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. 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...

  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. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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....

  11. 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....

  12. 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,...

  13. 75 FR 62387 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-10-08

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

  14. 75 FR 52737 - Pesticide Product Registrations; Unconditional and Conditional Approvals

    Science.gov (United States)

    2010-08-27

    ... AGENCY Pesticide Product Registrations; Unconditional and Conditional Approvals AGENCY: Environmental... the provisions of section 3(c)(5) and 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), of registrations for pesticide products containing active ingredients that were not...

  15. 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...

  16. 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)

  17. 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...

  18. 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...

  19. 75 FR 57019 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-09-17

    ... be affected. The North American Industrial Classification System (NAICS) codes have been provided to... production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532... Information? EPA has established a docket for this action under docket identification (ID) number...

  20. 78 FR 26258 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2013-05-06

    ... architectural and industrial maintenance (AIM) coatings into the Illinois SIP. DATES: This direct final rule... approvable into the Illinois SIP. Subpart C: Architectural and Industrial Maintenance Coatings Section 223... volatile organic compounds from consumer products and architectural and industrial maintenance coatings....

  1. 17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

    Science.gov (United States)

    2010-04-01

    ... in normal cash marketing channels. (iii) For cash settled contracts, an explanation as to how the... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Voluntary submission of new products for Commission review and approval. 40.3 Section 40.3 Commodity and Securities Exchanges...

  2. 14 CFR 193.17 - How must design and production approval holders handle information they receive from the FAA...

    Science.gov (United States)

    2010-01-01

    ... REGULATIONS PROTECTION OF VOLUNTARILY SUBMITTED INFORMATION § 193.17 How must design and production approval... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false How must design and production approval holders handle information they receive from the FAA under this part? 193.17 Section 193.17...

  3. 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...

  4. 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

  5. The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.

    Science.gov (United States)

    Green, William

    2013-01-01

    The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss. PMID:24640465

  6. Policy plan for the early approval for irradiated meat products and the promotion of irradiated meats in market

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Ju Woon [Team for Radiation Food Science and Biotechnology, Advanced Radiation Technology Institute, Korea Atomic Energy Research Institute, Jeongeup (Korea, Republic of); Kim, Wang Geun [Ministry of Education, Science and Technology, Seoul (Korea, Republic of); Kim, Kyong Su [Dept. of Food and Nutrition, Chosun University, Gwangju (Korea, Republic of); Yook, Hong Sun [Dept. of Food and Nutrition, Chungnam National University, Daejeon (Korea, Republic of); Kim, Cheon Jei [Division of Animal Life Science, Konkuk University, Seoul (Korea, Republic of)

    2008-11-15

    The consumption of meat products is gradually being increased by the development of livestock raising technology, industrialized farm management and international trade. This increased consumption also created new market for ready-to-eat and ready-to-cook meat products. However, these convenience meat products can be easily contaminated during the processing and storage by pathogens, and there have been many reported cases of food borne illness by meats. One of the most effective methods for the decontamination of meat products is the radiation technology. Food irradiation was the established, well-recognized and safe sterilization method. Many other countries researched the effect of irradiation on the meat products and approved the irradiation. In this article, the effectiveness, the international acceptance, the economics and the research trend of irradiation on meat products have been reviewed. Also, the policy plans for the early approval of the irradiated meat products in Korea and the promotion policy of irradiated meats in market were discussed.

  7. 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...

  8. 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...

  9. 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

  10. 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..., irritability, mild agitation, anxiety, anger, insomnia, sleep EEG disturbances, nausea, decreased appetite,...

  11. 77 FR 33659 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2012-06-07

    ... more stringent than, EPA's national consumer products and architectural and industrial maintenance (AIM... products and architectural and industrial maintenance coatings at Part 223 of Title 35 of the Illinois... architectural and industrial maintenance coatings. (i) Incorporation by reference. (A) Illinois...

  12. 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...

  13. 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.

  14. 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.

  15. [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.

  16. [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

  17. 76 FR 66663 - Approval and Promulgation of Implementation Plans; Illinois; Consumer Products and AIM Rules

    Science.gov (United States)

    2011-10-27

    ... limitations for the sale, supply, offered for sale, use, or manufacture for sale of aerosol adhesives, floor wax strippers, products containing ozone-depleting compounds, and charcoal lighter material. (3) Test... review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4,...

  18. Gender-specific Regulatory Challenges to Product Approval: A Panel Discussion

    OpenAIRE

    McGregor, Alyson J; Barr, Helen; Greenberg, Marna Rayl; Safdar, Basmah; Wildgoose, Peter; Wright, David W.; Hollander, Judd E.

    2014-01-01

    On May 13, 2014, a 1-hour panel discussion session titled “Gender-Specific Regulatory Challenges to Product Approval” was held during the Academic Emergency Medicine consensus conference, “Gender-Specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes.” The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and stude...

  19. 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

  20. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

    Science.gov (United States)

    Kesselheim, Aaron S; Gagne, Joshua J

    2015-10-01

    Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via product-specific determinations of therapeutic equivalence.

  1. Recent progress and future challenges in algal biofuel production [version 1; referees: 4 approved

    Directory of Open Access Journals (Sweden)

    Jonathan B. Shurin

    2016-10-01

    Full Text Available Modern society is fueled by fossil energy produced millions of years ago by photosynthetic organisms. Cultivating contemporary photosynthetic producers to generate energy and capture carbon from the atmosphere is one potential approach to sustaining society without disrupting the climate. Algae, photosynthetic aquatic microorganisms, are the fastest growing primary producers in the world and can therefore produce more energy with less land, water, and nutrients than terrestrial plant crops. We review recent progress and challenges in developing bioenergy technology based on algae. A variety of high-value products in addition to biofuels can be harvested from algal biomass, and these may be key to developing algal biotechnology and realizing the commercial potential of these organisms. Aspects of algal biology that differentiate them from plants demand an integrative approach based on genetics, cell biology, ecology, and evolution. We call for a systems approach to research on algal biotechnology rooted in understanding their biology, from the level of genes to ecosystems, and integrating perspectives from physical, chemical, and social sciences to solve one of the most critical outstanding technological problems.

  2. Gender-specific Regulatory Challenges to Product Approval: A Panel Discussion

    Science.gov (United States)

    McGregor, Alyson J.; Barr, Helen; Greenberg, Marna Rayl; Safdar, Basmah; Wildgoose, Peter; Wright, David W.; Hollander, Judd E.

    2015-01-01

    On May 13, 2014, a 1-hour panel discussion session titled “Gender-Specific Regulatory Challenges to Product Approval” was held during the Academic Emergency Medicine consensus conference, “Gender-Specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes.” The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and students engaged in research and clinical practice. A panel was convened involving a representative from the Office of Women’s Health of the U.S. Food and Drug Administration, two pharmaceutical executives, and a clinical EM researcher. The moderated discussion also involved audience members who contributed significantly to the dialogue. Historical background leading up to the session along with the main themes of the discussion are reproduced in this article. These revolve around sex- and gender-specific research, statistical analysis of sex and gender, clinical practice, financial costs associated with pharmaceutical development, adaptive design, and specific recommendations on the regulatory process as it affects the specialty of EM. PMID:25443664

  3. 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...

  4. 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.

  5. From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU.

    Science.gov (United States)

    Pellegrini, Graziella; Lambiase, Alessandro; Macaluso, Claudio; Pocobelli, Augusto; Deng, Sophie; Cavallini, Gian Maria; Esteki, Roza; Rama, Paolo

    2016-06-01

    In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was established in different facilities and the clinical application in several hospitals. Advanced therapy medicinal products, including stem cells, are unique products with different challenges than other drugs: some uncertainties, in addition to benefit, cannot be avoided. This review will focus on all recent developments in the stem cell-based corneal therapy.

  6. 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

  7. 77 FR 65854 - Notice of Request for Extension of Approval of an Information Collection; Importation of Products...

    Science.gov (United States)

    2012-10-31

    ... methods: Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail ;D=APHIS-2012-0055... carcasses, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds,...

  8. 76 FR 16533 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2011-03-24

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 Animal Drugs, Feeds, and Related Products..., 2010 (75 FR 65565) amending the animal drug regulations. The October 26, 2010, final rule amended the... medicated feed. This correction is being made to improve the accuracy of the animal drug regulations....

  9. Approving job profiles for curriculum profiles in health care programs : a study on process and product quality

    NARCIS (Netherlands)

    Mulder, Martin; Engels, Otto

    1992-01-01

    A study evaluated the approach used for validation of job profiles for curriculum development in three health care programs in the Netherlands: dietetics, podotherapy, and activity therapy. It also evaluated the quality of these job profiles and the relation between process and product quality. The

  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. 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...

  14. Ripasudil: first global approval.

    Science.gov (United States)

    Garnock-Jones, Karly P

    2014-12-01

    Ripasudil hydrochloride hydrate (Glanatec® ophthalmic solution 0.4 %; hereafter referred to as ripasudil) is a small-molecule, Rho-associated kinase inhibitor developed by Kowa Company, Ltd. for the treatment of glaucoma and ocular hypertension. This compound, which was originally discovered by D. Western Therapeutics Institute, Inc., reduces intraocular pressure (IOP) by directly acting on the trabecular meshwork, thereby increasing conventional outflow through the Schlemm's canal. As a result of this mechanism of action, ripasudil may offer additive effects in the treatment of glaucoma and ocular hypertension when used in combination with agents such as prostaglandin analogues (which increase uveoscleral outflow) and β blockers (which reduce aqueous production). The eye drop product has been approved in Japan for the twice-daily treatment of glaucoma and ocular hypertension, when other therapeutic agents are not effective or cannot be administered. Phase II study is underway for the treatment of diabetic retinopathy. This article summarises the milestones in the development of ripasudil leading to the first approval for glaucoma and ocular hypertension. PMID:25414122

  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. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

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

  18. 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...

  19. Depression: FDA-Approved Medications May Help

    Science.gov (United States)

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

  20. 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)

  1. 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

  2. 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.

  3. 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

  4. 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...

  5. 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...

  6. 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 ( ...

  7. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    ... about Your Treatment Research Drugs Approved for Malignant Mesothelioma This page lists cancer drugs approved by the ... are not listed here. Drugs Approved for Malignant Mesothelioma Alimta (Pemetrexed Disodium) Pemetrexed Disodium Drug Combinations Used ...

  8. 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) ...

  9. Drugs Approved for Bone Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Bone Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bone Cancer Abitrexate (Methotrexate) Cosmegen (Dactinomycin) Dactinomycin Denosumab Doxorubicin Hydrochloride ...

  10. 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...

  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. Drugs Approved for Leukemia

    Science.gov (United States)

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

  13. 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 ( ...

  14. 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.

  15. 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.

  16. Reflection on Approval and Evaluation of Healthy Foods Containing Bee Products%2005—2010年蜂类保健食品的审批情况及对审评监管的思考

    Institute of Scientific and Technical Information of China (English)

    萨翼; 蔡铁全

    2012-01-01

    目前用于申报保健食品的蜂产品有蜂胶、蜂蜡、蜂蜜、蜂土浆、蜂花粉、蜂蛹,本文对近年来已批准的各种蜂产品保健食品的审评审批情况归纳分析,主要从产品审批情况、配万、剂型、工艺、质量控制方面总结蜂产品的保健食品审评中常见情况和问题,针对日前此类热门产品申报过程中存在的问题进行分析,并就此类产品的研发及监管部门提出建议,以期更好地为含蜂产品类保健食品的研发、监管、申报提供数据支持。%Bee products are widely used in healthy foods, such as propolis, honey and royal jelly, in this article, the approval situation and common problems especially in the aspects of approved quantity, formulation, process and quality control of healthy foods containing bee products are reviewed. The problems related to the evaluation of healthy foods are also specifically analyzed. Moreover, some suggestions for the application of healthy foods containing bee products are proposed too, with the aim of providing theoretical supports for future research and development of healthy foods.

  17. Pembrolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-10-01

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

  18. Olodaterol: first global approval.

    Science.gov (United States)

    Gibb, Andrew; Yang, Lily P H

    2013-11-01

    Olodaterol (Striverdi(®) Respimat(®)) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat(®) Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD. PMID:24158691

  19. 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...

  20. 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

  1. 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

  2. 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. ...

  3. 48 CFR 45.606-1 - Contractor with an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

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

  4. 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...

  5. 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...

  6. 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...

  7. Linaclotide: first global approval.

    Science.gov (United States)

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

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

  8. 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

  9. Evolocumab: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2015-09-01

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

  10. 75 FR 68315 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2010-11-05

    ... Agricultural Marketing Service's (AMS) intention to request approval, from the Office of Management and Budget... informed production and marketing decisions. In addition, several Government agencies that purchase...

  11. 9 CFR 112.5 - Review and approval of labeling.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND...

  12. 77 FR 16544 - Pesticide Product Registration Approvals

    Science.gov (United States)

    2012-03-21

    ... to control grey snow mold and pink snow mold on golf course turf where continuous snow cover persists... of receipt published on April 14, 2010 (75 FR 19388; FRL- 8808-5). One comment was received...

  13. 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,...

  14. Adapting Drug Approval Pathways for Bacteriophage-Based Therapeutics.

    Science.gov (United States)

    Cooper, Callum J; Khan Mirzaei, Mohammadali; Nilsson, Anders S

    2016-01-01

    The global rise of multi-drug resistant bacteria has resulted in the notion that an "antibiotic apocalypse" is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long clinical history of phage therapy in Eastern Europe, combined with more recent in vitro and in vivo success, demonstrates the potential for whole phage or phage based antibacterial agents. To date, no whole phage or phage derived products are approved for human therapeutic use in the EU or USA. There are at least three reasons for this: (i) phages possess different biological, physical, and pharmacological properties compared to conventional antibiotics. Phages need to replicate in order to achieve a viable antibacterial effect, resulting in complex pharmacodynamics/pharmacokinetics. (ii) The specificity of individual phages requires multiple phages to treat single species infections, often as part of complex cocktails. (iii) The current approval process for antibacterial agents has evolved with the development of chemically based drugs at its core, and is not suitable for phages. Due to similarities with conventional antibiotics, phage derived products such as endolysins are suitable for approval under current processes as biological therapeutic proteins. These criteria render the approval of phages for clinical use theoretically possible but not economically viable. In this review, pitfalls of the current approval process will be discussed for whole phage and phage derived products, in addition to the utilization of alternative approval pathways including adaptive licensing and "Right to try" legislation. PMID:27536293

  15. 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 ...

  16. 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.

  17. 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,...

  18. 7 CFR 58.50 - Approval and form of official identification.

    Science.gov (United States)

    2010-01-01

    ... Dairy Products Marking, Branding, and Identifying Product § 58.50 Approval and form of official... in a shield in the form and design indicated in Figures 1, 2, and 3 of this section or such other form, design, or wording as may be approved by the Administrator. EC25SE91.014 EC25SE91.015...

  19. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... commercial or production batches according to an approved stability protocol or commitment. (iv... describing the specific tests and studies and acceptance criteria to be achieved to demonstrate the lack of... production batches according to an approved stability protocol or commitment; and (J) Any other...

  20. 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 ( ...

  1. 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- ...

  2. 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 §...

  3. 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...

  4. 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...

  5. 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...

  6. 49 CFR 236.913 - Filing and approval of PSPs.

    Science.gov (United States)

    2010-10-01

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

  7. 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

  8. 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.

  9. 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.

  10. Drugs Approved for Penile Cancer

    Science.gov (United States)

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

  11. Drugs Approved for 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 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.

  13. 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.

  14. 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 ...

  15. 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 ...

  16. Airworthiness Approval of Design Firms

    Directory of Open Access Journals (Sweden)

    Kanchan Biswas

    2006-01-01

    Full Text Available Aviation as a mode of transportation requires that the aircraft designed, developed, andoperated must be maintained under airworthy condition. The basic tenet of airworthiness is thatthe aircraft designed and developed are certified by the independent airworthiness regulatoryorganisations. This requires strict vigil during the development stages. With quantum jump inthe design and development activities, it has been extremely difficult for the regulatory bodiesto cope up with the demand of certification. Delegating this responsibility to a few approvedfirms prove very effective in maintaining the design control through approved agencies andpersonnel. Airworthiness approval of design firms taken up by the Centre for MilitaryAirworthiness & Certification, Bangalore, which is the airworthiness approval authority for militaryaircraft in India, is one such step. This paper discusses the scope and extent of such approvals.

  17. 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.

  18. 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.

  19. Drugs Approved for Lung Cancer

    Science.gov (United States)

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

  20. 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.

  1. 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.

  2. 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.

  3. Drugs Approved for Skin Cancer

    Science.gov (United States)

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

  4. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

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

  5. 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.

  6. 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...

  7. 38 CFR 21.292 - Course approvals.

    Science.gov (United States)

    2010-07-01

    ... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only... rehabilitation services under Chapter 31. (Authority: 38 U.S.C. 3106) (b) General. VA staff in consultation with... approved by one of the agencies identified in paragraph (c) of this section, VR&E staff shall...

  8. 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

  9. 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...

  10. 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

  11. 76 FR 50536 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-15

    ... the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the time period specified...; Approval Date: June 2, 2011. 2. EQT Production Company, Pad ID: Wohler, ABR-201106002, Chest Township...: June 27, 2011. 23. Chesapeake Appalachia, LLC, Pad ID: Lambs Farm, ABR-201106023, Smithfield...

  12. 77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

    Science.gov (United States)

    2012-10-03

    ... (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the... approval of the NADA and ANADAs listed in table 1 of this document because the products are no longer manufactured or marketed. Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been Requested...

  13. 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...

  14. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a biological product for which safety has... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  15. 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...

  16. 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...

  17. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2013-11-07

    ... concern, economic fraud, or an unfair competitive advantage. Commenters also requested greater access to... the Agency (76 FR 75809). FSIS also proposed to combine the regulations that provide for the approval... Marketing Service, removing it from the realm of a special statement or claim. Also in response to...

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  4. 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.

  5. 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

  6. 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)

  7. / 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.

  8. 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 ( ...

  9. 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 ...

  10. 15 CFR Schedule I to Part 700 - Approved Programs and Delegate Agencies

    Science.gov (United States)

    2010-01-01

    ... production and construction Do. D3 Canadian atomic energy program Do. Other Foreign Nations: G1 Certain... nations (other than Canada) production and construction Do. Co-Production: J1 F-16 Co-Production Program... them, as indicated below. Program identification symbol Approved program Delegate agency...

  11. 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:...

  12. 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.

  13. 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...

  14. 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...

  15. 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....

  16. 32 CFR 552.77 - Suspension approval.

    Science.gov (United States)

    2010-07-01

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

  17. 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...

  18. 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...

  19. Hunan Rare Earth Group Approved

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

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

  20. 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

  1. 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...

  2. 7 CFR 70.34 - Application for grading service in official plants; approval.

    Science.gov (United States)

    2010-01-01

    ... (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) VOLUNTARY GRADING OF POULTRY PRODUCTS AND RABBIT PRODUCTS Grading of Poultry... plant survey for poultry or rabbit grading has been completed and approved in accordance with...

  3. 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

  4. 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

  5. Repurposing of approved cardiovascular drugs.

    Science.gov (United States)

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

    2016-09-20

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

  6. 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...

  7. 9 CFR 316.5 - Branding ink; to be furnished by official establishments; approval by Program; color.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Branding ink; to be furnished by... THEIR CONTAINERS § 316.5 Branding ink; to be furnished by official establishments; approval by Program... provided in paragraphs (b) and (c) of this section, branding ink of any color, approved for the purpose...

  8. 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...

  9. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Science.gov (United States)

    2013-02-04

    ... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period... entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological... guidance to industry on enrichment strategies that can be used in clinical trials intended to...

  10. 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 ...

  11. 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…

  12. 24 CFR 214.103 - Approval criteria.

    Science.gov (United States)

    2010-04-01

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

  13. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  14. 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...

  15. 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)

  16. 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.

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

    Science.gov (United States)

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

    2016-09-01

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

  18. 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...

  19. 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...

  20. 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)...

  1. 76 FR 70108 - Notice of Intent To Request Approval To Revise and Extend an Information Collection

    Science.gov (United States)

    2011-11-10

    ... the dairy industry in planning, pricing, and projecting supplies of milk and milk products. Included...: Email: ombofficer@nass.usda.gov . Include docket number above in the subject line of the message. Fax... currently approved information collection, the Milk and Milk Products Surveys. Revision to burden hours...

  2. Research and development on Safety Production Assessment List Examination and Approval System of Urban Transit based on workflow%基于工作流的城市轨道交通安全生产考核表单流转审批系统研发

    Institute of Scientific and Technical Information of China (English)

    秦健; 李军; 钱进; 牛宏睿; 白丽

    2012-01-01

    In order to reduce the difficulty of the development for the process of complex list examination and approval, improve the management efficiency of the application system, it was proposed the Safety Production Assessment List Examination and Approval System of Urban Transit based on the workflow technology. The System could be flexible to meet the changes of the workflow. The process administrator could process intervention when it was needed. According to the reference model of the workflow, the process definition of the workflow, the exchange interface, the application interface of the workflow client, as well as the system management and monitoring interface were implemented. The System consisted of three parts of process definition, process execution control and process monitoring, provided list design, process steps and flow definition to support complex process, could meet the diversified needs of the rail transit safety production business process of Urban Transit.%为了降低复杂表单审批流程的开发难度,提高应用系统的管理效率,本文提出基于工作流技术的城市轨道交通安全生产考核表单流转审批系统.系统能够满足工作流程的变更,并在管理员需要时可以进行流程干预.依据工作流参考模型,实现工作流过程定义、交换接口、工作流客户应用程序接口、系统管理和监控接口,系统由流程定义、流程执行控制和流程监控3部分组成,提供表单设计、流程步骤及流转定义,支持复杂流程,可满足轨道交通安全生产业务流程多样化的需要.

  3. 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

  4. 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...

  5. FDA Approves First Fully Dissolvable Stent

    Science.gov (United States)

    ... newly approved stent is made from a biodegradable polymer that's commonly used in medical devices designed to ... the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, the U.S. Department ...

  6. 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 ...

  7. 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 ...

  8. 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.

  9. 7 CFR 1421.403 - DMA approval.

    Science.gov (United States)

    2010-01-01

    ... the entity's financial condition. (3) The entity's tax identification number. (4) A copy of any... services for which the approval to perform is sought. (7) A narrative explaining how the proposed...

  10. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

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

  11. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

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

  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. Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.

    Science.gov (United States)

    Ning, Yang-Min; Maher, V Ellen

    2015-03-01

    Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years.

  14. 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

  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. 46 CFR 163.003-9 - Approval procedure.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Ladder § 163.003-9 Approval procedure. (a) General. A pilot ladder... testing. Each approval test must be conducted in accordance with § 163.003-21. (c) Approval of alternatives. A pilot ladder that does not meet the materials, construction, or performance requirements...

  17. 46 CFR 163.002-9 - Approval procedure.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Hoist § 163.002-9 Approval procedure. (a) General. A pilot hoist... testing. Each approval test must be conducted in accordance with § 163.002-21. (c) Approval of alternative designs. A pilot hoist that does not meet the materials, construction, or performance requirements of...

  18. 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...

  19. 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...

  20. 76 FR 22359 - Notice of Request for Extension of Approval of an Information Collection; Importation of Poultry...

    Science.gov (United States)

    2011-04-21

    ... Approval of an Information Collection; Importation of Poultry Meat and Other Poultry Products From Sinaloa... importation of poultry meat and other poultry products from Sinaloa and Sonora, Mexico. DATES: We will... poultry meat and other poultry products from Sinaloa and Sonora, Mexico, contact Dr. Magde Elshafie,...

  1. 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 ...

  2. 76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

    Science.gov (United States)

    2011-06-17

    ... Enforcement Policy for Over-the- Counter Sunscreen Drug Products Marketed Without an Approved Application... ``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application.'' The draft guidance... enforcement policy for certain OTC sunscreen products marketed without an approved new drug application....

  3. 77 FR 10515 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2012-02-22

    ... producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are... Federal Register of March 31, 2010, (75 FR 16109) (FRL-8806-9), which announced that the company, HeiQ... used as an antimicrobial and preservative additive used to treat fibers, plastics, polymers,...

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

    Science.gov (United States)

    2010-10-01

    ... coordinates are converted to the Munsell notation which is cross-referenced to the color name in Section 13 of the “Color Names Dictionary” (see the discussion in section 10 of “the Universal Color Language”). ...) Chromaticity. The color of the burning signal must be vivid red as defined by Sections 13 and 14 of the...

  5. 46 CFR 160.021-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... shall not ignite or undergo marked decomposition. (7) Chromaticity. The color of the burning signal must be vivid red as defined by sections 13 and 14 of the “Color Names Dictionary.” Two identical test... notation which is cross-referenced to the color name in Section 13 of the “Color Names Dictionary” (see...

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

    Science.gov (United States)

    2010-10-01

    ... coordinates are converted to the Munsell notation which is cross-referenced to the color name in Section 13 of the “Color Names Dictionary” (see the discussion in Section 10 of “The Universal Color Language”). ...) Chromaticity. The color of the burning signal must be vivid red as defined by Sections 13 and 14 of the...

  7. 75 FR 35805 - Pesticide Product Registrations; Conditional Approvals

    Science.gov (United States)

    2010-06-23

    ... of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), of... 89034: 1. Insect Resistance Management: Simulation modeling, which addresses the cross-resistance of Cry1A.105, Cry1Fa, and Cry1Ac in the cotton-growing landscape and how such cross-resistance may...

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

    Science.gov (United States)

    Baldo, Brian A

    2015-02-01

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

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

    Science.gov (United States)

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

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

  10. From Measurements to Site Approval

    DEFF Research Database (Denmark)

    Toft, Henrik Stensgaard; Svenningsen, Lasse; Sørensen, John Dalsgaard

    2014-01-01

    for the turbulence and average values for the wind shear and air density. The analysis in the present paper shows that wind shear variations can have a significant influence on fatigue loads for some wind turbine sensors (components). The natural variation in shear should therefore be taken into account in site......In the present paper the influence of natural variations in turbulence, wind shear and air density on the fatigue damage equivalent loads during power production are investigated. In site suitability analysis it is normally assumed that the fatigue loads can be estimated based on a 90% quantile...

  11. 7 CFR 205.622 - Review of approved State organic programs.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Review of approved State organic programs. 205.622... MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Administrative State Organic...

  12. 77 FR 50514 - Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal...

    Science.gov (United States)

    2012-08-21

    ..., and Role in Evidence Appraisal Throughout the Total Product Life Cycle; Public Workshop; Request for... ``Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the..., best practices, and innovative methodologies for evidence appraisal. Date and Time: The public...

  13. 76 FR 4835 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Volatile Organic Compound...

    Science.gov (United States)

    2011-01-27

    ... control of volatile organic compound (VOC) emissions from reinforced plastic composites production... approve into Ohio's SIP new rule OAC 3745-21-25 ``Control of VOC Emissions from Reinforced Plastic... contains requirements that satisfy RACT standards for VOC emissions from reinforced plastic...

  14. 78 FR 23737 - Request for Extension and Revision of a Currently Approved Information Collection for Commodities...

    Science.gov (United States)

    2013-04-22

    .... Additionally, a lamb processing plant that did not slaughter an average of 75,000 lambs or process an average... the currently approved information collection used to compile and generate cattle, swine, lamb... plant's annual slaughter or production based upon the plant's estimate of annual slaughter capacity...

  15. 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…

  16. 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...

  17. 78 FR 23545 - Proposed Extension of Approval of Information Collection; Comment Request: Third Party Conformity...

    Science.gov (United States)

    2013-04-19

    ... COMMISSION Proposed Extension of Approval of Information Collection; Comment Request: Third Party Conformity... collection regarding a form used to evaluate whether third party conformity assessment bodies meet the requirements to test for compliance to specified children's product safety rules. Third party...

  18. 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...

  19. 10 CFR 70.23 - Requirements for the approval of applications.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Requirements for the approval of applications. 70.23 Section 70.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DOMESTIC LICENSING OF SPECIAL NUCLEAR... processes; (2) The theory and production of atomic energy, including processes, materials, and...

  20. 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...

  1. 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...

  2. 78 FR 38912 - Notice of Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2013-06-28

    ... amount of product in the supply channel. In addition, the Agricultural Marketing Service buys hundreds of... Agricultural Marketing Service Notice of Request for Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for comments. SUMMARY:...

  3. Program and Course Approval Handbook. Fifth Edition

    Science.gov (United States)

    California Community Colleges, Chancellor's Office, 2013

    2013-01-01

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

  4. 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...

  5. 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…

  6. 40 CFR 1042.210 - Preliminary approval.

    Science.gov (United States)

    2010-07-01

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

  7. Perkins Bill is Approved by Congress

    Science.gov (United States)

    Cavanagh, Sean

    2006-01-01

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

  8. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  9. 40 CFR 52.373 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  10. 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…

  11. 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...

  12. Approved Practices in Dairy Reproduction. Slide Script.

    Science.gov (United States)

    Roediger, Roger D.; Barr, Harry L.

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

  13. 42 CFR 422.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

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

  14. 42 CFR 423.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

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

  15. 28 CFR 48.15 - Temporary approval.

    Science.gov (United States)

    2010-07-01

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

  16. 7 CFR 3015.112 - Approval procedures.

    Science.gov (United States)

    2010-01-01

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

  17. 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

  18. 7 CFR 1735.61 - Approval criteria.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Mortgage Controls... of its mortgage or loan contract to obtain RUS approval of a merger or acquisition, the borrower... economic and loan-repayment feasibility characteristics of the proposed system are satisfactory;...

  19. 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...

  20. 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...

  1. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

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

  2. 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...

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

    Science.gov (United States)

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

    2015-12-01

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

  4. 77 FR 1388 - Lists of Regions Classified With Respect to Certain Animal Diseases and States Approved To...

    Science.gov (United States)

    2012-01-10

    ... Federal Register (Docket No. APHIS-2009-0035, 76 FR 31499-31507) to remove the lists of States approved to..., Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping... FEVER, CLASSICAL SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY:...

  5. 9 CFR 54.11 - Approval of laboratories to run official scrapie tests and official genotype tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of laboratories to run official scrapie tests and official genotype tests. 54.11 Section 54.11 Animals and Animal Products ANIMAL... hours; and (8) Will report all test results to State and Federal animal health officials within...

  6. 9 CFR 78.11 - Cattle moved to a specifically approved stockyard not in accordance with this part.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Cattle moved to a specifically... (INCLUDING POULTRY) AND ANIMAL PRODUCTS BRUCELLOSIS Restrictions on Interstate Movement of Cattle Because of Brucellosis § 78.11 Cattle moved to a specifically approved stockyard not in accordance with this part....

  7. 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...

  8. 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...

  9. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ... COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule by the Susquehanna River Basin.... SUPPLEMENTARY INFORMATION: This notice lists the projects, described below, receiving approval for...

  10. 78 FR 11947 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-02-20

    ... COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule by the Susquehanna River Basin.... SUPPLEMENTARY INFORMATION: This notice lists the projects, described below, receiving approval for...

  11. 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)...

  12. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

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

  13. 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...

  14. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-01-31

    ... to 7.500 mgd; Approval Date: October 11, 2011. 6. Seneca Resources Corporation, Pad ID: DCNR 100 Pad..., Wyoming County, Pa.; Consumptive Use of up to 7.500 mgd; Approval Date: October 20, 2011. 12. Seneca....; Consumptive Use of up to 4.000 mgd; Approval Date: October 20, 2011. 13. Seneca Resources Corporation, Pad...

  15. 10 CFR 52.143 - Staff approval of design.

    Science.gov (United States)

    2010-01-01

    ... the design in the form of a report available at the NRC Web site, http://www.nrc.gov. ... 10 Energy 2 2010-01-01 2010-01-01 false Staff approval of design. 52.143 Section 52.143 Energy... Standard Design Approvals § 52.143 Staff approval of design. Upon completion of its review of a...

  16. 44 CFR 78.9 - Planning grant approval process.

    Science.gov (United States)

    2010-10-01

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

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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,...

  2. 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...

  3. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

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

  4. 25 CFR 286.16 - Grant approval authority.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Grant approval authority. 286.16 Section 286.16 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ECONOMIC ENTERPRISES INDIAN BUSINESS DEVELOPMENT PROGRAM § 286.16 Grant approval authority. Applications for grants require approval by the...

  5. 48 CFR 1845.607-170 - Contractor's approved scrap procedure.

    Science.gov (United States)

    2010-10-01

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

  6. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    2010-07-01

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

  7. 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....

  8. 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...

  9. Guangxi and Qinghai Delegated Mining Right Transfer Approval Right

    Institute of Scientific and Technical Information of China (English)

    2013-01-01

    <正>To ensure timely adjustment of mining right transfer approval authority according to the requirements of the Ministry of Land and Resources, recently, Guangxi and Qinghai Land and Resources Department decided: The mining right previously approved by city and county level land and resources bureaus, and the transfer approval authority previously exercised by Guangxi Land and Resources Department,

  10. 49 CFR 1522.109 - TSA review and approval.

    Science.gov (United States)

    2010-10-01

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

  11. 7 CFR 1710.206 - Approval requirements for load forecasts prepared pursuant to approved load forecast work plans.

    Science.gov (United States)

    2010-01-01

    ... pursuant to approved load forecast work plans. 1710.206 Section 1710.206 Agriculture Regulations of the... requirements for load forecasts prepared pursuant to approved load forecast work plans. (a) Contents of load forecasts prepared under an approved load forecast work plan. In addition to the minimum requirements...

  12. 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...

  13. 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...

  14. 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

  15. 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...

  16. 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...

  17. 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...

  18. 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 ...

  19. 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 ...

  20. 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...

  1. [Approval of a bone bank: an institution's experience].

    Science.gov (United States)

    Jung, S; Wernerus, D; Reichel, H

    2012-03-01

    The new tissue laws of 2007 created a completely new situation for German musculoskeletal tissue banks. The objective of the new regulations in the recent German tissue act is to improve safety by reducing the risk of transmission of viral and nonviral diseases. Since 2007 tissue banks have to declare their intention to continue providing allografts to the local authorities until August 2011 based on the guidelines of the Federal Medical Association (Bundesärztekammer 2001) and according to § 144 of the Pharmaceutical Products Act (Arzneimittelgesetz). The Orthopedic University Clinic in Ulm applied for registration according to § 20 b and c of the Pharmaceutical Products Act in 2010. After submitting all the required documents, government officials controlled the equipment, distribution of responsible personnel, location of operating theatres and the laboratory and quality assurance documentation. After alluding to the lack of validation for the use of a hemoculture medium for testing ringer lactate solutions, permission according to § 20 b and c was granted with the obligation to transfer all serological and microbiological testing of tissue donors to another laboratory with its own approval under § 20 c of the Pharmaceutical Products Act.

  2. 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

  3. 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

  4. 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.

  5. 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...

  6. 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

  7. 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...

  8. 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

  9. 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.

  10. 7 CFR 205.621 - Submission and determination of proposed State organic programs and amendments to approved State...

    Science.gov (United States)

    2010-01-01

    ..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL... 7 Agriculture 3 2010-01-01 2010-01-01 false Submission and determination of proposed State organic programs and amendments to approved State organic programs. 205.621 Section 205.621 Agriculture...

  11. 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...

  12. 77 FR 14562 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval...

    Science.gov (United States)

    2012-03-12

    ... has no synthetic substitute, and is used by pharmaceutical companies to test sterility of products... published in the Federal Register (76 FR 59422) a notice of our intent to ask OMB to renew approval for this... explore providing a batch-type data entry program on our Web site to report recaptured tags. We...

  13. 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

    ... 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 of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing...

  14. 75 FR 61692 - Notice of Request for Extension and Revision of a Currently Approved Information Collection for...

    Science.gov (United States)

    2010-10-06

    ... opportunity for producers, in a specified production area, to work together to solve marketing problems and... Management and Budget (OMB). Forms needing OMB approval are contained in OMB No. 0581- 0215 and include forms... (ACP-5), inter- handler transfer (ACP-6), inventory shipments (ACP-7), producer delivery...

  15. 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...

  16. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ... Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials... provide guidance to industry on enrichment strategies that can be used in clinical trials intended...

  17. 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...

  18. 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, ...

  19. 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 ...

  20. 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....

  1. 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.

  2. 78 FR 28620 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-05-15

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

  3. 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...

  4. Waste Feed Delivery Environmental Permits and Approvals Plan

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    2000-01-18

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

  5. 46 CFR 161.012-11 - Approval tests.

    Science.gov (United States)

    2010-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL ELECTRICAL EQUIPMENT Personal Flotation Device Lights § 161.012-11 Approval tests. (a....012-7, except that technical data showing compliance with § 160.012-7(c) may be submitted with...

  6. 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...

  7. 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...

  8. 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...

  9. 14 CFR 135.419 - Approved aircraft inspection program.

    Science.gov (United States)

    2010-01-01

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

  10. 7 CFR 1735.62 - Approval of acquisitions and mergers.

    Science.gov (United States)

    2010-01-01

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

  11. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-10-25

    ... mgd; Approval Date: August 4, 2011. 8. Seneca Resources Corporation, Pad ID: Rich Valley Pad B, ABR... County, Pa.; Consumptive Use of up to 3.000 mgd; Approval Date: August 16, 2011. 31. Seneca Resources.... 38. Seneca Resources Corporation, Pad ID: DCNR 100 Pad G, ABR- 201108032, McIntyre Township,...

  12. 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...

  13. 46 CFR 163.003-21 - Approval tests.

    Science.gov (United States)

    2010-10-01

    ... following approval tests must be conducted: (1) Step flexibility test. This test is performed on six... test must be conducted on a ladder of the longest length for which approval has been requested. If the... made. After a test failure and any design change, the failed test, and any other previously...

  14. 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...

  15. 21 CFR 1240.83 - Approval of watering points.

    Science.gov (United States)

    2010-04-01

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

  16. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

  17. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

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

    Science.gov (United States)

    2012-11-07

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

  19. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-06-11

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

  20. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

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

  1. 7 CFR 272.9 - Approval of homeless meal providers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 4 2010-01-01 2010-01-01 false Approval of homeless meal providers. 272.9 Section 272... AGENCIES § 272.9 Approval of homeless meal providers. The State food stamp agency, or another appropriate... does in fact serve meals to homeless persons. Where the State food stamp agency identifies...

  2. 50 CFR Appendix B to Part 404 - Approved VMS

    Science.gov (United States)

    2010-10-01

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

  3. 18 CFR 154.6 - Acceptance for filing not approval.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Acceptance for filing... Provisions and Conditions § 154.6 Acceptance for filing not approval. The acceptance for filing of any tariff, contract or part thereof does not constitute approval by the Commission. Any filing which does not...

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

    Science.gov (United States)

    Blythe, Kenneth C.; Morrison, Dennis L.

    1992-01-01

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

  5. 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...

  6. 34 CFR 75.561 - Approval of indirect cost rates.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Approval of indirect cost rates. 75.561 Section 75.561 Education Office of the Secretary, Department of Education DIRECT GRANT PROGRAMS What Conditions Must Be Met... Education is the cognizant agency, the Secretary approves an indirect cost rate for a grantee other than...

  7. 34 CFR 76.561 - Approval of indirect cost rates.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Approval of indirect cost rates. 76.561 Section 76.561 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must.... (a) If the Department of Education is the cognizant agency, the Secretary approves an indirect...

  8. 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...

  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. 42 CFR 433.117 - Initial approval of replacement systems.

    Science.gov (United States)

    2010-10-01

    ... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement system must meet all conditions of initial approval of a mechanized claims processing and information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement system...

  11. 12 CFR 614.4460 - Loan approval responsibility.

    Science.gov (United States)

    2010-01-01

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

  12. 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

  13. 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.

  14. 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...

  15. 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... with written findings forming the basis of the Secretary's intent to approve or disapprove the...

  16. 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...

  17. 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...

  18. 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...

  19. 78 FR 27470 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-05-10

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

  20. 78 FR 17281 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-20

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

  1. 24 CFR 886.107 - Approval of applications.

    Science.gov (United States)

    2010-04-01

    ...) The Owner's Affirmative Fair Housing Marketing Plan is approvable. (b) The HUD-approved unit rents are.... Occupancy requirements are being met. Marketing and maintenance programs are being carried out in an... collection losses. (7) The Owner's plan for remedying any deferred maintenance, financial problems, or...

  2. 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...

  3. 76 FR 20070 - Commercial Space Transportation Safety Approval Performance Criteria

    Science.gov (United States)

    2011-04-11

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

  4. 49 CFR 1522.115 - Renewal of TSA approval.

    Science.gov (United States)

    2010-10-01

    ... be subject to both civil and criminal penalties under 49 CFR part 1540 and 18 U.S.C. 1001. Failure to... 49 Transportation 9 2010-10-01 2010-10-01 false Renewal of TSA approval. 1522.115 Section 1522.115..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION...

  5. 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

  6. 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)

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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

  12. Circular of the Ministry of Commerce on Further Improving Examination and Approval of Foreign Investment

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    @@ Competent commercial authorities of provinces,autonomous regions,municipalities directly under the Central Government,separately planning cities, arbin, Changchun, Shenyang, Jinan, Nanjing, Hangzhou, Guangzhou, Wuhan, Chengdu, Xi'an and Xingjiang Production and Construction Corps,national economic and technological development zones,and national border economic cooperation zones,For the purpose of carrying out the scientific outlook on development,and according to the requirements of the important spirits of the Second Plenary Session of the 17th Central Committee of the Communist Party of China and the State Council on promoting the reform of the administrative system of examination and approval and constructing service-oriented government,the Ministry of Commcrce will,based on expanding domestic demand and maintaining the stable and rapid growth of Chinese economy,determine to continuously deepen the reform of the administrative system of examination and approval of foreign investment and further expand the administrative authority for examination and approval of foreign investment of local competent commercial authorities and national economic and technological development zones.

  13. 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

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

  14. 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....

  15. 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 ...

  16. 49 CFR 178.74 - Approval of MEGCs.

    Science.gov (United States)

    2010-10-01

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

  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. 46 CFR 160.054-7 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ... fully the construction, material specification, arrangement, and list of contents to the Commander of... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall...

  19. 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,...

  20. 7 CFR 58.627 - Milk and dairy products.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Milk and dairy products. 58.627 Section 58.627..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General... Material § 58.627 Milk and dairy products. To produce ice cream and related products the raw milk and...

  1. 9 CFR 317.4 - Labeling approval.

    Science.gov (United States)

    2010-01-01

    ... is a printer's proof or equivalent which clearly shows all labeling features, size, location, and... carcass ink brands and meat food product ink and burning brands, which comply with parts 312 and 316...

  2. 7 CFR 52.53 - Approved identification.

    Science.gov (United States)

    2010-01-01

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

  3. 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...

  4. 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

  5. 4 National Standards for Rubber Belt Products Issued

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    On May 20, National General Administration of Quality Supervision, Inspection and Quarantine and National Standardization Administration approved to issue 4 national standards for rubber belt products, which come into effect from October 1.

  6. 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 ...

  7. 77 FR 42341 - New Postal Product

    Science.gov (United States)

    2012-07-18

    ... mail at a low cost within their target marketing areas. Request at 2. \\2\\ Docket No. MT2011-3, Order Approving Market Test of Experimental Product--Marketing Mail Made Easy, March 1, 2011, at 1 (Order No. 687). As proposed in Docket No. MT2011-3, the experimental product was named ``Marketing Mail Made...

  8. 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

  9. 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 ...

  10. 30 CFR 285.614 - When may I begin conducting activities under my approved SAP?

    Science.gov (United States)

    2010-07-01

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

  11. 10 CFR 52.145 - Finality of standard design approvals; information requests.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Finality of standard design approvals; information... approvals; information requests. (a) An approved design must be used by and relied upon by the NRC staff and... compliance with the current licensing basis of the standard design approval, information requests to...

  12. 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...

  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. 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...

  15. 49 CFR 1540.301 - Withdrawal of approval of a security program.

    Science.gov (United States)

    2010-10-01

    ... program approved or accepted by TSA under 49 CFR chapter XII, subchapter C. (b) Withdrawal of security program approval. TSA may withdraw the approval of a security program, if TSA determines continued... SECURITY: GENERAL RULES Responsibilities of Holders of TSA-Approved Security Programs § 1540.301...

  16. Radiochemical analyses of several spent fuel Approved Testing Materials

    Energy Technology Data Exchange (ETDEWEB)

    Guenther, R.J.; Blahnik, D.E.; Wildung, N.J.

    1994-09-01

    Radiochemical characterization data are described for UO{sub 2} and UO{sub 2} plus 3 wt% Gd{sub 2}O{sub 3} commercial spent nuclear fuel taken from a series of Approved Testing Materials (ATMs). These full-length nuclear fuel rods include MLA091 of ATM-103, MKP070 of ATM-104, NBD095 and NBD131 of ATM-106, and ADN0206 of ATM-108. ATMs 103, 104, and 106 were all irradiated in the Calvert Cliffs Nuclear Power Plant (Reactor No.1), a pressurized-water reactor that used fuel fabricated by Combustion Engineering. ATM-108 was part of the same fuel bundle designed as ATM-105 and came from boiling-water reactor fuel fabricated by General Electric and irradiated in the Cooper Nuclear Power Plant. Rod average burnups and expected fission gas releases ranged from 2,400 to 3,700 GJ/kgM. (25 to 40 Mwd/kgM) and from less than 1% to greater than 10%, respectively, depending on the specific ATM. The radiochemical analyses included uranium and plutonium isotopes in the fuel, selected fission products in the fuel, fuel burnup, cesium and iodine on the inner surfaces of the cladding, {sup 14}C in the fuel and cladding, and analyses of the gases released to the rod plenum. Supporting examinations such as fuel rod design and material descriptions, power histories, and gamma scans used for sectioning diagrams are also included. These ATMs were examined as part of the Materials Characterization Center Program conducted at Pacific Northwest Laboratory provide a source of well-characterized spent fuel for testing in support of the US Department of Energy Office of Civilian Radioactive Waste Management Program.

  17. 7 CFR 305.2 - Approved treatments.

    Science.gov (United States)

    2010-01-01

    ... products Pectinophora spp MB T301-a-5-1 or MB T301-a-5-2. (f) Cut flowers and greenery. The treatment...-2-1-1. Herbs, fresh (includes all fresh plant parts except seeds) External feeders and leafminers... Internal feeders MB T101-g-1. Yam Internal and external feeders MB T101-f-3. Zucchini Ceratitis...

  18. 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...

  19. 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.

  20. 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

  1. 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

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

    Science.gov (United States)

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

    2015-01-01

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

  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. 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...

  5. 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...

  6. 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...

  7. 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.)

  8. 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...

  9. 75 FR 60617 - Review and Approval of Projects

    Science.gov (United States)

    2010-10-01

    ... COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION: Final rule. SUMMARY: This document contains final rules that amend the project review... procedures for all project applications; clarify requirements for grandfathered projects increasing...

  10. 75 FR 36301 - Review and Approval of Projects

    Science.gov (United States)

    2010-06-25

    ... final at 71 FR 78570, December 29, 2006, updating and expanding the range of projects subject to... COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY: Susquehanna River Basin... proposed rules that would amend the project review regulations of the Susquehanna River Basin...

  11. 76 FR 60774 - Review and Approval of Projects

    Science.gov (United States)

    2011-09-30

    ..., 2011 (76 FR 41154) may be submitted to the Commission on or before November 10, 2011. ADDRESSES... 10, 2011, the written comment deadline for proposed rules that appeared in 76 FR 41154-41157 July 13... COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission....

  12. 77 FR 75915 - Review and Approval of Projects

    Science.gov (United States)

    2012-12-26

    ... COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION... would amend the project review regulations of the Susquehanna River Basin Commission (Commission) to... is to make further modifications to the Commission's project review regulations relating to...

  13. 77 FR 8095 - Review and Approval of Projects

    Science.gov (United States)

    2012-02-14

    ... COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION: Final rule. SUMMARY: This document contains final rules that would amend the project review regulations... hydrocarbon development project to an out-of- basin treatment or disposal facility; insert...

  14. 77 FR 14272 - Review and Approval of Projects

    Science.gov (United States)

    2012-03-09

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects CFR Correction In Title 18 of the Code of Federal Regulations, Part 400 to End, revised as of April 1, 2011, on page 118, in Sec. 806.6, (b)(1)(i) and (ii)...

  15. 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.

  16. 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

  17. 24 CFR 58.77 - Effect of approval of certification.

    Science.gov (United States)

    2010-04-01

    ... applicable provisions of law cited in § 58.1(b). (b) Public and agency redress. Persons and agencies seeking redress in relation to environmental reviews covered by an approved certification shall deal with the responsible entity and not with HUD. It is HUD's policy to refer all inquiries and complaints to...

  18. 7 CFR 1822.273 - Actions subsequent to loan approval.

    Science.gov (United States)

    2010-01-01

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

  19. 7 CFR 1703.141 - Approved purposes for loans.

    Science.gov (United States)

    2010-01-01

    ... relating to the establishment or expansion of the phase of the project that is being financed with the loan... been approved. The applicant must show that financing such costs are necessary for the establishment or continued operation of the project and that financing is not available for such costs elsewhere,...

  20. 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...

  1. 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...

  2. 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. |

  3. 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....

  4. 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.

  5. 36 CFR 9.37 - Plan of operations approval.

    Science.gov (United States)

    2010-07-01

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

  6. 29 CFR 1952.104 - Final approval determination.

    Science.gov (United States)

    2010-07-01

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

  7. 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...

  8. Experts Approve Development of A Micro-DAFC System

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

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

  9. 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.

  10. 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 ]...

  11. 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...

  12. 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...

  13. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... school level criterion specified in § 668.146(b); (14) For performance-based tests or tests containing... quantitative skills; (9) If a test has been revised from the most recent edition approved by the Secretary, an...), and an analysis of the effects of time on performance; (11) A technical manual that includes— (i)...

  14. 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...

  15. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

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

  16. 15 CFR 280.101 - Petitions for approval of documents.

    Science.gov (United States)

    2010-01-01

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

  17. 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....

  18. 21 CFR 514.111 - Refusal to approve an application.

    Science.gov (United States)

    2010-04-01

    ... shall consider, among other relevant factors: (i) The probable consumption of such drug and of any substance formed in or on food because of the use of such drug; (ii) The cumulative effect on man or animal... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Refusal to approve an application. 514.111...

  19. 21 CFR 1004.6 - Approval of plans.

    Science.gov (United States)

    2010-04-01

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

  20. 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...

  1. 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...

  2. 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...

  3. Pharmacovigilance of biologicals : dynamics in post-approval safety learning

    NARCIS (Netherlands)

    Vermeer, N.S.

    2015-01-01

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

  4. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ... at the enhanced matching rate authorized by 45 CFR 205.35, 45 CFR part 307 or 42 CFR part 433...) Automatic Data Processing Equipment and Services-Conditions for Federal Financial Participation (FFP) Specific Conditions for Ffp § 95.611 Prior approval conditions. (a) General acquisition requirements. (1)...

  5. 21 CFR 601.12 - Changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... qualitative or quantitative formulation, including inactive ingredients, or in the specifications provided in... affect the process methodology or process operating parameters. (iv) Relaxation of an acceptance... Evaluation and Research or the Director, Center for Drug Evaluation and Research, may approve a...

  6. 32 CFR 644.135 - Lease authorization and approvals.

    Science.gov (United States)

    2010-07-01

    ... Services Administration (GSA) charges a Standard Level User Charge (SLUC) for furnishing space. For title... demand of and refusal by the lessor, the Government makes such repairs in order to utilize the property... repairs made after demand and a refusal by the lessor, without prior approval of DAEN-REA-L. (g)...

  7. 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,...

  8. 29 CFR 500.160 - Approved State plans.

    Science.gov (United States)

    2010-07-01

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

  9. 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...

  10. 75 FR 71421 - Notice Announcing OMB Approval of Information Collections

    Science.gov (United States)

    2010-11-23

    ...) announces that the Office of Management and Budget (OMB) has approved certain collections of information... expiration dates. FOR FURTHER INFORMATION CONTACT: For the Talent Search Program: Geraldine Smith, U.S... collection is June 30, 2013. OMB Control No. 1840-0818, Talent Search Grant Application. The expiration...

  11. Interview with Robert Coffin, inventor of T-VEC: the first oncolytic immunotherapy approved for the treatment of cancer.

    Science.gov (United States)

    Coffin, Robert

    2016-02-01

    Interviewed by Ellen Clarke, Commissioning Editor, Future Science Group. Robert Coffin is co-founder and CEO of Replimune. Previously he was Founder and CTO of BioVex Inc, a spin out from his research group at University College London in 1999. He was the inventor of all BioVex products including OncoVEXGM-CSF (talimogene laherparepvec; T-VEC; Imlygic) and oversaw all research and clinical development including bringing T-VEC through to two pivotal Phase 3 studies in melanoma and head and neck cancer. BioVex was acquired by Amgen in 2011 where he was VP Global Development until 2013. T-VEC was approved by the FDA for use in advanced melanoma in October 2015, the first oncolytic therapy or gene therapy to be approved in USA. He was awarded a PhD in virology from Imperial College London prior to his move to University College London in 1991.

  12. Basic substances under EC 1107/2009 phytochemical regulation: experience with non-biocide and food products as biorationals

    Directory of Open Access Journals (Sweden)

    Marchand Patrice A.

    2016-07-01

    Full Text Available Basic Substances are a newly effective category of Plant Protection Product under EC Regulation No 1107/2009. The first approved application of Equisetum arvense L. opened Part C of Implementing Regulation (EU No 540/2011, which lists the basic substance approved. Although E. arvense was described as a fungicide extract, subsequent applications like chitosan were related to non-biocide molecules. Consequently, plant protection product data were collected from research on alternative or traditional crop protection methods. They are notably issued or derived from foodstuffs (plants, plant by-products, plant derived products, substances and derived substances from animal origin. Applications are currently submitted by our Institute, under evaluation at different stages of the approval process or already approved. Remarkably, this Basic Substance category under pesticide EU Regulation was surprisingly designed for these non-biocidal plant protection products. In fact, components described as the “active substance” of most of the actual applications are food products like sugars and lecithin. Basic Substance applications for these foodstuffs are therefore a straightforward way of easily gaining approval for them. Here we describe the approval context and detail the agricultural uses of theses food products as Biological Control Agents (BCAs or biorationals for crop protection. From all deposited or approved Basic Substance Application (BSA, a proof has been provided that non-biocide and food products via physical barrier or lure effects may be effective plant protection products with an acceptable low profile of concern for public and agricultural safety.

  13. 78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

    Science.gov (United States)

    2013-07-10

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

  14. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Science.gov (United States)

    2010-10-01

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

  15. 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...

  16. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    Science.gov (United States)

    2010-01-01

    ... and the Department of the Treasury at 31 CFR 103.121, which require a customer identification program. ... board of directors to approve the Bank Secrecy Act compliance program. (2) Customer identification... with customers or potential customers, beyond incidental contact with existing customers relating...

  17. Viagra's rise above women's health issues: an analysis of the social and political influences on drug approvals in the United States and Japan.

    Science.gov (United States)

    Hollander, Ilyssa

    2006-02-01

    In the United States, Viagra was approved in less than 6 months of its application to the Food and Drug Administration, while the medical abortion pill was approved 4 years after its application, and 17 years after research was first permitted. Congruently, the Ministry of Health in Japan legalized Viagra in 6 months, while oral contraceptives were approved 35 years after the ministry received initial applications. The pharmaceutical review agencies in each country are founded on safety and efficacy standards, in which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals demonstrate that conclusions may not have been based simply on science and health concerns. Instead, agency actions and application of pharmaceutical law appear to have been influenced by social and political pressures surrounding the products under scrutiny. Pharmaceutical regulations were effectively ignored or manipulated in the United States during the review process for medical abortion, and were applied inconsistently in Japan--ultimately yielding results that happened to conform to contemporary sociopolitical beliefs. Such disregard of legislation holds serious ramifications for public health, national consumer trust and the pharmaceutical industry. It is imperative that external pressures remain outside the scope of drug approval processes.

  18. 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.

  19. 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...

  20. 78 FR 16279 - HUD Healthcare Facility Documents: Notice Announcing Final Approved Documents and Assignment of...

    Science.gov (United States)

    2013-03-14

    ... the public review process for obtaining approval of changes to these specific healthcare facility... URBAN DEVELOPMENT HUD Healthcare Facility Documents: Notice Announcing Final Approved Documents and... Commissioner, HUD. ACTION: Notice. SUMMARY: This notice announces that the healthcare facility documents...

  1. 48 CFR 45.606-2 - Contractor without an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

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

  2. 76 FR 22709 - Medicare and Medicaid Programs; Approval of the American Association for Accreditation of...

    Science.gov (United States)

    2011-04-22

    ... HUMAN SERVICES Centers for Medicare & Medicaid Services Medicare and Medicaid Programs; Approval of the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for Deeming Authority for... decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities...

  3. 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...

  4. 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

  5. 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...

  6. 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...

  7. 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.

  8. 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

  9. 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.” ...

  10. 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, ...

  11. 78 FR 21171 - International Mail Product

    Science.gov (United States)

    2013-04-09

    ... International Business Reply Service (IBRS) Competitive Contract 3 negotiated service agreement (Agreement).\\1... Docket Nos. MC2011-21 and CP2011-59, Order No. 684, Order Approving International Business Reply Service... International Mail Product AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission...

  12. 78 FR 21633 - International Mail Product

    Science.gov (United States)

    2013-04-11

    ... International Business Reply Service (IBRS) Competitive Contract 3 negotiated service agreement (Agreement).\\1... Docket Nos. MC2011-21 and CP2011-59, Order No. 684, Order Approving International Business Reply Service... International Mail Product AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission...

  13. 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

  14. 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

  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. 78 FR 2878 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

    Science.gov (United States)

    2013-01-14

    ..., 2013, to approve changes to the Georgia State Implementation Plan (SIP) New Source Review Prevention of... ``Approval and Promulgation of Implementation Plans; Georgia: New Source Review-- Prevention of Significant... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Georgia: New Source...

  17. 77 FR 21453 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to New Source...

    Science.gov (United States)

    2012-04-10

    ....166(i)(5)(i)... Approved by Fully approved * * ). Beryllium, Vinyl interstate * Because the chloride... action at 76 FR 21835, April 19, 2011). Colorado has a federally approved NSR program for new and.... Background for This Action On December 7, 2005 (70 FR 72744), EPA published a notice of proposed...

  18. The State and Local Curriculum Approval Process in Illinois Community and Junior Colleges.

    Science.gov (United States)

    Parcells, Frank E.

    The program approval process of the Illinois Community College Board (ICCB) and the local process of course and program approval used by Illinois community colleges are detailed in this report. Following an introduction and study overview, course and program approval processes at John A. Logan College and Shawnee College are described and…

  19. 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...

  20. 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...

  1. 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,...

  2. 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...

  3. 78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A...., P.O. Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO... given that approval of NADA 008-019, and all supplements and amendments thereto, is hereby...

  4. 78 FR 70496 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

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

  5. 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)...

  6. 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...

  7. 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…

  8. 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...

  9. 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...

  10. 14 CFR 125.297 - Approval of flight simulators and flight training devices.

    Science.gov (United States)

    2010-01-01

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

  11. 48 CFR 1352.271-83 - Government review, comment, acceptance and approval.

    Science.gov (United States)

    2010-10-01

    ....271-83 Government review, comment, acceptance and approval. As prescribed in 48 CFR 1371.114, insert..., acceptance or approval by the Government as required under this contract and applicable specifications shall..., acceptance and approval. 1352.271-83 Section 1352.271-83 Federal Acquisition Regulations System DEPARTMENT...

  12. 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...

  13. 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...

  14. 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...

  15. 42 CFR 505.19 - Approval or denial of loan forgiveness.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Approval or denial of loan forgiveness. 505.19... INFRASTRUCTURE IMPROVEMENT PROGRAM Forgiveness of Indebtedness § 505.19 Approval or denial of loan forgiveness. (a) Approval of loan forgiveness. If CMS determines that a qualifying hospital has met the...

  16. 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...

  17. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

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

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 39 CFR 501.8 - Postage Evidencing System test and approval.

    Science.gov (United States)

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Postage Evidencing System test and approval. 501.8... AND DISTRIBUTE POSTAGE EVIDENCING SYSTEMS § 501.8 Postage Evidencing System test and approval. (a) To receive Postal Service approval, each Postage Evidencing System must be submitted by the provider...

  3. 33 CFR 175.21 - Condition; size and fit; approval marking.

    Science.gov (United States)

    2010-07-01

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

  4. 7 CFR 1710.209 - Approval requirements for load forecast work plans.

    Science.gov (United States)

    2010-01-01

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

  5. 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...

  6. 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...

  7. 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...

  8. 49 CFR 1522.121 - Security threat assessments for personnel of TSA-approved validation firms.

    Science.gov (United States)

    2010-10-01

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

  9. INDACATEROL: A NEW APPROVED MOLECULE TO TREAT COPD

    Directory of Open Access Journals (Sweden)

    Jaithlia Rajiv

    2011-05-01

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

  10. 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.

  11. Assisted Death: The Risks and Benefits of Tribunal Approval.

    Science.gov (United States)

    Handelman, Mark

    2016-02-01

    Should every request for physician-assisted death require approval from some kind of independent tribunal? The benefits include consistent interpretation of statutory or judge-created guidelines from hospital to hospital, accurate reporting of assisted deaths, a process that protects vulnerable patients and health practitioners, and assurance to the public that the process has sufficient safeguards. On the other hand, such a process might cause delays for persons suffering intolerably. Accessibility might be a problem, and there is the risk that the patient's personal health information becomes fodder for media sensationalism. The author weighs these risks and benefits and concludes that a tribunal approval process is a transparent system capable of helping the law clearly gel in a way that provides guidelines, encourages trust in the healthcare process generally and the assisted death process specifically. I PMID:27169206

  12. 77 FR 62150 - Approval and Promulgation of Implementation Plans; Kentucky; Approval of Revisions to the...

    Science.gov (United States)

    2012-10-12

    ... Performance for Existing Ferroalloy and Calcium Carbide Production Facilities. 6.48 Standard of 10/23/01 66 FR... in the NSR PM 2.5 Rule,\\2\\ 73 FR 28321 (May 16, 2008); (2) adopts PSD provisions related to the... precursor to ozone, 70 FR 71612 (November 29, 2005); and (3) adopts federal PSD regulations established...

  13. 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).

  14. 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...

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 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...

  20. 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.