WorldWideScience

Sample records for application supplement approvals

  1. 76 FR 46820 - Proposal To Refuse To Approve a Supplemental New Drug Application for Bromday (Bromfenac...

    Science.gov (United States)

    2011-08-03

    ... approve a supplemental new drug application submitted by ISTA Pharmaceuticals, Inc. (ISTA), for a new 2.4..., notice is given to ISTA Pharmaceuticals, Inc., and to all other interested persons, that the...

  2. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Science.gov (United States)

    2010-06-21

    ... Application; Penicillin G Procaine Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Notice... for a revised formulation of penicillin G procaine injectable suspension that includes lecithin as a... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G...

  3. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Science.gov (United States)

    2010-04-01

    ... supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs... dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any... with § 111.70(e); and (b) Quality control personnel must approve or reject the release for...

  4. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Science.gov (United States)

    2010-12-16

    ... December 22, 2009.\\3\\ \\2\\ 17 CFR 202.190. See Release No. 33-8724 (July 18, 2006) [71 FR 41998 (July 24... Release No. 63526/December 10, 2010] Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To Establish an Office of Outreach and Small Business Liaison in 2010 The...

  5. 76 FR 30189 - Receipt of Application for Approval

    Science.gov (United States)

    2011-05-24

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

  6. 21 CFR 814.39 - PMA supplements.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false PMA supplements. 814.39 Section 814.39 Food and... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... shall submit a PMA supplement for review and approval by FDA before making a change affecting the...

  7. 19 CFR 115.63 - Application for approval.

    Science.gov (United States)

    2010-04-01

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

  8. 7 CFR 1786.56 - Approval of applications.

    Science.gov (United States)

    2010-01-01

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

  9. Weakly Distributive Modules. Applications to Supplement Submodules

    Indian Academy of Sciences (India)

    Engin Büyükaşik; Yilmaz M Demirci

    2010-11-01

    In this paper, we define and study weakly distributive modules as a proper generalization of distributive modules. We prove that, weakly distributive supplemented modules are amply supplemented. In a weakly distributive supplemented module every submodule has a unique coclosure. This generalizes a result of Ganesan and Vanaja. We prove that -projective duo modules, in particular commutative rings, are weakly distributive. Using this result we obtain that in a commutative ring supplements are unique. This generalizes a result of Camillo and Lima. We also prove that any weakly distributive $\\oplus$-supplemented module is quasi-discrete.

  10. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Science.gov (United States)

    2010-04-01

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

  11. 21 CFR 601.12 - Changes to an approved application.

    Science.gov (United States)

    2010-04-01

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

  12. 76 FR 59863 - Application and Approval Process for New Programs

    Science.gov (United States)

    2011-09-27

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

  13. 12 CFR 516.280 - How will I know if my application has been approved?

    Science.gov (United States)

    2010-01-01

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

  14. 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...

  15. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... distribution of test scores for each edition, form, level, sub-test, or partial battery, for which approval is... submitted to the Secretary for review and approval, documentation of periodic reviews of the content...

  16. Application for approval of the Cold Lake Expansion Project

    International Nuclear Information System (INIS)

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

  17. 13 CFR 120.427 - Will SBA approve a securitization application from a capital impaired Securitizer?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Will SBA approve a securitization... securitization application from a capital impaired Securitizer? If a securitizer does not maintain the level of capital required by this subpart, SBA will not approve a securitization application from that securitizer....

  18. 77 FR 39983 - Migratory Bird Hunting; Application for Approval of Fluoropolymeric Shot Coatings as Nontoxic for...

    Science.gov (United States)

    2012-07-06

    ... of Fluoropolymeric Shot Coatings as Nontoxic for Waterfowl Hunting AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of application for nontoxic shot approval. SUMMARY: We, the U.S. Fish and Wildlife Service, announce that Spectra Shot, LLC, of Lafayette, Louisiana, has applied for approval of steel...

  19. 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)...

  20. 75 FR 80061 - Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA

    Science.gov (United States)

    2010-12-21

    ... HUMAN SERVICES Food and Drug Administration Abbott Laboratories, Inc.; Withdrawal of Approval of a New... (sibutramine hydrochloride (HCl)) oral capsules held by Abbott Laboratories, Inc. (Abbott), 100 Abbott Park Rd., Abbott Park, IL 60064. Abbott has voluntarily requested that approval of this application be...

  1. 78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

    Science.gov (United States)

    2013-08-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin AGENCY: Food... amending the animal drug regulations to reflect the withdrawal of approval of three new animal...

  2. 75 FR 52768 - Withdrawal of Approval of New Animal Drug Applications; Dichlorophene and Toluene Capsules

    Science.gov (United States)

    2010-08-27

    ... INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration... Veterinary Medicine, and in accordance with Sec. 514.116 Notice of withdrawal of approval of application (21... Veterinary Medicine. BILLING CODE 4160-01-S...

  3. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

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

  4. 44 CFR 350.7 - Application by State for review and approval.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Application by State for review and approval. 350.7 Section 350.7 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT... coverage of response in the ingestion exposure pathway EPZ. The application will also include plans of...

  5. Supplemental Report: Application of Emission Spectroscopy to Monitoring Technetium

    International Nuclear Information System (INIS)

    This report provides supplemental information to an earlier report BNF-98-003-0199, ''Evaluation of Emission Spectroscopy for the On-Line Analysis of Technetium''. In this report data is included from real Hanford samples as well as for solutions spiked with technetium. This supplemental work confirms the ability of ICP-ES to monitor technetium as it breaks through an ion exchange process

  6. 76 FR 20435 - Notice of Approval of the Supplemental Finding of No Significant Impact and Record of Decision...

    Science.gov (United States)

    2011-04-12

    ... and construction access road along Surf Bay, fuel storage facility, and a personnel camp. On December... facility; an airport access road; two hovercraft landing pads; a hovercraft storage and maintenance facility; and acquisition of a hovercraft The Supplemental FONSI/ROD provides the final...

  7. 24 CFR 1000.428 - For what reasons may HUD disapprove an application or approve an application for an amount less...

    Science.gov (United States)

    2010-04-01

    ... an application or approve an application for an amount less than that requested? 1000.428 Section... NATIVE AMERICAN HOUSING ACTIVITIES Federal Guarantees for Financing of Tribal Housing Activities § 1000.428 For what reasons may HUD disapprove an application or approve an application for an amount...

  8. 14 CFR 414.19 - Technical criteria for reviewing a safety approval application.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Technical criteria for reviewing a safety approval application. 414.19 Section 414.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... customized by the manufacturer that intends to produce the system, system component, or part. The...

  9. 78 FR 52536 - Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin...

    Science.gov (United States)

    2013-08-23

    ... Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl... Veterinary Medicine, and in accordance with Sec. 514.116 Notice of withdrawal of approval of application (21.... Dated: August 19, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. BILLING CODE...

  10. 76 FR 11490 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

    Science.gov (United States)

    2011-03-02

    ... Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276... Veterinary Medicine, and in accordance with Sec. 514.116 Notice of withdrawal of approval of application (21... 18, 2011. Bernadette Dunham, Director, Center for Veterinary Medicine. BILLING CODE 4160-01-P...

  11. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

    ... from sale for safety or effectiveness reasons under § 314.161, or the reference listed drug has been... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Refusal to approve an abbreviated new drug application. 314.127 Section 314.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH...

  12. 78 FR 19729 - Wild Bird Conservation Act; Receipt of Application for Approval

    Science.gov (United States)

    2013-04-02

    ... Fish and Wildlife Service Wild Bird Conservation Act; Receipt of Application for Approval AGENCY: Fish... certain activities with birds that are protected in accordance with the Wild Bird Conservation Act of 1992... activities with bird species covered under the Wild Bird Conservation Act of 1992. This notice is...

  13. 78 FR 64423 - Children's Online Privacy Protection Rule Applications for Approval of Proposed Parental Consent...

    Science.gov (United States)

    2013-10-29

    ...-3992, 4013. \\5\\ See 16 CFR 312.11; 78 FR at 3995-96, 4012-13. The Children's Online Privacy Protection... CFR Part 312 RIN 3084-AB20 Children's Online Privacy Protection Rule Applications for Approval of...Fly'') pursuant to the Children's Online Privacy Protection Rule. In addition, the FTC is...

  14. 78 FR 76829 - Approval of Application Submitted by Eastern Shoshone Tribe and Northern Arapaho Tribe for...

    Science.gov (United States)

    2013-12-19

    ...This notice announces that the EPA Regional Administrator for Region 8 has approved the December 2008 application submitted by the Northern Arapaho Tribe and Eastern Shoshone Tribe (Tribes) of the Wind River Indian Reservation for treatment in a similar manner as a state (TAS) pursuant to the Clean Air Act and the EPA's implementing regulations for purposes of certain Clean Air Act provisions.......

  15. 21 CFR 514.111 - Refusal to approve an application.

    Science.gov (United States)

    2010-04-01

    ... evaluate the safety of such drugs, are appropriate for the use of animal experimentation data; and (iv... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUG APPLICATIONS Administrative Actions on... new animal drug, that: (1) The reports of investigations required to be submitted pursuant to...

  16. 7 CFR 1942.5 - Application review and approval.

    Science.gov (United States)

    2010-01-01

    ...: Community Programs. The Rural Development Manager, with assistance as needed from the State Office, will...) PROGRAM REGULATIONS (CONTINUED) ASSOCIATIONS Community Facility Loans § 1942.5 Application review and... community within the service area has been omitted or discouraged from participating in the proposed...

  17. 29 CFR 3.5 - Payroll deductions permissible without application to or approval of the Secretary of Labor.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Payroll deductions permissible without application to or approval of the Secretary of Labor. 3.5 Section 3.5 Labor Office of the Secretary of Labor CONTRACTORS AND... STATES § 3.5 Payroll deductions permissible without application to or approval of the Secretary of...

  18. Characteristics of orphan drug applications that fail to achieve marketing approval in the USA.

    Science.gov (United States)

    Heemstra, Harald E; Leufkens, Hubert G M; Rodgers, R P Channing; Xu, Kui; Voordouw, Bettie C G; Braun, M Miles

    2011-01-01

    The US Orphan Drug Act has fostered the development of drugs for patients with rare diseases by granting 'orphan designations', although several orphan drugs for which a marketing application has been submitted to the FDA have failed to obtain approval. This study identified the clinical trial design, the level of experience of the sponsor and the level of interaction with the FDA to be associated with non-approval. Sponsors, therefore, should engage in dialogue with the FDA and thoughtfully design pivotal clinical trials in accordance with FDA guidance documents. PMID:21094692

  19. Military-specific application of nutritional supplements: a brief overview

    OpenAIRE

    Kyle Hoedebecke; Will Brink

    2015-01-01

    The Soldiers of America's military endure numerous physical and mental challenges that demand strict physical fitness regimens, extreme mental agility, and a perpetual readiness to deploy at a moment's notice. The chronicity of these stressors has the potential to dramatically reduce performance - both directly and indirectly.  Because of this risk, many Soldiers turn to nutritional supplements with hopes of optimizing performance. Increasing amounts of research have demonstrated that various...

  20. Irradiation update: Pork approval could launch major commercial applications

    International Nuclear Information System (INIS)

    In review of recent FDA actions and the probability of FDA issuance of basic food low irradiation dose regulations, a brief discussion considers the possible application of irradiation to fruits and vegetables and how irradiated products might be labelled. Irradiation control insect infestation without the human health risk posed by fumigants and their residues. At low dose levels the sprouting of tubers (potatoes, onions) is inhibited and the ripening of certain fruits is delayed, promoting storage quality and life. At higher doses food pasteurization occurs, destroying microbial pathogens such as Salmonella. Important considerations in selecting the irradiation source include cost, availability, penetrating power, maintenance, and special shielding needs. These and other factors are discussed

  1. 77 FR 36980 - Migratory Bird Hunting; Application for Approval of Copper-Clad Iron Shot as Nontoxic for...

    Science.gov (United States)

    2012-06-20

    ... of Copper-Clad Iron Shot as Nontoxic for Waterfowl Hunting AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of application for nontoxic shot approval. SUMMARY: We, the U.S. Fish and Wildlife Service, announce that Environ- Metal, Inc., of Sweet Home, Oregon, has applied for our approval of...

  2. 78 FR 57857 - Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of...

    Science.gov (United States)

    2013-09-20

    ... the Compliance Team for Initial CMS-Approval of its Rural Health Clinic Accreditation Program AGENCY... acknowledges the receipt of an application from the Compliance Team for initial recognition as a national... Compliance Team's request for initial CMS approval of its RHC accreditation program. This notice...

  3. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act... paragraphs (b)(3) and (b)(4) of this section, changes in the qualitative or quantitative formulation of...

  4. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... profile of the drug product. (vii) Changes solely affecting a natural product, a recombinant DNA-derived... derived from such studies; (vi) For a natural product, a recombinant DNA-derived protein/polypeptide, or a...) Changes solely affecting a natural protein, a recombinant DNA-derived protein/polypeptide or a complex...

  5. 76 FR 71926 - Defense Federal Acquisition Regulation Supplement: Applicability of Hexavalent Chromium Policy to...

    Science.gov (United States)

    2011-11-21

    ... Acquisition Regulation Supplement: Applicability of Hexavalent Chromium Policy to Commercial Items (DFARS Case... hexavalent chromium. DATES: Comment Date: Comments on the proposed rule should be submitted in writing to the.... SUPPLEMENTARY INFORMATION: I. Background DoD published a final rule at in the Federal Register at 76 FR 25569...

  6. 77 FR 39141 - Defense Federal Acquisition Regulation Supplement: Applicability of Hexavalent Chromium Policy to...

    Science.gov (United States)

    2012-06-29

    ... Acquisition Regulation Supplement: Applicability of Hexavalent Chromium Policy to Commercial Items (DFARS Case... material containing hexavalent chromium. DATES: Effective Date: June 29, 2012. FOR FURTHER INFORMATION... published a final rule (DFARS Case 2009-D004) in the Federal Register at 76 FR 25569 on May 5, 2011,...

  7. Evaluation of Supplemental Nutrition Assistance Program Education: Application of Behavioral Theory and Survey Validation

    Science.gov (United States)

    Wyker, Brett A.; Jordan, Patricia; Quigley, Danielle L.

    2012-01-01

    Objective: Application of the Transtheoretical Model (TTM) to Supplemental Nutrition Assistance Program Education (SNAP-Ed) evaluation and development and validation of an evaluation tool used to measure TTM constructs is described. Methods: Surveys were collected from parents of children receiving food at Summer Food Service Program sites prior…

  8. 77 FR 16039 - Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated...

    Science.gov (United States)

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration Abbott Laboratories et al.; Withdrawal of Approval of 35 New... Application No. Drug Applicant NDA 005545 Dicumarol Tablets... Abbott Laboratories, PA77/Bldg. AP30-1E, 200...)) Injection Preservative Free. NDA 010021 Placidyl Abbott Laboratories, (ethchlorvynol) 200 Abbott...

  9. Supplement to the approved requirements for the packaging, labelling and carriage of radioactive material by rail. Packaging, Labelling and Carriage of Radioactive Material by Rail Regulations 1996

    International Nuclear Information System (INIS)

    The ADR and RID Framework Directives require EC member states' arrangements for the carriage of dangerous goods on domestic road and rail journeys to align with the existing ADR and RID agreements which cover international journeys by road and rail. Because ADR and RID are updated every two years in line with technical and scientific developments, the ADR/RID Framework Directives are also revised on a two-year cycle, to require member states to amend their implementing legislation accordingly. In Great Britain, these two Directives were initially implemented on 1 September 1996 via regulations (usually referred to as the 'carriage regulations'), containing the general legal duties, supported by approved documents, and an Approved Code of Practice containing the detailed technical requirements. The following approved documents have been updated: (a) Approved Vehicle Requirements (AVR) - L89; (b) Approved Requirements and test methods for the classification and packaging of dangerous goods for carriage (ARTM) - L88; (c) Approved Requirements for the packaging, labelling and carriage of radioactive material by rail (ARCRR) - L94; (d) Approved Requirements for the construction of vehicles intended for the carriage of explosives by road (AEVR) - L92; and (e) Approved Carriage List (ACL) - L90

  10. 77 FR 25192 - Wild Bird Conservation Act; Receipt of Application for Approval of a Cooperative Breeding Program

    Science.gov (United States)

    2012-04-27

    ... Cooperative Breeding Program AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of... listed birds for scientific research, zoological breeding or display programs, or personal pet purposes, when the applicant meets certain criteria. We also may approve cooperative breeding programs of...

  11. 77 FR 59158 - Migratory Bird Hunting; Application for Approval of Copper-Clad Iron Shot and Fluoropolymer Shot...

    Science.gov (United States)

    2012-09-26

    ... approval for copper-clad iron shot in the Federal Register on June 20, 2012 (77 FR 36980), and one for the fluoropolymer shot coatings on July 6, 2012 (77 FR 39983). Having completed our review of the application..., 1994, ``Government-to-Government Relations with Native American Tribal Governments'' (59 FR 22951),...

  12. 40 CFR 86.094-22 - Approval of application for certification; test fleet selections; determinations of parameters...

    Science.gov (United States)

    2010-07-01

    ... certification; test fleet selections; determinations of parameters subject to adjustment for certification and...; test fleet selections; determinations of parameters subject to adjustment for certification and... may approve the application and select a test fleet in accordance with § 86.094-24. (b) Disapproval...

  13. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-10-26

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

  14. 75 FR 50797 - TTX Company-Application for Approval of Pooling of Car Service With Respect to Flatcars

    Science.gov (United States)

    2010-08-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Surface Transportation Board TTX Company--Application for Approval of Pooling of Car Service With Respect to Flatcars AGENCY: Surface Transportation Board. ACTION: Notice of final decision. SUMMARY: In...

  15. Department of Health application for approval of construction SP-100 Ground Engineering System Test Site

    Energy Technology Data Exchange (ETDEWEB)

    1990-04-01

    The following Application For Approval of Construction is being submitted by the US Department of Energy-Richland Operations Office, for the SP-100 Ground Engineering System Test Site, which will provide a new source of radioactive emissions to the atmosphere. The US Department of Energy, the National Aeronautics and Space Administration, and the US Department of Defense have entered into an agreement to jointly develop space nuclear reactor power system technology. A ground test of a reactor is necessary to demonstrate technology readiness of this major subsystem before proceeding with the flight system development and demonstration. It is proposed that the SP-100 test reactor be tested in the existing decommissioned Plutonium Recycle Test Reactor containment building (309 Building). The reactor will be operated for at least three months and up to 2 yr. Following the test, the 309 Building will be decontaminated for potential use in other programs. It is projected this new source of emissions will contribute approximately 0.05 mrem/yr dose to the maximally exposed offsite individual. This application is being submitted in response to those projected emissions that would provide the described offsite dose. 28 refs., 9 figs., 7 tabs.

  16. Wireless energy transmission to supplement energy harvesters in sensor network applications

    Energy Technology Data Exchange (ETDEWEB)

    Farinholt, Kevin M [Los Alamos National Laboratory; Taylor, Stuart G [Los Alamos National Laboratory; Park, Gyuhae [Los Alamos National Laboratory; Farrar, Charles R [Los Alamos National Laboratory

    2010-01-01

    In this paper we present a method for coupling wireless energy transmission with traditional energy harvesting techniques in order to power sensor nodes for structural health monitoring applications. The goal of this study is to develop a system that can be permanently embedded within civil structures without the need for on-board power sources. Wireless energy transmission is included to supplement energy harvesting techniques that rely on ambient or environmental, energy sources. This approach combines several transducer types that harvest ambient energy with wireless transmission sources, providing a robust solution that does not rely on a single energy source. Experimental results from laboratory and field experiments are presented to address duty cycle limitations of conventional energy harvesting techniques, and the advantages gained by incorporating a wireless energy transmission subsystem. Methods of increasing the efficiency, energy storage medium, target applications and the integrated use of energy harvesting sources with wireless energy transmission will be discussed.

  17. The application of reporter gene assays for the detection of endocrine disruptors in sport supplements

    NARCIS (Netherlands)

    Plotan, M.; Elliot, C.T.; Scippo, M.L.; Müller, M.; Antignac, J.P.; Malone, E.; Bovee, T.F.H.; Mitchell, S.; Connolly, L.

    2011-01-01

    The increasing availability and use of sports supplements is of concern as highlighted by a number of studies reporting endocrine disruptor contamination in such products. The health food supplement market, including sport supplements, is growing across the Developed World. Therefore, the need to en

  18. Artificial Tongue-Placed Tactile Biofeedback for perceptual supplementation: application to human disability and biomedical engineering

    CERN Document Server

    Vuillerme, Nicolas; Moreau-Gaudry, Alexandre; Demongeot, Jacques; Payan, Yohan

    2007-01-01

    The present paper aims at introducing the innovative technologies, based on the concept of "sensory substitution" or "perceptual supplementation", we are developing in the fields of human disability and biomedical engineering. Precisely, our goal is to design, develop and validate practical assistive biomedical and/technical devices and/or rehabilitating procedures for persons with disabilities, using artificial tongue-placed tactile biofeedback systems. Proposed applications are dealing with: (1) pressure sores prevention in case of spinal cord injuries (persons with paraplegia, or tetraplegia); (2) ankle proprioceptive acuity improvement for driving assistance in older and/or disabled adults; and (3) balance control improvement to prevent fall in older and/or disabled adults. This paper presents results of three feasibility studies performed on young healthy adults.

  19. 41 CFR 102-75.660 - What happens if DOI does not approve any applications or does not submit an assignment...

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What happens if DOI does... Disposal Property for Use As Public Park Or Recreation Areas § 102-75.660 What happens if DOI does not approve any applications or does not submit an assignment recommendation? If DOI does not approve...

  20. 76 FR 72955 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG

    Science.gov (United States)

    2011-11-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New... (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola...

  1. 77 FR 17068 - Medicare and Medicaid Programs; Approval of the Application by the American Association for...

    Science.gov (United States)

    2012-03-23

    ... appropriately to complaints against accredited facilities; and (5) survey review and decision-making process for... the Social Security Act (the Act) establish distinct criteria for facilities seeking designation as an... Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our...

  2. 77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

    Science.gov (United States)

    2012-08-20

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

  3. The application of reporter gene assays for the detection of endocrine disruptors in sport supplements

    International Nuclear Information System (INIS)

    The increasing availability and use of sports supplements is of concern as highlighted by a number of studies reporting endocrine disruptor contamination in such products. The health food supplement market, including sport supplements, is growing across the Developed World. Therefore, the need to ensure the quality and safety of sport supplements for the consumer is essential. The development and validation of two reporter gene assays coupled with solid phase sample preparation enabling the detection of estrogenic and androgenic constituents in sport supplements is reported. Both assays were shown to be of high sensitivity with the estrogen and androgen reporter gene assays having an EC50 of 0.01 ng mL-1 and 0.16 ng mL-1 respectively. The developed assays were applied in a survey of 63 sport supplements samples obtained across the Island of Ireland with an additional seven reference samples previously investigated using LC-MS/MS. Androgen and estrogen bio-activity was found in 71% of the investigated samples. Bio-activity profiling was further broken down into agonists, partial agonists and antagonists. Supplements (13) with the strongest estrogenic bio-activity were chosen for further investigation. LC-MS/MS analysis of these samples determined the presence of phytoestrogens in seven of them. Supplements (38) with androgen bio-activity were also selected for further investigation. Androgen agonist bio-activity was detected in 12 supplements, antagonistic bio-activity was detected in 16 and partial antagonistic bio-activity was detected in 10. A further group of supplements (7) did not present androgenic bio-activity when tested alone but enhanced the androgenic agonist bio-activity of dihydrotestosterone when combined. The developed assays offer advantages in detection of known, unknown and low-level mixtures of endocrine disruptors over existing analytical screening techniques. For the detection and identification of constituent hormonally active compounds the

  4. The application of reporter gene assays for the detection of endocrine disruptors in sport supplements

    Energy Technology Data Exchange (ETDEWEB)

    Plotan, Monika; Elliott, Christopher T. [Institute of Agri-Food and Land Use, School of Biological Sciences, Queen' s University Belfast, Belfast BT95AG, Northern Ireland (United Kingdom); Scippo, Marie Louise [Department of Food Sciences, University of Liege, 4000 Liege (Belgium); Muller, Marc [Molecular Biology and Genetic Engineering GIGA-R, University of Liege, 4000 Liege (Belgium); Antignac, Jean-Philippe [LABERCA, ENVN, USC INRA 2013, BP 50707, 44 307, Nantes (France); Malone, Edward [The State Laboratory, Young' s Cross, Celbridge, Co. Kildare (Ireland); Bovee, Toine F.H. [RIKILT Institute of Food Safety, P.O. Box 230, AE Wageningen 6700 (Netherlands); Mitchell, Samuel [Agri-Food and Biosciences Institute, Belfast BT9 5PX (United Kingdom); Connolly, Lisa, E-mail: l.connolly@qub.ac.uk [Institute of Agri-Food and Land Use, School of Biological Sciences, Queen' s University Belfast, Belfast BT95AG, Northern Ireland (United Kingdom)

    2011-08-26

    The increasing availability and use of sports supplements is of concern as highlighted by a number of studies reporting endocrine disruptor contamination in such products. The health food supplement market, including sport supplements, is growing across the Developed World. Therefore, the need to ensure the quality and safety of sport supplements for the consumer is essential. The development and validation of two reporter gene assays coupled with solid phase sample preparation enabling the detection of estrogenic and androgenic constituents in sport supplements is reported. Both assays were shown to be of high sensitivity with the estrogen and androgen reporter gene assays having an EC{sub 50} of 0.01 ng mL{sup -1} and 0.16 ng mL{sup -1} respectively. The developed assays were applied in a survey of 63 sport supplements samples obtained across the Island of Ireland with an additional seven reference samples previously investigated using LC-MS/MS. Androgen and estrogen bio-activity was found in 71% of the investigated samples. Bio-activity profiling was further broken down into agonists, partial agonists and antagonists. Supplements (13) with the strongest estrogenic bio-activity were chosen for further investigation. LC-MS/MS analysis of these samples determined the presence of phytoestrogens in seven of them. Supplements (38) with androgen bio-activity were also selected for further investigation. Androgen agonist bio-activity was detected in 12 supplements, antagonistic bio-activity was detected in 16 and partial antagonistic bio-activity was detected in 10. A further group of supplements (7) did not present androgenic bio-activity when tested alone but enhanced the androgenic agonist bio-activity of dihydrotestosterone when combined. The developed assays offer advantages in detection of known, unknown and low-level mixtures of endocrine disruptors over existing analytical screening techniques. For the detection and identification of constituent hormonally

  5. Application of artificial intelligence (AI) concepts to the development of space flight parts approval model

    Science.gov (United States)

    Krishnan, G. S.

    1997-01-01

    A cost effective model which uses the artificial intelligence techniques in the selection and approval of parts is presented. The knowledge which is acquired from the specialists for different part types are represented in a knowledge base in the form of rules and objects. The parts information is stored separately in a data base and is isolated from the knowledge base. Validation, verification and performance issues are highlighted.

  6. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Science.gov (United States)

    2013-08-02

    ... the Generic Drug User Fee Program for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act... 4 months based on the current trend. In contrast to previous non-fee paying FYs, the first year of... significant decrease in PAS submissions. Due to the trend of FY 2013 submissions, FDA utilized available...

  7. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Science.gov (United States)

    2012-10-25

    ... ingredient (API) facilities, and on type II active pharmaceutical ingredient DMFs to be made available for... 576 based on an annualized estimate of the number of receipts for FY 2012. In estimating the number...

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

    International Nuclear Information System (INIS)

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

  9. 42 CFR 422.102 - Supplemental benefits.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA organization...

  10. 42 CFR 8.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-10-01

    ..., accreditation survey team membership, and the identification of at least one licensed physician on the applicant... established to protect confidential information the applicant will collect or receive in its role as...

  11. Comparative Study of Process of Post Approval Change Application Submission and Approval for Marketing Authorization Variations in EU, US, India, Saudi Arabia and Singapore

    Directory of Open Access Journals (Sweden)

    Lokesh M.S

    2015-03-01

    Full Text Available The present research endeavors to shed light onto the role that post approval change management in overcoming non-compliance. The present study has focused on identifying the existing policies and procedure in this area and understanding the underlying concepts for post approval compliance for licenses pertaining to marketing authorization. The study compared and contrasted policies and procedures of regulatory authorities in India, US, EU, Saudi Arabia and Singapore. The major finding of the study indicates that though change management plays a crucial role in the lifecycle of a pharmaceutical. However, lack of defined framework coupled with lack of comprehension of the same has increased the cost of compliance resulting step-motherly treatment being mitigated towards compliance and license maintenance. The initiatives by the ICH with drafting of ICH Q12 guidelines is a welcome step forward and may help the pharmaceutical industry to comply with the regulations.

  12. Optimal Utilization of Microgrids Supplemented with Battery Energy Storage Systems in Grid Support Applications

    DEFF Research Database (Denmark)

    Anvari-Moghaddam, Amjad; Dragicevic, Tomislav; Vasquez, Juan Carlos;

    2015-01-01

    This paper proposes a control scheme which minimizes the operating cost of a grid connected micro-grid supplemented by battery energy storage system (BESS). What distinguishes approach presented here from conventional strategies is that not only the price of electricity is considered in the...

  13. Supplementation in the Columbia Basin : Summary Report Series : Final Report.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1992-12-01

    of Supplementation Project (RASP) was initiated as a result of a request by NPPC to address long-standing concerns about the need to coordinate supplementation research, monitoring and evaluation. Such coordination was also recommended by the Supplementation Technical Work Group. In August 1990, the NPPC gave conditional approval to proceed with the final design of the Yakima Production Project. The Council called on the Bonneville Power Administration (BPA) to fund immediately a supplementation assessment to reevaluate, prioritize and coordinate all existing and planned supplementation monitoring and evaluation activities in the basin. Providing for the participation of the fishery agencies and tribes and others having expertise in this area. RASP addresses four principal objectives: (1) provide an overview of ongoing and planned supplementation activities and identify critical uncertainties associated with supplementation, (2) construct a conceptual framework and model which estimates the potential benefits and risks of supplementation and prioritizes uncertainties, (3) provide guidelines for the development of supplementation projects, (4) develop a plan for regional coordination of research and monitoring. These objectives, once attained, will provide the technical tools fishery managers need to carry out the Council's direction to protect and enhance salmon and steelhead. RASP has further divided the four broad objectives into 12 technical topics: (1) definition of supplementation; (2) description of the diversity of supplementation projects; (3) objectives and performance standards; (4) identification of uncertainties; (5) supplementation theory; (6) development of a conceptual model of supplemented populations; (7) development of spreadsheet model of risks and benefits of supplementation; (8) classification of stocks, streams, and supplementation strategies; (9) regional design of supplementation evaluation and monitoring; (10) guidelines for planning

  14. Application for Approval : White Rose Canada-Newfoundland Benefits Plan and White Rose Development Plan : Decision 2001.01

    International Nuclear Information System (INIS)

    The White Rose offshore oil development project is located in the Jeanne d'Arc Basin 350 km east of Newfoundland. It is a co-venture between Husky Oil Operations Ltd. and Petro-Canada. The project is expected to recover 230 million barrels of oil over a 12 year period. This report explains the decision of the Canada-Newfoundland Offshore Petroleum Board regarding the application by Husky Oil and its partner for approval of its plans for the development of the White Rose oil field. The White Rose Development Plan describes the proponent's interpretation of the geology and reservoir characteristics of the oil field and provides estimates of hydrocarbon reserves. The drilling approach that the proponents plan to use at their facilities were also described along with the environmental parameters of the facilities. The Board's responsibility is to ensure that hydrocarbons are produced in accordance with good oil field practice including efficient recovery, prevention of waste and safe operational practices. The White Rose Canada-Newfoundland Benefits Plan addresses issues in the areas that will benefit the province, including: an East Coast Regional Office in St. John's, Newfoundland; employment; research and development; goods and services; disadvantaged individuals and groups; and monitoring and reporting. In terms of protection of the environment, the Board makes its assessment under the guidance of the Canadian Environmental Assessment Act which deals with issues such as the effects of routine releases of greenhouse gas emissions, drilling discharges, production discharges and accidental discharges. It also sets rules for decommissioning and abandonment of floating production, storage and off loading vessels and underwater facilities. The Board considered the application and has decided to approve the Benefits Plan, subject to certain conditions described in this report. tabs., figs., appendices

  15. 8 CFR 1208.14 - Approval, denial, referral, or dismissal of application.

    Science.gov (United States)

    2010-01-01

    ...) Alien in valid status. In the case of an applicant who is maintaining valid immigrant, nonimmigrant, or... is granted adjustment of status to lawful permanent resident, the Service may provide written...

  16. 8 CFR 208.14 - Approval, denial, referral, or dismissal of application.

    Science.gov (United States)

    2010-01-01

    ... status. In the case of an applicant who is maintaining valid immigrant, nonimmigrant, or Temporary... is granted adjustment of status to lawful permanent resident, the Service may provide written...

  17. Approved Applications for Permit to Drill - Not Drilled: As of Sept. 30, 2011

    Data.gov (United States)

    Bureau of Land Management, Department of the Interior — This table contains the total number of applications for permit to drill (APDs) by state that had not been drilled as of Sept. 30, 2011. Oil and gas operators may...

  18. Approval condition in application of bentonite grouting to the radioactive waste disposal

    International Nuclear Information System (INIS)

    The purpose of this study is to understand the flow properties and the permeability of bentonite grout added NaCl by the laboratory tests, and to clarify the approval condition of bentonite as materials. The viscosity of the bentonite suspension was measured under the weight ratio of water and bentonite (W/B) is 6 to 20. The suspension of which W/B is smaller than 10 is difficult to inject into the rock joints, because the viscosity is higher than the thickest cement milk on dam grouting. When the necessary permeability of the clay grout is assumed to be 10-7 (cm/sec), the W/B becomes 10 or less. Then, when we add NaCl to the suspension of which W/B is 6, the viscosity decreases as the amount of NaCl increases. The injectable viscosity is achieved by adding NaCl as the proportion of water to NaCl is 1 to 40. Next, the permeability of the bentonite suspension that added NaCl was examined by the falling head permeability test. It was found that the initial permeability 10-6 (cm/sec) decreased to 10-8∼10-9 (cm/sec) by the test of the sample of 'B:W:NaCl=20:20:1' for 10 days. From these results, the suspension to inject into the rock joints can be made by adding NaCl. And it was clarified that the groundwater permeation to the suspension causes the decrease of the permeability. In addition, the bentonite is swelling according to the infiltration of underground water, the persistence in the suppression effect of diffusion and stability to erosion can be expected. (author)

  19. Possibilities of the application of supplemental and nonconventional methods in prevention and health care in calves

    OpenAIRE

    KONRÁDOVÁ, Petra

    2008-01-01

    Diarrhoeas in calves pose one of the most serious risks of calf management and cause economic losses. This is the reason why the objective of this paper was to evaluate in operation conditions the effect of selected dietary supplements on the frequency of diarrhoea occurrence in calves in the first stages of the period after weaning for milk nutrition. An agricultural enterprise where the workers were willing to cooperate and provide the biological material was selected: ZEFA Volary. In 2005 ...

  20. Optimal Utilization of Microgrids Supplemented with Battery Energy Storage Systems in Grid Support Applications

    OpenAIRE

    Anvari-Moghaddam, Amjad; Dragicevic, Tomislav; Vasquez, Juan Carlos; Josep M. Guerrero

    2015-01-01

    This paper proposes a control scheme which minimizes the operating cost of a grid connected micro-grid supplemented by battery energy storage system (BESS). What distinguishes approach presented here from conventional strategies is that not only the price of electricity is considered in the formulation of the total operating cost but an additional item that takes into account inevitable battery degradation. The speed of degradation depends on battery technology and its mission profile and thi...

  1. Taurine supplementation in spontaneously hypertensive rats: Advantages and limitations for human applications

    OpenAIRE

    Suwanich, Atchariya; Wyss, J. Michael; Roysommuti, Sanya

    2013-01-01

    Taurine (2-aminoethanesulfonic acid) is a β-amino acid found in many tissues particularly brain, myocardium, and kidney. It plays several physiological roles including cardiac contraction, antioxidation, and blunting of hypertension. Though several lines of evidence indicate that dietary taurine can reduce hypertension in humans and in animal models, evidence that taurine supplementation reduces hypertension in humans has not been conclusive. One reason for the inconclusive nature of past stu...

  2. Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Status list as of 12 September 2000. Signature, ratification, acceptance, approval or accession

    International Nuclear Information System (INIS)

    The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 12 September 2000. The Joint Protocol entered into force on 27 April 1992

  3. 76 FR 52658 - State Program Requirements; Approval of Application for Program Revision to the National...

    Science.gov (United States)

    2011-08-23

    ... program application was described in the Federal Register (73 FR 34746) published on June 18, 2008. The... was described in the Federal Register (76 FR 28027) published on May 13, 2011. Notice of the program... to the Alaska Department of Environmental Conservation (ADEC) in four phases. Phases I-III have...

  4. 78 FR 78716 - Withdrawal of Approval of New Animal Drug Applications; Roxarsone

    Science.gov (United States)

    2013-12-27

    ... CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519... of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with Sec... applications. Dated: December 20, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine....

  5. 77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

    Science.gov (United States)

    2012-10-03

    ..., 2012. FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary Medicine (HFV-212), Food... Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with... applications. Dated: September 27, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine....

  6. 10 CFR 70.23 - Requirements for the approval of applications.

    Science.gov (United States)

    2010-01-01

    ... uranium hexafluoride, uranium enrichment facility construction and operation, or any other activity which... recovery, conversion of uranium hexafluoride, or involves the use of special nuclear material in a uranium... use of special nuclear material in a uranium enrichment facility, the applicable provisions of...

  7. Importance and Applicability of Approved Clinical Instructor Standards and Criteria to Certified Athletic Trainers in Different Clinical Education Settings

    OpenAIRE

    Weidner, Thomas G.; Henning, Jolene M.

    2005-01-01

    Context: For optimal clinical education of athletic training students, Clinical Instructor Educators and program directors need to proactively select, train, and evaluate their Approved Clinical Instructors (ACIs).

  8. 77 FR 31429 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2012-05-25

    ... approval of the proposed discontinuance of an automatic block signal (ABS) system and a traffic control... Railroad Signal System In accordance with Part 235 of Title 49 Code of Federal Regulations (CFR) and 49 U.S...) seeking approval for the discontinuance or modification of a signal system. FRA assigned the...

  9. National emission standards for hazardous air pollutants application for approval to stabilize the 105N Basin

    International Nuclear Information System (INIS)

    The 105N Basin (basin) Stabilization will place the basin in a radiologically and environmentally safe condition so that it can be decommissioned at a later date. The basin stabilization objectives are to inspect for Special Nuclear Material (SNM) (i.e., fuel assemblies and fuel pieces), remove the water from the basin and associated pits, and stabilize the basin surface. The stabilization will involve removal of basin hardware, removal of basin sediments, draining of basin water, and cleaning and stabilizing basin surfaces-to prevent resuspension of radioactive emissions to the air. These activities will be conducted in accordance with all applicable regulations. The basin is in the 105N Building, which is located in the 100N Area. The 100N Area is located in the Northern portion of the Hanford Site approximately 35 miles northwest of the city of Richland, Washington. The basin is a reinforced unlined concrete structure 150 feet long, 50 feet wide, and 24 feet deep. The basin is segregated into seven areas sharing a common pool of water; the Discharge/Viewing (''D'') Pit, the fuel segregation pit (including a water tunnel that connects the ''D'' pit and segregation pit), two storage basins designated as North Basin and South Basin, two cask load-out pits, and a fuel examination area. The North Basin floor is entirely covered and the South Basin is partly covered by a modular array of cubicles formed by boron concrete posts and boron concrete panels

  10. Prevention of significant deterioration application for approval to construct SP-100 Ground Engineering System Test Site

    Energy Technology Data Exchange (ETDEWEB)

    1990-04-01

    The following application is being submitted by the US Department of Energy, Richland Operations Office, P.O. Box 550, Richland, Washington 99352, pursuant to WAC 173-403-080, and in compliance with the Department of Ecology Guide to Processing a Prevention of Significant Deterioration (PSD) Permit'' for a new source of airborne radionuclide emissions at the Hanford Site in Washington State. The new source, the SP-100 Ground Engineering System (GES) Test Site, will be located in the 309 Building of the 300 Area. The US Department of Energy (DOE), the National Aeronautics and Space Administration (NASA), and the US Department of Defense (DOD) have entered into an agreement to jointly develop space nuclear reactor power system technology. The DOE has primary responsibility for developing and ground testing the nuclear subsystem. A ground test of a reactor is necessary to demonstrate technology readiness of this major subsystem before proceeding with the flight system development and demonstration. The SP-100 GES Test Site will provide a location for the operation and testing of a prototype space-based, liquid metal-cooled, fast flux nuclear reactor in an environment closely simulating the vacuum and temperature conditions of space operations. The purpose of the GES is to develop safe, compact, light-weight and durable space reactor power system technology. This technology will be used to provide electric power, in the range of tens to hundreds of kilowatts, for a variety of potential future civilian and military space missions requiring long-term, high-power level sources of energy. 20 refs., 8 figs., 7 tabs.

  11. Current guidelines applicable for the approval of topically applied dermatological drugs in the EU.

    Science.gov (United States)

    Straube, Myrjam Dorothea; Zesch, Achim

    2004-10-01

    Dermatologicals as well as other medicinal products are submitted to the rules governing medicinal products in the European Union (EU) (Directive 2001/83/EC). With appreciation of the EU enlargement those regulatories deserve a recent consideration with special regard to the peculiarities of external dermatological therapy, recently passed novel and future guidelines. As regards the criteria for authorization of a medicinal product it is set out in Regulation (EEC) 2309/93 Article 11(1) that a marketing authorization shall be refused if it appears that the quality, the safety or efficacy of the medicinal product have not been adequately or sufficiently demonstrated by the applicant. Article 26(1) of Council Directive 2001/83/EC is worded a little differently but the criteria are the same irrespective of the procedure for the marketing authorization. For the final evaluation of the benefit/risk profile of a topically applied dermatological medicinal product not only the active agent but the whole galenic formulation as well has to be taken into account as the extent of penetration of the active compound might be influenced by changing the non-active substances. Furthermore the vehicle itself - independent of the active agent - influence the dermatological disorder, often in dependence on the stage of the dermatopathy. With special concern to safety/tolerability the (photo)toxic and (photo)allergic potential of the dermatological drug have to be taken into consideration too. In case of total body therapy in children the differing percutaneous resorption due to another body surface/body weight relation deserves special concern. The following review gives a survey of the current most important EU-guidelines for the evaluation of the benefit/risk profile of topically applied dermatological medicinal drugs and an outlook on further developments. As systemically applied dermatological medicinal products are assessed like other systemically applied drugs they are not

  12. State waste discharge permit application for the 200 Area Effluent Treatment Facility and the State-Approved Land Disposal Site

    Energy Technology Data Exchange (ETDEWEB)

    1993-08-01

    Application is being made for a permit pursuant to Chapter 173--216 of the Washington Administrative Code (WAC), to discharge treated waste water and cooling tower blowdown from the 200 Area Effluent Treatment Facility (ETF) to land at the State-Approved Land Disposal Site (SALDS). The ETF is located in the 200 East Area and the SALDS is located north of the 200 West Area. The ETF is an industrial waste water treatment plant that will initially receive waste water from the following two sources, both located in the 200 Area on the Hanford Site: (1) the Liquid Effluent Retention Facility (LERF) and (2) the 242-A Evaporator. The waste water discharged from these two facilities is process condensate (PC), a by-product of the concentration of waste from DSTs that is performed in the 242-A Evaporator. Because the ETF is designed as a flexible treatment system, other aqueous waste streams generated at the Hanford Site may be considered for treatment at the ETF. The origin of the waste currently contained in the DSTs is explained in Section 2.0. An overview of the concentration of these waste in the 242-A Evaporator is provided in Section 3.0. Section 4.0 describes the LERF, a storage facility for process condensate. Attachment A responds to Section B of the permit application and provides an overview of the processes that generated the wastes, storage of the wastes in double-shell tanks (DST), preliminary treatment in the 242-A Evaporator, and storage at the LERF. Attachment B addresses waste water treatment at the ETF (under construction) and the addition of cooling tower blowdown to the treated waste water prior to disposal at SALDS. Attachment C describes treated waste water disposal at the proposed SALDS.

  13. State waste discharge permit application for the 200 Area Effluent Treatment Facility and the State-Approved Land Disposal Site

    International Nuclear Information System (INIS)

    Application is being made for a permit pursuant to Chapter 173--216 of the Washington Administrative Code (WAC), to discharge treated waste water and cooling tower blowdown from the 200 Area Effluent Treatment Facility (ETF) to land at the State-Approved Land Disposal Site (SALDS). The ETF is located in the 200 East Area and the SALDS is located north of the 200 West Area. The ETF is an industrial waste water treatment plant that will initially receive waste water from the following two sources, both located in the 200 Area on the Hanford Site: (1) the Liquid Effluent Retention Facility (LERF) and (2) the 242-A Evaporator. The waste water discharged from these two facilities is process condensate (PC), a by-product of the concentration of waste from DSTs that is performed in the 242-A Evaporator. Because the ETF is designed as a flexible treatment system, other aqueous waste streams generated at the Hanford Site may be considered for treatment at the ETF. The origin of the waste currently contained in the DSTs is explained in Section 2.0. An overview of the concentration of these waste in the 242-A Evaporator is provided in Section 3.0. Section 4.0 describes the LERF, a storage facility for process condensate. Attachment A responds to Section B of the permit application and provides an overview of the processes that generated the wastes, storage of the wastes in double-shell tanks (DST), preliminary treatment in the 242-A Evaporator, and storage at the LERF. Attachment B addresses waste water treatment at the ETF (under construction) and the addition of cooling tower blowdown to the treated waste water prior to disposal at SALDS. Attachment C describes treated waste water disposal at the proposed SALDS

  14. Calcium supplements

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/article/007477.htm Calcium supplements To use the sharing features on this page, please enable JavaScript. WHO SHOULD TAKE CALCIUM SUPPLEMENTS? Calcium is an important mineral for the ...

  15. 78 FR 65573 - Migratory Bird Hunting; Application for Approval of Copper-Clad Iron Shot and Fluoropolymer Shot...

    Science.gov (United States)

    2013-11-01

    ...We, the U.S. Fish and Wildlife Service, approve copper-clad iron shot and fluoropolymer coatings for hunting waterfowl and coots. We published a proposed rule for approval of copper-clad iron shot and fluoropolymer coatings in the Federal Register on September 26, 2012 (77 FR 59158). We considered comments on the proposed rule, and we believe that neither the shot nor the coatings will pose......

  16. Sports Supplements

    Science.gov (United States)

    ... sports supplements often use persuasive before and after pictures that make it look easy to get a muscular, toned body. But the goal of supplement advertisers is to make money by selling more supplements, and many claims may be misleading. Teens and kids may seem like an easy sell ...

  17. Methoprene application and diet protein supplementation to male melon fly, Bactrocera cucurbitae, modifies female remating behavior

    OpenAIRE

    ul Haq, Ihsan; Vreysen, Marc J. B.; Teal, P. E. A.; Hendrichs, Jorge

    2013-01-01

    Methoprene (an analogue of juvenile hormone) application and feeding on a protein diet is known to enhance male melon fly, Bactrocera cucurbitae Coquillett (Diptera: Tephritidae), mating success. In this study, we investigated the effect of these treatments on male B. cucurbitae's ability to inhibit female remating. While 14-d-old females were fed on protein diet, 6-d-old males were exposed to one of the following treatments: (i) topical application of methoprene and fed on a protein diet; (i...

  18. 18 CFR 1304.7 - Conditions of approvals.

    Science.gov (United States)

    2010-04-01

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

  19. 15 CFR Supplement No. 2 to Part 748 - Unique Application and Submission Requirements

    Science.gov (United States)

    2010-01-01

    ....S. naval nuclear propulsion plants. I (We) further certify that I (we) will furnish to the Bureau of... obtained. (ii) Maritime nuclear propulsion plants and related items. If you are submitting a license application to export or reexport technology relating to maritime nuclear propulsion plants and related...

  20. Brodalumab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-09-01

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

  1. 77 FR 24723 - AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

    Science.gov (United States)

    2012-04-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a... IRESSA (gefitinib) Tablets held by AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike,...

  2. 77 FR 40367 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules

    Science.gov (United States)

    2012-07-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New... DURACT (bromfenac sodium) Capsules, held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box...

  3. 21 CFR 314.54 - Procedure for submission of an application requiring investigations for approval of a new...

    Science.gov (United States)

    2010-04-01

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

  4. 77 FR 9296 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2012-02-16

    ... 112. The reason given is that the ABS system is not needed for efficient and safe operation of trains... Railroad Signal System In accordance with Part 235 of Title 49 of the Code of Federal Regulations (CFR) and... approval for the discontinuance or modification of a signal system. FRA assigned the petition Docket...

  5. 76 FR 21943 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2011-04-19

    ...) seeks approval of the proposed discontinuance and removal of the automatic block signal system (ABS) on... Railroad Signal System Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and 49 U.S.C. 20502... for the discontinuance or modification of the signal system, as detailed below. Docket Number...

  6. 76 FR 27170 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2011-05-10

    ... Railroad Signal System In accordance with part 235 of title 49 of the Code of Federal Regulations (CFR) and... approval for the discontinuance or modification of a signal system. FRA assigned the petition Docket Number... track 1. The Method of Operation on the running track, currently ABS-261 and CPS-261, will become...

  7. 75 FR 76069 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2010-12-07

    ... modification of the signal system on the Fitchburg Commuter Rail Line from milepost (MP) 1.4 Swift Interlocking... Discontinuance or Modification of a Railroad Signal System Pursuant to Title 49 Code of Federal Regulations (CFR... Administration (FRA) seeking approval for the discontinuance or modification of the signal system as...

  8. Glutamine supplementation

    OpenAIRE

    Wernerman, Jan

    2011-01-01

    Intravenous glutamine supplementation is standard care when parenteral nutrition is given for critical illness. There are data of a reduced mortality when glutamine supplementation is given. In addition, standard commercial products for parenteral nutrition do not contain any glutamine due to glutamine instability in aqueous solutions. For the majority of critical ill patients who are fed enterally, the available evidence is insufficient to recommend glutamine supplementation. Standard formul...

  9. Applicant's guide related to applications for shipment approval and certificate of package design or radioactive materials for civil usage transported by public roads, by water or by railroad. Guide No. 7, Index 0, version of 07/04/2009

    International Nuclear Information System (INIS)

    This guide introduces the French Nuclear Safety Authority's (ASN) recommendations to applicants in order to facilitate the case investigation of applications for shipment approval and certificates related to the transport of radioactive materials. It also specifies the modalities for the submission of safety reports to the Authority and to the French Institute for Radiation protection and Nuclear Safety (IRSN), the structure of the reports, the contents of the draft approval certificate, the minimum processing durations, the experience feedback from previous assessment and the provisions applicable in case of a package design or material change. This guide therefore applies to the package design or radioactive materials for which an ASN approval is required. It concerns the designs used for: - radioactive materials in a special form; - low dispersible radioactive materials; - packages containing 0.1 kg or more of uranium hexafluoride; - all packages containing fissile materials; - type B(U) packages and type B(M) packages; - type C packages. This guide also applies to shipments of radioactive materials and to features added to the package design for which an ASN approval is required by the regulations for the safe transport of dangerous goods

  10. Supplemental Colleges

    Data.gov (United States)

    Department of Homeland Security — The Supplemental Colleges layer attempts to capture additional Post Secondary Education campuses of colleges and universities associated with a single campus listed...

  11. Position paper on the applicability of supplemental standards to the uppermost aquifer at the Uranium Mill Tailings Vitro Processing Site, Salt Lake City, Utah

    International Nuclear Information System (INIS)

    This report documents the results of the evaluation of the potential applicability of supplemental standards to the uppermost aquifer underlying the Uranium Mill Tailings Remedial Action (UMTRA) Project, Vitro Processing Site, Salt Lake City, Utah. There are two goals for this evaluation: provide the landowner with information to make an early qualitative decision on the possible use of the Vitro property, and evaluate the proposed application of supplemental standards as the ground water compliance strategy at the site. Justification of supplemental standards is based on the contention that the uppermost aquifer is of limited use due to wide-spread ambient contamination not related to the previous site processing activities. In support of the above, this report discusses the site conceptual model for the uppermost aquifer and related hydrogeological systems and establishes regional and local background water quality. This information is used to determine the extent of site-related and ambient contamination. A risk-based evaluation of the contaminants' effects on current and projected land uses is also provided. Reports of regional and local studies and U.S. Department of Energy (DOE) site investigations provided the basis for the conceptual model and established background ground water quality. In addition, a limited field effort (4 through 28 March 1996) was conducted to supplement existing data, particularly addressing the extent of contamination in the northwestern portion of the Vitro site and site background ground water quality. Results of the field investigation were particularly useful in refining the conceptual site model. This was important in light of the varied ground water quality within the uppermost aquifer. Finally, this report provides a critical evaluation, along with the related uncertainties, of the applicability of supplemental standards to the uppermost aquifer at the Salt Lake City Vitro processing site

  12. Methoprene application and diet protein supplementation to male melon fly, Bactrocera cucurbitae, modifies female remating behavior.

    Science.gov (United States)

    Ul Haq, Ihsan; Vreysen, Marc J B; Teal, P E A; Hendrichs, Jorge

    2014-10-01

    Methoprene (an analogue of juvenile hormone) application and feeding on a protein diet is known to enhance male melon fly, Bactrocera cucurbitae Coquillett (Diptera: Tephritidae), mating success. In this study, we investigated the effect of these treatments on male B. cucurbitae's ability to inhibit female remating. While 14-d-old females were fed on protein diet, 6-d-old males were exposed to one of the following treatments: (i) topical application of methoprene and fed on a protein diet; (ii) no methoprene but fed on a protein diet; (iii) methoprene and sugar-fed only; and (iv) sugar-fed, 14-d-old males acted as controls. Treatments had no effect on a male's ability to depress the female remating receptivity in comparison to the control. Females mated with protein-deprived males showed higher remating receptivity than females first mated with protein-fed males. Methoprene and protein diet interaction had a positive effect on male mating success during the first and second mating of females. Significantly more females first mated with sugar-fed males remated with protein-fed males and females first mated with methoprene treated and protein-fed males were more likely to remate with similarly treated males. Females mating latency (time to start mating) was significantly shorter with protein-fed males, and mating duration was significantly longer with protein-fed males compared with protein-deprived males. These results are discussed in the context of methoprene and/or dietary protein as prerelease treatment of sterile males in area-wide control of melon fly integrating the sterile insect technique (SIT). PMID:24376160

  13. Methoprene application and diet protein supplementation to male melon fly, Bactrocera cucurbitae, modifies female remating behavior

    Science.gov (United States)

    ul Haq, Ihsan; Vreysen, Marc J B; Teal, P E A; Hendrichs, Jorge

    2014-01-01

    Methoprene (an analogue of juvenile hormone) application and feeding on a protein diet is known to enhance male melon fly, Bactrocera cucurbitae Coquillett (Diptera: Tephritidae), mating success. In this study, we investigated the effect of these treatments on male B. cucurbitae's ability to inhibit female remating. While 14-d-old females were fed on protein diet, 6-d-old males were exposed to one of the following treatments: (i) topical application of methoprene and fed on a protein diet; (ii) no methoprene but fed on a protein diet; (iii) methoprene and sugar-fed only; and (iv) sugar-fed, 14-d-old males acted as controls. Treatments had no effect on a male's ability to depress the female remating receptivity in comparison to the control. Females mated with protein-deprived males showed higher remating receptivity than females first mated with protein-fed males. Methoprene and protein diet interaction had a positive effect on male mating success during the first and second mating of females. Significantly more females first mated with sugar-fed males remated with protein-fed males and females first mated with methoprene treated and protein-fed males were more likely to remate with similarly treated males. Females mating latency (time to start mating) was significantly shorter with protein-fed males, and mating duration was significantly longer with protein-fed males compared with protein-deprived males. These results are discussed in the context of methoprene and/or dietary protein as prerelease treatment of sterile males in area-wide control of melon fly integrating the sterile insect technique (SIT). PMID:24376160

  14. TECHNICAL COMPARISON OF CANDIDATE ION EXCHANGE MEDIA FOR SMALL COLUMN ION EXCHANGE (SCIX) APPLICATIONS IN SUPPORT OF SUPPLEMENTAL LAW PRETREATMENT

    International Nuclear Information System (INIS)

    At-tank supplemental pretreatment including both filtration and small column ion exchange is currently under evaluation to facilitate salt waste retrieval and processing in the Hanford tank farms. Spherical resorcinol formaldehyde (sRF) resin is the baseline ion exchange resin for use in the Waste Treatment and Immobilization Plant (WTP). This document provides background and technical rationale to assist in determining whether spherical resorcinol formaldehyde (sRF) is also the appropriate ion exchange resin for supplemental LAW pretreatment processes and compares sRF with crystalline silicotitanate (CST) as potential supplemental pretreatment ion exchange media.

  15. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2004-01-01

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

  16. Dietary supplements in sport.

    Science.gov (United States)

    Burke, L M; Read, R S

    1993-01-01

    Studies of the dietary practices of athletes report that nutritional supplements are commonly used. Supplementation practices vary between sports and individual athletes; however, there is evidence that at least some athletes use a large number of supplements concurrently, often in doses that are very high in comparison with normal dietary intakes. In exploring supplementation practices we propose a classification system separating the supplements into dietary supplements and nutritional erogogenic aids. The dietary supplement is characterised as a product which can be used to address physiological or nutritional issues arising in sport. It may provide a convenient or practical means of consuming special nutrient requirements for exercise, or it may be used to prevent/reverse nutritional deficiencies that commonly occur among athletes. The basis of the dietary supplement is an understanding of nutritional requirements and physiological effects of exercise. When the supplement is used to successfully meet a physiological/nutritional goal arising in sport it may be demonstrated to improve sports performance. While there is some interest in refining the composition or formulation of some dietary supplements, the real interest belongs to the use or application of the supplement; i.e. educating athletes to understand and achieve their nutritional needs in a specific sports situation. The sports drink (carbohydrate-electrolyte replacement drink) is a well known example of a dietary supplement. Scientific attitudes towards the sports drink have changed over the past 20 years. Initial caution that carbohydrate-electrolyte fluids compromise gastric emptying during exercise has now been shown to be unjustified. Numerous studies have shown that 5 to 10% solutions of glucose, glucose polymers (maltodextrins) and other simple sugars all have suitable gastric emptying characteristics for the delivery of fluid and moderate amounts of carbohydrate substrate. The optimal

  17. Decision 99-7 : Application by Suncor Energy Inc. for amendment of approval no. 8101 for the proposed Project Millennium development

    International Nuclear Information System (INIS)

    The Alberta Energy and Utilities Board considered an application by Shell Canada Limited to amend Approval 8101 in respect of its existing oil sand mine and processing facilities in the Fort McMurray area. The proposed Project Millennium would be located at the site of the existing Suncor operation north of Fort McMurray and would consist of an expansion to the mining area and the addition of new processing units. The development would increase the production capacity to a minimum level of 12,185,000 cubic metres per year of crude oil products by 2002, and would allow the continuation of Suncor's operations until the year 2033. Suncor also submitted an environmental impact assessment report for review by the Board. Suncor advised the Board that an early decision was critical to avoid costly delays due to winter construction and also to enable Suncor to target the U.S. market before competition from Venezuela. After considering all of the evidence, the Board expressed itself satisfied with the application, and is prepared to issue the required approval

  18. Supplemental Oxygen

    Science.gov (United States)

    ... Disease Lookup > COPD > Diagnosing and Treating COPD Supplemental Oxygen Sometimes with chronic obstructive pulmonary disease (COPD), lung ... in people with severe lung disease Three Ways Oxygen Therapy Is Supplied Compressed oxygen gas and liquid ...

  19. Dietary Supplements

    Science.gov (United States)

    ... are not intended to treat, diagnose, prevent, or cure diseases. Do not take supplements instead of your ... Partners Women's Health Topics Mammography Women and Diabetes HPV, HIV, Birth Control Heart Health for Women Pregnancy ...

  20. Nepali Supplements.

    Science.gov (United States)

    Peace Corps, Washington, DC.

    This volume is intended as a supplement to Nepali language instruction. It contains songs, numerals, dialogues in Devanagari script, a Nepali-English, English-Nepali glossary, and an English-Nepali surveyor technical glossary. (AM)

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

    International Nuclear Information System (INIS)

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

  2. 7 CFR 959.123 - Approval.

    Science.gov (United States)

    2010-01-01

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

  3. Applicability of 100 TBq cesium 137 release into environment as a safety criterion for consequence assessment at reactor design approval stage

    International Nuclear Information System (INIS)

    The International Atomic Energy Agency (IAEA) fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation. Therefore, a severe accident consequence assessment has to be able to include all quantifiable consequences on people and the environment. Our previous studies on estimation of cost per severe accident succeeded in quantifying aforementioned consequences. However, the estimation requires enormous quantity of data, time and human resources, thus it may be inappropriate at the reactor design approval stage. Finnish government uses “100 TBq cesium 137 release into environment”, which was proved to generate limited health effects, as one of the reactor design criteria for accident consequences. In this study, we perform an evaluation of annual dose from the 100 TBq cesium 137 release and confirm limited health effects. We form the environmental impact index based on insights from our previous studies and used it to assess consequences to the environment. The estimated environmental impact index is very small, which confirms the limitedness of the environmental impacts of the release. These findings ensure the applicability of 100 TBq cesium 137 release into environment as a safety criterion for consequence assessment at reactor design approval stage. (author)

  4. Drugs Approved for Leukemia

    Science.gov (United States)

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

  5. Application of Orbitrap-mass spectrometry to differentiate isomeric sildenafil- and thiosildenafil-like analogues used for the adulteration of dietary supplements.

    Science.gov (United States)

    Kee, Chee-Leong; Ge, Xiaowei; Low, Min-Yong

    2015-01-01

    Two groups of isomeric phosphodiestrase-type 5 inhibitors (PDE-5), consisting of four sildenafil- and three thiosildenafil-like analogues, have been successfully differentiated using high-resolution MS/MS. The optimised MS/MS data obtained from each compound were used to build a database with the aid of mass processing software. Isomeric compounds with very close chromatographic separation like dimethylsildenafil and homosildenafil could be distinguished by their unique fingerprint fragment ions in the MS/MS database. All fragment ions were within the mass tolerance of 5 ppm. One case study using an adulterated dietary supplement is included to provide more insights into this application. PMID:26179419

  6. Glutamine supplementation.

    Science.gov (United States)

    Wernerman, Jan

    2011-01-01

    Intravenous glutamine supplementation is standard care when parenteral nutrition is given for critical illness. There are data of a reduced mortality when glutamine supplementation is given. In addition, standard commercial products for parenteral nutrition do not contain any glutamine due to glutamine instability in aqueous solutions. For the majority of critical ill patients who are fed enterally, the available evidence is insufficient to recommend glutamine supplementation. Standard formulation of enteral nutrition contains some glutamine: 2-4 g/L. However, this dose is insufficient to normalize glutamine plasma concentration.Plasma concentration of glutamine is low in many patients with critical illness and a low level is an independent risk factor for mortality. A low plasma glutamine concentration is the best indicator of glutamine depletion. Data are emerging about how the endogenous production of glutamine is regulated. We know that skeletal muscle is the major producer of glutamine and that a part of the profound depletion of skeletal muscle seen in critical illness is a reflection of the need to produce glutamine.Glutamine is utilized in rapidly dividing cells in the splanchnic area. Quantitatively most glutamine is oxidized, but the availability of glutamine in surplus is important for the de novo synthesis of nucleotides and necessary for cell division and protein synthesis. More knowledge about the regulation of the endogenous production of glutamine is needed to outline better guidelines for glutamine supplementation in the future. PMID:21906372

  7. 78 FR 47822 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2013-08-06

    ...-2013-0076. Applicant: Port of Los Angeles, Mr. Ron Groves, PE, Senior Civil Engineer, Engineering... published on April 11, 2000 (65 FR 19477). Robert C. Lauby, Deputy Associate Administrator for...

  8. Characterization of the Industrial Residues of Seven Fruits and Prospection of Their Potential Application as Food Supplements

    Directory of Open Access Journals (Sweden)

    Soraya de Oliveira Sancho

    2015-01-01

    Full Text Available Seven residues from tropical fruit (acerola, cashew apple, guava, mango, papaya, pineapple, and sapota processing were prospected for physicochemical parameters (pH, total soluble solids, water activity, reducing sugar, acidity, protein, moisture, ash, and lipids, functional compounds (total phenolic content, anthocyanins, ascorbic acid, and free radical scavenging activity—DPPH, fatty acid profile, and mineral content. Prospection of these industrial residues aimed its use as potential sources for food supplementation. Acerola residue was found to be a valuable source of anthocyanins, phenolics, and vitamin C; cashew apple residue could be a source of unsaturated fatty acids; pineapple and papaya residues could be used, respectively, as manganese and phosphorous source.

  9. BioTapestry now provides a web application and improved drawing and layout tools [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Suzanne M. Paquette

    2016-01-01

    Full Text Available Gene regulatory networks (GRNs control embryonic development, and to understand this process in depth, researchers need to have a detailed understanding of both the network architecture and its dynamic evolution over time and space. Interactive visualization tools better enable researchers to conceptualize, understand, and share GRN models. BioTapestry is an established application designed to fill this role, and recent enhancements released in Versions 6 and 7 have targeted two major facets of the program. First, we introduced significant improvements for network drawing and automatic layout that have now made it much easier for the user to create larger, more organized network drawings. Second, we revised the program architecture so it could continue to support the current Java desktop Editor program, while introducing a new BioTapestry GRN Viewer that runs as a JavaScript web application in a browser. We have deployed a number of GRN models using this new web application. These improvements will ensure that BioTapestry remains viable as a research tool in the face of the continuing evolution of web technologies, and as our understanding of GRN models grows.

  10. 7 CFR 948.123 - Approval.

    Science.gov (United States)

    2010-01-01

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

  11. 77 FR 6560 - Pesticide Product Registration Approval

    Science.gov (United States)

    2012-02-08

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

  12. 46 CFR 249.7 - Approval.

    Science.gov (United States)

    2010-10-01

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

  13. Nutritional supplements

    DEFF Research Database (Denmark)

    Petersen, Gry Bjerg; Andersen, Jens Rikardt

    2015-01-01

    Background: Several studies have indicated that cancer patients have significantly altered taste sensitivity without specifying the preferences. One of the related problems is low compliance to nutritional therapy with oral nutritional supplements (ONS) in patients suffering severe weight loss....... Objective: We wanted to investigate taste preferences and sensoric characteristics among three usually used ONS in patients with malignant haematological disease during cytotoxic treatment. Design: Tested drinks were: Protin® (protein-enriched-milk, ARLA), Nutridrink® (NUTRICIA) and hospital-produced drink...

  14. Prospects of in ovo feeding and nutrient supplementation for poultry: the science and commercial applications--a review.

    Science.gov (United States)

    Kadam, Mukund M; Barekatain, Mohammad R; Bhanja, Subrat K; Iji, Paul A

    2013-12-01

    In ovo supplementation of poultry embryos was first reported several decades ago, but it is only recently that concerted research has been directed at developing the technology for this process to be routinely used by the poultry industry. Although the technology of in ovo feeding was patented more than 10 years ago, it has not been widely adopted by the poultry industry. This review examines the early development of the enteric system of the poultry embryo; defines and distinguishes between in ovo feeding and in ovo nutrient administration; highlights the importance of early feeding of the chick; and discusses the development of in ovo feeding technology and its effects on hatchability, growth, gut health and immune response of chicks. The range of possible nutrients that can be administered is also explored. The limitations associated with embryo development and nutrient metabolism are highlighted, leading to the prediction of the future role of in ovo feeding in the poultry industry. PMID:23847062

  15. Research and application of radiation degraded chitosan for poultry feed supplement to enhance efficiency in raising chickens

    International Nuclear Information System (INIS)

    Irradiated chitosan in dry flek form was carried out on the gamma Co-60 source. The obtained results showed that the molecular weight of chitosan after irradiation was decreased with the increase of absorbed dose. Chitosans were irradiated of 20-30 kGy their molecular weight was 282 kDa and 10 kDa at dose of 300 kGy. The effect of irradiated chitosan on the growth development and the survival ratio of breeding chickens in the process were also studied. Field test results showed that the chicken feed supplemented by 300 ppm chitosan with molecular weight of 282 kDa, the weight of chickens increased by 113% and survival ratio was 100% while the normal survival ratio was only 93.34%. (author)

  16. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

    With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

  17. 21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

    Science.gov (United States)

    2010-04-01

    ... this chapter, but does not include transfer of the drug product for reasons other than sale within the...) application or abbreviated new drug application under section 505(j) of the act. 314.107 Section 314.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS...

  18. Post-Approval Studies

    Data.gov (United States)

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

  19. Decisions with reasons in the matter of an application by the Consumers` Gas Company Ltd., for an order or orders approving rates to be charged for the sale, distribution, transmission and storage of gas for its 1999 fiscal year

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-03-31

    The Ontario Energy Board examined an application by Consumers` Gas Company Ltd., for an order approving the rates to be charged for the sale, distribution, transmission and storage of gas for its 1999 fiscal year. This report addressed the approvals requested by Consumers` Gas for transactions between itself and an affiliate for specific regulatory treatment of certain programs. In its original application dated January 8, 1998, Consumers` Gas proposed to separate and remove the following from the existing operations of the regulated utility: (1) its merchandise sales program, (2) its heating parts replacement plan, and (3) about half of the service operations currently provided to customers. It was proposed that these services be transferred to Consumersfirst Ltd, a non-subsidiary affiliate of Consumers` Gas. Consumers` requested that an Unbundling Business Activities Deferral Account be established to record costs incurred in the 1998 and 1999 fiscal years in relation to the transfers proposed. It also requested approval for the ratemaking implications of its proposals relating to the rental program, including approval for the recovery from ratepayers of unrecorded deferred income taxes in relation to the program. This report presents the Board`s findings with respect to each of these requests.

  20. 50 CFR 15.26 - Approval of cooperative breeding programs.

    Science.gov (United States)

    2010-10-01

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

  1. 38 CFR 17.804 - Loan approval criteria.

    Science.gov (United States)

    2010-07-01

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

  2. Set-up and application of an analytical approach for the quality control of purified colostrum as food supplement.

    Science.gov (United States)

    Altomare, Alessandra; Regazzoni, Luca; Parra, Ximena Maria Paredes; Selmin, Francesca; Rumio, Cristiano; Carini, Marina; Aldini, Giancarlo

    2016-08-15

    A validated analytical procedure is here described for the quality control of the protein fraction of purified bovine colostrum used in food supplements. The proposed procedure starts with 1D and 2D-gel electrophoresis. The sample is then separated into two fractions by protein G affinity chromatography: the IgG enriched and the IgG depleted fraction (IgG-d). A size exclusion chromatography coupled to UV is then applied to the IgG and IgG-d fractions for the quantitative analysis of IgG and IgM, respectively. The IgG-d fraction is then analysed by HPLC-MS analysis for the quantitative analysis of β-lactoglobulins and α-lactoalbumin. The next step is to quantitatively measure a set of bioactive proteins selected from the bovine colostrum data bank on the basis of their claimed health benefits. The enzymatic activities of lactoperoxidase and xanthine dehydrogenase/oxidase are then tested as an index of protein functionality. PMID:27341426

  3. Supplemental exogenous NPK application alters biochemical processes to improve yield and drought tolerance in wheat (Triticum aestivum L.).

    Science.gov (United States)

    Shabbir, Rana Nauman; Waraich, E A; Ali, H; Nawaz, F; Ashraf, M Y; Ahmad, R; Awan, M I; Ahmad, S; Irfan, M; Hussain, S; Ahmad, Z

    2016-02-01

    The recent food security issues, combined with the threats from climate change, demand future farming systems to be more precise and accurate to fulfill the ever increasing global food requirements. The role of nutrients such as nitrogen (N), phosphorous (P), and potassium (K) in stimulating plant growth and development is well established; however, little is known about their function, if applied in combination, in improving crop yields under environmental stresses like drought. The aim of this study was to evaluate the effects of combined foliar spray of supplemental NPK (NPKc) on physiological and biochemical mechanisms that enhance the drought tolerance potential of wheat for improved yield. Foliar NPKc markedly influenced the accumulation of osmoprotectants and activity of both nitrogen assimilation and antioxidant enzymes. It significantly improved the concentration of proline (66 %), total soluble sugars (37 %), and total soluble proteins (10 %) and enhanced the activity of nitrate reductase, nitrite reductase, catalase, and peroxidase by 47, 45, 19, and 8 %, respectively, with respect to no spray under water-deficit conditions which, in turn, improve the yield and yield components. The accumulation of osmolytes and activity of antioxidant machinery were more pronounced in drought tolerant (Bhakkar-02) than sensitive genotype (Shafaq-06). PMID:26432272

  4. Diabetes and Dietary Supplements

    Science.gov (United States)

    ... R S T U V W X Y Z Diabetes and Dietary Supplements: In Depth Share: On This ... health product or practice. Are dietary supplements for diabetes safe? Some dietary supplements may have side effects, ...

  5. Patients' understanding of the regulation of dietary supplements.

    Science.gov (United States)

    Ashar, Bimal H; Miller, Redonda G; Pichard, Carmen P; Levine, Rachel; Wright, Scott M

    2008-02-01

    The Dietary Supplement Health and Education Act (DSHEA) permits manufacturers to sell products without providing pre-market evidence of safety or efficacy. One fundamental reason for the passage of the DSHEA was to empower consumers to make their own choices, free from governmental restriction. Yet, little is known about the public's understanding of the supplement regulatory process. We undertook a study to assess patients' knowledge regarding governmental oversight of product marketing and advertising. A survey of 300 adult patients from the Baltimore Metropolitan area was administered after showing participants an advertisement for a dietary supplement. Patients were asked questions regarding their understanding of federal regulation of the advertised product. A total of 52% of respondents were unaware that the dietary supplement had not been approved by the government while 63% were unaware that the advertisement for that supplement had not been pre-approved. Factors associated with a lack of understanding of the product approval process included lower education level (OR 2.52; 95% CI 1.52-4.19) and non-Caucasian race (OR 1.99; 95% CI 1.17-3.36). Lower education level was also associated with confusion regarding the advertisement approval process (OR 2.60; 95% CI 1.48-4.57). Based on these results, patients seem unclear about the government's role in the regulation of dietary supplements. Educational efforts should be geared towards clarifying these issues. PMID:18080205

  6. Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

    Data.gov (United States)

    U.S. Department of Health & Human Services — A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved...

  7. Annual Statistical Supplement, 2015

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2015 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  8. Annual Statistical Supplement, 2011

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2011 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  9. Annual Statistical Supplement, 2003

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2003 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  10. Annual Statistical Supplement, 2004

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2004 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  11. Annual Statistical Supplement, 2008

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2008 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  12. Annual Statistical Supplement, 2002

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2002 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  13. Annual Statistical Supplement, 2001

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2001 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  14. Annual Statistical Supplement, 2006

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2006 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  15. Annual Statistical Supplement, 2000

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2000 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  16. Annual Statistical Supplement, 2009

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2009 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  17. Annual Statistical Supplement, 2010

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2010 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  18. Annual Statistical Supplement, 2007

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2007 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  19. Annual Statistical Supplement, 2014

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2014 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  20. Annual Statistical Supplement, 2005

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2005 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  1. Supplemental design requirements document, Project W026

    International Nuclear Information System (INIS)

    This document supplements and extends the Functional Design Criteria, SP-W026-FDC-001, for the Waste Receiving and Processing Facility (WRAP), Module 1. It provides additional detailed requirements, summarizes key Westinghouse Hanford Company design guidance, and establishes baseline technical agreements to be used in definitive design of the WRAP-1 facility. Revision 3 of the Supplemental Design Requirements Document has been assigned an Impact Level of 3ESQ based on the content of the entire revision. The actual changes made from Revision 2 have an Impact Level of 3S and the basis for these changes was previously reviewed and approved per WHC correspondence No. 9355770

  2. More New Medication Approvals.

    Science.gov (United States)

    Turkoski, Beatrice B

    2016-01-01

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

  3. 21 CFR 316.31 - Scope of orphan-drug exclusive approval.

    Science.gov (United States)

    2010-04-01

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

  4. APPLICATION OF FILLERS IN CELLULOSIC PAPER BY SURFACE FILLING: AN INTERESTING ALTERNATIVE OR SUPPLEMENT TO WET-END ADDITION

    Directory of Open Access Journals (Sweden)

    Jing Shen,

    2012-01-01

    Full Text Available The application of fillers at the surface of cellulosic paper is an interesting and industrially-commercialized but not very well-known concept, in which the filler particles are essentially added to the voids of the fibrous matrixes. This so-called “surface filling” can be achieved by the use of fillers together with a polymer solution via film press or size press, an approach that is distinct from both wet-end filling and conventional coating of paper. As an easily practicable process, surface filling has some advantages over direct wet-end addition of fillers, such as minimizing the adverse effects of filler addition on paper strength. Efficient surface filling is somewhat dependent on the specific characteristics of both fillers and fibrous matrixes. Surface filling may provide interesting possibilities for the papermaking discipline; for example, it would open the door to maximizing the cost-effectiveness of paper mills, and efficiently adding new functionalities to cellulosic paper. From both practical and fundamental points of view, systematic exploration and understanding of surface filling of cellulosic paper would be of great significance to the papermaking industry.

  5. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

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

  6. 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.

  7. Sanitary Landfill Supplemental Test Final Report

    International Nuclear Information System (INIS)

    This report summarizes the performance of the Sanitary Landfill Supplemental Test data, an evaluation of applicability, conclusions, recommendations, and related information for implementation of this remediation technology at the SRS Sanitary Landfill

  8. 18 CFR 153.11 - Supplemental orders.

    Science.gov (United States)

    2010-04-01

    ..., OR MODIFY FACILITIES USED FOR THE EXPORT OR IMPORT OF NATURAL GAS Application Under Section 3 § 153... authorization, after opportunity for hearing, such supplemental orders implementing its authority under...

  9. 7 CFR 1710.405 - Supplemental financing documents.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Supplemental financing documents. 1710.405 Section... GUARANTEES Application Requirements and Procedures for Loans § 1710.405 Supplemental financing documents. (a) The borrower is responsible for ensuring that the loan documents required for supplemental...

  10. Drugs Approved for Brain Tumors

    Science.gov (United States)

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

  11. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  12. Drugs Approved for Prostate Cancer

    Science.gov (United States)

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

  13. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

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

  14. Environmental Report 1999 Data Supplement

    Energy Technology Data Exchange (ETDEWEB)

    Larson, J M; Biermann, A H; Harrach, R J; Althouse, P E; Bertoldo, N A; Blake, R G; Brandstetter, E R; Brigdon, S L; Brown, R A; Christofferson, E; Folks, K J; Gallegos, G M; Garcia, L M; Giesing, T A; Grayson, A R; Hall, L C; MacQueen, D H; Mathews, S; Peterson, S R; Taffet, M J; Tate, P J; Vellinger, R J; Ward, R J; Williams, R A

    2000-09-01

    This Data Supplement to the Lawrence Livermore National Laboratory's (LLNL's) annual ''Environmental Report 1999'' was prepared for the U.S. Department of Energy. The main volume is intended to provide all information on LLNL's environmental impact and compliance activities that is of interest to most readers. The Data Supplement supports main volume summary data and is essentially a detailed data report that provides individual data points, where applicable. Some summary data are also included in the Data Supplement, and more detailed accounts are given of sample collection and analytical methods. The two volumes are organized in a parallel fashion to aid the reader in cross-referencing between them. This supplement includes more detailed information to support the nine chapters in the main volume that cover monitoring of air, air effluent, sewerable water, surface water, ground water, soil and sediment, vegetation and foodstuff, environmental radiation, and quality assurance. The other five chapters in the main volume have no supporting information in the Data Supplement. As in our previous annual reports, data are presented in Systeme International (SI) units. In particular, the primary units used for radiological results are becquerels and sieverts for activity and dose, with curies and rem used secondarily (1 Bq = 2.7 x 10{sup -11} Ci; 1 Sv = 100 rem).

  15. Environmental Report 2000 Data Supplement

    Energy Technology Data Exchange (ETDEWEB)

    Biermann, A H; Althouse, P E; Bertoldo, N A; Blake, R G; Brigdon, S L; Brown, R A; Campbell, C G; Christofferson, E; Clark, L M; Folks, K J; Gallegos, G M; Grayson, A R; Harrach, R J; Larson, J M; MacQueen, D H; Mathews, S; Nisbet, B; Ring Peterson, S; Taffet, M J; Tate, P J; Vellinger, R J; Williams, R A

    2001-09-01

    This Data Supplement to the Lawrence Livermore National Laboratory's (LLNL's) annual ''Environmental Report 2000'' was prepared for the U.S. Department of Energy. The main volume is intended to provide all information on LLNL's environmental impact and compliance activities that is of interest to most readers. The Data Supplement supports main volume summary data and is essentially a detailed data report that provides individual data points, where applicable. Some summary data are also included in the Data Supplement, and more detailed accounts are given of sample collection and analytical methods. The two volumes are organized in a parallel fashion to aid the reader in cross-referencing between them. This supplement includes more detailed information to support the nine chapters in the main volume that cover monitoring of air surveillance, air effluent, sewerable water, surface water, groundwater, soil and sediment, vegetation and foodstuff, environmental radiation, and quality assurance. The other five chapters in the main volume have no supporting information in the Data Supplement. As in our previous annual reports, data are presented in Systeme International (SI) units. In particular, the primary units used for radiological results are becquerels and sieverts for activity and dose, with curies and rem used secondarily (1 Bq = 2.7 x 10{sup -11} Ci; 1 Sv = 100 rem).

  16. Taking iron supplements

    Science.gov (United States)

    ... medlineplus.gov/ency/article/007478.htm Taking iron supplements To use the sharing features on this page, ... levels. You may also need to take iron supplements as well to rebuild iron stores in your ...

  17. Dietary Supplements for Toddlers

    Science.gov (United States)

    ... Listen Español Text Size Email Print Share Dietary Supplements for Toddlers Page Content Article Body If you ... a diet recommended for children), she may need supplements of vitamins B12 and D as well as ...

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

    International Nuclear Information System (INIS)

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

  19. Emerging Supplements in Sports

    OpenAIRE

    Mason, Bryan C.; Lavallee, Mark E.

    2012-01-01

    Context: Nutritional supplements advertised as ergogenic are commonly used by athletes at all levels. Health care professionals have an opportunity and responsibility to counsel athletes concerning the safety and efficacy of supplements on the market. Evidence Acquisition: An Internet search of common fitness and bodybuilding sites was performed to identify supplement promotions. A search of MEDLINE (2000–August, 2011) was performed using the most commonly identified supplements, including gl...

  20. 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...

  1. 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.

  2. Drugs Approved for Melanoma

    Science.gov (United States)

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

  3. Drugs Approved for Neuroblastoma

    Science.gov (United States)

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

  4. FWS Approved Acquisition Boundaries

    Data.gov (United States)

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

  5. Application of a high resolution benchtop quadrupole-Orbitrap mass spectrometry for the rapid screening, confirmation and quantification of illegal adulterated phosphodiesterase-5 inhibitors in herbal medicines and dietary supplements.

    Science.gov (United States)

    Shi, Feng; Guo, Changchuan; Gong, Liping; Li, Jun; Dong, Peng; Zhang, Jinling; Cui, Ping; Jiang, Shuyin; Zhao, Yanxia; Zeng, Su

    2014-05-30

    In this study, the applicability of high resolution quadrupole-Orbitrap (Q-Orbitrap) mass spectrometry for the simultaneous qualitative and quantitative analysis of illegal adulterated phosphodiesterase-5 inhibitors (PDE-5 inhibitors) in herbal medicines and dietary supplements was investigated. The mass spectrometer was operated in full MS scan/dd-MS(2) (data-dependent MS(2)) mode. The use of 70,000 FWHM mass resolution and narrow mass windows (5 ppm) could effectively improve the selectivity of the method, increasing the signal-to-noise ratio for the analytes. The response showed good linear relationship with the analytes' concentrations over wide ranges (e.g., 0.05-10 μg/g for sildenafil) with all the coefficient of determinations (r(2)) >0.9996. The detection limits (LODs) were in the range of 1.0-5.0 ng/g for different analytes. The recoveries ranged from 85.4% to 96.7%. The intra- and inter-day accuracies were in the range of -6.6 to 10.1%, while the intra- and inter-day precision ranged from 0.0039% to 13.2%. Among 68 batches of herbal medicines and 20 batches of dietary supplements (including 83 capsules, 3 pellets and 2 liquid) samples, sildenafil was detected in 8 dietary supplements, while noracetildenafil was detected in only one dietary supplement. The novel Q-Orbitrap mass spectrometry has been proved to be a very promising and powerful tool for routine screening of illegal adulterate in herbal medicines and dietary supplements, ensuring food safety and public health. PMID:24377735

  6. Application of Nutritional Supplements in Swimming Ttraining%营养补剂在游泳训练中的应用

    Institute of Scientific and Technical Information of China (English)

    赖晓红; 杜敏

    2015-01-01

    合理地进行营养补充将有利于保持运动能力并促进运动技术的进一步提高,是保证游泳运动员良好竞技状态的重要条件,意义重大。就游泳运动的特点提出如何利用营养补剂提供建议。%Reasonable nutritional supplements will help keep the exercise capacity and to further improve the promotion of sport technique, is an important condition to ensure the competitive state of swimming athletes good, great significance for training and competition. This paper presents how to use nutritional supplements are reasonable nutrition supplement to provide advice swimming movement characteristics.

  7. 营养补剂在游泳训练中的应用%Application of Nutritional Supplements in Swimming Ttraining

    Institute of Scientific and Technical Information of China (English)

    赖晓红; 杜敏

    2015-01-01

    Reasonable nutritional supplements will help keep the exercise capacity and to further improve the promotion of sport technique, is an important condition to ensure the competitive state of swimming athletes good, great significance for training and competition. This paper presents how to use nutritional supplements are reasonable nutrition supplement to provide advice swimming movement characteristics.%合理地进行营养补充将有利于保持运动能力并促进运动技术的进一步提高,是保证游泳运动员良好竞技状态的重要条件,意义重大。就游泳运动的特点提出如何利用营养补剂提供建议。

  8. 5 CFR 9901.334 - Eligibility for pay increase associated with a supplement adjustment.

    Science.gov (United States)

    2010-01-01

    ...) When a local market supplement is adjusted under § 9901.333, employees to whom the supplement applies...” will not receive a pay increase under this section (i.e., the employee's local market supplement... employee is entitled to the full amount of any applicable local market supplement effective on the date...

  9. Application of the deuterated retinol dilution technique to detect changes in hepatic retinol reserves in infants who receive high dose vitamin A supplements

    International Nuclear Information System (INIS)

    The purpose of this pilot study is to determine whether the deuterated retinol dilution technique can detect changes in hepatic vitamin A reserves in Peruvian infants in response to supplementation with vitamin A palmitate. Approximately 40 infants, 9 months of age, will be recruited for the study and randomly assigned to four treatment groups. Hepatic vitamin A reserves will be estimated using the deuterated retinol dilution technique before and after administration of a single supplement containing either 0, 7.5, 15, or 30 mg RE as retinyl palmitate in corn oil. Mean hepatic vitamin A reserves will be calculated based on the plasma isotopic ratio of d4-retinol:retinol as per Furr, et. al. Hepatic vitamin A reserves will be compared within groups before and after supplementation, and among the four groups. The mean change in hepatic vitamin A reserves across the four treatment groups will be examined in relation to the amount of vitamin A supplement administered, using regression analysis. The results of the pilot study will provide information on the size and variation of hepatic vitamin A reserves in 9-month old Peruvian infants. This information will be useful for calculating samples sizes to evaluate vitamin A intervention strategies by estimating changes in hepatic vitamin A stores in this age group, using the DRD technique. (author)

  10. Hanford facility dangerous waste permit application, 616 Nonradioactive Dangerous Waste Storage Facility. Revision 2, Chapter 3.0, Waste characteristics supplemental information; Volume 2

    International Nuclear Information System (INIS)

    This report contains supplemental information concerning waste characteristics for numerous nonradioactive waste materials. Uniform hazardous waste manifests are included for routine as well as nonroutine waste streams. The manifests contain the following information: waste disposal analysis; general instructions; waste destination; and transportation representatives

  11. 40 CFR 1065.12 - Approval of alternate procedures.

    Science.gov (United States)

    2010-07-01

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

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

    Science.gov (United States)

    2010-01-01

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

  13. 46 CFR 160.076-25 - Approval testing.

    Science.gov (United States)

    2010-10-01

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

  14. Guidance for package approvals in the United Kingdom

    International Nuclear Information System (INIS)

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

  15. Venetoclax: First Global Approval.

    Science.gov (United States)

    Deeks, Emma D

    2016-06-01

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

  16. FDA approved radiopharmaceuticals

    International Nuclear Information System (INIS)

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

  17. Drugs Approved for Skin Cancer

    Science.gov (United States)

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

  18. Military-specific application of nutritional supplements: a brief overview [v1; ref status: indexed, http://f1000r.es/548

    Directory of Open Access Journals (Sweden)

    Kyle Hoedebecke

    2015-03-01

    Full Text Available The Soldiers of America's military endure numerous physical and mental challenges that demand strict physical fitness regimens, extreme mental agility, and a perpetual readiness to deploy at a moment's notice. The chronicity of these stressors has the potential to dramatically reduce performance - both directly and indirectly.  Because of this risk, many Soldiers turn to nutritional supplements with hopes of optimizing performance. Increasing amounts of research have demonstrated that various supplements may enhance overall physical prowess, health, and offer quicker recovery in the face of corporal or psychological extremes. Most individuals, including many medical and nutrition professionals, possess only an elementary comprehension of nutritional supplements and their effect on Soldiers in training or combat environments. Nevertheless, a grasp of these details is required for safety and optimal benefits. Various compounds have been evaluated - to include evidence within the military setting - and found to augment endurance, increase cognitive function, decrease knee pain, or offer hearing or lung protection in the face of high-energy impulses. These efficacious outcomes may serve to augment the health and longevity of these Soldiers; however, continued research is needed for efficacy and long-term safety within specific environments.

  19. Supplemental instruction in chemistry

    Science.gov (United States)

    Lundeberg, Mary A.

    This study was designed to measure some effects of supplemental instruction in chemistry. Supplemental instruction is a peer-led cooperative learning program that encourages students to develop conceptual understanding by articulating both understandings and misconceptions in a think-aloud fashion. Supplemental instruction was offered three hours weekly outside of class and lab time for students in four classes of General Organic and Biological Chemistry. Over a two-year period 108 students volunteered to participate in this program; 45 students did not participate. As measured by final grades in chemistry and responses to a questionnaire, supplemental instruction was effective in increasing students' achievement in chemistry. Further research is needed to determine the in-depth effects of supplemental instruction on students' learning, problem solving, and self-esteem.

  20. Reasons for decision in the matter of Coral Energy Canada Inc. : application for approval of modifications to the Firm Transportation Risk Alleviation Mechanism (FT-RAM) pilot for the TransCanada PipeLines Limited Mainline

    International Nuclear Information System (INIS)

    Coral Energy Canada Inc. (Coral) is one of the largest wholesale energy marketers and traders in North America whose customers include utilities, gas distribution companies, municipalities, rural electrical cooperatives, independent power producers, industrial customers and commercial customers. As such, it is one of the largest shippers on the TransCanada Mainline Natural Gas Transmission System operated by TransCanada PipeLines Limited. As part of its 2001 and 2002 tolls and tariff applications, TransCanada proposed a new service enhancement called the Firm Transportation (FT) Make-up credits, which has proven to be flawed. A modified service enhancement known as the Firm Transportation Risk Alleviation Mechanism (FT-RAM) was subsequently proposed so that credits could be applied against a shipper's monthly interruptible transportation (IT) service account, based on any unused demand charges from the shippers FT contracts. In order to promote long haul service, the credits are only given for long-haul contracts, primarily for points originating in Alberta and Saskatchewan. On September 30, 2005, Coral applied to the Alberta Energy and Utilities Board for approval of modifications to the (FT-RAM) pilot to be effective on November 1, 2005. Coral proposed that the existing pilot be expanded to include short-haul FT contracts in limited circumstances where the same shipper holds a long-haul contract that delivers to the same location as the receipt point of the short-haul FT contract. The Board sought views from interested party of the appropriate process and associated timelines that should be used to deal with the application. Certain parties suggested that it would be inappropriate for the Board to approve any modifications to the existing FT-RAM pilot until the terms and conditions underlying certain Toll Task Force Resolutions were fulfilled. This document presented the positions of the interested parties, Coral's response to the positions of parties, views of

  1. Dietary supplements in the Department of Defense: possible solutions to optimizing force readiness.

    Science.gov (United States)

    Gonsalves, Stephen; Stavinoha, Trisha; Hite, Linda; Costa, Janelle; Dilly, George; Deuster, Patricia A

    2012-12-01

    Dietary supplement use is common among military service members; approximately 17 to 20% report using high-risk weight-loss, performance-enhancing, and bodybuilding supplements. To date, no overarching policy or program has been approved or implemented to inform service members or educate health care providers on the potential adverse consequences of using multiple combinations of supplements or the pros and cons of supplements per se. A review of regulations, concerns, and possible solutions is provided. Importantly, the role of third-party certification and education is emphasized. PMID:23397690

  2. Herbs, Supplements and Alternative Medicines

    Science.gov (United States)

    ... Size: A A A Listen En Español Herbs, Supplements and Alternative Medicines It is best to get ... also more likely to use dietary supplements. Using Supplements Safely If you’re one of the many ...

  3. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

    Science.gov (United States)

    Wallace, Taylor C

    2015-08-01

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. PMID:26063064

  4. On closed weak supplemented modules

    Institute of Scientific and Technical Information of China (English)

    ZENG Qing-yi; SHI Mei-hua

    2006-01-01

    A module M is called closed weak supplemented if for any closed submodule N of M, there is a submodule K of M such that M=K+N and K(c)N<<M. Any direct summand of closed weak supplemented module is also closed weak supplemented.Any nonsingular image of closed weak supplemented module is closed weak supplemented. Nonsingular V-rings in which all nonsingular modules are closed weak supplemented are characterized in Section 4.

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

    Science.gov (United States)

    2013-08-05

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

  6. Cariprazine: First Global Approval.

    Science.gov (United States)

    McCormack, Paul L

    2015-11-01

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

  7. Obiltoxaximab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-05-01

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

  8. Osimertinib: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-02-01

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

  9. 77 FR 64980 - Chesapeake Renewable Energy LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2012-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Chesapeake Renewable Energy LLC; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of Chesapeake Renewable Energy LLC's application...

  10. 75 FR 52957 - Supplemental Funding Under the Food and Drug Administration's Food Emergency Response Laboratory...

    Science.gov (United States)

    2010-08-30

    ... HUMAN SERVICES Food and Drug Administration Supplemental Funding Under the Food and Drug Administration's Food Emergency Response Laboratory Network Microbiological Cooperative Agreement Program (U18) PAR-09-215; Request for Supplemental Applications AGENCY: Food and Drug Administration, HHS....

  11. 75 FR 53688 - Constellation Mystic Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-09-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Constellation Mystic Power, LLC; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of Constellation Mystic Power, LLC's application...

  12. 加味四物汤在痛经治疗中的应用%Application of supplemented Si Wu decoction in the treatment of dysmenorrhea

    Institute of Scientific and Technical Information of China (English)

    郭佳颖

    2014-01-01

    对于女人来说,尤其是年轻女人,痛经是一种常见病。从古代开始就有很多关于痛经的记载,古人认为,多是由于身体虚弱,感受风寒,损伤冲任之脉所致。当代人认为,大多是由于全身的气血运行不畅,导致血液运行受到阻碍所致。加味四物汤对痛经有一定的治疗作用,也被用于临床研究,取得很大的成效。本文就对痛经的病因及其治疗原则进行简单介绍,着重对加味四物汤的功能、痛经治疗中加味四物汤的作用以及加味四物汤在痛经治疗中的辨证施治进行阐述。%For women,dysmenorrhea is a common disease,and most are the young woman.Since the ancient times,there have been a lot of dysmenorrhea records.The ancients thought that it is due to physical weakness,cold,damaged the Chong and Ren meridian.Contemporary people think that it is mostly due to systemic blood running sluggish,leading to blood operation impeded. The supplemented Si Wu decoction is effective for the treatment of dysmenorrheal.It has been used in clinical research,and achieved great results.This paper introduces the etiology and treatment principle of dysmenorrhea,and discusses the function of supplemented Si Wu decoction,dysmenorrhea treatment effect of supplemented Si Wu decoction and supplemented Si Wu decoction dialectical therapy in the treatment of dysmenorrhea.

  13. Breastfeeding: Vitamin D Supplementation

    Science.gov (United States)

    ... Weight Breastfeeding Micronutrient Malnutrition State and Local Programs Vitamin D Supplementation Recommend on Facebook Tweet Share Compartir ... not provide infants with an adequate intake of vitamin D. Most breastfed infants are able to synthesize ...

  14. Iron supplements (image)

    Science.gov (United States)

    The mineral iron is an essential nutrient for humans because it is part of blood cells, which carry oxygen to all body cells. There is no conclusive evidence that iron supplements contribute to heart attacks.

  15. Application of high-performance liquid chromatography with charged aerosol detection for universal quantitation of undeclared phosphodiesterase-5 inhibitors in herbal dietary supplements.

    Science.gov (United States)

    Poplawska, Magdalena; Blazewicz, Agata; Bukowinska, Kinga; Fijalek, Zbigniew

    2013-10-01

    Incidents of detecting novel analogues of phosphodiesterase 5 (PDE-5) inhibitors in illicit dietary supplements for erectile dysfunction are constantly reported. However, little is known about their content in a single dose, mainly due to the poor availability or inaccessibility of pure reference standards. This study presents a new strategy of quantitative analysis of unknown and recently identified compounds. Charged aerosol detector (CAD), described as "universal detector", combined with high-performance liquid chromatography (HPLC) system proved to be a useful tool for fast and simple quantitation of PDE-5 inhibitors' analogues in a complex herbal matrix without individual reference standards available. Universal calibration was employed for calculations. Two easily obtainable reference materials - sildenafil and tadalafil - were selected as universal standards and the content of analogues was estimated with respect to their response. The error of proposed indirect determination was found to be ± 3%, which is less than enough to obtain a reliable result of the content. The elaborated method was applied for quantitative analyses of PDE-5 inhibitors and 10 analogues detected in 22 illicit dietary supplements and two bulk powdered herbal materials. All target analogues were identified using time-of-flight mass spectrometry with electrospray ionization. Obtained results indicate that the quantity of PDE-5 inhibitors in all tested samples is considered to be pharmacologically relevant. PMID:23850939

  16. Antioxidant supplements and mortality

    DEFF Research Database (Denmark)

    Bjelakovic, Goran; Nikolova, Dimitrinka; Gluud, Christian

    2014-01-01

    Oxidative damage to cells and tissues is considered involved in the aging process and in the development of chronic diseases in humans, including cancer and cardiovascular diseases, the leading causes of death in high-income countries. This has stimulated interest in the preventive potential of a...... antioxidant supplements. Today, more than one half of adults in high-income countries ingest antioxidant supplements hoping to improve their health, oppose unhealthy behaviors, and counteract the ravages of aging....

  17. Active components in food supplements

    NARCIS (Netherlands)

    Siemelink M; Jansen EHJM; Piersma AH; Opperhuizen A; LEO

    2000-01-01

    The growing food supplement market, where supplements are both more diverse and more easily available (e.g. through Internet) formed the backdrop to the inventory of the active components in food supplements. The safety of an increased intake of food components via supplements was also at issue her

  18. Supplement use by Young Athletes

    OpenAIRE

    Jill Anne McDowall

    2007-01-01

    This paper reviews studies of supplement use among child and adolescent athletes, focusing on prevalence and type of supplement use, as well as gender comparisons. Supplement use among adult athletes has been well documented however there are a limited number of studies investigating supplement use by child and adolescent athletes. A trend in the current literature revealed that the most frequently used supplements are in the form of vitamin and minerals. While health and illness prevention a...

  19. Necitumumab: First Global Approval.

    Science.gov (United States)

    Garnock-Jones, Karly P

    2016-02-01

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

  20. 7 CFR 1710.110 - Supplemental financing.

    Science.gov (United States)

    2010-01-01

    ... substantially in their entirety as set forth in 7 CFR 1717.154, applicants for a municipal rate loan will be... merger, consolidation, or transfer of system substantially in its entirety, and the provisions of 7 CFR... 7 Agriculture 11 2010-01-01 2010-01-01 false Supplemental financing. 1710.110 Section...

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

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    1999-02-24

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

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

    International Nuclear Information System (INIS)

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

  3. 14 CFR 121.555 - Compliance with approved routes and limitations: Domestic and flag operations.

    Science.gov (United States)

    2010-01-01

    ... limitations: Domestic and flag operations. 121.555 Section 121.555 Aeronautics and Space FEDERAL AVIATION...: CERTIFICATION AND OPERATIONS OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Flight Operations § 121.555 Compliance with approved routes and limitations: Domestic and flag operations. No...

  4. Nutritional supplements and the EU: is anyone happy?

    Science.gov (United States)

    Eberhardie, Christine

    2007-11-01

    In 2000 an estimated pound sterling 335 x 106 was spent on food supplements and herbal remedies in the UK. Until recently, The Trades Description Act 1968, the Food Safety Act 1990 and The Food Labelling Regulations 1996 (amended 2004) were the only form of regulation available to protect the public. The medical community has been concerned about the risk to patients of inaccurate dosages and poor-quality products as well as drug-nutrient and nutrient-nutrient interactions. Following growing concern about the type and quality of food supplements and herbal remedies available in the EU, the European Commission has published directives regulating food supplements (2002/46/EC) and herbal remedies (2004/24/EC and 2004/27/EC) available within the EU. The directives came into force in 2005 and limit the number and quality of permitted food supplements through the creation of a 'positive list' of approved supplements. In the present paper the new regulatory frameworks and the implications for the food supplement manufacturers, traditional and complementary therapists, the healthcare professions and patients will be examined. It would appear that there is considerable dissatisfaction with the regulations in their present form. Several questions remain: is regulation the answer; who decides which nutrients go on the positive list; what effect has the regulation had on patient safety and patient choice? PMID:17961271

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

    International Nuclear Information System (INIS)

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

  6. Multinational design approval programme

    International Nuclear Information System (INIS)

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

  7. Ergogenic Aids and Supplements.

    Science.gov (United States)

    Porrini, Marisa; Del Boʼ, Cristian

    2016-01-01

    Great interest is currently shown for the contribution of nutrition to optimize training and athletic performance, and a considerable debate exists about the potential ergogenic value of several dietary supplements. However, most of the products used by athletes do not provide sufficient scientific evidence regarding their efficacy in enhancing physical performance as well as their specificity of action and safety. For this reason, sport nutrition professionals need skills in evaluating the scientific value of papers and advertisements on ergogenic aids and supplements in order to support athletes in their choice. In the present chapter, the efficacy of some of the most popular supplements used by athletes and sport practitioners will be discussed. Particular attention will be devoted to amino acids and derivatives, caffeine and caffeinated energy drinks, and some antioxidants. PMID:27348226

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

    International Nuclear Information System (INIS)

    As part of environmental restoration activities at the Hanford Site, Bechtel Hanford, Inc. (BHI) is conducting a series of evaluations to determine appropriate release conditions for specific facilities following the completion of decontamination and decommissioning (D and D) projects. The release conditions, with respect to the residual volumetric radioactive contamination, are termed authorized limits. This two volume report provides the necessary evaluations for the 290-C trenches and 105-C process water tunnels, and is intended to serve as the technical basis for a request for approval of authorized limits of residual radioactive contamination levels associated with these facilities. Volume 2 contains the Source Term Determination. This volume contains the radiological characterization data, spreadsheet analyses, and results of efforts to determine the radiological source terms. The source terms characterize the radionuclides and activity concentration levels for the facilities, and serves as input to the various radiation exposure pathways and scenarios used to estimate the individual radiation doses that could result from release of these facilities. Based on the results of these evaluations, it is determined that the application of the proposed authorized limits for the 190-C trenches and the 105-C process water tunnels represents a safe and cost-effective approach to their final disposition

  9. Pharmacokinetic Studies in Healthy Subjects for the Development of an Extended-Release Tablet Formulation of Guaifenesin: A 505(b)(2) New Drug Application Approval.

    Science.gov (United States)

    Vilson, Lineau; Owen, Joel S

    2013-01-01

    Guaifenesin is an expectorant used to improve mucociliary clearance (MCC) and relieve chest congestion from upper respiratory tract infections. Immediate-release (IR) guaifenesin requires dosing every 4 hours to maintain efficacy because of the drug's short half-life. Extended-release (ER) guaifenesin has been developed to prolong efficacy and reduce dosing frequency. As part of the 505(b)(2) new drug application (NDA), the pharmacokinetics (PK) of an ER bi-layer tablet formulation of guaifenesin (Mucinex®) and bioequivalence to an over-the-counter (OTC) monograph IR formulation were evaluated in healthy subjects. In one study, subjects received 1,200 mg ER guaifenesin every 12 hours or 400 mg IR guaifenesin every 4 hours for 6 days. Steady-state exposures were equivalent between the two products, as demonstrated by AUC and Cmax . In another study, subjects received a single dose of 600 mg (fasted) or 1,200 mg (fasted or fed) ER bi-layer tablet formulations. AUC and Cmax were equivalent between both states for the 1,200 mg ER dose. However, Tmax of 1,200 mg ER guaifenesin was later in the fed than the fasted state. ER guaifenesin is bioequivalent to corresponding OTC monograph doses of IR guaifenesin. ER guaifenesin offers a convenient 12-hour dosing alternative to 4-hour dosing of IR guaifenesin. PMID:27121557

  10. Drugs Approved for Lung Cancer

    Science.gov (United States)

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

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

    OpenAIRE

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

    2016-01-01

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

  12. Determinants of dietary supplement use - healthy individuals use dietary supplements

    DEFF Research Database (Denmark)

    Kofoed, Christina L F; Christensen, Jane; Dragsted, Lars Ove;

    2015-01-01

    The prevalence of dietary supplement use varies largely among populations, and previous studies have indicated that it is high in the Danish population compared with other European countries. The diversity in supplement use across countries indicates that cultural and environmental factors could...... influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54 948 Danes, aged 50-64 years, who completed self-administrated questionnaires on diet, dietary supplements and...... intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher...

  13. [Optical Topography as an Auxiliary Laboratory Test for Differential Diagnosis of Depressive State: Clinical Application of Near-infrared Spectroscopy (NIRS) as the First Trial for Approved Laboratory Tests in Psychiatry].

    Science.gov (United States)

    Fukuda, Masato

    2015-01-01

    The lack of clinical laboratory tests is a major obstacle in the reliable diagnosis and quantitative treatment assessment and prevention of psychiatric disorders and in the development of patient-centric psychiatric practices. Optical topography has been approved as an insurance-covered auxiliary laboratory test for differential diagnosis of depressive state by Ministry of Health, Labour and Welfare in Japan since 2014. Near-infrared spectroscopy (NIRS), theoretical basis of optical topography, is one of functional neuroimaging techniques that has been increasingly employed in psychology and psychiatry. Because NIRS can detect only cerebral cortex reactivities with low spatial resolution and may suffer from contaminating signals from skin and skull, its data should be interpreted as a global index of cerebral cortex reactivities. Within these limitations, the advantages of NIRS over fMRI such as complete non-invasiveness, small measurement apparatus, high time resolution, and natural examination setting lead it to one of the preferred methods in studies of brain substrates of psychiatric disorders. Two-thirds of the original articles on NIRS application in psychiatry have been published by Japanese researchers. NIRS examination of major depressive disorder, bipolar disorder, and schizophrenia using a verbal fluency task of only three minutes demonstrated diagnosis-specific characteristics of frontal lobe function. These characteristics have been established as suggesting potential diagnosis of bipolar disorder or schizophrenia in clinically diagnosed major depressive disorder. In order to establish the application of NIRS as clinically useful laboratory tests in psychiatry, auxiliary nature of NIRS examination for differential diagnosis should be properly recognized both by patients and psychiatrists. PMID:26514047

  14. 21 CFR 314.170 - Adulteration and misbranding of an approved drug.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Adulteration and misbranding of an approved drug... Applications and Abbreviated Applications § 314.170 Adulteration and misbranding of an approved drug. All drugs... subject to the adulteration and misbranding provisions in sections 501, 502, and 503 of the act. FDA...

  15. Psychology: Teacher Supplement.

    Science.gov (United States)

    Stark, Rebecca

    This supplement provides teachers with tests, quizzes, answers to questions in the text, and general teaching information for using the student text, "Psychology," by Rebecca Stark. Quizzes included are on the topics of human development; the nervous system; the brain; cognitive development; sensation and perception; conditioning; learning;…

  16. Supplemental TV Taped Problems.

    Science.gov (United States)

    Squires, Robert G.; Frank, David V.

    1983-01-01

    Videotapes were developed as supplemental material for a course in chemical engineering thermodynamics. Describes the course, videotapes produced (includes list by topics as related to course content), and effectiveness of the tapes. Although no significant improvement in test performance was noted, students indicated they learned material faster…

  17. Oral Supplementation of Myoinositol

    DEFF Research Database (Denmark)

    Gregersen, G.; Bertelsen, B.; Harbo, H.;

    1983-01-01

    28 young diabetics with short disease duration participated in a double-blind study by taking 6 g of myoinositol or placebo daily for 2 months. The aim was to demonstrate a possible beneficial effect of this compound on subclinical diabetic neuropathy. Measurement of vibratory perception threshol...... of myoinositol in their muscle tissue remained uninfluenced by oral supplementation of myoinositol....

  18. Dietary Supplements: What Is Safe?

    Science.gov (United States)

    ... articles window. My Saved Articles » My ACS » Dietary Supplements: What Is Safe? Download Printable Version [PDF] » Dietary supplements include things like vitamins, minerals, herbs, or products ...

  19. Vitamin Supplements: Healthy or Hoax?

    Science.gov (United States)

    ... Recognition & Awards Healthy Workplace Food and Beverage Toolkit Vitamin Supplements: Healthy or Hoax? Updated:Jun 12,2015 Can vitamin and mineral supplements really make you healthier? Overwhelmed ...

  20. Weight Loss Nutritional Supplements

    Science.gov (United States)

    Eckerson, Joan M.

    Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children. Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight loss industry has responded by offering a variety of products that generates billions of dollars each year in sales. Most nutritional weight loss supplements are purported to work by increasing energy expenditure, modulating carbohydrate or fat metabolism, increasing satiety, inducing diuresis, or blocking fat absorption. To review the literally hundreds of nutritional weight loss supplements available on the market today is well beyond the scope of this chapter. Therefore, several of the most commonly used supplements were selected for critical review, and practical recommendations are provided based on the findings of well controlled, randomized clinical trials that examined their efficacy. In most cases, the nutritional supplements reviewed either elicited no meaningful effect or resulted in changes in body weight and composition that are similar to what occurs through a restricted diet and exercise program. Although there is some evidence to suggest that herbal forms of ephedrine, such as ma huang, combined with caffeine or caffeine and aspirin (i.e., ECA stack) is effective for inducing moderate weight loss in overweight adults, because of the recent ban on ephedra manufacturers must now use ephedra-free ingredients, such as bitter orange, which do not appear to be as effective. The dietary fiber, glucomannan, also appears to hold some promise as a possible treatment for weight loss, but other related forms of dietary fiber, including guar gum and psyllium, are ineffective.

  1. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

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

  2. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

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

  3. 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

  4. Vitamin and Mineral Supplement Fact Sheets

    Science.gov (United States)

    ... Tables Online DRI Tool Daily Value (DV) Tables Vitamin and Mineral Supplement Fact Sheets Search the list ... Supplements: Background Information Botanical Dietary Supplements: Background Information Vitamin and Mineral Fact Sheets Botanical Supplement Fact Sheets ...

  5. 77 FR 41191 - Proposed Collection; Comment Request: Effectiveness of the NIH Curriculum Supplements Programs

    Science.gov (United States)

    2012-07-12

    ... HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request: Effectiveness of the... review and approval. Proposed Collection: Title: The Effectiveness of the NIH Curriculum Supplements... teach science by featuring the latest NIH research and utilized research-based instructional methods....

  6. [ERGOGENIC SPORT SUPPLEMENTS FOR ATHLETES].

    Science.gov (United States)

    Arieli, Rakefet; Lahav, Yair

    2016-06-01

    Use of performance-enhancing supplements occurs at all levels of sports, from recreational athletes to professional athletes. Although some supplements do enhance athletic performance, many have no proven benefits and have adverse effects. Nutritional supplements are categorized into the following categories: I. Apparently Effective. II. Possibly Effective. III. Too Early To Tell. IV. Apparently Ineffective. This article will review 4 ergogenic supplements which are categorized in the first category--"Apparently Effective"--1) Buffer agents 2) Creatine 3) Caffeine and 4 Nitric Oxide. Given the widespread use of performance enhancing supplements, physicians, and dietitians should be prepared to counsel athletes about their effectiveness, safety and legality. PMID:27544991

  7. Effective Nutritional Supplement Combinations

    Science.gov (United States)

    Cooke, Matt; Cribb, Paul J.

    Few supplement combinations that are marketed to athletes are supported by scientific evidence of their effectiveness. Quite often, under the rigor of scientific investigation, the patented combination fails to provide any greater benefit than a group given the active (generic) ingredient. The focus of this chapter is supplement combinations and dosing strategies that are effective at promoting an acute physiological response that may improve/enhance exercise performance or influence chronic adaptations desired from training. In recent years, there has been a particular focus on two nutritional ergogenic aids—creatine monohydrate and protein/amino acids—in combination with specific nutrients in an effort to augment or add to their already established independent ergogenic effects. These combinations and others are discussed in this chapter.

  8. Resveratrol food supplements

    DEFF Research Database (Denmark)

    Aschemann-Witzel, Jessica; Grunert, Klaus G

    2015-01-01

    comparing US and Danish respondents, we aimed to identify whether sociodemographic variables, health status, health beliefs and behaviour and interest in food aspects specifically relevant to resveratrol (e.g., naturalness, indulgence, and Mediterranean food) explain favourable attitudes and adoption...... intentions toward resveratrol supplements. Methods: A survey sent to a representative online panel in the United States and Denmark was analysed using linear regression. Results: We find that sociodemographic variables contribute little to explaining favourable attitudes toward and adoption intentions of...... intention. An interest in the indulgence dimension of food explains positive attitudes in the United States and adoption intentions in both countries. Conclusions: The results indicate that potential consumers of resveratrol supplements are identified by their usage of complementary and alternative medicine...

  9. Food Components and Supplements

    DEFF Research Database (Denmark)

    Parlesak, Alexandr

    2012-01-01

    The major part of food consists of chemical compounds that can be used for energy production, biological synthesis, or maintenance of metabolic processes by the host. These components are defined as nutrients, and can be categorized into macronutrients (proteins, carbohydrates, triglycerides, and...... alcohol), minerals, and micronutrients. The latter category comprises 13 vitamins and a hand full of trace elements. Many micronutrients are used as food supplements and are ingested at doses exceeding the amounts that can be consumed along with food by a factor of 10–100. Both macro- and micronutrients...... supplements and contaminants can compete directly with drug oxidation, induce or suppress the expression of xenobiotic-metabolizing enzymes, change the bioavailability of drugs, and, in the case of live bacteria, bring in their own xenobiotic metabolism, including cytochrome P450 (CYP) activity. In numerous...

  10. 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.

  11. 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...

  12. Is It Really FDA Approved?

    Science.gov (United States)

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

  13. FDA-Approved HIV Medicines

    Science.gov (United States)

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

  14. 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.

  15. 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.

  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. 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.

  18. 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.

  19. 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.

  20. Drugs Approved for Breast Cancer

    Science.gov (United States)

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

  1. 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.

  2. 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.

  3. 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.

  4. Drugs Approved for Liver Cancer

    Science.gov (United States)

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

  5. The dilemma of approving antidotes.

    Science.gov (United States)

    Steffen, Christian

    2007-04-20

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

  6. 28 CFR 2.41 - Travel approval.

    Science.gov (United States)

    2010-07-01

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

  7. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, Tennessee Valley Authority. Supplement number 20

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-02-01

    This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), Supplement No. 14 (December 1994), Supplement No. 15 (June 1995), Supplement No. 16 (September 1995), Supplement No. 17 (October 1995), Supplement No. 18 (October 1995), and Supplement No. 19 (November 1995) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the issues identified in the SER.

  8. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, Tennessee Valley Authority. Supplement number 20

    International Nuclear Information System (INIS)

    This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), Supplement No. 14 (December 1994), Supplement No. 15 (June 1995), Supplement No. 16 (September 1995), Supplement No. 17 (October 1995), Supplement No. 18 (October 1995), and Supplement No. 19 (November 1995) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the issues identified in the SER

  9. Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products.

    Science.gov (United States)

    Fialkow, Jonathan

    2016-08-01

    Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters, omega-3-acid ethyl esters A, omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Most dietary supplements and all but one prescription formulation contain mixtures of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Products containing both EPA and DHA may raise low-density lipoprotein cholesterol (LDL-C). In clinical trials, the EPA-only prescription product, icosapent ethyl, did not raise LDL-C compared with placebo. To correct a common misconception, it is important to note that omega-3 fatty acid dietary supplements are not US FDA-approved over-the-counter drugs and are not required to demonstrate safety and efficacy prior to marketing. Conversely, prescription products are supported by extensive clinical safety and efficacy investigations required for FDA approval and have active and ongoing safety monitoring programs. While omega-3 fatty acid dietary supplements may have a place in the supplementation of diet, they generally contain lower levels of EPA and DHA than prescription products and are not approved or intended to treat disease. Perhaps due to the lack of regulation of dietary supplements, EPA and DHA levels may vary widely within and between brands, and products may also contain unwanted cholesterol or fats or potentially harmful components, including toxins and oxidized fatty acids. Accordingly, omega-3 fatty acid dietary supplements should not be substituted for prescription products. Similarly, prescription products containing DHA and EPA should not be substituted for the EPA-only prescription product, as DHA may raise LDL-C and thereby complicate the management of patients with dyslipidemia. PMID:27138439

  10. Bodybuilding supplementation and tooth decay.

    Science.gov (United States)

    Ali, M S; Batley, H; Ahmed, F

    2015-07-10

    Supplementation is a key component in bodybuilding and is increasingly being used by amateur weight lifters and enthusiasts to build their ideal bodies. Bodybuilding supplements are advertised to provide nutrients needed to help optimise muscle building but they can contain high amounts of sugar. Supplement users are consuming these products, while not being aware of their high sugar content, putting them at a higher risk of developing dental caries. It is important for dental professionals to recognise the increased risk for supplement users and to raise awareness, provide appropriate preventative advice and be knowledgeable of alternative products to help bodybuilders reach their goals, without increasing the risk of dental caries. PMID:26159983

  11. 76 FR 28123 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-05-13

    .... Additionally, five approved amendments to previously approved applications are listed. SUMMARY: The FAA... requirements of Sec. 158.15(b). Decision Date: March 11, 2011. For Further Information Contact: Irene Porter... training upgrade. Pre-conditioned air hose upgrade (five boarding bridges). Brief Description of...

  12. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Science.gov (United States)

    2010-10-01

    ... constructed in accordance with the plans and specifications in the application for approval. In each test only... 46 Shipping 6 2010-10-01 2010-10-01 false Approval Testing-Recreational Hybrid PFD's. 160.077-19 Section 160.077-19 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED)...

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

    International Nuclear Information System (INIS)

    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. 7 CFR 1724.54 - Requirements for RUS approval of plans and specifications.

    Science.gov (United States)

    2010-01-01

    ... the application. (See 7 CFR part 1710, subpart F.) Prior to issuing the plans and specifications for... 7 Agriculture 11 2010-01-01 2010-01-01 false Requirements for RUS approval of plans and... DESIGN POLICIES AND PROCEDURES Electric System Design § 1724.54 Requirements for RUS approval of...

  15. 42 CFR 489.13 - Effective date of agreement or approval.

    Science.gov (United States)

    2010-10-01

    ... survey. The agreement or approval is effective on the date the State agency, CMS, or the CMS contractor survey (including the Life Safety Code survey, if applicable) is completed, or on the effective date of... 42 Public Health 5 2010-10-01 2010-10-01 false Effective date of agreement or approval....

  16. 19 CFR 151.13 - Approval of commercial gaugers.

    Science.gov (United States)

    2010-04-01

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

  17. 10 CFR 72.234 - Conditions of approval.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

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

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

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

    International Nuclear Information System (INIS)

    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

  20. 76 FR 75809 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2011-12-05

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

  1. Pharmacovigilance on sexual enhancing herbal supplements.

    Science.gov (United States)

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2016-01-01

    The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the

  2. Pharmacovigilance on sexual enhancing herbal supplements

    Science.gov (United States)

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2015-01-01

    The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the

  3. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    D.W. Markman

    1999-09-17

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

  4. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. Alkylbenzene Project in Xinjiang Approved

    Institute of Scientific and Technical Information of China (English)

    Zhou Weiyong

    1996-01-01

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

  10. 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.

  11. Nutritional Supplements for Endurance Athletes

    Science.gov (United States)

    Rasmussen, Christopher J.

    Athletes engaged in heavy endurance training often seek additional nutritional strategies to help maximize performance. Specific nutritional supplements exist to combat certain factors that limit performance beginning with a sound everyday diet. Research has further demonstrated that safe, effective, legal supplements are in fact available for today's endurance athletes. Several of these supplements are marketed not only to aid performance but also to combat the immunosuppressive effects of intense endurance training. It is imperative for each athlete to research the legality of certain supplements for their specific sport or event. Once the legality has been established, it is often up to each individual athlete to decipher the ethics involved with ingesting nutritional supplements with the sole intent of improving performance.

  12. Regional Assessment of Supplementation Project

    International Nuclear Information System (INIS)

    The Fish and Wildlife Program of the Northwest Power Planning Council (NPPC) prescribes several approaches to achieve its goal of doubling the salmon and steelhead runs of the Columbia River. Among those approaches are habitat restoration, improvements in adult and juvenile passage at dams and artificial propagation. Supplementation will be a major part of the new hatchery programs. The purpose of the Regional Assessment of Supplementation Project (RASP) is to provide an overview of ongoing and planned supplementation activities, to construct a conceptual framework and model for evaluating the potential benefits and risks of supplementation and to develop a plan for better regional coordination of research and monitoring and evaluation of supplementation. RASP has completed its first year of work. Progress toward meeting the first year's objectives and recommendations for future tasks are contained in this report

  13. Unilateral approval - Is it working?

    International Nuclear Information System (INIS)

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

  14. APPLICATION OF REVERSE OSMOSIS TECHNOLOGY TO THE DESALINATION PROCESS IN SUPPLEMENT WATER FOR SUBMERGED ARC FURNACE%反渗透技术在矿热炉补充水除盐工艺的应用

    Institute of Scientific and Technical Information of China (English)

    吴秋勤; 曾世林; 王正

    2015-01-01

    This paper introduced the application of reverse osmosis technology to the desalination process in supplement water for submerged arc furnace. It tested the effects of original water suspended matter concentration,hardness and static pressure difference both sides of RO membrane on system operation, water yield and desalination rate. The result shows that original water suspended matter has great effects on system water production and original water hardness has less ef-fect on RO water production. It is beneficial to enhance desalination to decrease the static pressure difference both sides of RO membrane. It plays a key role in normal operation of system to increase combined deep pretreatment, decrease the original water concentration and strengthen germicide and algicide in pretreatment stage.%介绍了反渗透技术在矿热炉补充水除盐工艺中的应用,并进行了原水悬浮物浓度、硬度和RO膜两侧静压差对系统运行状况、产水量和除盐率影响的测试.结果表明,原水悬浮物对系统产水量有严重影响;原水硬度对RO产水量影响相对较小;RO膜两侧静差降低,有利于提高除盐率.增加组合深度预处理工序,降低原水的悬浮物浓度,强化预处理阶段杀菌灭藻,对除盐系统设备正常运行起关键作用.

  15. Drugs, Herbs and Supplements: MedlinePlus

    Science.gov (United States)

    ... https://medlineplus.gov/druginformation.html Drugs, Herbs and Supplements To use the sharing features on this page, ... included in drug packages, see DailyMed . Herbs and Supplements Browse dietary supplements and herbal remedies to learn ...

  16. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 15

    International Nuclear Information System (INIS)

    This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), and Supplement No. 14 (December 1994) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items, and proposed license conditions identified in the SER

  17. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 15

    Energy Technology Data Exchange (ETDEWEB)

    Tam, P.S.

    1995-06-01

    This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), and Supplement No. 14 (December 1994) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items, and proposed license conditions identified in the SER.

  18. Epclusa Approved for Chronic Hepatitis C

    Science.gov (United States)

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

  19. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

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

  20. Number of Drilling Permits Approved by Fiscal Year on Federal Lands by BLM

    Data.gov (United States)

    Bureau of Land Management, Department of the Interior — This table contains the total number of Applications for Permit to Drill (APDs) by state approved by the BLM each fiscal year. Oil and gas operators may not begin...

  1. 77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-01-13

    ...-0563, FDA- 2011-M-0564, FDA-2011-M-0600, FDA-2011-M-0601, FDA-2011-M-0630, and FDA-2011-M-0707] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications...

  2. Dietary supplements containing prohibited substances.

    Science.gov (United States)

    van der Bijl, P; Tutelyan, V A

    2013-01-01

    Dietary supplement use among athletes to enhance performance is proliferating as more individuals strive for obtaining that chemical competitive edge. As a result the concomitant use of dietary supplements containing performance-enhancing substances of those falling in the categories outlined in the current review, can also be expected to rise. This despite ever-increasing sophisticated analytical methodology techniques being used to assay dietary supplement and urine samples in doping laboratories. The reasons for this include that a variety of these chemical entities, many of them on the prohibited drug list of the WADA, are being produced on commercial scales in factories around the world (ephedrine and pseudoephedrine, sibutramine, methylhexaneamine, prohormones, 'classic' anabolic steroids, clenbuterol, peptide hormones etc.), aggressive marketing strategies are being employed by companies and these supplements can be easily ordered via e.g. the internet. It can also be anticipated that there will be an increase in the number of supplements containing 'designer' steroids and other 'newer' molecules. Chromatographic techniques combined with mass spectrometry leading to identification of molecular fragments and productions will assist in determining these substances. To prevent accidental doping, information regarding dietary supplements must be provided to athletes, coaches and sports doctors at all levels of competition. The risks of accidental doping via dietary supplement ingestion can be minimized by using 'safe' products listed on databases, e.g. such as those available in The Netherlands and Germany. PMID:24741950

  3. 28 CFR 2.93 - Travel approval.

    Science.gov (United States)

    2010-07-01

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

  4. 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...

  5. 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....

  6. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

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

  7. 12 CFR 611.510 - Approval procedures.

    Science.gov (United States)

    2010-01-01

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

  8. Prevalence of protein supplement use at gyms.

    Science.gov (United States)

    Sánchez Oliver, A; Miranda León, Ma T; Guerra-Hernández, E

    2011-01-01

    At the present time, the abuse of all class of sport nutritional supplements (NS) has extended the people who go regularly to gymnasiums. Between these substances there are the Protein Powder Supplements (PPS). The purpose of this study is to examine the consumption of PPS in 415 individuals from Seville fitness centers. All individuals were evaluated with anthropometric measurements and completed a questionnaire previously reviewed, evaluating the validity of the content, application, structure and presentation. 28% of the individuals were using or used PPS. Of the total, 42.7% of male individuals compared to 3.2% of the females. The use of PPS was higher than what has been reported in previous studies about supplement use in fitness center, 28% vs 10-14% aprox. The SPP use is associated with sex, age, and time of sport practiced. More than a 25% of the total individuals that attend a gym use PPS. The total individuals that attend a gym and use PPS far exceed the RDA of protein for general population and/or athletes, being able to cause problems of health. PMID:22072369

  9. 30 CFR 746.14 - Approval, disapproval or conditional approval, of mining plan.

    Science.gov (United States)

    2010-07-01

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

  10. China's Developing Dietary Supplement Industry

    Institute of Scientific and Technical Information of China (English)

    Jeff Crowther

    2011-01-01

    @@ With the increasingly large size and forward momentum of China's economy, one would think there has to be a well-developed dietary supplement industry.However, although China has been posting re-cord gains to its GDP, it is far behind the U.S., E.U.and Japan in regard to a well-defined and prosperous dietary supplement industry.With that said, having an established dietary supple-ment industry is not the measure by which countries are judged in terms of economic prowess.

  11. TEDS-M 2008 User Guide for the International Database. Supplement 2: National Adaptations of the TEDS-M Questionnaires

    Science.gov (United States)

    Brese, Falk, Ed.

    2012-01-01

    This supplement contains all adaptations made by countries to the international version of the TEDS-M questionnaires under careful supervision of and approval by the TEDS-M International Study Center at Michigan State University. This information provides users of the TEDS-M International Database with a guide to evaluate the availability of…

  12. Beware of Fraudulent 'Dietary Supplements'

    Science.gov (United States)

    ... firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to ... feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos ...

  13. 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.

  14. To supplement or not to supplement: a metabolic network framework for human nutritional supplements.

    Science.gov (United States)

    Nogiec, Christopher D; Kasif, Simon

    2013-01-01

    Flux balance analysis and constraint based modeling have been successfully used in the past to elucidate the metabolism of single cellular organisms. However, limited work has been done with multicellular organisms and even less with humans. The focus of this paper is to present a novel use of this technique by investigating human nutrition, a challenging field of study. Specifically, we present a steady state constraint based model of skeletal muscle tissue to investigate amino acid supplementation's effect on protein synthesis. We implement several in silico supplementation strategies to study whether amino acid supplementation might be beneficial for increasing muscle contractile protein synthesis. Concurrent with published data on amino acid supplementation's effect on protein synthesis in a post resistance exercise state, our results suggest that increasing bioavailability of methionine, arginine, and the branched-chain amino acids can increase the flux of contractile protein synthesis. The study also suggests that a common commercial supplement, glutamine, is not an effective supplement in the context of increasing protein synthesis and thus, muscle mass. Similar to any study in a model organism, the computational modeling of this research has some limitations. Thus, this paper introduces the prospect of using systems biology as a framework to formally investigate how supplementation and nutrition can affect human metabolism and physiology. PMID:23967053

  15. To supplement or not to supplement: a metabolic network framework for human nutritional supplements.

    Directory of Open Access Journals (Sweden)

    Christopher D Nogiec

    Full Text Available Flux balance analysis and constraint based modeling have been successfully used in the past to elucidate the metabolism of single cellular organisms. However, limited work has been done with multicellular organisms and even less with humans. The focus of this paper is to present a novel use of this technique by investigating human nutrition, a challenging field of study. Specifically, we present a steady state constraint based model of skeletal muscle tissue to investigate amino acid supplementation's effect on protein synthesis. We implement several in silico supplementation strategies to study whether amino acid supplementation might be beneficial for increasing muscle contractile protein synthesis. Concurrent with published data on amino acid supplementation's effect on protein synthesis in a post resistance exercise state, our results suggest that increasing bioavailability of methionine, arginine, and the branched-chain amino acids can increase the flux of contractile protein synthesis. The study also suggests that a common commercial supplement, glutamine, is not an effective supplement in the context of increasing protein synthesis and thus, muscle mass. Similar to any study in a model organism, the computational modeling of this research has some limitations. Thus, this paper introduces the prospect of using systems biology as a framework to formally investigate how supplementation and nutrition can affect human metabolism and physiology.

  16. Effects of Supplemental Irrigation and Nitrogen Application on Starch Granule Size Distribution of Maize Grain%补充灌溉和施氮对玉米籽粒淀粉粒粒度分布的影响

    Institute of Scientific and Technical Information of China (English)

    石德杨; 张海艳; 董树亭

    2014-01-01

    [Objective]Starch granule size distribution is an important factor to evaluate starch quality and is greatly influenced by environmental factor. Irrigation and nitrogen are the major agronomic measures for high yield and good quality of maize. Therefore, it is very important for quality control and directional utilization of starch to clarify the effects of supplemental irrigation and nitrogen application on starch granule size distribution, and analyze the relationship between starch granule size distribution, grain weight, starch pasting properties and starch components of maize grain.[Method]In this study, Zhengdan 958 was used. Two water treatments were carried out, rain-fed (W1) and supplemental irrigation (W2). Supplemental irrigation treatment and irrigation amount were determined by soil water content. If soil water content was lower than 60%of field capacity, irrigation was applied. If soil water content after irrigation arrived 80%of field capacity, irrigation was stopped. Irrigation amount was calculated according to the formula of m=10ρbH(βi -βj ), where m is the amount of supplementary irrigation (mm), H is the supplementary irrigation depth (cm) of the period, ρb is soil bulk density(g·cm-3) of the supplementary irrigation depth, βi is the objective water content (field capacity×objective and relative water content),βj is the natural water content. The highest nitrogen application rate was determined according to 3 kg nitrogen requirement for 100 kg kernels and the yield standard of 10 500 kg·hm-2 in 67 500 plants·hm-2 density. So, three nitrogen treatments were carried out, 0 (N1), 160 (N2) and 320 (N3) kg·hm-2. The volume, number and surface area distribution of starch granule in mature maize endosperm in irrigation and nitrogen application treatments were determined using laser particle size analyzer. Starch pasting properties were measured by RVA analyzer. Starch components were determined according to the double wavelengh method. The

  17. 324 building safety analysis report supplement

    International Nuclear Information System (INIS)

    Process engineering designs, major equipment and plant facilities to be utilized in commercial nuclear waste preparation and vitrification in the 324 Radiochemical Engineering Building are reviewed with regard to accident potential and consequences. This Safety Analysis Report Supplement compares calculated environmental doses anticipated from the Commercial Nuclear Waste Vitrification Project (CNWVP) routine operations with the average doses from past waste management operations conducted at the Hanford Project and finds them to be significantly less. The calculated CNWVP environmental doses are found to be far below presently applicable ERDA standards and standards proposed by the EPA for nuclear power operations

  18. Botanical Dietary Supplements: Background Information

    Science.gov (United States)

    ... plant, but many compounds may be responsible for valerian' ;s relaxing effect. Are botanical dietary supplements safe? Many ... before their full effects are achieved. For example, valerian may be effective as a sleep aid after ...

  19. Medicare and Medicaid Statistical Supplement

    Data.gov (United States)

    U.S. Department of Health & Human Services — The CMS Office of Enterprise Data and Analytics (OEDA) produced an annual Medicare and Medicaid Statistical Supplement report providing detailed statistical...

  20. Should You Take Dietary Supplements?

    Science.gov (United States)

    ... Recognizing Cataracts Health Capsules Predicting Response to Breast Cancer Drugs Volunteers Needed ... You Take Dietary Supplements? A Look at Vitamins, Minerals, Botanicals and More When you reach for that bottle ...

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

    OpenAIRE

    Rawson, N S

    2000-01-01

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

  2. Herbal Supplements: Cause for Concern?

    OpenAIRE

    Paolo Borrione; Luigi Di Luigi; Nicola Maffulli; Fabio Pigozzi

    2008-01-01

    More than 1400 herbal products or herbal-derived compounds are commonly commercialised for health uses worldwide (Tyler, 1996). Herbs are considered dietary supplements, and therefore are subjected to a very limited form of regulation, and advertisements normally highlight their potential activities without mentioning any side effect. Also, herbs are generally believed to be 'natural', and hence safe. Many nutritional supplements contains herb compounds usually not present in the diet (e.g. G...

  3. Vitamin D supplementation in neonates.

    Science.gov (United States)

    Wu, Zhe

    2014-01-01

    Vitamin D deficiency may lead to the development of rickets. In our paediatrics department in a major London hospital, we audited the number of babies with low vitamin D levels attending our prolonged jaundice clinic. Prior to our newly designed intervention, those babies with low vitamin D levels would be given a letter to encourage collection of supplementation from their GP. The GP would receive a letter which included a 14-page guideline on vitamin D supplementation. For this project, we included all breastfed babies that attended our prolonged jaundice clinic between August 2012 and December 2012. Those babies that were either vitamin D deficient or insufficient were identified. We then followed up these patients and asked them whether they were being prescribed the correct supplementation after being identified as vitamin deficient. For our intervention, we designed a leaflet to simplify guidelines that was then distributed to mothers and their GPs. Following this intervention, we re-audited the new cohort of patients who received the leaflet between August and November 2013. The study found 71% of babies to be vitamin D deficient. Moreover, almost two in five mothers had less than the recommended six months of vitamin supplementation during pregnancy. After identifying a deficiency, one would expect that uptake of vitamin supplementation would increase dramatically. However, only four in 10 babies went on to receive the correct dose and preparation of supplements. A marked increase in uptake was seen during the re-audit post intervention, with 71% of babies receiving correct supplementation. While an increase in government advertising would have contributed to the rise in uptake of vitamin D supplementation, a leaflet proved to be a simple yet effective intervention in improving vitamin uptake in babies. As a result, this was then implemented as part of trust guidelines. PMID:26733062

  4. Iron Supplementation and Altitude: Decision Making Using a Regression Tree

    Directory of Open Access Journals (Sweden)

    Laura A. Garvican-Lewis, Andrew D. Govus, Peter Peeling, Chris R. Abbiss, Christopher J. Gore

    2016-03-01

    Full Text Available Altitude exposure increases the body’s need for iron (Gassmann and Muckenthaler, 2015, primarily to support accelerated erythropoiesis, yet clear supplementation guidelines do not exist. Athletes are typically recommended to ingest a daily oral iron supplement to facilitate altitude adaptations, and to help maintain iron balance. However, there is some debate as to whether athletes with otherwise healthy iron stores should be supplemented, due in part to concerns of iron overload. Excess iron in vital organs is associated with an increased risk of a number of conditions including cancer, liver disease and heart failure. Therefore clear guidelines are warranted and athletes should be discouraged from ‘self-prescribing” supplementation without medical advice. In the absence of prospective-controlled studies, decision tree analysis can be used to describe a data set, with the resultant regression tree serving as guide for clinical decision making. Here, we present a regression tree in the context of iron supplementation during altitude exposure, to examine the association between pre-altitude ferritin (Ferritin-Pre and the haemoglobin mass (Hbmass response, based on daily iron supplement dose. De-identified ferritin and Hbmass data from 178 athletes engaged in altitude training were extracted from the Australian Institute of Sport (AIS database. Altitude exposure was predominantly achieved via normobaric Live high: Train low (n = 147 at a simulated altitude of 3000 m for 2 to 4 weeks. The remaining athletes engaged in natural altitude training at venues ranging from 1350 to 2800 m for 3-4 weeks. Thus, the “hypoxic dose” ranged from ~890 km.h to ~1400 km.h. Ethical approval was granted by the AIS Human Ethics Committee, and athletes provided written informed consent. An in depth description and traditional analysis of the complete data set is presented elsewhere (Govus et al., 2015. Iron supplementation was prescribed by a sports physician

  5. Mineral supplementation for grazing ruminants

    International Nuclear Information System (INIS)

    Grazing ruminants to which concentrate feeds cannot be economically fed must rely on self-feeding of mineral supplements. A number of factors affect mineral consumption of free-choice mixtures. Livestock exhibit little nutritional wisdom and will select palatable mixtures in preference to mixtures designed to meet their requirements. Palatability and appetite stimulators are often used to achieve a more uniform herd-wide consumption. It is best to formulate free-choice mixtures on the basis of analyses or other available data. However, when no information on mineral status is known, a free-choice complete mineral supplement is warranted. A 'complete' mineral mixture usually includes salt, a low fluoride P source, Ca, Co, Cu, I, Mn and Zn. Selenium, Mg, K, S, Fe or additional elements can be incorporated into a mineral supplement as new information suggests a need. The detriment to ruminant production caused by providing Ca, Se and Cu in excess can be greater than any benefit derived by providing a mineral supplement. In regions where high forage Mo predominates, three to five times the Cu content in mineral mixtures is needed to counteract Mo toxicity. Supplemental minerals are most critical during the wet season, when cattle are gaining weight rapidly and energy and protein supplies are adequate. Economic return on mineral supplementation is high. (author)

  6. Authentication of Herbal Supplements Using Next-Generation Sequencing

    Science.gov (United States)

    Braukmann, Thomas W. A.; Borisenko, Alex V.; Zakharov, Evgeny V.

    2016-01-01

    Background DNA-based testing has been gaining acceptance as a tool for authentication of a wide range of food products; however, its applicability for testing of herbal supplements remains contentious. Methods We utilized Sanger and Next-Generation Sequencing (NGS) for taxonomic authentication of fifteen herbal supplements representing three different producers from five medicinal plants: Echinacea purpurea, Valeriana officinalis, Ginkgo biloba, Hypericum perforatum and Trigonella foenum-graecum. Experimental design included three modifications of DNA extraction, two lysate dilutions, Internal Amplification Control, and multiple negative controls to exclude background contamination. Ginkgo supplements were also analyzed using HPLC-MS for the presence of active medicinal components. Results All supplements yielded DNA from multiple species, rendering Sanger sequencing results for rbcL and ITS2 regions either uninterpretable or non-reproducible between the experimental replicates. Overall, DNA from the manufacturer-listed medicinal plants was successfully detected in seven out of eight dry herb form supplements; however, low or poor DNA recovery due to degradation was observed in most plant extracts (none detected by Sanger; three out of seven–by NGS). NGS also revealed a diverse community of fungi, known to be associated with live plant material and/or the fermentation process used in the production of plant extracts. HPLC-MS testing demonstrated that Ginkgo supplements with degraded DNA contained ten key medicinal components. Conclusion Quality control of herbal supplements should utilize a synergetic approach targeting both DNA and bioactive components, especially for standardized extracts with degraded DNA. The NGS workflow developed in this study enables reliable detection of plant and fungal DNA and can be utilized by manufacturers for quality assurance of raw plant materials, contamination control during the production process, and the final product

  7. Authentication of Herbal Supplements Using Next-Generation Sequencing.

    Directory of Open Access Journals (Sweden)

    Natalia V Ivanova

    Full Text Available DNA-based testing has been gaining acceptance as a tool for authentication of a wide range of food products; however, its applicability for testing of herbal supplements remains contentious.We utilized Sanger and Next-Generation Sequencing (NGS for taxonomic authentication of fifteen herbal supplements representing three different producers from five medicinal plants: Echinacea purpurea, Valeriana officinalis, Ginkgo biloba, Hypericum perforatum and Trigonella foenum-graecum. Experimental design included three modifications of DNA extraction, two lysate dilutions, Internal Amplification Control, and multiple negative controls to exclude background contamination. Ginkgo supplements were also analyzed using HPLC-MS for the presence of active medicinal components.All supplements yielded DNA from multiple species, rendering Sanger sequencing results for rbcL and ITS2 regions either uninterpretable or non-reproducible between the experimental replicates. Overall, DNA from the manufacturer-listed medicinal plants was successfully detected in seven out of eight dry herb form supplements; however, low or poor DNA recovery due to degradation was observed in most plant extracts (none detected by Sanger; three out of seven-by NGS. NGS also revealed a diverse community of fungi, known to be associated with live plant material and/or the fermentation process used in the production of plant extracts. HPLC-MS testing demonstrated that Ginkgo supplements with degraded DNA contained ten key medicinal components.Quality control of herbal supplements should utilize a synergetic approach targeting both DNA and bioactive components, especially for standardized extracts with degraded DNA. The NGS workflow developed in this study enables reliable detection of plant and fungal DNA and can be utilized by manufacturers for quality assurance of raw plant materials, contamination control during the production process, and the final product. Interpretation of results should

  8. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2010-08-10

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

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

    Science.gov (United States)

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

    2016-01-01

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

  10. 7 CFR 1924.49 - State supplements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 12 2010-01-01 2010-01-01 false State supplements. 1924.49 Section 1924.49 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... supplements. State Supplements or policies will not be issued or adopted to either supplement or...

  11. Food Supplement Usage by Adolescent Males.

    Science.gov (United States)

    Fleischer, Barbara; Read, Marsha

    1982-01-01

    Adolescent males (N=568) responded to a questionnaire examining their food supplement usage, types of food supplements consumed, reasons for use and non-use, relationship of use to concern for health, and demographic and external factors influencing supplement use. Presents factors related to food supplement usage. (RC)

  12. 75 FR 74712 - Planet Energy (Maryland) Corp.; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-12-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Planet Energy (Maryland) Corp.; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding, of Planet Energy (Maryland) Corp.'s application...

  13. 75 FR 74711 - Planet Energy (Pennsylvania) Corp.; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-12-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Planet Energy (Pennsylvania) Corp.; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding, of Planet Energy (Pennsylvania) Corp.'s application...

  14. 75 FR 35017 - Brookfield Energy Marketing LP; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-06-21

    ... Energy Regulatory Commission Brookfield Energy Marketing LP; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of Brookfield Energy Marketing LP's application for...Library system by clicking on the appropriate link in the above list. They are also available for...

  15. Why US children use dietary supplements

    OpenAIRE

    Bailey, Regan L; Gahche, Jaime J; Thomas, Paul R.; Dwyer, Johanna T

    2013-01-01

    Background: Dietary supplements are used by one-third of children. We examined motivations for supplement use in children, the types of products used by motivations, and the role of physicians and health care practitioners in guiding choices about supplements. Methods: We examined motivations for dietary supplement use reported for children (from birth to 19 y of age; n = 8,245) using the National Health and Nutrition Examination Survey 2007–2010. Results: Dietary supplements were used by 31%...

  16. Performance Measurement for Supplemental Nutrition Assistance Program Modernization Initiatives.

    OpenAIRE

    Laura Castner; Amy Wodarek O'Reilly; Kevin Conway; Maura Bardos; Emily Sama-Miller

    2012-01-01

    This study for the USDA Food and Nutrition Service was conducted to determine existing measures for Supplemental Nutrition Assistance Program modernization initiatives, including call centers, online systems, document imaging, kiosks, partnering, waiving the face-to-face interview, shortened interviews, and online expedited applications.

  17. Identification and quantification of vinpocetine and picamilon in dietary supplements sold in the United States.

    Science.gov (United States)

    Avula, Bharathi; Chittiboyina, Amar G; Sagi, Satyanarayanaraju; Wang, Yan-Hong; Wang, Mei; Khan, Ikhlas A; Cohen, Pieter A

    2016-03-01

    Vinpocetine and picamilon are drugs prescribed in many countries to treat a variety of cerebrovascular disorders. In the United States, vinpocetine and picamilon have never been approved by the US Food and Drug Administration, but they are both available for sale directly to consumers as dietary supplements. We designed our study to determine the accuracy of supplement labels with regard to the presence and quantity of vinpocetine and picamilon. A validated ultra-high performance liquid chromatography-photodiode-array method was developed for the quantification of vinpocetine and picamilon. The separation was achieved using a reversed phase (C-18) column, photodiode array detection, and water/acetonitrile as the mobile phase. Vinpocetine and picamilon were detected at concentrations as low as 10 and 50 ng/mL, respectively. The presence of vinpocetine and picamilon was confirmed using reference standards. Twenty-three supplements labelled as containing vinpocetine were available for sale at two large supplement retail chains; 17 contained vinpocetine with quantities ranging from 0.3 to 32 mg per recommended daily serving. No vinpocetine was detected in six of the sampled supplements. The supplement label implied that vinpocetine was a constituent of lesser periwinkle in three of the supplements. Of the 31 picamilon supplements available for sale from a variety of retailers: 30 contained picamilon in quantities ranging from 2.7 to 721.5 mg per recommended daily serving. We found that consumers cannot obtain accurate information from supplement labels regarding the presence or quantity of vinpocetine and picamilon. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26426301

  18. Approval of radioactive consumer goods

    International Nuclear Information System (INIS)

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

  19. Chitosan supplementation and cholesterol

    Czech Academy of Sciences Publication Activity Database

    Koppová, Ingrid; Fliegerová, Kateřina; Šimůnek, Jiří; Kopečný, Jan

    Ancona : PUM, 2007, s. 6-6. [Application of Chitosan in Medical Sciences. Venezia (IT), 25.01.2007-26.01.2007] R&D Projects: GA AV ČR 1QS500200572 Institutional research plan: CEZ:AV0Z50450515 Keywords : chitosan Subject RIV: EE - Microbiology, Virology

  20. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    Directory of Open Access Journals (Sweden)

    Md Tausif Alam

    2014-01-01

    Full Text Available Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing, in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  1. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 17

    International Nuclear Information System (INIS)

    This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April.1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), Supplement No. 14 (December 1994), Supplement No. 15 (June 1995), and Supplement No. 16 (September 1995) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50--390 and 50--391). The facility is located in Rhea county, Tennessee, near the Watts Bar Dam on the Tennessee River. In this supplement, NRC examines the significant problems of construction quality and quality assurance effectiveness that led TVA to withdraw its certification in 1985 that Watts Bar Unit I was ready to load fuel. Also discussed are the extensive corrective actions performed by TVA according to its nuclear performance plans and other supplemental programs, and NRC's extensive oversight to determine whether the Watts Bar Unit 1 construction quality and TVA's operational readiness and quality assurance effectiveness are adequate for a low-power operating license to be issued. SSER 17 does not address Watts Bar Unit 2, except for the systems which are necessary to support Unit 1 operation

  2. Mipomersen sodium: first global approval.

    Science.gov (United States)

    Hair, Philip; Cameron, Fiona; McKeage, Kate

    2013-04-01

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

  3. Pharmacologically effective red yeast rice preparations marketed as dietary supplements illustrated by a case report.

    Science.gov (United States)

    Venhuis, B J; van Hunsel, F; van de Koppel, S; Keizers, P H J; Jeurissen, S M F; De Kaste, D

    2016-03-01

    This paper reports a typical statin-related adverse reaction from a red yeast rice (RYR) supplement and the analytical findings from the supplement. It also examines the regulatory framework governing botanical supplements in Europe. Two key events that shaped the current regulatory framework are reviewed. First, the Hecht-Pharma judgement by the European Court of Justice (ECJ) that inverted the precautionary principle in the Medicines Act to a reactionary principle. Following the Hecht-Pharma judgement, pharmacological active dietary supplements can be sold until sufficient signals of harm show that they are an unregistered medicine, placing a huge burden on regulatory authorities. Secondly, the European Food Safety Authority (EFSA) in 2011 approved the first health claim for pharmacologically active RYR dietary supplements. If the current regulatory status for pharmacologically active RYR dietary supplements does not permit adequate warning and active monitoring of adverse drug reactions, then the current regulatory framework may not be adequate to ensure consumer safety.Copyright © 2016 John Wiley & Sons, Ltd. PMID:26810781

  4. Nutritional Supplements for Strength Power Athletes

    Science.gov (United States)

    Wilborn, Colin

    Over the last decade research involving nutritional supplementation and sport performance has increased substantially. Strength and power athletes have specific needs to optimize their performance. Nutritional supplementation cannot be viewed as a replacement for a balanced diet but as an important addition to it. However, diet and supplementation are not mutually exclusive, nor does one depend on the other. Strength and power athletes have four general areas of supplementation needs. First, strength athletes need supplements that have a direct effect on performance. The second group of supplements includes those that promote recovery. The third group comprises the supplements that enhance immune function. The last group of supplements includes those that provide energy or have a direct effect on the workout. This chapter reviews the key supplements needed to optimize the performance and training of the strength athlete.

  5. Is vitamin C supplementation beneficial?

    DEFF Research Database (Denmark)

    Lykkesfeldt, Jens; Poulsen, Henrik Enghusen

    2010-01-01

    In contrast to the promised ‘antioxidant miracle' of the 1980s, several randomised controlled trials have shown no effect of antioxidant supplements on hard endpoints such as morbidity and mortality. The former over-optimistic attitude has clearly called for a more realistic assessment of the...... benefit:harm ratio of antioxidant supplements. We have examined the literature on vitamin C intervention with the intention of drawing a conclusion on its possible beneficial or deleterious effect on health and the result is discouraging. One of several important issues is that vitamin C uptake is tightly...... controlled, resulting in a wide-ranging bioavailability depending on the current vitamin C status. Lack of proper selection criteria dominates the currently available literature. Thus, while supplementation with vitamin C is likely to be without effect for the majority of the Western population due to...

  6. Caffeine Toxicity Due to Supplement Use in Caffeine--Naïve Individual: A Cautionary Tale.

    Science.gov (United States)

    Lystrup, Robert M; Leggit, Jeffery C

    2015-08-01

    Thousands of military members self-medicate with dietary supplements containing unknown quantities of pharmacologically active compounds. These poorly regulated substances can cause real harm to the military population, especially when they contain stimulants such as caffeine. When taken regularly, caffeine has several performance-enhancing benefits. However, when used excessively or in vulnerable populations, caffeine can cause several unwanted side effects such as nervousness, sensory disturbances, insomnia, arrhythmia, excitability, inattentiveness, restlessness, mood changes, gastrointestinal disturbances, and even psychosis. Vulnerable patients include the caffeine-naïve, physiologically stressed, young, and mentally ill patients. One such case describes a caffeine-naïve service member who suffered an adverse reaction after taking an allegedly moderate dose of caffeine from a pill he obtained from a teammate. This case highlights the importance of supplement awareness among service members, increased provider vigilance, third party verification, and enhanced regulation on the approval and marketing of dietary supplements. PMID:26226540

  7. 40 CFR 403.11 - Approval procedures for POTW pretreatment programs and POTW granting of removal credits.

    Science.gov (United States)

    2010-07-01

    ... denying requests for approval of POTW Pretreatment Programs and applications for removal credit... public notice of any Submission complying with the requirements of § 403.9(b) and, where removal credit... removal credit authorization is sought, with § 403.7. The Approval Authority may have up to an...

  8. 78 FR 28214 - Gainesville Renewable Energy Center, LLC; Supplemental Notice That Initial Market-Based Rate...

    Science.gov (United States)

    2013-05-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Gainesville Renewable Energy Center, LLC; Supplemental Notice That Initial... notice in the above-referenced proceeding, of Gainesville Renewable Energy Center, LLC's application...

  9. 78 FR 40473 - Plainfield Renewable Energy, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2013-07-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Plainfield Renewable Energy, LLC; Supplemental Notice That Initial Market... in the above-referenced proceeding, of Plainfield Renewable Energy, LLC's application for...

  10. 77 FR 2717 - Cherokee County Cogeneration Partners, LLC; Supplemental Notice That Initial Market-Based Rate...

    Science.gov (United States)

    2012-01-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Cherokee County Cogeneration Partners, LLC; Supplemental Notice That Initial... notice in the above-referenced proceeding of Cherokee County Cogeneration Partners, LLC's application...

  11. 77 FR 52016 - Brookfield Smoky Mountain Hydropower LLC; Supplemental Notice That Initial Market-Based Rate...

    Science.gov (United States)

    2012-08-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Brookfield Smoky Mountain Hydropower LLC; Supplemental Notice That Initial... notice in the above-referenced proceeding, of Brookfield Smoky Mountain Hydropower LLC's application...

  12. Application of dietary supplements in patients with type 2 diabetes mellitus in two areas of China%我国两地区2型糖尿病患者营养补充剂应用现状及相关因素

    Institute of Scientific and Technical Information of China (English)

    吕岩; 赵维纲; 王姮

    2010-01-01

    Objective To understand the application of dietary supplements among adult patients with type 2 diabetes mellitus (T2MD) in two areas of China. Methods A total of 615 T2MD patients were recruited from three hospitals in Beijing and Shenyang, with convenience sampling for the study using self-reported questionnaires. Data were statistically analyzed. Results Overall 34. 8% of the participants (22.5% in Beijing and 45.5% in Shenyang, respectively) reported ever use of at least one dietary supplement in the past 12 months. The most commonly used supplement was royal jelly ( 16. 1% ), followed by vitamins ( 10. 1% ), calcium (8. 8% ),fish oil (7. 3% ), spirulina (3.9%), and lecithin (2. 3% ). Except that royal jelly was used for complementary treatment for T2MD, most of the other supplements were used for improving their body defense. In addition, more than 20 other health dietary supplements were also used for diabetes-related conditions in 8. 5% of the participants surveyed. The participants' main sources of information about dietary supplements were from mass media or recommendations by relatives and friends. About half of supplements users perceived that the dietary supplements were effective. The application of dietary supplements was associated with gender, educational background, living area,perceived burden of medical cost, stage of diabetes, comorbidity, and body mass index (BMI) of the patients ( all P <0. 05). Conclusions Dietary supplements are widely used among T2MD patients in Beijing and Shenyang.The types of these dietary supplements are diverse and lack professional instructions. It is recommended that information on dietary supplements should be included in diabetes education.%目的 了解2型糖尿病患者营养补充剂的应用现状,并探讨其应用的相关因素.方法 采用方便抽样法,对北京及沈阳两地三家医疗机构的615例确诊的2型糖尿病患者进行问卷调查,并对数据进行统计学分析.结果 2型糖尿

  13. Supplements to Traditional Vocabulary Teaching

    Institute of Scientific and Technical Information of China (English)

    布亚男

    2012-01-01

      In a word, Vocabulary plays an indispensable part in language proficiency and provides much of the basis of how wel learns language, so it cannot be ignored. I discussed Schools’ viewpoints on the vocabulary teaching ,Reason for forgetting, Traditional approach to vocabulary teaching, supplements to vocabulary teaching,the author hope the above content can offer some hints for language learners.

  14. Herbal Supplements and Sport Performance

    Institute of Scientific and Technical Information of China (English)

    Ellen Coleman; Ron Maughan; Sozanne Nelson Steen; Rob Skinner

    2008-01-01

    @@ KEY POINTS ·Labels on dietary supplements can be misleading. Containers may include substantially more,but usually less,of the listed amounts of ingredients,and substances may be added? some of which can cause failed doping tests for athletes?

  15. 7 CFR 1735.90 - Preliminary approvals.

    Science.gov (United States)

    2010-01-01

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

  16. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

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

  17. 30 CFR 28.2 - Approved fuses.

    Science.gov (United States)

    2010-07-01

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

  18. 13 CFR 108.370 - Conditional approval.

    Science.gov (United States)

    2010-01-01

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

  19. Ordinal Position, Approval Motivation, and Interpersonal Attraction

    Science.gov (United States)

    Nowicki, Stephen, Jr.

    1971-01-01

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

  20. 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…

  1. Looks-Conscious Teens Trying Risky Supplements

    Science.gov (United States)

    ... fullstory_159576.html Looks-Conscious Teens Trying Risky Supplements Unregulated products can harm health, U.S. pediatricians' group ... News) -- Many teens are turning to risky, unregulated supplements to boost their looks, warns a leading group ...

  2. Anthocyanin analyses of Vaccinium fruit dietary supplements

    Science.gov (United States)

    Vaccinium fruit ingredients within dietary supplements were identified by comparisons with anthocyanin analyses of known Vaccinium profiles (demonstration of anthocyanin fingerprinting). Available Vaccinium supplements were purchased and analyzed; their anthocyanin profiles (based on HPLC separation...

  3. Kommentarer og supplement til DS 418

    DEFF Research Database (Denmark)

    Rode, Carsten; Saxhof, Bjarne

    1999-01-01

    Comments and Supplement for DS 418. Lecture note for DTU course 64040 Basic Course in Building Energy Technology.......Comments and Supplement for DS 418. Lecture note for DTU course 64040 Basic Course in Building Energy Technology....

  4. Muscle Mass and Weight Gain Nutritional Supplements

    Science.gov (United States)

    Campbell, Bill

    There are numerous sports supplements available that claim to increase lean body mass. However, for these sports supplements to exert any favorable changes in lean body mass, they must influence those factors regulating skeletal muscle hypertrophy (i.e., satellite cell activity, gene transcription, protein translation). If a given sports supplement does favorably influence one of these regulatory factors, the result is a positive net protein balance (in which protein synthesis exceeds protein breakdown). Sports supplement categories aimed at eliciting a positive net protein balance include anabolic hormone enhancers, nutrient timing pre- and postexercise workout supplements, anticatabolic supplements, and nitric oxide boosters. Of all the sports supplements available, only a few have been subject to multiple clinical trials with repeated favorable outcomes relative to increasing lean body mass. This chapter focuses on these supplements and others that have a sound theoretical rationale in relation to increasing lean body mass.

  5. Iodine supplementation: benefits outweigh risks.

    Science.gov (United States)

    Delange, F; Lecomte, P

    2000-02-01

    In 1990, iodine deficiency affected almost one-third of the world population and was the greatest single cause of preventable brain damage and mental retardation. Following a resolution adopted by the World Summit for Children in 1990. major programmes of iodine supplementation were implemented by the governments of the affected countries with the support of major donors. Iodisation of salt was recognised as the method of choice. Nine years later, by April 1999, 75% of the affected countries had legislation on salt iodisation and 68% of the affected populations had access to iodised salt. The prevalence of iodine deficiency disorders decreased drastically in most countries and the deficiency disappeared completely in some such as Peru. This result constitutes a public heath success unprecedented with a non-infectious disease. However, occasional adverse effects occurred. The principle effect is iodine-induced hyperthyroidism which occurs essentially in older people with autonomous nodular goitres, especially following iodine intake that is too rapid and of too massive an increment. The incidence of the disorder is usually low and reverts spontaneously to the background rate of hyperthyroidism or even below this rate after 1 to 10 years of iodine supplementation. The possible occurrence of iodine-induced thyroiditis in susceptible individuals has not been clearly demonstrated by large epidemiological surveys. Iodine supplementation is followed by an increased prevalence of occult papillary carcinoma of the thyroid discovered at autopsy but the prognosis of thyroid cancer is improved due to a shift towards differentiated forms of thyroid cancer that are diagnosed at earlier stages. Iodine-induced hyperthyroidism and other adverse effects can be almost entirely avoided by adequate and sustained quality control and monitoring of iodine supplementation which should also confirm adequate iodine intake. Available evidence clearly confirms that the benefits of correcting

  6. Waste feed delivery environmental permits and approvals plan

    International Nuclear Information System (INIS)

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

  7. Direct Summands of ⊕-Supplemented Modules

    Institute of Scientific and Technical Information of China (English)

    Nil Orhan; Derya Keskin Tütüncü; Rachid Tribak

    2007-01-01

    A module M is called ⊕-supplemented if every submodule of M has a supplement that is a direct summand of M. It is shown that if M is a ⊕-supplemented module and r(M) is a coclosed submodule of M for a left preradical r, then r(M) is a direct summand of M, and both r(M) and M/r(M) are ⊕-supplemented.

  8. Dietary supplementation practices of Singaporean athletes.

    Science.gov (United States)

    Slater, Gary; Tan, Benedict; Teh, Kong Chuan

    2003-09-01

    The supplementation practices of elite athletes in Singapore were studied using an anonymous questionnaire. Information was sought on not only the type of supplements used but also dosage, rationale for use, and other factors that might influence supplement use including selected demographic parameters and sources of information relating to supplements. Data was collected from 160 athletes across a spectrum of 30 sports. Use of supplements was widespread, with 77% of respondents acknowledging use of at least 1 product. Respondents ingested a total of 59 different supplements, with each athlete using on average 3.6 +/- 0.3 different products. Sports drinks, caffeine, vitamin C, multivitamin/mineral supplements, and essence of chicken were some of the most commonly ingested products, confirming that while vitamin/mineral supplements are popular, sports supplements and traditional/herbal preparations were also well accepted. Respondents preferred to source information pertaining to supplements from "significant others" and other readily accessible sources. A small number of respondents acknowledged the use of International Olympic Committee (IOC) banned or restricted substances, highlighting the need for athletes to consult sports medicine professionals with specialist knowledge of dietary supplements in advance of initiating any supplementation regime. PMID:14669932

  9. 47 CFR 61.86 - Supplements.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Supplements. 61.86 Section 61.86... Rules for Tariff Publications of Dominant and Nondominant Carriers § 61.86 Supplements. A carrier may not file a supplement except to suspend or cancel a tariff publication, or to defer the effective...

  10. 22 CFR 71.12 - Dietary supplements.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by...

  11. IMPORTANCE OF NUTRITIONAL SUPPLEMENTS IN SPORT ACTIVITIES

    OpenAIRE

    Gloria Sofia Margineantu

    2014-01-01

    The goals of sports performance cannot be reached only through training, but it includes also nutritional supplements along a proper diet. Especially in body shaping sports (fitness and bodybuilding) supplementation is a key factor contributing to the performance and compromise its failure often results. The right nutritional supplementation means not just what is consumed but when it is.

  12. 40 CFR 141.809 - Supplemental treatment.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Supplemental treatment. 141.809... treatment. (a) Any supplemental drinking water treatment units installed onboard existing or new aircraft... the manufacturer's plans and specifications and FAA requirements. (b) Water supplemental treatment...

  13. 75 FR 71687 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-11-24

    ... Request; Nomination Application for the U.S. EPA Montreal Protocol Awards; EPA ICR No. 2389.01, OMB... review and approval according to the procedures prescribed in 5 CFR 1320.12. On July 7, 2010 (75 FR 39012... . Title: Nomination Application for the U.S. EPA Montreal Protocol Awards ICR numbers: EPA ICR No....

  14. 77 FR 48127 - Approval of Subzone Status; Shimadzu USA Manufacturing, Inc., Canby, OR

    Science.gov (United States)

    2012-08-13

    ... Foreign-Trade Zones Board Approval of Subzone Status; Shimadzu USA Manufacturing, Inc., Canby, OR On May 8... activation limit of FTZ 45, on behalf of Shimadzu USA Manufacturing, Inc., in Canby, Oregon. The application... inviting public comment (77 FR 28568, 05/15/2012). The FTZ staff examiner reviewed the application...

  15. 75 FR 82429 - Determinations Concerning Need for Error Correction, Partial Approval and Partial Disapproval...

    Science.gov (United States)

    2010-12-30

    ... its application to, or provide assurances that it has adequate legal authority to apply to, all... highlight the gaps in its PSD program concerning the application of PSD, and the legal authority for... approval and partial disapproval. The state did not address, or provide adequate legal authority for,...

  16. 78 FR 76387 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-12-17

    ...-2835. Public Agency: City of Garden City, Kansas. Application Number: 13-01-C-00-GCK. Application Type... Garden City Regional Airport. Brief Description of Projects Approved for Collection and Use: Security... lighting. Rehabilitate taxiway--phase I. Install runway vertical/visual guidance system....

  17. 78 FR 9884 - Approval of Subzone Status; Zimmer Manufacturing BV; Ponce, Puerto Rico

    Science.gov (United States)

    2013-02-12

    ... Foreign-Trade Zones Board Approval of Subzone Status; Zimmer Manufacturing BV; Ponce, Puerto Rico Pursuant... application to the Board for the establishment of a subzone at the facility of Zimmer Manufacturing BV located... comment has been given in the Federal Register (77 FR 68102, 11/15/2012) and the application has...

  18. 14 CFR 21.339 - Special export airworthiness approval for aircraft.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Special export airworthiness approval for aircraft. 21.339 Section 21.339 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... demonstration, is included in the application; (e) For each prospective importing country, the applicant...

  19. Site Decommissioning Management Plan. Supplement 1

    International Nuclear Information System (INIS)

    The Nuclear Regulatory Commission (NRC) staff has identified 51 sites contaminated with radioactive material that require special attention to ensure timely decommissioning. While none of these sites represent an immediate threat to public health and safety, they have contamination that exceeds existing NRC criteria for unrestricted use. All of these sites require some degree of remediation, and several involve regulatory issues that must be addressed by the Commission before they can be released for unrestricted use and the applicable licenses terminated. This report contains the NRC stairs strategy for addressing the technical, legal, and policy issues affecting the timely decommissioning of the 51 sites and describes the status of decommissioning activities at the sites. This is supplement number one to NUREG-1444, which was published in October 1993

  20. 1999 petrographs : supplement to CAPP statistical handbook

    International Nuclear Information System (INIS)

    This powerpoint presentation consisted of a series of graphs which described key statistics applicable to the natural gas and crude oil industry in Canada. It was produced as a supplement to the Canadian Association of Petroleum Producers (CAPP) Statistical Handbook. The activities of the upstream petroleum sector for the ten-year period ending in 1999 were emphasized. Major trends in the industry are more easily identifiable and the graphs provide a quick overview. The graphs touched on a variety of topic including wells drilled by type, Canadian liquid hydrocarbon reserves by region and by type, Canadian oil sands, natural gas, natural gas liquid production, exploration and development expenditures, and industry payment to governments

  1. Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of 111In-BzDTPA-pertuzumab

    International Nuclear Information System (INIS)

    Introduction: 111In-BzDTPA-pertuzumab is a novel imaging probe for detecting changes in HER2 expression in breast cancer (BC) caused by treatment with trastuzumab (Herceptin). Our aim was to evaluate the pharmacokinetics, normal tissue biodistribution, radiation dosimetry and acute toxicity of 111In-BzDTPA-pertuzumab in non-tumor bearing mice in order to obtain regulatory approval to advance this agent to a first-in-humans Phase I/II clinical trial. Methods: Biodistribution and pharmacokinetic studies were performed in non-tumor bearing Balb/c mice injected i.v. with 111In-BzDTPA-pertuzumab (2.5 MBq; 2 μg). The cumulative number of disintegrations per source organ derived from the biodistribution data was used to predict the radiation absorbed doses in humans using OLINDA/EXM software. Acute toxicity was studied at two weeks post-injection of 111In-BzDTPA-pertuzumab (1.0 MBq, 20 μg) with comparison to control mice injected with unlabeled BzDTPA-pertuzumab (20 μg) or Sodium Chloride Injection USP. The dose of 111In-BzDTPA-pertuzumab corresponded to 23-times the human radioactivity dose and 10-times the protein dose on a MBq/kg and mg/kg basis, respectively. Toxicity was assessed by monitoring body mass, complete blood cell count (CBC), hematocrit (Hct), hemoglobin (Hb), serum creatinine (SCr) and alanine aminotransferease (ALT) and by histopathological examination of tissues at necropsy. Results: 111In-BzDTPA-pertuzumab exhibited a biphasic elimination from the blood with a distribution half-life (t1/2α) of 3.8 h and an elimination half-life (t1/2β) of 228.2 h. The radiopharmaceutical was distributed mainly in the blood, heart, lungs, liver, kidneys and spleen. The projected whole-body radiation absorbed dose in humans was 0.05 mSv/MBq corresponding to a total of 16.8 mSv for three separate administrations of 111In-BzDTPA-pertuzumab (111 MBq) planned for the Phase I/II trial. There were slight changes in Hb and SCr levels associated with administration of

  2. 5 CFR 7601.102 - Prior approval of outside employment.

    Science.gov (United States)

    2010-01-01

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

  3. Particle Suspension Mechanisms - Supplemental Material

    Energy Technology Data Exchange (ETDEWEB)

    Dillon, M B

    2011-03-03

    This supplemental material provides a brief introduction to particle suspension mechanisms that cause exfoliated skin cells to become and remain airborne. The material presented here provides additional context to the primary manuscript and serves as background for designing possible future studies to assess the impact of skin cells as a source of infectious aerosols. This introduction is not intended to be comprehensive and interested readers are encouraged to consult the references cited.

  4. Synthetic Androgens as Designer Supplements

    OpenAIRE

    Joseph, Jan Felix; Parr, Maria Kristina

    2015-01-01

    Anabolic androgenic steroids (AAS) are some of the most common performance enhancing drugs (PED) among society. Despite the broad spectrum of adverse effects and legal consequences, AAS are illicitly marketed and distributed in many countries. To circumvent existing laws, the chemical structure of AAS is modified and these designer steroids are sold as nutritional supplements mainly over the Internet. Several side effects are linked with AAS abuse. Only little is known about the pharmacologic...

  5. Dietary Supplements in Multiple Sclerosis

    OpenAIRE

    Alajbegović, A.; Alajbegović, S.; Đelilović-Vranić, J

    2011-01-01

    Replacement therapy is a treatment that is not based on accepted medical knowledge and science that is not in accordance with current medical doctrine. Additional treatment is not contrary to the accepted doctrine of medical schools, but serves only as a supplement to the accepted treatment. Most general practitioners in England and Germany do not contradict these forms of treatment. On average 2/3 of patients with MS in the course of the disease try alternate options and additional tre...

  6. Supplement Use of Elite Australian Swimmers.

    Science.gov (United States)

    Shaw, Gregory; Slater, Gary; Burke, Louise M

    2016-06-01

    This study examined the influence the Australian Institute of Sport (AIS) Sport Supplement Program had on supplement practices of elite Australian swimmers, comparing those guided by the Program with others in the same national team. Thirty-nine elite swimmers (13 AIS, 26 Other; 20 female, 19 male; age 21.8 ± 3.3 y) completed a questionnaire investigating supplement use. Ninety-seven percent of swimmers reported taking supplements or sports foods over the preceding 12 months. AIS swimmers reported using more total brands (p = .02) and supplements considered Ergogenic (p = .001) than Other swimmers who used more supplements considered to be lacking scientific support (p = .028). Swimmers rated the risk of a negative outcome from the use of supplements available in Australia (Mdn = 3.0) as less than the risk of supplements from international sources (Mdn = 4.0; p dietary supplements from supermarkets. These findings suggest that swimmers influenced by this sport supplement program more frequently use supplements that are recommended by allied health trained individuals, classified as evidence based and provided by the program. PMID:26630501

  7. Fort Nelson electrical generation project : British Columbia Hydro and Power Authority and TransAlta Energy Corporation Fort Nelson Electrical Generation Project : Report and recommendations of the Fort Nelson Electrical Generation Project Committee with respect to a decision on a project approval certificate application

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-09-01

    British Columbia Hydro and Power Authority (BC Hydro) and TransAlta Energy Corp. (TransAlta) have applied for a certificate of approval for the proposed construction of the Fort Nelson Energy Generation Project (FNEGP). The project will involve the design, construction, operation, dismantling and abandonment of a 45 MW combustion turbine power plant about 20 km south of Fort Nelson near Westcoast Energy`s gas plant. The proposed project will provide base load power to the town of Fort Nelson which now receives its electricity from Rainbow Lake, Alberta. Once FNEGP is operational, the standby diesel power plant in Fort Nelson will be decommissioned. The main issues raised during the review of the project were the potential impacts on air quality, water supply and waste management. It was determined that it is unlikely that the project will result in any significant negative impacts on terrestrial ecology, wildlife or aquatic life. The project would likely provide greenhouse gas offsets, since it would replace electricity from the Alberta Power Pool which is derived mostly from coal-fired thermal sources. Wastewater discharges from the project will be accommodated by Westcoast Energy`s wastewater treatment system. The proposed disposal of solid wastes and handling of special wastes was also found to be acceptable. Although there will be few opportunities for spills, the proponents have agreed to prepare an emergency response plan for use in the event of reportable spills. The socio-economic implications of the project are mostly positive with any negative impacts being minor in nature. Based on its review of the application the Project Committee recommended issuance of an approval certificate.

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

    International Nuclear Information System (INIS)

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

  9. Contents specification criteria for package design approvals in Germany

    International Nuclear Information System (INIS)

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

  10. SUPPLEMENTAL IRRIGATION THE IMBU TREE (Spondias tuberosa Arruda

    Directory of Open Access Journals (Sweden)

    Nilton de Brito Cavalcanti

    2011-07-01

    Full Text Available The imbu (Spondias tuberosa Arruda is a native tree of the semi-arid region of the Brazilian Northeast, whose fruit is of great importance for complementing the family income of small farmers. However, its reproductive cycle is still not very well known, especially a function to irrigation supplemental. This work was carried out to help follow the evolution of the reproductive cycle of the imbu, from the emission of the beginning of the floral bud to the ripening of the depending on the application of irrigation. This work was carried the Caatinga Experimental Station, Semiarid Embrapa of 8 plants. In each plant, 100 branches were randomly chosen from different parts of the crown and labelled for phenological data annotation. In the data obtained were determined averages standard deviations and coefficients of variation. The application of supplemental irrigation in imbuzeiro plants can significantly contribute to increase in fruit production.

  11. Approving of personal dosimeter services

    International Nuclear Information System (INIS)

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

  12. 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.

  13. FDA Approves Eye Implant for Aging Boomers

    Science.gov (United States)

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

  14. FDA Approves Implant to Battle Opioid Addiction

    Science.gov (United States)

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

  15. 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.

  16. 77 FR 68854 - Highland Associates, Inc. and Financial Investors Trust; Notice of Application

    Science.gov (United States)

    2012-11-16

    ... standard. 3. Applicants assert that the shareholders expect the Adviser and the Board to select the... without shareholder approval. Applicants: Highland Associates, Inc. (the ``Adviser'') and Financial... approval, to enter into and materially amend Subadvisory Agreements without obtaining shareholder...

  17. 78 FR 25301 - Notice of Intent To Prepare a Draft Supplemental Environmental Impact Statement for the Ruby...

    Science.gov (United States)

    2013-04-30

    ...: 14X5017] Notice of Intent To Prepare a Draft Supplemental Environmental Impact Statement for the Ruby...) is preparing a Draft Supplemental Environmental Impact Statement (EIS) for the Ruby Pipeline Project... Agency for Ruby Pipeline, LLC.'s (Ruby) application for the Ruby Pipeline Project. The FERC used...

  18. 75 FR 70741 - TPF Generation Holdings, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-11-18

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission TPF Generation Holdings, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding TPF Generation Holdings, LLC's application for...

  19. 75 FR 8325 - AEP Retail Energy Partners, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-02-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission AEP Retail Energy Partners, LLC; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of AEP Retail Energy Partner, LLC's application...

  20. 76 FR 53443 - ENBALA Power Networks (USA), Inc.; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2011-08-26

    ... Federal Energy Regulatory Commission ENBALA Power Networks (USA), Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization This is a supplemental notice in the above-referenced proceeding of ENBALA Power Networks (USA), Inc.'s application for...

  1. 75 FR 18201 - Big Horn II Wind Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-04-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Big Horn II Wind Project, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of Big Horn II Wind Project, LLC's application...

  2. 75 FR 35016 - EDF Industrial Power Services (NY), LLC; Supplemental Notice That Initial Market-Based Rate...

    Science.gov (United States)

    2010-06-21

    ... Energy Regulatory Commission EDF Industrial Power Services (NY), LLC; Supplemental Notice That Initial... supplemental notice in the above-referenced proceeding of EDF Industrial Power Services (NY), LLC's application...Library system by clicking on the appropriate link in the above list. They are also available for...

  3. 75 FR 70740 - New Harvest Wind Project LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-11-18

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission New Harvest Wind Project LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of New Harvest Wind Project LLC's application for...

  4. 75 FR 70738 - AP Gas & Electric (PA), LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-11-18

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission AP Gas & Electric (PA), LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding AP Gas & Electric (PA), LLC's application for...

  5. 76 FR 6613 - AP Gas & Electric (TX), LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2011-02-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission AP Gas & Electric (TX), LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of AP Gas & Electric (TX), LLC's application for...

  6. 75 FR 57016 - Top of the World Wind Energy, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-09-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Top of the World Wind Energy, LLC; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of Top of the World Wind Energy, LLC's application...

  7. 76 FR 6614 - Elk Wind Energy, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request...

    Science.gov (United States)

    2011-02-07

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Elk Wind Energy, LLC; Supplemental Notice That Initial Market- Based... supplemental notice in the above-referenced proceeding of Elk Wind Energy, LLC's application for...

  8. 75 FR 76004 - Planet Energy (New York) Corp.; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-12-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Planet Energy (New York) Corp.; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding, of Planet Energy (New York) Corp.'s application...

  9. 75 FR 74711 - Planet Energy (USA) Corp.; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-12-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Planet Energy (USA) Corp.; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding, of Planet Energy (USA) Corp.'s application for...

  10. 75 FR 48666 - Calpine Mid-Atlantic Marketing, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-08-11

    ... Energy Regulatory Commission Calpine Mid-Atlantic Marketing, LLC; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding, of Calpine Mid-Atlantic Marketing, LLC's application...Library system by clicking on the appropriate link in the above list. They are also available for...

  11. 75 FR 68352 - Yahoo Creek Wind Park, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-11-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Yahoo Creek Wind Park, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of Yahoo Creek Wind Park, LLC's application for...

  12. 75 FR 71426 - Blue Creek Wind Farm, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-11-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Blue Creek Wind Farm, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding, of Blue Creek Wind Farm, LLC's application for...

  13. 75 FR 63466 - Flat Water Wind Farm, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-10-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Flat Water Wind Farm, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of Flat Water Wind Farm, LLC's application for...

  14. 75 FR 4062 - Cosa Geothermal Power Holdings, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-01-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Cosa Geothermal Power Holdings, LLC; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of Cosa Geothermal Power Holdings, LLC's application...

  15. 75 FR 59257 - Merchants Plaza Energy, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-09-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Merchants Plaza Energy, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of Merchants Plaza Energy, LLC's application for...

  16. Safety Evaluation Report related to the operation of Fermi-2 (Docket No. 50-341). Supplement No. 5

    International Nuclear Information System (INIS)

    Supplement No. 5 to the Safety Evaluation Report (SER) related to the operation of the Fermi-2 facility, provides the NRC staff's evaluation of additional information submitted by the applicant regarding outstanding review issues identified in Supplement No. 4 to the SER dated September 1984. This supplement contains the staff's conclusion that there are no outstanding issues which must be resolved prior to issuance of a low-power operating license (i.e., less than five percent of full rated power) for the Fermi-2 facility. Supplement No. 5 to the SER also summarizes the conditions which are placed in the Fermi-2 operating license

  17. Probiotics supplementation for athletes - clinical and physiological effects.

    Science.gov (United States)

    Pyne, David B; West, Nicholas P; Cox, Amanda J; Cripps, Allan W

    2015-01-01

    Probiotic supplementation has traditionally focused on gut health. However, in recent years, the clinical applications of probiotics have broadened to allergic, metabolic, inflammatory, gastrointestinal and respiratory conditions. Gastrointestinal health is important for regulating adaptation to exercise and physical activity. Symptoms such as nausea, bloating, cramping, pain, diarrhoea and bleeding occur in some athletes, particularly during prolonged exhaustive events. Several studies conducted since 2006 examining probiotic supplementation in athletes or highly active individuals indicate modest clinical benefits in terms of reduced frequency, severity and/or duration of respiratory and gastrointestinal illness. The likely mechanisms of action for probiotics include direct interaction with the gut microbiota, interaction with the mucosal immune system and immune signalling to a variety of organs and systems. Practical issues to consider include medical and dietary screening of athletes, sourcing of recommended probiotics and formulations, dose-response requirements for different probiotic strains, storage, handling and transport of supplements and timing of supplementation in relation to travel and competition. PMID:25339255

  18. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages

    International Nuclear Information System (INIS)

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). 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

  19. Directory of certificates of compliance for radioactive materials packages. Volume 1, Revision 17: Report of NRC approved packages

    International Nuclear Information System (INIS)

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). 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

  20. Non-Mulberry and Mulberry Silk Protein Sericins as Potential Media Supplement for Animal Cell Culture

    OpenAIRE

    Sahu, Neety; Pal, Shilpa; Sapru, Sunaina; Kundu, Joydip; Talukdar, Sarmistha; Singh, N. Ibotambi; Yao, Juming; Kundu, Subhas C.

    2016-01-01

    Silk protein sericins, in the recent years, find application in cosmetics and pharmaceuticals and as biomaterials. We investigate the potential of sericin, extracted from both mulberry Bombyx mori and different non-mulberry sources, namely, tropical tasar, Antheraea mylitta; muga, Antheraea assama; and eri, Samia ricini, as growth supplement in serum-free culture medium. Sericin supplemented media containing different concentrations of sericins from the different species are examined for atta...

  1. Iodine Supplementation in the Newborn

    Directory of Open Access Journals (Sweden)

    Paolo Ghirri

    2014-01-01

    Full Text Available Iodine deficiency can be defined as the world’s greatest single cause of preventable brain damage. Fetal and neonatal hypothyroidism, caused by iodine deficiency can be prevented prior to conception and then during pregnancy and lactation when an adequate iodine supplementation is ensured. Extremely low birth weight preterm babies risk having a negative iodine balance status in the first weeks of life, exacerbating the hypothyroxinaemia of the prematurity. It is important to ensure that these babies are provided with an adequate iodine intake from the first days of life. Mothers and newborns should avoid environmental iodine excess during pregnancy or lactation.

  2. Nutritional Supplements to Enhance Recovery

    Science.gov (United States)

    Ziegenfuss, Tim N.; Landis, Jamie; Greenwood, Mike

    The ability to recover from intense exercise often separates good athletes from great ones. In the past, "recovery" often simply included rest, physical modalities (e.g., massage, hydration therapy) and meeting basic nutritional needs for fluid and energy intake. Today, athletes have a number of additional options to help them recover from high intensity training, one of which includes the judicious use of dietary supplements. This chapter briefly reviews nutritional strategies that have a strong theoretical background for enhancing rehydration/electrolyte balance, replenishing energy reserves, minimizing oxidative damage, and stimulating muscle repair.

  3. 27 CFR 40.394 - Notice of approval of bond.

    Science.gov (United States)

    2010-04-01

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

  4. 45 CFR 2400.42 - Approval of Plan of Study.

    Science.gov (United States)

    2010-10-01

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

  5. 46 CFR 160.023-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

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

  6. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

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

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

    Science.gov (United States)

    2010-01-01

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

  8. Consumer protection in the food supplements area

    OpenAIRE

    Luptáková, Marcela

    2014-01-01

    The topic of this diploma thesis is the Consumer protection in the food supplements area. The work has been devided into three parts. The first part is devoted to the overview about categorization of the products with the impact on health. This part of this work also includes the elementary terms, which are: food, food supplements, medicinal products, cosmetics products and medical devices. The second chapter is devoted to the matter of food supplements as such. The third chapter deals with t...

  9. 突水点长观资料在煤矿水文补勘中的应用%Application of Water Bursting Point Long -term Observation Data in Coal Mine Hydrogeological Supplement Exploration

    Institute of Scientific and Technical Information of China (English)

    贾鹏宙

    2015-01-01

    扩建、延深水平矿井水文地质补充勘探,应充分利用矿井已有的地质和水文地质资料,尤其是具有水文地质意义的井下长期涌水点。双柳煤矿太原组灰岩含水层富水性较弱,且埋深较大,在地面施工大口径水文勘探孔工程量大、费用高,且勘探周期长。根据水文地质补勘充分利用郭家山风井涌水长期观测资料,配合适量的小孔径地面观测孔,较好地控制了井田太原组灰岩含水层的地下水流程,取得了较准确的水文地质参数,既节省了勘探费用,又提高了勘探成果的可靠性。%Hydrogeological supplement exploration of expanding and deepening level mine should make full use of existing mine geological and hydrogeological data,especially the underground long -term water point with hydrogeo-logical significance.Shuangliu coal mine of Taiyuan group limestone aquifer water yield property is weak and the bur-ied depth is larger.It will lead to large quantities,high cost and long exploration period of constructing the hydrologic exploration hole of large diameter in the ground.According to the hydrogeological supplement exploration,makes use of air shaft water burst long -term observation data in Guojiashan,cooperates with the moderate small -bore ground observation hole,it better controls the groundwater flow of Taiyuan group limestone aquifer.Obtains the accurate hydrogeological parameters.Saves the exploration cost,and improves the reliability of exploration results.

  10. 78 FR 26407 - Goldman Sachs Trust II, et al.; Notice of Application

    Science.gov (United States)

    2013-05-06

    ... standard for the reasons discussed below. 6. Applicants assert that the shareholders expect the Adviser... shareholder approval and would grant relief from certain disclosure requirements. APPLICANTS: Goldman Sachs... shareholder approval. 4. Applicants request an order to permit the Adviser, subject to Board approval,...

  11. Dietary Supplement Ingredient Database (DSID): New Tool for Assessing Nutrient Intake from Dietary Supplements

    Science.gov (United States)

    Accurate information on the nutrient composition of dietary supplements is essential for determining their contribution to dietary intake. This year, the preliminary release of dietary supplement composition information is now available for researchers' use in evaluating diet and health interrelatio...

  12. 30 CFR 28.25 - Changes or modifications of approved fuses; issuance of modification of certificate of approval.

    Science.gov (United States)

    2010-07-01

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

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

    OpenAIRE

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

    2012-01-01

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

  14. Gamma-irradiated sewage solids as supplemental feed for ruminants

    International Nuclear Information System (INIS)

    Sewage represents a vast resource of nutrients that could be useful in supplemental feeding of livestock, especially ruminants, which can subsist on cellulosic and hemicellulosic herbage when supplemented with nitrogen and minerals. A large scale, long term research project at New Mexico State University, Las Cruces, and Sandia National Laboratories, Albuquerque, has evaluated dried solids from primary (''undigested'') sewage sludge as a supplemental feed for cattle and sheep. Dried sewage solids were subjected to γ-irradiation, 10 Gy (1 Mrad), using 137Cs, as a means of pathogen reduction. Digestibility of energy was about 60%, digestibility of N about 70%, and biological value of N (retention of absorbed N) about 65%. Intake and digestibility of poor quality roughages were improved about equally by experimental supplements with sewage solids or cottonseed meal. Reproduction of beef cows on arid range was improved, and calf weaning weights increased about equally by cottonseed meal and by experimental supplements with 50% or more sewage solids. Mature ewes fed irradiated sewage solids as 7% of total diet for over two years reproduced as well as ewes fed conventionally, but ewe lambs fed 7% irradiated sewage solids from weaning through early mating (at 8 months old) reproduced poorly. Tissue uptakes of heavy metals and halogenated hydrocarbons were low, and no induction of mixed function oxidase was observed. Prospective benefits from use of sewage products seem substantial and risks of toxicants seem manageable. Constraints on feeding of sewage products could be removed by means of appropriate selection and processing of sludges and application of technology to ensure safety and efficacy of products. (author)

  15. Nagra thermochemical data base. II. Supplement data 05/92

    International Nuclear Information System (INIS)

    Chemical thermodynamic data for aqueous species, minerals, and gases are required by Nagra for geochemical modelling. The Nagra thermochemical data base contains core and supplemental data. Core data for well-characterised entities were individually carefully selected and given by Pearson and Berner (1991). Supplemental data are for less common entities and for elements principally of safety assessment concern. They were selected in groups from other data bases for geochemical modelling and did not receive individual scrutiny. This report gives tables with the Nagra thermochemical data as of 5/92. It includes the core data described in the earlier report with supplemental data for the elements aluminium, silicon, iron, and manganese, the actinides thorium, uranium, neptunium, plutonium, and americium, and elements found as fission or activation products in nuclear waste, including nickel, zirconium, niobium, molybdenum, technetium, palladium, tin, selenium and iodine. Aqueous complexes of four representative organic anions are also included. The sources of these supplemental data are described in the text. Other compilations of data were examined during the selection on the supplemental data. These included the data bases used at the Paul Scherrer Institut with the geochemical programs MINEQL as of 3/91, PHREEQE as of 4/91, and the HATCHES 3.0 data base. This report also gives tables comparing selected data in these three data bases with values from the Nagra data base. This data base has not yet been tested for a full range of nuclear waste management applications, although such work is in progress. It should thus be regarded as a reference fixed point for quality assurance purpose and not critically reviewed standard. (author) tabs., refs

  16. Tie-down assessment of radioactive material packages on conveyances approach to competent authority approval applications in accordance with TS-R 1 (June 2000) and TS-G-1.1 (June 2002)

    International Nuclear Information System (INIS)

    This paper summarizes the authors' findings, during carrying out many package tie-down assessments, regarding the approach to the assessment process, and the issues that may arise. The current regulatory framework, as outlined in the abstract, is considered and possible areas for further development or research are discussed. The safe transport of a package containing radioactive material requires a secure system of retention on the conveyance during transport. The requirements for the assessment of this tie-down system are covered by International Atomic Energy Authority (IAEA) Regulations, and by the specific regulatory and guidance materials applying in the country of application. The IAEA regulations have recently been updated in TS-R-1 (June 2000) [1] and TS-G-1.1 (June 2002) [2]. In particular, Appendix V of reference [2] specifically covers 'Package Stowage and Retention during Transport'. In the United Kingdom the Transport Container Standardisation Committee (TCSC) provides guidance on the application of the IAEA regulations in TCSC 1006 ''The securing of Radioactive Materials on Conveyances'' [3], and this document has also been revised in December 2003. The basic requirement of the IAEA regulations is to maintain the integrity of the components of the package and its retention systems during routine operations (TS-R-1 Para 612). In accident conditions the package is permitted and may be required as part of the design (the weak-link approach as discussed later in this paper) to separate from the conveyance, while preserving the package integrity. Any tie-down attachments on the package shall be so designed that, under normal and accident conditions of transport, the forces in those attachments shall not impair the ability of the package to meet the requirements of the Regulations. (TS-R-1 Para 636)

  17. Dietary supplements and pediatric non-alcoholic fatty liverdisease: Present and the future

    Institute of Scientific and Technical Information of China (English)

    2015-01-01

    Non-alcoholic fatty liver disease (NAFLD) is the mostcommon chronic liver disease in children. High prevalenceof pediatric obesity and sedentary lifestyle hasaugmented the incidence of NAFLD in children. Obesityis associated with an increased risk of NAFLD throughvarious mechanisms such as intensification of insulinresistance and increased levels of inflammatory markers.There is no approved medical intervention for treatmentof pediatric NAFLD; the only proven strategy in managementof pediatric NAFLD is lifestyle modification.Recently, the effects of nutritional supplements havebeen examined in the management of pediatric NAFLD.The purpose of this review is to summarize the studiesevaluating the effects of nutritional supplements onpediatric NAFLD and explain the future direction in thisfield.

  18. Considerations, clues and challenges: Gaining Ethical and Trust research approval when using the NHS as a research setting

    International Nuclear Information System (INIS)

    Substantial changes have been made in recent years to the process of obtaining ethical and research governance approval for research projects in the NHS. The advent of the Integrated Research Application System (IRAS) has streamlined the process, providing a single point of entry. Ethical approval gained in one part of the country is now valid throughout the UK. The previous process of gaining research governance approval in NHS Trusts was maligned and it has been overhauled with the introduction of the National Institute of Health Research (NIHR) Coordinated System for gaining NHS Permission. In addition to updating the reader about the new processes around gaining ethical and Trust approval for research within an NHS setting, essential research project documentation needed for submission are discussed. The aspects of a proposal that Ethics Committees and Trust R and D Departments consider when reviewing applications are highlighted. The implemented changes to the research approval processes will mostly benefit large multi-centre studies; small scale unfunded studies and student projects are potentially at risk of being marginalised in the quest for a streamlined ethics and NHS Trust research governance approval process. However, researchers' familiarity with the approval system should minimise rejection rates and delays.

  19. 78 FR 50410 - Black Bear Development Holdings, LLC; Supplemental Notice that Initial Market-Based Rate Filing...

    Science.gov (United States)

    2013-08-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Black Bear Development Holdings, LLC; Supplemental Notice that Initial... notice in the above-referenced proceeding of Black Bear Development Holdings, LLC's application...

  20. Safety Evaluation Report related to the operation of Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Docket Nos. STN 50-528, STN 50-529, and STN 50-530). Supplement No. 8

    International Nuclear Information System (INIS)

    Purpose of this supplement is to update the Safety Evaluation Report by providing an evaluation of additional information submitted by the applicant since Supplement No. 7 was issued and matters that the staff had under review when Supplement No. 7 was issued, specifically those issues which required resolution prior to plant operation of Unit 1 above 5% full power

  1. 7 CFR 1484.30 - How does FAS formalize its working relationship with approved Cooperators?

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false How does FAS formalize its working relationship with... FAS formalize its working relationship with approved Cooperators? FAS will notify each applicant in... sign the program agreement and submit the signed agreement to the Director, Marketing Operations...

  2. 77 FR 55171 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Deferral for CO2

    Science.gov (United States)

    2012-09-07

    ... permitting authorities and sources (75 FR 31514). EPA accomplished this by tailoring the applicability... amended by the `Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule' (75 FR 31514).'' EPA approved this revision into the Maryland SIP on August 2, 2012 (77 FR 45949). B....

  3. 77 FR 23178 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Deferral for CO2

    Science.gov (United States)

    2012-04-18

    ... authorities and sources (75 FR 31514). EPA accomplished this by tailoring the applicability criteria that... approve that SIP revision (76 FR 27898). B. EPA's Biomass Deferral Rule On July 20, 2011, EPA promulgated... rulemaking at 76 FR 43490. The biomass deferral delays until July 21, 2014 the consideration of CO...

  4. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-08-19

    ... the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsand...-0724, FDA-2013-M-0738, and FDA-2013-M-0758] Medical Devices; Availability of Safety and Effectiveness...., Docket No. Applicant Trade name Approval date P120016, FDA-2013-M-0592..... Cardiva Medical, Inc....

  5. 78 FR 59701 - Medicare Program; Approval of Accrediting Organization for Suppliers of Advanced Diagnostic...

    Science.gov (United States)

    2013-09-27

    ..., Federal Register (75 FR 4088), we announced the approval of the American College of Radiology (ACR), the... on November 25, 2009 (74 FR 61738), as corrected in the November 30, 2009 correcting document (74 FR 62579) and set forth as application criteria in a November 25, 2009 Federal Register notice (74 FR...

  6. 78 FR 9973 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2013-02-12

    ... with the requirements of the Act and the rules and regulations thereunder applicable to a national... Commission believes that it is consistent with the Act for the Exchange to reduce the response times in the... COMMISSION Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a...

  7. 40 CFR 80.235 - How does a refiner obtain approval as a small refiner?

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false How does a refiner obtain approval as a small refiner? 80.235 Section 80.235 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...) The small refiner status application must contain the following information for the company...

  8. 30 CFR 57.22304 - Approved equipment (II-A mines).

    Science.gov (United States)

    2010-07-01

    ... requirements of 30 CFR parts 18 through 36. (b) While cutting or drilling is in progress, equipment not approved by MSHA under the applicable requirements of 30 CFR parts 18 through 36 shall remain at least 100... nonapproved equipment is taken to a face or bench after blasting. (d) Mine power transformers and...

  9. 40 CFR 35.2122 - Approval of user charge system and proposed sewer use ordinance.

    Science.gov (United States)

    2010-07-01

    ... Treatment Works § 35.2122 Approval of user charge system and proposed sewer use ordinance. If the project is... proposed sewer use ordinance. 35.2122 Section 35.2122 Protection of Environment ENVIRONMENTAL PROTECTION... existing) sewer use ordinance § 35.2130). If the applicant has a sewer use ordinance or user charge...

  10. 77 FR 17072 - Medicare and Medicaid Programs; Approval of the Community Health Accreditation Program for...

    Science.gov (United States)

    2012-03-23

    ... appropriately to complaints against accredited facilities; and, (5) survey review and decision-making process... 1861(m) and (o) and 1891 and 1895 of the Social Security Act (the Act) establish distinct criteria for... accreditation program for HHAs expires March 31, 2012. II. Deeming Applications Approval Process Section...

  11. 76 FR 22709 - Medicare and Medicaid Programs; Approval of the American Association for Accreditation of...

    Science.gov (United States)

    2011-04-22

    ... accredited facilities; and (5) survey review and decision-making process for accreditation. A comparison of..., ``organizations''), provided certain requirements are met. Section 1861(p)(4) of the Social Security Act (the Act.... Deeming Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable...

  12. 78 FR 53149 - Medicare and Medicaid Programs: Continued Approval of American Osteopathic Association/Healthcare...

    Science.gov (United States)

    2013-08-28

    ...) survey review and decision-making process for accreditation. The comparison of AOA/HFAP's accreditation... services in a hospital provided certain requirements are met. Section 1861(e) of the Social Security Act.... Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure...

  13. 77 FR 51537 - Medicare and Medicaid Programs; Continued Approval of Det Norske Veritas Healthcare's (DNVHC's...

    Science.gov (United States)

    2012-08-24

    ... appropriately to complaints against accredited facilities; and (5) survey review and decision-making process for... are met. Section 1861(e) of the Social Security Act (the Act) establishes distinct criteria for... hospital accreditation program expires September 26, 2012. II. Application Approval Process Section...

  14. 78 FR 45231 - Medicare and Medicaid Programs; Initial Approval of Center for Improvement in Healthcare Quality...

    Science.gov (United States)

    2013-07-26

    ... complaints against accredited facilities; and, (5) survey review and decision-making process for... services in a hospital provided certain requirements are met. Section 1861(e) of the Social Security Act... every 6 years, or sooner, as determined by CMS. II. Application Approval Process Section...

  15. 77 FR 70783 - Medicare and Medicaid Programs; Approval of the Accreditation Association for Ambulatory Health...

    Science.gov (United States)

    2012-11-27

    ... decision-making process for accreditation. The comparison of AAAHC's accreditation to CMS's current... are met. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) requires ASCs to meet ] health... program expires on December 20, 2012. II. Application Approval Process Section 1865(a)(3)(A) of the...

  16. 75 FR 11990 - Chicago Executive Airports Noise Exposure Map Approval and Noise Compatibility Program Review

    Science.gov (United States)

    2010-03-12

    ... applicant's data, information or plans, or constitute a commitment to approve a noise compatibility program... Chicago Executive Airport Board of Directors for Chicago Executive Airport under the provisions of 49 U.S... Board of Directors submitted to the FAA on June 18, 2009 noise exposure maps, descriptions and...

  17. 75 FR 39932 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-07-13

    ... February 19, 2010 (75 FR 7476), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received... Application for Sustainable Water Leadership Program (Renewal) AGENCY: Environmental Protection Agency (EPA... of Management and Budget (OMB) for review and approval. This is a request to renew an...

  18. 75 FR 26223 - ETC Katy Pipeline, Ltd.; Notice of Petition for Rate Approval

    Science.gov (United States)

    2010-05-11

    ... Energy Regulatory Commission ETC Katy Pipeline, Ltd.; Notice of Petition for Rate Approval May 3, 2010. Take notice that on April 28, 2010, ETC Katy Pipeline, Ltd. (ETC) filed, pursuant to section 284.123(b... the Commission's Regulations. ETC states that these rates will be applicable to the firm...

  19. 76 FR 59927 - Treatment of Aliens Whose Employment Creation Immigrant (EB-5) Petitions Were Approved After...

    Science.gov (United States)

    2011-09-28

    ... SECURITY 8 CFR Parts 216 and 245 RIN 1615-AA90 Treatment of Aliens Whose Employment Creation Immigrant (EB... applications and petitions of qualifying aliens whose employment-creation immigrant petitions were approved by...-273 Provisions C. Summary of the Adjudications Required by Public Law 107-273 III. Aliens Eligible...

  20. 76 FR 17181 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2011-03-28

    ... of Renewed Approval of Information Collection: SWIFT Customer Satisfaction Survey AGENCY: Federal...: SWIFT Customer Satisfaction Survey. Form Numbers: There are no FAA forms associated with this collection... information is necessary to determine how satisfied applicants are with the automated staffing solution....

  1. 40 CFR 80.1340 - How does a refiner obtain approval as a small refiner?

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false How does a refiner obtain approval as a small refiner? 80.1340 Section 80.1340 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... small refiner status application must contain the following information for the company seeking...

  2. 77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-12-13

    ... and Budget (OMB) approval of the Information Collection: Work-Study Program of the Child Labor... application and written participation agreement. In order to utilize the child labor work study provisions... and Hour Division. Title: Work-Study Program of the Child Labor Regulations (WSP) Regulations 29...

  3. 76 FR 41451 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2011-07-14

    ... accordance with the Paperwork Reduction Act of 1995, this notice announces that the Foreign Agricultural...: Specialty Sugar Certificate Application. OMB Number: 0551-0025. Expiration Date of Approval: December 31... and Molasses, subpart B--Specialty Sugar) established terms and conditions under which...

  4. 77 FR 21977 - Whitestone Power and Communications; Notice Concluding Pre-Filing Process and Approving Process...

    Science.gov (United States)

    2012-04-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Whitestone Power and Communications; Notice Concluding Pre- Filing Process and Approving Process Plan and Schedule a. Type of Filing: Notice of Intent To File an Application for a Hydrokinetic Pilot Project License....

  5. 77 FR 73612 - Notice of Request for Extension of Approval of an Information Collection; Introduction of...

    Science.gov (United States)

    2012-12-11

    ... information and recordkeeping requirements, including APHIS- issued permits, applicants' field testing records... collection of information, including the validity of the methodology and assumptions used; (3) Enhance the... Animal and Plant Health Inspection Service Notice of Request for Extension of Approval of an...

  6. 77 FR 60672 - Approval for Manufacturing Authority, Foreign-Trade Zone 99, Fisker Automotive, Inc., (Electric...

    Science.gov (United States)

    2012-10-04

    ... given in the Federal Register (77 FR 19000, 3-29-2012) and the application has been processed pursuant... Foreign-Trade Zones Board Approval for Manufacturing Authority, Foreign-Trade Zone 99, Fisker Automotive..., has requested manufacturing authority on behalf of Fisker Automotive, Inc., within FTZ 99--Site...

  7. Review of non-FDA-approved fillers.

    Science.gov (United States)

    Ellis, David A F; Segall, Lorne

    2007-05-01

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

  8. Dietary Supplements and Sports Performance: Herbals

    Directory of Open Access Journals (Sweden)

    Williams Melvin

    2006-06-01

    Full Text Available Abstract This is the fourth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations. The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance.

  9. Antioxidant supplements for preventing gastrointestinal cancers

    DEFF Research Database (Denmark)

    Bjelakovic, G; Nikolova, D; Simonetti, R G;

    2004-01-01

    Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory.......Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory....

  10. Dietary Supplements and Sports Performance: Herbals

    OpenAIRE

    Williams Melvin

    2006-01-01

    Abstract This is the fourth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance.

  11. Antioxidant supplements for preventing gastrointestinal cancers

    DEFF Research Database (Denmark)

    Bjelakovic, Goran; Nikolova, Dimitrinka; Simonetti, Rosa G;

    2008-01-01

    Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory.......Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory....

  12. Dietary Supplements and Sports Performance: Amino Acids

    OpenAIRE

    Williams Melvin

    2005-01-01

    Abstract This is the third in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance.

  13. Enhanced Nutrition Education Instead of Consuming Supplements

    Science.gov (United States)

    Crowder, Todd; Kidd, Kellie; Jensen, Nancy; Jensen, Laura

    2008-01-01

    Fueled by the internet, instantaneous videos, and the emphasis to look "right" or always win athletic competitions, many students are seeking information on nutrition and dietary supplements. Classroom observations reveal student interest and discussions are among the highest when the topic is dietary supplements. Teachers and coaches provide an…

  14. 14 CFR 91.211 - Supplemental oxygen.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Supplemental oxygen. 91.211 Section 91.211 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR TRAFFIC...) At flight altitudes above flight level 250 unless at least a 10-minute supply of supplemental...

  15. CURRENT POPULATION SURVEY MARRIAGE AND FERTILITY SUPPLEMENT

    Science.gov (United States)

    These supplements to the June round of the Current Population Survey (conducted at five-year intervals starting in 1971) were designed to examine transitions in the American family and to measure the demographic implications of these transitions for children. The supplements ask ...

  16. 30 CFR 75.361 - Supplemental examination.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Supplemental examination. 75.361 Section 75.361... MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.361 Supplemental examination. (a) Except for certified persons conducting examinations required by this subpart, within 3 hours before...

  17. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391): Supplement No. 19

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-11-01

    Supplement No. 19 to the Safety Evaluation Report for the application filed by the Tennessee Valley Authority for license to operate Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, located in Rhea County Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation with (1) additional information submitted by the applicant since Supplement No. 18 was issued, and (2) matters that the staff had under review when Supplement No. 18 was issued.

  18. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391): Supplement No. 19

    International Nuclear Information System (INIS)

    Supplement No. 19 to the Safety Evaluation Report for the application filed by the Tennessee Valley Authority for license to operate Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, located in Rhea County Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation with (1) additional information submitted by the applicant since Supplement No. 18 was issued, and (2) matters that the staff had under review when Supplement No. 18 was issued

  19. Safety Evaluation Report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 12

    Energy Technology Data Exchange (ETDEWEB)

    Tam, P.S.

    1993-10-01

    Supplement No. 12 to the Safety Evaluation Report for the application filed by the Tennessee Valley Authority for license to operate Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, located in Rhea County, Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation of (1) additional information submitted by the applicant since Supplement No. 11 was issued, and (2) matters that the staff had under review when Supplement No. 11 was issued.

  20. Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 14

    International Nuclear Information System (INIS)

    Supplement No. 14 to the Safety Evaluation Report for the application filed by the Tennessee Valley Authority for license to operate Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, located in Rhea County, Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation with additional information submitted by the applicant since Supplement No. 13 was issued, and matters that the staff had under review when Supplement No. 13 was issued

  1. Regional Assessment of Supplementation Project. Status report

    Energy Technology Data Exchange (ETDEWEB)

    1991-10-01

    The Fish and Wildlife Program of the Northwest Power Planning Council (NPPC) prescribes several approaches to achieve its goal of doubling the salmon and steelhead runs of the Columbia River. Among those approaches are habitat restoration, improvements in adult and juvenile passage at dams and artificial propagation. Supplementation will be a major part of the new hatchery programs. The purpose of the Regional Assessment of Supplementation Project (RASP) is to provide an overview of ongoing and planned supplementation activities, to construct a conceptual framework and model for evaluating the potential benefits and risks of supplementation and to develop a plan for better regional coordination of research and monitoring and evaluation of supplementation. RASP has completed its first year of work. Progress toward meeting the first year`s objectives and recommendations for future tasks are contained in this report.

  2. Regional Assessment of Supplementation Project : Status Report.

    Energy Technology Data Exchange (ETDEWEB)

    Unknown author

    1991-10-01

    The Fish and Wildlife Program of the Northwest Power Planning Council (NPPC) prescribes several approaches to achieve its goal of doubling the salmon and steelhead runs of the Columbia River. Among those approaches are habitat restoration, improvements in adult and juvenile passage at dams and artificial propagation. Supplementation will be a major part of the new hatchery programs. The purpose of the Regional Assessment of Supplementation Project (RASP) is to provide an overview of ongoing and planned supplementation activities, to construct a conceptual framework and model for evaluating the potential benefits and risks of supplementation and to develop a plan for better regional coordination of research and monitoring and evaluation of supplementation. RASP has completed its first year of work. Progress toward meeting the first year's objectives and recommendations for future tasks are contained in this report.

  3. Mineral supplementation in Tunisian smallholder dairy farms

    International Nuclear Information System (INIS)

    The aim of the experiment was to determine the effects of supplementation of di-calcium-phosphate in the form of blocks in late pregnancy (2 months before calving), on production and reproduction parameters of dairy cattle in smallholder farms. The experiment covered 63 animals in 20 smallholder farms, divided into control and supplemented groups. Results showed that mineral supplementation had a significant effect on calf weight, milk fat content and reproduction parameters. Calves born to cattle supplemented with di-calcium-phosphate were heavier by 1.67 kg than those in the control group. Similarly, the average milk fat content in the supplemented group was 5.6 g/L (P0.05). (author)

  4. IAEA Board of Governors approves IAEA action plan to combat nuclear terrorism

    International Nuclear Information System (INIS)

    The IAEA Board of Governors today approved in principal an action plan designed to upgrade worldwide protection against acts of terrorism involving nuclear and other radioactive materials. In approving the plan, the Board has recognized that the first line of defense against nuclear terrorism is the strong physical protection of nuclear facilities and materials. 'National measures for protecting nuclear material and facilities are uneven in their substance and application,' the IAEA says. 'There is wide recognition that the international physical protection regime needs to be strengthened.'

  5. Guidelines for approved medical officers on health surveillance of radiation workers

    International Nuclear Information System (INIS)

    As a result of the adoption of the Council of the European Communities Directive No. 80/836 Euratom which lays down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, there is a need for nominating Approved Medical Officers whose functions in respect of hospital workers are outlined in the Department of Health Circular, Oct. 1983 (Appendix 1), and which are considered applicable to all other workers. This document outlines the role of the Approved Medical Officer and proides information to aid him/her in this work (author)

  6. HERBAL SUPPLEMENTS: CAUSE FOR CONCERN?

    Directory of Open Access Journals (Sweden)

    Paolo Borrione

    2008-12-01

    Full Text Available More than 1400 herbal products or herbal-derived compounds are commonly commercialised for health uses worldwide (Tyler, 1996. Herbs are considered dietary supplements, and therefore are subjected to a very limited form of regulation, and advertisements normally highlight their potential activities without mentioning any side effect. Also, herbs are generally believed to be 'natural', and hence safe. Many nutritional supplements contains herb compounds usually not present in the diet (e.g. Ginko biloba, horse- chestnut, and only 10% of the herbs used in nutritional supplements are commonly present in the food (e.g. garlic, soy, blueberry, green the, ginger, curcuma (Eisenberg et al., 1993. There is much interest in "alternative natural approaches" in sport. It is appealing for athletes to use 'natural' substances with similar activity to 'pharmacological' ones in term of improving performance, are not considered doping, and are considered side-effects free (Table 1. Indeed, many herbal dietary supplements marketed on internet are presented as legal alternative to illicit drugs (Denneey et al., 2005. EcdysteroidsEcdysteroids are the steroid hormones of arthropods (Figure 1. They also occur in some plants, where they are known as phytoecdysteroids, and are believed to contribute to deter invertebrate predators. In insects, they regulate moulting and metamorphosis, may regulate reproduction and diapause. Most actions of ecdysteroids are mediated by intracellular receptor complexes, which regulate gene expression in a tissue- and development-specific manner (Lehmann et al 1989.Several phytoecdysteroids have anabolic growth-promoting effects on mice, rats, pigs and Japanese quails. Ecdysteroids stimulate muscle growth, and this anabolic effect promotes increased physical performance without training. Ecdysteroids are also able to increase muscle ATP content in vitamin D-deprived rats (Báthori, 2002. Ecdysteroids stimulate protein synthesis in the

  7. 40 CFR 52.722 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  8. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  9. 7 CFR 1735.61 - Approval criteria.

    Science.gov (United States)

    2010-01-01

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

  10. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

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

  11. 23 CFR 645.215 - Approvals.

    Science.gov (United States)

    2010-04-01

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

  12. 77 FR 16544 - Pesticide Product Registration Approvals

    Science.gov (United States)

    2012-03-21

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

  13. Side effects of cytokines approved for therapy.

    Science.gov (United States)

    Baldo, Brian A

    2014-11-01

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

  14. 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…

  15. 46 CFR 58.16-10 - Approvals.

    Science.gov (United States)

    2010-10-01

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

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

    International Nuclear Information System (INIS)

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

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

    Science.gov (United States)

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

    2015-01-01

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

  18. 7 CFR 1948.61 - State supplements and guides.

    Science.gov (United States)

    2010-01-01

    ...) PROGRAM REGULATIONS (CONTINUED) RURAL DEVELOPMENT Section 601 Energy Impacted Area Development Assistance... Public Law 103-354 office). (a) State supplements. State Directors may supplement this subpart...

  19. 30 CFR 28.20 - Certificates of approval; scope of approval.

    Science.gov (United States)

    2010-07-01

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

  20. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

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