WorldWideScience

Sample records for biothrax product approval

  1. Effect of Anthrax Immune Globulin on Response to BioThrax (Anthrax Vaccine Adsorbed) in New Zealand White Rabbits

    OpenAIRE

    Malkevich, Nina V.; Basu, Subhendu; Rudge, Thomas L.; Clement, Kristin H.; Chakrabarti, Ajoy C.; Aimes, Ronald T.; Nabors, Gary S.; Skiadopoulos, Mario H.; Ionin, Boris

    2013-01-01

    Development of anthrax countermeasures that may be used concomitantly in a postexposure setting requires an understanding of the interaction between these products. Anthrax immune globulin intravenous (AIGIV) is a candidate immunotherapeutic that contains neutralizing antibodies against protective antigen (PA), a component of anthrax toxins. We evaluated the interaction between AIGIV and BioThrax (anthrax vaccine adsorbed) in rabbits. While pharmacokinetics of AIGIV were not altered by vaccin...

  2. 77 FR 6560 - Pesticide Product Registration Approval

    Science.gov (United States)

    2012-02-08

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

  3. 77 FR 16544 - Pesticide Product Registration Approvals

    Science.gov (United States)

    2012-03-21

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

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

    Science.gov (United States)

    2010-10-01

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

  5. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

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

  6. 46 CFR 160.036-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  7. 46 CFR 160.037-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  8. 46 CFR 160.022-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  9. 46 CFR 160.024-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  10. 46 CFR 160.021-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  11. 46 CFR 160.028-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  12. 46 CFR 160.057-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  13. 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...

  14. 46 CFR 160.040-5 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  15. 46 CFR 160.031-5 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  16. 5 CFR 1305.2 - Production prohibited unless approved.

    Science.gov (United States)

    2010-01-01

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

  17. 7 CFR 987.157 - Approved date product manufacturers.

    Science.gov (United States)

    2010-01-01

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

  18. Inactive ingredient Search for Approved Drug Products

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final...

  19. Procedures for the approval of oil spill treatment products

    International Nuclear Information System (INIS)

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

  20. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    Science.gov (United States)

    2010-01-01

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

  1. 75 FR 61497 - Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request...

    Science.gov (United States)

    2010-10-05

    ... drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing... the approval of drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The BPCI...

  2. 76 FR 82077 - Food Ingredients and Sources of Radiation Listed or Approved for Use in the Production of Meat...

    Science.gov (United States)

    2011-12-30

    ... Meat and Poultry Products'' (64 FR 72168). Among other things, this final rule consolidated various... and Sources of Radiation Listed or Approved for Use in the Production of Meat and Poultry Products... listed or approved for use in the production of meat and poultry products. DATES: December 30,...

  3. 78 FR 26258 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2013-05-06

    ...' consumer products and AIM rules into the State's SIP (77 FR 33659). In our June 7, 2012, rulemaking, we... Cleaners, Footwear or leather Care Products, General Purpose Degreasers, and Graffiti Removers'' to the... that were affected by the rule as approved by EPA at 77 FR 33659), and July 1, 2012 (for...

  4. 7 CFR 987.164 - Shipments of product dates and disposition of restricted dates in approved product outlets.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Shipments of product dates and disposition of restricted dates in approved product outlets. 987.164 Section 987.164 Agriculture Regulations of the..., Vegetables, Nuts), DEPARTMENT OF AGRICULTURE DOMESTIC DATES PRODUCED OR PACKED IN RIVERSIDE...

  5. 75 FR 35805 - Pesticide Product Registrations; Conditional Approvals

    Science.gov (United States)

    2010-06-23

    ... published a notice of receipt in the Federal Register of July 25, 2007 (72 FR 40876) (FRL-8129-7), which announced that Monsanto Company had submitted applications to register pesticide products containing the new... applications from Monsanto Company, 800 North Lindbergh Boulevard, St. Louis, MO 63167, to register...

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

    Directory of Open Access Journals (Sweden)

    Bate R

    2012-07-01

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

  7. Quality assurance in production and use of special form radioactive material - focal points in BAM approvals

    International Nuclear Information System (INIS)

    BAM as the competent authority for approval of special form radioactive material attaches great importance to a detailed audit of the required quality assurance programs for design, manufacture, testing, documentation, use, maintenance and inspection. Applicants have to submit, together with application documentation information on general arrangements for quality assurance, as well as on quality assurance in production and in operation. Fields where BAM has often found deficiencies are leak test methods, weld seam quality and the safety level after use

  8. Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles

    OpenAIRE

    Bruce Y Lee; Burke, Donald S

    2009-01-01

    As history has demonstrated, post-approval obstacles can impede a vaccine’s use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine’s technology can still be easily made may improve a vaccine’s chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business deve...

  9. Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles.

    Science.gov (United States)

    Lee, Bruce Y; Burke, Donald S

    2010-04-01

    As history has demonstrated, post-approval obstacles can impede a vaccine's use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine's technology can still be easily made may improve a vaccine's chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business development managers, policy makers, public health officials, health care workers, third party payors, etc.) earlier in a vaccine's development. PMID:19782109

  10. 49 CFR 236.1013 - PTC Development Plan and Notice of Product Intent content requirements and Type Approval.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false PTC Development Plan and Notice of Product Intent... TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES Positive Train Control Systems § 236.1013 PTC Development Plan and Notice of Product Intent content requirements and Type Approval. (a) For a PTC system...

  11. 21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Testing and approval or rejection of components, drug product containers, and closures. 211.84 Section 211.84 Food and Drugs FOOD AND DRUG... with filth, insect infestation, or other extraneous adulterant shall be examined against...

  12. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 556, and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole...: The Food and Drug Administration (FDA) is amending the animal drug regulations by removing...

  13. Nutrition recommendations and the Children's Food and Beverage Advertising Initiative's 2014 approved food and beverage product list.

    Science.gov (United States)

    Schermbeck, Rebecca M; Powell, Lisa M

    2015-01-01

    We compare the Children's Food and Beverage Advertising Initiative's (CFBAI's) April 2014 list of food and beverage products approved to be advertised on children's television programs with the federal Interagency Working Group's nutrition recommendations for such advertised products. Products were assessed by using the nutrients to limit (saturated fat, trans fat, sugar, and sodium) component of the Interagency Working Group's recommendations. Fifty-three percent of the listed products did not meet the nutrition recommendations and, therefore, were ineligible to be advertised. We recommend continued monitoring of food and beverage products marketed to children. PMID:25906434

  14. Quality assurance in the production and use of special form radioactive material - focal points in BAM approvals

    International Nuclear Information System (INIS)

    BAM, as the competent authority for approval of special form radioactive material, attaches great importance to a detailed audit of the required quality assurance programmes for design, manufacture, testing, documentation, use, maintenance and inspection. Applicants have to submit, together with their application documentation, information on general arrangements for quality assurance, as well as on quality assurance in production and in operation. Fields where BAM has often found deficiencies are leak test methods, weld seam quality and the safety level after use. (author)

  15. 75 FR 67054 - Listing of Approved Drug Products Containing Dronabinol in Schedule III

    Science.gov (United States)

    2010-11-01

    ...\\ 51 FR 17476 (May 13, 1986). DEA subsequently transferred the FDA-approved Marinol formulation from schedule II to schedule III. 64 FR 35928 (July 2, 1999). Recently, firms have submitted to FDA ANDAs for.... (7) Its psychic or physiological dependence liability. (8) Whether the substance is an...

  16. #DDOD Use Case: Historical Structured Product Labels for FDA-Approved Drugs

    Data.gov (United States)

    U.S. Department of Health & Human Services — SUMMARY DDOD use case to request access historical label revisions of FDA-approved drugs. WHAT IS A USE CASE? A “Use Case” is a request that was made by the user...

  17. Nutrition Recommendations and the Children’s Food and Beverage Advertising Initiative’s 2014 Approved Food and Beverage Product List

    OpenAIRE

    Schermbeck, Rebecca M.; Powell, Lisa M.

    2015-01-01

    We compare the Children’s Food and Beverage Advertising Initiative’s (CFBAI’s) April 2014 list of food and beverage products approved to be advertised on children’s television programs with the federal Interagency Working Group’s nutrition recommendations for such advertised products. Products were assessed by using the nutrients to limit (saturated fat, trans fat, sugar, and sodium) component of the Interagency Working Group’s recommendations. Fifty-three percent of the listed products did n...

  18. The potential of plants as a system for the development and production of human biologics [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Qiang Chen

    2016-05-01

    Full Text Available The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.

  19. Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India.

    Science.gov (United States)

    Lee, Sau L; Saluja, Bhawana; García-Arieta, Alfredo; Santos, Gustavo Mendes Lima; Li, Ying; Lu, Sarah; Hou, Shuguang; Rebello, Juliet; Vaidya, Abhijit; Gogtay, Jaideep; Purandare, Shrinivas; Lyapustina, Svetlana

    2015-09-01

    This article describes regulatory approaches for approval of "generic" orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the "original" product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as "generic" and "reference" drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. PMID:26002510

  20. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].

    Science.gov (United States)

    Jost, Nils; Schüssler-Lenz, Martina; Ziegele, Bettina; Reinhardt, Jens

    2015-11-01

    The aim of scientific advice is to support pharmaceutical developers in regulatory and scientific questions, thus facilitating the development of safe and efficacious new medicinal products. Recent years have shown that the development of advanced therapy medicinal products (ATMPs) in particular needs a high degree of regulatory support. On one hand, this is related to the complexity and heterogeneity of this group of medicinal products and on the other hand due to the fact that mainly academic research institutions and small- and medium-sized enterprises (SMEs) are developing ATMPs. These often have limited regulatory experience and resources. In 2009 the Paul-Ehrlich-Institut (PEI) initiated the Innovation Office as a contact point for applicants developing ATMPs. The mandate of the Innovation Office is to provide support on regulatory questions and to coordinate national scientific advice meetings concerning ATMPs for every phase in drug development and especially with view to the preparation of clinical trial applications. On the European level, the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicinal Agency (EMA) offers scientific advice. This article describes the concepts of national and EMA scientific advice concerning ATMPs and summarizes the experience of the last six years. PMID:26369763

  1. Nutrition Recommendations and the Children’s Food and Beverage Advertising Initiative’s 2014 Approved Food and Beverage Product List

    Science.gov (United States)

    Powell, Lisa M.

    2015-01-01

    We compare the Children’s Food and Beverage Advertising Initiative’s (CFBAI’s) April 2014 list of food and beverage products approved to be advertised on children’s television programs with the federal Interagency Working Group’s nutrition recommendations for such advertised products. Products were assessed by using the nutrients to limit (saturated fat, trans fat, sugar, and sodium) component of the Interagency Working Group’s recommendations. Fifty-three percent of the listed products did not meet the nutrition recommendations and, therefore, were ineligible to be advertised. We recommend continued monitoring of food and beverage products marketed to children. PMID:25906434

  2. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2010-05-05

    ... medicated article was voluntarily withdrawn (60 FR 37651, July 21, 1995) and approved conditions of use for... NADA 45-738, were removed (60 FR 39847, July 21, 1995). At this time, the tolerances for residues of... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 Animal Drugs, Feeds, and...

  3. FDA approved radiopharmaceuticals

    International Nuclear Information System (INIS)

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

  4. Recent advances in the elucidation of enzymatic function in natural product biosynthesis [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Tan Gao-Yi

    2015-12-01

    Full Text Available With the successful production of artemisinic acid in yeast, the promising potential of synthetic biology for natural product biosynthesis is now being realized. The recent total biosynthesis of opioids in microbes is considered to be another landmark in this field. The importance and significance of enzymes in natural product biosynthetic pathways have been re-emphasized by these advancements. Therefore, the characterization and elucidation of enzymatic function in natural product biosynthesis are undoubtedly fundamental for the development of new drugs and the heterologous biosynthesis of active natural products. Here, discoveries regarding enzymatic function in natural product biosynthesis over the past year are briefly reviewed.

  5. Recent advances in the elucidation of enzymatic function in natural product biosynthesis [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Gao-Yi Tan

    2016-02-01

    Full Text Available With the successful production of artemisinic acid in yeast, the promising potential of synthetic biology for natural product biosynthesis is now being realized. The recent total biosynthesis of opioids in microbes is considered to be another landmark in this field. The importance and significance of enzymes in natural product biosynthetic pathways have been re-emphasized by these advancements. Therefore, the characterization and elucidation of enzymatic function in natural product biosynthesis are undoubtedly fundamental for the development of new drugs and the heterologous biosynthesis of active natural products. Here, discoveries regarding enzymatic function in natural product biosynthesis over the past year are briefly reviewed.

  6. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Science.gov (United States)

    2010-01-01

    ... provisions of 21 CFR part 101, promulgated under the Federal Food, Drug, and Cosmetic Act and the Fair... container in use or proposed for use in respect to egg products at any official plant is false or misleading... of labels for use in official egg products plants. 590.411 Section 590.411 Animals and...

  7. Everolimus: the first approved product for patients with advanced renal cell cancer after sunitinib and/or sorafenib

    Directory of Open Access Journals (Sweden)

    Chris Coppin

    2010-04-01

    Full Text Available Chris CoppinMedical Oncology, BC Cancer Agency and University of British Columbia, Vancouver, CanadaAbstract: Everolimus (RAD001, Afinitor® Novartis is the first oral inhibitor of mTOR (mammalian target of rapamycin to reach the oncology clinic. Everolimus 10 mg daily achieves complete inhibition of its target at below the maximum tolerable dose for most patients. A phase III randomized placebo-controlled trial has examined the impact of everolimus in patients with clear cell renal cancers and progressive disease on or within 6 months of the VEGFR tyrosine kinase inhibitors sunitinib and/or sorafenib. The primary endpoint of progression-free survival was increased from median 1.9 to 4.9 months (hazard ratio 0.33, P < 0.001 and 25% were still progression-free after 10 months of everolimus therapy. There was a delay in time to decline of performance status and trends to improvement in quality of life, disease-related symptoms, and overall survival despite crossover of the majority of patients assigned to placebo. In 2009, everolimus was approved in the US and Europe as the only validated option for this indication. Toxicities are usually mild to moderate and can be managed with dose reduction or interruption if necessary. Opportunistic infections and non-infectious pneumonitis are seen as a class effect. Management of common practical management issues are discussed. Clinical trials are in progress to examine additional roles for everolimus in renal cancer, alone and in combination with other agents.Keywords: everolimus, drug therapy, advanced renal cancer

  8. 77 FR 26706 - Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat...

    Science.gov (United States)

    2012-05-07

    ...., color) did not change when compared with untreated products. Another condition of the waivers was that... sodium benzoate and sodium propionate in vacuum packaging or modified atmosphere packaging with nitrogen and carbon dioxide and found that the type of packaging did not have a technical effect on...

  9. 27 CFR 40.394 - Notice of approval of bond.

    Science.gov (United States)

    2010-04-01

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

  10. 30 CFR 28.25 - Changes or modifications of approved fuses; issuance of modification of certificate of approval.

    Science.gov (United States)

    2010-07-01

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

  11. Drugs Approved for Leukemia

    Science.gov (United States)

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

  12. BRAZIL’S ACADEMIC PRODUCTION IN ENTREPRENEURSHIP: AN ANALYSIS OF PAPERS APPROVED AT ANPAD EVENTS FROM 2001 TO 2012

    Directory of Open Access Journals (Sweden)

    Edson Sadao Iizuka

    2015-12-01

    Full Text Available This paper aims to analyze Brazil’s academic production on entrepreneurship with a specific focus on the papers resulting from the framework of the following ANPAD-sponsored events from 2001 to 2012: EMA, EnEO, Symposium, EnEPQ, 3Es, EnGPR, EnAPG and EnANPAD. These events see the country’s top entrepreneurship researchers raising issues and sharing their interests, which make them ideal for gaining a privileged understanding of the themes latest news and relevant trends. An exploratory study approach was taken, qualitative as to the nature of the literature and using content analysis and quantitative for the corresponding descriptive statistics. A total of 150 papers containing the term “entrepreneurship” in the title were located by ANPAD´s electronic search system and subsequently analyzed. After the analysis of the 5,251 references used in the papers ,it was found that there were 22 authors who appeared frequently and the 23 most cited references were identified. The findings also show a predominance of qualitative methodologies (58.7% of the total. The papers focused on 10 main themes, with the three most common being: (iStarting New Businesses; (ii Teaching and Learning; (iii Intrapreneurship. It is understood that the results allow for reflections on the theme of the future of entrepreneurship in Brazil.

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

    OpenAIRE

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

    2012-01-01

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

  14. 76 FR 75809 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2011-12-05

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

  15. 30 CFR 28.2 - Approved fuses.

    Science.gov (United States)

    2010-07-01

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

  16. Medicamentos Biotecnológicos: Requisitos Exigidos para el Desarrollo y Aprobación de Biosimilares Biological Medicinal Products: Requirements for the Development and Approval of Biosimilars

    Directory of Open Access Journals (Sweden)

    Begoña Calvo

    2010-01-01

    Full Text Available En este artículo se revisan las directrices europeas de comparabilidad que establecen la metodología para la determinación de biosimilitud entre los medicamentos biosimilares (follow-on biologics en USA y el medicamento biológico de referencia. Los biosimilares son medicamentos biológicos parecidos pero no idénticos al medicamento original y pueden ser fabricados por cualquier fabricante al finalizar el periodo de patente de los medicamentos biotecnológicos. En el articulo se detallan las directrices de la Agencia Europea del Medicamento (EMA y de la Conferencia Internacional de Armonización (ICH a tener en cuenta en el desarrollo y aprobación de estos medicamentos. Se demuestra que los medicamentos biosimilares no pueden considerarse medicamentos genéricos, siendo necesario realizar una serie de ensayos adicionales previos a la obtención de la autorización de comercialización.This article reviews the European guidelines on drugs comparability that establish the methodology for verifying biosimilarity between the so-called biosimilar drugs and the reference biological medicinal product. Biosimilars are biological medicines similar but not identical to the original drugs and can be manufactured by any laboratory after the expiration of biotech drugs patent. The guidelines of the European Medicines Agency (EMA and the International Conference on Harmonization (ICH that must be considered in the development and approval of these drugs also are reviewed. It is shown that biosimilars cannot be considered as generic drugs, being necessary to conduct additional assays prior to obtain marketing authorization.

  17. 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...

  18. Approval of radioactive consumer goods

    International Nuclear Information System (INIS)

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

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

    Science.gov (United States)

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

    2015-01-01

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

  20. More New Medication Approvals.

    Science.gov (United States)

    Turkoski, Beatrice B

    2016-01-01

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

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

    Science.gov (United States)

    2010-07-01

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

  2. 27 CFR 4.50 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

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

  3. Drugs Approved for Brain Tumors

    Science.gov (United States)

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

  4. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  5. Drugs Approved for Prostate Cancer

    Science.gov (United States)

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

  6. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

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

  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. 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.

  9. Drugs Approved for Melanoma

    Science.gov (United States)

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

  10. 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.

  11. 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...

  12. Brodalumab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-09-01

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

  13. 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...

  14. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

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

  15. Venetoclax: First Global Approval.

    Science.gov (United States)

    Deeks, Emma D

    2016-06-01

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

  16. Drugs Approved for Skin Cancer

    Science.gov (United States)

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

  17. Mipomersen sodium: first global approval.

    Science.gov (United States)

    Hair, Philip; Cameron, Fiona; McKeage, Kate

    2013-04-01

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

  18. Cariprazine: First Global Approval.

    Science.gov (United States)

    McCormack, Paul L

    2015-11-01

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

  19. 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...

  20. 30 CFR 28.3 - Installation, use, and maintenance of approved fuses.

    Science.gov (United States)

    2010-07-01

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

  1. 75 FR 42672 - Approval and Promulgation of Implementation Plans; New Jersey; 8-hour Ozone Control Measures

    Science.gov (United States)

    2010-07-22

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

  2. Obiltoxaximab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-05-01

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

  3. Osimertinib: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-02-01

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

  4. Necitumumab: First Global Approval.

    Science.gov (United States)

    Garnock-Jones, Karly P

    2016-02-01

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

  5. Approved Animal Drug Products (Green Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions,...

  6. Multinational design approval programme

    International Nuclear Information System (INIS)

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

  7. Drugs Approved for Lung Cancer

    Science.gov (United States)

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

  8. 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,...

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

    Directory of Open Access Journals (Sweden)

    Chia-Wei eTsai

    2015-12-01

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

  10. 76 FR 4835 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Volatile Organic Compound...

    Science.gov (United States)

    2011-01-27

    ...EPA is proposing to approve a new rule for the control of volatile organic compound (VOC) emissions from reinforced plastic composites production operations to Ohio's State Implementation plan (SIP). This rule applies to any facility that has reinforced plastic composites production operations. This rule is approvable because it satisfies the requirements for reasonably available control......

  11. 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- ...

  12. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

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

  13. 27 CFR 4.93 - Approval of grape variety names.

    Science.gov (United States)

    2010-04-01

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

  14. 27 CFR 5.51 - Label approval and release.

    Science.gov (United States)

    2010-04-01

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

  15. 27 CFR 4.91 - List of approved prime names.

    Science.gov (United States)

    2010-04-01

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

  16. 27 CFR 4.40 - Label approval and release.

    Science.gov (United States)

    2010-04-01

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

  17. 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

  18. 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.

  19. 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...

  20. Is It Really FDA Approved?

    Science.gov (United States)

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

  1. FDA-Approved HIV Medicines

    Science.gov (United States)

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

  2. 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.

  3. 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.

  4. 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.

  5. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. The dilemma of approving antidotes.

    Science.gov (United States)

    Steffen, Christian

    2007-04-20

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

  14. 28 CFR 2.41 - Travel approval.

    Science.gov (United States)

    2010-07-01

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

  15. Pesticide Product Label System

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Pesticide Product Label System (PPLS) provides a collection of pesticide product labels (Adobe PDF format) that have been approved by EPA under Section 3 of the...

  16. 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

  17. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Science.gov (United States)

    2010-04-01

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

  18. 7 CFR 1948.82 - Plan and State Investment Strategy approval procedure.

    Science.gov (United States)

    2010-01-01

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

  19. 77 FR 8095 - Review and Approval of Projects

    Science.gov (United States)

    2012-02-14

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

  20. 9 CFR 590.435 - Wholesomeness and approval of materials.

    Science.gov (United States)

    2010-01-01

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

  1. 78 FR 53474 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-08-29

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

  2. Decision 99-8 : Shell Canada Limited application to construct and operate an oil sands bitumen upgrader in the Fort Saskatchewan area : Shell Canada Products Limited application to amend refinery approval in the Fort Saskatchewan area

    International Nuclear Information System (INIS)

    The Alberta Energy and Utilities Board considered an application by Shell Canada Limited to construct and operate an oil sands bitumen upgrader on Shell's property adjoining the existing Scotford refinery in the County of Strathcona. The upgrader would process bitumen from Shell's proposed Muskeg River Mine, located 70 km north of Fort McMurray, and other feedstocks available in the area. The Board also considered an application for an amendment to the existing Scotford refinery approval, Industrial Development Permit 89-10, for the processing of 3.75 million cubic metres per year of sour conversion feedstock. Under a coordinated application process, Shell filed a joint Shell Scotford Upgrader application/Environmental Impact Assessment. Issues considered with respect to these applications were: technology selection, air/health, sulphur recovery, noise/traffic, and land use conflict. Shell stated that its Scotford refinery is the most energy efficient refinery in the Americas and that is has the highest liquid yield per unit volume of crude oil feedstock of any refinery in the world. The refinery's hydrocracking capacity would make it possible to use hydro-conversion technology for its upgrader which is environmentally advantageous. After examining all of the evidence pertaining to the applications, the Board found the projects to be in the public interest and is prepared to approve the Scotford Upgrader and Scotford Refinery modifications assuming that certain prescribed conditions are met

  3. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

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

  4. Drugs Approved for Cervical Cancer

    Science.gov (United States)

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

  5. Drugs Approved for Testicular Cancer

    Science.gov (United States)

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

  6. 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.

  7. 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.

  8. / production

    Indian Academy of Sciences (India)

    François Arleo; Pol-Bernard Gossiaux; Thierry Gousset; Jörg Aichelin

    2003-04-01

    For more than 25 years /Ψ production has helped to sharpen our understanding of QCD. In proton induced reaction some observations are rather well understood while others are still unclear. The current status of the theory of /Ψ production will be sketched, paying special attention to the issues of formation time and /Ψ re-interaction in a nuclear medium.

  9. Unilateral approval - Is it working?

    International Nuclear Information System (INIS)

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

  10. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    Science.gov (United States)

    Xu, Kui; Coté, Timothy R

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients. PMID:21357612

  11. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    Science.gov (United States)

    Xu K; Coté TR

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.

  12. Epclusa Approved for Chronic Hepatitis C

    Science.gov (United States)

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

  13. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

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

  14. 9 CFR 316.5 - Branding ink; to be furnished by official establishments; approval by Program; color.

    Science.gov (United States)

    2010-01-01

    ... official establishments; approval by Program; color. 316.5 Section 316.5 Animals and Animal Products FOOD...; color. (a) The operator of each official establishment shall furnish all ink for marking products with... provided in paragraphs (b) and (c) of this section, branding ink of any color, approved for the purpose...

  15. Establishment of Master Cell Stock and Working Cell Bank of MDCK Lines and Selection and Evaluation of the Lines as Candidate Viral Substrates for Approval Production of Combinational Canine Attenuated-live Virus Vaccines

    Institute of Scientific and Technical Information of China (English)

    ZHANG De-li; FANG Fu-de; LI Liu-jin; XIA Geng-tian; HE Xu-yu; GAO Bu-xian; BAI Xiao-hong; HUANG Gao-sheng; LIU Shang-gao; YEN Lung-fei

    2002-01-01

    Under the prerequisite that the incidence of cancer or tumor in negative-control nude mice inoculated subcutaneously with primary feline or canine kidney cell cultures purified in vitro at passage 3 was 0(0/22) and 0 (0/10), respectively. The incidence of the progressively-growing malignant tumor(MT) in positive-control nude mice inoculated subcutaneously with Hela cell cultures of KB, X, or NM20/X strain was 10/10, 25/25 and 5/51, respectively. The results showed that the incidence of tumor in nude mice with di-and hyperploid YB strain of MDCK cell during 17 - 23 passages, with hyper- and hypoploid KA strain of MDCK cell during 6 - 8 passages, with hypoploid WB strain of MDCK cell on passage 6, with hyper-and hypopioid H strain of MDCK cell during 8 - 24 passages was 2/24, 6/10, 5/10 and 10/15, respectively. The chromosomal analysis results showed that the ratio of difference in the rate of modal chromosome number between high(mcs + n) and lowest (mcs)passages was not more than 5- 15% and the structure aberrations was generally 0-3%. These results proved that the genetic characteristics of chromosomal number of cell lines determines their tumorigenicity, but it is species-specific. MDCK line has tumorigenicity no matter what its chromosome karyotype is, at least it has very low tumorigenicity even when its modal chromosome number is hypoploid. It is thus evident that MDCK cell of WB or H strain can be approved as substrate for the preparation of attenuated viral vaccines, but MDCK cell of YB or KA strain can not be approved as substrate for the preparation of attenuated viral vaccines.

  16. 28 CFR 2.93 - Travel approval.

    Science.gov (United States)

    2010-07-01

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

  17. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  18. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  19. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

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

  20. 12 CFR 611.510 - Approval procedures.

    Science.gov (United States)

    2010-01-01

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

  1. 78 FR 55238 - Notice of Request for New Approval of Information Collection

    Science.gov (United States)

    2013-09-10

    ... forest products. Estimated Number of Respondents: 1400 per annum. Estimated Number of Responses per..., Administrator, Foreign Agricultural Service. BILLING CODE 3410-10-P ... Foreign Agricultural Service Notice of Request for New Approval of Information Collection AGENCY:...

  2. 75 FR 53371 - Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas Dispersion Models

    Science.gov (United States)

    2010-08-31

    ... Pipeline and Hazardous Materials Safety Administration Liquefied Natural Gas Facilities: Obtaining Approval... Safety Administration (PHMSA) issues federal safety standards for siting liquefied natural gas (LNG...) NFPA 59A: Standard for the Production, Storage, and Handling of Liquefied Natural Gas. That...

  3. 30 CFR 746.14 - Approval, disapproval or conditional approval, of mining plan.

    Science.gov (United States)

    2010-07-01

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

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

    OpenAIRE

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

    2016-01-01

    Background: The U.S Food and Drugs Administration (FDA) is the worlds leading drug regulatory authority. There are reports of more product pipelines in oncology therapy area. The objective of this study was to see the overall trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals. Methods: New drug approvals data obtained from publicly available databases of the U.S. FDA from 2011 through 2015. For the drug products identi...

  5. Consumer approval of irradiated meat still tentative

    International Nuclear Information System (INIS)

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

  6. Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998

    OpenAIRE

    Rawson, N S

    2000-01-01

    BACKGROUND: The timeliness with which national regulatory agencies approve new drugs for marketing affects health care professionals and patients. An unnecessarily long approval process delays access to new medications that may improve patients' health status. The author compared drug approval times in Canada, Australia, Sweden, the United Kingdom and the United States. METHODS: Application and approval dates of new chemical or biological substances (excluding diagnostic products, and new sal...

  7. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2010-08-10

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

  8. Biomedicines—Moving Biologic Agents into Approved Treatment Options

    Directory of Open Access Journals (Sweden)

    Kenneth Cornetta

    2013-03-01

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

  9. 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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    OpenAIRE

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

    2016-01-01

    Background: As per World Trade Organisation (WTO), from the year 2005, India granted product patent recognition to all new chemical entities (NCEs). This may affect the new drug approvals in India. The purpose of this study was to compare the new drug approvals in India with the United States (US) and the European Union (EU) regions. Methods: We obtained information about regulatory approval of new drugs in the US, EU, or India of last 5 years (from 2011 through 2015) from the publicly acc...

  12. 30 CFR 35.4 - Types of hydraulic fluid for which certificates of approval may be granted.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Types of hydraulic fluid for which certificates..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FIRE-RESISTANT HYDRAULIC FLUIDS General Provisions § 35.4 Types of hydraulic fluid for which certificates of approval may be...

  13. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to ... seized products, and criminally prosecuted people responsible for marketing these illegal diet products. In addition, FDA maintains ...

  14. 7 CFR 959.123 - Approval.

    Science.gov (United States)

    2010-01-01

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

  15. 7 CFR 948.123 - Approval.

    Science.gov (United States)

    2010-01-01

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

  16. 7 CFR 1735.90 - Preliminary approvals.

    Science.gov (United States)

    2010-01-01

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

  17. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

    ... SERVICES Plastic Surgery § 549.51 Approval procedures. The Clinical Director shall consider individually any request from an inmate or a BOP medical consultant. (a) In circumstances where plastic surgery is... forward the surgery request to the Office of Medical Designations and Transportation for approval. (b)...

  18. 13 CFR 108.370 - Conditional approval.

    Science.gov (United States)

    2010-01-01

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

  19. Ordinal Position, Approval Motivation, and Interpersonal Attraction

    Science.gov (United States)

    Nowicki, Stephen, Jr.

    1971-01-01

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

  20. 46 CFR 249.7 - Approval.

    Science.gov (United States)

    2010-10-01

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

  1. E-Approval Plans in Research Libraries

    Science.gov (United States)

    Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Maurizio Bendandi

    2010-03-01

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

  3. 18 CFR 1304.7 - Conditions of approvals.

    Science.gov (United States)

    2010-04-01

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

  4. 5 CFR 7601.102 - Prior approval of outside employment.

    Science.gov (United States)

    2010-01-01

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

  5. 77 FR 28380 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-05-14

    ... for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 9, 2011 (76 FR... acetal resin; acrylic and modacrylic fiber; hydrogen fluoride and polycarbonate production. ] Estimated... following four categories: Polycarbonates (PC) Production, Acrylic and Modacrylic Fibers (AMF)...

  6. Immunization with a Recombinant, Pseudomonas fluorescens-Expressed, Mutant Form of Bacillus anthracis-Derived Protective Antigen Protects Rabbits from Anthrax Infection

    OpenAIRE

    Reed, Matthew D.; Wilder, Julie A.; Mega, William M.; Hutt, Julie A.; Kuehl, Philip J.; Valderas, Michelle W.; Chew, Lawrence L.; Liang, Bertrand C.; Squires, Charles H.

    2015-01-01

    Protective antigen (PA), one of the components of the anthrax toxin, is the major component of human anthrax vaccine (Biothrax). Human anthrax vaccines approved in the United States and Europe consist of an alum-adsorbed or precipitated (respectively) supernatant material derived from cultures of toxigenic, non-encapsulated strains of Bacillus anthracis. Approved vaccination schedules in humans with either of these vaccines requires several booster shots and occasionally causes adverse inject...

  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™. PMID:27317353

  8. Approving of personal dosimeter services

    International Nuclear Information System (INIS)

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

  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. FDA Approves Eye Implant for Aging Boomers

    Science.gov (United States)

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

  11. FDA Approves Implant to Battle Opioid Addiction

    Science.gov (United States)

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

  12. Drugs Approved for Head and Neck Cancer

    Science.gov (United States)

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

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

    Science.gov (United States)

    1996-04-22

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

  14. 45 CFR 2400.42 - Approval of Plan of Study.

    Science.gov (United States)

    2010-10-01

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

  15. 7 CFR 1726.36 - Documents subject to RUS approval.

    Science.gov (United States)

    2010-01-01

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

  16. 77 FR 14724 - Notice of Request for Extension of Approval of an Information Collection; Importation of Pork...

    Science.gov (United States)

    2012-03-13

    ... Approval of an Information Collection; Importation of Pork-filled Pasta Products AGENCY: Animal and Plant... collection associated with regulations for the importation of pork- filled pasta products. DATES: We will...: For information on regulations for the importation of pork-filled pasta products, contact Dr. Magde...

  17. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer ... FDA-Approved Under the Federal Food, Drug and Cosmetics Act (as amended by the Dietary Supplement Health ...

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

    Directory of Open Access Journals (Sweden)

    Luca Tacconi

    2008-12-01

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

  19. 75 FR 52737 - Pesticide Product Registrations; Unconditional and Conditional Approvals

    Science.gov (United States)

    2010-08-27

    ..., (703) 308-8097, bacchus.shanaz@epa.gov . 11. Cold pressed neem oil docket number: EPA-HQ-OPP-2007-0996... Symbols 84185-G, 84185-U and 84185-G) containing the active ingredient, Cold Pressed Neem Oil. At the time... use ] of Cold Pressed Neem Oil, and information on social, economic, and environmental......

  20. Observations and suggestions for improved transport/packaging approvals

    International Nuclear Information System (INIS)

    This paper has been developed from my personal experience as Manager, Facility Licensing with Global Nuclear Fuels in Wilmington, NC over the past four years. All of my examples involve the movement of Type A, fissile material, however, the observations and recommendations clearly have universal application to the movement of other nuclear materials. The observations are global in nature embracing the US, Canada, Japan, the European Union as well others. All of these countries openly report and ascribe to the fact that they have adopted the IAEA Regulations for the Safe Transport of Radioactive Material. The materials involved typically include UF6, UO2 powder, BWR fuel assemblies and process intermediates. Many of the papers here discuss the technical details of testing and the interpretation of the test results associated with the approval of transport packages. The technical details of demonstrating safety are of course very important in the overall assurance of safety. My discussion involves, for the most part, Section VIII - Approval and Administrative Requirements of TS-R-1. I have focused on this area because significant non-productive time is spent on these administrative matters and to a degree this non-productive time spent potentially detracts from meeting the objective of safe transport of nuclear materials

  1. Review of non-FDA-approved fillers.

    Science.gov (United States)

    Ellis, David A F; Segall, Lorne

    2007-05-01

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

  2. 7 CFR 330.210a - Administrative instructions listing approved packing materials for plant pests.

    Science.gov (United States)

    2010-01-01

    ... materials for plant pests. 330.210a Section 330.210a Agriculture Regulations of the Department of... PEST REGULATIONS; GENERAL; PLANT PESTS; SOIL, STONE, AND QUARRY PRODUCTS; GARBAGE Movement of Plant Pests § 330.210a Administrative instructions listing approved packing materials for plant pests. (a)...

  3. 77 FR 6057 - Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation...

    Science.gov (United States)

    2012-02-07

    ... Foreign-Trade Zones Board Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation, (Pharmaceutical and Biological Intravenous Product Manufacturing), Chicago, IL Pursuant to its... District, grantee of Foreign-Trade Zone 22, has requested manufacturing authority on behalf of...

  4. 75 FR 340 - Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular...

    Science.gov (United States)

    2010-01-05

    ...- 17-09); Whereas, notice inviting public comment has been given in the Federal Register (74 FR 8052... Foreign-Trade Zones Board Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular Diagnostic Products), Chicago, IL, Area Pursuant to its authority under the...

  5. 77 FR 38269 - Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 7M; Amgen Manufacturing...

    Science.gov (United States)

    2012-06-27

    ... Foreign-Trade Zones Board Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 7M; Amgen Manufacturing Limited (Biotechnology and Healthcare Products); Juncos, Puerto Rico Pursuant to its authority... Company, grantee of FTZ 7, has requested an expansion of the scope of manufacturing authority on behalf...

  6. 77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

    Science.gov (United States)

    2012-08-20

    ...., Lake Forest, IL 60045. Hospira, Inc., has notified the Agency in writing that this product is no longer...: August 9, 2012. Karen Midthun, Director, Center for Biologics Evaluation and Research. BILLING CODE 4160... HUMAN SERVICES Food and Drug Administration Hospira, Inc.; Withdrawal of Approval of a New...

  7. The "Good Housekeeping" Seal of Approval: An Historical Analysis 1909-1975.

    Science.gov (United States)

    Oliver, Lauren

    Examining the evolution of the "Good Housekeeping" Seal of Approval--one of the first codes to set standards for the products advertised in a periodical, a study analyzed issues of "Good Housekeeping" magazine from 1909 to 1975 (with the exception of issues from July 1929 to December 1938). The study also examined elements that may have been…

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

    Science.gov (United States)

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

    2014-01-01

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

  9. 40 CFR 52.722 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  10. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  11. 7 CFR 1735.61 - Approval criteria.

    Science.gov (United States)

    2010-01-01

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

  12. 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…

  13. 23 CFR 645.215 - Approvals.

    Science.gov (United States)

    2010-04-01

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

  14. Side effects of cytokines approved for therapy.

    Science.gov (United States)

    Baldo, Brian A

    2014-11-01

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

  15. 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…

  16. 46 CFR 58.16-10 - Approvals.

    Science.gov (United States)

    2010-10-01

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

  17. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

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

  18. PUBLIC APPROVAL OF PLANT AND ANIMAL BIOTECHNOLOGY IN KOREA: AN ORDERED PROBIT ANALYSIS

    OpenAIRE

    Hallman, William K.; Onyango, Benjamin M.; Govindasamy, Ramu; Jang, Ho-Min; Puduri, Venkata S.

    2004-01-01

    This study analyzes predictors of Korean public acceptance of the use of biotechnology to create genetically modified food products. Results indicate that the consumers with above average knowledge of specific outcomes of genetic modification were more likely than those with inaccurate or no knowledge to approve use of plant or animal genetic modification for the creation of new food products. Young South Koreans consumers (ages 20 to 29 years old) were more likely than old consumers (ages 50...

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

    OpenAIRE

    Luca Tacconi; Robert Nasi; Paolo Omar Cerutti

    2008-01-01

    One of the main objectives of the 1994 Cameroonian forestry law is to improve the management of production forests by including minimum safeguards for sustainability into compulsory forest management plans. As of 2007, about 3.5 million hectares (60%) of the productive forests are harvested following the prescriptions of 49 approved management plans. The development and implementation of these forest management plans has been interpreted by several international organizations as long awaited ...

  20. 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. PMID:26584531

  1. 76 FR 30189 - Receipt of Application for Approval

    Science.gov (United States)

    2011-05-24

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

  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... submitted to the Secretary for review and approval, documentation of periodic reviews of the content...

  3. Doctors Often Overestimate Promise of Newly Approved Drugs

    Science.gov (United States)

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

  4. 76 FR 37057 - Notice of Request for Extension of Approval of an Information Collection; Virus-Serum-Toxin Act...

    Science.gov (United States)

    2011-06-24

    ... concerning production, packaging, labeling, and shipping of these products and set standards for the testing... collection of information, including the validity of the methodology and assumptions used; (3) Enhance the... Animal and Plant Health Inspection Service Notice of Request for Extension of Approval of an...

  5. 77 FR 5480 - Notice of Request for Approval of an Information Collection; Importation of Animal and Poultry...

    Science.gov (United States)

    2012-02-03

    .../milk products for analysis, testing, or examination; certificates of origin for milk and milk products... the burden of the collection of information, including the validity of the methodology and assumptions...; ] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service Notice of Request for Approval of...

  6. 46 CFR 164.007-3 - Conditions of approval.

    Science.gov (United States)

    2010-10-01

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

  7. 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...

  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. 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...

  10. 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....

  11. 18 CFR 12.34 - Approval of independent consultant.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Approval of independent... PROJECT WORKS Inspection by Independent Consultant § 12.34 Approval of independent consultant. At least 60... Director of the Office of Energy Projects Licensing for approval, with a copy to the Regional Engineer,...

  12. 46 CFR 8.530 - Plan development and approval.

    Science.gov (United States)

    2010-10-01

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

  13. 48 CFR 2806.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  14. 48 CFR 570.502-1 - Justification and approval requirements.

    Science.gov (United States)

    2010-10-01

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

  15. 48 CFR 606.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  16. 48 CFR 1406.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  17. 48 CFR 1306.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  18. 38 CFR 17.804 - Loan approval criteria.

    Science.gov (United States)

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Loan approval criteria... Transitional Housing Loan Program § 17.804 Loan approval criteria. Upon consideration of the application package, loan approval will be based on the following: (a) Favorable financial history and status, (1)...

  19. 46 CFR 162.018-8 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

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

  20. 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...

  1. 46 CFR 131.710 - Approved work vests.

    Science.gov (United States)

    2010-10-01

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

  2. 7 CFR 1717.609 - RUS approval of general manager.

    Science.gov (United States)

    2010-01-01

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

  3. 7 CFR 1717.308 - RUS approval of nonconforming rates.

    Science.gov (United States)

    2010-01-01

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

  4. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

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

  5. Three Newly Approved Analgesics: An Update

    OpenAIRE

    Saraghi, Mana; Hersh, Elliot V.

    2013-01-01

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

  6. Credit Risk Management - Loan Approval Process

    OpenAIRE

    Lulzim Rashiti; Branimir Kalas; Lazar Drec; Nino Stameski

    2016-01-01

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

  7. Social desirability, approval and public good contribution

    OpenAIRE

    Daniel John Zizzo; Piers Fleming

    2009-01-01

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

  8. Academic Program Approval and Review Practices

    Directory of Open Access Journals (Sweden)

    Don G. Creamer

    1999-08-01

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

  9. Drug updates and approvals: 2015 in review.

    Science.gov (United States)

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

    2015-12-12

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

  10. 46 CFR 162.050-13 - Factory production and inspection.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Factory production and inspection. 162.050-13 Section..., AND MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Pollution Prevention Equipment § 162.050-13 Factory production and inspection. (a) Equipment manufactured under Coast Guard approval...

  11. Product Quality of Parenteral Vancomycin Products in the United States

    OpenAIRE

    Nambiar, S; Madurawe, R. D.; Zuk, S. M.; Khan, S. R.; Ellison, C. D.; Faustino, P.J.; Mans, D. J.; Trehy, M. L.; Hadwiger, M. E.; Boyne, M. T.; K Biswas; Cox, E. M.

    2012-01-01

    In response to concerns raised about the quality of parenteral vancomycin products, the U.S. Food and Drug Administration (FDA) is investigating the product quality of all FDA-approved parenteral vancomycin products available in the United States. Product quality was evaluated independently at two FDA Office of Testing and Research (FDA-OTR) sites. In the next phase of the investigation, being done in collaboration with the National Institute of Allergy and Infectious Diseases, the in vivo ac...

  12. Impact of Clinical Response on Different Approved Doses in Japan and the United States.

    Science.gov (United States)

    Sugita, Yuko; Inoue, Eisuke; Narukawa, Mamoru

    2012-10-01

    The pharmaceutical industry has increasingly aimed to achieve efficient strategies for simultaneous international and worldwide development of medicines, and there has been a growing need to understand ethnic differences in drug evaluation. Japan is one of the unique countries in which substantial domestic clinical data are required for dose selection as well as for marketing authorization. However, it appears challenging to accumulate a large amount of data in a single country in the recent shift to international drug development. To gain a better understanding of the influence of ethnic factors, the dosages of the products approved in Japan during 2003-2010 were reviewed, and differences in clinical responses between Japan and the United States were evaluated using a modeling approach. Of new medicines (new molecular entities) approved in Japan, 39 products (28.1%) have been approved at a different dose level compared with the United States, of which 13 products have considerable difference, twice or greater. Of those 13 products, only 2 were suggested to have a different clinical response, although limited data availability should be taken into careful consideration. Further investigation is recommended to establish new approaches for appropriate dose selection and thereby increase the efficiency of international drug development. PMID:27121458

  13. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... are imported, sold online, and heavily promoted on social media sites. Some can also be found on ... firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to ...

  14. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... products. To help people with long-term weight management, FDA has approved prescription drugs such as Belviq, ... Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance Federal, State & Local Officials Consumers Health ...

  15. Radiation Emitting Product Corrective Actions and Recalls

    Data.gov (United States)

    U.S. Department of Health & Human Services — This database provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and...

  16. 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.

  17. Shareholders, creditors approve utility reorganization plan

    International Nuclear Information System (INIS)

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

  18. Alternate approaches for pediatric type 1 diabetes drug development and potential regulatory approval: a perspective.

    Science.gov (United States)

    Turner, J Rick; Close, Kelly L; Fleming, G Alexander; Wherrett, Diane K; DiMeglio, Linda A

    2015-10-01

    The incidence and prevalence of pediatric type 1 diabetes are increasing globally, including in the U.S. While the increasing number of cases of pediatric diabetes makes expeditious availability of new medical products and therapies for diabetes care essential, there have been many barriers encountered in bringing some drugs and devices to pediatric patients who may benefit. Newer insulins have been studied and approved for use in children. However, hurdles exist in the inclusion of children in studies of therapies aimed at preventing β-cell loss in those with new-onset diabetes and those at risk for type 1 diabetes. This Perspective focuses on potential solutions to the challenges experienced in bringing new drugs for pediatric type 1 diabetes to marketing approval. Given their central importance as the users of medical products, patient perspectives are included along with scientific and regulatory considerations. PMID:26404928

  19. An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins

    OpenAIRE

    Heinemann, Lutz; Khatami, Hootan; McKinnon, Ross; Home, Philip

    2015-01-01

    Abstract Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars were reviewed. Information was sourced through Internet searching and cross-referencing guide...

  20. THE GOOD HOUSEKEEPING SEAL OF APPROVAL: FROM INNOVATIVE CONSUMER PROTECTION TO POPULAR BADGE OF QUALITY

    Directory of Open Access Journals (Sweden)

    Lauren Strach

    2003-01-01

    Full Text Available By providing information through factual content, editorial comments, and advertising, the great magazine expansion of the late 19th century reduced market imperfections for many consumer goods. Given the virtual absence of government and non-profit sources of information, some magazines even took the initiative to prohibit misleading advertising. However, in the early 20th century Good Housekeeping surpassed normal practices and created both a guaranty for advertised products and a Seal of Approval from the Good Housekeeping Institute.

  1. Levomilnacipran extended release: first global approval.

    Science.gov (United States)

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

    2013-09-01

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

  2. 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...

  3. Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition.

    Science.gov (United States)

    Evens, Ronald P

    2016-01-01

    The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recombinant human insulin in 1982, originating from the Genentech company. The pharma industry in the early years of 1970s and 1980s engaged with biotechnology companies only to a small extent with their in-licensing of a few recombinant molecules, led by Roche, Eli Lilly, and Johnson and Johnson. However, subsequently and dramatically over the last 25 years, biotechnology has become a primary driver of product and technology innovation and has become a cornerstone in new product development by all biopharma companies. This review demonstrates these evolutionary changes regarding approved products, product pipelines, novelty of the products, FDA approval rates, product sales, financial R&D investments in biotechnology, partnerships, mergers and acquisitions, and patent issues. We now have about 300 biotechnology products approved in USA covering 16 medical disciplines and about 250 indications, with the engagement of 25 pharma companies, along with their biotechnology company innovators and partners. The biotechnology pipeline involves over 1000 molecules in clinical trials, including over 300 molecules associated with the top 10 pharma companies. Product approval rates by the FDA for biotechnology products are over double the rate for drugs. Yes, the R&D paradigm has changed with biotechnology now as one of the major focuses for new product development with novel molecules by the whole biopharma industry. PMID:26475480

  4. 75 FR 52709 - Notice of Request for Extension of Approval of an Information Collection; Importation of Animals...

    Science.gov (United States)

    2010-08-27

    ...; ] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service Notice of Request for Extension of Approval of an Information Collection; Importation of Animals and Poultry, Animal and Poultry Products, Certain Animal Embryos, Semen, and Zoological Animals AGENCY: Animal and Plant Health Inspection...

  5. 9 CFR 55.8 - Official CWD tests and approval of laboratories to conduct official CWD tests.

    Science.gov (United States)

    2010-01-01

    ... determines that the laboratory: (1) Employs personnel assigned to supervise the testing who are qualified to... cases for at least 1 year and from positive cases for 5 years; (7) Will allow APHIS to inspect 1 the... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Official CWD tests and approval...

  6. 9 CFR 54.11 - Approval of laboratories to run official scrapie tests and official genotype tests.

    Science.gov (United States)

    2010-01-01

    ... he or she determines that the laboratory: (1) Employs personnel assigned to supervise the testing who... retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of laboratories to...

  7. 21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS Records and Reports § 510.305 Maintenance...

  8. 21 CFR 314.54 - Procedure for submission of an application requiring investigations for approval of a new...

    Science.gov (United States)

    2010-04-01

    ..., or sale of the drug product. (vi) Any patent certification or statement required under section 505(b... requiring investigations for approval of a new indication for, or other change from, a listed drug. 314.54 Section 314.54 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  9. Board approves three new graduate degree programs; all further support key university research, teaching and outreach objectives

    OpenAIRE

    Hincker, Lawrence

    2007-01-01

    Responding to future directions in medical product discovery and development, and the emerging needs of industry and regulatory agencies, Virginia Tech and Georgetown University have created a joint graduate level degree program, a Master of Science in Biomedical Technology Development and Management, approved today by Virginia Tech's Board of Visitors.

  10. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims......

  11. 76 FR 34032 - Notice of Revision and Request for Extension of Approval of an Information Collection; Swine...

    Science.gov (United States)

    2011-06-10

    ... infectious and communicable diseases can be transmitted to swine. APHIS' regulations promulgated under the... interstate spread of swine diseases and to request extension of approval of the information collection to... products to prevent the dissemination within the United States of animal diseases and pests of...

  12. Council approves statement on natural hazards

    Science.gov (United States)

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

  13. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... seized products, and criminally prosecuted people responsible for marketing these illegal diet products. In addition, FDA maintains an online list of tainted weight-loss products. To help people with long-term weight management, FDA has approved prescription drugs such as Belviq, ...

  14. Organic tomato transplant production and supplemental fertilizers

    Science.gov (United States)

    Producing healthy transplants for organic production systems is an essential step in the process of maximizing crop yields. All components entering into the organic crop production system must be approved for organic use, including the seed, soil media, and fertilizer used in transplant production....

  15. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... products. To help people with long-term weight management, FDA has approved prescription drugs such as Belviq, ... one week.” use of the words “guaranteed” or “scientific breakthrough.” products marketed in a foreign language. products ...

  16. 28 CFR 551.31 - Approval of an organization.

    Science.gov (United States)

    2010-07-01

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

  17. 30 CFR 75.800-2 - Approved circuit schemes.

    Science.gov (United States)

    2010-07-01

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

  18. 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...

  19. 34 CFR 668.156 - Approved State process.

    Science.gov (United States)

    2010-07-01

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

  20. 25 CFR 216.7 - Approval of mining plan.

    Science.gov (United States)

    2010-04-01

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

  1. 43 CFR 23.8 - Approval of mining plan.

    Science.gov (United States)

    2010-10-01

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

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

    Science.gov (United States)

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

    2005-01-01

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

  3. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-10-25

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

  4. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

  5. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-26

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

  6. 76 FR 63833 - Commission Approval of Divestiture Agreements

    Science.gov (United States)

    2011-10-14

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

  7. 14 CFR 21.609 - Approval for deviation.

    Science.gov (United States)

    2010-01-01

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

  8. 28 CFR 20.23 - Documentation: Approval by OJARS.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Documentation: Approval by OJARS. 20.23 Section 20.23 Judicial Administration DEPARTMENT OF JUSTICE CRIMINAL JUSTICE INFORMATION SYSTEMS State and Local Criminal History Record Information Systems § 20.23 Documentation: Approval by OJARS. Within...

  9. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

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

  10. 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...

  11. 19 CFR 115.63 - Application for approval.

    Science.gov (United States)

    2010-04-01

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

  12. 48 CFR 206.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  13. 48 CFR 2406.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  14. 48 CFR 806.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  15. 48 CFR 306.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  16. 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.

  17. 7 CFR 714.45 - Approval by Deputy Administrator.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 7 2010-01-01 2010-01-01 false Approval by Deputy Administrator. 714.45 Section 714... PENALTIES ERRONEOUSLY, ILLEGALLY, OR WRONGFULLY COLLECTED § 714.45 Approval by Deputy Administrator. The Deputy Administrator shall review each claim forwarded to him by the State committee to determine...

  18. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

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

  19. 42 CFR 37.42 - Approval of roentgenographic facilities.

    Science.gov (United States)

    2010-10-01

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

  20. 46 CFR 160.076-25 - Approval testing.

    Science.gov (United States)

    2010-10-01

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

  1. 21 CFR 900.6 - Withdrawal of approval.

    Science.gov (United States)

    2010-04-01

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

  2. 75 FR 13204 - Notice of Petition for Approval

    Science.gov (United States)

    2010-03-18

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

  3. 46 CFR 162.017-6 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

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

  4. 40 CFR 57.603 - Criteria for approval.

    Science.gov (United States)

    2010-07-01

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

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

    International Nuclear Information System (INIS)

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

  6. 49 CFR 238.21 - Special approval procedure.

    Science.gov (United States)

    2010-10-01

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

  7. 14 CFR 414.29 - Safety approval transfer.

    Science.gov (United States)

    2010-01-01

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

  8. 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

  9. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

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

  10. 38 CFR 21.4263 - Approval of flight training courses.

    Science.gov (United States)

    2010-07-01

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

  11. 7 CFR 1717.608 - RUS approval of contracts.

    Science.gov (United States)

    2010-01-01

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

  12. Thirty-seven NSFC-KOSEF Cooperative Projects Approved

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

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

  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. How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?

    Science.gov (United States)

    Bogaert, Peter; Van Keymeulen, Eveline

    2012-09-01

    This article sheds light on the relationship, or rather, absence of a relationship, between patent rights and regulatory approval procedures in the EU. The principle of 'patent linkage' has long been recognized and applied by regulatory authorities in the USA. The European Commission, however, opposes the idea of linking patent rights to marketing authorizations and pricing and reimbursement decisions. This position is grounded in Article 126 of Directive 2001/83 and is expected not to change anytime soon, given the clear reaffirmation thereof in the recent Sector Inquiry Report and Transparency Directive Proposal. Therefore, the European Medicines Agency or national authorities are not permitted to refuse approval and, likely, pricing and reimbursement of a generic when the innovative reference product is still protected by a patent. The authors, however, advocate that there are strong legal arguments for patent holders to challenge regulatory decisions that did not respect their patent rights before the competent national courts. PMID:24236878

  15. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2013-09-05

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

  16. 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

  17. Characterization of spent fuel approved testing material--ATM-104

    Energy Technology Data Exchange (ETDEWEB)

    Guenther, R.J.; Blahnik, D.E.; Jenquin, U.P.; Mendel, J.E.; Thomas, L.E.; Thornhill, C.K.

    1991-12-01

    The characterization data obtained to date are described for Approved Testing Material 104 (ATM-104), which is spent fuel from Assembly DO47 of the Calvert Cliffs Nuclear Power Plant (Unit 1), a pressurized-water reactor. This report is one in a series being prepared by the Materials Characterization Center at Pacific Northwest Laboratory (PNL) on spent fuel ATMs. The ATMs are receiving extensive examinations to provide a source of well-characterized spent fuel for testing in the US Department of Energy Office of Civilian Radioactive Waste Management (OCRWM) Program. ATM-104 consists of 128 full-length irradiated fuel rods with rod-average burnups of about 42 MWd/kgM and expected fission gas release of about 1%. A variety of analyses were performed to investigate cladding characteristics, radionuclide inventory, and redistribution of fission products. Characterization data include (1) fabricated fuel design, irradiation history, and subsequent storage and handling history; (2) isotopic gamma scans; (3) fission gas analyses; (4) ceramography of the fuel and metallography of the cladding; (5) special fuel studies involving analytical transmission electron microscopy (AEM) and electron probe microanalyses (EPMA); (6) calculated nuclide inventories and radioactivities in the fuel and cladding; and (7) radiochemical analyses of the fuel and cladding.

  18. Characterization of spent fuel approved testing material--ATM-104

    International Nuclear Information System (INIS)

    The characterization data obtained to date are described for Approved Testing Material 104 (ATM-104), which is spent fuel from Assembly DO47 of the Calvert Cliffs Nuclear Power Plant (Unit 1), a pressurized-water reactor. This report is one in a series being prepared by the Materials Characterization Center at Pacific Northwest Laboratory (PNL) on spent fuel ATMs. The ATMs are receiving extensive examinations to provide a source of well-characterized spent fuel for testing in the US Department of Energy Office of Civilian Radioactive Waste Management (OCRWM) Program. ATM-104 consists of 128 full-length irradiated fuel rods with rod-average burnups of about 42 MWd/kgM and expected fission gas release of about 1%. A variety of analyses were performed to investigate cladding characteristics, radionuclide inventory, and redistribution of fission products. Characterization data include (1) fabricated fuel design, irradiation history, and subsequent storage and handling history; (2) isotopic gamma scans; (3) fission gas analyses; (4) ceramography of the fuel and metallography of the cladding; (5) special fuel studies involving analytical transmission electron microscopy (AEM) and electron probe microanalyses (EPMA); (6) calculated nuclide inventories and radioactivities in the fuel and cladding; and (7) radiochemical analyses of the fuel and cladding

  19. 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)

  20. Environmental approvals in New Brunswick : economic considerations

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-07-01

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

  1. Guidance for package approvals in the United Kingdom

    International Nuclear Information System (INIS)

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

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

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    1999-02-24

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

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

    International Nuclear Information System (INIS)

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

  4. Scientific considerations in the review and approval of generic enoxaparin in the United States.

    Science.gov (United States)

    Lee, Sau; Raw, Andre; Yu, Lawrence; Lionberger, Robert; Ya, Naiqi; Verthelyi, Daniela; Rosenberg, Amy; Kozlowski, Steve; Webber, Keith; Woodcock, Janet

    2013-03-01

    In 2010, the US Food and Drug Administration (FDA) approved a generic low-molecular-weight heparin without clinical safety or efficacy data under the Abbreviated New Drug Application (ANDA) pathway. To enable a determination of active ingredient sameness of generic and innovator enoxaparin products, the FDA developed a scientifically rigorous approach based on five criteria: first, equivalence of physicochemical properties; second, equivalence of heparin source material and mode of depolymerization; third, equivalence in disaccharide building blocks, fragment mapping and sequence of oligosaccharide species; fourth, equivalence in biological and biochemical assays; and finally, equivalence of in vivo pharmacodynamic profile. In addition to fulfillment of these criteria, FDA also used in vitro, ex vivo and model animal data to ensure there was no increased immunogenicity risk of the generic enoxaparin product relative to the brand name product. The approval of the highly complex enoxaparin product using this framework under the ANDA pathway represents a major development. It also suggests that analytical and scientific advancements may in certain cases allow the elimination of unnecessary in vivo testing in animals and humans. PMID:23471071

  5. Grandfathering of competent authority approved packages

    International Nuclear Information System (INIS)

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

  6. 7 CFR 52.53 - Approved identification.

    Science.gov (United States)

    2010-01-01

    ... a USDA color standard, defect guide or other similar aid under such terms and conditions as may be... bear a brand name, trademark, product name, company name, or any other descriptive material...

  7. Requirements for US regulatory approval of the International Thermonuclear Experimental Reactor (ITER)

    International Nuclear Information System (INIS)

    The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project

  8. FDA Approves New Drug to Treat Bladder Cancer

    Science.gov (United States)

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

  9. 78 FR 27470 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-05-10

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

  10. 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,...

  11. 40 CFR 82.38 - Approved independent standards testing organizations.

    Science.gov (United States)

    2010-07-01

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

  12. 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...

  13. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    2010-07-01

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

  14. Living with Fibromyalgia, Drugs Approved to Manage Pain

    Science.gov (United States)

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

  15. Xalkori Approved for Rare Genetic Form of Lung Cancer

    Science.gov (United States)

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

  16. 7 CFR 1786.56 - Approval of applications.

    Science.gov (United States)

    2010-01-01

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

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

    Data.gov (United States)

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

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

    OpenAIRE

    Yuan, Shu

    2015-01-01

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

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

    OpenAIRE

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

    2013-01-01

    This article reviews the approval process of genetically modified organisms (GMOs) in Japan. The purpose of this review is to explain the Japanese safety approval procedures for food, feed, and imported GMOs and place it in an international context through a comparison with the United States and the European Union (EU). While the regulatory regime in the United States and EU is often discussed, little is understood about the Japanese regulations. However, Japan plays an important role in term...

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

    Science.gov (United States)

    Turkoski, Beatrice B

    2016-01-01

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

  1. 21 CFR 211.192 - Production record review.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production record review. 211.192 Section 211.192... Production record review. All drug product production and control records, including those for packaging and... established, approved written procedures before a batch is released or distributed. Any...

  2. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... to an FDA-approved drug or as having effects similar to prescription drugs. back to top Advice for Consumers Generally, if ... Loss Products More in Consumer Updates Animal & ... Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco ...

  3. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... as amended by the Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and ...

  4. 78 FR 39783 - New Postal Product

    Science.gov (United States)

    2013-07-02

    ... Statement of Supporting Justification, Dennis R. Nicoski, Manager, Field Sales Strategy and Contracts... business day after the Commission issues all necessary regulatory approval. Id. at 3. The contract will... noticing a recently-filed Postal Service request to add a new product to the competitive product list....

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

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-04-01

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

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

    OpenAIRE

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices. PMID:27159747

  8. Application for approval of the Cold Lake Expansion Project: volume 1: project description

    International Nuclear Information System (INIS)

    Imperial Oil Resources Limited has applied for approval from both the Alberta Energy and Utilities Board and the Albert Environmental Protection Branch for approvals to expand bitumen recovery operations at Cold Lake, Alberta. The proposed project will consist of: (1) a new three-phase oil field development called Mahkeses which will recover 46 million cubic metres of bitumen at a production rate of 4,800 cubic metres per day, (2) a 220 megawatt electrical power cogeneration facility at the Mahkeses central plant, and (3) additional development to maintain and optimize bitumen steam production at the company's existing Maskwa and Mahihkan operation areas at Cold Lake. Cyclic steam stimulation will be used to recover the bitumen. The expansion will involve drilling new wells, construction of pipelines and multiwell pads. Production will be processed at the plants before the bitumen is mixed with diluent to reduce its viscosity. The bitumen will be transported to markets through pipeline systems originating in Cold Lake. Approximately 45 per cent of the electricity generated from the electrical power cogeneration facility will be used on site. The remainder will be available for sale to the Alberta Power Pool. 18 refs., 32 tabs., 55 figs

  9. Vaccination of Rhesus Macaques with the Anthrax Vaccine Adsorbed Vaccine Produces a Serum Antibody Response That Effectively Neutralizes Receptor-Bound Protective Antigen In Vitro ▿

    OpenAIRE

    Clement, Kristin H.; Rudge, Thomas L.; Mayfield, Heather J.; Carlton, Lena A.; Hester, Arelis; Niemuth, Nancy A.; Sabourin, Carol L.; Brys, April M.; Quinn, Conrad P.

    2010-01-01

    Anthrax toxin (ATx) is composed of the binary exotoxins lethal toxin (LTx) and edema toxin (ETx). They have separate effector proteins (edema factor and lethal factor) but have the same binding protein, protective antigen (PA). PA is the primary immunogen in the current licensed vaccine anthrax vaccine adsorbed (AVA [BioThrax]). AVA confers protective immunity by stimulating production of ATx-neutralizing antibodies, which could block the intoxication process at several steps (binding of PA t...

  10. 12 CFR 516.280 - How will I know if my application has been approved?

    Science.gov (United States)

    2010-01-01

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

  11. 38 CFR 21.4155 - Evaluations of State approving agency performance.

    Science.gov (United States)

    2010-07-01

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

  12. 7 CFR 4290.510 - Approval of RBIC's Investment Adviser/Manager.

    Science.gov (United States)

    2010-01-01

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

  13. 21 CFR 316.31 - Scope of orphan-drug exclusive approval.

    Science.gov (United States)

    2010-04-01

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

  14. 7 CFR 1717.613 - RUS approval of data processing and system control equipment.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of data processing and system control... AND GUARANTEED ELECTRIC LOANS Operational Controls § 1717.613 RUS approval of data processing and... approval from RUS before purchasing data processing equipment or system control equipment, such approval...

  15. 9 CFR 317.4 - Labeling approval.

    Science.gov (United States)

    2010-01-01

    ... indication of final color, as specified in § 317.2. FSIS will accept sketches that are hand drawn, computer.... Indication of final color may be met by: submission of a color sketch, submission of a sketch which indicates... carcass ink brands and meat food product ink and burning brands, which comply with parts 312 and 316...

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

    International Nuclear Information System (INIS)

    Type B packages and all packages containing fissile material, as well as special form materials, special arrangements and certain shipments, are required to be approved by the Competent Authority. In the United Kingdom, this function is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division of the Department of the Environment, Transport and the Regions (RMTD). Competent Authority approval is given only after a detailed assessment of the design by the specialist staff of RMTD. There are three facets to the assessment procedure, namely engineering, criticality and radiation protection, and quality assurance. The applicant is responsible for making the case for approval, but the assessment is facilitated if the Competent Authority is involved with the designer at an early stage in development and during the construction of the test prototype. Central to the approval process is the regulatory test program, which is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test program, the applicant submit a formal application, supported by the Design Safety Report, which provides a full analysis of the design and the test results, including the behaviour of the package under normal and accident conditions of transport, the manufacturing and maintenance procedures, quality assurance and the emergency provisions for the operation of the package. RMTD produces a comprehensive Guide to Applications, which details the information required in all types of application for Competent Authority approval in the United Kingdom. (authors)

  17. PEGylation of Biopharmaceuticals: A Review of Chemistry and Nonclinical Safety Information of Approved Drugs.

    Science.gov (United States)

    Turecek, Peter L; Bossard, Mary J; Schoetens, Freddy; Ivens, Inge A

    2016-02-01

    Modification of biopharmaceutical molecules by covalent conjugation of polyethylene glycol (PEG) molecules is known to enhance pharmacologic and pharmaceutical properties of proteins and other large molecules and has been used successfully in 12 approved drugs. Both linear and branched-chain PEG reagents with molecular sizes of up to 40 kDa have been used with a variety of different PEG derivatives with different linker chemistries. This review describes the properties of PEG itself, the history and evolution of PEGylation chemistry, and provides examples of PEGylated drugs with an established medical history. A trend toward the use of complex PEG architectures and larger PEG polymers, but with very pure and well-characterized PEG reagents is described. Nonclinical toxicology findings related to PEG in approved PEGylated biopharmaceuticals are summarized. The effect attributed to the PEG part of the molecules as observed in 5 of the 12 marketed products was cellular vacuolation seen microscopically mainly in phagocytic cells which is likely related to their biological function to absorb and remove particles and macromolecules from blood and tissues. Experience with marketed PEGylated products indicates that adverse effects in toxicology studies are usually related to the active part of the drug but not to the PEG moiety. PMID:26869412

  18. 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

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

    Science.gov (United States)

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

    2016-03-01

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

  20. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

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

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

  2. 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 ...

  3. 2015 in review: FDA approval of new drugs.

    Science.gov (United States)

    Kinch, Michael S

    2016-07-01

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

  4. 46 CFR 160.171-25 - Production testing.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production testing. 160.171-25 Section 160.171-25...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Immersion Suits § 160.171-25 Production testing. (a) Immersion suit production testing is conducted under the procedures in this section and subpart 159.007 of...

  5. 46 CFR 160.174-25 - Production testing.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production testing. 160.174-25 Section 160.174-25...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Thermal Protective Aids § 160.174-25 Production testing. (a) Thermal protective aid production testing is conducted under the procedures in this section and...

  6. 7 CFR 58.210 - Dry storage of product.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Dry storage of product. 58.210 Section 58.210... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) GRADING AND INSPECTION, GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1...

  7. 40 CFR 300.920 - Addition of products to Schedule.

    Science.gov (United States)

    2010-07-01

    ... pursuant to the provisions in 40 CFR part 2, subpart B. Such information must be submitted separately from... approval of the product. To avoid possible misinterpretation or misrepresentation, any label, advertisement...) Dispersants. (1) To add a dispersant to the NCP Product Schedule, submit the technical product data...

  8. 21 CFR 814.19 - Product development protocol (PDP).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA...

  9. Criteria relating to the approval of consumer goods containing radioactive substances: a consultative document

    International Nuclear Information System (INIS)

    The National Radiological Protection Board currently provides manufacturers and suppliers of consumer goods containing radioactive substances with advice on the acceptability of their products. Examples of such goods available to the public include radioluminous devices such as clocks, watches and compasses, products containing gaseous tritium light sources, ionisation chamber smoke detectors and thorium gas mantles. In the present document, detailed proposals are put forward for criteria which the Board may use when considering applications for the approval of goods containing radioactive substances to ensure that they are safe. The proposals relate to the radiation doses to consumers and others who may be exposed as a consequence of their activities, and also consider the benefits to consumers. They are concerned with doses arising during normal use, through accidents and misuse, and as a consequence of uncontrolled disposal. (U.K.)

  10. Tetracel (American Home Products).

    Science.gov (United States)

    Jones, D H

    2001-01-01

    American Home Products (AHP) is developing Tetracel as a vaccine for children (aged 12 to 18 months) against diphtheria, tetanus, pertussis and Haemophilus influenzae type B (Hib) [275146]. The components are contained in AHP's two currently marketed vaccines. ACEL-Immune contains diphtheria and tetanus toxoids with acellular pertussis vaccine adsorbed, and HibTITER contains the Haemophilus influenzae B conjugate vaccine (diphtheria CRM197 protein conjugate) [239655]. As of January 2000, Lehman Brothers predicted Tetracel to be approved in the US during 2000 [354434]. PMID:11527012

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

    Science.gov (United States)

    Shrawder, Jack; And Others

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

  12. 24 CFR 945.201 - Approval to designate housing.

    Science.gov (United States)

    2010-04-01

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

  13. 30 CFR 918.10 - State regulatory program approval.

    Science.gov (United States)

    2010-07-01

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

  14. 19 CFR 151.13 - Approval of commercial gaugers.

    Science.gov (United States)

    2010-04-01

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

  15. 34 CFR 668.146 - Criteria for approving tests.

    Science.gov (United States)

    2010-07-01

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

  16. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

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

  17. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

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

  18. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-26

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

  19. 78 FR 15402 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-11

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

  20. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

  1. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

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

  2. 38 CFR 21.4267 - Approval of independent study.

    Science.gov (United States)

    2010-07-01

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

  3. 31 CFR 3.23 - Approval of claims.

    Science.gov (United States)

    2010-07-01

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

  4. 10 CFR 72.234 - Conditions of approval.

    Science.gov (United States)

    2010-01-01

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

  5. 40 CFR 82.160 - Approved equipment testing organizations.

    Science.gov (United States)

    2010-07-01

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

  6. 46 CFR 160.176-5 - Approval procedures.

    Science.gov (United States)

    2010-10-01

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

  7. 77 FR 42002 - Revision of Approved Information Collection

    Science.gov (United States)

    2012-07-17

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

  8. 78 FR 1718 - Approved Tests for Bovine Tuberculosis in Cervids

    Science.gov (United States)

    2013-01-09

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

  9. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

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

  10. 14 CFR 21.500 - Approval of engines and propellers.

    Science.gov (United States)

    2010-01-01

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

  11. 7 CFR 1735.62 - Approval of acquisitions and mergers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval of acquisitions and mergers. 1735.62 Section 1735.62 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Mortgage Controls on Acquisitions...

  12. 12 CFR 303.62 - Transactions requiring prior approval.

    Science.gov (United States)

    2010-01-01

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

  13. 48 CFR 906.304 - Approval of the justification.

    Science.gov (United States)

    2010-10-01

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

  14. 10 CFR 903.22 - Final rate approval.

    Science.gov (United States)

    2010-01-01

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

  15. 75 FR 5844 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-02-04

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

  16. 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.

  17. 75 FR 17758 - Approved Recovery Plan for the Scaleshell Mussel

    Science.gov (United States)

    2010-04-07

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

  18. 43 CFR 23.7 - Approval of exploration plan.

    Science.gov (United States)

    2010-10-01

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

  19. 25 CFR 225.22 - Approval of minerals agreements.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Approval of minerals agreements. 225.22 Section 225.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS OIL AND GAS, GEOTHERMAL... required, with section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C))...

  20. 77 FR 26037 - Renewal of Approved Information Collection

    Science.gov (United States)

    2012-05-02

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

  1. 77 FR 29747 - Notice of Request for Information Collection Approval

    Science.gov (United States)

    2012-05-18

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

  2. 46 CFR 160.053-6 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

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

  3. 27 CFR 24.258 - Certificates of approval or exemption.

    Science.gov (United States)

    2010-04-01

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

  4. 48 CFR 32.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

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

  5. 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...

  6. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

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

  7. 45 CFR 1355.53 - Conditions for approval of funding.

    Science.gov (United States)

    2010-10-01

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

  8. 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.

  9. 29 CFR 1952.246 - Changes to approved plans.

    Science.gov (United States)

    2010-07-01

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

  10. 50 CFR Appendix B to Part 404 - Approved VMS

    Science.gov (United States)

    2010-10-01

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

  11. 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. |

  12. 19 CFR 134.45 - Approved markings of country name.

    Science.gov (United States)

    2010-04-01

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

  13. Senate approves global warming bill; House bill introduced

    International Nuclear Information System (INIS)

    This article examines the Senate approved global warming bill and its impact to the Department of Energy (DOE) and the power industry. The bill requires stabilization or reduction of the greenhouse gases produced by the United States by the year 2005. DOE is required to develop a least-cost national energy strategy. A similar bill has been introduced into the House

  14. 22 CFR 129.6 - Requirement for license/approval.

    Science.gov (United States)

    2010-04-01

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

  15. 21 CFR 601.12 - Changes to an approved application.

    Science.gov (United States)

    2010-04-01

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

  16. 76 FR 59863 - Application and Approval Process for New Programs

    Science.gov (United States)

    2011-09-27

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

  17. 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.

  18. The Cost of Delaying Approval of Golden Rice

    NARCIS (Netherlands)

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

    2014-01-01

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

  19. 20 CFR 656.32 - Revocation of approved labor certifications.

    Science.gov (United States)

    2010-04-01

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

  20. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Science.gov (United States)

    2010-04-01

    ... chapter is required for marketing. In the absence of an approved application, such product is also..., 1990, any such OTC drug product initially introduced or initially delivered for introduction...

  1. 78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

    Science.gov (United States)

    2013-07-10

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

  2. 78 FR 65030 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Approval of...

    Science.gov (United States)

    2013-10-30

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

  3. 75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-05-04

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

  4. 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.

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 76 FR 75523 - Vessel Monitoring Systems; Approved Mobile Transmitting Units and Communications Service...

    Science.gov (United States)

    2011-12-02

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

  11. 5 CFR 7301.102 - Prior approval for outside teaching, speaking and writing.

    Science.gov (United States)

    2010-01-01

    ... or Federal regulation, including 5 CFR part 2635. ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside teaching... approval for outside teaching, speaking and writing. (a) Before engaging in outside teaching, speaking...

  12. 7 CFR 1710.209 - Approval requirements for load forecast work plans.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

    2010-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Vihang S. Chawan

    2015-08-01

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

  15. Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

    Science.gov (United States)

    Smith, Colleen

    2015-01-01

    Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation. PMID:26292478

  16. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... Feed Download PDF (245 K) En Español On this page: Tainted Products Dietary Supplements are not FDA-Approved Know the Warning Signs Advice for Consumers “This year, I’m going to lose some weight.” ...

  17. 78 FR 70968 - New Postal Product

    Science.gov (United States)

    2013-11-27

    ... Statement of Supporting Justification, Dennis R. Nicoski, Manager, Field Sales Strategy and Contracts... business day after the Commission issues all necessary regulatory approval. Id. at 2. The contract will... competitive product list. This notice informs the public of the filings, invites public comment, and...

  18. 78 FR 70970 - New Postal Product

    Science.gov (United States)

    2013-11-27

    ... Statement of Supporting Justification, Dennis R. Nicoski, Manager, Field Sales Strategy and Contracts... business day after the Commission issues all necessary regulatory approval. Id. at 2. The contract will... competitive product list. This notice informs the public of the filings, invites public comment, and...

  19. 78 FR 70084 - New Postal Product

    Science.gov (United States)

    2013-11-22

    ... Strategy and Contracts, asserts that the contract will cover its attributable costs and increase... become effective one business day after the Commission issues all necessary regulatory approval. Id. at 3... competitive product list. This notice informs the public of the filing, invites public comment, and...

  20. 78 FR 70969 - New Postal Product

    Science.gov (United States)

    2013-11-27

    ... Statement of Supporting Justification, Dennis R. Nicoski, Manager, Field Sales Strategy and Contracts... business day after the Commission issues all necessary regulatory approval. Id. at 2. The contract will... competitive product list. This notice informs the public of the filings, invites public comment, and...

  1. Beware of Products Promising Miracle Weight Loss

    Medline Plus

    Full Text Available ... contained triamterene, a powerful diuretic (sometimes known as “water pills”) that can have serious side-effects and ... products. To help people with long-term weight management, FDA has approved prescription drugs such as Belviq, ...

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

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-02-01

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

  4. 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...

  5. 75 FR 38591 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-07-02

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

  6. 75 FR 51155 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-08-18

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

  7. 75 FR 41369 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD Revision 1; Withdrawal

    Science.gov (United States)

    2010-07-16

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

  8. 75 FR 41404 - List of Approved Spent Fuel Storage Casks: NUHOMS®

    Science.gov (United States)

    2010-07-16

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

  9. 14 CFR 91.1077 - Training program and revision: Initial and final approval.

    Science.gov (United States)

    2010-01-01

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

  10. 43 CFR 45.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

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

  11. 13 CFR 106.303 - Who has authority to approve and sign a Fee Based Record?

    Science.gov (United States)

    2010-01-01

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

  12. 50 CFR 221.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

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

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

    Science.gov (United States)

    2010-01-01

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

  14. 75 FR 65567 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards

    Science.gov (United States)

    2010-10-26

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

  15. 25 CFR 290.5 - Who approves tribal revenue allocation plans?

    Science.gov (United States)

    2010-04-01

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

  16. 30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests... means approved by the Secretary, and tests for methane shall be made with a methane detector approved...

  17. 30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.

    Science.gov (United States)

    2010-07-01

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

  18. 22 CFR 201.85 - Legal effect of USAID approvals and decisions.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Legal effect of USAID approvals and decisions... § 201.85 Legal effect of USAID approvals and decisions. In any transaction subject to this part 201... funds. Any decision by USAID to exercise or refrain from exercising these approval rights shall be...

  19. 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...

  20. 13 CFR 108.380 - Final approval as a NMVC Company.

    Science.gov (United States)

    2010-01-01

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

  1. 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...

  2. 7 CFR 1427.1086 - Approval of warehouse, requests for reconsideration.

    Science.gov (United States)

    2010-01-01

    ... CFR part 780. When appealing under such regulations, the warehouseman shall be considered as a... 7 Agriculture 10 2010-01-01 2010-01-01 false Approval of warehouse, requests for reconsideration... Standards for Approval of Warehouses for Cotton and Cotton Linters § 1427.1086 Approval of...

  3. 77 FR 48167 - Approved Tribal-State Class III Gaming Compact; Indian Gaming

    Science.gov (United States)

    2012-08-13

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

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

    OpenAIRE

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

    2013-01-01

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

  5. 78 FR 47253 - Approval and Promulgation of Air Quality Implementation Plans; Maine; Oxides of Nitrogen...

    Science.gov (United States)

    2013-08-05

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

  6. 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...

  7. 40 CFR 63.95 - Additional approval criteria for accidental release prevention programs.

    Science.gov (United States)

    2010-07-01

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

  8. 46 CFR 160.171-19 - Approval testing for child size immersion suit.

    Science.gov (United States)

    2010-10-01

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

  9. 46 CFR 160.171-17 - Approval testing for adult size immersion suit.

    Science.gov (United States)

    2010-10-01

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

  10. 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...

  11. 7 CFR 1717.159 - Applications for RUS approvals of mergers.

    Science.gov (United States)

    2010-01-01

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

  12. 7 CFR 1751.104 - Obtaining RUS approval of a proposed Modernization Plan.

    Science.gov (United States)

    2010-01-01

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

  13. 7 CFR 1717.611 - RUS approval of expenditures for legal, accounting, engineering, and supervisory services.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of expenditures for legal, accounting... COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Operational Controls § 1717.611 RUS approval of... contract requires the borrower to obtain approval from RUS before incurring expenses for legal,...

  14. 7 CFR 1717.612 - RUS approval of borrower's bank or other depository.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  16. 7 CFR 319.8-11 - From approved areas of Mexico.

    Science.gov (United States)

    2010-01-01

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

  17. Digital repositories certification: the Data Seal of Approval

    Directory of Open Access Journals (Sweden)

    Stefano Allegrezza

    2015-09-01

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

  18. Implications of Recent Drug Approvals for Older Adults

    Science.gov (United States)

    Eisenhower, Christine; Koronkowski, Michael; Marcum, Zachary

    2016-01-01

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

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

    International Nuclear Information System (INIS)

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

  20. Waste feed delivery environmental permits and approvals plan

    International Nuclear Information System (INIS)

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

  1. Chinese Government Approves Nanhai Oil Refinery Project of CNOOC

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

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

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

    OpenAIRE

    Cave (née Pickworth), E.

    2000-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Fowler, K.D.

    1998-08-03

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

  4. Ethical considerations in orphan drug approval and use.

    Science.gov (United States)

    Kesselheim, A S

    2012-08-01

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

  5. Sex offender grouping within a probation approved premises

    OpenAIRE

    Reeves, Carla

    2008-01-01

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

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

    Science.gov (United States)

    Yuan, Shu

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

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

    2010-12-01

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

  8. Approved Antiviral Drugs over the Past 50 Years.

    Science.gov (United States)

    De Clercq, Erik; Li, Guangdi

    2016-07-01

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

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

    International Nuclear Information System (INIS)

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

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

    International Nuclear Information System (INIS)

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

  11. Contents specification criteria for package design approvals in Germany

    International Nuclear Information System (INIS)

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

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

    OpenAIRE

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

    2016-01-01

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

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

    OpenAIRE

    Jagannadha Avasarala

    2016-01-01

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

  14. 46 CFR 160.017-27 - Production tests and examination.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production tests and examination. 160.017-27 Section 160... examination. (a) General. Each ladder manufactured under Coast Guard approval must be tested in accordance... for effective monitoring throughout the production schedule. (e) Visual examination. The...

  15. 46 CFR 163.003-27 - Production tests and examination.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production tests and examination. 163.003-27 Section 163... examination. (a) General. Each ladder produced under Coast Guard approval must be tested in accordance with... for effective monitoring throughout the production schedule. (e) Visual examination. The...

  16. Boom in production of organic line mussels in Denmark

    OpenAIRE

    Jokumsen, Alfred

    2015-01-01

    Organic farming of line mussels makes a significant foot print in the development of the Danish Aquaculture sector targeting 10 % of the production being organic by 2018. Currently 9 production units have been approved for a total production of some 3,500 tons/year. In particular the Danish production of line mussels is taken place in the ”Limfjorden” (North West Jutland), where the main producer currently is Seafood Limfjord in cooperation with the mussel processing company Vildsund Blue in ...

  17. Farther Export Tariff Laid on Some RE Metallic Products

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ To further regulate the export of high-energy-consumption and high-pollution products and resources products, promote the import of energy products, resource products and key components and facilitate the trade balance, and approved by the 9th Meeting of Tariff Regulations Commission of the State Council, China would adjust the import and export tariff rate of some commodities since June 1st, 2007.

  18. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

    ... Energy Production Company, Pad ID: ENDLESS MOUNTAIN RECREATION, ABR-201209001, New Milford Township... Energy Production Company, Pad ID: WOOSMAN PAD, ABR-201209006, New Milford Township, Susquehanna County... Production Company, Pad ID: SWOPE PAD, ABR- 201209007, Jackson Township, Susquehanna County, Pa.;...

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

    International Nuclear Information System (INIS)

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

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

    Science.gov (United States)

    Gum, Mary A.

    1988-01-01

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

  1. Drugs and other product choices.

    Science.gov (United States)

    Hyman, Paul M; Carvajal, Ricardo

    2009-01-01

    Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature. PMID:19453345

  2. 75 FR 9095 - Production and Airworthiness Approval, Part Marking, and Miscellaneous Amendments; Correction

    Science.gov (United States)

    2010-03-01

    ... published on October 16, 2009 (74 FR 53368). The purpose of that final rule was to update and standardize... . SUPPLEMENTARY INFORMATION: Background On October 16, 2009 (74 FR 53368), we published a final rule that.... In final rule FR Doc. E9-24821 published on October 16, 2009 (74 FR 53368), make the...

  3. Production of Basal Bodies in bulk for dense multicilia formation [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Xiumin Yan

    2016-06-01

    Full Text Available Centriole number is normally under tight control and is directly linked to ciliogenesis. In cells that use centrosomes as mitotic spindle poles, one pre-existing mother centriole is allowed to duplicate only one daughter centriole per cell cycle. In multiciliated cells, however, many centrioles are generated to serve as basal bodies of the cilia. Although deuterosomes were observed more than 40 years ago using electron microscopy and are believed to produce most of the basal bodies in a mother centriole-independent manner, the underlying molecular mechanisms have remained unknown until recently. From these findings arise more questions and a call for clarifications that will require multidisciplinary efforts.

  4. Lower Cost and Faster Product Approval Through Proper Software Design Controls

    Science.gov (United States)

    STEVENS, KEVIN; JOHNSON, ANTHONY

    2007-01-01

    The market success of a medical device depends in large part on how well its software is programmed. Focusing heavily on the device while treating the software as an afterthought can lead to costly recalls and liability concerns. PMID:22478690

  5. 17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

    Science.gov (United States)

    2010-04-01

    ... and §§ 37.7 and 38.4 of this chapter, a designated contract market or registered derivatives... over the submitting designated contract market or registered derivatives transaction execution facility... reasonably can be expected to be available to short traders and salable by long traders at its market...

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

    International Nuclear Information System (INIS)

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

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

    OpenAIRE

    Barrows, Randolph C.; Ezzard, John

    2011-01-01

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

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

    OpenAIRE

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

    2008-01-01

    Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri L...

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

    International Nuclear Information System (INIS)

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

  10. 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...

  11. 75 FR 4901 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-01-29

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

  12. 76 FR 52917 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

    Science.gov (United States)

    2011-08-24

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

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

    Science.gov (United States)

    2013-02-04

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

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

    Science.gov (United States)

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

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

  16. 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.

  17. 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.

  18. 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.

  19. 78 FR 76389 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-12-17

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

  20. 76 FR 11751 - Notice of Request for Extension of Approval of an Information Collection; Environmental...

    Science.gov (United States)

    2011-03-03

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