WorldWideScience

Sample records for biothrax product approval

  1. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

    ..., AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... based. MSHA will select an approved conveyor belt to be audited; the selected belt will be...

  2. Establishment approval in international trade of animal products

    NARCIS (Netherlands)

    Rau, M.L.; Ge, L.; Valeeva, N.I.; Wagenberg, van C.P.A.

    2012-01-01

    This report provides an overview of different approaches of establishment approval as well as its implementation and organisation in international agrifood trade. The focus is on animal products as establishment approval is particularly used for exporting these products. Based on trade data, 8

  3. 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...

  4. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  5. Accelerated approval of oncology products: the food and drug administration experience.

    Science.gov (United States)

    Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

    2011-04-20

    We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

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

    Science.gov (United States)

    2010-01-01

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

  7. 78 FR 29780 - Fees for Testing, Evaluation, and Approval of Mining Products

    Science.gov (United States)

    2013-05-21

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

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

    Directory of Open Access Journals (Sweden)

    Bate R

    2012-07-01

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

  9. 75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products

    Science.gov (United States)

    2010-12-29

    ..., and Approval of Mining Products AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION..., evaluating, and approving mining products as provided by 30 CFR part 5. MSHA charges applicants a fee to... materials manufactured for use in the mining industry. The new fee schedule, effective January 1, 2011, is...

  10. An analysis of FDA-approved drugs: natural products and their derivatives.

    Science.gov (United States)

    Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton

    2016-02-01

    Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. 14 CFR 193.17 - How must design and production approval holders handle information they receive from the FAA...

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

    Sipp, Douglas

    2015-04-02

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

  13. 78 FR 26301 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2013-05-06

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2010-0394; EPA-R05-OAR-2012-0786; FRL-9786-1] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and... consumer products categories into the State's SIP. Finally, EPA is proposing to approve language to clarify...

  14. The big picture on nanomedicine: the state of investigational and approved nanomedicine products.

    Science.gov (United States)

    Etheridge, Michael L; Campbell, Stephen A; Erdman, Arthur G; Haynes, Christy L; Wolf, Susan M; McCullough, Jeffrey

    2013-01-01

    Developments in nanomedicine are expected to provide solutions to many of modern medicine's unsolved problems, so it is no surprise that the literature contains many articles discussing the subject. However, existing reviews tend to focus on specific sectors of nanomedicine or to take a very forward-looking stance and fail to provide a complete perspective on the current landscape. This article provides a more comprehensive and contemporary inventory of nanomedicine products. A keyword search of literature, clinical trial registries, and the Web yielded 247 nanomedicine products that are approved or in various stages of clinical study. Specific information on each was gathered, so the overall field could be described based on various dimensions, including FDA classification, approval status, nanoscale size, treated condition, nanostructure, and others. In addition to documenting the many nanomedicine products already in use in humans, this study identifies several interesting trends forecasting the future of nanomedicine. In this one of a kind review, the state of nanomedicine commercialization is discussed, concentrating only on nanomedicine-based developments and products that are either in clinical trials or have already been approved for use. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. 77 FR 26706 - Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat...

    Science.gov (United States)

    2012-05-07

    ... Listed and Approved for Use in the Production of Meat and Poultry Products AGENCY: Food Safety and... the regulations prohibit for use in meat or poultry products. Under this proposal, new uses of these substances in meat or poultry products would continue to be approved by the Food and Drug Administration (FDA...

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

    Science.gov (United States)

    Nema, Sandeep; Brendel, Ronald J

    2011-01-01

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

  17. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

    Science.gov (United States)

    Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer

    2016-06-01

    To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.

  18. 77 FR 2308 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2012-01-17

    ...: Notice is hereby given that, pursuant to 19 CFR 151.13, Altol Petroleum Product Service, Parque Industrial Sabanetas, Edificio M- 1380-01-02, Ponce, PR 00731, has been approved to gauge petroleum...

  19. 78 FR 57406 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2013-09-18

    ... INFORMATION: Notice is hereby given pursuant to 19 CFR 151.13, that Altol Petroleum Product Service, Parque Industrial Sabanetas, Edificio M-1380-01-02, Ponce, PR 00731, has been approved to gauge petroleum, petroleum...

  20. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-10-26

    ... 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran AGENCY...) is amending the animal drug regulations by removing those portions that reflect approval of eight new...

  1. Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-

    Science.gov (United States)

    2017-11-22

    This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.

  2. 78 FR 26258 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2013-05-06

    ... adopt these VOC limits to create more consistency in regional and national markets for consumer products... organic compound (VOC) content limits and associated provisions for additional consumer products categories into the state's SIP. Finally, EPA is approving language to clarify VOC limit applicability for...

  3. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry...

  4. 6 CFR 5.44 - Testimony and production of documents prohibited unless approved by appropriate Department...

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Testimony and production of documents prohibited... in Litigation § 5.44 Testimony and production of documents prohibited unless approved by appropriate... or request, including in connection with any litigation, provide oral or written testimony by...

  5. 12 CFR 1253.8 - Availability of new product to an Enterprise after it has been approved for the other Enterprise.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Availability of new product to an Enterprise after it has been approved for the other Enterprise. 1253.8 Section 1253.8 Banks and Banking FEDERAL HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS § 1253.8 Availability of new...

  6. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

    Science.gov (United States)

    Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

    2018-02-01

    Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

  7. 30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines constructed of components... APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.95 Approval of machines constructed of components approved...

  8. 75 FR 61497 - Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request...

    Science.gov (United States)

    2010-10-05

    ... Price Competition and Innovation Act of 2009 (BPCI Act) that amends the Public Health Service Act (PHS... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0477] Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for...

  9. 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.

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

    International Nuclear Information System (INIS)

    Lee, Ju Woon; Kim, Wang Geun; Kim, Kyong Su; Yook, Hong Sun; Kim, Cheon Jei

    2008-01-01

    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

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

    OpenAIRE

    Lee, Bruce Y.; 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...

  12. Study on the Implications of Asynchronous GMO Approvals for EU Imports of Animal Feed Products

    NARCIS (Netherlands)

    Nowicki, P.L.; Aramyan, L.H.; Baltussen, W.H.M.; Dvortsin, L.; Jongeneel, R.A.; Perez Dominguez, I.; Wagenberg, van C.P.A.; Kalaitzandonakes, N.; Kaufman, J.; Miller, D.; Franke, L.; Meerbeek, B.

    2010-01-01

    The aim of this study is to understand the implications of asynchronous approvals for genetically modified organisms (GMOs) that are imported to the European Union for use within animal feed products, specifically with regard to the EU livestock sector, as well as upon the upstream and downstream

  13. 30 CFR 14.7 - Approval marking and distribution records.

    Science.gov (United States)

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.7 Approval marking and distribution records. (a) An approved conveyor belt must be marketed only under the name specified in the approval. (b) Approved conveyor belt must be legibly and...

  14. 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

    2015-04-23

    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.

  15. THE BIG PICTURE ON SMALL MEDICINE: THE STATE OF NANOMEDICINE PRODUCTS APPROVED FOR USE OR IN CLINICAL TRIALS

    Science.gov (United States)

    Etheridge, Michael L.; Campbell, Stephen A.; Erdman, Arthur G.; Haynes, Christy L.; Wolf, Susan M.; McCullough, Jeffrey

    2015-01-01

    Developments in nanomedicine are expected to provide solutions to many of modern medicine’s unsolved problems, so it is no surprise that literature is flush with articles discussing the subject. However, existing reviews tend to focus on specific sectors of nanomedicine or take a very forward looking stance and fail to provide a complete perspective on the current landscape. This article provides a more comprehensive and contemporary inventory of nanomedicine products. A keyword search of literature, clinical trial registries, and the Web, yielded 247 nanomedicine products that are approved or in various stages of clinical study. Specific information on each was gathered, so the overall field could be described based on various dimensions, including: FDA classification, approval status, nanoscale size, treated condition, nanostructure, and others. In addition to documenting the large number of nanomedicine products already in human use, this study indentifies some interesting trends forecasting the future of nanomedicine. PMID:22684017

  16. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2010-05-05

    ... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

  17. 75 FR 57019 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-09-17

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

  18. 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.

  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 be...

  20. Changing innovation into a registered product: From concept to regulatory approval.

    Science.gov (United States)

    Rhodes, Linda

    2018-05-01

    Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples. The regulatory path is discussed, with a review of the various oversight agencies, and the categories of data required to be submitted, including safety, efficacy, manufacturing, environmental impact and human food safety. In conclusion, the cost, development time, and barriers to innovation in veterinary medical pharmaceuticals are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

  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

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

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

    Science.gov (United States)

    Wish, Jay B

    2014-09-05

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

  3. 30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

    Science.gov (United States)

    2010-07-01

    ... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES... having jurisdiction at the mine where such equipment is to be operated stating the modifications which...

  4. Is It Really FDA Approved?

    Science.gov (United States)

    ... satisfaction before companies can market them in interstate commerce. Some examples of biologics that require approval are ... it means the agency has determined that the benefits of the product outweigh the known risks for ...

  5. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve or...

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

    International Nuclear Information System (INIS)

    Rolle, A.; Buhlemann, L.

    2004-01-01

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

  7. Approval of radioactive consumer goods

    International Nuclear Information System (INIS)

    Paynter, R.A.

    1992-01-01

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

  8. Gender-specific Regulatory Challenges to Product Approval: a panel discussion.

    Science.gov (United States)

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

    2014-12-01

    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. © 2014 by the Society for Academic Emergency Medicine.

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

    Directory of Open Access Journals (Sweden)

    Laura M McNamee

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

  10. 76 FR 41154 - Review and Approval of Projects

    Science.gov (United States)

    2011-07-13

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

  11. The European Medicines Agency's approval of new medicines for type 2 diabetes.

    Science.gov (United States)

    Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

    2018-05-08

    Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

  12. 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.

  13. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

    2010-08-27

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

  15. 9 CFR 317.4 - Labeling approval.

    Science.gov (United States)

    2010-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Paolo Omar. Cerutti

    2008-12-01

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

  17. Analysis of time to regulatory and ethical approval of SATVI TB ...

    African Journals Online (AJOL)

    Background. Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product. Aim. Our aim was to ...

  18. 21 CFR 515.20 - Approval of medicated feed mill license applications.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Approval of medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.20 Approval of medicated feed mill license applications. Within 90 days after an...

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

    Science.gov (United States)

    2004-04-08

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

  20. Applicant's guide related to requests of shipping approval and of acceptance of parcel models or radioactive products aimed at civilian use transported on public road - Guide nr 7 - Index 0, release of the 07/04/2009

    International Nuclear Information System (INIS)

    2009-01-01

    This guide presents the recommendations made by the ASN to applicants in order to facilitate approval requests and shipping approvals related to the transportation of radioactive products. After a recall of the legal context, these recommendations address the documents to be provided in support of an approval request or of a shipping approval, the content of the safety file, the instruction delay, the approval certificate, and changes brought to the parcel model. Appendices contain issues raised by expertise based on experiences, the European PDSR (Package Design Safety Report), and a model for the elaboration of a certificate project

  1. 30 CFR 18.91 - Electric equipment for which field approvals will be issued.

    Science.gov (United States)

    2010-07-01

    ..., by the owner-coal mine operator of such machines including any associated electrical equipment... 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...

  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 § 4.93...

  3. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  5. A drug's life: the pathway to drug approval.

    Science.gov (United States)

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  6. 27 CFR 4.91 - List of approved prime names.

    Science.gov (United States)

    2010-04-01

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

  7. 9 CFR 55.8 - Official CWD tests and approval of laboratories to conduct official CWD tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Official CWD tests and approval of laboratories to conduct official CWD tests. 55.8 Section 55.8 Animals and Animal Products ANIMAL AND PLANT... on live or dead animals, and will base the approval or disapproval of a test on the evaluation by...

  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.

  9. Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments.

    Science.gov (United States)

    2017-03-23

    On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. Thereafter, the Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation that would result in Syndros (and other oral solutions containing dronabinol) being placed in schedule II of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.

  10. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Science.gov (United States)

    2010-04-01

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

  11. Criteria of acceptability relating to the approval of consumer goods containing radioactive substances

    International Nuclear Information System (INIS)

    Paynter, R.A.

    1992-01-01

    The criteria are described which the Board intends to use when considering goods containing radioactive substances for approval under the regulations that the Government intends to make with respect to such goods. Some products are deemed unacceptable in principle because there would appear to be no justification for the use of radioactive substances in them. Examples of such products are given. Other products may be approved for supply to the public depending on the doses likely to be received by individuals, principally those who use the products. A lower dose is considered acceptable from products that do not contribute to safety than from products that do. In the interim, before the regulations are made, the criteria will be used as the basis of the Board's advice to suppliers and manufacturers of goods containing radioactive substances. (Author)

  12. 30 CFR 18.80 - Approval of machines assembled with certified or explosion-proof components.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines assembled with certified... ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Machines Assembled With Certified or Explosion-Proof Components, Field...

  13. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    Science.gov (United States)

    2010-07-01

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

  14. 75 FR 32355 - Notice of Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-06-08

    .... Expiration Date of Approval: November 30, 2010. Type of Request: Revision of a currently approved information... retailers to market product. The Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), section 203(g... ornamental trade, which includes packers, processors, brokers, retailers, producers, and associated...

  15. Bacteria-eating virus approved as food additive.

    Science.gov (United States)

    Bren, Linda

    2007-01-01

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

  16. Biomedicines?Moving Biologic Agents into Approved Treatment Options

    OpenAIRE

    Cornetta, Kenneth

    2013-01-01

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

  17. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Science.gov (United States)

    2010-04-01

    ... after manufacture. 115.41 Section 115.41 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT... PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.41 Certificate of approval for containers approved after manufacture. The Certifying Authority shall...

  18. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Approval based on evidence of effectiveness from... the effectiveness of these products only when: (1) There is a reasonably well-understood...

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

    Science.gov (United States)

    Beck, Alain; Reichert, Janice M

    2013-01-01

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

  20. 75 FR 51437 - Notice of Request for Extension of a Currently Approved Information Collection (Advanced Meat...

    Science.gov (United States)

    2010-08-20

    ... Request for Extension of a Currently Approved Information Collection (Advanced Meat Recovery) AGENCY: Food... information collection regarding the regulatory requirements associated with the production of meat from Advanced Meat Recovery systems because the OMB approval will expire on January 31, 2011. DATES: Comments on...

  1. No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.

    Science.gov (United States)

    Kelly, Jeremiah J; David, Michael

    2009-01-01

    Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under Section 351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the one hundred and tenth Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics. Any legislation in the one hundred and eleventh Congress must determine: (1) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (2) if human clinical trials should be mandatory or discretionary; (3) the feasibility of interchangeability determinations in light of patient safety concerns; (4) the duration of marketing exclusivity for associated products; (5) which products are eligible for follow-on approval; and (6) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the one hundred and eleventh Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent process that capitalizes on FDA's growing expertise with follow-on biologics approvals under Section 505(b)(2) of the FD&C Act.

  2. Redfield Energy Approval

    Science.gov (United States)

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

  3. 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.

  4. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

    Science.gov (United States)

    DiMasi, Joseph A

    2013-06-01

    Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

  5. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  6. 76 FR 41086 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Volatile Organic Compound...

    Science.gov (United States)

    2011-07-13

    ... compound (VOC) emissions from reinforced plastic composites production operations. This rule applies to any facility that has reinforced plastic composites production operations. This rule is approvable because it... subpart WWWW of 40 CFR part 63, for Reinforced Plastic Composites Production, underestimate emissions...

  7. Biomedicines—Moving Biologic Agents into Approved Treatment Options

    Directory of Open Access Journals (Sweden)

    Kenneth Cornetta

    2013-03-01

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

  8. Drugs Approved for Breast Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Raloxifene Hydrochloride Tamoxifen Citrate Drugs ...

  9. 12 CFR 1253.4 - New product approval.

    Science.gov (United States)

    2010-01-01

    ... Enterprise and the mortgage finance and financial system. The Enterprise may then offer the new product... Enterprise or the mortgage finance or financial system. If the Director disapproves the new product, the... the Enterprise or the mortgage finance or financial system. (6) If the Director fails to make a...

  10. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  11. 77 FR 46739 - Proposed Extension of Approval of Information Collection; Comment Request-Baby Bouncers and...

    Science.gov (United States)

    2012-08-06

    ... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Baby Bouncers and Walker-Jumpers AGENCY: Consumer Product Safety Commission. ACTION... information collection requirements for manufacturers and importers of children's articles known as baby...

  12. 77 FR 38725 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Volatile Organic...

    Science.gov (United States)

    2012-06-29

    ... compound (VOC) emissions limits and other restrictions on consumer products that are sold, supplied.... This supplementary information section is arranged as follows: I. Background II. Contents of Indiana's... approval is based on the model rule developed by the Ozone Transport Commission (OTC) for consumer products...

  13. 78 FR 38912 - Notice of Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2013-06-28

    ... immediate production and marketing decisions and as a guide to the amount of product in the supply channel... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Document No. AMS-FV-13-0022] Notice of Request for Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service...

  14. 77 FR 55812 - Proposed Extension of Approval of Information Collection; Comment Request-Baby Bouncers and...

    Science.gov (United States)

    2012-09-11

    ... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0038] Proposed Extension of Approval of Information Collection; Comment Request--Baby Bouncers and Walker-Jumpers AGENCY: Consumer Product Safety... collection requirements for manufacturers and importers of children's articles known as baby-bouncers and...

  15. Requirements for the approval of dosimetry services under the Ionising Radiations Regulations 1985: Pt. 2: Internal radiations

    International Nuclear Information System (INIS)

    1991-01-01

    Guidance for dosimetry services on the requirements for approval by the Health and Safety Executive (HSE) is provided in three parts. This part sets out the procedures and criteria that will be used by HSE in the assessment of dosimetry services seeking approval in relation to internal radiations (including radon decay products). (author)

  16. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    Science.gov (United States)

    2010-06-11

    ...] Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for... Biologics Evaluation and Research (CBER) are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product...

  17. 27 CFR 25.55 - Formulas for fermented products.

    Science.gov (United States)

    2010-04-01

    ... purposes (including consumer taste testing), produce a fermented product without an approved formula, but... is my formula approval valid? Your formula approved under this section remains in effect until: you... request to the Assistant Chief, Advertising, Labeling and Formulation Division, Alcohol and Tobacco Tax...

  18. 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...

  19. 78 FR 59949 - Accreditation and Approval of Inspectorate America Corporation, as a Commercial Gauger and...

    Science.gov (United States)

    2013-09-30

    ... test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes for... CFR 151.13, that Inspectorate America Corporation, 2 Williams Street, Chelsea, MA 02150, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable...

  20. Observations and suggestions for improved transport/packaging approvals

    International Nuclear Information System (INIS)

    Vaughan, C.

    2004-01-01

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

  1. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

    Science.gov (United States)

    Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

    2018-05-02

    There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  2. Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

    Science.gov (United States)

    KuKanich, Butch; Warner, Matt; Hahn, Kevin

    2017-02-01

    OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

  3. 76 FR 45769 - Notice of Request for Extension of Approval of an Information Collection; Pork and Poultry...

    Science.gov (United States)

    2011-08-01

    ...] Notice of Request for Extension of Approval of an Information Collection; Pork and Poultry Products From... regulations for pork and poultry products from Mexico transiting the United States. DATES: We will consider... information on pork and poultry products from Mexico transiting the United States, contact Dr. Lynette...

  4. Need for certification of household water treatment products: examples from Haiti.

    Science.gov (United States)

    Murray, Anna; Pierre-Louis, Jocelyne; Joseph, Flaurine; Sylvain, Ginelove; Patrick, Molly; Lantagne, Daniele

    2015-04-01

    To evaluate four household water treatment (HWT) products currently seeking approval for distribution in Haiti, through the application of a recently-developed national HWT product certification process. Four chemical treatment products were evaluated against the certification process validation stage by verifying international product certifications confirming treatment efficacy and reviewing laboratory efficacy data against WHO HWT microbiological performance targets; and against the approval stage by confirming product composition, evaluating treated water chemical content against national and international drinking water quality guidelines and reviewing packaging for dosing ability and usage directions in Creole. None of the four evaluated products fulfilled validation or approval stage requirements. None was certified by an international agency as efficacious for drinking water treatment, and none had data demonstrating its ability to meet WHO HWT performance targets. All product sample compositions differed from labelled composition by >20%, and no packaging included complete usage directions in Creole. Product manufacturers provided information that was inapplicable, did not demonstrate product efficacy, and was insufficient to ensure safe product use. Capacity building is needed with country regulatory agencies to objectively evaluate HWT products. Products should be internationally assessed against WHO performance targets and also locally approved, considering language, culture and usability, to ensure effective HWT. © 2014 John Wiley & Sons Ltd.

  5. Electronic Approval of Invoices (AEF)

    CERN Document Server

    2004-01-01

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

  6. 75 FR 16458 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-04-01

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

  7. 78 FR 20630 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2013-04-05

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Plastic Parts and Products... compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an... www.regulations.gov . Title: NESHAP for Plastic Parts and Products Surface Coating (Renewal). ICR...

  8. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

    Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  9. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  10. 40 CFR 52.2122 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

  11. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2010-08-10

    ....gov ). FOR FURTHER INFORMATION CONTACT: For information on credit account approval for reimbursable..., at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable... Inspection Service [Docket No. APHIS-2010-0071] Notice of Request for Extension of Approval of an Information...

  12. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2013-09-05

    ...] Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval for... (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit account... Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable...

  13. 40 CFR 52.1772 - Approval status.

    Science.gov (United States)

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans for... CTGs issued by the previous January. (b) New Source review permits issued pursuant to section 173 of...

  14. Regulatory Approval Decisions in the Presence of Market Externalities: The Case of Genetically Modified Wheat

    OpenAIRE

    Furtan, William Hartley; Gray, Richard S.; Holzman, J.J.

    2005-01-01

    This study examines the optimal approval strategy for genetically modified (GM) wheat varieties in Canada and the United States. Without an affordable segregation system, the introduction of GM wheat will create a market for "lemons" that will result in the loss of important export markets. Using a differentiated product trade model for spring wheat, with endogenous technology pricing, a payoff matrix is generated for the possible approval outcomes. Results show that the existence of the mark...

  15. 7 CFR 1710.406 - Loan approval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the Administrator...

  16. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  17. 21 CFR 310.4 - Biologics; products subject to license control.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Biologics; products subject to license control... to license control. (a) If a drug has an approved license under section 351 of the Public Health.... (b) To obtain marketing approval for radioactive biological products for human use, as defined in...

  18. 46 CFR 159.007-11 - Production inspections and tests: Yearly report.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests: Yearly report. 159.007-11 Section 159.007-11 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production...

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

    International Nuclear Information System (INIS)

    Petti, D.A.; Haire, J.C.

    1993-12-01

    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

  20. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290 as.... (c) The Administrator approves Rule 10 CSR 10-2.230 as identified under § 52.1320, paragraph (c)(70... SIP would be the emission limits stated in the rule. (d) The Administrator approves Rule 10 CSR 10-5...

  1. 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.

  2. 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...

  3. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

    ... Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Kidney (Renal Cell) Cancer Afinitor (Everolimus) Aldesleukin Avastin (Bevacizumab) Axitinib Bevacizumab Cabometyx ( ...

  4. Basic Substances under EU Pesticide Regulation: An Opportunity for Organic Production?

    Directory of Open Access Journals (Sweden)

    Patrice A. Marchand

    2017-02-01

    Full Text Available Some of the active substances allowed in organic production are now approved as basic sub- stances under the EU plant protection products regulation. Previously, all organic farming permitted active substances were approved as conventional plant protection products. In accordance with the criteria of Article 23 of the EU regulation (EC No 1107/2009, basic substances are granted without maximum residue limits and have a good prospect for being included in Annex II of organic farming Regulation (EC 889/2008. In fact, most of them are already permitted in organic farming. At this stage, it seems desirable to organize applications in order to avoid duplications and to clarify strategy across Europe. This organization should be planned in order to identify corresponding knowledge and data from field experiments, and to further constitute the most crucial issues related to organic production. A work of this nature was initially supported by IFOAM-EU for lecithin, calcium hydroxide and Quassia extract. The Institut Technique de l’Agriculture Biologique (ITAB was previously engaged in a large-scale approval plan motivated by the continuous demand for the regularization of compounds/substances already in use and has a mandate for testing and approving new compatible substances. Thus, the horsetail extract (Equisetum arvense was the first approved basic substance and ITAB has obtained 11 of the 15 basic substances approved at the EU level.

  5. Lessons from innovation in drug-device combination products.

    Science.gov (United States)

    Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

    2012-01-01

    Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon. Copyright © 2011 Elsevier B.V. All rights reserved.

  6. Trial endpoints for drug approval in oncology: Chemoprevention.

    Science.gov (United States)

    Beitz, J

    2001-04-01

    As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

  7. 40 CFR 52.2352 - Change to approved plan.

    Science.gov (United States)

    2010-07-01

    ... Utah's approved State Implementation Plan (SIP). This rule language pertains to State Sales Tax... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Change to approved plan. 52.2352... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Utah § 52.2352 Change to approved...

  8. The Evolution of Approval Services.

    Science.gov (United States)

    Warzala, Martin

    1994-01-01

    Describes major developments in book approval plans used by academic libraries for acquisition and for information dissemination and document distribution services based on approval-like concepts. Topics addressed include publishers; marketing; the impact of library automation; value-added services; the economic climate; the influence of…

  9. 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

  10. 77 FR 39988 - Notice of Request for Approval of a New Information Collection

    Science.gov (United States)

    2012-07-06

    ...), this notice announces the intention of the Risk Management Agency (RMA) to request approval for a new..., Product Analysis & Accounting Division, U.S. Department of Agriculture Risk Management Agency, Beacon... & Accounting Division, U.S. Department of Agriculture Risk Management Agency, Beacon Facility-Mail Stop 0811, P...

  11. 75 FR 1799 - Agency Information Collection Activities: Accreditation of Commercial Laboratories and Approval...

    Science.gov (United States)

    2010-01-13

    ... information collection be extended with no change to the burden hours. This document is published to obtain... appropriate automated, electronic, mechanical, or other technological techniques or other forms of information... information in deciding whether to approve individuals or businesses desiring to measure bulk products or to...

  12. 48 CFR 750.7105 - Approving authorities.

    Science.gov (United States)

    2010-10-01

    ... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7105 Approving authorities. All authority to approve actions...

  13. Consumer and health literacy: The need to better design tobacco-cessation product packaging, labels, and inserts.

    Science.gov (United States)

    Weiss, Stephanie M; Smith-Simone, Stephanie Y

    2010-03-01

    Tobacco-cessation product packaging and instruction materials may not be appropriate for some smokers and may contribute to the underuse and misuse of evidence-based treatments. The dual goals of this project are to analyze literacy levels of Food and Drug Administration (FDA)-approved and non-approved tobacco-cessation product packaging, directions, and claims, and to identify and categorize claims found on product packaging. The Campaign for Tobacco Free Kids (CTFK) maintains the Quitting and Reducing Tobacco Use Inventory of Products (QuiTIP) database, which catalogs products marketed and sold to consumers to reduce or quit use of tobacco products. It also includes all medications approved by the FDA for tobacco cessation as well as a sample of non-approved products such as homeopathic, herbal, nutritional, or dietary supplements commonly marketed as either cessation aids or alternative tobacco/nicotine products. This paper assesses the reading levels required to understand product packaging, labeling, and instructions using the Simple Measure of Gobbledygook (SMOG) and identifies claims on the product package labels using standard qualitative methods. Key findings show that the average reading levels needed to understand instructions for both FDA-approved and non-approved cessation products are above the reading levels recommended to ensure maximum comprehension. Improving the packaging and directions of evidence-based tobacco-cessation products so that they are preferably at or below a fifth-grade reading level, along with using consumer-based design principles to develop packaging, may help smokers take advantage of and correctly use products that will greatly increase their chances of successful quitting. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  14. 76 FR 67496 - New Postal Product

    Science.gov (United States)

    2011-11-01

    ... POSTAL REGULATORY COMMISSION [Docket No. CP2012-1; Order No. 919] New Postal Product AGENCY... to the Inbound Competitive Multi-Service Agreements with Foreign Postal Operators 1 product. \\1... Operators 1 to the Competitive Product List and Approving Included Agreement, September 29, 2010 (Order No...

  15. Vedolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-07-01

    Vedolizumab [Entyvio(®) (US, Europe)], a humanized monoclonal antibody α4β7 integrin receptor antagonist, has been developed by Millennium Pharmaceuticals (d/b/a Takeda Pharmaceuticals International) for the treatment of ulcerative colitis and Crohn's disease. Vedolizumab has received its first global approval for the treatment of ulcerative colitis and Crohn's disease in the US, for use in adult patients with moderate-to-severe disease who have had an inadequate response, loss of response or intolerance to one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor-α inhibitor) or demonstrated dependence on corticosteroids. Vedolizumab has since been approved for ulcerative colitis and Crohn's disease in the EU, Norway, Iceland and Liechtenstein. This article summarizes the milestones in the development of vedolizumab leading to its first approval for the treatment of ulcerative colitis and Crohn's disease.

  16. 19 CFR 115.55 - Termination of approval.

    Science.gov (United States)

    2010-04-01

    ... vehicle by a major repair or alteration of any of the essential features required in § 115.51. Repairs by... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Individual Road Vehicles § 115.55 Termination of approval. Approval of a road...

  17. 20 CFR 617.22 - Approval of training.

    Science.gov (United States)

    2010-04-01

    .... Perkins Vocational and Applied Technology Education Act, and employers). (i) This means that training is...) Conditions for approval. Training shall be approved for an adversely affected worker if the State agency...) available for an adversely affected worker. (i) This means that for the worker for whom approval of training...

  18. 30 CFR 75.1108 - Approved conveyor belts.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved conveyor belts. 75.1108 Section 75... Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1108 Approved conveyor belts. (a) Until December 31, 2009 conveyor belts placed in service in underground coal mines shall be: (1) Approved under...

  19. 45 CFR 1340.13 - Approval of applications.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Approval of applications. 1340.13 Section 1340.13... NEGLECT PREVENTION AND TREATMENT PROGRAM CHILD ABUSE AND NEGLECT PREVENTION AND TREATMENT Grants to States § 1340.13 Approval of applications. (a) The Commissioner shall approve an application for an award for...

  20. 21 CFR 820.90 - Nonconforming product.

    Science.gov (United States)

    2010-04-01

    ... procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the...

  1. 78 FR 29784 - New Postal Product

    Science.gov (United States)

    2013-05-21

    ... POSTAL REGULATORY COMMISSION [Docket No. CP2013-62; Order No. 1716] New Postal Product AGENCY... filing concerning the addition of Global Expedited Package Services 3 Contract to the competitive product... GEPS 3 product on grounds of functional equivalence to a previously approved baseline agreement. Id. at...

  2. 78 FR 65016 - New Postal Product

    Science.gov (United States)

    2013-10-30

    ... Product AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing recent Postal Service filings requesting the addition of Priority Mail Contract 66 to the competitive product... Contract 66 to the competitive product list.\\1\\ It is the successor agreement to the contract approved in...

  3. 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...

  4. 27 CFR 17.133 - Food product formulas.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Food product formulas. 17.133 Section 17.133 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU... PRODUCTS Formulas and Samples Approval of Formulas § 17.133 Food product formulas. Formulas for nonbeverage...

  5. 27 CFR 5.55 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Approval of... certificates of label approval and certificates of exemption from label approval, as well as appeal procedures...

  6. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

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

  7. 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

  8. 78 FR 4478 - New Postal Product

    Science.gov (United States)

    2013-01-22

    ... POSTAL REGULATORY COMMISSION [Docket No. CP2013-42; Order No. 1623] New Postal Product AGENCY... within the Global Plus 2C product on the grounds of functional equivalence to previously approved.... Id. at 1. Background. The Commission added Global Plus 2 to the competitive product list, based on...

  9. Selection of an Alternative Production Part Approval Process to Improve Weapon Systems Production Readiness

    Science.gov (United States)

    2017-09-01

    production outcomes: 1) knowledge gaps in technology, 2) design instability and 3) manufacturing knowledge gaps. Only manufacturing knowledge gaps...ability to produce at a desired production rate. Each item produced under this manufacturing development is to meet that item’s design requirements. The...represented with respect to assessing manufacturing design and development with a verification and demonstration. DOD acquisition waits to assess production

  10. 7 CFR 330.210a - Administrative instructions listing approved packing materials for plant pests.

    Science.gov (United States)

    2010-01-01

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

  11. Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

    Science.gov (United States)

    Chambers, James D; May, Katherine E; Neumann, Peter J

    2013-06-01

    The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

  12. HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

    Energy Technology Data Exchange (ETDEWEB)

    Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

    2007-05-15

    The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

  13. Recent advances in (therapeutic protein drug development [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    H.A. Daniel Lagassé

    2017-02-01

    Full Text Available Therapeutic protein drugs are an important class of medicines serving patients most in need of novel therapies. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders. The latest advances in protein-engineering technologies have allowed drug developers and manufacturers to fine-tune and exploit desirable functional characteristics of proteins of interest while maintaining (and in some cases enhancing product safety or efficacy or both. In this review, we highlight the emerging trends and approaches in protein drug development by using examples of therapeutic proteins approved by the U.S. Food and Drug Administration over the previous five years (2011–2016, namely January 1, 2011, through August 31, 2016.

  14. Analysis of the Education Program Approval Process: A Program Evaluation.

    Science.gov (United States)

    Fountaine, Charles A.; And Others

    A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

  15. 76 FR 47085 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Science.gov (United States)

    2011-08-04

    ... manufacturers take action to prevent the further use of devices for which no PMA or PDP has been filed and may... completion of a product development protocol (PDP) for the class III preamendments device pacemaker... injury designed to be eliminated or reduced by requiring this device to meet the statute's approval...

  16. Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

    Science.gov (United States)

    Mattingly, T Joseph; Simoni-Wastila, Linda

    2017-10-01

    Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

  17. 49 CFR 1522.109 - TSA review and approval.

    Science.gov (United States)

    2010-10-01

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

  18. 49 CFR 1522.115 - Renewal of TSA approval.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false Renewal of TSA approval. 1522.115 Section 1522.115..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

  19. 29 CFR 1952.157 - Changes to approved plan.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS North Carolina § 1952.157 Changes to approved plan. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved North Carolina's... section 17 of the Act as amended on November 5, 1990. (2) [Reserved] (b) The Voluntary Protection Program...

  20. 48 CFR 2922.103-4 - Approvals.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Approvals. 2922.103-4 Section 2922.103-4 Federal Acquisition Regulations System DEPARTMENT OF LABOR SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2922.103-4 Approvals. The “agency...

  1. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

    ...) VOCATIONAL REHABILITATION AND EDUCATION All Volunteer Force Educational Assistance Program (Montgomery GI...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C...) Section 21.4265—Practical training approved as institutional training or on-job training; (10) Section 21...

  2. Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007-15: Report from the Medical Products Agency.

    Science.gov (United States)

    Svedlund, Erika; Larsson, Maria; Hägerkvist, Robert

    2017-06-01

    In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. Adverse drug reactions reported to the Swedish Medical Product Agency during 2007-15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval.

  3. 33 CFR 115.70 - Advance approval of bridges.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges prior...

  4. Implementation of quality assurance with respect to product quality and scheduling

    International Nuclear Information System (INIS)

    Schleimer, W.F.

    1986-04-01

    Quality assurance means the whole range of actions which are necessary to meet the client's requirements for the product and the test methods. Audits: The preconditions for fabrication must be fulfilled by approval of the manufacturer's quality assurance system, the staff's qualification, his procedures and his equipments. This is done by means of a system audit at KWU or an equivalent organisation. Specifications: For quality assurance the requirements for the components are fixed in specifications. There are material specifications, process/procedure specifications, components specifications. Approval of Component Design and Manufacture (Scheduling): The approval procedure of a structurally welded part is described as an example of the approval of component design and manufacture, thus representing one small piece of a mechanical equipment. In-Process Surveillance (Product Audit): At KWU the in-process surveillance is regulated by a KQ- or product audit concept. In this concept we have K- and KQ-steps. The list of KQ-steps will be presented. Documentation: All test or examination steps are documented with certificates, lists, and stamps for the final documentation. 19 figs

  5. 77 FR 37904 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-06-25

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

  6. 76 FR 76401 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-12-07

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Cellulose Products... in paper, will be made available for public viewing at http://www.regulations.gov as EPA receives... information about the electronic docket, go to http://www.regulations.gov . Title: NESHAP for Cellulose...

  7. 77 FR 22789 - Withdrawal of Approval of Part of a New Animal Drug Application; Tiamulin

    Science.gov (United States)

    2012-04-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0262... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of... to the production indications for use of increased rate of weight gain and improved feed efficiency...

  8. 77 FR 29335 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-05-17

    ... Activities; Submission to OMB for Review and Approval; Comment Request; Application for New and Amended... collection activity and its expected burden and costs. DATES: Additional comments may be submitted on or... a pesticide product as required under Section 3 of the Federal Insecticide, Fungicide, and [[Page...

  9. 76 FR 64237 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants Rule

    Science.gov (United States)

    2011-10-18

    ...-9480-5] Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants... chemical production and polytetrafluoroethylene operations; from paint, resin, and adhesive manufacturing; and from adhesive and sealant application. This SIP revision also pertains to an addition of a new...

  10. 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…

  11. 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...

  12. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Science.gov (United States)

    2010-05-24

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

  13. 7 CFR 1710.105 - State regulatory approvals.

    Science.gov (United States)

    2010-01-01

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

  14. 75 FR 70936 - Accreditation and Approval of Inspectorate America Corporation, as a Commercial Gauger and...

    Science.gov (United States)

    2010-11-19

    ... to 19 CFR 151.12 and 19 CFR 151.13, Inspectorate America Corporation, 2 Williams Street, Chelsea, MA 02150, has been approved to gauge and accredited to test petroleum and petroleum products for customs... conduct the specific test or gauger service requested. Alternatively, inquires regarding the specific test...

  15. 75 FR 17682 - Notice of Request for an Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2010-04-07

    ... have proven to be a quick and inexpensive way for AMS to get customer opinions and feedback about USDA... use of the customer opinion postcards to get voluntary customer feedback on various products each year... currently approved information collection in support of customer-focused improvement initiatives for USDA...

  16. Perspectives used for gaining approval of budgets.

    Science.gov (United States)

    Franks-Joiner, G L

    1990-01-01

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

  17. Frequency and Severity of Neutropenia Associated with Food and Drug Administration Approved and Compounded Formulations of Lomustine in Dogs with Cancer

    OpenAIRE

    Burton, J.H.; Stanley, S.D.; Knych, H.K.; Rodriguez, C.O.; Skorupski, K.A.; Rebhun, R.B.

    2015-01-01

    Background Compounded lomustine is used commonly in veterinary patients. However, the potential variability in these formulations is unknown and concern exists that compounded formulations of drugs may differ in potency from Food and Drug Administration (FDA)?approved products. Hypothesis/Objectives The initial objective of this study was to evaluate the frequency and severity of neutropenia in dogs treated with compounded or FDA?approved formulations of lomustine. Subsequent analyses aimed t...

  18. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

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

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

    Science.gov (United States)

    2013-03-11

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

  20. 78 FR 11947 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-02-20

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

  1. 78 FR 17281 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-20

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

  2. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

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

  3. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

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

  4. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

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

  5. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

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

  6. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-06-11

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

  7. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

  8. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

  9. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-26

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

  10. Applying for ethical approval for research: the main issues.

    Science.gov (United States)

    Gelling, Leslie

    2016-01-13

    The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

  11. Poet Marion Approval

    Science.gov (United States)

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  12. Poet Portland Approval

    Science.gov (United States)

    This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  13. Poet Alexandria Approval

    Science.gov (United States)

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  14. Poet Laddonia Approval

    Science.gov (United States)

    This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

  15. Medicinal Product Regulation: Portugal׳s Framework.

    Science.gov (United States)

    Herdeiro, Maria Teresa; Bastos, Paulo D; Teixeira-Rodrigues, António; Roque, Fátima

    2016-09-01

    The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

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

    Science.gov (United States)

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

    2017-02-08

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

  17. Pharmaceutical R&D performance by firm size: approval success rates and economic returns.

    Science.gov (United States)

    DiMasi, Joseph A

    2014-01-01

    The R&D productivity of pharmaceutical firms has become an increasingly significant concern of industry, regulators, and policymakers. To address an important aspect of R&D performance, public and private data sources were used to estimate clinical phase transition and clinical approval probabilities for the pipelines of the 50 largest pharmaceutical firms (by sales) by 3 firms size groups (top 10 firms, top 11-20 firms, and top 21-50 firms). For self-originated compounds, the clinical approval success rates were 14.3%, 16.4%, and 18.4% for top 10 firms, top 11-20 firms, and top 21-50 firms, respectively. The results showing higher success rates for smaller firms were largely driven by outcomes for the small-molecule drugs. Adjustments for the relatively small differences in therapeutic class distributions across the firm size groups showed that the success rate for small-molecule self-originated drugs was 6% below average for top 10 firms and 17% above average for top 21-50 firms. Although success rates for small firms were higher, this advantage was offset to some degree by lower returns on approved drugs, suggesting different strategic objectives with regard to risk and reward by firm size.

  18. Stocking characteristics and perceived increases in sales among small food store managers/owners associated with the introduction of new food products approved by the Special Supplemental Nutrition Program for Women, Infants, and Children.

    Science.gov (United States)

    Ayala, Guadalupe X; Laska, Melissa N; Zenk, Shannon N; Tester, June; Rose, Donald; Odoms-Young, Angela; McCoy, Tara; Gittelsohn, Joel; Foster, Gary D; Andreyeva, Tatiana

    2012-09-01

    The present study assessed the impact of the 2009 food packages mandated by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) on perceived sales, product selection and stocking habits of small, WIC-authorized food stores. A cross-sectional study involving in-depth interviews with store managers/owners. Small, WIC-authorized food stores in eight major cities in the USA. Fifty-two store managers/owners who had at least 1 year of experience in the store prior to study participation. The WIC-approved food products (fresh, canned and frozen fruits; fresh, canned and frozen vegetables; wholegrain/whole-wheat bread; white corn/whole-wheat tortillas; brown rice; lower-fat milk (sales of new WIC-approved foods including those considered most profitable (wholegrain/whole-wheat bread (89 %), lower-fat milk (89 %), white corn/whole wheat tortillas (54 %)), but perceived no changes in sales of processed fruits and vegetables. Supply mechanisms and frequency of supply acquisition were only moderately associated with perceived sales increases. Regardless of type or frequency of supply acquisition, perceived increases in sales provided some evidence for the potential sustainability of these WIC policy efforts and translation of this policy-based strategy to other health promotion efforts aimed at improving healthy food access in underserved communities.

  19. Poet Fostoria Approval

    Science.gov (United States)

    This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

    Sriphiromya, Pakawadee; Theeraroungchaisri, Anuchai

    2015-02-01

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

  2. Immunotherapy Combination Approved for Advanced Kidney Cancer

    Science.gov (United States)

    FDA has approved the combination of the immunotherapy drugs nivolumab (Opdivo) and ipilimumab (Yervoy) as an initial treatment for some patients with advanced kidney cancer. The approval is expected to immediately affect patient care, as this Cancer Currents post explains.

  3. Poet Leipsic Approval

    Science.gov (United States)

    This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

  4. Guidance for package approvals in the United Kingdom

    International Nuclear Information System (INIS)

    Morgan-Warren, E.J.

    2004-01-01

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

  5. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GENERAL ADMINISTRATION... for Department approval, signed by the appropriate State official, to the Director, Administration for... of procurement activities beyond that approved in the APD; (D) A change in system concept, or a...

  6. 8 CFR 207.6 - Control over approved refugee numbers.

    Science.gov (United States)

    2010-01-01

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

  7. 77 FR 42341 - New Postal Product

    Science.gov (United States)

    2012-07-18

    ... cost within their target marketing areas. Request at 2. \\2\\ Docket No. MT2011-3, Order Approving Market... Service request to add Every Door Direct Mail-Retail (EDDM-R) to the market dominant product list. This... adding Every Door Direct Mail-Retail (EDDM-R) to the market dominant product list and establishing the...

  8. 76 FR 38601 - Notice of Request for Extension of Approval of an Information Collection; Self-Certification...

    Science.gov (United States)

    2011-07-01

    ... approval of an information collection. Abstract: The Marketing and Regulatory Programs (MRP) agencies of.... agricultural products and protect the health of domestic animal and plant resources. The MRP agencies are the... human resource management, for the three MRP agencies are provided by the MRP Business Services unit of...

  9. 77 FR 73414 - Approval for Expansion of Manufacturing Authority; Foreign-Trade Subzone 41H; Mercury Marine...

    Science.gov (United States)

    2012-12-10

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1871] Approval for Expansion of Manufacturing Authority; Foreign-Trade Subzone 41H; Mercury Marine (Marine Propulsion Products); Fond du Lac and... manufacturing authority on behalf of Mercury Marine, operator of Subzone 41H at the Mercury Marine facilities in...

  10. 47 CFR 400.5 - Approval and award.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Approval and award. 400.5 Section 400.5 Telecommunication NATIONAL TELECOMMUNICATIONS AND INFORMATION ADMINISTRATION, DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E-911 GRANT PROGRAM § 400.5 Approval...

  11. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

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

  12. Characterization of residual oils for biodiesel production

    Directory of Open Access Journals (Sweden)

    Edmilson Antonio Canesin

    2014-01-01

    Conclusions: The obtained results suggesting that it is possible to take advantage of these residues for biodiesel production as the obtained products were approved according to the rules established by the National Association of Petroleum (ANP; the bovine samples were the exception regarding moisture and acidity.

  13. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

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

  14. 48 CFR 52.222-16 - Approval of Wage Rates.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Approval of Wage Rates. 52....222-16 Approval of Wage Rates. As prescribed in 22.407(b), insert the following clause: Approval of Wage Rates (FEB 1988) All straight time wage rates, and overtime rates based thereon, for laborers and...

  15. 7 CFR 1717.609 - RUS approval of general manager.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of general manager. 1717.609 Section... Operational Controls § 1717.609 RUS approval of general manager. (a) If a borrower's mortgage or loan contract... general manager of the borrower's system, such approval is hereby granted provided that the borrower is in...

  16. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    2010-07-01

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

  17. 2016 in review: FDA approvals of new molecular entities.

    Science.gov (United States)

    Griesenauer, Rebekah H; Kinch, Michael S

    2017-11-01

    An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. 78 FR 58512 - Notice of Request for Extension of Approval of an Information Collection; Swine Health

    Science.gov (United States)

    2013-09-24

    ... respondent increased because more swine are being moved due to changes in production practices and..., a Permit to Move Restricted Animals (VS Form 1-27), a certificate of veterinary inspection (CVI), an... moved to slaughter in a means of conveyance sealed with an official seal. Since the last approval of...

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

    Science.gov (United States)

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

    2014-01-01

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

  20. 24 CFR 886.107 - Approval of applications.

    Science.gov (United States)

    2010-04-01

    ...) The Owner's Affirmative Fair Housing Marketing Plan is approvable. (b) The HUD-approved unit rents are... climatic or geological conditions or local codes are examples which may justify such variations. (d) A... neighborhood in a substantially adverse manner. Examples of such adverse effects are (1) substantial move-outs...

  1. New Breast Cancer Treatment Approved | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... Breast Cancer Treatment Approved Follow us New Breast Cancer Treatment Approved Photo: Wikimedia Commons IN THE NEWS - Breast ... Food and Drug Administration approved a new breast cancer treatment that aims to reduce the risk of the ...

  2. 7 CFR 915.45 - Production research, marketing research and development.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Production research, marketing research and... Production research, marketing research and development. The committee may, with the approval of the Secretary, establish or provide for the establishment of production research, marketing research and...

  3. 76 FR 13970 - Notice of Request for Extension of Approval of an Information Collection; Black Stem Rust...

    Science.gov (United States)

    2011-03-15

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

  4. FDA approves efavirenz. Food and Drug Administration.

    Science.gov (United States)

    Highleyman, L

    1998-10-01

    The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

  5. 48 CFR 1819.7203 - Mentor approval process.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Mentor approval process... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

  6. 78 FR 4121 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Cut...

    Science.gov (United States)

    2013-01-18

    ... and extension of approval of an information collection. Abstract: The Plant Protection Act (PPA, 7 U.S... flowers, nurseries, registered production sites, and the national plant protection organizations of... DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2012-0111...

  7. [Reporting ethics board approval in German medical theses and journals].

    Science.gov (United States)

    Zenz, Michael; Zenz, Julia; Grieger, Maximilian

    2018-06-05

    Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

  8. 27 CFR 4.50 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Approval of Labels of... of exemption from label approval, as well as appeal procedures, see part 13 of this chapter. [T.D...

  9. 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... purpose shall be used to apply ink brands bearing official marks to carcasses of cattle, sheep, swine, or...

  10. 75 FR 340 - Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular...

    Science.gov (United States)

    2010-01-05

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1654] Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular Diagnostic Products), Chicago, IL, Area Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u...

  11. 14 CFR 21.609 - Approval for deviation.

    Science.gov (United States)

    2010-01-01

    ... deviation. (a) Each manufacturer who requests approval to deviate from any performance standard of a TSO shall show that the standards from which a deviation is requested are compensated for by factors or... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval for deviation. 21.609 Section 21...

  12. 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)

  13. Off-label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121

    International Nuclear Information System (INIS)

    Thomadsen, Bruce R.; Thompson, Heaton H. II; Jani, Shirish K.

    2010-01-01

    Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use can be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the

  14. Off-label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121

    Energy Technology Data Exchange (ETDEWEB)

    Thomadsen, Bruce R.; Thompson, Heaton H. II; Jani, Shirish K. [Department of Medical Physics, University of Wisconsin, Madison, Wisconsin 53705 (United States); Hagerstown, Maryland 21740 (United States); and others

    2010-05-15

    Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use can be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a

  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. 42 CFR 102.73 - Approval of benefits.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Approval of benefits. 102.73 Section 102.73 Public... PROGRAM Secretarial Determinations § 102.73 Approval of benefits. When the Secretary has determined that benefits will be paid to a requester and has calculated the type and amount of such benefits, he will...

  17. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-10-25

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

  18. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-26

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

  19. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

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

  20. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-01-31

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

  1. Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.

    Science.gov (United States)

    2016-01-05

    The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.

  2. 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...

  3. 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.

  4. The approval mechanism solves the prisoner's dilemma theoretically and experimentally

    OpenAIRE

    Tatsuyoshi Saijo; Yoshitaka Okano; Takafumi Yamakawa

    2015-01-01

    Consider a situation where players in a prisoner's dilemma game can approve or reject the other's choice such as cooperation or defection. If both players approve the other's choice, the outcome is the one they chose, whereas if either one rejects the other's choice, the outcome is the one when both defect, which we name the approval mechanism herein (this is inspired by the Cold War doctrine of mutually assured destruction). Experimentally, we find that the cooperation rate with the approval...

  5. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

    Markman, D.W.

    1999-01-01

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

  6. Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

    Science.gov (United States)

    Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

    2017-11-01

    This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

  7. 42 CFR 8.6 - Withdrawal of approval of accreditation bodies.

    Science.gov (United States)

    2010-10-01

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

  8. Pharmaceutical product development: A quality by design approach

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  9. Pharmaceutical product development: A quality by design approach.

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

  10. Poet North Manchester Approval

    Science.gov (United States)

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  11. Cognitive Properties of Approval Voting : an Experimental Approach

    Directory of Open Access Journals (Sweden)

    Krzysztof Przybyszewski

    2011-01-01

    Full Text Available The paper summarizes two series of experiments demonstrating the cognitive properties of approval voting. The former series is devoted to mental processes induced in decision makers who use the method of approval voting. Based on cognitive effort, the use of choice strategies is presented in this paper. The observations of respondents show that most of them use relatively effortless strategy of eliminating alternatives and attributes. Few respondents use more sophisticated methods. The other series of experiments analyses the number of alternatives chosen in approval voting. It appears that the average number is not constant, even for similar votes but it depends on the subject of voting. The number of chosen alternatives and the subjective significance of the scope of voting are negatively or positively correlated in the case of special votes. The analyzed experiments show that the cognitive properties of approval voting have a diverse structure. (original abstract

  12. 7 CFR 1717.159 - Applications for RUS approvals of mergers.

    Science.gov (United States)

    2010-01-01

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

  13. 7 CFR 4290.510 - Approval of RBIC's Investment Adviser/Manager.

    Science.gov (United States)

    2010-01-01

    ... INVESTMENT COMPANY (âRBICâ) PROGRAM Managing the Operations of a RBIC Management and Compensation § 4290.510... approval of the management contract. Approval of an Investment Adviser/Manager for one RBIC does not... 7 Agriculture 15 2010-01-01 2010-01-01 false Approval of RBIC's Investment Adviser/Manager. 4290...

  14. 30 CFR 250.119 - Will MMS approve subsurface gas storage?

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Will MMS approve subsurface gas storage? 250....119 Will MMS approve subsurface gas storage? The Regional Supervisor may authorize subsurface storage of gas on the OCS, on and off-lease, for later commercial benefit. To receive MMS approval you must...

  15. 75 FR 36301 - Review and Approval of Projects

    Science.gov (United States)

    2010-06-25

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY... document contains proposed rules that would amend the project review regulations of the Susquehanna River... the scope of withdrawals requiring review and approval; improve notice procedures for all project...

  16. Editorial: Ethics approval: responsibilities of journal editors, authors ...

    African Journals Online (AJOL)

    Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply ...

  17. Consumer approval of irradiated meat still tentative

    International Nuclear Information System (INIS)

    Hollingsworth, P.

    1998-01-01

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

  18. 29 CFR 1952.10 - Requirements for approval of State posters.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

  19. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Review, negotiation, and approval of bids. 422.256... Information and Plan Approval § 422.256 Review, negotiation, and approval of bids. (a) Authority. Subject to... submitted under § 422.252 and conduct negotiations with MA organizations regarding these bids (including the...

  20. 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.

  1. Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

    Science.gov (United States)

    Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

    2015-01-01

    Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

  2. First emergency contraceptive product hits U.S. market shelves.

    Science.gov (United States)

    1998-11-01

    The Preven Emergency Contraceptive Kit, a product approved by the US Food and Drug Administration (USFDA) for emergency contraception, is now on the market for sale. Produced by Gynetics of Somerville, NJ, the kit consists of an easy-to-use pregnancy test, patient information guide, and 4 blue pills, each containing 0.05 mg ethinyl estradiol and 0.25 mg levonorgestrel. After a woman determines that she is not pregnant by using the kit's test, she takes 2 pills as soon as possible within 72 hours after having unprotected sexual intercourse. The remaining 2 pills are taken 12 hours later. Although Preven is available now only by prescription, Gynetics will cooperate with the USFDA in assessing whether it should be sold over the counter. One course of Preven costs about $20 at a pharmacy, less than any oral contraceptive pills currently used as emergency contraceptives. The Preven Kit carries Health Care Financing Administration approval for Medicaid reimbursement, and most health maintenance organizations have agreed to cover its costs. Two more progestin-only emergency contraceptive products may enter the US market in 1999. Gynetics is in the advanced stages of developing a levonorgestrel-only emergency contraceptive, while Women's Capital Corp. of Seattle, WA, and Washington, DC, plans to submit its application for product approval to the USFDA for a similar progestin-only product by the end of October.

  3. 44 CFR 78.9 - Planning grant approval process.

    Science.gov (United States)

    2010-10-01

    ..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

  4. 7 CFR 1703.121 - Approved purposes for grants.

    Science.gov (United States)

    2010-01-01

    ... Approved purposes for grants. For distance learning and telemedicine projects, grants shall finance only... studies relating to the establishment or expansion of the phase of the project that is being financed with... initial capital assets associated with the project. The following are approved grant purposes: (a...

  5. Dabrafenib Plus Trametinib Approved for Melanoma, Thyroid Cancer

    Science.gov (United States)

    FDA recently approved the combination of dabrafenib (Taflinar) and trametinib (Mekinist) to treat some patients with melanoma and anaplastic thyroid cancer whose tumors have a mutation in the BRAF gene. As this Cancer Currents blog post explains, this is the first treatment approved specifically for anaplastic thyroid

  6. 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.

  7. Poet Lake Crystal Approval

    Science.gov (United States)

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

  8. 22 CFR 96.63 - Renewal of accreditation or approval.

    Science.gov (United States)

    2010-04-01

    ... for renewal in a timely fashion. Before deciding whether to renew the accreditation or approval of an... accrediting entity or the Secretary during its most current accreditation or approval cycle, the accrediting...

  9. Clone of EPA Approved Regulations in the Texas SIP

    Science.gov (United States)

    changed name to EPA Approved Regulations in the Texas SIP, Add links to:Texas Read Me; Texas SIP History;Current/Previous SIP-Approved Regulations; Delete regulations--now in /node/191099, removed tables

  10. 46 CFR 163.003-27 - Production tests and examination.

    Science.gov (United States)

    2010-10-01

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

  11. 46 CFR 160.017-27 - Production tests and examination.

    Science.gov (United States)

    2010-10-01

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

  12. CORN, LP Goldfield Approval

    Science.gov (United States)

    This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

  13. HSE statement on the approval of dosimetry services

    International Nuclear Information System (INIS)

    1992-09-01

    This statement is intended to assist dosimetry services who may wish to be approved by the U.K. Health and Safety Executive under Regulation 15 of the Ionising Radiations Regulations 1985. It also serves to inform approved dosimetry services of changes in the arrangements which HSE makes for approval and reassessment of dosimetry services. A general description of the administrative arrangements for making application is given and the subsequent processing of such applications by the HSE is outlined. Background notes on the requirements of the Regulations are given in Appendix I. The fees which are chargeable from 20/8/92 are given in Appendix II. (Author)

  14. 21 CFR 515.25 - Revocation of order refusing to approve a medicated feed mill license application or suspending...

    Science.gov (United States)

    2010-04-01

    ... medicated feed mill license application or suspending or revoking a license. 515.25 Section 515.25 Food and..., FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.25 Revocation of order refusing to approve a medicated feed mill license application or suspending or revoking a...

  15. Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis.

    Science.gov (United States)

    Rathore, Anurag S; Pathak, Mili; Jain, Renu; Jadaun, Gaurav Pratap Singh

    2016-07-01

    Monitoring the quality of pharmaceutical products is a global challenge, heightened by the implications of letting subquality drugs come to the market on public safety. Regulatory agencies do their due diligence at the time of approval as per their prescribed regulations. However, product quality needs to be monitored post-approval as well to ensure patient safety throughout the product life cycle. This is particularly complicated for biotechnology-based therapeutics where seemingly minor changes in process and/or raw material attributes have been shown to have a significant effect on clinical safety and efficacy of the product. This article provides a perspective on the topic of monitoring the quality of biotech therapeutics. In the backdrop of challenges faced by the regulatory agencies, the potential use of multivariate data analysis as a tool for effective monitoring has been proposed. Case studies using data from several insulin biosimilars have been used to illustrate the key concepts.

  16. Avelumab: First Global Approval.

    Science.gov (United States)

    Kim, Esther S

    2017-05-01

    Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

  17. 5 CFR 1320.16 - Delegation of approval authority.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Delegation of approval authority. 1320.16... PAPERWORK BURDENS ON THE PUBLIC § 1320.16 Delegation of approval authority. (a) OMB may, after complying... delegation of review authority shall be made unless the agency demonstrates to OMB that the Senior Official...

  18. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    2000-01-01

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

  19. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... quantitative skills; (9) If a test has been revised from the most recent edition approved by the Secretary, an... Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY... inquiries; (3) Each edition and form of the test for which the publisher requests approval; (4) The...

  20. 50 CFR 37.22 - Approval of exploration plan.

    Science.gov (United States)

    2010-10-01

    ... § 37.21(b), the Regional Director shall promptly publish notice of the application and text of the plan... exploration plan shall be approved by the Regional Director if he determines that it satisfies the....11(b), or minimize adverse impacts on subsistence uses, the Regional Director may approve or...

  1. 7 CFR 319.8-11 - From approved areas of Mexico.

    Science.gov (United States)

    2010-01-01

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

  2. A Good Year: FDA Approved Nine New Cancer Drugs in 2014

    Science.gov (United States)

    In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

  3. 38 CFR 21.9765 - Program of education approval.

    Science.gov (United States)

    2010-07-01

    ... education offered by an institution of higher learning if that program of education is approved under 38 U.S... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21...

  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. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

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

    Science.gov (United States)

    Govil, Ashul; Hao, Steven C

    2016-10-01

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

  7. Why should ethics approval be required prior to publication of health promotion research?

    Science.gov (United States)

    Newson, Ainsley J; Lipworth, Wendy

    2015-12-01

    Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

  8. 42 CFR 410.142 - CMS process for approving national accreditation organizations.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false CMS process for approving national accreditation... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving national accreditation organizations. (a) General rule. CMS may approve and recognize a nonprofit or not...

  9. Neratinib: First Global Approval.

    Science.gov (United States)

    Deeks, Emma D

    2017-10-01

    Neratinib (Nerlynx™) is an oral, irreversible inhibitor of the human epidermal growth factor receptors HER1 (EGFR), HER2 and HER4. The drug originally arose from research by Wyeth (now Pfizer) and is now being developed by Puma Biotechnology primarily for the treatment of HER2-positive (HER+) breast cancer. Neratinib is approved in the USA for the extended adjuvant treatment of patients with HER2+ early-stage breast cancer who have been previously treated with a trastuzumab-based adjuvant regimen, and is in the preregistration phase for this indication in the EU. Neratinib, as monotherapy and/or combination therapy, is also in phase 3 development for metastatic breast cancer and in phase 1/2 development for advanced breast cancer and other solid tumours, including non-small cell lung cancer, colorectal cancer and glioblastoma. This article summarizes the milestones in the development of neratinib leading to this first approval for breast cancer.

  10. Productivity improvement opportunities at Navy public works activities

    OpenAIRE

    Dieffenbach, Richard Jacob

    1992-01-01

    Approved for public release; distribution is unlimited This study identifies six principal opportunities for productivity improvement at Navy Public Works in-house maintenance activities: improving work assignment, increasing shop supervisor effectiveness, reducing long lunches and early quits (through understanding of work impediments as demotivational contributors), improving service order management, improving job quality and miscellaneous opportunities. Activity "productivity opportu...

  11. Miracle drug: Brazil approves never-tested cancer medicine.

    Science.gov (United States)

    Kuchenbecker, Ricardo S; Mota, Daniel M

    2017-07-01

    Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.

  12. 75 FR 29803 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-05-27

    ... Turbine Engine Powered Airplanes. Type of Request: Extension without change of a currently approved....S. EPA pollution requirements in lieu of searching through extensive paper records. ADDRESSES...

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. Electronic Voucher Approval - Financial Management

    Data.gov (United States)

    US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...

  18. 30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...

  19. 78 FR 58311 - Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop...

    Science.gov (United States)

    2013-09-23

    ... public workshop must register online by December 20, 2013. Early registration is recommended because...; however, it does not alter the statutory standards for marketing approval. To gain approval, all drugs must demonstrate substantial evidence of effectiveness, safety, and product quality for the treatment...

  20. 46 CFR 159.007-7 - Application for acceptance for production inspections and tests: Coast Guard action.

    Science.gov (United States)

    2010-10-01

    ... and tests: Coast Guard action. 159.007-7 Section 159.007-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL....007-7 Application for acceptance for production inspections and tests: Coast Guard action. (a) From...

  1. 14 CFR 183.63 - Continuing requirements: Products, parts or appliances.

    Science.gov (United States)

    2010-01-01

    ... appliances. 183.63 Section 183.63 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... Designation Authorization § 183.63 Continuing requirements: Products, parts or appliances. For any approval or certificate for a product, part or appliance issued under the authority of this subpart, or under the...

  2. As Technologies for Nucleotide Therapeutics Mature, Products Emerge.

    Science.gov (United States)

    Beierlein, Jennifer M; McNamee, Laura M; Ledley, Fred D

    2017-12-15

    The long path from initial research on oligonucleotide therapies to approval of antisense products is not unfamiliar. This lag resembles those encountered with monoclonal antibodies, gene therapies, and many biological targets and is consistent with studies of innovation showing that technology maturation is a critical determinant of product success. We previously described an analytical model for the maturation of biomedical research, demonstrating that the efficiency of targeted and biological development is connected to metrics of technology growth. The present work applies this model to characterize the advance of oligonucleotide therapeutics. We show that recent oligonucleotide product approvals incorporate technologies and targets that are past the established point of technology growth, as do most of the oligonucleotide products currently in phase 3. Less mature oligonucleotide technologies, such as miRNAs and some novel gene targets, have not passed the established point and have not yielded products. This analysis shows that oligonucleotide product development has followed largely predictable patterns of innovation. While technology maturation alone does not ensure success, these data show that many oligonucleotide technologies are sufficiently mature to be considered part of the arsenal for therapeutic development. These results demonstrate the importance of technology assessment in strategic management of biomedical technologies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  3. 12 CFR 918.5 - Approval by Finance Board.

    Science.gov (United States)

    2010-01-01

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

  4. 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.

  5. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

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

  6. Drugs Approved for 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.

  7. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

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

  8. Drugs Approved for 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 38 CFR 21.4263 - Approval of flight training courses.

    Science.gov (United States)

    2010-07-01

    ..., and aircraft identification number; (xi) An accounts receivable ledger; (xii) Individual instructor... higher learning are the only entities that can offer flight courses. A State approving agency may approve a flight course only if a flight school or an institution of higher learning offers the course. A...

  15. 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.

  16. 7 CFR 1735.62 - Approval of acquisitions and mergers.

    Science.gov (United States)

    2010-01-01

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

  17. 5 CFR 7401.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE MERIT SYSTEMS PROTECTION BOARD § 7401.102 Prior approval... written approval from the employee's supervisor and the concurrence of the Designated Agency Ethics... name of the employer or organization; (ii) The nature of the legal activity or other work to be...

  18. Reporting ethics committee approval in public administration research.

    Science.gov (United States)

    Jordan, Sara R; Gray, Phillip W

    2014-03-01

    While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

  19. 77 FR 48167 - Approved Tribal-State Class III Gaming Compact; Indian Gaming

    Science.gov (United States)

    2012-08-13

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

  20. 75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-11-22

    ... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... for the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18...

  1. 30 CFR 75.600-1 - Approved cables; flame resistance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved cables; flame resistance. 75.600-1 Section 75.600-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE... cables; flame resistance. Cables shall be accepted or approved by MSHA as flame resistant. [57 FR 61223...

  2. 40 CFR 80.93 - Individual baseline submission and approval.

    Science.gov (United States)

    2010-07-01

    ... or methodology deviations will be approved or disapproved by the Director of the Office of Mobile... approval by the Director of the Office of Mobile Sources, or designee. (ii) Petitions, “showings,” and..., business address and business phone number of the company contact; (iii) Address and physical location of...

  3. 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.

  4. 75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-05-04

    ... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(e...

  5. 7 CFR 1735.90 - Preliminary approvals.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Requirements for... franchises, licenses, and permits; (4) All required regulatory body approvals; (5) All required corporate...

  6. Analyses of marketplace tacrolimus drug product quality: bioactivity, NMR and LC-MS.

    Science.gov (United States)

    Sommers, Cynthia D; Pang, Eric S; Ghasriani, Houman; Berendt, Robert T; Vilker, Vincent L; Keire, David A; Boyne, Michael T

    2013-11-01

    Tacrolimus (FK506) is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Recent clinical reports suggested a significant reduction in the tacrolimus concentration/dose ratio in the plasma of liver and kidney recipients when the reference listed drug was substituted with a generic drug. In response to these concerns about switching between tacrolimus from different approved manufacturers during treatment, the FDA initiated purity, potency and quality studies of the innovator and generic tacrolimus products available in the US marketplace. A combination of analytical methods, including mass spectrometry (LC-MS), nuclear magnetic resonance (NMR) and bioactivity assay were developed and validated to assess the quality of tacrolimus. These tests measured the identity, impurities and activity of tacrolimus from active pharmaceutical ingredient (API) sources and with formulated drug product from five different approved manufactures. In addition, some testing was performed on tacrolimus capsules obtained from a non US approved Indian source. The data obtained showed no discernible difference in the impurity profiles and potency between the generic and innovator tacrolimus products. Copyright © 2013. Published by Elsevier B.V.

  7. 32 CFR 736.7 - Approval by the Attorney General.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Approval by the Attorney General. 736.7 Section..., PATENTS, AND CONTRACTS DISPOSITION OF PROPERTY § 736.7 Approval by the Attorney General. Prior to the... inventions, irrespective of cost, the Department of the Navy must notify the Attorney General of the proposed...

  8. 5 CFR 6601.102 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... approval for outside employment. (a) Before engaging in any outside employment with a prohibited source... (including the name of the person, group or other organization for whom the work is to be performed), and a... activity, and, if so, how much. (b) Approval shall be granted only upon determination that the outside...

  9. 24 CFR 990.145 - Dwelling units with approved vacancies.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Dwelling units with approved vacancies. 990.145 Section 990.145 Housing and Urban Development Regulations Relating to Housing and Urban...; Computation of Eligible Unit Months § 990.145 Dwelling units with approved vacancies. (a) A PHA is eligible to...

  10. OMB Recommended vs Approved Operating Budget

    Data.gov (United States)

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

  11. A Wave Glider for Studies of Biofouling and Ocean Productivity

    Science.gov (United States)

    2017-11-07

    Report: A Wave Glider for Studies of Biofouling and Ocean Productivity The views, opinions and/or findings contained in this report are those of the...Biofouling and Ocean Productivity Report Term: 0-Other Email: john.breier@utrgv.edu Distribution Statement: 1-Approved for public release; distribution is...sensors, and engineered test surfaces was procured to study controls on ocean productivity , plankton distribution, larval settling, and biofouling. We

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

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2013-01-01

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

  13. 12 CFR 563g.19 - Approval of the security.

    Science.gov (United States)

    2010-01-01

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

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

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

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

  15. 25 CFR 1200.15 - What is the approval process for management plans?

    Science.gov (United States)

    2010-04-01

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

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

    Science.gov (United States)

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

    2018-02-01

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

  17. Drug-device combination products: regulatory landscape and market growth.

    Science.gov (United States)

    Bayarri, L

    2015-08-01

    Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  18. 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.

  19. 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.

  20. 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.

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

    Science.gov (United States)

    2010-07-01

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

  3. [Update on microbiological quality assurance meat and meat products in Morocco].

    Science.gov (United States)

    Rachidi, H; Latrache, H

    2018-03-01

    Food safety has become an absolute necessity in all countries. As a result, Morocco has taken several measures and actions to develop food safety and food-borne disease control. This study aimed to highlight the level of improvement in the quality assurance of meat and meat products in Morocco. It is based on a non-exhaustive review of the regulatory texts governing food safety in the country, as well as a statistical study on establishments of meat and meat products adopting a self-checking system and approved by the National Office of Sanitary Safety of Food. Morocco has introduced several laws and regulations requiring sanitary control of food products. Also, the number of establishments of meat and meat products adopting a system of self-control and approved by the National Office of Sanitary Safety of Food has improved significantly. It has increased from 58 in 2007 to 273 in 2016. The adoption of self-monitoring systems allows better access to international markets, improved quality of food products and a considerable reduction in microbial contamination. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

  4. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

    Science.gov (United States)

    Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

    2015-01-01

    In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

  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 take...

  6. 21 CFR 56.113 - Suspension or termination of IRB approval of research.

    Science.gov (United States)

    2010-04-01

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

  7. Credit Risk Management - Loan Approval Process

    Directory of Open Access Journals (Sweden)

    Lulzim Rashiti

    2016-03-01

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

  8. The translation of product concept to bone products: a partnership of therapeutic effectiveness and commercialization.

    Science.gov (United States)

    Ratcliffe, Anthony

    2011-12-01

    The fields of tissue engineering and regenerative medicine have the capacity to substantially impact clinical care through the introduction of new products that can address unmet clinical needs, or significantly improve on present therapies. These products will be developed through the demonstration of therapeutic effectiveness, adequate safety, and meeting regulatory requirements. The technology used in the product will dictate the product development and manufacturing costs; the regulatory pathway; and the time taken to complete clinical trials, gain regulatory approval, and become commercialized. A comparison of the required investment of time and funds, with the potential revenue generated, allows for a determination of the likely commercialization opportunity. Ultimately, the long-term success of a product will be dependent on its clinical effectiveness and commercial viability. © Mary Ann Liebert, Inc.

  9. 77 FR 46760 - Information Collections Approved by the Office of Management and Budget

    Science.gov (United States)

    2012-08-06

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

  10. Labeling of Pesticide Products under the National Organic Program

    Science.gov (United States)

    This notice describes how registrants can obtain EPA approval of label language indicating that all ingredients in a pesticide product and all uses of that pesticide meet the criteria defined in the USDA National Organic Program Rule.

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

    Directory of Open Access Journals (Sweden)

    Lauren Strach

    2003-01-01

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

  12. 30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; maintenance and... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.204 Approved sampling devices; maintenance and...

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

    Science.gov (United States)

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

    2010-01-01

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

  14. Application of Pharmacokinetics and Pharmacodynamics in Product Life Cycle Management. A Case Study with a Carbidopa-Levodopa Extended-Release Formulation.

    Science.gov (United States)

    Modi, Nishit B

    2017-05-01

    Increasing costs in discovering and developing new molecular entities and the continuing debate on limited company pipelines mean that pharmaceutical companies are under significant pressure to maximize the value of approved products. Life cycle management in the context of drug development comprises activities to maximize the effective life of a product. Life cycle approaches can involve new formulations, new routes of delivery, new indications or expansion of the population for whom the product is indicated, or development of combination products. Life cycle management may provide an opportunity to improve upon the current product through enhanced efficacy or reduced side effects and could expand the therapeutic market for the product. Successful life cycle management may include the potential for superior efficacy, improved tolerability, or a better prescriber or patient acceptance. Unlike generic products where bioequivalence to an innovator product may be sufficient for drug approval, life cycle management typically requires a series of studies to characterize the value of the product. This review summarizes key considerations in identifying product candidates that may be suitable for life cycle management and discusses the application of pharmacokinetics and pharmacodynamics in developing new products using a life cycle management approach. Examples and a case study to illustrate how pharmacokinetics and pharmacodynamics contributed to the selection of dosing regimens, demonstration of an improved therapeutic effect, or regulatory approval of an improved product label are presented.

  15. 7 CFR 1425.4 - Approval.

    Science.gov (United States)

    2010-01-01

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

  16. Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress.

    Science.gov (United States)

    Decter-Frain, Ari; Frimer, Jeremy A

    2016-01-01

    What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a "big data" approach-the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition.

  17. Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress

    Directory of Open Access Journals (Sweden)

    Ari eDecter-Frain

    2016-02-01

    Full Text Available What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a big data approach—the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC, we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996-2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping. A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition.

  18. 75 FR 56663 - Agency Information Collection (Quarterly Report of State Approving Agency Activities); Activity...

    Science.gov (United States)

    2010-09-16

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

  19. Pharmaceutical protein production by yeast: towards production of human blood proteins by microbial fermentation

    DEFF Research Database (Denmark)

    Martinez Ruiz, José Luis; Liu, Lifang; Petranovic, Dina

    2012-01-01

    Since the approval of recombinant insulin from Escherichia coli for its clinical use in the early 1980s, the amount of recombinant pharmaceutical proteins obtained by microbial fermentations has significantly increased. The recent advances in genomics together with high throughput analysis...... of recombinant therapeutics using yeast Saccharomyces cerevisiae as a model platform, and discusses the future potential of this platform for production of blood proteins and substitutes....

  20. 30 CFR 90.205 - Approved sampling devices; operation; air flowrate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...

  1. 19 CFR 210.69 - Approval of complainant's temporary relief bond.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Approval of complainant's temporary relief bond. 210.69 Section 210.69 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION INVESTIGATIONS OF UNFAIR PRACTICES IN IMPORT TRADE ADJUDICATION AND ENFORCEMENT Temporary Relief § 210.69 Approval of...

  2. Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. Final rule.

    Science.gov (United States)

    2015-07-08

    The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.

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

    Science.gov (United States)

    Greene, Louise Eleanor; Bearn, David R

    2013-06-01

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

  4. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Science.gov (United States)

    2011-09-29

    ... monograph need not obtain FDA approval before marketing if their drug product meets the conditions in part... introduce into the United States an OTC drug product that had been marketed solely in a foreign country...

  5. 23 CFR 420.209 - What are the conditions for approval?

    Science.gov (United States)

    2010-04-01

    ... Management § 420.209 What are the conditions for approval? (a) As a condition for approval of FHWA planning... management process that identifies and results in implementation of RD&T activities expected to address high priority transportation issues. The management process must include: (1) An interactive process for...

  6. 75 FR 71187 - Wolverine Bank, MI; Approval of Conversion Application

    Science.gov (United States)

    2010-11-22

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

  7. 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.

  8. 76 FR 48941 - Notification of Petition for Approval; Product Safety Plan

    Science.gov (United States)

    2011-08-09

    ... workers, and other railway equipment, while also increasing railroad productivity. Marquette asserts the... behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act...

  9. 75 FR 63445 - Vessel Monitoring Systems; Approved Mobile Transmitting Units and Communications Service...

    Science.gov (United States)

    2010-10-15

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

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

    Science.gov (United States)

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

    2017-06-01

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

  11. New product testing and the utilization of user expertise: Evidence from the Pharmaceutical industry

    DEFF Research Database (Denmark)

    Smed, Marie; Salomo, Søren; Schultz, Carsten

    2012-01-01

    A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before marke....... Further, with a dispersed user network a positive effect is observed on the mean to communicate directly as issues occur. The effect of virtual communication is therefore stronger than traditional face-to-face interaction patterns.......A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before market...... the knowledge generated and shared by medical sites and Pharmaceutical producers in late stage product development. The results show, that information regarding usage patterns and product related services are more difficult to transfer between user and developer, than issues directly related to the product...

  12. 75 FR 56530 - Public Information Collections Approved by Office of Management and Budget

    Science.gov (United States)

    2010-09-16

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

  13. 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.

  14. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

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

  15. 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.

  16. 25 CFR 225.28 - Approval of amendments to minerals agreements.

    Science.gov (United States)

    2010-04-01

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

  17. 28 CFR 2.206 - Travel approval and transfers of supervision.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval and transfers of supervision. 2.206 Section 2.206 Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION AND RECOMMITMENT OF PRISONERS, YOUTH OFFENDERS, AND JUVENILE DELINQUENTS District of Columbia Supervised Releasees § 2.206 Travel approval and...

  18. Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress

    Science.gov (United States)

    Decter-Frain, Ari; Frimer, Jeremy A.

    2016-01-01

    What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a “big data” approach—the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition. PMID:26941691

  19. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.

    Science.gov (United States)

    Deak, Dalia; Outterson, Kevin; Powers, John H; Kesselheim, Aaron S

    2016-09-06

    A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information from company filings, press releases, and media reports. Four antibiotics were approved for acute bacterial skin and skin-structure infection. Seven had similar mechanisms of action to those of previously approved drugs. Six were initially developed by small to midsized companies, and 7 are currently marketed by 1 of 3 large companies. The drugs spent a median of 6.2 years in clinical trials (interquartile range [IQR], 5.4 to 8.8 years) and 8 months in FDA review (IQR, 7.5 to 8 months). The median number of patients enrolled in the pivotal trials was 666 (IQR, 553 to 739 patients; full range, 44 to 1005 patients), and median trial duration was 18 months (IQR, 15 to 22 months). Seven drugs were approved on the basis of pivotal trials evaluating noninferiority. One drug demonstrated superiority on an exploratory secondary end point, 2 showed decreased efficacy in patients with renal insufficiency, and 1 showed increased mortality compared with older drugs. Seven of the drugs are substantially more expensive than their trial comparators. Limitations are that future research may show benefit to patients, new drugs from older classes may show superior effectiveness in specific patient populations, and

  20. 75 FR 50711 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Final Approval and...

    Science.gov (United States)

    2010-08-17

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

  1. Drugs Approved for Gastrointestinal Stromal Tumors

    Science.gov (United States)

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

  2. 19 CFR 115.42 - Approval plates.

    Science.gov (United States)

    2010-04-01

    ... possible methods of accomplishing this are: (1) Placing an “X” in front of the numeric portion of the... element of such number. The specific method of altering the approval number may be established by each...

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

    African Journals Online (AJOL)

    Fr. Ikenga

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

  4. MORE ON THE APPROVAL OF ANTONINSKO-ZOZULENETSKIY CARPS OF UKRAINIAN BREEDS

    Directory of Open Access Journals (Sweden)

    O. Oleksiyenko

    2015-12-01

    back constitution and without any signs of defects and diseases were selected. An important role during the selection was also given the distinct manifestation of secondary sexual features in males and females. The high productive qualities of domestic carp contributed to their spread in the near abroad and far abroad countries as well. They were exported to Russia, Moldova, Romania, China, with the aim of pure breeding and improvement of native carp forms. Based on the analysis of long-term studies on the rearing of Antoninsko-Zozulenetskiy arrays of Ukrainian framed and scaly breeds, it was found that their fish breeding and biological indicators comply with the requirements of the Regulation on testing of selection achievements in animal breeding and can be submitted to the relevant authorities for consideration and approval as a type of inbreeding Ukrainian framed and scaly carp breeds. Originality. The analysis of fish breeding and biological indicators of Antoninsko-Zozulenetskiy carp of Ukrainian framed and Ukrainian scaly breeds serve as the basis for submission them in the status of inbreed types and approval as a selection achievement. Practical value. Growing of Antoninsko-Zozulenetskiy carps in production conditions will promote an increase in fish production in ponds and production of marketable fish.

  5. 76 FR 78610 - Notice of Intent To Suspend the Nursery Production, the Nursery and Floriculture Chemical Use...

    Science.gov (United States)

    2011-12-19

    ... Nursery Production, the Nursery and Floriculture Chemical Use, and the Christmas Tree Production Surveys... Agricultural Statistics Service (NASS) to suspend currently approved information collections for all Nursery and Christmas Tree Production Surveys along with the Nursery and Floriculture Chemical Use Survey...

  6. 76 FR 71309 - Notice of Intent To Suspend the Distillers Co-Products Survey and All Associated Reports

    Science.gov (United States)

    2011-11-17

    ... Distillers Co-Products Survey and All Associated Reports AGENCY: National Agricultural Statistics Service... Distillers Co- Products survey currently approved under docket 0535-0247. FOR FURTHER INFORMATION CONTACT... . SUPPLEMENTARY INFORMATION: Title: Suspension of Distillers Co-Products Survey. OMB Control Number: 0535-0247...

  7. 13 CFR 108.140 - SBA approval of initial Management Expenses.

    Science.gov (United States)

    2010-01-01

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

  8. 13 CFR 108.380 - Final approval as a NMVC Company.

    Science.gov (United States)

    2010-01-01

    ... VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.380 Final approval as a... amount of Regulatory Capital set forth in its application, pursuant to § 108.310(a)(1); and (B) The... at least 30 percent of its Regulatory Capital if the Conditionally Approved NMVC Company— (i) Already...

  9. 78 FR 63937 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    Science.gov (United States)

    2013-10-25

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

  10. 78 FR 63887 - Approval and Promulgation of Implementation Plans; Approval and Promulgation of State Air Quality...

    Science.gov (United States)

    2013-10-25

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

  11. FDA Approves First Therapeutic Cancer Vaccine

    Science.gov (United States)

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

  12. 75 FR 54215 - Agency Request for Approval of a Previously Approved Information Collection(s): Uniform...

    Science.gov (United States)

    2010-09-03

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

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

    Science.gov (United States)

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

    2012-06-01

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

  14. 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)

  15. 46 CFR 164.009-3 - Noncombustible materials not requiring specific approval.

    Science.gov (United States)

    2010-10-01

    ...) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Noncombustible Materials for... noncombustible materials may be used in merchant vessel construction though not specifically approved under this subpart: (a) Sheet glass, block glass, clay, ceramics, and uncoated fibers. (b) All metals, except...

  16. Implementing Product Platforms: A Case Study

    DEFF Research Database (Denmark)

    Nielsen, Ole Fiil; Mortensen, Niels Henrik

    2006-01-01

    The paper describes a case study dealing with the process of creating and implementing a product platform. The paper espessially deals with the fact that to obtain the benefits of platforms a permanent change in behaviour in product development must be ensured. This change in behaviour requires...... acceptance and approval from the organisation in general and the commitment from management to enforce agreed-upon decisions. The case study itself was performed in the Danish company LEGO Group. The case study had two objectives: To create a technical architecture and align this architecture...

  17. In-use vs. type-approval fuel consumption of current passenger cars in Europe

    International Nuclear Information System (INIS)

    Ntziachristos, L.; Mellios, G.; Tsokolis, D.; Keller, M.; Hausberger, S.; Ligterink, N.E.; Dilara, P.

    2014-01-01

    In-use fuel consumption data of 924 passenger cars (611 petrol, 313 diesel) were collected from various European sources and were evaluated in comparison to their corresponding type-approval values. The analysis indicated that the average in-use fuel consumption was higher than the type-approval one by 11% for petrol cars and 16% for diesel cars. Comparison of this dataset with the Travelcard database in the Netherlands showed that the deviation increased for late model years and in particular for cars with low type-approval values. The deviation was higher than 60% for vehicles registered in 2012 within the 90–100 gCO 2 /km bin. Unrealistic vehicle resistances used in type-approval were identified as one of the prime reasons of the difference. A simplified linear model developed in the study may be used to predict in-use fuel consumption based on data publicly available. The model utilizes the fuel consumption measured in type-approval, the mass, and the engine capacity to provide in-use fuel consumption. This may be either used to correct fuel consumption factors currently utilized by emission models (e.g. COPERT, HBEFA, VERSIT+, and others) or could be used independently to make projections on how fuel consumption may develop on the basis of changing future passenger cars characteristics. - Highlights: • In-use fuel consumption of petrol and diesel passenger cars is 11% and 16% higher than type-approval, respectively. • The relative difference between in-use and type-approval increases for late model and vehicles with low consumption. • Unrealistically low vehicle resistances are identified as a prime reason of low type-approval fuel consumption. • A model developed predicts in-use consumption on the basis of type-approval consumption, vehicle mass, and engine capacity

  18. 46 CFR 159.005-15 - Approval of equipment or material: Suspensions, withdrawals, and terminations.

    Science.gov (United States)

    2010-10-01

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

  19. Time to institutional review board approval with local versus central review in a multicenter pragmatic trial.

    Science.gov (United States)

    Neuman, Mark D; Gaskins, Lakisha J; Ziolek, Tracy

    2018-02-01

    Central institutional review board (IRB) review will be required for National Institutes of Health-funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB review for multicenter studies. We compared the amount of time required for central versus local IRB review and approval for sites in one ongoing multicenter randomized trial. The REGAIN Trial (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; clinicaltrials.gov number: NCT02507505) is an ongoing randomized trial comparing standard-care spinal anesthesia to standard-care general anesthesia for patients undergoing hip fracture surgery. After approval of the protocol by the sponsor IRB, each participating US site opted either to submit the protocol for local IRB review or to designate the sponsor IRB as the IRB of record (i.e. central IRB) via an authorization agreement after a limited local review. For each US REGAIN site approved through 18 April 2017, we assessed (1) the time in calendar days from protocol receipt to IRB submission, (2) the time in calendar days from IRB submission to IRB approval, and (3) the total time in calendar days from protocol receipt to IRB approval (i.e. time from protocol receipt to IRB submission plus time from IRB submission to IRB approval). The main study protocol was submitted to the sponsor IRB on 25 May 2015 and approved on 8 July 2015 (44 days). Out of 34 sites, 9 received initial approval from the central (sponsor) IRB; 25 sought initial approval via local review. The median time from protocol receipt to IRB submission was 39 days for sites approved by the central IRB (interquartile range: 35-134) versus 58 days for sites approved via local review (interquartile range: 41-105; p = 0.711). The median time from IRB submission to IRB approval for sites approved by

  20. Methodological aspects of accounting production cost of public sector entities

    Directory of Open Access Journals (Sweden)

    Людмила Геннадіївна Ловінська

    2015-09-01

    Full Text Available The necessity of obtaining objective information about the activities of the public sector in various areas of the production is defined. It is proved an expediency of development the Project of «Guidelines for the structure of production costs» on the basis of the approved in the public sector NP(SAPS 135 "Costs". The need for accounting costs by type of activity (operational, financial and investment is marked. The composition of production costs is defined

  1. Montana Advanced Biofuels Great Falls Approval

    Science.gov (United States)

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

  2. ASTM lights the way for tissue engineered medical products standards: jump start for combination medical products that restore biological function of human tissues.

    Science.gov (United States)

    Picciolo, G L; Stocum, D L

    2001-01-01

    Everybody hopes for better health and restoration of impaired bodily function, and now that hope is illuminated by the promise of powerful biological tools that make human cells grow and replace human tissue. ASTM Committee F04 on Medical and Surgical Materials and Devices is taking the lead by defining some of those tools as standards that can be used for the development, production, testing, and regulatory approval of medical products.

  3. 7 CFR 1948.82 - Plan and State Investment Strategy approval procedure.

    Science.gov (United States)

    2010-01-01

    ... the State Investment Strategy for Energy Impacted Areas. (c) Appropriate growth management and/or... 7 Agriculture 13 2010-01-01 2009-01-01 true Plan and State Investment Strategy approval procedure... Impacted Area Development Assistance Program § 1948.82 Plan and State Investment Strategy approval...

  4. 42 CFR 8.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Application for approval as an accreditation body... accreditation body. (a) Eligibility. Private nonprofit organizations or State governmental entities, or... an accreditation body. (b) Application for initial approval. Three copies of an accreditation body...

  5. 14 CFR 21.305 - Approval of materials, parts, processes, and appliances.

    Science.gov (United States)

    2010-01-01

    ..., and appliances. 21.305 Section 21.305 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION..., Parts, Processes, and Appliances § 21.305 Approval of materials, parts, processes, and appliances. Whenever a material, part, process, or appliance is required to be approved under this chapter, it may be...

  6. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    Science.gov (United States)

    2010-01-01

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

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

    International Nuclear Information System (INIS)

    1980-05-01

    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. Supercollider: Footprint approved

    International Nuclear Information System (INIS)

    Anon.

    1990-01-01

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

  9. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-10-04

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

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

    Science.gov (United States)

    2010-07-01

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

  11. 49 CFR 1522.121 - Security threat assessments for personnel of TSA-approved validation firms.

    Science.gov (United States)

    2010-10-01

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

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

    Science.gov (United States)

    Carpenter, Daniel P

    2003-01-01

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

  13. 75 FR 24774 - Fairmount Bank, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2010-05-05

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

  14. Auditing the process of ethics approval for Master's degrees at a ...

    African Journals Online (AJOL)

    Objective. This study audited the process of ethics approval for Master's research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa. Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master's proposal for the year 2010 was reviewed.

  15. Lessons from EU voluntary Labelling Schemes for GM-Free Processed Food Products

    NARCIS (Netherlands)

    Venus, T.J.; Kalaitzandonakes, Nicholas; Wesseler, J.H.H.

    2016-01-01

    In the European Union, a mandatory GMO labeling law for food and feed products that contain more than 0.9 % EU-approved GMOs has been in place since the early 2000s. This law does not include animal products derived from animals that were fed with GM feed. To enable consumers to also choose animal

  16. Analysis of research ethics board approval times in an academic department of medicine.

    Science.gov (United States)

    Tsang, Teresa S M; Jones, Meaghan; Meneilly, Graydon S

    2015-04-01

    As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols. © The Author(s) 2015.

  17. 75 FR 15645 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to the Emission...

    Science.gov (United States)

    2010-03-30

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

  18. Child Nutrition Labeling for Meat and Poultry Products.

    Science.gov (United States)

    Wade, Cheryl; And Others

    Prepared for food manufacturers, this publication contains instructions for calculating the contribution that a meat or poultry product makes toward the meal pattern requirements of child nutrition programs. It also contains instructions on how to apply for and obtain the approval for a label containing a child nutrition statement. These…

  19. 77 FR 26438 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

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

  20. 75 FR 31508 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-06-03

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

  1. Appel à propositions en matière de stratégies de production | CRDI ...

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

    Integrating poverty and environmental concerns into value-chain analysis : a strategic framework and practical guide. Téléchargez le PDF. Rapports. Productive strategies call for proposals : annex 2 - approved action research. Téléchargez le PDF. Rapports. Productive strategies call for proposals : final technical report.

  2. Radiation requirements for uranium project approvals

    International Nuclear Information System (INIS)

    Hondros, J.

    2014-01-01

    Uranium mining projects in Australia must receive approval under both state and national laws based on a wide ranging impact assessment of the project. The process may take a number of years and involves multiple levels and parts of government and public consultation and scrutiny. The impact assessment is broad and usually covers; environmental, social, health, public safety and economic aspects. Information provided in the approvals documentation needs to be presented in a credible and understandable manner for all audiences. This means making complex information simpler, while making sure that it maintains its technical integrity. Poorly communicated information, which is overly complex, overly simplified or incomplete, can result in significant delays to the project approval which can potentially impact on project timelines. For uranium projects, along with other projects involving radioactive materials, such as minerals sands and rare earths, radiation and its impacts usually draw a disproportionate amount of both government and public scrutiny compared to other potential impacts and risks. It is therefore of key importance that radiation assessments are properly performed and results clearly presented and communicated with sufficient detail for stakeholders to make informed decisions. It is also important to ensure that the radiation risk is presented in perspective with other risks of the project. This presentation outlines a structure for a radiation impact assessment based on experience from a number of projects in Australia. The structure aims to be clear and simple and ensure the right balance between scientific fact, digestible information and demonstrable competence. (author)

  3. 30 CFR 285.103 - When may MMS prescribe or approve departures from these regulations?

    Science.gov (United States)

    2010-07-01

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

  4. 30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.

    Science.gov (United States)

    2010-07-01

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

  5. Isotope production potential at Sandia National Laboratories: Product, waste, packaging, and transportation

    International Nuclear Information System (INIS)

    Trennel, A.J.

    1995-01-01

    The U.S. Congress directed the U.S. Department of Energy to establish a domestic source of molybdenum-99, an essential isotope used in nuclear medicine and radiopharmacology. An Environmental Impact Statement for production of 99 Mo at one of four candidate sites is being prepared. As one of the candidate sites, Sandia National Laboratories is developing the Isotope Production Project. Using federally approved processes and procedures now owned by the U.S. Department of Energy, and existing facilities that would be modified to meet the production requirements, the Sandia National Laboratories' Isotope Project would manufacture up to 30 percent of the U.S. market, with the capacity to meet 100 percent of the domestic need if necessary. This paper provides a brief overview of the facility, equipment, and processes required to produce isotopes. Packaging and transportation issues affecting both product and waste are addressed, and the storage and disposal of the four low-level radioactive waste types generated by the production program are considered. Recommendations for future development are provided

  6. 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.

  7. 6 CFR 27.240 - Review and approval of security vulnerability assessments.

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Review and approval of security vulnerability assessments. 27.240 Section 27.240 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY CHEMICAL FACILITY ANTI-TERRORISM STANDARDS Chemical Facility Security Program § 27.240 Review and approval...

  8. 46 CFR 167.45-30 - Use of approved fire-fighting equipment.

    Science.gov (United States)

    2010-10-01

    ... PUBLIC NAUTICAL SCHOOL SHIPS Special Firefighting and Fire Prevention Requirements § 167.45-30 Use of approved fire-fighting equipment. Portable fire extinguishers or fire-extinguishing systems which conform... 46 Shipping 7 2010-10-01 2010-10-01 false Use of approved fire-fighting equipment. 167.45-30...

  9. 42 CFR 8.13 - Revocation of accreditation and accreditation body approval.

    Science.gov (United States)

    2010-10-01

    ... GENERAL PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Certification and Treatment Standards § 8.13... period of 1 year after the date of withdrawal of approval of the accreditation body, unless SAMHSA.... (2) Within 1 year from the date of withdrawal of approval of an accreditation body, or within any...

  10. New veterinary medicinal products authorised by centralised procedure

    Directory of Open Access Journals (Sweden)

    Simona Sturzu

    2012-06-01

    Full Text Available Veterinary medicinal products that are subject to authorization via the centralized procedure according to Regulation (EC no. 726/2004 are included in the Community register of veterinary medicines, that is published on the European Commission website and product information of them are published on the website of the European Medicines Agency. Each competent authority involved in the linguistic review process of product information annexed to the Marketing Authorization for medicinal products authorized centrally (SPC, leaflet, information about the marketing authorization holder, product labeling conditions, approve the version in the language mother of each Member State. In the second half of 2011 have received marketing authorization via the centralized procedure a total of four veterinary medicinal products, presented above.

  11. Ethics approval: responsibilities of journal editors, authors and research ethics committees.

    Science.gov (United States)

    Bain, Luchuo Engelbert

    2017-01-01

    Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

  12. 7 CFR 966.124 - Approved receiver.

    Science.gov (United States)

    2010-01-01

    ... limited to, the following information: (1) Name, address, contact person, telephone number, and e-mail... 7 Agriculture 8 2010-01-01 2010-01-01 false Approved receiver. 966.124 Section 966.124 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements...

  13. FDA-approved small-molecule kinase inhibitors

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  14. 77 FR 59335 - Approval and Promulgation of Implementation Plans; North Carolina: Approval of Rocky Mount Motor...

    Science.gov (United States)

    2012-09-27

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

  15. 6 CFR 27.245 - Review and approval of site security plans.

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Review and approval of site security plans. 27.245 Section 27.245 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY CHEMICAL FACILITY ANTI-TERRORISM STANDARDS Chemical Facility Security Program § 27.245 Review and approval of site...

  16. Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

    Science.gov (United States)

    Lawrence, Dana J

    2011-11-01

    To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

  17. 25 CFR 87.12 - Insuring the proper performance of approved plans.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Insuring the proper performance of approved plans. 87.12... DISTRIBUTION OF INDIAN JUDGMENT FUNDS § 87.12 Insuring the proper performance of approved plans. A timetable... regarding the maintenance of the timetable, a full accounting of any per capita distribution, and the...

  18. 13 CFR 115.62 - Prohibition on participation in Prior Approval program.

    Science.gov (United States)

    2010-01-01

    ... Prior Approval program. 115.62 Section 115.62 Business Credit and Assistance SMALL BUSINESS... in Prior Approval program. A PSB Surety is not eligible to submit applications under subpart B of this part. This prohibition does not extend to an Affiliate, as defined in 13 CFR § 121.103, of a PSB...

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

    Science.gov (United States)

    2010-04-01

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

  20. Problems of the current law concerning official plan approval

    International Nuclear Information System (INIS)

    Bluemel, W.

    1986-01-01

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

  1. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

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

  2. 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.

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

    International Nuclear Information System (INIS)

    1983-12-01

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

  4. 21 CFR 500.84 - Conditions for approval of the sponsored compound.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Conditions for approval of the sponsored compound. 500.84 Section 500.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Used in Food-Producing Animals § 500.84 Conditions for approval of the sponsored compound. (a) On the...

  5. 15 CFR 1150.3 - Approved markings.

    Science.gov (United States)

    2010-01-01

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

  6. 50 CFR 223.207 - Approved TEDs.

    Science.gov (United States)

    2010-10-01

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

  7. Quality Management in the New Product Development: a PPAP Approach

    OpenAIRE

    Johanna Hermans; Yang Liu

    2013-01-01

    The purpose of this paper is to test Production Part Approval Process (PPAP) as a tool to build quality into the new product and processes and ensure that it meets the customer expectations. Research method is qualitative method using so called case-study to study the suitability of PPAP as a tool for quality management by building quality right into the new product and process. The case studies have been made with three different kinds of companies. PPAP is suitable tool for quality manageme...

  8. 78 FR 30300 - Enterprise TE Products Pipeline Company LLC; Notice of Petition for Declaratory Order

    Science.gov (United States)

    2013-05-22

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Docket No. OR13-20-000] Enterprise TE Products Pipeline Company LLC; Notice of Petition for Declaratory Order Take notice that on May 14, 2013...), Enterprise TE Products Pipeline Company LLC filed a petition seeking a declaratory order approving priority...

  9. Bortezomib: a novel therapy approved for multiple myeloma.

    Science.gov (United States)

    Richardson, Paul G; Anderson, Kenneth C

    2003-10-01

    Cellular homeostasis requires routine degradation of key regulatory proteins, including tumor suppressor gene products, transcription factors, cell-cycle proteins and their inhibitors, as well as damaged and misfolded proteins. A critical part of this process is mediated by the 26S proteasome, a multi-subunit enzyme found in the nucleus and cytoplasm of all eukaryotic cells. Because of its essential role in many cellular processes controlling growth and survival, the proteasome has been identified as a potential target for cancer therapy. Drugs known to inhibit proteasome activity have been shown to induce cell-cycle arrest and programmed cell death (apoptosis). The impact of this finding is heightened by research showing that cancer cells are more sensitive to the proapoptotic effects of proteasome inhibition than normal cells. Preclinical evidence using bortezomib, the only proteasome inhibitor to enter clinical trials, suggests that proteasome inhibition may be effective in the treatment of hematologic and solid malignancies by promoting apoptosis, retarding angiogenesis, and inhibiting tumor cell adhesion and production of growth factors by acting on molecules such as nuclear factor-kappaB. Further preclinical evidence suggests that the antitumor effects of cytotoxic chemotherapy or radiotherapy may be enhanced by the addition of a proteasome inhibitor. Bortezomib was recently approved for the treatment of multiple myeloma. It is currently being investigated, both as a single agent and in combination, in phase I and II trials in a variety of tumor types.

  10. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    Science.gov (United States)

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

  11. 76 FR 56001 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-09-09

    ...: Regional intermodal transportation center. Determination: Partially approved. The FAA determined that... Approved for Collection and Use at a $3.00 PFC Level: Public information display kiosks. Wildlife hazard assessment study. Interactive employee training module. Blast fence extension--taxiway D. Aircraft rescue and...

  12. 78 FR 32077 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-05-29

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

  13. 77 FR 429 - Clarification and Further Guidance on the Fireworks Approvals Policy

    Science.gov (United States)

    2012-01-05

    ... 173 [Docket No. PHMSA-2011-0315; Notice No. 11-13] Clarification and Further Guidance on the Fireworks... fireworks approvals applications from fireworks manufacturers or their designated agents and grant approvals only to manufacturers of fireworks devices. This clarification and additional guidance follows the...

  14. 32 CFR 644.67 - Approval of Title by the Attorney General.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Approval of Title by the Attorney General. 644.67... § 644.67 Approval of Title by the Attorney General. (a) General. Section 355 of the Revised Statutes of... delegated to the Department of the Army, subject to the supervision and review of the Attorney General...

  15. Reflections on the Ethics-Approval Process

    Science.gov (United States)

    Murray, Lee; Pushor, Debbie; Renihan, Pat

    2012-01-01

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

  16. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  17. US-Approved Intra-Articular Hyaluronic Acid Injections are Safe and Effective in Patients with Knee Osteoarthritis: Systematic Review and Meta-Analysis of Randomized, Saline-Controlled Trials

    Science.gov (United States)

    Miller, Larry E.; Block, Jon E.

    2013-01-01

    We conducted a systematic review and meta-analysis of randomized saline-controlled trials to determine the safety and efficacy of US-approved intra-articular hyaluronic acid (IAHA) injections for symptomatic knee osteoarthritis. A total of 29 studies representing 4,866 unique subjects (IAHA: 2,673, saline: 2,193) were included. IAHA injection resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to pre-injection values, with standardized mean difference (SMD) values ranging from 1.07–1.37 (all P injection of US-approved HA products is safe and efficacious in patients with symptomatic knee osteoarthritis. PMID:24027421

  18. 77 FR 74185 - Information Collection Approved by Office of Management and Budget

    Science.gov (United States)

    2012-12-13

    ... FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by Office of Management and... Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). An agency may...

  19. 78 FR 16601 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-03-18

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

  20. 76 FR 20802 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-04-13

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved or Rescinded for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects... the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  1. 76 FR 50536 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-15

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved or Rescinded for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects... the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  2. 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.

  3. 77 FR 71006 - Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for the Treatment...

    Science.gov (United States)

    2012-11-28

    ... poisoning and unapproved injectable drug products containing sodium thiosulfate labeled for the treatment of... for the treatment of cyanide poisoning are new drugs that require approved new drug applications (NDAs... Injection and Sodium Thiosulfate Injection drug product, labeled for treatment of acute cyanide poisoning...

  4. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

    Science.gov (United States)

    Kesselheim, A S

    2010-06-01

    In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

  5. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC approved packages

    International Nuclear Information System (INIS)

    1988-12-01

    This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  6. Directory of certificates of compliance for radioactive materials packages, Report of NRC approved packages

    International Nuclear Information System (INIS)

    1990-10-01

    This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  7. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

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

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

    International Nuclear Information System (INIS)

    1993-10-01

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

  9. 40 CFR 131.21 - EPA review and approval of water quality standards.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.21 EPA review and approval of water quality standards. (a) After the State submits its... analysis. (b) The Regional Administrator's approval or disapproval of a State water quality standard shall...

  10. 77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-12-13

    ... proposal to extend Office of Management and Budget (OMB) approval of the Information Collection: Work-Study... reporting requirements that include a Work Study Program application and written participation agreement. In... private school system to file with the Wage and Hour Division Administrator an application for approval of...

  11. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    Science.gov (United States)

    2010-04-01

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

  12. Approved Air Quality Implementation Plans in Region 10

    Science.gov (United States)

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

  13. Supply Network Planning for New Product Market Entry in the Pharmaceutical Industry

    DEFF Research Database (Denmark)

    Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin

    2011-01-01

    uncertainty and the risk of a forced label change and includes solution robustness. While considering limited shelf life of the drug, the supply of packaging material and outsourcing, the objective of our model is to reduce supply chain cost including lost peak sales from delayed market entry....... planning before and during the market entry of the drug after the drug has been approved. Production of the active pharmaceutical ingredient [API] is characterized by long change-over times due to cleaning requirements. Production planning is long term, multiple batches of each drug are produced...... industry, reimbursement negotiations have to be carried out before a drug can be marketed. These negotiations both necessitate time phasing market entries and introduce a series of uncertainties e.g. varying allowed price and awarded subsidy. Also if the label is not approved for marketing, all packaged...

  14. 30 CFR 75.1103-2 - Automatic fire sensors; approved components; installation requirements.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic fire sensors; approved components... Protection § 75.1103-2 Automatic fire sensors; approved components; installation requirements. (a) The components of each automatic fire sensor required to be installed in accordance with the provisions of § 75...

  15. 9 CFR 130.11 - User fees for inspecting and approving import/export facilities and establishments.

    Science.gov (United States)

    2010-01-01

    ... hourly user fee rate in § 130.30(2) applies to biosecurity level two laboratories. (b) [Reserved] [65 FR... approval) Per year $537.00 $553.00 $570.00 $587.00 $604.00 Inspection for approval of biosecurity level three labs (all inspections related to approving the laboratory for handling one defined set of...

  16. Revised guideline for the approval procedure of package designs in Germany

    International Nuclear Information System (INIS)

    Nitsche, F.; Roedel, R.

    2004-01-01

    The IAEA Regulations for the Safe Transport of Radioactive Material, TS-R-1 are applied in Germany through the implementation of the Dangerous Goods Transport Regulations for class 7 of the International Modal Organisations (ADR, RID, IMDG-Code, ICAO-TI). Based on this the approval procedures for packages designs applied in Germany are in compliance with the provisions of TS-R-1. The Guideline R 003 issued by the Ministry of Transport, Building and Housing (BMVBW) in 1991 is the basis for the package design approval procedures in Germany. This Guideline has been reviewed and revised to reflect latest developments in the regulations as well as in the regulatory practice. In particular it has been extended to the approval procedures of Type C packages, packages subject to transitional arrangements, special form and low dispersible radioactive material and provides more detailed information to the applicant about the requested documentation. Publication of this revised guideline has been delayed but it is expected to take place in October 2004. The paper gives an overview about the main parts and provisions of this revised Guideline R 003 with the focus on package design approval procedures

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

    Science.gov (United States)

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

    2007-01-01

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

  18. Antimicrobial usage and resistance in beef production

    OpenAIRE

    Cameron, Andrew; McAllister, Tim A.

    2016-01-01

    Antimicrobials are critical to contemporary high-intensity beef production. Many different antimicrobials are approved for beef cattle, and are used judiciously for animal welfare, and controversially, to promote growth and feed efficiency. Antimicrobial administration provides a powerful selective pressure that acts on the microbial community, selecting for resistance gene determinants and antimicrobial-resistant bacteria resident in the bovine flora. The bovine microbiota includes many harm...

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

    Science.gov (United States)

    Schimmer, Joshua; Breazzano, Steven

    2016-06-01

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

  20. 44 CFR 78.10 - Project grant approval process.

    Science.gov (United States)

    2010-10-01

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

  1. Re-establishment of RTG unicouple production

    International Nuclear Information System (INIS)

    Braun, J.F.; Kuhl, K.D.

    1992-01-01

    The approach that was utilized to start u and requalify manufacture of the thermoelectric unicouple devices for the Cassini RTG (Radioisotope Thermoelectric Generator) program are described in this paper. Key elements involved in this effort were: engineering review of specifications; training of operators; manufacturing product verification runs; and management review of results. Appropriately, issues involved in activating a fabrication process that has been idle for nearly a decade, such as upgrading equipment, adhering to updated environmental, health, and safety requirements, or approving new vendors, are also addressed. The cumulative results of the startup activities have verified that a production line for this type of device can be reopened successfully

  2. 76 FR 33019 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-06-07

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

  3. 75 FR 31510 - Fox Chase Bancorp, Inc., Hatboro, PA; Approval of Conversion

    Science.gov (United States)

    2010-06-03

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

  4. 30 CFR 250.290 - What operations require approval of the Conceptual Plan?

    Science.gov (United States)

    2010-07-01

    ... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information Deepwater Operations Plans (dwop) § 250.290 What operations require approval of the Conceptual Plan? You may... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What operations require approval of the...

  5. Product quality of parenteral vancomycin products in the United States.

    Science.gov (United States)

    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; Biswas, K; Cox, E M

    2012-06-01

    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 activity of these products will be evaluated in an appropriate animal model. This paper summarizes results of the FDA investigation completed thus far. One site used a validated ultrahigh-pressure liquid chromatography method (OTR-UPLC), and the second site used the high-performance liquid chromatography (HPLC) method for related substances provided in the British Pharmacopeia (BP) monograph for vancomycin intravenous infusion. Similar results were obtained by the two FDA-OTR laboratories using two different analytical methods. The products tested had 90 to 95% vancomycin B (active component of vancomycin) by the BP-HPLC method and 89 to 94% vancomycin by OTR-UPLC methods. Total impurities were 5 to 10% by BP-HPLC and 6 to 11% by OTR-UPLC methods. No single impurity was >2.0%, and the CDP-1 level was ≤ 2.0% across all products. Some variability in impurity profiles of the various products was observed. No adverse product quality issues were identified with the six U.S. vancomycin parenteral products. The quality parameters of all parenteral vancomycin products tested surpassed the United States Pharmacopeia acceptance criteria. Additional testing will characterize in vivo performance characteristics of these products.

  6. 76 FR 39874 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    2011-07-07

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

  7. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    2010-01-01

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

  8. 46 CFR 163.002-9 - Approval procedure.

    Science.gov (United States)

    2010-10-01

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

  9. 7 CFR 1427.10 - Approved storage.

    Science.gov (United States)

    2010-01-01

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

  10. 78 FR 58273 - Approval for Manufacturing (Production) Authority, Foreign-Trade Zone 284, Liberty Pumps, Inc...

    Science.gov (United States)

    2013-09-23

    ... (Production) Authority, Foreign-Trade Zone 284, Liberty Pumps, Inc. (Submersible and Water Pumps), Bergen, New... (production) authority on behalf of Liberty Pumps, Inc., within FTZ 284 in Bergen, New York (FTZ Docket 5-2012... manufacturing (production) authority under zone procedures within FTZ 284 on behalf of Liberty Pumps, Inc., as...

  11. Review of experiments for research reactors - approved 1974

    International Nuclear Information System (INIS)

    Anon.

    1977-01-01

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

  12. 24 CFR 28.20 - Request for approval by the Department of Justice.

    Science.gov (United States)

    2010-04-01

    ... Department of Justice. 28.20 Section 28.20 Housing and Urban Development Office of the Secretary, Department....20 Request for approval by the Department of Justice. (a) If the General Counsel or designee... written request to the Department of Justice for approval to issue a complaint under § 28.25. (b) The...

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

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

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

  14. 27 CFR 5.51 - Label approval and release.

    Science.gov (United States)

    2010-04-01

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

  15. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.

    Science.gov (United States)

    Wang, Bo; Kesselheim, Aaron S

    2015-09-23

    To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs' originally approved indications. Systematic review. Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs' supplemental and original indication approvals. The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (Pindications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. © Wang et al 2015.

  16. U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

    Science.gov (United States)

    Wing, Deborah A; Powers, Barbara; Hickok, Durlin

    2010-04-01

    The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical-legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.

  17. A planning support system to optimize approval of private housing development projects

    Science.gov (United States)

    Hussnain, M. Q.; Wakil, K.; Waheed, A.; Tahir, A.

    2016-06-01

    Out of 182 million population of Pakistan, 38% reside in urban areas having an average growth rate of 1.6%, raising the urban housing demand significantly. Poor state response to fulfil the housing needs has resulted in a mushroom growth of private housing schemes (PHS) over the years. Consequently, only in five major cities of Punjab, there are 383 legal and 150 illegal private housing development projects against 120 public sector housing schemes. A major factor behind the cancerous growth of unapproved PHS is the prolonged and delayed approval process in concerned approval authorities requiring 13 months on average. Currently, manual and paper-based approaches are used for vetting and for granting the permission which is highly subjective and non-transparent. This study aims to design a flexible planning support system (PSS) to optimize the vetting process of PHS projects under any development authority in Pakistan by reducing time and cost required for site and documents investigations. Relying on the review of regulatory documents and interviews with professional planners and land developers, this study describes the structure of a PSS developed using open- source geo-spatial tools such as OpenGeo Suite, PHP, and PostgreSQL. It highlights the development of a Knowledge Module (based on regulatory documents) containing equations related to scheme type, size (area), location, access road, components of layout plan, planning standards and other related approval checks. Furthermore, it presents the architecture of the database module and system data requirements categorized as base datasets (built-in part of PSS) and input datasets (related to the housing project under approval). It is practically demonstrated that developing a customized PSS to optimize PHS approval process in Pakistan is achievable with geospatial technology. With the provision of such a system, the approval process for private housing schemes not only becomes quicker and user-friendly but also

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...

  19. 38 CFR 21.258 - Cost limitations on approval of self-employment plans.

    Science.gov (United States)

    2010-07-01

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

  20. 14 CFR 414.35 - Public notification of the criteria by which a safety approval was issued.

    Science.gov (United States)

    2010-01-01

    ... issued. For each grant of a safety approval, the FAA will publish in the Federal Register a notice of the... which a safety approval was issued. 414.35 Section 414.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety...