms but mishandle rare terms. This could yield poorness of the resulting thesaurus. Assessment of point-wise mutual information is one of the known statistical methods of term extraction and it finds rare terms successfully. Although, it extracts many false terms at that. The proposed approach consists of point-wise mutual information application for rare terms extraction and filtering of candidates by criterion of joint occurrence with the other candidates. We build “documents-by-terms” matrix that is subjected to singular value decomposition to eliminate noise and reveal strong interconnections. Then we pass on to the resulting matrix “terms-by-terms” that reproduces strength of interconnections between words. This approach was approved on a documents collection from “Geology” domain with the use of contrast documents from such topics as “Politics”, “Culture”, “Economics” and “Accidents” on some Internet resources. The experimental results demonstrate operability of this method for rare terms extraction.

  13. 14 CFR 193.17 - How must design and production approval holders handle information they receive from the FAA...

    Science.gov (United States)

    2010-01-01

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

  14. Nurse Case Managers' Experiences on Case Management for Long-term Hospitalization in Korea

    OpenAIRE

    Jinjoo Oh, Ph.D., RN, GNP; Seieun Oh, Ph.D., RN

    2017-01-01

    Purpose: The implementation of case management for long-term hospitalization use has been approved for controlling medical cost increases in other countries. But, introduction of the case management in Korea has created issues that hinder its effective operation. This qualitative study aimed to obtain further understanding of the issues surrounding the management of Medical Aid beneficiaries' use of long-term hospitalization from the case managers' perspectives and to provide suggestions for ...

  15. Machine terms dictionary

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1979-04-15

    This book gives descriptions of machine terms which includes machine design, drawing, the method of machine, machine tools, machine materials, automobile, measuring and controlling, electricity, basic of electron, information technology, quality assurance, Auto CAD and FA terms and important formula of mechanical engineering.

  16. RxTerms

    Data.gov (United States)

    U.S. Department of Health & Human Services — RxTerms is a drug interface terminology derived from RxNorm for prescription writing or medication history recording (e.g. in e-prescribing systems, PHRs). RxTerms...

  17. (AGA) Pre Term Babies

    African Journals Online (AJOL)

    Haematological Indices in Healthy Appropriate For-Gestational-Age (AGA) Pre Term Babies. ... International Journal of Medicine and Health Development. Journal Home ... Patient and Methods: All consecutive healthy pre-term new born babies delivered at UNTH and admitted into the hospital NBSCU were included.

  18. Toyotarity. Term, model, range

    Directory of Open Access Journals (Sweden)

    Stanisław Borkowski

    2013-04-01

    Full Text Available The Toyotarity and BOST term was presented in the chapter. The BOST method allows to define relations between material resources and human resources and between human resources and human resources (TOYOTARITY. This term was also invented by the Author (and is legally protected. The idea of methodology is an outcome of 12 years of work.

  19. Dictionary of Marketing Terms.

    Science.gov (United States)

    Everhardt, Richard M.

    A listing of words and definitions compiled from more than 10 college and high school textbooks are presented in this dictionary of marketing terms. Over 1,200 entries of terms used in retailing, wholesaling, economics, and investments are included. This dictionary was designed to aid both instructors and students to better understand the…

  20. Dynamic term structure models

    DEFF Research Database (Denmark)

    Andreasen, Martin Møller; Meldrum, Andrew

    This paper studies whether dynamic term structure models for US nominal bond yields should enforce the zero lower bound by a quadratic policy rate or a shadow rate specification. We address the question by estimating quadratic term structure models (QTSMs) and shadow rate models with at most four...

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

    Science.gov (United States)

    Govil, Ashul; Hao, Steven C

    2016-10-01

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

  2. Observations and suggestions for improved transport/packaging approvals

    International Nuclear Information System (INIS)

    Vaughan, C.

    2004-01-01

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

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

    International Nuclear Information System (INIS)

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

    2003-01-01

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

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

    Science.gov (United States)

    Sriphiromya, Pakawadee; Theeraroungchaisri, Anuchai

    2015-02-01

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

  5. Safety review and approval process for the TFTR

    International Nuclear Information System (INIS)

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

    1983-01-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

    Schimmer, Joshua; Breazzano, Steven

    2016-06-01

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

  8. 30 CFR 285.706 - How do I nominate a CVA for MMS approval?

    Science.gov (United States)

    2010-07-01

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

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

    Science.gov (United States)

    2010-01-01

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

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

    International Nuclear Information System (INIS)

    1983-12-01

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

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

    International Nuclear Information System (INIS)

    1988-01-01

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

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

    International Nuclear Information System (INIS)

    1993-10-01

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

  13. 75 FR 68315 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2010-11-05

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

  14. 7 CFR 4290.470 - Prior approval of merger, consolidation, or reorganization of RBIC.

    Science.gov (United States)

    2010-01-01

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

  15. Long-term collections

    CERN Multimedia

    Collectes à long terme

    2007-01-01

    The Committee of the Long Term Collections (CLT) asks for your attention for the following message from a young Peruvian scientist, following the earthquake which devastated part of her country a month ago.

  16. Glossary of Dental Terms

    Science.gov (United States)

    ... more... Coffee and Doughnuts: A Disastrous Combo for Teeth? The sugars in doughnuts have been identified as ... More print this article enlarge text Glossary of Dental Terms Oral Health Defined Amalgam silver/mercury alloy ...

  17. 1994 Characterization report for the state approved land disposal site

    International Nuclear Information System (INIS)

    Swanson, L.C.

    1994-01-01

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

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

    Science.gov (United States)

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

    2017-06-01

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

  19. Request for approval, vented container annual release fraction

    International Nuclear Information System (INIS)

    HILL, J.S.

    1999-01-01

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

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

    International Nuclear Information System (INIS)

    HILL, J.S.

    1999-01-01

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

  1. Toward a comprehensive long term nicotine policy.

    Science.gov (United States)

    Gray, N; Henningfield, J E; Benowitz, N L; Connolly, G N; Dresler, C; Fagerstrom, K; Jarvis, M J; Boyle, P

    2005-06-01

    Global tobacco deaths are high and rising. Tobacco use is primarily driven by nicotine addiction. Overall tobacco control policy is relatively well agreed upon but a long term nicotine policy has been less well considered and requires further debate. Reaching consensus is important because a nicotine policy is integral to the target of reducing tobacco caused disease, and the contentious issues need to be resolved before the necessary political changes can be sought. A long term and comprehensive nicotine policy is proposed here. It envisages both reducing the attractiveness and addictiveness of existing tobacco based nicotine delivery systems as well as providing alternative sources of acceptable clean nicotine as competition for tobacco. Clean nicotine is defined as nicotine free enough of tobacco toxicants to pass regulatory approval. A three phase policy is proposed. The initial phase requires regulatory capture of cigarette and smoke constituents liberalising the market for clean nicotine; regulating all nicotine sources from the same agency; and research into nicotine absorption and the role of tobacco additives in this process. The second phase anticipates clean nicotine overtaking tobacco as the primary source of the drug (facilitated by use of regulatory and taxation measures); simplification of tobacco products by limitation of additives which make tobacco attractive and easier to smoke (but tobacco would still be able to provide a satisfying dose of nicotine). The third phase includes a progressive reduction in the nicotine content of cigarettes, with clean nicotine freely available to take the place of tobacco as society's main nicotine source.

  2. Can market stability be improved. Government and export contract approvals

    International Nuclear Information System (INIS)

    Livingston, R.S.

    1983-01-01

    The following aspects are discussed: long-term contracts vs spot or short-term uranium transactions; impact of widely fluctuating prices on primary producing/exporting countries and their producers; forecast of growing and largely predictable demand for uranium over next decade or two; effects of government actions; Australian development and export policies. (U.K.)

  3. Nonprice terms and conditions

    International Nuclear Information System (INIS)

    Anon.

    1991-01-01

    In this and the following chapter the authors review some of the more common provisions contained in wheeling contracts. Here they discuss nonprice terms and conditions. In the next chapter they look at the manner in which they address the pricing issue. At the outset one should note that there is a relationship between price and nonprice terms and condition. A couple of the provisions discussed here affect the risks incurred by the wheeling utility and the price it may charge for that service. These provisions include the length of the contract, the degree to which service can be interrupted and the ability to terminate the contract early, among others. These provisions are often characterized as nonprice terms and conditions. In reality, however, these factors have a direct bearing on the overall cost of wheeling services provided

  4. The analysis of the market success of FDA approvals by probing top 100 bestselling drugs

    Science.gov (United States)

    Polanski, Jaroslaw; Bogocz, Jacek; Tkocz, Aleksandra

    2016-05-01

    Target-oriented drug discovery is the main research paradigm of contemporary drug discovery. In target-oriented approaches, we attempt to maximize in vitro drug potency by finding the optimal fit to the target. This can result in a higher molecular complexity, in particular, the higher molecular weight (MW) of the drugs. However, a comparison of the successful developments of pharmaceuticals with the general trends that can be observed in medicinal chemistry resulted in the conclusion that the so-called molecular obesity is an important reason for the attrition rate of drugs. When analyzing the list of top 100 drug bestsellers versus all of the FDA approvals, we discovered that on average lower-complexity (MW, ADMET score) drugs are winners of the top 100 list in terms of numbers but that, especially, up to some optimal MW value, a higher molecular complexity can pay off with higher incomes. This indicates that slim drugs are doing better but that fat drugs are bigger fishes to catch.

  5. Insight into the cellular fate and toxicity of aluminium adjuvants used in clinically approved human vaccinations.

    Science.gov (United States)

    Mold, Matthew; Shardlow, Emma; Exley, Christopher

    2016-08-12

    Aluminium adjuvants remain the most widely used and effective adjuvants in vaccination and immunotherapy. Herein, the particle size distribution (PSD) of aluminium oxyhydroxide and aluminium hydroxyphosphate adjuvants was elucidated in attempt to correlate these properties with the biological responses observed post vaccination. Heightened solubility and potentially the generation of Al(3+) in the lysosomal environment were positively correlated with an increase in cell mortality in vitro, potentially generating a greater inflammatory response at the site of simulated injection. The cellular uptake of aluminium based adjuvants (ABAs) used in clinically approved vaccinations are compared to a commonly used experimental ABA, in an in vitro THP-1 cell model. Using lumogallion as a direct-fluorescent molecular probe for aluminium, complemented with transmission electron microscopy provides further insight into the morphology of internalised particulates, driven by the physicochemical variations of the ABAs investigated. We demonstrate that not all aluminium adjuvants are equal neither in terms of their physical properties nor their biological reactivity and potential toxicities both at the injection site and beyond. High loading of aluminium oxyhydroxide in the cytoplasm of THP-1 cells without immediate cytotoxicity might predispose this form of aluminium adjuvant to its subsequent transport throughout the body including access to the brain.

  6. 15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

    Science.gov (United States)

    2010-01-01

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

  7. 76 FR 33019 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-06-07

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

  8. 77 FR 46964 - Oklahoma: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Science.gov (United States)

    2012-08-07

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

  9. 77 FR 59879 - Idaho: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Science.gov (United States)

    2012-10-01

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

  10. 77 FR 29231 - Oklahoma: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Science.gov (United States)

    2012-05-17

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

  11. 76 FR 26616 - Wisconsin: Incorporation by Reference of Approved State Hazardous Waste Management Program

    Science.gov (United States)

    2011-05-09

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

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

    International Nuclear Information System (INIS)

    1969-01-01

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

  13. 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...

  14. 76 FR 30200 - Forging Machines; Extension of the Office of Management and Budget's (OMB) Approval of...

    Science.gov (United States)

    2011-05-24

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

  15. 77 FR 64339 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

    Science.gov (United States)

    2012-10-19

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

  16. 78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

    Science.gov (United States)

    2013-03-25

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

  17. 78 FR 16601 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-03-18

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

  18. 78 FR 63375 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

    Science.gov (United States)

    2013-10-24

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

  19. 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...

  20. 75 FR 42339 - List of Approved Spent Fuel Storage Casks: NAC-MPC System, Revision 6

    Science.gov (United States)

    2010-07-21

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

  1. 78 FR 32077 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-05-29

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

  2. 78 FR 45 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

    Science.gov (United States)

    2013-01-02

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

  3. 24 CFR 1000.112 - How will HUD determine whether to approve model housing activities?

    Science.gov (United States)

    2010-04-01

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

  4. 77 FR 56241 - Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000

    Science.gov (United States)

    2012-09-12

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

  5. 75 FR 31510 - Fox Chase Bancorp, Inc., Hatboro, PA; Approval of Conversion

    Science.gov (United States)

    2010-06-03

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

  6. 38 CFR 21.258 - Cost limitations on approval of self-employment plans.

    Science.gov (United States)

    2010-07-01

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

  7. 77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

    Science.gov (United States)

    2012-03-06

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

  8. 78 FR 43145 - Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard

    Science.gov (United States)

    2013-07-19

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

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

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

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

  10. 75 FR 52065 - SharePlus Federal Bank, Plano, TX; Approval of Conversion Application

    Science.gov (United States)

    2010-08-24

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

  11. 75 FR 51333 - Madison Square Federal Savings Bank, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2010-08-19

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

  12. 75 FR 24774 - Fairmount Bank, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2010-05-05

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

  13. 76 FR 27753 - American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application

    Science.gov (United States)

    2011-05-12

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

  14. 75 FR 31511 - Ideal Federal Savings Bank, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2010-06-03

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

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

    Science.gov (United States)

    2010-04-01

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

  16. 13 CFR 108.140 - SBA approval of initial Management Expenses.

    Science.gov (United States)

    2010-01-01

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

  17. 48 CFR 301.106 - Office of Management and Budget approval under the Paperwork Reduction Act.

    Science.gov (United States)

    2010-10-01

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

  18. 76 FR 32321 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the...

    Science.gov (United States)

    2011-06-06

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

  19. 24 CFR 982.612 - Group home: State approval of group home.

    Science.gov (United States)

    2010-04-01

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

  20. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    Science.gov (United States)

    2010-04-01

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