WorldWideScience

Sample records for nonpostable terms approved

  1. NASA thesaurus alphabetical update: Subject terms for indexing scientific and technical information

    Science.gov (United States)

    1971-01-01

    The NASA THESAURUS - ALPHABETICAL UPDATE is an alphabetical listing of all subject terms (postable and nonpostable) that are currently approved for use in the NASA scientific and technical information system. Contained in the listing are the subject terms that were listed in the Preliminary Edition of the NASA THESAURUS and the additional subject terms that were approved during the period January 1, 1967 June 30, 1971. Complete Thesaurus structuring, including scope notes, category assignments, and cross-references, is provided for each term as appropriate.

  2. 75 FR 31288 - Plant-Verified Drop Shipment (PVDS)-Nonpostal Documentation

    Science.gov (United States)

    2010-06-03

    ... 111 Plant-Verified Drop Shipment (PVDS)--Nonpostal Documentation AGENCY: Postal Service TM . ACTION...; and to require segregation of documentation presented at the time of induction. DATES: Effective Date... other documentation presented at the time of mailing. This measure ensures that postal personnel will...

  3. 18 CFR 806.31 - Term of approvals.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Term of approvals. 806.31 Section 806.31 Conservation of Power and Water Resources SUSQUEHANNA RIVER BASIN COMMISSION REVIEW... for a period of five consecutive years, the approval shall be null and void, unless a waiver is...

  4. 14 CFR 414.31 - Monitoring compliance with the terms and conditions of a safety approval.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Monitoring compliance with the terms and conditions of a safety approval. 414.31 Section 414.31 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety Approval Review and Issuance §...

  5. Vocabulary of aerospace safety terms pertaining to cryogenic safety, fires, explosions, and structure failure

    Science.gov (United States)

    Pelouch, J. J., Jr.; Mandel, G.; Ordin, P. M.

    1976-01-01

    This vocabulary listing characterizes the contents of over 10,000 documents of the NASA Aerospace Safety Research and Data Institute's (ASRDI) safety engineering collection. The ASRDI collection is now one of the series accessible on the NASA RECON data base. There are approximately 6,300 postable terms that describe literature in the areas of cryogenic fluid safety, specifically hydrogen, oxygen, liquified natural gas; fire and explosion technology; and the mechanics of structural failure. To facilitate the proper selection of information nonpostable, related and array terms have been included in this listing.

  6. 40 CFR 63.94 - Approval of State permit terms and conditions that substitute for a section 112 rule.

    Science.gov (United States)

    2010-07-01

    ... approval of a State program under this section and making a preliminary determination of equivalence, the... the Regional Office's decision, the State shall limit the number of sources for which it submits... conditions that are sufficient, in the Administrator's judgement, to allow the Administrator to...

  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. 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…

  10. 76 FR 78955 - Review of Nonpostal Services

    Science.gov (United States)

    2011-12-20

    ... Docket No. MC2008-1 (Phase IIR) to consider issues on remand. Docket Nos. MC2008-1 (Phase II) and MC2008-1 (Phase IIR) are part of the same proceeding. Comments are due January 13, 2012.\\10\\ Reply comments... ordered: 1. The Commission establishes Docket No. MC2008-1 (Phase IIR) to consider issues on remand....

  11. Drugs Approved for Melanoma

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Melanoma This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome ( ...

  12. Natural rates of teacher approval and disapproval in the classroom.

    Science.gov (United States)

    White, M A

    1975-01-01

    Sixteen classroom observational studies were conducted to determine natural rates of teacher verbal approval and disapproval in the classroom. Rates of teacher verbal approval and disapproval were measured by the Teacher Approval and Disapproval Observation Record (TAD) over Grades 1 through 12. Teacher verbal approval rates dropped over grade, with a marked drop after second grade. In every grade after second, the rate of teacher verbal disapproval exceeded the rate of teacher verbal approval. These rates are interpreted in terms of reinforcement theory.

  13. 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....

  14. Post-Approval Studies

    Data.gov (United States)

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

  15. 46 CFR 30.10-3 - Approved-TB/ALL.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Approved-TB/ALL. 30.10-3 Section 30.10-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY TANK VESSELS GENERAL PROVISIONS Definitions § 30.10-3 Approved—TB/ALL. The term approved means approved by the Commandant unless otherwise stated. ...

  16. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

    ... GENERAL TERMS AND CONDITIONS FOR INVESTMENT ASSISTANCE § 302.18 Post-approval requirements. (a) General. A... the terms and conditions of the Investment Assistance, including any special terms and applicable Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply...

  17. 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.

  18. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  19. Drugs Approved for Lung Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer drugs approved by the ... listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate (Methotrexate) Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation) ...

  20. 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 ...

  1. FWS Approved Acquisition Boundaries

    Data.gov (United States)

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

  2. FWS Approved Acquisition Boundaries

    Data.gov (United States)

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

  3. FWS Approved Acquisition Boundaries

    Data.gov (United States)

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

  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. 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.

  7. 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...

  8. 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...

  9. 78 FR 69125 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-11-18

    ... to continue, the collection of information on the purchases of crude helium by Federal helium... information, you are not obligated to respond. The BLM will request a 3-year term of approval for this... Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management...

  10. 75 FR 27375 - Review of Nonpostal Services Language

    Science.gov (United States)

    2010-05-14

    ..., Photocopying Service, Electronic Postmark (EPM), Notary Public Services, and Stored Value Cards. Docket No... language is available on the Commission's Web site ( http://www.prc.gov ). \\3\\ Notary Public Services and..., Leasing, Licensing or Other Non-Sale Disposition of Tangible Property; Advertising; Mail...

  11. Pembrolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-10-01

    Pembrolizumab [Keytruda(®) (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.

  12. Pomalidomide: first global approval.

    Science.gov (United States)

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  13. Apremilast: first global approval.

    Science.gov (United States)

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

    Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

  14. Heartland Winthrop Approval

    Science.gov (United States)

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products 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 program.

  15. 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

  16. FDA Approval for Imiquimod

    Science.gov (United States)

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

  17. FHR Iowa Falls Approval

    Science.gov (United States)

    This October 22, 2015, letter from EPA approves the petition from Flint Hills Resources, LLC, regarding non-grandfathered ethanol produced through the FHR Iowa Falls Process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the R

  18. FDA Approvals - Cancer Currents Blog

    Science.gov (United States)

    A catalog of posts from NCI’s Cancer Currents blog on new Food and Drug Administration approvals of cancer drugs. All posts include summaries of the evidence to support the new approvals and what they mean for patients.

  19. Drugs Approved for Skin Cancer

    Science.gov (United States)

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

  20. 13 CFR 302.8 - Pre-approval Investment Assistance costs.

    Science.gov (United States)

    2010-01-01

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

  1. Pitolisant: First Global Approval.

    Science.gov (United States)

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.

  2. 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.

  3. Rucaparib: First Global Approval.

    Science.gov (United States)

    Syed, Yahiya Y

    2017-04-01

    Rucaparib (Rubraca™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by Clovis Oncology, Inc. (Boulder, CO, USA) for the treatment of solid tumours. It has been approved in the USA as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. A marketing authorization application for rucaparib for the same indication has been submitted to the European Medicines Agency. Rucaparib is also under phase II or III investigation in ovarian, breast and prostate cancer. This article summarizes the milestones in the development of rucaparib leading to this first approval for ovarian cancer.

  4. Ipilimumab: first global approval.

    Science.gov (United States)

    Cameron, Fiona; Whiteside, Glenn; Perry, Caroline

    2011-05-28

    Ipilimumab (Yervoy®) is an anti-cytotoxic T-lymphocyte antigen (CTLA)-4 monoclonal antibody that has been approved in the US for the first- or second-line treatment of patients with malignant melanoma. In the EU, it is awaiting approval as second-line therapy for melanoma. Ipilimumab blocks the effects of the negative T-cell regulator CTLA-4, which may in turn augment T-cell responses to tumour cells. Preclinical studies have indicated that antibody blocking of CTLA-4 can lead to potent immune responses. Ipilimumab is also in development as first- and second-line therapy for prostate cancer where it has progressed to phase III clinical trials worldwide, and it is in phase II development for non-small cell lung cancer. Ipilimumab was originated by the University of California, Berkeley, in the US and subsequently licensed to Medarex, which was later acquired by Bristol-Myers Squibb. This article summarizes the milestones in the development of intravenous ipilimumab leading to this first approval. This profile has been extracted from Wolters Kluwer's R&D Insight drug pipeline database. R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  5. Baricitinib: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2017-03-13

    Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Regulatory approval to market baricitinib as a treatment for RA has also been sought in the USA and Japan. This article summarizes the milestones in the development of baricitinib leading to this first global approval for the treatment for moderate to severe active RA in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

  6. Evolocumab: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2015-09-01

    Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a negative regulator of low-density lipoprotein (LDL)-receptors-thereby improving the ability of the liver to bind LDL-cholesterol (LDL-C), leading to reduced LDL-C blood levels. The drug reduces LDL-C levels in patients with hypercholesterolaemia when used as monotherapy or in conjunction with a statin. This article summarizes the milestones in the development of evolocumab leading to this approval for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet with or without a statin and/or other lipid lowering therapies, and in adults and adolescents aged ≥12 years with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

  7. 25 CFR 84.004 - Are there types of contracts and agreements that do not require Secretarial approval under this...

    Science.gov (United States)

    2010-04-01

    ... are exempt from Secretarial approval under the terms of a corporate charter authorized by 25 U.S.C...-Governance Act, 25 U.S.C. 458aa. (i) Contracts or agreements that are subject to approval by the...

  8. Why Is Cross-Sex-Role Behavior More Approved for Girls than for Boys? A Status Characteristic Approach.

    Science.gov (United States)

    Feinman, Saul

    1981-01-01

    Investigates approval/disapproval of behavioral performance in terms of the relative status of male and female role positions. Reports that male role behaviors are more highly approved than female role behaviors for both male and female college students. (ST)

  9. 30 CFR 18.11 - Approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 18.11 Section 18.11 Mineral... plate. (a)(1) The notice of approval will be accompanied by a photograph of an approval plate, bearing... number shall be added to the original approval number on the approval plate. (Example: Original approval...

  10. Ataluren: first global approval.

    Science.gov (United States)

    Ryan, Nicola J

    2014-09-01

    Nonsense mutations are implicated in 5-70 % of individual cases of most inherited diseases, including Duchenne muscular dystrophy (DMD) and cystic fibrosis. Ataluren (Translarna™) is an orally available, small molecule compound that targets nonsense mutations, and is the first drug in its class. Ataluren appears to allow cellular machinery to read through premature stop codons in mRNA, enabling the translation process to produce full-length, functional proteins. This article summarizes the milestones in the development of ataluren leading to its conditional first approval for nonsense mutation DMD.

  11. Obinutuzumab: first global approval.

    Science.gov (United States)

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  12. Safinamide: first global approval.

    Science.gov (United States)

    Deeks, Emma D

    2015-04-01

    Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson's disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

  13. NASA thesaurus. Volume 2: Access vocabulary

    Science.gov (United States)

    1988-01-01

    The access vocabulary, which is essentially a permuted index, provides access to any word or number in authorized postable and nonpostable terms. Additional entries include postable and nonpostable terms, other word entries and pseudo-multiword terms that are permutations of words that contain words within words. The access vocabulary contains almost 42,000 entries that give increased access to the hierarchies in Volume 1 - Hierarchical Listing.

  14. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    ... Human Papillomavirus (HPV) Nonavalent Vaccine Recombinant Human Papillomavirus (HPV) Quadrivalent Vaccine Drugs Approved to Treat Cervical Cancer Avastin (Bevacizumab) Bevacizumab Blenoxane (Bleomycin) Bleomycin Hycamtin (Topotecan ...

  15. FDA-Approved HIV Medicines

    Science.gov (United States)

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with HIV medicines is ... approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the ...

  16. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2004-01-01

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

  17. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

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

  18. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Types of respirators to be approved; scope of... Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.50 Types of respirators to be approved; scope of approval. Approvals shall be issued for the types of respirators...

  19. 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

  20. 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...

  1. Mavyret Approved for Hepatitis C

    Science.gov (United States)

    ... news/fullstory_167618.html Mavyret Approved for Hepatitis C A chronic viral infection of the liver To ... treat adults with certain types of chronic hepatitis C virus (HCV). The combination drug is the first ...

  2. 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.

  3. Elosulfase alfa: first global approval.

    Science.gov (United States)

    Sanford, Mark; Lo, Jin Han

    2014-04-01

    Elosulfase alfa (Vimizim™) is a recombinant form of N-acetylgalactosamine-6-sulfatase (GALNS) that was developed by BioMarin Pharmaceutical Inc. as an enzyme replacement therapy for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Patients with MPS IVA have a GALNS deficiency, which results in serious musculoskeletal, cardiorespiratory and other system disturbances. Elosulfase alfa was approved by the US FDA on 14 February 2014 for the treatment of MPS IVA. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recently recommended that elosulfase alfa be approved for use in the EU in the same indication. Within the last year, the manufacturer has also filed applications for approval for the use of elosulfase alfa in MPS IVA in Brazil, Australia, Canada and Mexico. This article summarizes the milestones in the development of elosulfase alfa leading to its first global approval in MPS IVA.

  4. Is It Really FDA Approved?

    Science.gov (United States)

    ... must be proven safe and effective to FDA’s satisfaction before companies can market them in interstate commerce. ... product to market. back to top FDA approves food additives in food for people. Although FDA does ...

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Drugs Approved for Breast Cancer

    Science.gov (United States)

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

  13. 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.

  14. 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.

  15. Drugs Approved for Prostate Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for prostate cancer. The list includes generic ...

  16. Trulance Approved for Chronic Constipation

    Science.gov (United States)

    ... news/fullstory_163171.html Trulance Approved for Chronic Constipation Drug designed to stimulate upper gastrointestinal tract To ... U.S. Food and Drug Administration to treat persistent constipation of unknown (idiopathic) cause in adults. Some 42 ...

  17. Rucaparib Approved for Ovarian Cancer.

    Science.gov (United States)

    2017-02-01

    The FDA approved the PARP inhibitor rucaparib to treat women with advanced ovarian cancer who have already been treated with at least two chemotherapies and have a BRCA1 or BRCA2 gene mutation identified by an approved companion diagnostic test. The agency also gave a nod to the FoundationFocus CDxBRCA test to detect BRCA alterations. ©2017 American Association for Cancer Research.

  18. 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... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  19. 75 FR 71293 - Approval and Promulgation of Implementation Plans; State of California; 2007 South Coast State...

    Science.gov (United States)

    2010-11-22

    ... furnaces, space heaters, facility modernizations, livestock waste, residential wood burning, commercial...-approved 75 FR 46845, 08/04/10. from space heaters. Rule 1110.2--Liquid and gaseous SIP-approved 74 FR... achieves near-term reductions in emissions of NO X , PM, and VOC or reactive organic gas (ROG) which are...

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

    Science.gov (United States)

    2012-02-15

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval... State of Illinois submitted a primacy application for its approved Public Water System...

  2. Drug approval and surveillance.

    Science.gov (United States)

    Potts, M

    1980-01-01

    This article argues that current regulations governing the licensing of drugs, particularly in the U.S., need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use. In terms of research and development of new forms of contraception, this proposal would have great impact. It is believed that the U.S./Food and Drug Administration (FDA) requirements--animal experiments and Phase 1 and 2 clinical trials--not only put an unacceptable financial burden on any institution attempting to develop new contraceptives, but do not demonstrably contribute to the reduction of risks. The author questions whether even if oral contraceptives introduced prior to new U.S./FDA regulations had been subject to these current regulations that convincing evidence would have been found to alert anyone to the now-known rare adverse effects, such as risk of thromboembolism. It is pointed out that these sorts of rare risks were uncovered by continuous screening processes which are not now a part of the FDA drug regulation requirements. The author also questions the politics of "conpulsory safety," such as might be legislated for regulated car safety belt use. Citing a partnership already established between government and private industry in high-risk/low cost ventures in the aerospace industry, the author sees no reason why such a relationship could not evolve in the pharmaceutical industry. In Britain, proposals have been made to establish a fund to compensate patients adversely affected by drugs which pharmaceutical companies would reimburse if proved negligent; such a fund may work in the U.S. under new regulations which stress postmarketing surveillance.

  3. Medicare Program; hospital inpatient prospective payment systems for acute care hospitals and the long-term care hospital prospective payment system changes and FY2011 rates; provider agreements and supplier approvals; and hospital conditions of participation for rehabilitation and respiratory care services; Medicaid program: accreditation for providers of inpatient psychiatric services. Final rules and interim final rule with comment period.

    Science.gov (United States)

    2010-08-16

    : We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain provisions of the Affordable Care Act and other legislation. In addition, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. We are updating the payment policy and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and setting forth the changes to the payment rates, factors, and other payment rate policies under the LTCH PPS. In addition, we are finalizing the provisions of the August 27, 2009 interim final rule that implemented statutory provisions relating to payments to LTCHs and LTCH satellite facilities and increases in beds in existing LTCHs and LTCH satellite facilities under the LTCH PPS. We are making changes affecting the: Medicare conditions of participation for hospitals relating to the types of practitioners who may provide rehabilitation services and respiratory care services; and determination of the effective date of provider agreements and supplier approvals under Medicare. We are also setting forth provisions that offer psychiatric hospitals and hospitals with inpatient psychiatric programs increased flexibility in obtaining accreditation to participate in the Medicaid program. Psychiatric hospitals and hospitals with inpatient psychiatric programs will have the choice of undergoing a State survey or of obtaining accreditation from a national accrediting organization whose hospital accreditation

  4. Alkylbenzene Project in Xinjiang Approved

    Institute of Scientific and Technical Information of China (English)

    Zhou Weiyong

    1996-01-01

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

  5. 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.

  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. Discrimination of approved drugs from experimental drugs by learning methods

    Directory of Open Access Journals (Sweden)

    Li Yixue

    2011-05-01

    Full Text Available Abstract Background To assess whether a compound is druglike or not as early as possible is always critical in drug discovery process. There have been many efforts made to create sets of 'rules' or 'filters' which, it is hoped, will help chemists to identify 'drug-like' molecules from 'non-drug' molecules. However, among the chemical space of the druglike molecules, the minority will be approved drugs. Classifying approved drugs from experimental drugs may be more helpful to obtain future approved drugs. Therefore, discrimination of approved drugs from experimental ones has been done in this paper by analyzing the compounds in terms of existing drugs features and machine learning methods. Results Four methodologies were compared by their performance to classify approved drugs from experimental ones. The best results were obtained by SVM, in which the accuracy is 0.7911, the sensitivity is 0.5929, and the specificity is 0.8743. Based on the results, consensus model was developed to effectively discriminate drugs, which further pushed the correct classification rate up to 0.8517, sensitivity up to 0.7242, specificity up to 0.9352. The applications on the Traditional Chinese Medicine Ingredients Database (TCM-ID tested the methods. Therefore this model has been proven to be a potent tool for identifying drug molecules. Conclusion The studies would have potential applications in the research of combinatorial library design and virtual high throughput screening for drug discovery.

  8. 45 CFR 1326.21 - Application approval.

    Science.gov (United States)

    2010-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO INDIAN TRIBES FOR SUPPORT AND NUTRITION SERVICES § 1326.21 Application approval. (a) Approval of any...

  9. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  10. 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....

  11. 12 CFR 611.510 - Approval procedures.

    Science.gov (United States)

    2010-01-01

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

  12. 30 CFR 22.10 - Approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 22.10 Section 22.10 Mineral... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by manufacturers. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible methane...

  13. 30 CFR 20.13 - Approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 20.13 Section 20.13 Mineral... MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.13 Approval plate. The manufacturer shall attach, stamp, or mold an approval plate on the battery container or housing of each...

  14. 32 CFR 552.77 - Suspension approval.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Suspension approval. 552.77 Section 552.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY MILITARY RESERVATIONS AND....77 Suspension approval. The installation commander will personally approve all cases in...

  15. Hunan Rare Earth Group Approved

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    <正>Following Guangdong,Guangxi,Fujian and Jiangxi,Hunan announced that it would consolidate its rare earth resources-the consolidation plan of Hunan Rare Earth Group has been approved. Consolidation of the rare earth industry of south China is in full swing.According to "Several Opinions of the State Council on Promoting the Sustainable and Healthy Development of Rare Earth Industry"(hereinafter referred to as "Several Opinions")released in 2011,

  16. Nelfinavir: fourth protease inhibitor approved.

    Science.gov (United States)

    1997-01-01

    The Food and Drug Administration (FDA) has granted accelerated approval to nelfinavir in both adult and pediatric formulations. Agouron, the manufacturer, used innovative computerized drug design techniques to discover, design, and refine the nelfinavir molecule. Nelfinavir is marketed under the trade name Viracept, and costs $5,000 per year. Early clinical trials find it to be as powerful as the other protease inhibitors, but with a different resistance profile. The drug has relatively few drug indications; however, several compounds have been contraindicated.

  17. 42 CFR 84.33 - Approval labels and markings; approval of contents; use.

    Science.gov (United States)

    2010-10-01

    ... Approval and Disapproval § 84.33 Approval labels and markings; approval of contents; use. (a) Full-scale... at the following locations: Respirator type Label type Location Self-contained breathing apparatus... to whom it is issued to maintain or cause to be maintained the approved quality control sampling...

  18. 7 CFR 58.159 - Terms.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Terms. 58.159 Section 58.159 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections... Plants Approved for USDA Inspection and Grading Service 1 Explanation of Terms § 58.159 Terms. (a)...

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

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

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

  20. 77 FR 66607 - Placer County Water Agency; Notice of Application for Approval of Contract for the Sale of Power...

    Science.gov (United States)

    2012-11-06

    ... Energy Regulatory Commission Placer County Water Agency; Notice of Application for Approval of Contract for the Sale of Power for a Period Extending Beyond the Term of the License Take notice that on July 17, 2012, Placer County Water Agency filed with the Commission an application for approval of:...

  1. 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.

  2. Repurposing of approved cardiovascular drugs.

    Science.gov (United States)

    Ishida, Junichi; Konishi, Masaaki; Ebner, Nicole; Springer, Jochen

    2016-09-20

    Research and development of new drugs requires both long time and high costs, whereas safety and tolerability profiles make the success rate of approval very low. Drug repurposing, applying known drugs and compounds to new indications, has been noted recently as a cost-effective and time-unconsuming way in developing new drugs, because they have already been proven safe in humans. In this review, we discuss drug repurposing of approved cardiovascular drugs, such as aspirin, beta-blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, cardiac glycosides and statins. Regarding anti-tumor activities of these agents, a number of experimental studies have demonstrated promising pleiotropic properties, whereas all clinical trials have not shown expected results. In pathological conditions other than cancer, repurposing of cardiovascular drugs is also expanding. Numerous experimental studies have reported possibilities of drug repurposing in this field and some of them have been tried for new indications ('bench to bedside'), while unexpected results of clinical studies have given hints for drug repurposing and some unknown mechanisms of action have been demonstrated by experimental studies ('bedside to bench'). The future perspective of experimental and clinical studies using cardiovascular drugs are also discussed.

  3. 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.

  4. 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....

  5. Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

    NARCIS (Netherlands)

    Duijnhoven, R.G.; Straus, S.M.J.M.; Raine, J.M.; de Boer, A.; Hoes, A.W.; De Bruin, M.L.

    2013-01-01

    Background: At the time of approval of a new medicine, there are few long-term data on the medicine’s benefit–risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This study of the n

  6. Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

    NARCIS (Netherlands)

    R.G. Duijnhoven (Ruben); S.M.J.M. Straus (Sabine); J.W. Raine (John); A.C. de Boer (Anthonius); A.W. Hoes (Arno); M.L. de Bruin (Marie)

    2013-01-01

    textabstractBackground: At the time of approval of a new medicine, there are few long-term data on the medicine's benefit-risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This st

  7. 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 Machines Assembled With Certified or Explosion-Proof Components, Field Modifications of Approved Machines... and Certification Center, 765 Technology Drive, Triadelphia, WV 26059. (b) Proposed...

  8. 10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF... approval. (a) An access permittee who has a need to use, process, store, reproduce, transmit, or handle...

  9. INDACATEROL: A NEW APPROVED MOLECULE TO TREAT COPD

    Directory of Open Access Journals (Sweden)

    Jaithlia Rajiv

    2011-05-01

    Full Text Available Indacaterol approved as once-daily bronchodilator for chronic obstructive pulmonary disease (COPD. Indacaterol is a new molecular entity in the β2-adrenergic agonist class taken only once a day unlike the currently available β2-adrenergic agonist that helps relax muscles around lung airways to prevent COPD symptoms, such as wheezing and breathlessness. It is approved only for the treatment of chronic obstructive pulmonary disease (COPD (long-term data in patients with asthma are thus far lacking. It is delivered as an aerosol formulation through a dry powder inhaler. The most commonly reported side effects/adverse effects in patients taking Indacaterol (> 2% and more common than placebo are runny nose, cough, sore throat, headache, and nausea. The main benefit, it is Long Acting β2-adrenergic agonist (LABA, once in a day dosing is sufficient.

  10. 24 CFR 214.103 - Approval criteria.

    Science.gov (United States)

    2010-04-01

    ... counseling staff must possess a working knowledge of HUD's housing and single-family mortgage insurance... COUNSELING PROGRAM Approval and Disapproval of Housing Counseling Agencies § 214.103 Approval criteria. The... counseling agencies, branches, and affiliates that are included in one application: (a) Nonprofit and...

  11. 7 CFR 22.308 - Project approval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Project approval. 22.308 Section 22.308 Agriculture Office of the Secretary of Agriculture RURAL DEVELOPMENT COORDINATION Roles and Responsibilities of State Governments § 22.308 Project approval. State and multicounty jurisdictional planning is a State and local...

  12. 9 CFR 317.4 - Labeling approval.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling approval. 317.4 Section 317.4 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... by descriptive language the final colors, or submission with the sketch of previously approved final...

  13. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

    ...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C.... (1) Section 21.4250 (except paragraph (c)(1))—Jurisdiction for course and licensing and certification... study; and (12) Section 21.4268—Approval of licensing and certification tests. (Authority: 38...

  14. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status. 52.1323 Section 52.1323 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290...

  15. 46 CFR 154.1005 - Equipment approval.

    Science.gov (United States)

    2010-10-01

    ... carried. (b) Each submerged cargo pump motor installation must be specially approved by the Commandant (CG... FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Design, Construction and Equipment Electrical § 154.1005 Equipment approval. (a) Electrical equipment that is required to be intrinsically safe...

  16. 40 CFR 49.10042 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... TRIBAL CLEAN AIR ACT AUTHORITY Implementation Plans for Tribes-Region X Implementation Plan for the Cow Creek Band of Umpqua Indians of Oregon § 49.10042 Approval status. There are currently no EPA-approved Tribal rules or measures in the implementation plan for the Reservation of the Cow Creek Band of Umpqua...

  17. Obinutuzumab breaks through to FDA approval.

    Science.gov (United States)

    2014-01-01

    The U.S. Food and Drug Administration approved the monoclonal antibody obinutuzumab for use with chlorambucil in patients with previously untreated chronic lymphocytic leukemia. The drug is the first to receive approval under the agency's breakthrough therapy designation, created in July 2012.

  18. 14 CFR 21.325 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.325... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Export Airworthiness Approvals § 21.325 Export airworthiness approvals. (a) Kinds of approvals. (1) Export airworthiness approval of Class I products is...

  19. 13 CFR 130.610 - General terms.

    Science.gov (United States)

    2010-01-01

    ... CFR 143 and applicable OMB Circulars. ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false General terms. 130.610 Section 130... § 130.610 General terms. Upon approval of the initial or renewal application, SBA will enter into...

  20. Examining Approval and Disapproval Behaviors of Teachers Working in Inclusive Classrooms

    Directory of Open Access Journals (Sweden)

    Nevin GÜNER YILDIZ

    2014-01-01

    Full Text Available The purpose of this study is to determine frequency of approval and disapproval behaviors of teachers working in inclusive classrooms during lessons and to investigate whether teachers’ approval and disapproval behaviors differ in terms of their demographical characteristics. The study group consisted of 45 teachers who worked in three public schools in Ankara and who had students with special needs in their classrooms. In order to determine approval and disapproval behaviors teachers used, one hour video recordings in the classrooms of teachers in the study group were done and data of this study were analyzed by reviewing video recordings using Teacher Behaviors Observation Form and Demographical Information form was used to determine demographical characteristics of teachers. In terms of the analysis of data, mean of approval behaviors used by teachers per minute in one lesson was 0.42 whereas mean of disapproval behaviors was found to be 1.41 and the difference between these two values was statistically significant. The frequency of approval and disapproval behaviors teachers used did not differ significantly in terms of their gender, age, experience, and departments they graduated however these behaviors changed significantly in terms of teachers’ grade levels they were working in.

  1. Modelling seasonality in Australian building approvals

    Directory of Open Access Journals (Sweden)

    Harry M Karamujic

    2012-02-01

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

  2. 46 CFR 160.005-7 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, Fibrous Glass, Adult and Child (Jacket Type), Models 52 and 56 § 160.005-7 Procedure for approval. General. Manufacturers seeking approval of a life...

  3. 46 CFR 160.002-7 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, Kapok, Adult and Child (Jacket Type), Models 3 and 5 § 160.002-7 Procedure for approval. General. Manufacturers seeking approval of a life preserver...

  4. The dilemma of approving antidotes.

    Science.gov (United States)

    Steffen, Christian

    2007-04-20

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

  5. Depression: FDA-Approved Medications May Help

    Science.gov (United States)

    ... Products For Consumers Home For Consumers Consumer Updates Depression: FDA-Approved Medications May Help Share Tweet Linkedin ... symptoms in some people. back to top Diagnosing Depression Diagnosis—which should be from a health care ...

  6. 30 CFR 7.409 - Approval marking.

    Science.gov (United States)

    2010-07-01

    ... approval number in addition to the number and size (gauge) of conductors and cable type. For cables containing electric conductors, the marking shall also include the voltage rating. For splices, the...

  7. 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.

  8. Actemra Approved for Certain Blood Vessel Inflammation

    Science.gov (United States)

    ... 165836.html Actemra Approved for Certain Blood Vessel Inflammation Drug will treat adults with a condition called ... to treat adults with giant cell arteritis, an inflammation of the blood vessels (vasculitis). In a media ...

  9. 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.

  10. 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.

  11. FDA Approves First Immunotherapy for Lymphoma

    Science.gov (United States)

    The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)

  12. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for kidney (renal cell) cancer. The list ...

  13. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for soft tissue sarcoma. The list includes ...

  14. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for non-Hodgkin lymphoma. The list includes ...

  15. Antidiabetic herbal drugs officially approved in China.

    Science.gov (United States)

    Jia, Wei; Gao, Wenyuan; Tang, Lida

    2003-12-01

    Over the centuries, Chinese herbal drugs have served as a major source of medicines for the prevention and treatment of diseases including diabetes mellitus (known as 'Xiao-ke'). It is estimated that more than 200 species of plants exhibit hypoglycaemic properties, including many common plants, such as pumpkin, wheat, celery, wax guard, lotus root and bitter melon. To date, hundreds of herbs and traditional Chinese medicine formulas have been reported to have been used for the treatment of diabetes mellitus. This paper provides a brief review of the antidiabetic drugs of plant origin that have been approved by the Chinese health regulatory agency for commercial use in China. It was believed, through pharmacological studies, that medicinal herbs were meticulously organized in these antidiabetic drug formulas such that polysaccharide containing herbs restore the functions of pancreatic tissues and cause an increase in insulin output by the functional beta cells, while other ingredients enhance the microcirculation, increase the availability of insulin and facilitate the metabolism in insulin-dependent processes. Pharmacological and clinical evaluations indicated that these drugs had a mild, but significant, blood glucose lowering effect and that the long-term use of these agents may be advantageous over chemical drugs in alleviating some of the chronic diseases and complications caused by diabetes. Additionally, the use of these natural agents in conjunction with conventional drug treatments, such as a chemical agent or insulin, permits the use of lower doses of the drug and/or decreased frequency of administration which decreases the side effects most commonly observed. Copyright 2003 John Wiley & Sons, Ltd.

  16. 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 < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for 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.

  17. 36 CFR 28.15 - Approval of local zoning ordinances.

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Approval of local zoning... INTERIOR FIRE ISLAND NATIONAL SEASHORE: ZONING STANDARDS Federal Standards and Approval of Local Ordinances § 28.15 Approval of local zoning ordinances. (a) The Secretary shall approve local ordinances...

  18. 30 CFR 35.9 - Certificates of approval.

    Science.gov (United States)

    2010-07-01

    ... APPROVAL OF MINING PRODUCTS FIRE-RESISTANT HYDRAULIC FLUIDS General Provisions § 35.9 Certificates of approval. (a) Upon completion of an investigation of a hydraulic fluid MSHA will issue to the applicant... notification of approval will be issued. If a certificate of approval is issued, no test data or...

  19. Recently approved systemic therapies for acne vulgaris and rosacea.

    Science.gov (United States)

    Del Rosso, James Q

    2007-08-01

    Until recently, with the exception of oral isotretinoin for the treatment of severe recalcitrant nodular acne, systemic therapy for acne vulgaris and rosacea has been based on anecdotal support, clinical experience, and small clinical trials. Tetracycline derivatives are the predominant systemic agents that have been used for both disease states, prescribed in dose ranges that produce antibiotic activity. Anti-inflammatory dose doxycycline, a controlled-release (CR) 40-mg capsule formulation of doxycycline that is devoid of antibiotic activity when administered once daily, was US Food and Drug Administration (FDA)-approved for the treatment of inflammatory lesions (papules and pustules) of rosacea, based on large-scale phase 3 pivotal trials and long-term microbiologic and safety data. Also, an extended-release (ER) tablet formulation of minocycline was approved by the FDA for the treatment of inflammatory lesions of moderate to severe acne vulgaris in patients 12 years and older based on large-scale phase 3 clinical trials that evaluated efficacy and safety, dose-response analysis, and long-term data. This article discusses the studies and clinical applications related to the use of these agents.

  20. 76 FR 39858 - Western Pacific Fisheries; Approval of a Marine Conservation Plan for Guam

    Science.gov (United States)

    2011-07-07

    ..., including support for long-term habitat assessment and monitoring of Guam coral reef flat communities... Marine Conservation Plan for Guam AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and... approval of a marine conservation plan for Guam. DATES: This agency decision is effective from June...

  1. 28 CFR 58.15 - Qualifications for approval as a nonprofit budget and credit counseling agency.

    Science.gov (United States)

    2010-07-01

    ... nonprofit budget and credit counseling agency. 58.15 Section 58.15 Judicial Administration DEPARTMENT OF... Qualifications for approval as a nonprofit budget and credit counseling agency. (a) Definition of agency. As used in this section the term “agency” means nonprofit budget and credit counseling agency....

  2. 75 FR 72688 - Approval and Promulgation of Implementation Plans; New Mexico; Interstate Transport of Pollution

    Science.gov (United States)

    2010-11-26

    ... public inspection in the Region 6 Freedom of Information Act (FOIA) Review Room between the hours of 8:30.... Statutory and Executive Order Reviews I. What action is EPA taking? We are approving a submission from the... term ``interfere with maintenance.'' It establishes a process to identify any specific receptors...

  3. High Falls generation station expansion approvals process

    Energy Technology Data Exchange (ETDEWEB)

    Litschko, C. [Lakeland Holding, Bracebridge, ON (Canada)

    2005-07-01

    Lakeland Holding Ltd. is the parent company for Lakeland Power Distribution Ltd., Bracebridge Generation Ltd., and Lakeland Energy Ltd. This PowerPoint presentation highlighted the High Falls generation expansion process. During construction of the High Falls plant, a concrete foundation was built beside the plant for future expansion. The expansion process involves building a 1,500 kilowatt generator to supply electricity to as many as 1600 households. The presentation described the context and background for the expansion and presented information on the water power generation plants. It presented site specifications as well as the approvals process by which final approval was granted in 2004. Observations and lessons learned from the approval process were identified. figs.

  4. [State of Michigan Teacher Education Manual 1970, Sections I and II--Approval of Teacher Education Institutions and Approval of Teacher Education Programs at Approved Teacher Education Institutions].

    Science.gov (United States)

    Michigan State Dept. of Education, Lansing. Teacher Preparation and Professional Development Services.

    This document presents rules and regulations of the Michigan State Board of Education concerning procedures for the approval of teacher education institutions and teacher education programs. The first section details processes in institutional approval, presenting: (1) legislative authority; (2) characteristics of the Approved Program System; (3)…

  5. 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...

  6. 40 CFR 52.373 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... approves the total suspended particulate regulation for foundry sand processes as submitted and identified... the particulate matter and not the requirement to emit not more than 0.75 pounds of particulate per ton of material cast, a provision which may be found in state regulation 19-508-18(f)(3)....

  7. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

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

  8. 40 CFR 1042.210 - Preliminary approval.

    Science.gov (United States)

    2010-07-01

    ... specific provisions that apply for deterioration factors. Decisions made under this section are considered... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Preliminary approval. 1042.210 Section 1042.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION...

  9. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... provisions do not meet the requirements of 40 CFR 51.160 for scope. EPA also disapproves 45 CSR 13 section 9... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status. 52.2522 Section 52.2522 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...

  10. Commonwealth Agri-Energy, LLC Approval

    Science.gov (United States)

    This December 15, 2016 letter from EPA approves the petition from Commonwealth Agri-Energy, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the CAA for renewable fuel (D-code 6) RINs under the RFS program.

  11. 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…

  12. 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…

  13. Perkins Bill is Approved by Congress

    Science.gov (United States)

    Cavanagh, Sean

    2006-01-01

    Career and technical education programs will face new pressure to show that they are academically rigorous and guiding high school students through a lineup of courses that prepares them for college or the workplace, under a bill approved by Congress. The reauthorization of the federal law known as the Perkins Act--dealing with what traditionally…

  14. 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...

  15. 7 CFR 3015.112 - Approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Approval procedures. 3015.112 Section 3015.112 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF THE CHIEF FINANCIAL OFFICER, DEPARTMENT OF AGRICULTURE UNIFORM FEDERAL ASSISTANCE REGULATIONS Programmatic Changes and Budget...

  16. 28 CFR 48.15 - Temporary approval.

    Science.gov (United States)

    2010-07-01

    ... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) NEWSPAPER PRESERVATION ACT § 48.15 Temporary... temporary approval may do so by delivering a statement of protest or telephoning his views to an employee of the Department of Justice, whose name, address and telephone number shall be designated by...

  17. 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

  18. 42 CFR 422.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Deemed approval. 422.2266 Section 422.2266 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Medicare Advantage Marketing Requirements § 422.2266...

  19. 42 CFR 423.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Deemed approval. 423.2266 Section 423.2266 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D Marketing Requirements §...

  20. 7 CFR 322.4 - Approved regions.

    Science.gov (United States)

    2010-01-01

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

  1. Approval of Spouse in Middle Age.

    Science.gov (United States)

    Troll, Lillian E.

    A strongly positive opinion of spouse in middle age tends to be associated with social conformity and family integration. Mutually approving couples were more often politically moderate, homogamous in religious background, and had more interpersonal power than their children. They also had more highly integrated family structures with low conflict…

  2. Approved Practices in Dairy Reproduction. Slide Script.

    Science.gov (United States)

    Roediger, Roger D.; Barr, Harry L.

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with approved practices in dairy reproduction. Included in the guide are narrations for use with 200 slides dealing with the following topics: the importance of good reproduction, the male and female roles in reproduction, selection of…

  3. 28 CFR 2.41 - Travel approval.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.41 Section 2.41 Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION AND RECOMMITMENT OF PRISONERS, YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel...

  4. Program and Course Approval Handbook. Fifth Edition

    Science.gov (United States)

    California Community Colleges, Chancellor's Office, 2013

    2013-01-01

    This "Program and Course Approval Handbook" assists California Community College (CCC) administrators, faculty, and staff in the development of programs and courses and the submission of these proposals for review by the Chancellor's Office. By law, the Chancellor is required to prepare and distribute a handbook for program and course…

  5. 7 CFR 3565.103 - Approval requirements.

    Science.gov (United States)

    2010-01-01

    ... lender must provide the Agency with an annual audited financial statement conducted in accordance with... reserves, to have an acceptable level of financial soundness as determined by a lender rating service (such... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM Lender Requirements § 3565.103 Approval requirements....

  6. 7 CFR 52.53 - Approved identification.

    Science.gov (United States)

    2010-01-01

    ...) When graded against a U.S. grade standard, meet the quality requirements for U.S Grade C or better; (5) Meet applicable fill weight and/or drained weight, Brix or other characteristics of a commodity related... approved by USDA inspection service prior to use. (b) Inspection (Continuous) grade and inspection...

  7. Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar.

    Science.gov (United States)

    Agarwal, Amit B; McBride, Ali

    2016-08-01

    The World Health Organization defines a biosimilar as "a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product." Biosimilars are biologic medical products that are very distinct from small-molecule generics, as their active substance is a biological agent derived from a living organism. Approval processes are highly regulated, with guidance issued by the European Medicines Agency and US Food and Drug Administration. Approval requires a comparability exercise consisting of extensive analytical and preclinical in vitro and in vivo studies, and confirmatory clinical studies. Extrapolation of biosimilars from their original indication to another is a feasible but highly stringent process reliant on rigorous scientific justification. This review focuses on the processes involved in gaining biosimilar approval and extrapolation and details the comparability exercise undertaken in the European Union between originator erythropoietin-stimulating agent, Eprex(®), and biosimilar, Retacrit™.

  8. An analysis of FDA-approved drugs for inflammation and autoimmune diseases.

    Science.gov (United States)

    Kinch, Michael S; Merkel, Janie

    2015-08-01

    The term 'inflammation' captures a variety of disease processes linked with the immune system. An analysis of US Food and Drug Administration (FDA)-approved nuclear molecular entities (NMEs) reveals notable trends in terms of acute and chronic inflammatory indications. The number of NMEs peaked during the 1990s and has since declined by more than 50%. Whereas pharmaceutical companies have dominated the field, biotechnology companies now receive half of new approvals and academia has a relatively large role in terms of pivotal first patents. Another notable trend is that the relative number of NMEs targeting allergy has been decreasing, whereas those targeting autoimmune indications is increasing. Unlike other indications, NMEs for inflammation tend towards nuclear receptors and cytokines, and a disproportionate number of biologics target cytokine pathways.

  9. 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

  10. 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.

  11. AOA Approval of ACGME Internship and Residency Training.

    Science.gov (United States)

    Duffy, Thomas; Martinez, Bulmaro

    2011-04-01

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

  12. Florida Transformer Public Notice for Proposed PCB Storage Approval

    Science.gov (United States)

    Announcement of a Public Notice period for the proposed renewal of the PCB Commercial Storage Approval for Florida Transformer. Florida Transformer has requested to renew the PCB Approval. The renewal includes an additional tank storage and the acceptance

  13. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Pollution Prevention Equipment § 162.050-23 Separator: Approval... hour, the separator must be inclined at an angle of 22.5° with the plane of its normal...

  14. 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...

  15. FDA Approves New Treatment for Dust Mite Allergies

    Science.gov (United States)

    ... page: https://medlineplus.gov/news/fullstory_163882.html FDA Approves New Treatment for Dust Mite Allergies Odactra ... life," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "The approval ...

  16. 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...

  17. Effects of simulated approval-seeking and avoiding on self-disclosure, self-presentation, and interpersonal attraction.

    Science.gov (United States)

    Pellegrini, R J; Hicks, R A; Meyers-Winton, S

    1978-03-01

    Forty-eight undergraduate women assigned an approval-seeking or approval-avoiding role disclosed significantly more to a male listener (C) than did control Ss given no particular set, with no difference found between seeking and avoiding conditions in intimacy of disclosure. But content analyses indicated that approval-seeking Ss presented themselves significantly more positively, and approval-avoiding Ss significantly more negatively than did controls. These data supported the hypothesis that disclosure may serve as an instrumental affiliative act associated with both interpersonal approach and avoidance motives. The hypothesis that simulated attraction facilitates actual attraction was supported more clearly in analyses of Ss' liking ratings of C than in Ss' ratings of C's attractiveness or desirability as a dating partner. The latter findings are discussed in terms of intimacy implications of the attraction measures used.

  18. Common Terms

    Science.gov (United States)

    ... Print Page Text Size: A A A Listen Common Terms Below is a list of diabetes-related ... a skin condition characterized by darkened skin patches; common in people whose body is not responding correctly ...

  19. 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...

  20. 48 CFR 1845.607-170 - Contractor's approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Contractor's approved scrap... Contractor Inventory 1845.607-170 Contractor's approved scrap procedure. (a) When a contractor has an approved scrap procedure, certain property may be routinely disposed of in accordance with that...

  1. 29 CFR 4211.21 - Changes subject to PBGC approval.

    Science.gov (United States)

    2010-07-01

    ... method or modification to an allocation method that is not permitted under § 4211.12 if the method or... 29 Labor 9 2010-07-01 2010-07-01 false Changes subject to PBGC approval. 4211.21 Section 4211.21... Subject to PBGC Approval § 4211.21 Changes subject to PBGC approval. (a) General rule. Subject to...

  2. 44 CFR 78.9 - Planning grant approval process.

    Science.gov (United States)

    2010-10-01

    ... MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Planning grant approval process. 78.9 Section 78.9 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY...

  3. 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...

  4. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-26

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  5. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  6. 48 CFR 32.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Recommendation for... Recommendation for approval. If recommending approval, the contracting officer shall transmit the following... authorization (see 32.410). (g) The recommendation for approval of the advance payment request....

  7. 27 CFR 24.26 - Authority to approve.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS WINE Administrative and Miscellaneous Provisions Authorities § 24.26 Authority to approve. The appropriate TTB officer is authorized to approve, except as otherwise provided in... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Authority to approve....

  8. 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...

  9. 29 CFR 4221.14 - PBGC-approved arbitration procedures.

    Science.gov (United States)

    2010-07-01

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

  10. 50 CFR 15.26 - Approval of cooperative breeding programs.

    Science.gov (United States)

    2010-10-01

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

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

    Science.gov (United States)

    2010-07-01

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

  12. 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...

  13. 7 CFR 1737.51 - Approval of loan design.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval of loan design. 1737.51 Section 1737.51... of Application Procedures § 1737.51 Approval of loan design. RUS shall notify the borrower when the preloan data concerning the system design and costs and subscriber projections have been approved. If...

  14. 14 CFR 21.269 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

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

  15. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... currently in production, the manufacturer will notify MSHA when it is available. Representatives of the...

  16. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false USDA-approved laboratory. 996.22 Section 996.22 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing... laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology...

  17. Thiazolidinediones: a comparative review of approved uses.

    Science.gov (United States)

    Sood, V; Colleran, K; Burge, M R

    2000-01-01

    Thiazolidinediones are a powerful and clinically important new class of oral antidiabetic agents that act by improving insulin sensitivity. Troglitazone is the prototype drug in this class but was withdrawn from the market in March 2000 due to its association with idiosyncratic hepatotoxicity. Currently two thiazolidinediones, rosiglitazone and pioglitazone, are U.S. Food and Drug Administration (FDA) approved for treatment of type 2 diabetes. These agents bind to and activate peroxisome proliferator-activator receptor gamma (PPAR-gamma) and work by altering the expression of genes involved in glucose uptake, glucose disposal, and lipid metabolism. The drugs differ in receptor binding and potency due to differences in their side chain moieties. These agents are rapidly absorbed from the gastrointestinal tract and are metabolized mainly in the liver. Rosiglitazone is FDA approved for monotherapy and for use in combination therapy with metformin or sulfonylureas. Pioglitazone is FDA approved for monotherapy as well as for use in combination therapy with metformin, insulin, or sulfonylureas. These drugs may also cause significant changes in plasma lipid concentrations, and improved insulin sensitivity may improve ovulatory function and fertility in women with polycystic ovary syndrome. The most serious side effect of the thiazolidinediones is hepatotoxicity. Although rosiglitazone and pioglitazone were not associated with hepatotoxicity in premarketing clinical trials, there were two recent case reports of idiosyncratic hepatotoxicity in patients treated with rosiglitazone. In addition, these agents may be associated with edema and some hematological changes. The purpose of this review is to provide an overview of the two currently approved thiazolidinediones and to suggest an approach for their safe and rational use.

  18. Sincere Voting with Cardinal Preferences: Approval Voting

    OpenAIRE

    Ballester, Miguel Angel; Rey-Biel, Pedro

    2007-01-01

    We discuss sincere voting when voters have cardinal preferences over alter- natives. We interpret sincerity as opposed to strategic voting, and thus define sincerity as the optimal behaviour when conditions to vote strategically vanish. When voting mechanisms allow for only one message type we show that this op- timal behaviour coincides with an intuitive and common definition of sincerity. For voting mechanisms allowing for multiple message types, such as approval vot- ing (AV), there exists...

  19. 22 CFR 202.1 - Definition of terms.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Definition of terms. 202.1 Section 202.1...-PROFIT RELIEF AGENCIES § 202.1 Definition of terms. (a) The Administrator means the Administrator of the... rehabilitation supplies shipped in support of programs approved by AID as well as administrative supplies...

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther...... to be unreliable. Although previous SMKI research was concentrated on tyrosine kinase inhibitors for cancer treatment, recent progress indicates diversification of SMKI research in terms of new targets, mechanistic types, and therapeutic indications....

  1. Shanghai-Nanjing Intercity Railway Approved

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

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

  2. Shareholders, creditors approve utility reorganization plan

    Energy Technology Data Exchange (ETDEWEB)

    1990-04-12

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

  3. Six steps to fast-track insurance approval for bariatric surgery.

    Science.gov (United States)

    Frezza, Eldo E

    2006-05-01

    Most of the health-insurers approve bariatric surgery for patients according to the NIH standards, while others only approve the surgery if the patient has a BMI >50. Therefore, it is important for the physician to know and carefully follow the various criteria of different insurance companies. We suggest 6 steps to fast-track insurance approval: 1) a multidisciplinary team; 2) 6-month diet; 3) comprehensive medical evaluation; 4) flexibility and consistency; 5) analysis of each patient indication; 6) quality of cost-effectiveness and long-term monitoring and benefits. In the event that an insurance company rejects the request for surgery, a blueprint of an appeal letter is very important. The appeal letter should stress the indications and benefits of surgery for your patients. Insurance company criteria may differ from the NIH guidelines. Irrespective of this, the steps outlined will help speed the insurance approval process and reduce paperwork and confusion. Most often, rejections stem from letters that were not written clearly or that lacked one or more of the elements delineated above. If the surgeon follows the 6 steps described, he/she should meet less disappointment, as in our experience that went from 50% to 90% success because of better communication with insurance and more appropriate paperwork.

  4. 78 FR 785 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2013-01-04

    ... COMMISSION Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change To... invest in ``Financial Instruments.'' The term ``Financial Instruments,'' as defined in Commentary .02(b... Malaysia (``Malaysia'') (each a ``Futures Exchange'' and collectively, ``Futures Exchanges''), and (b)...

  5. 77 FR 47459 - Options Price Reporting Authority; Order Approving an Amendment to the Plan for Reporting of...

    Science.gov (United States)

    2012-08-08

    ... COMMISSION Options Price Reporting Authority; Order Approving an Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Revise the Definition of the Term ``Nonprofessional'' August 2, 2012. I. Introduction On May 31, 2012, the Options Price Reporting Authority (``OPRA...

  6. 21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.

    Science.gov (United States)

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use...; (7) Any clinical investigation involving human subjects described in the HDE, subject to the institutional review board regulations in part 56 of this chapter or the informed consent regulations in part...

  7. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

    Science.gov (United States)

    Yang, Brian W; Iorio, Matthew L; Day, Charles S

    2017-03-15

    The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

  8. Additional safety risk to exceptionally approved drugs in Europe?

    Science.gov (United States)

    Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; Eichler, Hans-Georg; de Graeff, Pieter A; Mol, Peter G M

    2011-09-01

    Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of serious safety issues. A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval. Outcome variables were frequency and timing of a first Direct Healthcare Professional Communication (DHPC). An association between approval procedure and the time from market approval to DHPC was assessed using Kaplan-Meyer survival analysis and Cox-regression to correct for covariates. In total 289 new drugs were approved. Forty-six (16.4%) were approved under EC or CA, of which seven received a DHPC (15%). This was similar to the standard approval drugs (243), of which 33 received one or more DHPC (14%, P= 0.77). The probability of acquiring a DHPC for standard approval drugs vs. EC/CA drugs during 11-year follow-up is 22% (95% CI 14%, 29%) and 26% (95% CI 8%, 44%), respectively (log-rank P= 0.726). This difference remained not significant in the Cox-regression model: hazard ratio 0.94 (95% CI 0.40, 2.20). Only drug type was identified as a confounding covariate. The EC/CA procedure is not associated with a higher probability of DHPCs despite limited clinical development data. These data do not support the view that early drug approval increases the risk of serious safety issues emerging after market approval. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

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

    Data.gov (United States)

    US Fish and Wildlife Service, 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...

  10. 14 CFR 171.25 - Minimum requirements for approval.

    Science.gov (United States)

    2010-01-01

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

  11. 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

  12. ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

    Energy Technology Data Exchange (ETDEWEB)

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

    2002-11-01

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

  13. 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.

  14. 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)

  15. 10 CFR 25.8 - Information collection requirements: OMB approval.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 25.8 Section 25.8 Energy NUCLEAR REGULATORY COMMISSION ACCESS AUTHORIZATION General Provisions § 25.8...), 25.21(c), 25.27(b), 25.29, and 25.31, SF-86 is approved under control number 3206-0007. (3) In §...

  16. Regional Curriculum Colloquia and Delegated Approval Authority. Adopted Spring 1997.

    Science.gov (United States)

    Academic Senate for California Community Colleges, Sacramento.

    In the California Community Colleges (CCC), authority is conditionally delegated to local college districts to approve new credit courses, articulate courses with other district colleges, and approve graduation requirements. This document details policies adopted by the CCC's Academic Senate regarding the scope, mechanisms, and conditions of that…

  17. 30 CFR 250.118 - Will MMS approve gas injection?

    Science.gov (United States)

    2010-07-01

    ... recovery; (2) Prevent flaring of casinghead gas; or (3) Implement other conservation measures approved by... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Will MMS approve gas injection? 250.118 Section 250.118 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS...

  18. 19 CFR 113.15 - Retention of approved bonds.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Retention of approved bonds. 113.15 Section 113.15 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE... bonds approved by the port director, except the bond containing the agreement to pay court...

  19. 40 CFR 1065.12 - Approval of alternate procedures.

    Science.gov (United States)

    2010-07-01

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

  20. 12 CFR 918.5 - Approval by Finance Board.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Bottles not constituting approved containers. 27.206 Section 27.206 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX... officer that such bottle is not an approved container for distilled spirits for consumption in the...

  2. 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.... Occupancy requirements are being met. Marketing and maintenance programs are being carried out in an... collection losses. (7) The Owner's plan for remedying any deferred maintenance, financial problems, or...

  3. 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....

  4. 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.

  5. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  6. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  7. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

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

    Science.gov (United States)

    2011-10-25

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., described below, receiving approval for the consumptive use of water pursuant to the Commission's...

  9. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-01-31

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., described below, receiving approval for the consumptive use of water pursuant to the Commission's...

  10. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-06-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  11. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

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

    Science.gov (United States)

    2012-09-26

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  13. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  14. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  15. 14 CFR 135.419 - Approved aircraft inspection program.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approved aircraft inspection program. 135.419 Section 135.419 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program....

  16. 48 CFR 232.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Recommendation for approval. 232.409-1 Section 232.409-1 Federal Acquisition Regulations System DEFENSE ACQUISITION... for Non-Commercial Items 232.409-1 Recommendation for approval. Follow the procedures at PGI...

  17. 48 CFR 332.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Recommendation for approval. 332.409-1 Section 332.409-1 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Recommendation for approval. The Contracting Officer shall transmit the information in FAR 32.409-1 (or FAR...

  18. 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 count

  19. 78 FR 28620 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-05-15

    ... Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management... Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval..., competitive, and organized group recreational uses of the public lands, and individual use of special...

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

    NARCIS (Netherlands)

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

    2013-01-01

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

  1. 28 CFR 512.17 - Monitoring approved research projects.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Monitoring approved research projects. 512.17 Section 512.17 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.17 Monitoring approved research projects. The...

  2. Additional safety risk to exceptionally approved drugs in Europe?

    NARCIS (Netherlands)

    Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; Eichler, Hans-Georg; de Graeff, Pieter A.; Mol, Peter G. M.

    2011-01-01

    AIMS Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of

  3. 49 CFR 107.403 - Designation of approval agencies.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Designation of approval agencies. 107.403 Section 107.403 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS... MATERIALS PROGRAM PROCEDURES Designation of Approval and Certification Agencies § 107.403 Designation...

  4. 5 CFR 575.308 - Approval criteria and written determination.

    Science.gov (United States)

    2010-01-01

    ... retention incentive for an individual employee or group or category of employees using the approval criteria... REGULATIONS RECRUITMENT, RELOCATION, AND RETENTION INCENTIVES; SUPERVISORY DIFFERENTIALS; AND EXTENDED ASSIGNMENT INCENTIVES Retention Incentives § 575.308 Approval criteria and written determination. (a) An...

  5. 7 CFR 319.37-9 - Approved packing material.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Approved packing material. 319.37-9 Section 319.37-9..., and Other Plant Products 1,2 § 319.37-9 Approved packing material. Any restricted article at the time of importation or offer for importation into the United States shall not be packed in a...

  6. 38 CFR 17.71 - Revocation of VA approval.

    Science.gov (United States)

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Revocation of VA approval... Community Residential Care § 17.71 Revocation of VA approval. (a) If a hearing official determines under... residential care facility and notify the community residential care facility of this revocation. (b)...

  7. 12 CFR 614.4460 - Loan approval responsibility.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loan approval responsibility. 614.4460 Section 614.4460 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS... approval of such loans by the appropriate bank board, or establishment of a policy under which...

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

    NARCIS (Netherlands)

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

    2013-01-01

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

  9. 46 CFR 160.056-7 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Rescue Boat § 160.056-7 Procedure for approval. (a) The... jurisdiction of the place of manufacture of the rescue boat. (b) Formal plans will not be required. However, a... descriptive data of hull material, buoyant material, and equipment. (c) When plans and data are satisfactory...

  10. 28 CFR 551.31 - Approval of an organization.

    Science.gov (United States)

    2010-07-01

    ... MISCELLANEOUS Inmate Organizations § 551.31 Approval of an organization. (a) An inmate must submit a request for recognition of a proposed inmate organization to the Warden. The organization may not become active without... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Approval of an organization. 551.31...

  11. 50 CFR Appendix B to Part 404 - Approved VMS

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Approved VMS B Appendix B to Part 404... MARINE NATIONAL MONUMENT Pt. 404, App. B Appendix B to Part 404—Approved VMS I. VMS Mobile Transceiver Unit Thrane & Thrane Sailor 3026D Gold VMS The Thrane & Thrane Sailor 3026D Gold VMS (TT-3026D)...

  12. 78 FR 37848 - ASME Code Cases Not Approved for Use

    Science.gov (United States)

    2013-06-24

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

  13. 32 CFR 644.135 - Lease authorization and approvals.

    Science.gov (United States)

    2010-07-01

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

  14. 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

  15. Electronic Approval: Another Step toward a Paperless Office.

    Science.gov (United States)

    Blythe, Kenneth C.; Morrison, Dennis L.

    1992-01-01

    Pennsylvania State University's award-winning electronic approval system allows administrative documents to be electronically generated, approved, and updated in the university's central database. Campus business can thus be conducted faster, less expensively, more accurately, and with greater security than with traditional paper approval…

  16. 76 FR 33651 - Approval and Promulgation of Implementation Plans; ID

    Science.gov (United States)

    2011-06-09

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; ID AGENCY: Environmental... Implementation Plan (SIP) that were submitted to EPA by the State of Idaho on April 16, 2007. This SIP submittal... through 668. Sec. 52.670 Identification of plan. * * * * * (c) * * * EPA-Approved Idaho Regulations State...

  17. 21 CFR 1240.83 - Approval of watering points.

    Science.gov (United States)

    2010-04-01

    ... communicable diseases. (b) The Commissioner of Food and Drugs may base his approval or disapproval of a... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Approval of watering points. 1240.83 Section 1240.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  18. 49 CFR 236.1031 - Previously approved PTC systems.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Previously approved PTC systems. 236.1031 Section... Train Control Systems § 236.1031 Previously approved PTC systems. (a) Any PTC system fully implemented and operational prior to March 16, 2010, may receive PTC System Certification if the applicable PTC...

  19. Additional safety risk to exceptionally approved drugs in Europe?

    NARCIS (Netherlands)

    Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; Eichler, Hans-Georg; de Graeff, Pieter A.; Mol, Peter G. M.

    AIMS Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of

  20. 40 CFR 256.04 - State plan approval, financial assistance.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false State plan approval, financial... 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...

  1. 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...

  2. 76 FR 20070 - Commercial Space Transportation Safety Approval Performance Criteria

    Science.gov (United States)

    2011-04-11

    ... Federal Aviation Administration Commercial Space Transportation Safety Approval Performance Criteria... received, a safety approval for the ability of its Space Training System: Model 400 (STS-400) to replicate....19 (a)(4). NASTAR's ] STS-400 suborbital space flight simulator (a multi-axis centrifuge) is...

  3. Gene therapy for cancer: regulatory considerations for approval.

    Science.gov (United States)

    Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

    2015-12-01

    The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.

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

    Science.gov (United States)

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

    2016-06-01

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

  5. Key Decision Record Creation and Approval Module

    Science.gov (United States)

    Hebert, Barrt; Messer, Elizabeth A.; Albasini, Colby; Le, Thang; ORourke, William, Sr.; Stiglets, Tim; Strain, Ted

    2012-01-01

    Retaining good key decision records is critical to ensuring the success of a project or operation. Having adequately documented decisions with supporting documents and rationale can greatly reduce the amount of rework or reinvention over a project's, vehicle's, or facility's lifecycle. Stennis Space Center developed and uses a software tool that automates the Key Decision Record (KDR) process for its engineering and test projects. It provides the ability for a user to log key decisions that are made during the course of a project. By customizing Parametric Technology Corporation's (PTC) Windchill product, the team was able to log all information about a decision, and electronically route that information for approval. Customizing the Windchill product allowed the team to directly connect these decisions to the engineering data that it might affect and notify data owners of the decision. The user interface was created in JSP and Javascript, within the OOTB (Out of the Box) Windchill product, allowing users to create KDRs. Not only does this interface allow users to create and track KDRs, but it also plugs directly into the OOTB ability to associate these decision records with other relevant engineering data such as drawings, designs, models, requirements, or specifications

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

    NARCIS (Netherlands)

    Duijnhoven, R.G.

    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 medicine

  7. 31 CFR 354.1 - Definitions of terms.

    Science.gov (United States)

    2010-07-01

    ... STUDENT LOAN MARKETING ASSOCIATION (SALLIE MAE) § 354.1 Definitions of terms. (a) Adverse claim means a... National Conference of Commissioners on Uniform State laws and approved by the American Bar Association on... means the Student Loan Marketing Association, a stock holder-owned corporation and...

  8. 36 CFR 14.9 - Terms and conditions.

    Science.gov (United States)

    2010-07-01

    ... Section 14.9 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR RIGHTS-OF-WAY Nature of Interest § 14.9 Terms and conditions. An applicant, by accepting a right-of-way... to the project for which the right-of-way is approved, and to the lands which are included in the...

  9. 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

  10. Term Graph Rewriting and Parallel Term Rewriting

    CERN Document Server

    Corradini, Andrea; 10.4204/EPTCS.48.3

    2011-01-01

    The relationship between Term Graph Rewriting and Term Rewriting is well understood: a single term graph reduction may correspond to several term reductions, due to sharing. It is also known that if term graphs are allowed to contain cycles, then one term graph reduction may correspond to infinitely many term reductions. We stress that this fact can be interpreted in two ways. According to the "sequential interpretation", a term graph reduction corresponds to an infinite sequence of term reductions, as formalized by Kennaway et.al. using strongly converging derivations over the complete metric space of infinite terms. Instead according to the "parallel interpretation" a term graph reduction corresponds to the parallel reduction of an infinite set of redexes in a rational term. We formalize the latter notion by exploiting the complete partial order of infinite and possibly partial terms, and we stress that this interpretation allows to explain the result of reducing circular redexes in several approaches to te...

  11. 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)

  12. 77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

    Science.gov (United States)

    2012-03-06

    ... National Institute of Standards and Technology Announcing Approval of Federal Information Processing... announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS) Publication... announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS)...

  13. Guidance for package approvals in the United Kingdom

    Energy Technology Data Exchange (ETDEWEB)

    Morgan-Warren, E. [Radioactive Materials Transport Div., Dept. for Transport, London (United Kingdom)

    2004-07-01

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

  14. Phage approved in food, why not as a therapeutic?

    Science.gov (United States)

    Sarhan, Wessam A; Azzazy, Hassan M E

    2015-01-01

    Bacterial resistance is not only restricted to human infections but is also a major problem in food. With the marked decrease in produced antimicrobials, the world is now reassessing bacteriophages. In 2006, ListShield™ received the US FDA approval for using phage in food. Nevertheless, regulatory approval of phage-based therapeutics is still facing many challenges. This review highlights the use of bacteriophages as biocontrol agents in the food industry. It also focuses on the challenges still facing the regulatory approval of phage-based therapeutics and the proposed approaches to overcome such challenges.

  15. 75 FR 13337 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-03-19

    .... Security improvements. Snow equipment purchase--liquid deice truck. Brief Description of Project Approved... annual enplanements at Dallas Love Field. Brief Description of Projects Approved for Collection and...

  16. 75 FR 39619 - Proposed Information Collection (Quarterly Report of State Approving Agency) Activities Activity...

    Science.gov (United States)

    2010-07-09

    ... expenses incurred in the approval and supervision of education and training programs. DATES: Written... collection. Abstract: VA reimburses SAAs for expenses incurred in the approval and supervision of...

  17. Income status and approval for bariatric surgery in a publicly funded regional obesity program.

    Science.gov (United States)

    Halloran, Kieran; Padwal, Raj S; Johnson-Stoklossa, Carlene; Sharma, Arya M; Birch, Dan W

    2011-03-01

    Bariatric surgery has emerged as an effective and safe treatment for severe obesity and utilization rates have increased dramatically. In private health care settings, low socioeconomic status is associated with a reduced likelihood of undergoing a bariatric procedure. Whether this relationship is also present in a universally accessible, publicly funded health care system is not currently known. A retrospective analysis of the Edmonton Weight Wise obesity program clinical registry was conducted. Patients who were unemployed, on long-term disability or receiving social assistance were classified as "low income" status. The remaining patients were categorized as "regular income" status. Multivariable logistic regression analysis was used to examine the association between low income status and approval for surgery within 1 year of program entry. Thirty-three (7%) of 419 patients were ineligible for surgery or excluded because of missing income status data. Of the remaining 386 patients, 72 (19%) were of low income status and 89 (23%) were approved for surgery. Low income patients were older, heavier, and had greater comorbidity. Compared to patients of regular income status, those with low income status were less likely to be approved for surgery (15.3% versus 24.8%; adjusted OR 0.45; 95% CI 0.22 to 0.94). Within a publicly funded and universally accessible regional obesity program, lower income status patients were less likely to be approved for bariatric surgery. Further study is necessary to clarify this apparent disparity and to determine if program modifications are necessary to ensure equity across all socioeconomic strata.

  18. 78 FR 59711 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-09-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management... Management, Information Collection Clearance Officer. BILLING CODE 4310-84-P...

  19. Drug approval processes: A case study of rivaroxaban

    Directory of Open Access Journals (Sweden)

    Sally A Arif

    2013-01-01

    Full Text Available Rivaroxaban, a Xa inhibitor, was recently approved (March 2013 in the setting of post-acute coronary syndromes (ACS by the European Medicine Agency. This is in contrast to not being approved by the Food and Drug Agency in the United States for the same indication in 2012 and 2013. The FDA′s decision was based on a lack of follow-up data for the patients enrolled in the study based on the pivotal Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome (ATLAS-ACS 2-TIMI 51 trial. While both agencies have similar roles when functioning as drug regulatory bodies and goal of granting approval of safe and efficacious drugs, the difference in approval outcome in the case of rivaroxaban highlights the differences in drug review process when both agencies are presented with the same Phase 3 data to review.

  20. The Facts on Bipolar Disorder and FDA-Approved Treatments

    Science.gov (United States)

    ... Home For Consumers Consumer Updates The Facts on Bipolar Disorder and FDA-Approved Treatments Share Tweet Linkedin ... to top What to Do if You Suspect Bipolar Disorder If you suspect you have a bipolar ...

  1. 75 FR 62387 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-10-08

    ... AGENCY Pesticide Product Registrations; Conditional Approval AGENCY: Environmental Protection Agency (EPA...., to conditionally register the pesticide products Paladin Technical, Paladin, and Paladin EC... provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),...

  2. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... distribution of test scores for each edition, form, level, sub-test, or partial battery, for which approval is....147; (5) Documentation of test development, including a history of the test's use; (6) Norming...

  3. 75 FR 43865 - Licenses, Certifications, and Approvals for Material Licensees

    Science.gov (United States)

    2010-07-27

    ..., Certifications, and Approvals for Material Licensees AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule... material licenses, and irradiators. The proposed changes would clarify the definitions of ``construction'' and ``commencement of construction'' with respect to materials licensing actions instituted under the...

  4. 75 FR 60617 - Review and Approval of Projects

    Science.gov (United States)

    2010-10-01

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

  5. 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...

  6. 24 CFR 990.145 - Dwelling units with approved vacancies.

    Science.gov (United States)

    2010-04-01

    ... and anti-crime initiatives. (b) On a project-by-project basis, subject to prior HUD approval and for... resulting from project modernization or unit modernization (such as work necessary to reoccupy vacant...

  7. 17 CFR 250.63 - Approval of reorganization fees.

    Science.gov (United States)

    2010-04-01

    ... (CONTINUED) GENERAL RULES AND REGULATIONS, PUBLIC UTILITY HOLDING COMPANY ACT OF 1935 Solicitations and Reorganizations § 250.63 Approval of reorganization fees. All fees, expenses and remuneration, whether interim or...

  8. 49 CFR 178.74 - Approval of MEGCs.

    Science.gov (United States)

    2010-10-01

    ... this chapter +to obtain approval of a new design. When a series of MEGCs is manufactured without change... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR...

  9. 40 CFR 35.940-3 - Costs allowable, if approved.

    Science.gov (United States)

    2010-07-01

    ... of compost residues which result from wastewater treatment, if EPA has approved a program for use of the compost. (d) Acquisition of an operable portion of a treatment works. This type of acquisition...

  10. 5 CFR 5701.101 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... profession involving a fiduciary relationship, as defined in 5 CFR 2636.305(b), approval will be granted only... employment or business relationship involving the provision of personal services by the employee, whether or...

  11. 75 FR 78681 - Renewal of a Currently Approved Information Collection

    Science.gov (United States)

    2010-12-16

    ... practices, and analyze ] innovation in the national service and volunteering community. This conference... COMMUNITY SERVICE Renewal of a Currently Approved Information Collection AGENCY: Corporation for National and Community Service. ACTION: Notice. SUMMARY: The Corporation for National and Community Service...

  12. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ...: Kupetsky, ABR-201211010, Nicholson Township, Wyoming County, Pa.; Consumptive Use of Up to 7.500 mgd..., Nicholson Township, Wyoming County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: November...

  13. Approval times and the safety of new pharmaceuticals.

    Science.gov (United States)

    Rudholm, Niklas

    2004-12-01

    This study examined the relationship between the approval times for new pharmaceuticals and the number of adverse drug reactions reported to the Swedish Medical Products Agency. Yearly time-series data concerning the number of adverse drug reactions, as well as data concerning prices and quantities sold for 25 pharmaceutical substances during the period 1972-1996 were used. The results show that shorter approval times are associated with more adverse drug reactions, but also that the effects are quite small.

  14. Adapting drug approval pathways for bacteriophage-based therapeutics

    Directory of Open Access Journals (Sweden)

    Callum Cooper

    2016-08-01

    Full Text Available The global rise of multi-drug resistant bacteria has resulted in the notion that an antibiotic apocalypse is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long clinical history of phage therapy in Eastern Europe, combined with more recent in vitro and in vivo success, demonstrates the potential for whole phage or phage based antibacterial agents. To date, no whole phage or phage derived products are approved for human therapeutic use in the EU or USA. There are at least three reasons for this: (i phages possess different biological, physical and pharmacological properties compared to conventional antibiotics. Phages need to replicate in order to achieve a viable antibacterial effect, resulting in complex pharmacodynamics / pharmacokinetics. (ii The specificity of individual phages requires multiple phages to treat single species infections, often as part of complex cocktails. (iii The current approval process for antibacterial agents has evolved with the development of chemically based drugs at its core, and is not suitable for phages. Due to similarities with conventional antibiotics, phage derived products such as endolysins are suitable for approval under current processes as biological therapeutic proteins. These criteria render the approval of phages for clinical use theoretically possible but not economically viable. In this review, pitfalls of the current approval process will be discussed for whole phage and phage derived products, in addition to the utilization of alternative approval pathways including adaptive licensing and Right to try legislation.

  15. Approved routes and alternative paths: the construction of women's rarity in large accounting firms. Evidence from the Big Four France

    OpenAIRE

    Lupu (ioan), Ioana

    2011-01-01

    Despite decades of gender-balanced recruitment and clear-cut criteria for promotion based on meritocracy, women in public accounting firms remain proportionally fewer in number in the highest levels of the hierarchy than men. This paper aims to explore the mechanisms fostering women's rarity in top positions within French accounting firms in terms of organizationally constructed approved paths. Drawing on 21 semi-structured interviews with both male and female accountants, the specificities o...

  16. Term Graph Rewriting and Parallel Term Rewriting

    Directory of Open Access Journals (Sweden)

    Andrea Corradini

    2011-02-01

    Full Text Available The relationship between Term Graph Rewriting and Term Rewriting is well understood: a single term graph reduction may correspond to several term reductions, due to sharing. It is also known that if term graphs are allowed to contain cycles, then one term graph reduction may correspond to infinitely many term reductions. We stress that this fact can be interpreted in two ways. According to the "sequential interpretation", a term graph reduction corresponds to an infinite sequence of term reductions, as formalized by Kennaway et.al. using strongly converging derivations over the complete metric space of infinite terms. Instead according to the "parallel interpretation" a term graph reduction corresponds to the parallel reduction of an infinite set of redexes in a rational term. We formalize the latter notion by exploiting the complete partial order of infinite and possibly partial terms, and we stress that this interpretation allows to explain the result of reducing circular redexes in several approaches to term graph rewriting.

  17. 42 CFR 84.36 - Delivery of changed or modified approved respirator.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Delivery of changed or modified approved respirator... Approval and Disapproval § 84.36 Delivery of changed or modified approved respirator. An approved respirator for which a formal certificate of modification has been issued shall be delivered, with...

  18. 30 CFR 23.12 - Wording, purpose, and use of approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Wording, purpose, and use of approval plate. 23... use of approval plate. (a) Approval plate. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible device. The plate shall bear the emblem of the Mine Safety and Health...

  19. 7 CFR 1427.1086 - Approval of warehouse, requests for reconsideration.

    Science.gov (United States)

    2010-01-01

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

  20. 77 FR 21453 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to New Source...

    Science.gov (United States)

    2012-04-10

    ... and 2.. notice. A-I.B.10 D-II.A.5 Baseline Area Yes 51.166(b)(15)..... Approved by Fully approved... D-VIII Area Yes, with the 51.166(e)......... Approved by Fully approved * * Classifications... modified sources impacting attainment and non-attainment areas in the State. This action is being...

  1. 21 CFR 314.153 - Suspension of approval of an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Suspension of approval of an abbreviated new drug... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... new drug application. (a) Suspension of approval. The approval of an abbreviated new drug...

  2. 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...

  3. 75 FR 65551 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-10-25

    ... Authority, Wichita, Kansas. Application Number: 10-07-C-00-ICT. Application Type: Impose and use a PFC. PFC... Disapprovals. In September 2010, there were four applications approved. This notice also includes information on seven applications, one approved in May 2009, two approved in July 2010, and four approved...

  4. 21 CFR 822.3 - How do you define the terms used in this part?

    Science.gov (United States)

    2010-04-01

    ... reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section of the part defines the following terms: (a) Act means the Federal Food... surveillance, the submission of a plan to us for approval, the content of the submission, and the conduct...

  5. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.

    Science.gov (United States)

    2017-01-01

    Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients

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

    Science.gov (United States)

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

    2016-03-01

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

  7. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    D.W. Markman

    1999-09-17

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

  8. 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.

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

    Science.gov (United States)

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

    2015-01-01

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

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

    OpenAIRE

    Rudolph, Karen D.; Caldwell, Melissa S.; CONLEY, COLLEEN S.

    2005-01-01

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

  11. 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 GABAA receptor (GABAAR) antagonists in adult animals, but none of the compounds investigated are approved for human use. We explored the therapeutic potential of flumazenil (FLUM), a GABAAR 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.

  12. 36 CFR 9.37 - Plan of operations approval.

    Science.gov (United States)

    2010-07-01

    ..., natural catastrophe, acts of God, etc., for inspection shall not be included when computing either this... determination regarding the impact of this operation and cumulative impacts of all proposed and existing... Preservations Act of 1966 as implemented by 36 CFR part 800. (f) Approval of each plan of operations...

  13. 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...

  14. 29 CFR 500.160 - Approved State plans.

    Science.gov (United States)

    2010-07-01

    ... accordance with 29 CFR part 70. (c) Every enumerated delegated function shall be valid in all states. ... 29 Labor 3 2010-07-01 2010-07-01 false Approved State plans. 500.160 Section 500.160 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS MIGRANT...

  15. 30 CFR 75.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... conductors are a part of the system will be approved if a solid connection is made to the neutral conductor... low resistance to earth; (c) A solid connection to a grounding conductor, other than the neutral conductor of a resistance grounded system, extending to a low resistance ground field located on the...

  16. 30 CFR 77.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... in resistance grounded systems, where the enclosed conductors are a part of the system, will be approved if a solid connection is made to the neutral conductor; in all other systems, the following... earth; (b) A solid connection to a grounding conductor, other than the neutral conductor of a...

  17. Juvenile delinquency among students of an approved sheltered girls ...

    African Journals Online (AJOL)

    Juvenile delinquency among students of an approved sheltered girls' school in Lagos, ... 65.6% did so from financial problems, 6.3% as a result of poor performance ... Mother's educational level (p=0.0245), maternal alcohol consumption ...

  18. 78 FR 6830 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-01-31

    ... mineral materials. The Office of Management and Budget (OMB) has assigned control number 1004-0001 to this... authorized removal and uses of vegetative and mineral materials to ensure sustainable resource management and... Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management...

  19. 19 CFR 113.14 - Approved form of bond inadequate.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Approved form of bond inadequate. 113.14 Section 113.14 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT... inadequate. If the port director believes that none of the conditions contained in subpart G of this part...

  20. Psychodiagnostic Testing in APA-Approved Clinical Psychology Programs.

    Science.gov (United States)

    Piotrowski, Chris; Keller, John W.

    The utility and popularity of psychodiagnostic testing has been investigated in applied clinical settings, but little data exist concerning academicians' attitudes toward psychological testing. To assess attitudes toward psychodiagnostic training in doctoral, clinical psychology programs, all fully APA-approved (American Psychological Association)…

  1. 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...

  2. 9 CFR 317.5 - Generically approved labeling.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Generically approved labeling. 317.5 Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... section), or guarantees, or which is not a domestic product labeled in a foreign language; (2) Labeling...

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

    Science.gov (United States)

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

  4. 5 CFR 470.311 - Final project approval.

    Science.gov (United States)

    2010-01-01

    ... Projects § 470.311 Final project approval. (a) The Office of Personnel Management will consider all timely...) The Office of Personnel Management shall provide a copy of the final version of the project plan to... 470.311 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL...

  5. Endoscopy: consensus on approving propofol sedation by nonanesthesiologists.

    Science.gov (United States)

    Riphaus, Andrea

    2010-04-01

    Propofol sedation by nonanesthesiologists is still a highly controversial issue despite the fact that numerous studies have approved this sedation regimen for gastrointestinal endoscopy. A new position statement from a collaboration of four different American gastroenterology and hepatology societies outlines the latest recommendations for nonanesthesiologist administration of propofol.

  6. 7 CFR 1781.19 - Approval, closing, and cancellation.

    Science.gov (United States)

    2010-01-01

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

  7. 21 CFR 314.125 - Refusal to approve an application.

    Science.gov (United States)

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... study that is described in the application and that is essential to show that the drug is safe for use... adequately protected. (17) The applicant or contract research organization that conducted a...

  8. 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... Muscat Grand Noir Green Hungarian Grenache Grignolino Grillo Gros Verdot Helena Herbemont Higgins...

  9. 40 CFR 80.93 - Individual baseline submission and approval.

    Science.gov (United States)

    2010-07-01

    ...: (i) Refinery block flow diagram, showing principal refining units; (ii) Principal refining unit..., whether or not the auditor was retained through the baseline approval process. (ii) Identification of the... samples from batch processes, including volume of each batch sampled; and (G) Baseline fuel parameter...

  10. 5 CFR 7801.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    .... 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior approval...) Upon a significant change in the nature or scope of the outside employment or the employee's official...

  11. 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 §...

  12. 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 inclusio

  13. 10 CFR 1016.12 - Termination of security facility approval.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Termination of security facility approval. 1016.12 Section 1016.12 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical... when: (a) There is no longer a need to use, process, store, reproduce, transmit, or handle Restricted...

  14. 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.

  15. 33 CFR 100.30 - Approval required for holding event.

    Science.gov (United States)

    2010-07-01

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

  16. 29 CFR 1952.104 - Final approval determination.

    Science.gov (United States)

    2010-07-01

    ... dam construction projects; and private sector maritime employment on or adjacent to navigable waters... Final approval determination. (a) In accordance with Section 18(e) of the Act and procedures in 29 CFR... exception of temporary labor camps in agriculture, general industry, construction and logging) is at...

  17. 21 CFR 1004.6 - Approval of plans.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Approval of plans. 1004.6 Section 1004.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) RADIOLOGICAL... person who contests denial of a plan shall have an opportunity for a regulatory hearing before the...

  18. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    Science.gov (United States)

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.

  19. 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

  20. The Cost of Delaying Approval of Golden Rice

    OpenAIRE

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

    2014-01-01

    More than 250,000 children go blind every year because of Vitamin A deficiency. Vitamin A intake can be enhanced by consuming Golden Rice—a genetically engineered variety of rice. It was available for commercialization in 2002, but approval has been delayed. We estimate that this delay has resulted in 600,000 to 1.2 million additional cases of blindness.

  1. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ...) Automatic Data Processing Equipment and Services-Conditions for Federal Financial Participation (FFP... of procurement activities beyond that approved in the APD; (D) A change in system concept, or a... Management Information System (FAMIS)-type projects, in accordance with section 402(e)(2)(C) of the Social...

  2. 19 CFR 134.45 - Approved markings of country name.

    Science.gov (United States)

    2010-04-01

    ... OF THE TREASURY COUNTRY OF ORIGIN MARKING Method and Location of Marking Imported Articles § 134.45 Approved markings of country name. (a) Language. (1) Except as otherwise provided in paragraph (a)(2) of this section, the markings required by this part shall include the full English name of the country...

  3. Approval and Disapproval of Textbooks in the Late Ottoman Empire

    Science.gov (United States)

    Açikgöz, Betül

    2017-01-01

    During the rapidly changing political atmosphere of the 1910s, the practice of sanctioning scholastic knowledge began to be implemented in the yearly selection of textbooks due to political contingencies. The study shows the procedures of approval and disapproval practised by the Grand Council of Education and the Copyright and Translation Office…

  4. 49 CFR 236.913 - Filing and approval of PSPs.

    Science.gov (United States)

    2010-10-01

    ... for Processor-Based Signal and Train Control Systems § 236.913 Filing and approval of PSPs. (a) Under... architectural concepts; the PSP describes a product that uses design or safety assurance concepts considered... the end of the system design review phase of product development and 180 days prior to...

  5. 7 CFR 1737.90 - Loan approval requirements.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE PRE-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED TELECOMMUNICATIONS LOANS Final... Disaster Protection Act of 1973, as amended (the “Flood Insurance Act”), RUS shall not approve financial... which has been identified by the Director of the Federal Emergency Management Agency (the “Director of...

  6. Biosimilar agents in oncology/haematology: from approval to practice.

    Science.gov (United States)

    Niederwieser, Dietger; Schmitz, Stephan

    2011-04-01

    The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products.

  7. 46 CFR 160.077-6 - Approval procedures.

    Science.gov (United States)

    2010-10-01

    ... PFD of sufficiently similar design. (2) Engineering analysis showing that the test is not applicable...) Alternative Requirements. A PFD that does not meet requirements in this subpart may still be approved if the device— (1) Meets other requirements prescribed by the Commandant in place of or in addition...

  8. [Lake Mason and Soo Line Marsh project design approval

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This letter is the approval from the U.S. Fish and Wildlife Service of the designs created by Ducks Unlimited, Inc. for the Lake Mason and Soo Line Marsh National...

  9. 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...

  10. 45 CFR 95.623 - Waiver of prior approval requirements.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Waiver of prior approval requirements. 95.623 Section 95.623 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GENERAL ADMINISTRATION-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE...

  11. Approval and Disapproval of Textbooks in the Late Ottoman Empire

    Science.gov (United States)

    Açikgöz, Betül

    2017-01-01

    During the rapidly changing political atmosphere of the 1910s, the practice of sanctioning scholastic knowledge began to be implemented in the yearly selection of textbooks due to political contingencies. The study shows the procedures of approval and disapproval practised by the Grand Council of Education and the Copyright and Translation Office…

  12. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

    ... engaged in a substantial effort to develop, design, build or operate a chemical processing plant or other... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... capable of making a contribution to research and development in the field of nuclear reactors for...

  13. Experts Approve Development of A Micro-DAFC System

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ Proposed research into a micro-power system for a direct alcohol fuel cell (DAFC)was approved by a panel of experts at an evaluation meeting held under the auspices of the CAS Bureau of High-tech Development on Oct. 28 in Dalian, Northeast China's Liaoning Province.

  14. 15 CFR 280.101 - Petitions for approval of documents.

    Science.gov (United States)

    2010-01-01

    ... requirements for the certification of manufacturing systems as fastener quality assurance systems by an..., shall approve such petition if the document provides equal or greater rigor and reliability as compared... information to allow the Director, NIST, to make this determination. (b) Accreditation. (1) A...

  15. 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...

  16. 14 CFR 21.500 - Approval of engines and propellers.

    Science.gov (United States)

    2010-01-01

    ... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Engines, Propellers, Materials, Parts.... type certificate for an aircraft engine or propeller manufactured in a foreign country with which the... with each such aircraft engine or propeller imported into this country, a certificate of...

  17. 7 CFR 1822.273 - Actions subsequent to loan approval.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE LOANS AND GRANTS PRIMARILY FOR REAL ESTATE PURPOSES RURAL HOUSING LOANS AND GRANTS Rural Housing... 1822.273 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE.... After the loan is approved, actions to be taken will be in accordance with 7 CFR part 3560, subpart B....

  18. 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.

  19. Biosimilar agents in oncology/haematology: from approval to practice

    Science.gov (United States)

    Niederwieser, Dietger; Schmitz, Stephan

    2011-01-01

    The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products. PMID:21175852

  20. 33 CFR 157.12g - Plan approval requirements.

    Science.gov (United States)

    2010-07-01

    ... things, the location and mounting of components, arrangements for maintaining the integrity of the... manufacturer's specific installation criteria. (g) A copy of the certificate of type approval for the oil... system and confirming the installation reflects the manufacturer's specific installation criteria....

  1. 5 CFR 8401.103 - 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. 8401.103 Section 8401.103 Administrative Personnel FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION..., including the rendering of advice or consultation, which involves application of the skills of a profession...

  2. 7 CFR 987.157 - Approved date product manufacturers.

    Science.gov (United States)

    2010-01-01

    ... product manufacturer: Each applicant is subject to an inspection of his/her manufacturing plant to verify that proper equipment to convert dates into products is in place and that the plant meets appropriate... furnished or its own investigation, and may revoke any approval for cause. The name and address of all...

  3. 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... suitable for the worker and available at a reasonable cost. (i) Such training means the training being... experience. (ii) Available at a reasonable cost means that training may not be approved at one provider when...

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

    Science.gov (United States)

    2010-01-01

    ....305(b)(1) or involves a fiduciary relationship as defined in 5 CFR 2636.305(b)(2). Note to § 7401.102... this section, employment means any form of non-Federal employment or business relationship involving..., administrator, trustee, or other personal fiduciary in such matters must obtain the approval required by law of...

  5. 9 CFR 381.133 - Generically approved labeling.

    Science.gov (United States)

    2010-01-01

    ... bearing pictorial designs, emblematic designs or illustrations, e.g., floral arrangements, illustrations of animals, fireworks, etc. are used with approved labeling (the use of such designs will not make...) Inserts, tags, liners, pasters, and like devices containing printed or graphic matter and for use on, or...

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

    Science.gov (United States)

    2013-01-09

    ... INFORMATION CONTACT: Dr. C. William Hench, Senior Staff Veterinarian, Eradication and Surveillance Team....'' The definition of designated accredited veterinarian in Sec. 77.20 has stated that a designated accredited veterinarian is an accredited veterinarian who is trained and approved by cooperating State and...

  7. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Science.gov (United States)

    2010-01-01

    ... 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... be a complete reproduction of the label as it will appear on the package, including any color...

  8. 19 CFR 151.13 - Approval of commercial gaugers.

    Science.gov (United States)

    2010-04-01

    ... appropriate procedures published by such professional organizations as the American Society for Testing and... application contain? An application for Customs approval must contain the following information: (i) The.... The facility must be staffed with persons having the necessary education, training, knowledge, and...

  9. Following specific podocyte injury captopril protects against progressive long term renal damage [version 1; referees: 1 approved, 2 approved with reservations

    Directory of Open Access Journals (Sweden)

    Yu S Zhou

    2015-06-01

    Full Text Available Background: Angiotensin converting enzyme inhibitors (ACEi reduce proteinuria and preserve kidney function in proteinuric renal diseases. Their nephroprotective effect exceeds that attributable to lowering of blood pressure alone. This study examines the potential of ACEi to protect from progression of injury after a highly specific injury to podocytes in a mouse model. Methods: We created transgenic (Podo-DTR mice in which graded specific podocyte injury could be induced by a single injection of diphtheria toxin. Transgenic and wild-type mice were given the ACEi captopril in drinking water, or water alone, commencing 24h after toxin injection. Kidneys were examined histologically at 8 weeks and injury assessed by observers blinded to experimental group. Results: After toxin injection, Podo-DTR mice developed acute proteinuria, and at higher doses transient renal impairment, which subsided within 3 weeks to be followed by a slow glomerular scarring process. Captopril treatment in Podo-DTR line 57 after toxin injection at 5ng/g body weight reduced proteinuria and ameliorated glomerular scarring, matrix accumulation and glomerulosclerosis almost to baseline (toxin: 17%; toxin + ACEi 10%, p<0.04; control 7% glomerular scarring. Podocyte counts were reduced after toxin treatment and showed no recovery irrespective of captopril treatment (7.1 and 7.3 podocytes per glomerular cross section in water and captopril-treated animals compared with 8.2 of wild-type controls, p<0.05. Conclusions: Observations in Podo-DTR mice support the hypothesis that continuing podocyte dysfunction is a key abnormality in proteinuric disease. Our model is ideal for studying strategies to protect the kidney from progressive injury following podocyte depletion. Demonstrable protective effects from captopril occur, despite indiscernible preservation or restoration of podocyte counts, at least after this degree of relatively mild injury.

  10. Larval zebrafish model for FDA-approved drug repositioning for tobacco dependence treatment.

    Directory of Open Access Journals (Sweden)

    Margot A Cousin

    Full Text Available Cigarette smoking remains the most preventable cause of death and excess health care costs in the United States, and is a leading cause of death among alcoholics. Long-term tobacco abstinence rates are low, and pharmacotherapeutic options are limited. Repositioning medications approved by the U.S. Food and Drug Administration (FDA may efficiently provide clinicians with new treatment options. We developed a drug-repositioning paradigm using larval zebrafish locomotion and established predictive clinical validity using FDA-approved smoking cessation therapeutics. We evaluated 39 physician-vetted medications for nicotine-induced locomotor activation blockade. We further evaluated candidate medications for altered ethanol response, as well as in combination with varenicline for nicotine-response attenuation. Six medications specifically inhibited the nicotine response. Among this set, apomorphine and topiramate blocked both nicotine and ethanol responses. Both positively interact with varenicline in the Bliss Independence test, indicating potential synergistic interactions suggesting these are candidates for translation into Phase II clinical trials for smoking cessation.

  11. 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.

  12. Short term teleconnections associated with an individual tropical cyclone

    OpenAIRE

    Woll, Stephen C.

    1993-01-01

    Approved for public release; distribution is unlimited. The short term teleconnections associated with an individual western Pacific tropical cyclone have been investigated using an atmospheric general circulation model. The general strategy was to use the GCM, in combination with several tropical cyclone bogusing procedures, to isolate the effects on the global circulation of the tropical cyclone. The bogusing procedures were used to alter the tropical cyclone in the initial conditions fo...

  13. 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

  14. 78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

    Science.gov (United States)

    2013-07-10

    ... Business Information or other information whose disclosure is restricted by statute. Certain other material.... FOR FURTHER INFORMATION CONTACT: Andy Chang, Environmental Engineer, Attainment Planning and... of IDEM's SIP-approved update to the definition of the 2006 PM 2.5 NAAQS? III. What action is...

  15. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Science.gov (United States)

    2010-10-01

    ... described at 42 CFR part 488, subpart A apply to transplant centers, including the periodic review of... are not Medicare-approved as of June 28, 2007. A transplant center, including a kidney transplant... Report and 1-year patient and graft survival data contained in the most recent Scientific Registry...

  16. 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.

  17. 77 FR 50936 - Approval and Promulgation of Air Quality Implementation Plans; Nevada; Regional Haze State and...

    Science.gov (United States)

    2012-08-23

    ... San Juan Generating Station in New Mexico. Response 1: It is important to note that EPA is approving... EPA, 2012 U.S. App. LEXIS 1056 (9th Cir. January 19, 2012). Therefore, we are finalizing our approval...

  18. 48 CFR 45.606-2 - Contractor without an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... approved scrap procedure. 45.606-2 Section 45.606-2 Federal Acquisition Regulations System FEDERAL... Contractor without an approved scrap procedure. The contractor shall submit an inventory disposal schedule for all scrap....

  19. 78 FR 56225 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...

    Science.gov (United States)

    2013-09-12

    ... AGENCY Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...) for review and approval in accordance with the Paperwork Reduction Act: ``Soil Fumigant Risk... measures necessary for reregistration eligibility for certain soil fumigant chemicals are...

  20. 77 FR 24441 - Approval and Promulgation of Implementation Plans; California; Revisions to the California State...

    Science.gov (United States)

    2012-04-24

    ... Ninth Circuit Court of Appeals of EPA's 2009 approval of a revision to the California SIP related to..., the 9th Circuit Court of Appeals remanded the approval of PEST-1 to EPA with the instructions...

  1. 75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-11-22

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin... notice lists the projects, described ] below, receiving approval for the consumptive use of...

  2. 45 CFR 1801.31 - Approval of graduate programs by the Foundation.

    Science.gov (United States)

    2010-10-01

    ... approval. The graduate program proposed for approval may differ from that proposed by the Scholar when... statement of interest in a career in public service that specifies in detail how their graduate program...

  3. 77 FR 58131 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Mississippi

    Science.gov (United States)

    2012-09-19

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Mississippi... allow electronic reporting. DATES: EPA's approval is effective on September 19, 2012. FOR FURTHER...

  4. 76 FR 46798 - Cross-Media Electronic Reporting: Authorized Program Revision Approvals, Commonwealth of Kentucky

    Science.gov (United States)

    2011-08-03

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Cross-Media Electronic Reporting: Authorized Program Revision Approvals, Commonwealth of Kentucky... allow electronic reporting. DATES: EPA's approval is effective August 3, 2011. FOR FURTHER INFORMATION...

  5. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Science.gov (United States)

    2010-04-01

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

  6. Antelope Valley Air Quality Management District; Approval of California Air Plan Revisions

    Science.gov (United States)

    EPA is proposing to approve and conditionally approve revisions to the Antelope Valley Air Quality Management District (AVAQMD or “District”) portion of the California State Implementation Plan (SIP).

  7. 76 FR 70807 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-11-15

    ... emergency radio dispatch system is used for both eligible (aircraft rescue and firefighting and aviation... Federal Aviation Administration Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Monthly notice of PFC approvals...

  8. 77 FR 6535 - Notice of Intent To Seek Approval To Collect Information

    Science.gov (United States)

    2012-02-08

    ... National Agricultural Library Notice of Intent To Seek Approval To Collect Information AGENCY: National... extend currently approved data collection form. Abstract: This Web-based form collects information to.... Information collected includes the following: Preference of workshop date, signature, name,...

  9. 77 FR 15367 - Public Water System Supervision Program Approval for the State of Minnesota

    Science.gov (United States)

    2012-03-15

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Minnesota AGENCY: Environmental... of Minnesota is revising its approved public water system supervision program for four major...

  10. 77 FR 21099 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-04-09

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

  11. 78 FR 18336 - Public Water System Supervision Program Approval for the State of Michigan

    Science.gov (United States)

    2013-03-26

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

  12. 77 FR 76034 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-12-26

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

  13. 78 FR 14791 - Public Water System Supervision Program Approval for the State of Indiana

    Science.gov (United States)

    2013-03-07

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

  14. 75 FR 80493 - Public Water System Supervision Program Approval for the State of Wisconsin

    Science.gov (United States)

    2010-12-22

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Wisconsin AGENCY: Environmental... of Wisconsin submitted a primacy application for its approved Public Water System Supervision...

  15. 78 FR 54232 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2013-09-03

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service Notice of Request for Extension of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request... that the Agricultural Marketing Service (AMS) is requesting approval from the Office of Management...

  16. Results of Shipboard Approval Tests of Ballast Water Treatment Systems in Freshwater

    Science.gov (United States)

    2014-11-01

    Results of Shipboard Approval Tests of Ballast Water Treatment Systems in Freshwater Distribution Statement A: Approved for public release...distribution is unlimited. November 2014 Report No. CG-D-05-15 Results of Shipboard Approval Tests of BWT Systems in Freshwater ii...London, CT 06320 Results of Shipboard Approval Tests of BWT Systems in Freshwater iii UNCLAS//Public | CG-926 R&DC | Cangelosi, et al

  17. 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.

  18. 48 CFR 45.606-1 - Contractor with an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... approved scrap procedure. 45.606-1 Section 45.606-1 Federal Acquisition Regulations System FEDERAL... Contractor with an approved scrap procedure. (a) The contractor may dispose of scrap resulting from production or testing under this contract without Government approval. However, if the scrap...

  19. 30 CFR 72.710 - Selection, fit, use, and maintenance of approved respirators.

    Science.gov (United States)

    2010-07-01

    ... approved respirators. 72.710 Section 72.710 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Selection, fit, use, and maintenance of approved respirators. In order to ensure the maximum amount of respiratory protection, approved respirators shall be selected, fitted, used, and maintained in...

  20. 48 CFR 1401.7001-1 - Review and approval by Assistant Secretaries.

    Science.gov (United States)

    2010-10-01

    ... Assistant Secretaries. 1401.7001-1 Section 1401.7001-1 Federal Acquisition Regulations System DEPARTMENT OF....7001-1 Review and approval by Assistant Secretaries. Contract actions shall be reviewed and approved by Assistant Secretaries as prescribed in 211-255 DM. Their approvals shall be obtained before requesting any...

  1. 78 FR 57407 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2013-09-18

    ... SECURITY U.S. Customs and Border Protection Approval of Altol Petroleum Product Service, as a Commercial... approval of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given, pursuant to CBP regulations, that Altol Petroleum Product Service, has been approved to gauge...

  2. 78 FR 57406 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2013-09-18

    ... SECURITY U.S. Customs and Border Protection Approval of Altol Petroleum Product Service, as a Commercial... approval of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given, pursuant to CBP regulations, that Altol ] Petroleum Product Service, has been approved to gauge...

  3. 7 CFR 1710.209 - Approval requirements for load forecast work plans.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval requirements for load forecast work plans... LOANS AND GUARANTEES Load Forecasts § 1710.209 Approval requirements for load forecast work plans. (a... utility plant of $500 million or more must maintain an approved load forecast work plan. RUS...

  4. 10 CFR 52.145 - Finality of standard design approvals; information requests.

    Science.gov (United States)

    2010-01-01

    ... approvals; information requests. (a) An approved design must be used by and relied upon by the NRC staff and... any proceeding under part 2 of this chapter. (c) Except for information requests seeking to verify compliance with the current licensing basis of the standard design approval, information requests to the...

  5. 30 CFR 19.12 - Wording, purpose, and use of approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Wording, purpose, and use of approval plate. 19... plate. (a) Approval plate. The manufacturer shall attach, stamp, or mold an approval plate on the battery container of each permissible lamp. The plate shall bear the emblem of the Mine Safety and Health...

  6. 7 CFR 1717.613 - RUS approval of data processing and system control equipment.

    Science.gov (United States)

    2010-01-01

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

  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...

  8. 14 CFR 125.297 - Approval of flight simulators and flight training devices.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a) Flight simulators and flight training devices approved by the Administrator may be used in training...

  9. 14 CFR 21.333 - Issue of export airworthiness approval tags for Class III products.

    Science.gov (United States)

    2010-01-01

    ... for Class III products. 21.333 Section 21.333 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... Approvals § 21.333 Issue of export airworthiness approval tags for Class III products. (a) An applicant is entitled to an export airworthiness approval tag for Class III products if that applicant shows, except...

  10. 76 FR 62635 - Approval and Promulgation of Air Quality Implementation Plans; Commonwealth of Virginia; Section...

    Science.gov (United States)

    2011-10-11

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Commonwealth of... (EPA). ACTION: Final rule. SUMMARY: EPA is approving submittals from the Commonwealth of Virginia... published a notice of proposed rulemaking (NPR) for the Commonwealth of Virginia. The NPR proposed approval...

  11. 76 FR 54410 - Approval and Promulgation of Air Quality Implementation Plans; Commonwealth of Pennsylvania...

    Science.gov (United States)

    2011-09-01

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Commonwealth of... (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve submittals from the Commonwealth of... Pennsylvania, the Commonwealth has a SIP approved PSD program in place and EPA has found that the 110(a)(2...

  12. 77 FR 25366 - Underground Storage Tank Program: Approved State Program for the State of Oregon

    Science.gov (United States)

    2012-04-30

    ... AGENCY 40 CFR Part 282 Underground Storage Tank Program: Approved State Program for the State of Oregon... Agency (EPA) to grant approval to any State to operate its underground storage tank program in the State... statutory and regulatory provisions. This rule codifies the prior approval of Oregon's underground storage...

  13. 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...

  14. 42 CFR 403.222 - State with an approved regulatory program.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false State with an approved regulatory program. 403.222 Section 403.222 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Programs § 403.222 State with an approved regulatory program. (a) A State has an approved...

  15. 42 CFR 403.308 - State systems under demonstration projects-mandatory approval.

    Science.gov (United States)

    2010-10-01

    ...-mandatory approval. 403.308 Section 403.308 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... Reimbursement Control Systems § 403.308 State systems under demonstration projects—mandatory approval. CMS will... approval of a State system are met under § 403.304 (b)(1)-(10) and § 403.304(c), and, if appropriate §...

  16. 7 CFR 330.210a - Administrative instructions listing approved packing materials for plant pests.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Administrative instructions listing approved packing... Pests § 330.210a Administrative instructions listing approved packing materials for plant pests. (a) The following materials are approved as packing materials for use with any shipment of plant pests in...

  17. 30 CFR 18.91 - Electric equipment for which field approvals will be issued.

    Science.gov (United States)

    2010-07-01

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

  18. 28 CFR 2.206 - Travel approval and transfers of supervision.

    Science.gov (United States)

    2010-07-01

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

  19. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  20. 75 FR 71135 - Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug Application

    Science.gov (United States)

    2010-11-22

    ... HUMAN SERVICES Food and Drug Administration Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug... Administration (FDA) is withdrawing approval of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules... be marketed under approved abbreviated new drug applications (ANDAs). The holders of ANDAs...

  1. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Refusal to approve an abbreviated new drug... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.127 Refusal to approve an abbreviated new...

  2. 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...

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

    Science.gov (United States)

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

    2014-01-01

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

  4. 34 CFR 668.143 - Approval of State tests or assessments.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Approval of State tests or assessments. 668.143 Section... or assessments. (a) The Secretary approves tests or other assessments submitted by a State that the... assessment described in paragraph (a) of this section. (c) If the Secretary approves a State's tests...

  5. 17 CFR 240.14a-20 - Shareholder approval of executive compensation of TARP recipients.

    Science.gov (United States)

    2010-04-01

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

  6. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 5 2010-04-01 2010-04-01 false Stockholder approval of incentive stock option... incentive stock option plans. This section addresses the stockholder approval of incentive stock option... such cases an incentive stock option plan must be approved: (a) By a majority of the votes cast at...

  7. 33 CFR 175.21 - Condition; size and fit; approval marking.

    Science.gov (United States)

    2010-07-01

    ...; and (c) Legibly marked with its approval number, as specified in 46 CFR part 160. ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Condition; size and fit; approval...; size and fit; approval marking. No person may use a recreational boat unless each PFD required by §...

  8. 76 FR 61999 - Policy Statement: Inappropriate Design Approval Holder (DAH) Restrictions on the Use and...

    Science.gov (United States)

    2011-10-06

    ... Federal Aviation Administration 14 CFR Part 21 Policy Statement: Inappropriate Design Approval Holder (DAH... the proposed policy statement addressing the action taken by some Design Approval Holders (DAH...(b) requires the holder of a design approval to furnish at least one set of complete Instructions...

  9. 43 CFR 45.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... OMB approved the information collection provisions of this subpart? Yes. This rule contains provisions that would collect information from the public. It therefore requires approval by the Office of... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Has OMB approved the...

  10. 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...

  11. 21 CFR 900.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Application for approval as an accreditation body... approval as an accreditation body. (a) Eligibility. Private nonprofit organizations or State agencies capable of meeting the requirements of this subpart A may apply for approval as accreditation bodies....

  12. 47 CFR 1.10004 - What am I allowed to do if I am approved?

    Science.gov (United States)

    2010-10-01

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

  13. 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...

  14. 78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at... 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO-GEN... approval of NADA 008-019, and all supplements and amendments thereto, is hereby withdrawn. Elsewhere...

  15. 78 FR 70496 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the.... Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO-GEN... gave notice that approval of NADA 008-019, and all supplements and amendments thereto, is...

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

    Science.gov (United States)

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

    2014-01-01

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

  17. Implications of Recent Drug Approvals for Older Adults

    Science.gov (United States)

    Eisenhower, Christine; Koronkowski, Michael; Marcum, Zachary

    2016-01-01

    More than 100 medications were approved by the US Food and Drug Administration as new drugs or for new indications in 2014 and 2015. Several of the new drugs may benefit older adults, but adverse events and pharmacokinetic changes due to aging must be considered. This article will focus on three recently approved drugs that are marketed for chronic conditions that can affect older adults: suvorexant, for treatment of insomnia; edoxaban, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of venous thromboembolism; and droxidopa, for treatment of symptomatic neurogenic orthostatic hypotension. Information about indications, mechanisms of action, dosing, efficacy, and safety are reviewed. The place of each agent in therapy for older adults is also discussed. PMID:27340374

  18. 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.

  19. 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.

  20. Chinese Government Approves Nanhai Oil Refinery Project of CNOOC

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

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

  1. 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

  2. French approval procedures for pyrotechnical automotive safety equipments

    OpenAIRE

    Aufauvre, Lionel; Branka, Ruddy

    2005-01-01

    International audience; Pyrotechnical articles for civil uses may be subject to national procedures before placing on the market According to the French decree n°90-153, 16 February 1990 as modified; explosives that are dispensed with EC marking and that are not excluded of the decree application have to conform to approved types. Pyrotechnical automotive safety equipments such gas generators for airbag modules or seat-belt pretensioners, pyrotechnie relay compositions and/or igniters inside ...

  3. Glossary of Terms

    Science.gov (United States)

    ... Terms Glossary of Terms Profession of Medicine The art and science of maintaining health; recognizing, understanding, preventing, ... accredited school of medicine or osteopathy Note: The definition of physician in federal law is sometimes used ...

  4. 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.

  5. Bisimilarity of Open Terms

    NARCIS (Netherlands)

    Rensink, Arend; Palamidessi, C.; Parrow, J.

    1997-01-01

    The standard way of lifting a binary relation, R, from closed terms of an algebra to open terms is to define its closed-instance extension, R_{ci}, which holds for a given pair of open terms if and only if R holds for all their closed instantiations. In this paper, we study alternatives for the case

  6. 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.

  7. 12 CFR 900.2 - Terms relating to Bank operations, mission and supervision.

    Science.gov (United States)

    2010-01-01

    ..., section or paragraph: Acquired member assets or AMA means those assets that may be acquired by a Bank... means the Financial Management Policy For The Federal Home Loan Bank System approved by the Finance... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Terms relating to Bank operations, mission...

  8. 42 CFR 52b.10 - What are the terms and conditions of awards?

    Science.gov (United States)

    2010-10-01

    ...) Construction schedule inspection. Prior to the start of construction, the grantee shall submit an approved copy of the construction schedule (critical path method) to the Director in the form and manner as the... NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS § 52b.10 What are the terms and conditions of awards?...

  9. Long-term Follow-up and Outcome of Phenylketonuria Patients on Sapropterin : A Retrospective Study

    NARCIS (Netherlands)

    Keil, Stefanie; Anjema, Karen; van Spronsen, Francjan J.; Lambruschini, Nilo; Burlina, Alberto; Belanger-Quintana, Amaya; Couce, Maria L.; Feillet, Francois; Cerone, Roberto; Lotz-Havla, Amelie S.; Muntau, Ania C.; Bosch, Annet M.; Meli, Concetta A. P.; de Villemeur, Thierry Billette; Kern, Ilse; Riva, Enrica; Giovannini, Marcello; Damaj, Lena; Leuzzi, Vincenzo; Blau, Nenad

    2013-01-01

    OBJECTIVE: Sapropterin dihydrochloride, the synthetic form of 6R-tetrahydrobiopterin (BH4), is an approved drug for the treatment of patients with BH4-responsive phenylketonuria (PKU). The purpose of this study was to assess genotypes and data on the long-term effects of BH4/sapropterin on metabolic

  10. Dexmedetomidine hydrochloride as a long-term sedative

    Directory of Open Access Journals (Sweden)

    Kunisawa T

    2011-07-01

    Full Text Available Takayuki KunisawaSurgical Operation Department, Asahikawa Medical University Hospital, Asahikawa, Hokkaido, JapanAbstract: Dexmedetomidine undoubtedly is a useful sedative in the intensive care setting because it has a minimal effect on the respiratory system. Dexmedetomidine infusions lasting more than 24 hours have not been approved since the first approval was acquired in the US in 1999. However, in 2008, dexmedetomidine infusions for prolonged use were approved in Colombia and in the Dominican Republic, and the number of countries that have granted approval for prolonged use has been increasing every year. This review discusses the literature examining prolonged use of dexmedetomidine and confirms the efficacy and safety of dexmedetomidine when it is used for more than 24 hours. Dexmedetomidine was administered at varying doses (0.1–2.5 µg/kg/hour and durations up to 30 days. Dexmedetomidine seems to be an alternative to benzodiazepines or propofol for achieving sedation in adults because the incidences of delirium and coma associated with dexmedetomidine are lower than the corresponding incidences associated with benzodiazepines and propofol, although dexmedetomidine administration can cause mild adverse effects such as bradycardia. Controlled comparative studies on the efficacy and safety of dexmedetomidine and other sedatives in pediatric patients have not been reported. However, dexmedetomidine seems to be effective in managing extubation, reducing the use of conventional sedatives, and as an alternative for inducing sedation in patients for whom traditional sedatives induce inadequate sedation. Prolonged dexmedetomidine infusion has not been reported to have any serious adverse effects. Dexmedetomidine appears to be an alternative long-term sedative, but further studies are needed to establish its efficacy and safety.Keywords: dexmedetomidine, prolonged sedation, long-term

  11. [Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice].

    Science.gov (United States)

    López-Siguero, Juan Pedro; Palla García, Margarida; Martínez Busto, Elena; Rebollo, Francisco José; Pombo, Manuel

    2017-06-28

    Recombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. This review is focused on the scientific evidence published about this drug in the last ten years, including the clinical trials on which the approval of the regulatory authority is based, and the most relevant studies evaluating the clinical impact of the drug in clinical practice. The equivalence between biosimilar and original product has been confirmed in the clinical trials published by Romer et al. and López-Siguero et al. Furthermore, studies carried out in real-life conditions confirm its long-term efficacy and safety, as well as the absence of clinical impact by switching treatment from the original to the biosimilar product. The number of patients receiving this medication has continuously increased since its approval. Its equivalence with the original product has been verified. Preliminary data from the post-authorisation PATRO study confirm the efficacy and safety of the biosimilar product in comparison with data from clinical trials. However, final results must be evaluated at the end of the study, which will provide additional information about the long-term efficacy and safety of the biosimilar drug. Copyright © 2017. Publicado por Elsevier España, S.L.U.

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

    Directory of Open Access Journals (Sweden)

    Kravetz Frédéric

    2016-01-01

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

  13. 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...... evidence of forecaster herding. On the contrary, forecasters anti-herd and, thereby, tend to intentionally scatter their forecasts around the consensus forecast. The extent of anti-herding seems to vary over time.We also found that more pronounced anti-herding leads to less accurate forecasts....

  14. 42 CFR 84.35 - Changes or modifications of approved respirators; issuance of modification of certificate of...

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Changes or modifications of approved respirators... modifications of approved respirators; issuance of modification of certificate of approval. (a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of...

  15. 25 CFR 224.71 - What standards will the Secretary use to decide to approve a final proposed TERA?

    Science.gov (United States)

    2010-04-01

    ... approve a final proposed TERA? 224.71 Section 224.71 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE... the Secretary use to decide to approve a final proposed TERA? The Secretary will consider the best... approve a final proposed TERA. The Secretary must approve a final proposed TERA if it contains...

  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. 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…

  18. Interpreting uncertainty terms.

    Science.gov (United States)

    Holtgraves, Thomas

    2014-08-01

    Uncertainty terms (e.g., some, possible, good, etc.) are words that do not have a fixed referent and hence are relatively ambiguous. A model is proposed that specifies how, from the hearer's perspective, recognition of facework as a potential motive for the use of an uncertainty term results in a calibration of the intended meaning of that term. Four experiments are reported that examine the impact of face threat, and the variables that affect it (e.g., power), on the manner in which a variety of uncertainty terms (probability terms, quantifiers, frequency terms, etc.) are interpreted. Overall, the results demonstrate that increased face threat in a situation will result in a more negative interpretation of an utterance containing an uncertainty term. That the interpretation of so many different types of uncertainty terms is affected in the same way suggests the operation of a fundamental principle of language use, one with important implications for the communication of risk, subjective experience, and so on.

  19. 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...

  20. Japanese government takes steps toward approving birth control pill.

    Science.gov (United States)

    1995-10-27

    On September 12, 1995, the Central Pharmaceutical Affairs Council of Japan recommended approval of low-dose oral contraceptives as a method of family planning. Doctors should be able to prescribe the pills after the standing members of the Council, part of the Ministry of Health and Family Welfare, meet next March. High-dose oral contraceptives can be obtained currently to treat menstrual irregularities, although many of the 200,000 prescriptions written annually are used for family planning. Approval for the low-dose contraceptives has been slow because of concerns regarding a possible relaxation of sexual mores (1965); adverse side effects (until 1987 when the Japanese Ministry of Health initiated clinical trials that established the safety and efficacy of the contraceptives); increased rates of human immunodeficiency virus (HIV) infection (1992); a higher number of drug reimbursement claims under the national health insurance system; and a decline in Japan's birthrate. Japan's birthrate fell from 4.5 children per woman in 1947 to 1.5 in 1993. 80% of contraceptive users rely on condom; 22% use the rhythm method, usually in conjunction with the condom; 7% use the IUD; and less than 2% use sterilization. Sterilization is only permitted for married couples and only when the woman's life or health is in danger, or either spouse has a mental illness, leprosy, or a hereditary disorder.

  1. International Federation of Nurse Anesthetists' anesthesia program approval process.

    Science.gov (United States)

    Horton, B J; Anang, S P; Riesen, M; Yang, H-J; Björkelund, K B

    2014-06-01

    The International Federation of Nurse Anesthetists is improving anaesthesia patient care through a voluntary Anesthesia Program Approval Process (APAP) for schools and programmes. It is the result of a coordinated effort by anaesthesia leaders from many nations to implement a voluntary quality improvement system for education. These leaders firmly believe that meeting international education standards is an important way to improve anaesthesia, pain management and resuscitative care to patients worldwide. By 2013, 14 anaesthesia programmes from France, Iceland, Indonesia, Philippines, Sweden, Switzerland, Netherlands, Tunisia and the USA had successfully completed the process. Additional programmes were scheduled for review in 2014. Faculty from these programmes, who have successfully completed APAP, show how anaesthesia educators throughout the world seek to continually improve education and patient care by pledging to meet common education standards. As national governments, education ministers and heads of education institutions work to decrease shortages of healthcare workers, they would benefit from considering the value offered by quality improvement systems supported by professional organizations. When education programmes are measured against standards developed by experts in a profession, policy makers can be assured that the programmes have met certain standards of quality. They can also be confident that graduates of approved programmes are appropriately trained healthcare workers for their citizens. © 2014 International Council of Nurses.

  2. QbD implementation and Post Approval Lifecycle Management (PALM).

    Science.gov (United States)

    Ohage, Ettore; Iverson, Raquel; Krummen, Lynne; Taticek, Ron; Vega, Maria

    2016-09-01

    Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11) [1-3]. An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes concepts for implementing the control strategy for a monoclonal antibody including a Design Space for routine commercial manufacturing, and the Post Approval Lifecycle Management (PALM) plan that is used to manage any remaining risks during the commercial lifecycle. The PALM plan is part of the submitted dossier in the regional section and serves as a regulatory agreement between the manufacturer and the health authority specifying how process and product attributes are monitored to ensure both remain within a controlled state post-approval, process parameter changes are managed within the design space, and the control system is updated as necessary based on further process and product knowledge.

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

    Science.gov (United States)

    Govil, Ashul; Hao, Steven C

    2016-10-01

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

  4. Enzymes approved for human therapy: indications, mechanisms and adverse effects.

    Science.gov (United States)

    Baldo, Brian A

    2015-02-01

    Research and drug developments fostered under orphan drug product development programs have greatly assisted the introduction of efficient and safe enzyme-based therapies for a range of rare disorders. The introduction and regulatory approval of 20 different recombinant enzymes has enabled, often for the first time, effective enzyme-replacement therapy for some lysosomal storage disorders, including Gaucher (imiglucerase, taliglucerase, and velaglucerase), Fabry (agalsidase alfa and beta), and Pompe (alglucosidase alfa) diseases and mucopolysaccharidoses I (laronidase), II (idursulfase), IVA (elosulfase), and VI (galsulfase). Approved recombinant enzymes are also now used as therapy for myocardial infarction (alteplase, reteplase, and tenecteplase), cystic fibrosis (dornase alfa), chronic gout (pegloticase), tumor lysis syndrome (rasburicase), leukemia (L-asparaginase), some collagen-based disorders such as Dupuytren's contracture (collagenase), severe combined immunodeficiency disease (pegademase bovine), detoxification of methotrexate (glucarpidase), and vitreomacular adhesion (ocriplasmin). The development of these efficacious and safe enzyme-based therapies has occurred hand in hand with some remarkable advances in the preparation of the often specifically designed recombinant enzymes; the manufacturing expertise necessary for commercial production; our understanding of underlying mechanisms operative in the different diseases; and the mechanisms of action of the relevant recombinant enzymes. Together with information on these mechanisms, safety findings recorded so far on the various adverse events and problems of immunogenicity of the recombinant enzymes used for therapy are presented.

  5. Streamlining of building permit approval processing of town and country planning department in Ghana

    Directory of Open Access Journals (Sweden)

    Noriss Kweku Hammah

    2015-12-01

    Full Text Available To date, the Ghanaian development control system has proven unsuccessful in delivering quality planning application approvals in a timely manner and it is doubtful whether it is possible to achieve that basic goal in its current form. Planning application approval assessment is performed conjointly by various planning organizations spearheaded by Accra Town and Country Planning Department (TCPD. The success in delivering quality approvals in a timely manner therefore depends on the inter-organizational task interdependency, collaboration, and teamwork of the various planning agencies that form the Accra Metropolitan Assembly. The paper puts into perspective the TCPD organizational workflow and knowledge flow based on their strategies, size, leadership style, organizational complexities, and their competencies to contribute to the success of the approval process. Further, this paper examines the reasons behind the increasing amorphous planning and unapproved development/construction and identifies the various planning approval problems. Finally, it offers modalities to curtail planning approval delays.

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

    OpenAIRE

    RUDOLPH, KAREN D.; Bohn, Lauren E.

    2013-01-01

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

  7. A Needs Assessment of Marriage and Family Therapy Approved Supervision in Utah

    OpenAIRE

    2005-01-01

    This research presents data gathered through a needs assessment regarding approved supervision in Utah. A sample of ISO therapists in Utah gave descriptive facts about the current need for supervision in Utah as well as the number of therapists that are willing to provide supervision. Additionally, therapists that are not currently approved supervisors indicated whether or not they would be willing to become approved supervisors, what would make the designation more appealing, and what would ...

  8. [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.

  9. Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and Oils

    Science.gov (United States)

    2009-02-18

    qualification plan entitled "Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and Oils," produced by the subcontractor, Southwest...102 Enclosure 1 February 12, 2009 Fuel Qualification Plan; 3/27/07–4/24/09 Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and...Institute, Grand Forks, ND Southwest Research Institute, San Antonio, TX CLIN 0008 10 COMMERCIAL APPROVAL PLAN FOR SYNTHETIC JET FUEL FROM HYDROTREATED FATS

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

    Science.gov (United States)

    2010-07-01

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

  11. What is the Process Approvals for Survey Research in the Department of Defense (DoD)

    Science.gov (United States)

    2017-04-26

    JAC legal office for an ethics review. To assist you in making this decision about whether to request a legal review, the following examples are... processes are reported to be confusing. The survey approval process between services is inconsistent and time consuming . Barriers, real or perceived...MDW/SGVU SUBJECT: Professional Presentation Approval 11APR 2017 1. Your paper, entitled What is the Process ? Approvals for Survey Research in the

  12. 75 FR 55334 - Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five New Drug Applications

    Science.gov (United States)

    2010-09-10

    ... Five New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of five new drug applications (NDAs)...

  13. 75 FR 45007 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2010-07-30

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

  14. 78 FR 58598 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2013-09-24

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

  15. 76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Science.gov (United States)

    2011-08-30

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

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

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

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

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

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

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

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

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

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

  19. 76 FR 4364 - Credit Watch Termination Initiative; Termination of Direct Endorsement (DE) Approval

    Science.gov (United States)

    2011-01-25

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

  20. 76 FR 38407 - Credit Watch Termination Initiative; Termination of Direct Endorsement (DE) Approval

    Science.gov (United States)

    2011-06-30

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

  1. 76 FR 38406 - Credit Watch Termination Initiative; Termination of Origination Approval Agreements

    Science.gov (United States)

    2011-06-30

    ... Origination Approval Agreements terminated. FOR FURTHER INFORMATION CONTACT: The Quality Assurance Division... Accountant (CPA) qualified to perform audits under Government Auditing Standards as provided by the...

  2. 76 FR 22120 - Credit Watch Termination Initiative; Termination of Origination Approval Agreements

    Science.gov (United States)

    2011-04-20

    ... Origination Approval Agreements terminated. ] FOR FURTHER INFORMATION CONTACT: The Quality Assurance Division... Accountant (CPA) qualified to perform audits under Government Auditing Standards as provided by the...

  3. 76 FR 22119 - Credit Watch Termination Initiative; Termination of Direct Endorsement (DE) Approval

    Science.gov (United States)

    2011-04-20

    ... Approval terminated. FOR FURTHER INFORMATION CONTACT: The Quality Assurance Division, Office of Housing...) qualified to perform audits under Government Auditing Standards as provided by the Government Accountability...

  4. 76 FR 53148 - Credit Watch Termination Initiative; Termination of Direct Endorsement (DE) Approval

    Science.gov (United States)

    2011-08-25

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

  5. 75 FR 67387 - Credit Watch Termination Initiative Termination of Origination Approval Agreements

    Science.gov (United States)

    2010-11-02

    ... Origination Approval Agreements terminated. FOR FURTHER INFORMATION CONTACT: The Quality Assurance Division...) qualified to perform audits under Government Auditing Standards as provided by the Government Accountability...

  6. Astrophysical terms in Armenian

    Science.gov (United States)

    Yeghikian, A. G.

    2015-07-01

    There are quite a few astrophysical textbooks (to say nothing about monographs) in Armenian, which are, however out of date and miss all the modern terms concerning space sciences. Many terms have been earlier adopted from English and, especially, from Russian. On the other hand, teachers and lecturers in Armenia need scientific terms in Armenian adequately reproducing either their means when translating from other languages or (why not) creating new ones. In short, a permanently updated astrophysical glossary is needed to serve as explanation of such terms. I am not going here to present the ready-made glossary (which should be a task for a joint efforts of many professionals) but instead just would like to describe some ambiguous examples with comments where possible coming from my long-year teaching, lecturing and professional experience. A probable connection between "iron" in Armenian as concerned to its origin is also discussed.

  7. 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.

  8. D-term strings

    CERN Document Server

    Dvali, Gia; Van Proeyen, A; Dvali, Gia; Van Proeyen, Antoine

    2004-01-01

    We study the embedding of cosmic strings, related to the Abrikosov-Nielsen-Olesen vortex solution, into d=4, N=1 supergravity. We find that the local cosmic string solution which saturates the BPS bound of supergravity with the D-term potential for the Higgs field and with the constant Fayet--Iliopoulos term, has 1/2 of supersymmetry unbroken. We observe an interesting relation between the gravitino supersymmetry transformation, positive energy condition and the deficit angle of the cosmic string. We argue that the string solutions with the magnetic flux with F-term potential cannot be supersymmetric, which leads us to a conjecture that D1-strings of string theory in the effective 4d supergravity may be described by the D-term strings, which we study in this paper.

  9. Index of Glossary Terms

    Science.gov (United States)

    ... be limited. Home Visit Global Sites Search Help? Index of Glossary Terms Share this page: Was this ... Serum Serum Sickness Shock Shwachman-Diamond Syndrome Sideroblastic Anemia Sigmoidoscopy Sign Somatic Cells Specificity Spina bifida Spirochete ...

  10. Plagiarism (Coming to Terms).

    Science.gov (United States)

    Bowden, Darsie

    1996-01-01

    Explores the origins of the word "plagiarism" and concepts of authorship. Examines a number of current issues concerning plagiarism, for instance, how the term complicates teacher-student relationships and peer cooperation in writing. (TB)

  11. Understanding anatomical terms.

    Science.gov (United States)

    Mehta, L A; Natrajan, M; Kothari, M L

    1996-01-01

    Words are our masters and words are our slaves, all depending on how we use them. The whole of medical science owes its origin to Greco-Roman culture and is replete with terms whose high sound is not necessarily accompanied by sound meaning. This is even more the case in the initial, pre-clinical years. Anatomical terminology seems bewildering to the initiate; and maybe that is a reason why love of anatomy as a subject does not always spill over through later years. Employing certain classifications of the origin of the anatomical terms, we have prepared an anthology that we hope will ease the student's task and also heighten the student's appreciation of the new terms. This centers on revealing the Kiplingian "how, why, when, where, what, and who" of a given term. This presentation should empower students to independently formulate a wide network of correlations once they understand a particular term. The article thus hopes to stimulate students' analytic and synthetic faculties as well. A small effort can reap large rewards in terms of enjoyment of the study of anatomy and the related subjects of histology, embryology, and genetics. It is helpful to teachers and students alike. This exercise in semantics and etymology does not demand of the student or his teacher any background in linguistics, grammar, Greek, Latin, Sanskrit, anatomy, or medicine.

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

    Science.gov (United States)

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

    2016-11-01

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

  13. The clinically approved antiviral drug sofosbuvir inhibits Zika virus replication

    Science.gov (United States)

    Sacramento, Carolina Q.; de Melo, Gabrielle R.; de Freitas, Caroline S.; Rocha, Natasha; Hoelz, Lucas Villas Bôas; Miranda, Milene; Fintelman-Rodrigues, Natalia; Marttorelli, Andressa; Ferreira, André C.; Barbosa-Lima, Giselle; Abrantes, Juliana L.; Vieira, Yasmine Rangel; Bastos, Mônica M.; de Mello Volotão, Eduardo; Nunes, Estevão Portela; Tschoeke, Diogo A.; Leomil, Luciana; Loiola, Erick Correia; Trindade, Pablo; Rehen, Stevens K.; Bozza, Fernando A.; Bozza, Patrícia T.; Boechat, Nubia; Thompson, Fabiano L.; de Filippis, Ana M. B.; Brüning, Karin; Souza, Thiago Moreno L.

    2017-01-01

    Zika virus (ZIKV) is a member of the Flaviviridae family, along with other agents of clinical significance such as dengue (DENV) and hepatitis C (HCV) viruses. Since ZIKV causes neurological disorders during fetal development and in adulthood, antiviral drugs are necessary. Sofosbuvir is clinically approved for use against HCV and targets the protein that is most conserved among the members of the Flaviviridae family, the viral RNA polymerase. Indeed, we found that sofosbuvir inhibits ZIKV RNA polymerase, targeting conserved amino acid residues. Sofosbuvir inhibited ZIKV replication in different cellular systems, such as hepatoma (Huh-7) cells, neuroblastoma (SH-Sy5y) cells, neural stem cells (NSC) and brain organoids. In addition to the direct inhibition of the viral RNA polymerase, we observed that sofosbuvir also induced an increase in A-to-G mutations in the viral genome. Together, our data highlight a potential secondary use of sofosbuvir, an anti-HCV drug, against ZIKV. PMID:28098253

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

    CERN Document Server

    Lin, Andrew

    2010-01-01

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

  15. 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.

  16. Understand Work of Approving Terms from Changes of Term "Intravenous Hyperalimentation"%从"静脉高营养"名词的变迁看名词审定

    Institute of Scientific and Technical Information of China (English)

    蒋朱明; 张思源; 于康; 朱预

    2009-01-01

    @@ 一 历史回顾 1971年,北京协和医院外科在引进氨基酸、维生素等营养基质的基础上,参考了美国Dudrick、Wilmore等学者的文献,将较为正规的静脉营养技术应用于临床.

  17. FDA-approved immunosuppressants targeting staphylococcal superantigens: mechanisms and insights

    Directory of Open Access Journals (Sweden)

    Krakauer T

    2017-05-01

    Full Text Available Teresa Krakauer Department of Immunology, Molecular Translational Sciences Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Frederick, MD, USA Abstract: Immunostimulating staphylococcal enterotoxin B (SEB and related superantigenic toxins cause diseases in human beings and laboratory animals by hyperactivating cells of the immune system. These protein toxins bind to the major histocompatibility complex class II (MHC II molecules and specific Vβ regions of T-cell receptors (TCRs, resulting in the stimulation of both monocytes/macrophages and T lymphocytes. The bridging of TCR with MHC II molecules by superantigens triggers intracellular signaling cascades, resulting in excessive release of proinflammatory mediators and massive polyclonal T-cell proliferation. The early induction of tumor necrosis factor α, interleukin 1 (IL-1, interleukin 2 (IL-2, interferon gamma (IFNγ, and macrophage chemoattractant protein 1 promotes fever, inflammation, and multiple organ injury. The signal transduction pathways for staphylococcal superantigen-induced toxicity downstream from TCR/major histocompatibility complex (MHC ligation and interaction of cell surface co-stimulatory molecules include the mitogen-activated protein kinase cascades and cytokine receptor signaling, activating nuclear factor kB (NFkB and the phosphoinositide 3-kinase/mammalian target of rapamycin pathways. Knowledge of host regulation within these activated pathways and molecules initiated by SEB and other superantigens enables the selection of US Food and Drug Administration (FDA-approved drugs to interrupt and prevent superantigen-induced shock in animal models. This review focuses on the use of FDA-approved immunosuppressants in targeting the signaling pathways induced by staphylococcal superantigens. Keywords: immunosuppressant, superantigen, toxic shock, NFkB, mTORC1

  18. OTO: Ontology Term Organizer.

    Science.gov (United States)

    Huang, Fengqiong; Macklin, James A; Cui, Hong; Cole, Heather A; Endara, Lorena

    2015-02-15

    The need to create controlled vocabularies such as ontologies for knowledge organization and access has been widely recognized in various domains. Despite the indispensable need of thorough domain knowledge in ontology construction, most software tools for ontology construction are designed for knowledge engineers and not for domain experts to use. The differences in the opinions of different domain experts and in the terminology usages in source literature are rarely addressed by existing software. OTO software was developed based on the Agile principles. Through iterations of software release and user feedback, new features are added and existing features modified to make the tool more intuitive and efficient to use for small and large data sets. The software is open source and built in Java. Ontology Term Organizer (OTO; http://biosemantics.arizona.edu/OTO/ ) is a user-friendly, web-based, consensus-promoting, open source application for organizing domain terms by dragging and dropping terms to appropriate locations. The application is designed for users with specific domain knowledge such as biology but not in-depth ontology construction skills. Specifically OTO can be used to establish is_a, part_of, synonym, and order relationships among terms in any domain that reflects the terminology usage in source literature and based on multiple experts' opinions. The organized terms may be fed into formal ontologies to boost their coverage. All datasets organized on OTO are publicly available. OTO has been used to organize the terms extracted from thirty volumes of Flora of North America and Flora of China combined, in addition to some smaller datasets of different taxon groups. User feedback indicates that the tool is efficient and user friendly. Being open source software, the application can be modified to fit varied term organization needs for different domains.

  19. A Food and Drug Administration-approved asthma therapeutic agent impacts amyloid β in the brain in a transgenic model of Alzheimer disease.

    Science.gov (United States)

    Hori, Yukiko; Takeda, Shuko; Cho, Hansang; Wegmann, Susanne; Shoup, Timothy M; Takahashi, Kazue; Irimia, Daniel; Elmaleh, David R; Hyman, Bradley T; Hudry, Eloise

    2015-01-23

    Interfering with the assembly of Amyloid β (Aβ) peptides from monomer to oligomeric species and fibrils or promoting their clearance from the brain are targets of anti-Aβ-directed therapies in Alzheimer disease. Here we demonstrate that cromolyn sodium (disodium cromoglycate), a Food and Drug Administration-approved drug already in use for the treatment of asthma, efficiently inhibits the aggregation of Aβ monomers into higher-order oligomers and fibrils in vitro without affecting Aβ production. In vivo, the levels of soluble Aβ are decreased by over 50% after only 1 week of daily intraperitoneally administered cromolyn sodium. Additional in vivo microdialysis studies also show that this compound decreases the half-life of soluble Aβ in the brain. These data suggest a clear effect of a peripherally administered, Food and Drug Administration-approved medication on Aβ economy, supporting further investigation of the potential long-term efficacy of cromolyn sodium in Alzheimer disease.

  20. Fixed-Term Homotopy

    Directory of Open Access Journals (Sweden)

    Hector Vazquez-Leal

    2013-01-01

    Full Text Available A new tool for the solution of nonlinear differential equations is presented. The Fixed-Term Homotopy (FTH delivers a high precision representation of the nonlinear differential equation using only a few linear algebraic terms. In addition to this tool, a procedure based on Laplace-Padé to deal with the truncate power series resulting from the FTH method is also proposed. In order to assess the benefits of this proposal, two nonlinear problems are solved and compared against other semianalytic methods. The obtained results show that FTH is a power tool capable of generating highly accurate solutions compared with other methods of literature.