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

    ... HUMAN SERVICES Food and Drug Administration Proposal To Refuse To Approve a Supplemental New Drug Application for Bromday (Bromfenac Ophthalmic Solution), 0.09%; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA), 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

    ... new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The supplemental NADA provides... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G procaine... supplemental NADA is approved as of April 23, 2010. In accordance with the freedom of information provisions...

  3. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Science.gov (United States)

    2013-12-27

    ... Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of... holders of an approved drug or biological product to change the product labeling to reflect certain types... biological product to change the product labeling to reflect certain types of newly acquired information...

  4. 78 FR 67985 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

    Science.gov (United States)

    2013-11-13

    ... therapy. As a drug is used more widely or under diverse conditions, new information regarding the risks... applicant should submit a proposed narrative description of the proposed labeling change in the CBE-0 supplement for posting on the FDA Web page. This brief narrative description should include the...

  5. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Science.gov (United States)

    2013-08-02

    ..., Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical... active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to... one or more finished dosage forms of a human generic drug or an active pharmaceutical ingredient...

  6. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Science.gov (United States)

    2012-10-25

    ... applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II active pharmaceutical ingredient DMFs to be made available for... pharmaceutical ingredients other than by reference to a DMF will pay an additional fee that is based on...

  7. 78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

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

  8. 78 FR 70496 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

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

  9. 21 CFR 515.11 - Supplemental medicated feed mill license applications.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Supplemental medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Applications § 515.11 Supplemental medicated feed mill license applications. (a) After approval of a medicated...

  10. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Science.gov (United States)

    2010-12-16

    ... 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 Sarbanes-Oxley Act of 2002 \\1\\ (the ``Sarbanes-Oxley Act'') established the Public Company Accounting...

  11. 78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

    Science.gov (United States)

    2013-02-20

    .... Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. 5. Hand Delivery... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION... Supplemental Motor Vehicle Emissions Budget Update AGENCY: Environmental Protection Agency (EPA)....

  12. 30 CFR 250.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Science.gov (United States)

    2010-07-01

    ... discharged; (6) Request a new H2S area classification, or increase the concentration of H2S to a... supplement your approved EP, DPP, or DOCD when you propose to conduct activities on your lease(s) or...

  13. 28 CFR 58.17 - Procedures for denying an application or removing an agency from the approved list, and the...

    Science.gov (United States)

    2010-07-01

    ... credit counseling agency. (b) No administrative review will be granted to any applicant that submitted an... supplemented by, an interim directive, which may immediately remove an agency from the approved list. Such an interim directive may be issued if one or more of the following are specifically found: (1) The agency...

  14. 21 CFR 314.125 - Refusal to approve an application.

    Science.gov (United States)

    2010-04-01

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

  15. 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...

  16. 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.

  17. 21 CFR 314.153 - Suspension of approval of an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

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

  18. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

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

  19. 75 FR 55334 - Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five New Drug Applications

    Science.gov (United States)

    2010-09-10

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

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

    Science.gov (United States)

    2010-11-22

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

  1. 30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

    Science.gov (United States)

    2010-07-01

    ... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Machines Assembled With Certified or Explosion-Proof Components, Field Modifications of Approved Machines... and Certification Center, 765 Technology Drive, Triadelphia, WV 26059. (b) Proposed...

  2. 21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.

    Science.gov (United States)

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW... that is described in the application or abbreviated application and that is essential to show that the... or contract research organization that conducted a bioavailability or bioequivalence study...

  3. 21 CFR 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

    Science.gov (United States)

    2010-04-01

    ... or abbreviated application for a new drug. 314.152 Section 314.152 Food and Drugs FOOD AND DRUG... APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug. If the Food and...

  4. 21 CFR 900.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-04-01

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

  5. 77 FR 50702 - Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications

    Science.gov (United States)

    2012-08-22

    ... Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications... introduction into interstate commerce of products without approved new drug applications violates section...

  6. 21 CFR 99.205 - Application for exemption from the requirement to file a supplemental application.

    Science.gov (United States)

    2010-04-01

    ... prohibitive or that it would be unethical to conduct the studies necessary to submit a supplemental... unethical to conduct the studies necessary for the supplemental application for a new use, the manufacturer... adequacy of the existing data; and (ii) Explaining why it would be unethical to conduct the further...

  7. 75 FR 75548 - SI Financial Group, Inc., Willimantic, CT; Approval of Conversion Application

    Science.gov (United States)

    2010-12-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Office of Thrift Supervision SI Financial Group, Inc., Willimantic, CT; Approval of Conversion Application Notice is hereby given that on November 10, 2010, the Office of Thrift Supervision approved the application of SI Bancorp, MHC,...

  8. 75 FR 52065 - SharePlus Federal Bank, Plano, TX; Approval of Conversion Application

    Science.gov (United States)

    2010-08-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Office of Thrift Supervision SharePlus Federal Bank, Plano, TX; Approval of Conversion Application Notice is hereby given that on August 12, 2010, the Office of Thrift Supervision approved the application...

  9. 42 CFR 8.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-10-01

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

  10. 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 Drug Application for MERIDIA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for...

  11. 5 CFR 630.905 - Approval of application to become a leave recipient.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Approval of application to become a leave recipient. 630.905 Section 630.905 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS ABSENCE AND LEAVE Voluntary Leave Transfer Program § 630.905 Approval of application to become...

  12. 5 CFR 630.1007 - Approval of application to become a leave recipient.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Approval of application to become a leave recipient. 630.1007 Section 630.1007 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS ABSENCE AND LEAVE Voluntary Leave Bank Program § 630.1007 Approval of application to become...

  13. 24 CFR 886.107 - Approval of applications.

    Science.gov (United States)

    2010-04-01

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

  14. 77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

    Science.gov (United States)

    2012-08-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Hospira, Inc.; Withdrawal of Approval of a New Drug... Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for DEXTRAN 70...

  15. 78 FR 46984 - Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA

    Science.gov (United States)

    2013-08-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pfizer, Inc.; Withdrawal of Approval of a New Drug... Administration (FDA) is withdrawing approval of a new drug application (NDA) for BEXTRA (valdecoxib) 10...

  16. 75 FR 65642 - Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride...

    Science.gov (United States)

    2010-10-26

    ...The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these...

  17. 21 CFR 515.20 - Approval of medicated feed mill license applications.

    Science.gov (United States)

    2010-04-01

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

  18. 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)...

  19. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

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

  20. 76 FR 22713 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

    Science.gov (United States)

    2011-04-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine; Correction AGENCY: Food and Drug Administration, HHS....

  1. 78 FR 36641 - Proposed Information Collection (Application for Approval of a Licensing or Certification and...

    Science.gov (United States)

    2013-06-18

    ... AFFAIRS Proposed Information Collection (Application for Approval of a Licensing or Certification and Organization or Entity) Activity: Comment Request AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Veterans Benefits Administration (VBA), Department...

  2. 75 FR 47680 - Proposed Information Collection (Application for Approval of a Licensing or Certification and...

    Science.gov (United States)

    2010-08-06

    ... AFFAIRS Proposed Information Collection (Application for Approval of a Licensing or Certification and Organization or Entity) Activity: Comment Request AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Veterans Benefits Administration (VBA), Department...

  3. 78 FR 2295 - Consideration of Approval of Application Containing Sensitive Unclassified Non-Safeguards...

    Science.gov (United States)

    2013-01-10

    ... From the Federal Register Online via the Government Publishing Office ] NUCLEAR REGULATORY COMMISSION Consideration of Approval of Application Containing Sensitive Unclassified Non-Safeguards Information Regarding Proposed Energy Future Holdings Corporation Internal Restructuring AGENCY:...

  4. 78 FR 66748 - Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications...

    Science.gov (United States)

    2013-11-06

    ... Approval of 14 New Drug Applications; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS... hearing on the Agency's proposal to withdraw approval of 14 new drug applications (NDAs) from multiple... to remove the products from the market. Any new drug product marketed without an approved new...

  5. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

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

  6. 20 CFR 416.305 - You must file an application to receive supplemental security income benefits.

    Science.gov (United States)

    2010-04-01

    ... supplemental security income benefits. 416.305 Section 416.305 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Filing of Applications General...) Exceptions. You need not file a new application if— (1) You have been receiving benefits as an...

  7. 76 FR 79701 - Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97...

    Science.gov (United States)

    2011-12-22

    ... 70 New Drug Applications and 97 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug... withdrawal of approval of 70 new drug applications (NDAs) and 97 abbreviated new drug applications...

  8. 75 FR 28815 - Application and Re-certification Packages for Approval of Nonprofit Organizations in FHA Activities

    Science.gov (United States)

    2010-05-24

    ... URBAN DEVELOPMENT Application and Re-certification Packages for Approval of Nonprofit Organizations in... public comments on the subject proposal. In general, a nonprofit organization must be HUD-approved and meet specific requirements to maintain approval and remain on the Nonprofit Organization Roster...

  9. 78 FR 78716 - Withdrawal of Approval of New Animal Drug Applications; Roxarsone

    Science.gov (United States)

    2013-12-27

    ... Applications; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and... five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's... requested that FDA withdraw approval of the following five NADAs for roxarsone oral dosage form...

  10. 49 CFR 107.402 - Application for designation as an approval or certification agency.

    Science.gov (United States)

    2010-10-01

    ... organization or person seeking designation as an approval or certification agency shall apply in writing to the... designation must be in English and include the following information: (1) Name and address of the applicant... with § 105.40 to serve as agent for service of process. (2) If the applicant's principal place...

  11. 27 CFR 479.64 - Procedure for approval of application.

    Science.gov (United States)

    2010-04-01

    ..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN OTHER FIREARMS Tax on Making Firearms Application to Make A Firearm § 479.64 Procedure...

  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. 75 FR 27119 - ViewPoint Financial Group, Inc., Plano, Texas; Approval of Conversion Application

    Science.gov (United States)

    2010-05-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Office of Thrift Supervision ViewPoint Financial Group, Inc., Plano, Texas; Approval of Conversion... application of ViewPoint MHC and ViewPoint Bank, Plano, Texas, to convert to the stock form of...

  14. 78 FR 70062 - Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

    Science.gov (United States)

    2013-11-22

    ...; Carbarsone; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for roxarsone or... longer manufactured or marketed: NADA 007-891 for 3-NITRO (roxarsone) Type A medicated article, NADA...

  15. 75 FR 9276 - Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion Application

    Science.gov (United States)

    2010-03-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Office of Thrift Supervision Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion... application of Harvard Savings Bank, Harvard, Illinois, to convert to the stock form of organization....

  16. 7 CFR 1485.14 - Application approval and formation of agreements.

    Science.gov (United States)

    2010-01-01

    ... resources, approve those applications which it considers to present the best opportunity for developing...) Export volume and value and market share goals in each country; (v) Description of evaluation plan and suitability of the plan for performance measurement; and (vi) Past program results and evaluations,...

  17. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Science.gov (United States)

    2013-05-31

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture'' dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for......

  18. 76 FR 27753 - American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application

    Science.gov (United States)

    2011-05-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Office of Thrift Supervision American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion... application of American Eagle Savings Bank, Boothwyn, Pennsylvania, to convert to the stock form...

  19. 77 FR 39983 - Migratory Bird Hunting; Application for Approval of Fluoropolymeric Shot Coatings as Nontoxic for...

    Science.gov (United States)

    2012-07-06

    ... Fish and Wildlife Service 50 CFR Part 20 RIN 1018-AY66 Migratory Bird Hunting; Application for Approval... INFORMATION CONTACT: George Allen, at 703-358-1825. SUPPLEMENTARY INFORMATION: Background The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703-712 and 16 U.S.C. 742 a-j) implements migratory bird...

  20. 14 CFR 26.47 - Holders of and applicants for a supplemental type certificate-Alterations and repairs to...

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Holders of and applicants for a... Alterations § 26.47 Holders of and applicants for a supplemental type certificate—Alterations and repairs to... supplemental certificate, the holder of the supplemental certificate must— (1) Review the alteration data...

  1. 77 FR 66607 - Placer County Water Agency; Notice of Application for Approval of Contract for the Sale of Power...

    Science.gov (United States)

    2012-11-06

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

  2. 76 FR 78530 - Applications for Food and Drug Administration Approval To Market a New Drug; Revision of...

    Science.gov (United States)

    2011-12-19

    ... Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-- Discontinuance... concern that, although the Orange Book lists all drug products with approved new drug applications (NDA) and abbreviated new drug applications (ANDA), it is not possible to determine whether the...

  3. 77 FR 24724 - Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug Application for OFORTA

    Science.gov (United States)

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug Application for OFORTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for...

  4. 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...

  5. 77 FR 24723 - AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

    Science.gov (United States)

    2012-04-25

    ... New Drug Application for IRESSA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA)...

  6. Confiscated black market products and nutritional supplements with non-approved ingredients analyzed in the Cologne Doping Control Laboratory 2009.

    Science.gov (United States)

    Kohler, Maxie; Thomas, Andreas; Geyer, Hans; Petrou, Michael; Schänzer, Wilhelm; Thevis, Mario

    2010-01-01

    Doping control laboratories are frequently confronted with new substances that may be misused by athletes. Besides new pharmaceuticals, where method development for their detection is dependent on the availability of the substance and corresponding administration studies, some professional and amateur athletes are using illicit 'black market' products, which either differ from known pharmaceuticals but cause similar effects or still are undergoing clinical trials and are therefore rarely available to doping control laboratories. In the Cologne Doping Control Laboratory, different confiscated products and legally obtained nutritional supplements were analyzed in 2009, and various findings were reported including GH-labelled injection vials without any pharmacologically active content; combinations of products indicating the attempt to mask growth hormone abuse; unpurified long-R(3) -IGF-1; nutritional supplements containing the growth hormone releasing peptide-2 (GHRP-2); and ampoules containing the selective androgen receptor modulator Andarine (S-4). This review provides an overview on the substances that were analyzed in 2009. Ingredients relevant for doping control were identified by means of liquid chromatography and mass spectrometry methods. The awareness of new products on the black market and in nutritional supplements is of utmost importance for laboratories to develop detection methods accordingly and screen for new substances as early as possible.

  7. 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

    ... Drug Applications and 64 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 35 new drug applications (NDAs) and 64 abbreviated new drug applications (ANDAs) from multiple applicants. The holders...

  8. Harmful aquatic organisms in ballast water: application for basic approval of the VARUNA ballast water treatment system

    NARCIS (Netherlands)

    Jak, R.G.; Jongbloed, R.H.; Sneekes, A.C.; Kaag, N.H.B.M.

    2014-01-01

    This document contains the non-confidential information related to the application for Basic Approval of the VARUNA Ballast Water Treatment System submitted in accordance with the Procedure for approval of ballast water management systems that make use of Active Substances (G9) adopted by resolution

  9. 78 FR 33426 - Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX

    Science.gov (United States)

    2013-06-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Eli Lilly and Co.; Withdrawal of Approval of a New Drug... Administration (FDA) is withdrawing approval of a new drug application (NDA) for ORAFLEX (benoxaprofen)...

  10. Pharmacogenomic information in FDA-approved drug labels: Application to pediatric patients.

    Science.gov (United States)

    Green, D J; Mummaneni, P; Kim, I W; Oh, J M; Pacanowski, M; Burckart, G J

    2016-06-01

    Pharmacogenomic (PGx) information is increasingly being incorporated into US Food and Drug Administration-approved drug labels. We reviewed the data source (adults vs. pediatrics) of PGx information in approved drug labels and assessed the suitability of applying adult-derived PGx information and related prescribing recommendations to the care of pediatric patients. We identified 65 drugs with labels containing PGx information and that have also been evaluated in children and found that in the majority of cases (56/65, 86%), the PGx information described was derived from adult studies. The application of PGx information from adults to pediatrics was deemed suitable for 71.4% (n = 40) of the drugs and unclear for 28.6% (n = 16). An ontogeny effect, limited or conflicting data regarding ontogeny of the genetic biomarker, or a difference in the pathophysiology or progression of the adult vs. pediatric disease were the primary reasons for deeming direct application from adults to pediatrics unclear.

  11. 76 FR 64951 - Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug...

    Science.gov (United States)

    2011-10-19

    ... HUMAN SERVICES Food and Drug Administration Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS... new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple...

  12. 78 FR 48177 - Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin

    Science.gov (United States)

    2013-08-07

    .... FDA-2013-N-0883] Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin...) Extended-Release Tablets, held by Purdue Pharma L.P. (Purdue), One Stamford Forum, Stamford, CT...

  13. 77 FR 31828 - Notice of Request for Revision of a Currently Approved Collection Application for Plant Variety...

    Science.gov (United States)

    2012-05-30

    ... Information or Comments: Contact Bernadette Thomas, Information Technology Specialist, Plant Variety Protection Office (PVPO), Science and Technology, AMS, Room 401, National Agricultural Library (NAL), 10301... and revision to the currently approved information collection ``Application for ] Plant...

  14. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ..., or drug advertising of false, misleading, or unsupported intended uses or claims for effectiveness... effectiveness of the drug. (ii) Drug substance means an active ingredient as defined under § 210.3(b)(7) of this... effectiveness of the drug. (ii) These changes include, but are not limited to: (A) Except those described...

  15. 21 CFR 314.70 - Supplements and other changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... paragraphs (c) and (d) of this section, changes in the qualitative or quantitative formulation of the drug... methodologies related to sterilization process validation, relevant validation protocols and a list of relevant... with that of a different design that does not affect the process methodology or process...

  16. Opinion paper food supplements: the European regulation and its application in France. Thoughts on safety of food supplements.

    Science.gov (United States)

    Maixent, J M

    2012-06-30

    The first definition of food supplements in France was established by decree 96-307 of April 10th 1996. In 2002, the European Community adopted a regulation for food supplements (European Directive 2002/46/CE June 10th). This was an important event in the regulation of food supplements. The European regulation was adopted in France, with some modifications, by decree 2006-352 of March 20th 2006. The European Regulation on food supplements is more defined than those for any other food types and is exemplary. The Regulation on addition of vitamins and minerals to food differs from the regulation on the addition of other substances such as amino acids, essential fatty acids, fibers, carbohydrates, various plant, and herbal extracts. While the Regulation includes vitamins and minerals to the positive list of supplements, other substances are included in the negative list of supplements. According to the Regulation, substances added to food supplements must have a nutritional or physiological effect. The increased use of food supplements led to the creation of a department specialized in the safety of food supplement. The safety of food supplements is a permanent concern for sanitary authorities. These authorities have recently combined scientific methodological approaches and a collective expertise to implement and monitor simple and useful rules that insure consumer's safety. Safety laws aim to protect the consumers of food supplements.

  17. 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…

  18. 76 FR 59144 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58...

    Science.gov (United States)

    2011-09-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction AGENCY: Food...

  19. 21 CFR 515.25 - Revocation of order refusing to approve a medicated feed mill license application or suspending...

    Science.gov (United States)

    2010-04-01

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

  20. 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

    ... introduction into interstate commerce when approval of the application or abbreviated application for the drug... for 5 years of exclusive marketing under § 314.108(b)(2) and the patent owner or its representative or... application first commences commercial marketing of its drug product; or (ii) The date of a decision of...

  1. 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...

  2. 78 FR 2451 - Grand Gulf ESP Site; Consideration of Approval of Application Regarding Proposed Creation of a...

    Science.gov (United States)

    2013-01-11

    ... COMMISSION Grand Gulf ESP Site; Consideration of Approval of Application Regarding Proposed Creation of a... (ESP) ESP-002, for the ] Grand Gulf ESP Site, currently held by System Energy Resources, Inc. (SERI). The direct transfer of the Grand Gulf ESP would be to a new limited liability company, System...

  3. 78 FR 76327 - Notice of Approval of South Carolina's Application for Avoidance of 2013 Credit Reduction Under...

    Science.gov (United States)

    2013-12-17

    ... Employment and Training Administration Notice of Approval of South Carolina's Application for Avoidance of... avoidance of the 2013 credit reduction under this section. It has been determined that South Carolina met all of the criteria of section 3302(g) and thus qualifies for credit reduction avoidance....

  4. 76 FR 33756 - Notice of Approval of the Primacy Application for National Primary Drinking Water Regulations for...

    Science.gov (United States)

    2011-06-09

    ... AGENCY Notice of Approval of the Primacy Application for National Primary Drinking Water Regulations for... following offices: (1) Missouri Department of Natural Resources, Public Drinking Water Branch, 1101... Pesticides Division, Drinking Water Management Branch, 901 North 5th Street, Kansas City, Kansas 66101....

  5. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Science.gov (United States)

    2010-04-01

    ... secret or confidential commercial or financial information under § 20.61. (3) Any adverse reaction report... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Confidentiality of data and information in a premarket approval application (PMA) file. 814.9 Section 814.9 Food and Drugs FOOD AND DRUG...

  6. Risk Management Supplement to IEEE-15288.1

    Science.gov (United States)

    2015-05-15

    AND MISSILE SYSTEMS CENTER TAILORING RISK MANAGEMENT SUPPLEMENT TO IEEE -15288.1 APPROVED FOR PUBLIC RELEASE...IEC- IEEE -15288: 2015, SYSTEMS AND SOFTWARE ENGINEERING — SYSTEM LIFE CYCLE PROCESSES...1 2.2. IEEE -15288.1: 2015, STANDARD FOR APPLICATION OF SYSTEMS ENGINEERING ON DEFENSE PROGRAMS

  7. 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.

  8. 7 CFR 1436.9 - Loan amount and loan application approvals.

    Science.gov (United States)

    2010-01-01

    ... fees, except for filing fees; environmental and historic review fees including archaeological study... wiring; electrical motors; off-farm paid labor; on-farm site preparation and construction equipment costs... facility loans, the agency approval officials may only approve loans, subject to available funds....

  9. 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.

  10. 78 FR 52536 - Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin...

    Science.gov (United States)

    2013-08-23

    ...; Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice... withdraw approval of NADA 098-371 for use of nicarbazin, penicillin, and roxarsone in 3-way,...

  11. The effect size, study design, and development experience in commercially sponsored studies for new drug applications in approved drugs

    OpenAIRE

    Fukunaga, Satoshi; Kusama, Makiko; Ono, Shunsuke

    2014-01-01

    Pharmaceutical companies incorporate different features into the trials for new drug applications (NDAs) to render them efficient, making use of their experience. The objective of this analysis was to examine the associations between outcome and features related to study design and clinical development experience in commercially sponsored clinical trials. We collected data of phase 2 and phase 3 trials of all the drugs that obtained approval for depression, schizophrenia, asthma, hypertension...

  12. 7 CFR 1710.110 - Supplemental financing.

    Science.gov (United States)

    2010-01-01

    ... supplemental financing according to their plant revenue ratio (PRR), as defined in § 1710.2, based on the most recent year-end data available on the date of loan approval, as follows: PRR Supplemental loan...

  13. APPLICATION OF LEAN METHODOLOGY PRESCRIPTION OF NUTRITION SUPPLEMENTS ASMEDICATION BY DIETITIANS

    Directory of Open Access Journals (Sweden)

    J Woods

    2012-06-01

    Full Text Available In a major Victorian hospital, dietitians observed that requests tomedical staff to prescribe nutritional supplements via themedication chart were inefficient. This led to delays in the deliveryof nutritional recommendations, thus compromising patients’nutritional status. Lean Methodology was applied to simplify theordering of patients’ nutritional supplements as medication(NSAM by dietitians. A literature review was conducted. Directobservation and value stream mapping were used to identifyprocess time and wasted time related to NSAM prescription. Adetailed root cause analysis of identified issues was undertaken,followed by the development of an implementation plan. Thefollowing problems were identified: ordering process wascomplicated and not linear, delay in patient receiving NSAM (2.8days, range 0–23 days, and 60% repeat requests by the dietitian forNSAM. An implementation plan was developed which included:submission to the Medical Executive Committee to seekprescribing privileges for dietitians; dietetic competency trainingand credentialing, communication strategy, development ofprescribing and administering procedures; and ward education.Dietetic prescribing privileges were granted, implemented, andevaluation of this change in dietetic practice undertaken. Inconclusion, application of Lean Methodology enabled dietitians toclearly examine, in a systematic manner, delays, risks andinefficiencies with our current process of ordering NSAM. It led toa plan of action to improve quality of care to our patients, includingrenal patients, and reduce waste in our health care setting by timelyand appropriate commencement of NSAM.

  14. 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

  15. 5 CFR 5502.107 - Supplemental disclosure of financial interests in substantially affected organizations applicable...

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Supplemental disclosure of financial... SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.107 Supplemental disclosure of financial interests in substantially affected...

  16. 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.

  17. 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...

  18. Covariance Structure Model Fit Testing under Missing Data: An Application of the Supplemented EM Algorithm

    Science.gov (United States)

    Cai, Li; Lee, Taehun

    2009-01-01

    We apply the Supplemented EM algorithm (Meng & Rubin, 1991) to address a chronic problem with the "two-stage" fitting of covariance structure models in the presence of ignorable missing data: the lack of an asymptotically chi-square distributed goodness-of-fit statistic. We show that the Supplemented EM algorithm provides a…

  19. 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

  20. 12 CFR 516.290 - What will happen if OTS does not approve or disapprove my application within two calendar years...

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false What will happen if OTS does not approve or disapprove my application within two calendar years after the filing date? 516.290 Section 516.290 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY APPLICATION PROCESSING PROCEDURES OTS Review Standard Treatment § 516.290...

  1. 77 FR 8865 - Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval

    Science.gov (United States)

    2012-02-15

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

  2. 14 CFR 303.04 - General rules governing application content, procedure and conditions of approval.

    Science.gov (United States)

    2010-01-01

    ... applicants shall file an affidavit executed by the individual responsible for the search explaining why they... is filed with the Documentary Services Division. (j) The applicant shall, if requested,...

  3. 21 CFR 1312.31 - Schedule I: Application for prior written approval.

    Science.gov (United States)

    2010-04-01

    ... IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES Transshipment and In-Transit Shipment of Controlled... documents or written statements of fact relevant to the application as he deems necessary to determine... applicant of an opportunity to present such documents or facts for consideration by the Administrator...

  4. 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

  5. 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

  6. 77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

    Science.gov (United States)

    2012-10-03

    ...; Butorphanol; Doxapram; Triamcinolone; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Notice.../ANADA No. Trade name (drug) Applicant 100-556 Vigorena Feeds Hy-Ty Springfield Milling Premix...

  7. 78 FR 46799 - Supplemental Nutrition Assistance Program: Privacy Protections of Information From Applicant...

    Science.gov (United States)

    2013-08-02

    .... Russell National School Lunch Act or the School Breakfast Program established under the Child Nutrition... / Friday, August 2, 2013 / Rules and Regulations#0;#0; ] DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 272 RIN 0584-AD91 Supplemental Nutrition Assistance Program: Privacy Protections...

  8. 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...

  9. Regulations applicable to plant food supplements and related products in the European Union.

    Science.gov (United States)

    Silano, Vittorio; Coppens, Patrick; Larrañaga-Guetaria, Ainhoa; Minghetti, Paola; Roth-Ehrang, René

    2011-12-01

    This paper deals with the current regulatory and legal settings of traditional plant food supplements and herbal medicinal products in the European Union (EU). Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, including the use of additives and maximum levels of contaminants and residues. However, due to limited harmonization at the EU level, specific national regulations adopted at a Member State level also apply and mutual recognition is the mechanism through which such products can be marketed in EU countries other than those of origin. Unlike food supplements, marketing of traditional herbal medicinal products is regulated by an ad hoc Directive (i.e. Directive 2004/24/EC) covering in detail all the relevant aspects of these products, including a facilitated registration procedure at national level. However, by distinguishing traditional herbal medicinal products from plant food supplements and establishing selective marketing modalities for these two product categories, the EU has been confronted with implementation difficulties for traditional herbal medicinal products and a lack of homogeneity in the regulatory approaches adopted in different EU Member States. In fact, currently the nature of the commercial botanical products made available to consumers as traditional medicinal products or food supplements, depends largely on the EU Member State under consideration as a consequence of how competent National Authorities and manufacturing companies interpret and apply current regulations rather than on the intrinsic properties of the botanical products and their constituents. When the EU approach is compared with approaches adopted in some non-European countries to regulate these product categories, major differences become evident.

  10. Dietary Supplements

    Science.gov (United States)

    Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, and energy bars. Supplements do not have to go through the testing that drugs do. Some supplements ...

  11. [Applications and approved projectsof general program, young scientist fund and fund for less developedregion of national natural science funds in discipline of Chinese materia medica, NSFC in 2012].

    Science.gov (United States)

    Huang, Ming-Qing; Han, Li-Wei; Wu, Xiu-Hong; Bi, Ming-Gang; Shang, Hong-Cai; Liu, Yun-Fang; He, Wei-Ming; Li, Dan-Dan; Dong, Yan; Wang, Chang-En

    2013-01-01

    The applications accepted and approved by general program, young scientist fund and fund for less developed region of national natural science funds in the discipline of Chinese materia medica, NSFC in 2012 have been introduced. The research contents of the funded projects in the popular research areas have been summarized and the problems in the applications have been analyzed to give a reference to the scientists in the field of Chinese materia medica.

  12. 78 FR 730 - State Program Requirements; Approval of Application To Administer Partial National Pollutant...

    Science.gov (United States)

    2013-01-04

    ... Elimination System program under the Clean Water Act. SUMMARY: On December 20, 2012, the Regional... pursuant to Section 402(b) of the Clean Water Act (CWA or ``the Act''). The AgPDES program will be..., Texas 75202. A copy of ODAFF's application is available online at the EPA Region 6 web page:...

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

    Science.gov (United States)

    2013-10-29

    ..., such as Social Security number, date of birth, driver's license number or other state identification... determinations on the applications. The federal government re- opened on October 17, 2013. In order to ensure... order to account for the time period in which the government was shut down. Accordingly, the...

  14. Genomic variant annotation workflow for clinical applications [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Thomas Thurnherr

    2016-10-01

    Full Text Available Annotation and interpretation of DNA aberrations identified through next-generation sequencing is becoming an increasingly important task. Even more so in the context of data analysis pipelines for medical applications, where genomic aberrations are associated with phenotypic and clinical features. Here we describe a workflow to identify potential gene targets in aberrated genes or pathways and their corresponding drugs. To this end, we provide the R/Bioconductor package rDGIdb, an R wrapper to query the drug-gene interaction database (DGIdb. DGIdb accumulates drug-gene interaction data from 15 different resources and allows filtering on different levels. The rDGIdb package makes these resources and tools available to R users. Moreover, rDGIdb queries can be automated through incorporation of the rDGIdb package into NGS sequencing pipelines.

  15. 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.

  16. The effect size, study design, and development experience in commercially sponsored studies for new drug applications in approved drugs.

    Science.gov (United States)

    Fukunaga, Satoshi; Kusama, Makiko; Ono, Shunsuke

    2014-01-01

    Pharmaceutical companies incorporate different features into the trials for new drug applications (NDAs) to render them efficient, making use of their experience. The objective of this analysis was to examine the associations between outcome and features related to study design and clinical development experience in commercially sponsored clinical trials. We collected data of phase 2 and phase 3 trials of all the drugs that obtained approval for depression, schizophrenia, asthma, hypertension, and diabetes in Japan from 1970 to 2011. In total, 145 trials from 90 test drugs were eligible for our study. We calculated the effect size, the standard mean of differences between test drug and comparator therapeutic effects, as the objective variable for use in our analysis. A linear mixed effect model with nested and crossed random effects was used in the analysis including variety of therapeutic area, test drugs and clinical trials. The analysis showed that trial features including sample size, subjective endpoints and active comparator of the same mode of action were negatively associated with effect size. In addition, sponsors' domestic clinical development experience with similar drugs seemed to have a positive association, but prior development experience in foreign countries did not. The accumulation of skills and knowledge within sponsors, and accumulated experience in domestic professionals who implement clinical trials under study contracts with sponsors would be of great importance for yielding clear outcomes. This study provides additional evidence with respect to possible sizes and directions of the influence of study design features that must be considered when planning and implementing trials for new drug applications, and when retrospectively comparing outcomes from trials with different designs and environments.

  17. Application of the instructional congruence framework: Developing supplemental materials for English language learners

    Science.gov (United States)

    Drews, Tina Skjerping

    2009-12-01

    This dissertation is a study of the instructional congruence framework as it was used to develop and pilot a supplemental science unit on energy and the environment for sixth grade students in Arizona. With the growing linguistic and cultural diversity of children in American schools, congruent materials are more important now than ever before. The supplemental materials were designed by the researcher and underwent a six person, three educator and three engineer, panel review. The revised materials were then piloted in two sixth grade classrooms in the Southwest with high numbers of English language learners. Classroom observation, teacher interviews, and the classroom observation protocol were utilized to understand the fidelity to the instructional congruence framework. The fidelity of implementation of materials was subject to the realities of varied educational contexts. Piloting materials in urban contexts with diverse students involved additional challenges. The results of the study explore the challenges in creating instructionally congruent materials for diverse students in urban contexts. Recommendations are provided for curriculum developers that undertake the task of creating instructionally congruent materials and emphasize the need to devise innovative methods of creation, while understanding that there is no perfect solution. The education community as a whole could benefit from incorporating and synthesizing the instructional congruence framework in order to provide maximum opportunities in science for all students.

  18. 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.

  19. MetaGenSense: A web-application for analysis and exploration of high throughput sequencing metagenomic data [version 3; referees: 1 approved, 2 approved with reservations

    Directory of Open Access Journals (Sweden)

    Damien Correia

    2016-12-01

    Full Text Available The detection and characterization of emerging infectious agents has been a continuing public health concern. High Throughput Sequencing (HTS or Next-Generation Sequencing (NGS technologies have proven to be promising approaches for efficient and unbiased detection of pathogens in complex biological samples, providing access to comprehensive analyses. As NGS approaches typically yield millions of putatively representative reads per sample, efficient data management and visualization resources have become mandatory. Most usually, those resources are implemented through a dedicated Laboratory Information Management System (LIMS, solely to provide perspective regarding the available information. We developed an easily deployable web-interface, facilitating management and bioinformatics analysis of metagenomics data-samples. It was engineered to run associated and dedicated Galaxy workflows for the detection and eventually classification of pathogens. The web application allows easy interaction with existing Galaxy metagenomic workflows, facilitates the organization, exploration and aggregation of the most relevant sample-specific sequences among millions of genomic sequences, allowing them to determine their relative abundance, and associate them to the most closely related organism or pathogen. The user-friendly Django-Based interface, associates the users’ input data and its metadata through a bio-IT provided set of resources (a Galaxy instance, and both sufficient storage and grid computing power. Galaxy is used to handle and analyze the user’s input data from loading, indexing, mapping, assembly and DB-searches. Interaction between our application and Galaxy is ensured by the BioBlend library, which gives API-based access to Galaxy’s main features. Metadata about samples, runs, as well as the workflow results are stored in the LIMS. For metagenomic classification and exploration purposes, we show, as a proof of concept, that integration

  20. 76 FR 24850 - Notice of Request for a Revision of a Currently Approved Information Collection (Application for...

    Science.gov (United States)

    2011-05-03

    ..., national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or... Web site provides the ability to type short comments directly into the comment field on this Web page... Exemptions. OMB Number: 0583-0082. Expiration Date of Approval: 07/31/2011. Type of Request: Revision of...

  1. 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...

  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... below, no later than 5 p.m. on October 21, 2013. ADDRESSES: In commenting, please refer to file code CMS... Services, Attention: CMS-3287-PN, P.O. Box 8016, Baltimore, MD 21244-8010. Please allow sufficient time...

  3. 22 CFR 401.18 - Supplemental or amended applications and statements.

    Science.gov (United States)

    2010-04-01

    ... statements. 401.18 Section 401.18 Foreign Relations INTERNATIONAL JOINT COMMISSION, UNITED STATES AND CANADA... appears to the Commission that either an application, a statement in response or a statement in reply is not sufficiently definite and complete, the Commission may require a more definite and...

  4. 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,...

  5. 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...

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-03-01

    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.

  7. Immersive Virtual Environment Technology to Supplement Environmental Perception, Preference and Behavior Research: A Review with Applications.

    Science.gov (United States)

    Smith, Jordan W

    2015-09-11

    Immersive virtual environment (IVE) technology offers a wide range of potential benefits to research focused on understanding how individuals perceive and respond to built and natural environments. In an effort to broaden awareness and use of IVE technology in perception, preference and behavior research, this review paper describes how IVE technology can be used to complement more traditional methods commonly applied in public health research. The paper also describes a relatively simple workflow for creating and displaying 360° virtual environments of built and natural settings and presents two freely-available and customizable applications that scientists from a variety of disciplines, including public health, can use to advance their research into human preferences, perceptions and behaviors related to built and natural settings.

  8. Sports Supplements

    Science.gov (United States)

    ... not getting the whole story about how supplements work, if they are really effective, and the risks you take by using them. Androstenedione and DHEA ... like testicular cancer, infertility, stroke, and an increased risk of heart ... height. Natural steroid supplements can also cause breast development ...

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

    Energy Technology Data Exchange (ETDEWEB)

    RAMSEY AA; THORSON MR

    2010-12-28

    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.

  10. 30 CFR 35.9 - Certificates of approval.

    Science.gov (United States)

    2010-07-01

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

  11. 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

  12. 75 FR 65551 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-10-25

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

  13. Calcium supplements

    Science.gov (United States)

    ... do not help. Always tell your provider and pharmacist if you are taking extra calcium. Calcium supplements ... 2012:chap 251. The National Osteoporosis Foundation (NOF). Clinician's Guide to prevention and treatment of osteoporosis . National ...

  14. 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...

  15. Drugs Approved for Melanoma

    Science.gov (United States)

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

  16. Elosulfase alfa: first global approval.

    Science.gov (United States)

    Sanford, Mark; Lo, Jin Han

    2014-04-01

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

  17. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

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

  18. 78 FR 52430 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins...

    Science.gov (United States)

    2013-08-23

    ... Animal Drug Applications; Quali- Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin... (pyrantel tartrate), NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC...

  19. Validation and application of reporter gene assays for the determination of estrogenic and androgenic endocrine disruptor activity in sport supplements.

    Science.gov (United States)

    Plotan, Monika; Elliott, Christopher T; Oplatowska, Michalina; Connolly, Lisa

    2012-07-01

    Previously developed estrogen and androgen mammalian reporter gene assays (RGAs) were assessed for their potential use as a quantitative screening method in the detection of estrogenic and androgenic endocrine disruptors (EDs) in sport supplements. The validation of both RGAs coupled with dispersive solid phase extraction (dSPE) was performed in accordance with European Commission Decision EC/2002/6579 for biological screening methods. Decision limits (CCα) and detection capabilities (CCβ) were established for both the estrogen and androgen RGAs. All samples were compliant with CCα and CCβ in both bioassays. Recovery rates were 96 % for 17β-estradiol and 115 % for dihydrotestosterone as obtained in their corresponding RGA. Both estrogens and androgens were stable in samples for more than 3 weeks, when stored at -20 °C. Specificity, good repeatability (coefficients of variation (CV), 12-25 %), reproducibility and robustness of both bioassays were also observed. Four different ED modes of action were determined for estrogens and androgens in 53 sport supplements, using the validated RGAs. This study revealed that 89 % of the investigated sport supplements contained estrogenic EDs and 51 % contained androgenic compounds. In conclusion, both bioassays are suitable for sport supplement screening of estrogenic and androgenic EDs.

  20. 5 CFR 5502.106 - Supplemental disclosure of prohibited financial interests applicable to employees of the Food and...

    Science.gov (United States)

    2010-01-01

    ... Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS... been excluded from the requirement of filing a confidential financial disclosure report under the... excluded from the requirement of filing a public financial disclosure report under the procedures in 5...

  1. 5 CFR 630.1107 - Notification of approval or disapproval of an application to become an emergency leave recipient.

    Science.gov (United States)

    2010-01-01

    ... of an application to become an emergency leave recipient. 630.1107 Section 630.1107 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS ABSENCE AND LEAVE Emergency Leave... emergency leave recipient. Once the employee's application to become an emergency leave recipient is...

  2. Statistical design considerations applicable to clinical trials of iodine supplementation in pregnant women who may be mildly iodine deficient.

    Science.gov (United States)

    Troendle, James F

    2016-09-01

    No large, randomized, placebo-controlled trial of iodine supplementation in pregnant women in a region of mild or moderate iodine deficiency has been completed in which a primary outcome measure was an assessment of the neurobehavioral development of the offspring at age ≥2 y. In this article, I discuss considerations for the design of such a trial in a region of mild iodine deficiency, with a focus on statistical methods and approaches. Exposure and design issues include the ethics of using a placebo, the potential for overexposure to iodine, and the possibility of community randomization. The main scientific goal of the trial is important in determining the follow-up period. If the goal is to determine whether iodine supplementation during pregnancy improves neurobehavioral development in the offspring, then follow-up should continue until a reasonably reliable assessment can be conducted, which might be at age ≥2 y. Once the timing of assessment is decided, the impact of potential loss to follow-up should be considered so that appropriate statistical methods can be incorporated into the design. The minimum sample size can be calculated by using a sample size formula that incorporates noncompliance and assumes that a certain proportion of study participants do not have any outcome observed. To have sufficient power to detect a reasonably modest difference in neurobehavioral development scores using an assessment tool with an SD of 15, a large number of participants (>500/group) is required. The minimum adequate number of participants may be even larger (>1300/group) depending on the magnitude of the difference in outcome between the supplementation and placebo groups, the estimated proportion of the iodine-supplementation group that fails to take the supplement, and the estimated proportion of pregnancies that do not produce outcome measurements.

  3. 77 FR 38717 - Supplemental Standards of Ethical Conduct for Employees

    Science.gov (United States)

    2012-06-29

    ... RECONSTRUCTION 5 CFR Part 9303 RIN 3460-AA01 Supplemental Standards of Ethical Conduct for Employees AGENCY... Ethics (OGE), is adopting as final, without changes, an interim rule for SIGAR employees that will... supplemental regulation includes a requirement that SIGAR employees obtain prior approval for certain types...

  4. 24 CFR 214.103 - Approval criteria.

    Science.gov (United States)

    2010-04-01

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

  5. MICROBIOLOGICAL QUALITY OF FOOD SUPPLEMENTS.

    Science.gov (United States)

    Ratajczak, Magdalena; Kubicka, Marcelina M; Kamińska, Dorota; Długaszewska, Jolanta

    2015-01-01

    Many specialists note that the food offered today - as a result of very complex technological processing - is devoid of many components that are important for the organism and the shortages have to be supplemented. The simplest for it is to consume diet supplements that provide the missing element in a concentrated form. In accordance with the applicable law, medicinal products include all substances or mixtures of substances that are attributed with properties of preventing or treating diseases with humans or animals. Permits to admit supplements to the market are issued by the Chief Sanitary Inspector and the related authorities; permits for medicines are issued by the Chief Pharmaceutical Inspector and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Therefore, admittance of a supplement to the market is less costly and time consuming_than admittance of a medicine. Supplements and medicines may contain the same component but medicines will have a larger concentration than supplements. Sale of supplements at drug stores and in the form of tablets, capsules, liquids or powders makes consumer often confusing supplements with medicines. Now there are no normative documents specifying limits of microbiological impurities in diet supplements. In Polish legislation, diet supplements are subject to legal acts concerning food. Medicines have to comply with microbiological purity requirements specified in the Polish Pharmacopeia. As evidenced with the completed tests, the proportion of diet supplement samples with microbiological impurities is 6.5%. Sales of diet supplements have been growing each year, they are consumed by healthy people but also people with immunology deficiencies and by children and therefore consumers must be certain that they buy safe products.

  6. Specialty Engineering Supplement to IEEE-15288.1

    Science.gov (United States)

    2015-05-15

    MISSILE SYSTEMS CENTER TAILORING SPECIALTY ENGINEERING SUPPLEMENT TO IEEE -15288.1 APPROVED FOR PUBLIC RELEASE; DISTRIBUTION...IS UNLIMITED 1 Tailoring of IEEE 15288.1: Specialty Engineering Supplement. 1. Intent of this Tailoring Document This tailoring document is...historically deemed valuable to mission assurance/success of high-reliability space systems. This tailoring document supplements IEEE 15288.1-2015 Annex E

  7. 5 CFR 890.203 - Application for approval of, and proposal of amendments to, health benefit plans.

    Science.gov (United States)

    2010-01-01

    ... 20415. Application letters must be accompanied by any descriptive material, financial data, or other documentation required by OPM. Plans must submit the letter and attachments in the OPM-specified format by... to an expected break-even point including a sufficient amount for unexpected contingencies;...

  8. The analysis of economic capital application of credit approval in commercial banks%浅析经济资本在商业银行授信审批中的应用

    Institute of Scientific and Technical Information of China (English)

    胡晓磊; 刘庆卫

    2014-01-01

    This paper firstly analyzed the problems exposed in current commercial bank credit approval, then analyzed the significance of economic capital management in credit approval stage, and finally put forward some thoughts and suggestion for the application of economic capital approach in credit approval process.%本文结合当前商业银行授信审批中暴露出的问题,分析了在授信审批阶段科学应用经济资本管理工具的重要意义,提出了在授信审批环节应用经济资本的思路及建议。

  9. Innovative Applications of Robotic Surgery: Renal Allograft and Autologous Transplantation [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Jason Lee

    2016-01-01

    Full Text Available Robotic surgery has enabled surgeons to offer more patients a minimally invasive surgical option in the management of their complex diseases. While renal transplantation is associated with significant improvements in quantity and quality of life for most end-stage renal disease (ESRD patients, it is also not devoid of its surgical risks and potential morbidities. Robotic-assisted kidney transplantation is a recently described, innovative application of the robotic surgery platform, and early experiences suggest that it is associated with comparable graft function and lower rates of complications. Urinary tract obstruction, though less common than ESRD, can be a serious threat to renal function. Severe ureteric stricture disease can represent a clinically complex problem requiring major reconstructive surgery. Completely intra-corporeal robotic renal auto-transplantation is another innovative application of the robotic surgery platform and represents a significant advancement in urologic surgery. Initial reports of this procedure demonstrate safety, feasibility, and excellent renal function outcomes.

  10. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

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

  11. 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.

  12. 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...

  13. 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...

  14. Application of Dairy Proteins as Technological and Nutritional Improvers of Calcium-Supplemented Gluten-Free Bread

    Directory of Open Access Journals (Sweden)

    Cristina M. Rosell

    2013-11-01

    Full Text Available Effect of dairy proteins on gluten-free dough behavior, and nutritional and technological properties of gluten-free bread was evaluated. Experimental doughs, containing dairy powders, showed low consistency. Obtained gluten-free breads were rich in proteins, and, regarding the energy value delivered by proteins, they could be considered as a source of proteins or high in proteins. Applied dairy proteins affected the technological properties of experimental breads causing a significant (p < 0.05 increase of the specific volume, crust darkening, and crumb lightness, depending on the dairy supplementation level, rather than the protein type. Dairy proteins incorporated at a 12% level, significantly (p < 0.05 decreased the hardness; nevertheless, the highest amount of proteins tested led to the opposite effect. These results indicate that milk proteins tested could be successfully added to gluten-free bread with beneficial effects on technological and nutritional properties.

  15. Application of dairy proteins as technological and nutritional improvers of calcium-supplemented gluten-free bread.

    Science.gov (United States)

    Krupa-Kozak, Urszula; Bączek, Natalia; Rosell, Cristina M

    2013-11-14

    Effect of dairy proteins on gluten-free dough behavior, and nutritional and technological properties of gluten-free bread was evaluated. Experimental doughs, containing dairy powders, showed low consistency. Obtained gluten-free breads were rich in proteins, and, regarding the energy value delivered by proteins, they could be considered as a source of proteins or high in proteins. Applied dairy proteins affected the technological properties of experimental breads causing a significant (p supplementation level, rather than the protein type. Dairy proteins incorporated at a 12% level, significantly (p proteins tested led to the opposite effect. These results indicate that milk proteins tested could be successfully added to gluten-free bread with beneficial effects on technological and nutritional properties.

  16. 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...

  17. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

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

  18. Nutritional supplements

    DEFF Research Database (Denmark)

    Petersen, Gry Bjerg; Andersen, Jens Rikardt

    2015-01-01

    , metal, gritty, consistence and ability to drink 150 ml (one glass), and the patients arranged the drinks in order of preference. Results: The sensory qualities differed significantly concerning sweet (p...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...

  19. What Can Be Learned from Recent New Drug Applications? A Systematic Review of Drug Interaction Data for Drugs Approved by the US FDA in 2015.

    Science.gov (United States)

    Yu, Jingjing; Zhou, Zhu; Owens, Katie H; Ritchie, Tasha K; Ragueneau-Majlessi, Isabelle

    2017-01-01

    As a follow up to previous reviews, the aim of the present analysis was to systematically examine all drug metabolism, transport, pharmacokinetics (PK), and drug-drug interaction (DDI) data available in the 33 new drug applications (NDAs) approved by the Food and Drug Administration (FDA) in 2015, using the University of Washington Drug Interaction Database, and to highlight the significant findings. In vitro, a majority of the new molecular entities (NMEs) were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. In vivo, 95 clinical DDI studies displayed positive PK interactions, with an area under the curve (AUC) ratio ≥ 1.25 for inhibition or ≤ 0.8 for induction. When NMEs were considered as victim drugs, 21 NMEs had at least one positive clinical DDI, with three NMEs shown to be sensitive substrates of CYP3A (AUC ratio ≥ 5 when coadministered with strong inhibitors): cobimetinib, isavuconazole (the active metabolite of prodrug isavuconazonium sulfate), and ivabradine. As perpetrators, nine NMEs showed positive inhibition and three NMEs showed positive induction, with some of these interactions involving both enzymes and transporters. The most significant changes for inhibition and induction were observed with rolapitant, a moderate inhibitor of CYP2D6 and lumacaftor, a strong inducer of CYP3A. Physiologically based pharmacokinetics simulations and pharmacogenetics studies were used for six and eight NMEs, respectively, to inform dosing recommendations. The effects of hepatic or renal impairment on the drugs' PK were also evaluated to support drug administration in these specific populations.

  20. 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.

  1. Review of fiber methods and applicability to fortified foods and supplements: choosing the correct method and interpreting results.

    Science.gov (United States)

    Zielinski, Garrett; Rozema, Brent

    2013-05-01

    Fiber is known to be an important part of our nutrition and has many positive health benefits, including weight management and maintaining heart health. In recent years, a number of new ingredients have been manufactured or isolated that are being used to increase the health benefits of a product. Some are used as prebiotics that stimulate the growth of the beneficial bacteria in the gut, or are used as replacements for sugars, starch, or fat in manufactured foods. Fiber supplements have also been produced that can be taken to provide additional fiber to the diet. The term "fiber" does not relate to a single analyte or entity, but instead relates to a multitude of components. This adds to the complexity of analytical testing as there are a number of AOAC International and AACC International official methods which have been validated and can be used. Although methods have been developed for specific fiber ingredients, a number of methods have also been developed to capture just "fiber". These "fiber" methods will capture differing degrees of the different fiber ingredients, so knowledge of the fiber sources is critical. The net result is that a variety of testing approaches may be used, but caution must be exercised in order to ensure that the total fiber result is accurately determined. A critical review of available fiber methodology and possible testing approaches is presented, along with how to accurately interpret and understand results.

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. Impact of foliar application of nano micronutrient fertilizers and titanium dioxide nanoparticles on the growth and yield components of barley under supplemental irrigation

    Directory of Open Access Journals (Sweden)

    Mohsen JANMOHAMMADI

    2016-10-01

    Full Text Available Nano-fertilizers are new generation of the synthetic fertilizers which contain readily available nutrients in nano scale range. Nano fertilizers are preferred largely due to their efficiency and environment friendly nature compared to conventional chemical fertilizers. To evaluate the effects of foliar spray of micronutrient nano-fertilizer (iron and zinc and nano-titanium dioxide (nTiO2 solution on grain yield and its components in barley under supplemental irrigation conditions, a field experiment was carried out in the semi-arid highland region of Maragheh, Iran. Barley plants were separately treated with of chelated nano-scale zinc oxide (ZnO and ferric oxide (Fe2O3 suspensions during tillering stage, booting and milky stages. Results revealed that days to anthesis and maturity significantly increased after application of both nano-fertilizers. Furthermore, a considerable improvement was observed in grain mass, spike length, number of the grains per spike, chlorophyll content, grain yield and harvest index by application of nano-fertilizer. However the impact of nano zinc fertilizer was more prominent than iron. Foliar application of nTiO2 positively affected some morphophysiological characteristics like as days to anthesis, chlorophyll content and straw yield. The results suggest that the delivery of Zn into barley seedling through spray of nano-fertilizer can be an efficient nutrient management strategy in semi-arid regions. Overall, our result indicated that the integration of nanotechnology in fertilizer products can improve fertilizer use efficiency and significantly increase of barley yield. However, plant response to nanoparticles significantly depend on concentration and time of application as well as size, shape, and surface functionalization of the particles.

  17. Style as Supplement - Supplement as Style

    DEFF Research Database (Denmark)

    Sørensen, Bent

    as a meta-documentary, or an always-already deconstructed communication mainly dealing with the act of communicating about philosophy, rather than communicating philosophical insight as such. Philosophy is thus shown to be communication, transmission, situated and framed speech acts - supplements...... and deferrals. This is of course another link in the infinite Derridean chain of supplements to supplements of supplements - in his writings, his persona and the legacy of images of him left behind in the archives. How does this perpetual deferral reflect itself in Derrida's visual and verbal style......, or inversely how does his style always/already produce these supplements and deferrals?...

  18. 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.

  19. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

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

  20. Drugs Approved for Lung Cancer

    Science.gov (United States)

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

  1. Inorganic elemental compositions of commercial multivitamin/mineral dietary supplements: application of collision/reaction cell inductively coupled-mass spectroscopy

    Science.gov (United States)

    Microwave digestion followed by analysis using ICP-MS has been shown to be a simple, fast reliable method for the multi-element determination in multivitamin/mineral dietary supplements (MVM). A study of 35 popular MVM dietary supplements revealed that composition and levels varied among products, a...

  2. 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.

  3. 14 CFR 21.333 - Issue of export airworthiness approval tags for Class III products.

    Science.gov (United States)

    2010-01-01

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

  4. 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.

  5. 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.

  6. FWS Approved Acquisition Boundaries

    Data.gov (United States)

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

  7. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  8. 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...

  9. 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).

  10. 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).

  11. 75 FR 80493 - Public Water System Supervision Program Approval for the State of Wisconsin

    Science.gov (United States)

    2010-12-22

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

  12. 77 FR 41191 - Proposed Collection; Comment Request: Effectiveness of the NIH Curriculum Supplements Programs

    Science.gov (United States)

    2012-07-12

    ... NIH Curriculum Supplements Programs SUMMARY: In compliance with the requirements of section 3506(c)(2... review and approval. Proposed Collection: Title: The Effectiveness of the NIH Curriculum Supplements... will attempt to assess customer demographics and their satisfaction with the NIH curriculum...

  13. [Food supplements : Legal requirements, borderline issues and other aspects].

    Science.gov (United States)

    Noble, Pia

    2017-03-01

    Food supplements are classified as foods. They are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect. Their purpose is to supplement the normal diet. Food supplements have to comply with the applicable legal provisions of the food law. In order to ensure the health protection of consumers, food supplements that will be put on the market must be safe. For food supplements, regulations exist at the EU level as well as at the national level. Specific requirements are regulated in the Ordinance on Food Supplements, with which the European Directive on Food Supplements was transposed into German law. The European and German legal provisions applicable to food supplements are outlined. Important aspects regarding the delimitation between food supplements and medicinal products are addressed. These borderline issues are of special importance to food supplements which are marketed in dose forms such as capsules, tablets etc., the typical forms of medicinal products. Problems resulting from the lack of harmonized rules are described. The European harmonization of the rules is still incomplete for substances with a nutritional or physiological effect other than vitamins and minerals for use in food supplements. The setting of maximum amounts of vitamins and minerals present in food supplements as envisaged in the Directive on Food Supplements has not yet been implemented.

  14. 77 FR 20697 - Supplemental Standards of Ethical Conduct for Employees

    Science.gov (United States)

    2012-04-06

    ... RECONSTRUCTION 5 CFR Part 9303 RIN 3460-AA01 Supplemental Standards of Ethical Conduct for Employees AGENCY... Office of Government Ethics (OGE), is issuing an interim regulation for SIGAR employees that will... regulation includes a requirement that SIGAR employees obtain prior approval for certain types of...

  15. Cofinitely weak supplemented modules

    OpenAIRE

    Alizade, Rafail; Büyükaşık, Engin

    2003-01-01

    We prove that a module M is cofinitely weak supplemented or briefly cws (i.e., every submodule N of M with M/N finitely generated, has a weak supplement) if and only if every maximal submodule has a weak supplement. If M is a cws-module then every M-generated module is a cws-module. Every module is cws if and only if the ring is semilocal. We study also modules, whose finitely generated submodules have weak supplements.

  16. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

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

  17. 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...

  18. 7 CFR 52.53 - Approved identification.

    Science.gov (United States)

    2010-01-01

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

  19. Commercially marketed supplements for bodybuilding athletes.

    Science.gov (United States)

    Grunewald, K K; Bailey, R S

    1993-02-01

    We conducted a survey of 624 commercially available supplements targeted towards bodybuilding athletes. Over 800 performance claims were made for these supplements. Supplements include amino acids, boron, carnitine, choline, chromium, dibencozide, ferulic acid, gamma oryzanol, medium chain triglycerides, weight gain powders, Smilax compounds and yohimbine. Many performance claims advertised were not supported by published research studies. In some instances, we found no research to validate the claims; in other cases, research findings were extrapolated to inappropriate applications. For example, biological functions of some non-essential compounds were interpreted as performance claims for the supplements. Claims for others were based on their ability to enhance hormonal release or activity. We suggest that more research be conducted on this group of athletes and their nutritional needs. Furthermore, the effectiveness and safety of supplements merit further investigation.

  20. 42 CFR 84.35 - Changes or modifications of approved respirators; issuance of modification of certificate of...

    Science.gov (United States)

    2010-10-01

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

  1. Pembrolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-10-01

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

  2. Pomalidomide: first global approval.

    Science.gov (United States)

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

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

  3. Apremilast: first global approval.

    Science.gov (United States)

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

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

  4. Abbreviated New Drug Applications and 505(b)(2) Applications. Final rule.

    Science.gov (United States)

    2016-10-06

    The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.

  5. 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。

  6. FDA Approval for Imiquimod

    Science.gov (United States)

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

  7. Heartland Winthrop Approval

    Science.gov (United States)

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  8. FHR Iowa Falls Approval

    Science.gov (United States)

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

  9. Resveratrol food supplements

    DEFF Research Database (Denmark)

    Aschemann-Witzel, Jessica; Grunert, Klaus G

    2015-01-01

    . 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, rather than......Background: Consumers increasingly choose food supplements in addition to their diet. Research on supplement users finds they are likely to be female, older and well-educated; Furthermore, supplement users are often characterised as being especially health-oriented, an observation which is termed...... the ‘inverse supplement hypothesis’. However, results are dependent on the substance in question. Little is known so far about botanicals in general, and more specifically, little is known about resveratrol. The psychographic variables of food supplement users are yet relatively underexplored. By comparing US...

  10. Preventive and Therapeutic Role of Dietary Inositol Supplementation in Periconceptional Period and During Pregnancy: A Summary of Evidences and Future Applications.

    Science.gov (United States)

    Noventa, Marco; Vitagliano, Amerigo; Quaranta, Michela; Borgato, Shara; Abdulrahim, Baydaa; Gizzo, Salvatore

    2016-03-01

    Although inositol dietary deficiency in the general population has not been demonstrated at the serum level, several findings are emerging regarding the impact of inositol supplementation in periconceptional period and in early phases of pregnancy. We are aimed to summarize all experimental (murine in vivo and in vitro murine embryo studies) and clinical (human) evidences regarding the role of inositol in the prevention and treatment of folate-resistant embryo neural tube defects (FR-NTDs) and gestational diabetes mellitus (GDM). We also collected all information regarding the effect that inositol supplementation may have in the metabolic reassessment of early and late pregnancy in order to draw evidence-based conclusions and suggest further studies defining the potential therapeutic role of this molecule in human reproduction. The systematic review of literature clearly showed that inositol supplementation in preconceptional period and in early phase of pregnancy reduces the risk of developing GDM in patients at increased risk. Furthermore, continued intake during pregnancy improves the metabolic status of affected patients, but further studies are needed to confirm this end point. All women at risk of FR-NTDs assuming inositol from the periconceptional period until late pregnancy are reported to have healthy newborns without any significant complications linked to inositol supplementation.

  11. [Trade of food supplement: food or drug supplement?

    Science.gov (United States)

    Siracusa, Margherita; Petrelli, Fabio

    2016-09-01

    The aporia is obvious: food supplement, classified and regulated by food law, sometimes have the characteristics and the typical effects of medicines. In addition, these are produced by pharmaceutical companies and, through the scientific officer, are prescribed by doctors and dispensed by pharmacies. This study will attempt to retrace the winding, and sometimes overlapping, regulatory pathways of the legislation on food supplement, food and medicines. It will be important object the particular application of the precautionary principle behind the legislation on food supplement: application "in posterior", so the controls on the purity of the product and the possible effects resulting from the assumption is carried out ex post trade. So we try to disentangle the intricate legislation with the national (and European) Court contributions. In particular, after a brief analysis of the rulings of the Competition and Market Authority on misleading advertising and by the Supreme Court in relation to crimes against health damage, it will come to the analysis of interpretative problems of a purely criminal law nature, in light of the recent proposal for reform about agribusiness crimes. Finally, it will be inevitable to analyze briefly the recent implementation of the d.lgs. n. 17/2004 concerning the distance trade of non-prescription medicines. There is no doubt that now, internet represents the preferred distribution channel for pharmaceutical products (including food supplement) and the most tempting "place" (because of control difficulties) for the realization of criminal conduct. The conclusion will be that the need to achieve more targeted and homogeneous regulatory measures, while also having to protect - public and individual - health through the protection of the legal security in one with the protection of the right to information.

  12. Linaclotide: first global approval.

    Science.gov (United States)

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

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

  13. Pitolisant: First Global Approval.

    Science.gov (United States)

    Syed, Yahiya Y

    2016-09-01

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

  14. Baricitinib: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2017-03-13

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

  15. Evolocumab: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2015-09-01

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

  16. 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.

  17. Impact of foliar application of nano micronutrient fertilizers and titanium dioxide nanoparticles on the growth and yield components of barley under supplemental irrigation

    OpenAIRE

    Mohsen JANMOHAMMADI; Tahereh AMANZADEH; Sabaghnia, Naser; Shahryar DASHTI

    2016-01-01

    Nano-fertilizers are new generation of the synthetic fertilizers which contain readily available nutrients in nano scale range. Nano fertilizers are preferred largely due to their efficiency and environment friendly nature compared to conventional chemical fertilizers. To evaluate the effects of foliar spray of micronutrient nano-fertilizer (iron and zinc) and nano-titanium dioxide (nTiO2) solution on grain yield and its components in barley under supplemental irrigation conditions, a field e...

  18. Resveratrol food supplements

    DEFF Research Database (Denmark)

    Aschemann-Witzel, Jessica; Grunert, Klaus G

    2015-01-01

    Background: Consumers increasingly choose food supplements in addition to their diet. Research on supplement users finds they are likely to be female, older and well-educated; Furthermore, supplement users are often characterised as being especially health-oriented, an observation which is termed...... the ‘inverse supplement hypothesis’. However, results are dependent on the substance in question. Little is known so far about botanicals in general, and more specifically, little is known about resveratrol. The psychographic variables of food supplement users are yet relatively underexplored. By 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...

  19. 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.

  20. 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.

  1. Supplemental design requirements document, Project W026. Revision 3

    Energy Technology Data Exchange (ETDEWEB)

    Weidert, J.R.

    1993-10-08

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

    Science.gov (United States)

    2013-11-07

    ... submitted for evaluation and approval before use under the final rule are: (1) Labels for chicken produced..., such as ``no antibiotics administered'' or ``vegetarian fed''; (4) instructional or...

  3. 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...

  4. 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....

  5. 75 FR 35017 - Brookfield Energy Marketing LP; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-06-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal 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...

  6. Applications for Oncologic Drugs: A Descriptive Analysis of the Oncologic Drugs Advisory Committee Reviews

    Science.gov (United States)

    Kiet, Tuyen K.; Monk, Bradley J.; Young-Lin, Nichole; Blansit, Kevin; Kapp, Daniel S.; Amanam, Idoroenyi

    2014-01-01

    Background Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. Methods All applications referred to the ODAC from 2001 to 2012 were reviewed. Results Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001–2004, 2005–2008, 2009–2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). Conclusion. Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs. PMID:24599479

  7. Supplements for exotic pets.

    Science.gov (United States)

    Mejia-Fava, Johanna; Colitz, Carmen M H

    2014-09-01

    The use of supplements has become commonplace in an effort to complement traditional therapy and as part of long-term preventive health plans. This article discusses historical and present uses of antioxidants, vitamins, and herbs. By complementing traditional medicine with holistic and alternative nutrition and supplements, the overall health and wellness of exotic pets can be enhanced and balanced. Further research is needed for understanding the strengths and uses of supplements in exotic species. Going back to the animals' origin and roots bring clinicians closer to nature and its healing powers.

  8. Obinutuzumab: first global approval.

    Science.gov (United States)

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

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

  9. Safinamide: first global approval.

    Science.gov (United States)

    Deeks, Emma D

    2015-04-01

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

  10. Drugs Approved for Cervical Cancer

    Science.gov (United States)

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

  11. 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.

  12. Herbal Products and Supplements

    Science.gov (United States)

    ... black cohosh, echinacea, garlic, ginkgo, saw palmetto, and St. John's wort.Are herbal health products and supplements safe?Herbs ... not work the way it should. For example, St. John's wort reduces the amount of certain drugs absorbed by ...

  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. FDA 101: Dietary Supplements

    Science.gov (United States)

    ... that is otherwise adulterated or misbranded. Dietary supplement advertising, including ads broadcast on radio and television, falls ... feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos ...

  15. 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...... of 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....

  16. 78 FR 78311 - Approval and Promulgation of Implementation Plans; Washington: Kent, Seattle, and Tacoma Second...

    Science.gov (United States)

    2013-12-26

    ... program, a prohibition on open burning, and industrial emission controls. These control measures were... 17, 2008). The information was supplemented with annual 2011 industrial emissions reported to PSCAA... an approved attainment Emissions Inventory? C. Does the Limited Maintenance Plan Include an...

  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. Vitamin D supplementation guidelines.

    Science.gov (United States)

    Pludowski, Pawel; Holick, Michael F; Grant, William B; Konstantynowicz, Jerzy; Mascarenhas, Mario R; Haq, Afrozul; Povoroznyuk, Vladyslav; Balatska, Nataliya; Barbosa, Ana Paula; Karonova, Tatiana; Rudenka, Ema; Misiorowski, Waldemar; Zakharova, Irina; Rudenka, Alena; Łukaszkiewicz, Jacek; Marcinowska-Suchowierska, Ewa; Łaszcz, Natalia; Abramowicz, Pawel; Bhattoa, Harjit P; Wimalawansa, Sunil J

    2017-02-12

    Research carried out during the past two-decades extended the understanding of actions of vitamin D, from regulating calcium and phosphate absorption and bone metabolism to many pleiotropic actions in organs and tissues in the body. Most observational and ecological studies report association of higher serum 25-hydroxyvitamin D [25(OH)D] concentrations with improved outcomes for several chronic, communicable and non-communicable diseases. Consequently, numerous agencies and scientific organizations have developed recommendations for vitamin D supplementation and guidance on optimal serum 25(OH)D concentrations. The bone-centric guidelines recommend a target 25(OH)D concentration of 20ng/mL (50nmol/L), and age-dependent daily vitamin D doses of 400-800IU. The guidelines focused on pleiotropic effects of vitamin D recommend a target 25(OH)D concentration of 30ng/mL (75nmol/L), and age-, body weight-, disease-status, and ethnicity dependent vitamin D doses ranging between 400 and 2000IU/day. The wise and balanced choice of the recommendations to follow depends on one's individual health outcome concerns, age, body weight, latitude of residence, dietary and cultural habits, making the regional or nationwide guidelines more applicable in clinical practice. While natural sources of vitamin D can raise 25(OH)D concentrations, relative to dietary preferences and latitude of residence, in the context of general population, these sources are regarded ineffective to maintain the year-round 25(OH)D concentrations in the range of 30-50ng/mL (75-125nmol/L). Vitamin D self-administration related adverse effects, such as hypercalcemia and hypercalciuria are rare, and usually result from taking extremely high doses of vitamin D for a prolonged time.

  19. CLSI performance standards for antimicrobial susceptibility testing of bacteria isoloated from aquatic animals; second information supplement. CLSI document VET03/VET04-S2

    Science.gov (United States)

    The supplemental information presented in this document is intended for use with the antimicrobial susceptibility testing procedures published in the following Clinical and Laboratory Standards Institute (CLSI) approved documents VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacte...

  20. 78 FR 76383 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-12-17

    ... Airport Authority, Mobile, Alabama. Application Number: 13-06-C-00-MOB. Application Type: Impose and use a... Regional Airport (MOB). Determination: Approved. Based on information submitted in the public agency's... annual enplanements at MOB. Brief Description of Projects Approved for Collection and Use:...

  1. FDA-Approved HIV Medicines

    Science.gov (United States)

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

  2. The Influence of 8-Weeks of Whey Protein and Leucine Supplementation on Physical and Cognitive Performance

    Science.gov (United States)

    2009-03-01

    extension resistance training than did a carbohydrate placebo (22%). Protein and branched chain amino acids ( BCAA ) supplementation may also improve... BCAAs scored better on both mood levels and 2 Approved for public release; distribution unlimited, Public Affairs Case File No. 09-189, 27 April 2009...supplemented subjects with whey and casein (WC), whey and BCAAs (WBC), or placebo (P) over 10 weeks of resistance training (RT). They observed a significant

  3. 医院科技人员请假审批系统的研制与应用%Development and Application of Leave Approval System for Technical Professionals of the Hospital

    Institute of Scientific and Technical Information of China (English)

    刘同波; 邱明辉; 郭旭

    2012-01-01

    The management of staff applying for a leave is difficult for the administration department of our hospital. This paper introduces a web-based staff leave approval system through the hospital internal network. The design and implementation technology of the system are presented in detail. The application status and effects of the system are summarized. The system has been operating for two years which helps improve work efficiency for both high-level managers and ordinary employees. The system is well received by all hospital users.%大型综合型医院科技人员外出请假管理一直是困扰管理部门的一个难题.介绍了解放军总医院自行研制的基于浏览器方式的人员外出请假审批系统,详细描述了系统的设计和实现技术,并对系统的应用情况和应用效果进行了总结.系统在医院稳定运行近两年,收到了良好效果,具有广泛应用价值.

  4. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Science.gov (United States)

    2010-10-01

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

  5. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

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

  6. Kentucky Department for Natural Resources and Environmental Protection permit application for air contaminant source: SRC-I demonstration plant, Newman, Kentucky. Supplement I. [Additional information on 38 items requested by KY/DNREP

    Energy Technology Data Exchange (ETDEWEB)

    Pearson, Jr., John F.

    1981-02-13

    In response to a letter from KY/DNREP, January 19, 1981, ICRC and DOE have prepared the enclosed supplement to the Kentucky Department for Natural Resources and Environmental Protection Permit Application for Air Contaminant Source for the SRC-I Demonstration Plant. Each of the 38 comments contained in the letter has been addressed in accordance with the discussions held in Frankfort on January 28, 1981, among representatives of KY/DNREP, EPA Region IV, US DOE, and ICRC. The questions raised involve requests for detailed information on the performance and reliability of proprietary equipment, back-up methods, monitoring plans for various pollutants, composition of wastes to flares, emissions estimates from particular operations, origin of baseline information, mathematical models, storage tanks, dusts, etc. (LTN)

  7. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    Science.gov (United States)

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.

  8. 75 FR 44047 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-07-27

    ... of Sec. 158.29. PFC Applications Approved Public Agency: County and City of Spokane, Washington...--runway plow. Airfield friction tester. Snow removal equipment--airfield snow blower. PFC application...

  9. 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.

  10. Supplements and sports.

    Science.gov (United States)

    Jenkinson, David M; Harbert, Allison J

    2008-11-01

    Use of performance-enhancing supplements occurs at all levels of sports, from professional athletes to junior high school students. Although some supplements do enhance athletic performance, many have no proven benefits and have serious adverse effects. Anabolic steroids and ephedrine have life-threatening adverse effects and are prohibited by the International Olympic Committee and the National Collegiate Athletic Association for use in competition. Blood transfusions, androstenedione, and dehydroepiandrosterone are also prohibited in competition. Caffeine, creatine, and sodium bicarbonate have been shown to enhance performance in certain contexts and have few adverse effects. No performance benefit has been shown with amino acids, beta-hydroxy-beta-methylbutyrate, chromium, human growth hormone, and iron. Carbohydrate-electrolyte beverages have no serious adverse effects and can aid performance when used for fluid replacement. Given the widespread use of performance-enhancing supplements, physicians should be prepared to counsel athletes of all ages about their effectiveness, safety, and legality.

  11. 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

  12. [Regulation of food supplements in the European Union and its member states. Part 2].

    Science.gov (United States)

    Petrenko, A S; Ponomareva, M N; Sukhanov, B P

    2014-01-01

    The article discusses various aspects of the regional (the European Union) and national (European countries) regulation related to food supplements. The use of botanicals and minor bioactive substances in food supplements, and their labelling are studied. The EU principle of mutual recognition is described in the context of current challenges that exist in the regulatory harmonisation between the EU member states. The concept of novel foods and novel ingredients is also presented, and the procedure of their pre-market approval is described in detail. Basic principles of using claims for food supplements are also outlined.

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

    Directory of Open Access Journals (Sweden)

    Noriss Kweku Hammah

    2015-12-01

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

  14. 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....

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. Is It Really FDA Approved?

    Science.gov (United States)

    ... does not approve cosmetics. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body ... and provide the agency with a notification before marketing a new formula. FDA conducts yearly inspections of ...

  2. 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...

  3. 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.

  4. Drugs Approved for Skin Cancer

    Science.gov (United States)

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

  5. 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.

  6. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

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

  7. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

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

  8. Drugs Approved for Bone Cancer

    Science.gov (United States)

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

  9. Drugs Approved for Prostate Cancer

    Science.gov (United States)

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

  10. Trulance Approved for Chronic Constipation

    Science.gov (United States)

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

  11. 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.

  12. 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 ...

  13. Dietary Supplements: What Is Safe?

    Science.gov (United States)

    ... and side effects of dietary supplements Dietary supplement advertising and promotion Talking with your doctor about dietary ... Statistics Center Volunteer Learning Center Follow Us Twitter Facebook Instagram Cancer Information, Answers, and Hope. Available Every ...

  14. 红细胞生成刺激剂及铁剂在肾脏病中的合理应用%Reasonable application of erythropoiesis-stimulating agents and iron supplements in patients with kidney diseases

    Institute of Scientific and Technical Information of China (English)

    王彩丽

    2014-01-01

    贫血是慢性肾脏病(CKD)的重要并发症之一,促红细胞生成素(EPO)分泌不足和铁缺乏是CKD患者贫血的主要原因,不合理应用红细胞生成刺激剂(ESA)和铁剂,使血红蛋白水平过高、过低,都会导致临床不良事件的发生,本文主要根据2012年改善全球肾脏预后(KDIGO)贫血治疗指南和2014年肾性贫血诊断与治疗中国专家共识,就ESA、铁剂的合理应用等方面进行讨论,提醒临床医师权衡治疗时的风险和获益,合理应用ESA及铁剂,将血红蛋白的水平稳定维持在安全的靶目标范围内,避免贫血治疗带来的不良反应,同时做到贫血治疗的个体化。%Anemia is an important complication of patients with chronic kidney disease (CKD), whose main causes are reduction of renal erythropoietin (EPO ) secretion and iron deficiency. The unreasonable application of erythropoiesis-stimulating agents (ESAs)and iron supplements can make the hemoglobin level too high or too low,which will lead to the occurrence of clinical adverse reactions.This review discussed about the reasonable use of ESAs and iron supplements according to the 2012 Kidney Disease:lmproving Global Outcomes (KDIGO)anemia treatment guidelines and the 2014 Chinese experts consensus of diagnosis and treatment of renal anemia,to remind clinicians to evaluate the risk and benefit of the treatment of anemia,to apply ESAs and iron supplements reasonably,to maintain the hemoglobin level in a safe target range,to avoid the side effects of anaemia management,and to individualize the treatment of anaemia.

  15. 76 FR 38050 - Defense Federal Acquisition Regulation Supplement; Management of Manufacturing Risk in Major...

    Science.gov (United States)

    2011-06-29

    ... Regulation Supplement; Management of Manufacturing Risk in Major Defense Acquisition Programs (DFARS Case... require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C... Government procurement. Mary Overstreet, Editor, Defense Acquisition Regulations System. Therefore, 48...

  16. 36 CFR 9.40 - Supplementation or revision of plan of operations.

    Science.gov (United States)

    2010-07-01

    ... of plan of operations. 9.40 Section 9.40 Parks, Forests, and Public Property NATIONAL PARK SERVICE... revision of plan of operations. (a) A proposal to supplement or revise an approved plan of operations may... to address conditions not previously contemplated by notifying the appropriate party in writing...

  17. 77 FR 2682 - Defense Federal Acquisition Regulation Supplement; DoD Voucher Processing

    Science.gov (United States)

    2012-01-19

    ... vouchers not selected for a pre-payment review will be considered to be provisionally approved and will be... after a pre-payment review. Interim vouchers not selected for a pre-payment review will be considered to... Regulation Supplement; DoD Voucher Processing AGENCY: Defense Acquisition Regulations System, Department...

  18. SUPPLEMENT USE BY YOUNG ATHLETES

    Directory of Open Access Journals (Sweden)

    Jill Anne McDowall

    2007-09-01

    Full Text Available 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 are the main reasons for taking supplements, enhanced athletic performance was also reported as a strong motivating factor. Generally, females are found to use supplements more frequently and are associated with reasons of health, recovery, and replacing an inadequate diet. Males are more likely to report taking supplements for enhanced performance. Both genders equally rated increased energy as another reason for engaging in supplement use. Many dietary supplements are highly accessible to young athletes and they are particularly vulnerable to pressures from the media and the prospect of playing sport at increasingly elite levels. Future research should provide more direct evidence regarding any physiological side effects of taking supplements, as well as the exact vitamin and mineral requirements for child and adolescent athletes. Increased education for young athletes regarding supplement use, parents and coaches should to be targeted to help the athletes make the appropriate choices

  19. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  20. 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.

  1. Predawn and high intensity application of supplemental blue light decreases the quantum yield of PSII and enhances the amount of phenolic acids, flavonoids, and pigments in Lactuca sativa.

    Science.gov (United States)

    Ouzounis, Theoharis; Razi Parjikolaei, Behnaz; Fretté, Xavier; Rosenqvist, Eva; Ottosen, Carl-Otto

    2015-01-01

    To evaluate the effect of blue light intensity and timing, two cultivars of lettuce [Lactuca sativa cv. "Batavia" (green) and cv. "Lollo Rossa" (red)] were grown in a greenhouse compartment in late winter under natural light and supplemental high pressure sodium (SON-T) lamps yielding 90 (±10) μmol m(-2) s(-1) for up to 20 h, but never between 17:00 and 21:00. The temperature in the greenhouse compartments was 22/11°C day/night, respectively. The five light-emitting diode (LED) light treatments were Control (no blue addition), 1B 06-08 (Blue light at 45 μmol m(-2) s(-1) from 06:00 to 08:00), 1B 21-08 (Blue light at 45 μmol m(-2) s(-1) from 21:00 to 08:00), 2B 17-19 (Blue at 80 μmol m(-2) s(-1) from 17:00 to 19:00), and 1B 17-19 (Blue at 45 μmol m(-2) s(-1) from 17:00 to 19:00). Total fresh and dry weight was not affected with additional blue light; however, plants treated with additional blue light were more compact. The stomatal conductance in the green lettuce cultivar was higher for all treatments with blue light compared to the Control. Photosynthetic yields measured with chlorophyll fluorescence showed different response between the cultivars; in red lettuce, the quantum yield of PSII decreased and the yield of non-photochemical quenching increased with increasing blue light, whereas in green lettuce no difference was observed. Quantification of secondary metabolites showed that all four treatments with additional blue light had higher amount of pigments, phenolic acids, and flavonoids compared to the Control. The effect was more prominent in red lettuce, highlighting that the results vary among treatments and compounds. Our results indicate that not only high light level triggers photoprotective heat dissipation in the plant, but also the specific spectral composition of the light itself at low intensities. However, these plant responses to light are cultivar dependent.

  2. [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.

  3. 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.

  4. Supplemental topics on voids

    Energy Technology Data Exchange (ETDEWEB)

    Rood, H.J.

    1988-09-01

    Several topics concerning voids are presented, supplementing the report of Rood (1988). The discovery of the Coma supercluster and void and the recognition of the cosmological significance of superclusters and voids are reviewed. Galaxy redshift surveys and redshift surveys for the Abell clusters and very distant objects are discussed. Solar system and extragalactic dynamics are examined. Also, topics for future observational research on voids are recommended. 50 references.

  5. Discrimination of approved drugs from experimental drugs by learning methods

    Directory of Open Access Journals (Sweden)

    Li Yixue

    2011-05-01

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

  6. 13 CFR 108.380 - Final approval as a NMVC Company.

    Science.gov (United States)

    2010-01-01

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

  7. 77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-12-13

    ... Division Administrator an application for approval of a Work Study Program as one that does not interfere... and Hour Division. Title: Work-Study Program of the Child Labor Regulations (WSP) Regulations 29 CFR... Hour Division RIN 1235-0024 Proposed Extension of the Approval of Information Collection...

  8. Accession Medical Standards Analysis and Research Activity (AMSARA) 2015, Annual Report, and four Supplemental Applicants and Accessions Tables for: Army, Air Force, Marine, and Navy

    Science.gov (United States)

    2016-03-11

    the number of first time enlisted active duty applicants with a medical disqualification related to gender and identity disorders for FY 2008-2011 in...Elizabeth R. Packnett, MPH Principal Public Health Analyst Contractor, ManTech Health Hoda Elmasry, MPH Public Health Analyst Contractor...ManTech Health Xiaoshu Feng, MS Statistician Contractor, ManTech Health Nadia Garvin, MHS Public Health Analyst Contractor, ManTech

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

    Science.gov (United States)

    2016-03-01

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

  10. 46 CFR 160.077-6 - Approval procedures.

    Science.gov (United States)

    2010-10-01

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

  11. 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

  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

    and lifestyle between 1993 and 1997. A health index including smoking, physical activity, alcohol and diet, and a metabolic risk index including waist circumference, urinary glucose and measured hypertension were constructed. Logistic regression was used to investigate these determinants in relation...... common supplement use. In conclusion, those with the healthiest lifestyle were more likely to use dietary supplements. Thus, lifestyle and dietary composition should be considered as confounders on supplement use and health outcomes....

  13. Authentication of Herbal Supplements Using Next-Generation Sequencing

    OpenAIRE

    Ivanova, Natalia V.; Kuzmina, Maria L.; Thomas W A Braukmann; 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-grae...

  14. 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

  15. Supplementing managed competition.

    Science.gov (United States)

    Higgins, W

    President Clinton's proposal for health care reform calls for managed competition within global expenditure targets. However, it is unlikely that health plans will have sufficient leverage with providers to negotiate arrangements consistent with expenditure targets in nonurban areas. This paper describes a reimbursement system based on competitive prospective payment and capitation (CPPC) which can supplement managed competition in less populous areas or replace managed competition should that strategy prove unsuccessful. The CPPC system is capable of enforcing an expenditure target while encouraging the formation of capitated networks and creating strong incentives for efficiency. It is generally compatible with the Clinton administration's version of managed competition.

  16. Zinc supplementation in burn patients.

    Science.gov (United States)

    Caldis-Coutris, Nancy; Gawaziuk, Justin P; Logsetty, Sarvesh

    2012-01-01

    Micronutrient supplementation is a common practice throughout many burn centers across North America; however, uncertainty pertaining to dose, duration, and side effects of such supplements persists. The authors prospectively collected data from 23 hospitalized patients with burn sizes ranging from 10 to 93% TBSA. Each patient received a daily multivitamin and mineral supplement, 50 mg zinc (Zn) daily, and 500 mg vitamin C twice daily. Supplements were administered orally or enterally. Albumin, prealbumin, C-reactive protein, serum Zn, and serum copper were measured weekly during hospital admission until levels were within normal reference range. Our study concluded that 50 mg daily dose of Zn resulted in normal serum levels in 19 of 23 patients at discharge; 50 mg Zn supplementation did not interfere with serum copper levels; and Zn supplements, regardless of administration route, did not result in gastrointestinal side effects.

  17. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  18. 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.

  19. 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.

  20. Alkylbenzene Project in Xinjiang Approved

    Institute of Scientific and Technical Information of China (English)

    Zhou Weiyong

    1996-01-01

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

  1. Broadband and Microwave Dielectric Studies on Ba5Nb4O15 Ceramics Supplemented with Its Nanoparticles for Cryogenic Electronic Applications

    Science.gov (United States)

    Anil Kumar, C.; Pamu, D.

    2017-02-01

    Ba5Nb4O15 (BNO) nanopowders were prepared by sol-gel process. The effect of BNO nanopowders ( x = 1 wt.%, 2 wt.%, and 3 wt.%) on micron-sized BNO polycrystalline powders were studied systematically. Transmission electron microscope (TEM) images of BNO nanoparticles revealed spherical and cylindrical shapes with average particle sizes of 45 nm and 60 nm, respectively. Further, the dielectric response of BNO ceramics with x wt.% of nanosized particles ( x = 1-3) measured in the temperature range of 80°C to 200°C showed relaxation behaviour and is described by using Havriliak-Negami equation. The best microwave dielectric properties of ɛ r and Q × f 0 values of 39.2 GHz and 59,000 GHz, at 6.52 GHz are obtained for the x = 3 wt.% sample, sintered at 1100°C, and is attributed to maximum density, large and uniform microstructure. The acquired static dielectric response of BNO ceramics with x wt.% of nanosized particles ( x = 1-3) are suitable for cryogenic electronic and dielectric resonator applications.

  2. Dietary supplements for aquatic sports.

    Science.gov (United States)

    Derave, Wim; Tipton, Kevin D

    2014-08-01

    Many athletes use dietary supplements, with use more prevalent among those competing at the highest level. Supplements are often self-prescribed, and their use is likely to be based on an inadequate understanding of the issues at stake. Supplementation with essential micronutrients may be useful when a diagnosed deficiency cannot be promptly and effectively corrected with food-based dietary solutions. When used in high doses, some supplements may do more harm than good: Iron supplementation, for example, is potentially harmful. There is good evidence from laboratory studies and some evidence from field studies to support health or performance benefits from appropriate use of a few supplements. The available evidence from studies of aquatic sports is small and is often contradictory. Evidence from elite performers is almost entirely absent, but some athletes may benefit from informed use of creatine, caffeine, and buffering agents. Poor quality assurance in some parts of the dietary supplements industry raises concerns about the safety of some products. Some do not contain the active ingredients listed on the label, and some contain toxic substances, including prescription drugs, that can cause health problems. Some supplements contain compounds that will cause an athlete to fail a doping test. Supplement quality assurance programs can reduce, but not entirely eliminate, this risk.

  3. 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.

  4. 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...

  5. 76 FR 77182 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; General Conformity...

    Science.gov (United States)

    2011-12-12

    ... Conformity Requirements for Federal Agencies Applicable to Federal Actions AGENCY: Environmental Protection... adopted by Virginia for the purpose of incorporating Federal general conformity requirements revisions... approving Virginia's general conformity SIP revision and if that provision may be severed from the...

  6. 77 FR 53249 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2012-08-31

    ... and Budget (OMB) approval to renew an information collection. The FAA collects information from... monitoring. Information is collected in the application, and grant agreement amendments; financial management... projects. Frequency: Information is collected on occasion. Estimated Average Burden per Response:...

  7. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-08-04

    .... Applicant Trade name Approval date P050050 FDA-2011-M-0323....... Small Bone Scandinavian total ankle May 27, 2009. Innovations, Inc. replacement system. P060004(S1) FDA-2011-M-0256... Carl Zeiss Meditec,...

  8. 78 FR 57213 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-09-17

    ... of Sec. 158.29. PFC Applications Approved Public Agency: City of Savannah and Savannah Airport...: Noise compatibility program at BUF. Glycol treatment project at BUF. Runway friction tester at BUF....

  9. 75 FR 2090 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Volatile Organic Compound...

    Science.gov (United States)

    2010-01-14

    ... Organic Compound Automobile Refinishing Rules for Indiana AGENCY: Environmental Protection Agency (EPA... relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds... Plan (SIP). These rule revisions extend the applicability of Indiana's approved volatile...

  10. Dietary supplementation of polyunsaturated fatty acids in Caenorhabditis elegans.

    Science.gov (United States)

    Deline, Marshall L; Vrablik, Tracy L; Watts, Jennifer L

    2013-11-29

    Fatty acids are essential for numerous cellular functions. They serve as efficient energy storage molecules, make up the hydrophobic core of membranes, and participate in various signaling pathways. Caenorhabditis elegans synthesizes all of the enzymes necessary to produce a range of omega-6 and omega-3 fatty acids. This, combined with the simple anatomy and range of available genetic tools, make it an attractive model to study fatty acid function. In order to investigate the genetic pathways that mediate the physiological effects of dietary fatty acids, we have developed a method to supplement the C. elegans diet with unsaturated fatty acids. Supplementation is an effective means to alter the fatty acid composition of worms and can also be used to rescue defects in fatty acid-deficient mutants. Our method uses nematode growth medium agar (NGM) supplemented with fatty acid sodium salts. The fatty acids in the supplemented plates become incorporated into the membranes of the bacterial food source, which is then taken up by the C. elegans that feed on the supplemented bacteria. We also describe a gas chromatography protocol to monitor the changes in fatty acid composition that occur in supplemented worms. This is an efficient way to supplement the diets of both large and small populations of C. elegans, allowing for a range of applications for this method.

  11. 32 CFR 552.77 - Suspension approval.

    Science.gov (United States)

    2010-07-01

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

  12. 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...

  13. 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....

  14. 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...

  15. 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.......g., secondary plant metabolites such as flavonoids), or as contaminants that enter the food chain at different stages or during the food production process. For these components, a wide spectrum of biological effects was observed that ranges from health-threatening impacts (e.g., polycyclic aromatic amines......, 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...

  16. Food Components and Supplements

    DEFF Research Database (Denmark)

    Parlesak, Alexandr

    2012-01-01

    .g., secondary plant metabolites such as flavonoids), or as contaminants that enter the food chain at different stages or during the food production process. For these components, a wide spectrum of biological effects was observed that ranges from health-threatening impacts (e.g., polycyclic aromatic amines...... the growth of these bacteria (prebiotics) are added to food to achieve health effects exceeding its pure nutritional function. Several of these effects are mediated by enzyme systems involved in xenobiotic and drug metabolism, and in some cases this might lead to undesired interactions with medication...... cases, nutrients, food contaminants, and secondary plant metabolites can themselves become substrates for xenobiotic-metabolizing enzymes, resulting in health-promoting or health-threatening products. This chapter focuses on how important components of our daily nutrition and supplements can interfere...

  17. 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.

  18. 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.

  19. Hunan Rare Earth Group Approved

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

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

  20. Nelfinavir: fourth protease inhibitor approved.

    Science.gov (United States)

    1997-01-01

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

  1. 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.

  2. 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.

  3. Dietary Supplements: What You Need to Know

    Science.gov (United States)

    ... dietary supplements? Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids. What are the ...

  4. An examination of structure-function claims in dietary supplement advertising in the U.S.: 2003-2009.

    Science.gov (United States)

    Avery, Rosemary J; Eisenberg, Matthew D; Cantor, Jonathan H

    2017-01-21

    Dietary supplement advertising cannot claim a causal link between the product and the treatment, prevention, or cure of a disease unless manufacturers seek approval from the FDA for a health claim. Manufacturers can make structure-function (S-F) claims without FDA approval linking a supplement to a body function or system using words such as "may help" or "promotes." These S-F claims are examined in this study in order to determine whether they mimic health claims for which the FDA requires stricter scientific evidence. Data include S-F claims in supplement advertisements (N=6179) appearing in US nationally circulated magazines (N=137) from 2003 to 2009. All advertisements were comprehensively coded for S-F claims, seals of approval, and other claims of guarantee. S-F claims associate supplements with a wide variety of health conditions, many of which are serious diseases and/or ailments. A significant number of the specific verbs used in these S-F claims are indicative of disease treatment/cure effects, thereby possibly mimicking health claims to the average consumer. The strength of the clinical associations made are largely unsubstantiated in the medical literature. Claims that a product is "scientifically proven" or "guaranteed" were largely unsubstantiated by clinical literature. Ads carrying externally validating seals of approval were highly prevalent. S-F claims that strongly mimic FDA-prohibited health claims are likely to create confusion in interpretation and possible public health concerns are discussed.

  5. 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.

  6. Dietary supplements in sport nutrition

    OpenAIRE

    BOČAN, David

    2015-01-01

    Thesis deals with dietary supplements and their use by amateurs and professionals.The theoretical part is in the 1st part devoted to supplements and their legislation,forms and division.To the 2nd part was selected substances used by athletes and further discussed in terms of their function and effects on the organism.Within the general information was drafted in the 3rd part risks related to the use of dietary supplements due to wrong dosage or concentration and the issue of doping. Research...

  7. 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.

  8. French approval procedures for pyrotechnical automotive safety equipments

    OpenAIRE

    Aufauvre, Lionel; Branka, Ruddy

    2005-01-01

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

  9. 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.

  10. Added Value via SPI supplement

    Data.gov (United States)

    U.S. Environmental Protection Agency — Supplement that indicates where to find the source data sets on the EPA system. This dataset is associated with the following publication: Bowden, J., K.D. Talgo, T....

  11. 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...

  12. 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

  13. 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...

  14. 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

  15. 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.

  16. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    Science.gov (United States)

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    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.

  17. 14 CFR 23.1443 - Minimum mass flow of supplemental oxygen.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Minimum mass flow of supplemental oxygen... Equipment Miscellaneous Equipment § 23.1443 Minimum mass flow of supplemental oxygen. (a) If continuous flow oxygen equipment is installed, an applicant must show compliance with the requirements of...

  18. Repurposing of approved cardiovascular drugs.

    Science.gov (United States)

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

    2016-09-20

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

  19. 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)

  20. Observation of Human Retinal Remodeling in Octogenarians with a Resveratrol Based Nutritional Supplement

    Directory of Open Access Journals (Sweden)

    Donn Carroll

    2013-06-01

    Full Text Available Purpose: Rare spontaneous remissions from age-related macular degeneration (AMD suggest the human retina has large regenerative capacity, even in advanced age. We present examples of robust improvement of retinal structure and function using an OTC oral resveratrol (RV based nutritional supplement called Longevinex® or L/RV (circa 2004, Resveratrol Partners, LLC, Las Vegas, NV, USA. RV, a polyphenolic phytoalexin caloric-restriction mimic, induces hormesis at low doses with widespread beneficial effects on systemic health. RV alone inhibits neovascularization in the murine retina. Thus far, published evidence includes L/RV mitigation of experimentally induced murine cardiovascular reperfusion injury, amelioration of human atherosclerosis serum biomarkers in a human Japanese randomized placebo controlled trial, modulation of micro RNA 20b and 539 that control hypoxia-inducing-factor (HIF-1 and vascular endothelial growth factor (VEGF genes in the murine heart (RV inhibited micro RNA20b 189-fold, L/RV 1366-fold. Little is known about the effects of L/RV on human ocular pathology. Methods: Absent FDA IRB approval, but with permission from our Chief of Staff and medical center IRB, L/RV is reserved for AMD patients, on a case-by-case compassionate care basis. Patients include those who progress on AREDS II type supplements, refuse intra-vitreal anti-VEGF injections or fail to respond to Lucentis®, Avastin® or Eylea®. Patients are clinically followed traditionally as well as with multi-spectral retinal imaging, visual acuity, contrast sensitivity, cone glare recovery and macular visual fields. Three cases are presented. Results: Observed dramatic short-term anti-VEGF type effect including anatomic restoration of retinal structure with a suggestion of improvement in choroidal blood flow by near IR multispectral imaging. The visual function improvement mirrors the effect seen anatomically. The effect is bilateral with the added benefit of better

  1. OMB Recommended vs Approved Operating Budget

    Data.gov (United States)

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

  2. 43 CFR 4.1134 - Supplementation of responses.

    Science.gov (United States)

    2010-10-01

    ... APPEALS PROCEDURES Special Rules Applicable to Surface Coal Mining Hearings and Appeals Discovery § 4.1134 Supplementation of responses. A party who has responded to a request for discovery with a response that was... question directly addressed to— (1) The identity and location of persons having knowledge of...

  3. A Phase II Trial on the Effect of Low-Dose versus High-Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)

    Science.gov (United States)

    2013-10-01

    Vitamin D, vitamin D2 , vitamin D3 (Sweetman 2007; IOM 2003; O’Neil et al. 2001) Source material(s): Vitamin D2 /Ergocalciferol (Sweetman...Major Goal - Enroll human subjects into a phase II clinical trial with vitamin D3 supplementation Task II.1 (mo 0-5): establish IRB approvals at 4...and review history with females. Task II.5 (mo 6-15): first enrollment period for 25(OH)D serum screening/ vitamin D3 supplementation Cannot

  4. Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

    Science.gov (United States)

    2005-02-03

    The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited

  5. 75 FR 27551 - Commercial Energy of Montana, Inc.; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-05-17

    ... Energy Regulatory Commission Commercial Energy of Montana, Inc.; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of Commercial Energy of Montana, Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes...

  6. 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

    Energy Technology Data Exchange (ETDEWEB)

    Tam, P.S.

    1995-10-01

    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), 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.

  7. 14 CFR 21.325 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

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

  8. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  9. Obinutuzumab breaks through to FDA approval.

    Science.gov (United States)

    2014-01-01

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

  10. 46 CFR 154.1005 - Equipment approval.

    Science.gov (United States)

    2010-10-01

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

  11. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

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

  12. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs.

    Science.gov (United States)

    Ross, Joseph S; Dzara, Kristina; Downing, Nicholas S

    2015-04-01

    The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients' access to new and effective therapeutics. We used qualitative methods to characterize the safety and efficacy reasons why applications for novel therapeutics approved by the FDA between 2001 and 2011 required multiple review cycles prior to approval. Among ninety-six applications approved between 2001 and 2011 that required multiple review cycles, safety concerns contributed to seventy-four (77.1 percent) and efficacy concerns to forty-three (44.8 percent). Our study suggests that multiple review cycles appear to play an important role in allowing the FDA to protect public health and in ensuring adequate understanding of clinical benefits and risks prior to approval.

  13. 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....

  14. 15 CFR 923.133 - Procedure for conducting continuing reviews of approved State CZM programs.

    Science.gov (United States)

    2010-01-01

    ... will submit a financial assistance application or work program, whichever is applicable, on a timetable... evaluation team indicating that they wish to receive the final findings. Notice of the availability of the... approved CZM program; (B) The management agency is effectively playing a leadership role in coastal...

  15. 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.

  16. Is vitamin C supplementation beneficial?

    DEFF Research Database (Denmark)

    Lykkesfeldt, Jens; Poulsen, Henrik Enghusen

    2010-01-01

    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 saturation through their normal diet, there could be a large subpopulation with a potential health problem that remains uninvestigated. The present review discusses the relevance of the available literature on vitamin C supplementation and proposes guidelines for future randomised intervention trials....

  17. 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...

  18. 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...

  19. 77 FR 5008 - Minco Wind Interconnection Services, LLC; Supplemental Notice That Initial Market-Based Rate...

    Science.gov (United States)

    2012-02-01

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

  20. 77 FR 57083 - American Illuminating Company, LLC; Supplemental Notice that Initial Market-Based Rate Filing...

    Science.gov (United States)

    2012-09-17

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

  1. "The Times/The Times Higher Education Supplement"--League Tables in Britain: An Insider's View.

    Science.gov (United States)

    Jobbins, David

    2002-01-01

    Describes how "The Times" and "The Times Higher Education Supplement" use publicly available and verifiable data to publish university league tables as an aid to the application process for young people seeking the most appropriate course programs and institutions. (EV)

  2. 77 FR 24697 - Somerset Operating Company, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2012-04-25

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

  3. 77 FR 6110 - Bishop Hill Interconnection LLC; Supplemental Notice that Initial Market-Based Rate Filing...

    Science.gov (United States)

    2012-02-07

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

  4. 75 FR 75955 - Notice of Request for Extension and Revision of a Currently Approved Information Collection for...

    Science.gov (United States)

    2010-12-07

    ... canned ripe olives, raisins, and dates which are required to be inspected by AMS, subject to exemptions... the regulations regarding all licensed samplers upon approval of the application. Estimate of...

  5. Pyridoxine supplementation during isoniazid therapy.

    Science.gov (United States)

    Snider, D E

    1980-12-01

    Vitamin B6 (pyridoxine) supplementation during isoniazid (INH) therapy is necessary in some patients to prevent the development of peripheral neuropathy. In vivo pyridoxine is converted into coenzymes which play an essential role in the metabolism of protein, carbohydrates, fatty acids, and several other substances, including brain amines, INH apparently competitively inhibits the action of pyridoxine in these metabolic functions. The reported frequency of INH-induced neuropathy in various studies is reviewed and population groups at relatively high risk of developing this complication are identified. The routine use of pyridoxine supplementation to prevent peripheral neuropathy in high risk populations is recommended.

  6. 78 FR 11754 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplement Motor...

    Science.gov (United States)

    2013-02-20

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION... County to account for changes in the emissions model and vehicle miles traveled (VMT) projection model... operation. The Regional Office's official hours of business are Monday through Friday, 8:30 to...

  7. 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

  8. Nutritional supplement products: does the label information influence purchasing decisions for the physically active?

    Science.gov (United States)

    2013-01-01

    Background The increase in sales of nutritional supplement globally can be attributed, in part, to aggressive marketing by manufacturers, rather than because the nutritional supplements have become more effective. Furthermore, the accuracy of the labelling often goes unchallenged. Therefore, any effects of the supplement, may be due to contaminants or adulterants in these products not reflected on the label. Methods A self-administered questionnaire was used to determine how consumers of nutritional supplements acquired information to assist their decision-making processes, when purchasing a product. The study was approved by the University of Cape Town, Faculty of Health Sciences Human Research Ethics Committee. The questionnaire consisted of seven, closed and open-ended questions. The participants were asked to respond to the questions according to a defined list of statements. A total of 259 participants completed and returned questionnaires. The data and processing of the returned questionnaires was captured using Windows-based Microsoft® Office Excel 2003 SP 1 (Excel © 1985–2003 Microsoft Corporation). Statistica Version 10 (copyright © Stat Soft, Inc. 1984–2011) was used to calculate the descriptive statistics. Results The main finding of the study was that nearly 70% of the respondents who purchased supplements were strongly influenced by container label information that stipulated that the nutritional supplement product is free of banned substances. The second finding was that just over 50% of the respondents attached importance to the quality of the nutritional supplement product information on the container label. The third finding was that about 40% of the respondents were strongly influenced by the ingredients on the labels when they purchased nutritional supplements. Conclusion This study, (i) identifies short-comings in current labelling information practices, (ii) provides opportunities to improve label and non-label information and

  9. Active pharmaceutical ingredients detected in herbal food supplements for weight loss sampled on the Dutch market.

    Science.gov (United States)

    Reeuwijk, Noortje M; Venhuis, Bastiaan J; de Kaste, Dries; Hoogenboom, Ron L A P; Rietjens, Ivonne M C M; Martena, Martijn J

    2014-01-01

    Herbal food supplements claiming to reduce weight may contain active pharmacological ingredients (APIs) that can be used for the treatment of overweight and obesity. The aim of this study was to determine whether herbal food supplements for weight loss on the Dutch market contain APIs with weight loss properties. Herbal food supplements intended for weight loss (n = 50) were sampled from August 2004 to May 2013. An HPLC-DAD-MS/MS method was used to screen for the presence of the APIs in herbal supplements. In 24 samples the APIs sibutramine, desmethylsibutramine (DMS), didesmethylsibutramine (DDMS), rimonabant, sildenafil and/or the laxative phenolphthalein were identified 41 times. The presence of these APIs was, however, not stated on the label. The potential pharmacological effects of the detected APIs were estimated using data from reported effective doses of approved drugs. Use of 20 of the 24 herbal food supplements may result in potential pharmacological effects. Furthermore, risk assessment of phenolphthalein, a suspected carcinogen and found to be present in 10 supplements, based on the margin of exposure (MOE) approach, resulted in MOE values of 96-30,000. MOE values lower than 10,000 (96-220) were calculated for the daily intake levels of four out of these 10 supplements in which phenolphthalein was found. However, taking into account that weight loss preparations may be used for only a few weeks or months rather than during a lifetime, MOE values may be two to three orders of magnitude higher. The current study shows that the use of food supplements with sibutramine, DMS, DDMS and/or phenolphthalein could result in pharmacological effects.

  10. New supplements to infant formulas.

    Science.gov (United States)

    Eshach Adiv, Orly; Berant, Moshe; Shamir, Raanan

    2004-12-01

    Foods, which, in addition to their nutritional attributes, contain also elements that are considered to be health-promoting, have been termed "functional foods". In this regard, human milk has gained recognition as being the ultimate functional food for infants - by its biological compatibility, nutritional value and the undisputed added value of its health promoting qualities. Intensive research activity has recently evolved in a quest to identify and define the components of human milk that might confer disease-preventing and health-enhancing properties and to determine the instances and clinical conditions in which these factors become particularly important. The outcome of such research would also provide a rationale for advocating the supplementation of commercial infant formulas with such substances. In effect, the body of data accumulated from scientific and clinical studies on nucleotides, probiotics, prebiotics and long-chain polyunsaturated fatty acids in human milk and as additives to infant formula, has become regarded as convincing enough by the infant formula industry so as to launch into the market formulas supplemented with one or more of these factors - in an effort to emulate human milk and its beneficial effects. The following review is intended for the reader to obtain a general idea of the new supplements that have been introduced to infant formulas. We summarize the pertinent experimental and clinical observations concerning each of the supplements, pointing out their potential specific benefits, their possible disadvantages and the issues that still remain unresolved.

  11. 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.

  12. A Supplement for Teaching Beowulf

    Science.gov (United States)

    Milosh, Joseph

    1970-01-01

    Suggests supplementing the teaching of "Beowulf" to high school students with (1) translation and grammatical analysis of parts of the original lines, (2) study of Anglo-Saxon poetic techniques, and (3) students' imitation of old English poetic techniques in New English. (SW)

  13. 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?

  14. Potassium supplementation and heart rate

    NARCIS (Netherlands)

    Gijsbers, L.; Molenberg, Famke; Bakker, S.J.L.; Geleijnse, J.M.

    2016-01-01

    Background and aims: Increasing the intake of potassium has been shown to lower blood pressure, but whether it also affects heart rate (HR) is largely unknown. We therefore assessed the effect of potassium supplementation on HR in a meta-analysis of randomized controlled trials. Methods and resul

  15. Clinical use of glutamine supplementation.

    Science.gov (United States)

    Wernerman, Jan

    2008-10-01

    Endogenous production of glutamine may become insufficient during critical illness. The shortage of glutamine is reflected as a decrease in plasma concentration, which is a prognostic factor for poor outcome in sepsis. Because glutamine is a precursor for nucleotide synthesis, rapidly dividing cells are most likely to suffer from a shortage. Therefore, exogenous glutamine supplementation is necessary. In particular, when i.v. nutrition is given, extra glutamine supplementation becomes critical, because most present formulations for i.v. use do not contain any glutamine for technical reasons. The major part of endogenously produced glutamine comes from skeletal muscle. For patients staying a long time in the intensive care unit (ICU), the muscle mass decreases rapidly, which leaves a tissue of diminishing size to maintain the export of glutamine. The metabolic and nutritional adaptation in long-staying ICU patients is poorly studied and is one of the fields that needs more scientific evidence for clinical recommendations. To date, there is evidence to support the clinical use of glutamine supplementation in critically ill patients, in hematology patients, and in oncology patients. Strong evidence is presently available for i.v. glutamine supplementation to critically ill patients on parenteral nutrition. This must be regarded as the standard of care. For patients on enteral nutrition, more evidence is needed. To guide administration of glutamine, there are good arguments to use measurement of plasma glutamine concentration for guidance. This will give an indication for treatment as well as proper dosing. Most patients will have a normalized plasma glutamine concentration by adding 20-25 g/24 h. Furthermore, there are no reported adverse or negative effects attributable to glutamine supplementation.

  16. 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.

  17. 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....

  18. 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...

  19. 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.

  20. 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... Requirements § 91.211 Supplemental oxygen. (a) General. No person may operate a civil aircraft of U.S. registry... the required minimum flight crew is provided with and uses supplemental oxygen for that part of...

  1. 43 CFR 7.32 - Supplemental definitions.

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Supplemental definitions. 7.32 Section 7... RESOURCES Department of the Interior Supplemental Regulations § 7.32 Supplemental definitions. For purposes of this subpart, the following definitions will be used: (a) Site of religious or cultural...

  2. 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...

  3. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

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

  4. 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.

  5. 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.

  6. FDA Approves First Immunotherapy for Lymphoma

    Science.gov (United States)

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

  7. Depression: FDA-Approved Medications May Help

    Science.gov (United States)

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

  8. 30 CFR 7.409 - Approval marking.

    Science.gov (United States)

    2010-07-01

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

  9. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

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

  10. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

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

  11. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

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

  12. Site Annual Environmental Report for 1997 - Data Supplement

    Energy Technology Data Exchange (ETDEWEB)

    Biermann, A.H.; Althouse, P.E.; Brandstetter, E.R.; Christofferson, E.C.; Fields, B.C.; Gallegos, G.M.; Garcia, L.M.; Harrach, R.J.; Larson, J.M.; Tate, P.J.

    1998-09-01

    This Data Supplement to the Lawrence Livermore National Laboratory's (LLNL's) annual Environmental Report 1997 (called Volume 2 in previous years) 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. Not all of the data in the Data Supplement tables have been reduced to the proper number of significant figures; however, summary data in both volumes are expressed using the proper number of significant figures. 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 four 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 {minus}11} Ci; 1 Sv = 100 rem).

  13. Synthetic androgens as designer supplements.

    Science.gov (United States)

    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 pharmacological effects and metabolism of unapproved steroids due to the absence of clinical studies. The large number of designer steroid findings in dietary supplements and the detection of new compounds combined with legal loopholes for their distribution in many countries show that stricter regulations and better information policy are needed.

  14. 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.

  15. Vitamin D Supplementation in Submariners

    Science.gov (United States)

    2008-12-02

    also known as cholecalciferol . This is a result of the reaction between 7-dehydrocholesterol in the epidermis and ultraviolet radiation in the...skin) (From Diet) Vitamin D3 ( Cholecalciferol ) UV light Vitamin D2 (Ergocalciferol) Liver 25-Hydroxy Vitamin D (Calcidiol) Kidney 1,25-Dihydroxy...monthly oral vitamin D3 ( cholecalciferol ) supplementation on fractures and mortality in men and women living in the community: randomized double

  16. 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...

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

    Science.gov (United States)

    2010-07-01

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

  18. Creatine supplementation and swimming performance.

    Science.gov (United States)

    Leenders, N M; Lamb, D R; Nelson, T E

    1999-09-01

    The purpose of this study was to determine if oral creatine (CR) ingestion, compared to a placebo (PL), would enable swimmers to maintain a higher swimming velocity across repeated interval sets over 2 weeks of supplementation. Fourteen female and 18 male university swimmers consumed a PL during a 2-week baseline period. Using a randomized, double-blind design, during the next 2 weeks subjects consumed either CR or PL. Swimming velocity was assessed twice weekly during 6 X 50-m swims and once weekly during 10 X 25-yd swims. There was no effect of CR on the 10 X 25-yd interval sets for men and women and no effect on the 6 X 50-m interval sets for women. In contrast, for men, CR significantly improved mean overall swimming velocity in the 6 X 50-m interval after 2 weeks of supplementation, whereas PL had no effect. Although ineffective in women, CR supplementation apparently enables men to maintain a faster mean overall swimming velocity during repeated swims each lasting about 30 s; however, CR was not effective for men in repeated swims each lasting about 10 - 15 s.

  19. 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.

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

    Science.gov (United States)

    White, M A

    1975-01-01

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

  1. 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...

  2. 75 FR 68354 - Milner Dam 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 Milner Dam Wind Park, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of Milner Dam Wind Park, LLC's application for...

  3. 76 FR 2368 - Balance Power Systems, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2011-01-13

    ... Energy Regulatory Commission Balance Power Systems, LLC; Supplemental Notice That Initial Market-Based... supplemental notice in the above-referenced proceeding of Balance Power Systems, LLC's application for market... 20426. The filings in the above-referenced proceeding are accessible in the Commission's eLibrary...

  4. 75 FR 73074 - Duke Energy Hanging Rock II, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-11-29

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

  5. 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...

  6. 75 FR 57015 - Kit Carson Windpower, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-09-17

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

  7. 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...

  8. 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...

  9. 75 FR 76727 - Evergreen Wind Power III, LLC; Supplemental Notice that Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-12-09

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

  10. 75 FR 18201 - Juniper Canyon Wind Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-04-09

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

  11. 75 FR 52321 - Dry Lake Wind Power II LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-08-25

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

  12. 75 FR 37430 - Plymouth Rock Energy, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-06-29

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

  13. 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...

  14. 75 FR 74039 - FPL Energy Montezuma Wind, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-11-30

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

  15. 75 FR 71427 - Domtar Paper Company, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-11-23

    ... Federal Energy Regulatory Commission Domtar Paper Company, LLC; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding, of Domtar Paper Company, LLC's application for market... Commission encourages electronic submission of protests and interventions in lieu of paper, using the...

  16. 76 FR 34227 - Fred Meyer Stores, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2011-06-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Docket No. ER11-3615-000 Fred Meyer Stores, Inc.; Supplemental Notice That... supplemental notice in the above-referenced proceeding of Fred Meyer Stores, Inc.'s application for...

  17. 75 FR 10245 - S.J. Energy Partners, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-03-05

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

  18. 75 FR 16098 - Southern Turner Cimarron I, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-03-31

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Southern Turner Cimarron I, LLC; Supplemental Notice That Initial... supplemental notice in the above-referenced proceeding of Southern Turner Cimarron I, LLC's application...

  19. 75 FR 1363 - Dynegy Services Plum Point LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-01-11

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

  20. 75 FR 68351 - Thousand Springs Wind Park, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2010-11-05

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

  1. 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...

  2. 75 FR 62808 - Eagle Power Authority, Inc; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-10-13

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

  3. 75 FR 25235 - Eagle Creek Hydro Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2010-05-07

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

  4. 76 FR 4649 - ACS Energy Services, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2011-01-26

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

  5. Application of Health Belief Model\\'s constructs for predicting regular consumption of folic acid supplements in pregnant women referred to Borazjan’s health centers in 2014-15

    Directory of Open Access Journals (Sweden)

    Zohre kafaee

    2016-04-01

    Full Text Available Background: One of the most common disorders in pregnancy is Folic Acid deficiency and its complications. The aim of this study was to examine the predictors of regular use of folic acid supplements based on HBM in pregnant women referred to Borazjan’s health centers. Material and Methods: In this cross-sectional study, 228 pregnant women or women with planning of pregnancy referred to health centers of Borazjan with random sampling method evaluated. Data was collected with questionnaire in 4 parts included demographic characteristics, knowledge, health belief model constructs and questions about folic acid supplement use. Data was analyzed by SPSS software with using appropriate statistical tests. Results: The mean age of samples was 27.4±5.41. 144 patients (63.2% consumed Folic Acid pills regularly, and 84 patients (36.8% had irregular use. The awareness of folic acid in 22.8% of women was good, 59.6%  and 17.5% of samples had intermediate and poor awareness, respectively. The perceived barriers (P<0.001, perceived benefits (P=0.002 and self-efficacy (P<0.001 had relation with consumption of folic acid and among demographic variables, only education level (P=0.04 had relation with the consumption of pills. In logistic regression perceived barriers was only predictor. Age and educational level had indirect effect in regular consume pill. Conclusion: Perceived barriers was strongest predictors of folic acid use, therefore intervention based on health belief model, with emphasis on reducing barriers is necessary for improving the use of this medicine during pregnancy.

  6. 78 FR 13497 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Deferral for CO2

    Science.gov (United States)

    2013-02-28

    ...EPA is approving a State Implementation Plan (SIP) revision submitted by the Maryland Department of the Environmental (MDE) on April 4, 2012. This revision defers until July 21, 2014 the application of the Prevention of Significant Deterioration (PSD) permitting requirements to biogenic carbon dioxide (CO2) emissions from bioenergy and other biogenic stationary sources in the State......

  7. 78 FR 51807 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2013-08-21

    ... and Budget (OMB) approval to renew an information collection. The FAA collects information from.... Information is collected in the application, and grant agreement amendments; financial management; and.... Frequency: Information is collected on occasion. Estimated Average Burden per Response: 6.75...

  8. 49 CFR 173.56 - New explosives-definition and procedures for classification and approval.

    Science.gov (United States)

    2010-10-01

    ... requirements in APA Standard 87-1 (IBR, see § 171.7 of this subchapter); (2) A thermal stability test is... the Associate Administrator following the applicable requirements in APA Standard 87-1, and is... device for which approval is requested conforms to APA Standard 87-1 and that the descriptions...

  9. 76 FR 76971 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Arkansas

    Science.gov (United States)

    2011-12-09

    ... its 40 CFR Part 272--Approved State Hazardous Waste Management EPA-authorized program for electronic reporting of annual hazardous waste information submitted under 40 CFR parts 262, 264, and 265 is being... Arkansas Department of Environmental Quality (AR DEQ) submitted an application for its Hazardous...

  10. 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...

  11. 78 FR 28275 - Office of Commercial Space Transportation; Safety Approval Performance Criteria

    Science.gov (United States)

    2013-05-14

    ... reviewing a safety approval application per 14 CFR 414.19(a)(1). The FAA's evaluation included assessment of... consciousness) due to hypoxia. Understand the effects of prolonged oxygen use. Understand the difference between... about the performance criteria, you may contact Randal Maday, Licensing and Evaluation Division...

  12. 25 CFR 224.74 - When must the Secretary approve or disapprove a final proposed TERA?

    Science.gov (United States)

    2010-04-01

    ... proposed TERA? 224.74 Section 224.74 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY... disapprove a final proposed TERA? The Secretary must approve or disapprove a final proposed TERA or a revised final proposed TERA within 270 days of the Director's receipt of a complete application for a TERA....

  13. 75 FR 35027 - Notice of Public Information Collection Approved By the Office of Management and Budget

    Science.gov (United States)

    2010-06-21

    ... COMMISSION Notice of Public Information Collection Approved By the Office of Management and Budget June 16, 2010. SUMMARY: The Federal Communications Commission (FCC) has received the Office of Management and... increase in the station's FM Digital ERP). (2) Licensees to submit an application to the Media Bureau,...

  14. 76 FR 31674 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2011-06-01

    ... of Renewed Approval of Information Collection; SWIFT Customer Satisfaction Survey AGENCY: Federal... determine how satisfied applicants are with the automated staffing solution. The information enables the FAA....Scott@faa.gov . SUPPLEMENTARY INFORMATION: OMB Control Number: 2120-0699. Title: SWIFT...

  15. 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...

  16. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Science.gov (United States)

    2010-01-01

    ... RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee... licensee's activities. Each application shall include: (a) A description of the waste containing licensed..., and the proposed manner and conditions of waste disposal; and (b) An analysis and evaluation...

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

    Science.gov (United States)

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

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

  18. High Falls generation station expansion approvals process

    Energy Technology Data Exchange (ETDEWEB)

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

    2005-07-01

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

  19. Nutritional supplements and ergogenic AIDS.

    Science.gov (United States)

    Liddle, David G; Connor, Douglas J

    2013-06-01

    Performance enhancing drugs, ergogenic aids, and supplements come in many forms. The financial, personal, social, and health-related impact of these substances has wide and varied consequences. This article reviews common substances and practices used by athletes. It discusses the history, use, effects, and adverse effects of androgenic anabolic steroids, peptide hormones, growth factors, masking agents, diuretics, volume expanders, β-blockers, amphetamines, caffeine, other stimulants, and creatine. The evidence base behind the use, safety, and efficacy of these items as well as testing for these substances is discussed.

  20. Research on the Construction and Application of Three-Dimension Examination and Approval Assistant System in Urban Planning%上海市3维城市规划辅助审批系统建设与应用研究

    Institute of Scientific and Technical Information of China (English)

    汪旻琦; 冯琰; 顾星晔; 张唯

    2013-01-01

    With the development of computer hardware and GIS technology and the requirements of "Digital City",the original method of urban planning based on 2D cannot meet the demand of current urban planning.The paper introduces the structure and creativity of the 3D examination and approval assistant system in urban planning,and also describes the main functions and the method to implement the system.At last the paper introduces the application of system in the actual urban planning projects with practical cases.%随着计算机软硬件和GIS技术的发展,以及“数字城市”的提出与实施,原有基于2维平面规划审批技术已不能满足目前城市规划审批的工作需求.本文在介绍规划设计方案辅助决策系统建设的基础上,阐述了上海市3维城市规划辅助审批系统的结构与创新点,并详细描述了系统中主要功能的设计思想与实现方法,最终结合实际规划项目简述了系统的应用.

  1. 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.

  2. Overview of Dietary Supplements in Prostate Cancer.

    Science.gov (United States)

    Yacoubian, Aline; Dargham, Rana Abu; Khauli, Raja B; Bachir, Bassel G

    2016-11-01

    Prostate cancer is a key health concern for men with its etiology still under investigation. Recently, the role of dietary supplements has been noted to have a major inhibitory effect on prostate cancer and numerous studies have been conducted in this regard. This review provides a summary on numerous recent studies conducted in this field. Some of the studies reviewed revealed a protective role for supplements, and others showed no correlation while some even had an adverse effect. The mechanism of how these supplements act on the prostate is still not clear. Further studies are warranted especially for supplements that have been shown to have a potential inhibitory role in prostate cancer.

  3. Herbal and dietary supplement hepatotoxicity.

    Science.gov (United States)

    Navarro, Victor J

    2009-11-01

    Herbal and dietary supplements (HDS) are commonly used in the United States and throughout the world. The Dietary Supplement Health and Education Act and public standards set through the U.S. Pharmacopeia provide regulatory framework for these products. These regulations help to ensure the safety of grandfathered and new HDS coming onto the market, and the opportunity to identify and take action against unsafe products that have been distributed. The clinical patterns of presentation and severity of HDS-associated hepatotoxicity can be highly variable, even for the same product. In addition, accurate causality assessment in cases of suspected HDS hepatotoxicity is confounded by infrequent ascertainment of product intake by healthcare providers, under-reporting of HDS use by patients, the ubiquity of HDS and the complexity of their components, and the possibility for product adulteration. Additional measures to prevent HDS-induced hepatotoxicity include greater consumer and provider awareness, increased spontaneous reporting, and reassessment of regulations regarding the manufacturing, distribution, and marketing of these products.

  4. 76 FR 6128 - Energy Exchange International, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2011-02-03

    ...-000] Energy Exchange International, LLC; Supplemental Notice That Initial Market-Based Rate Filing... the above-referenced proceeding Energy Exchange International, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for...

  5. Glutamine Supplemented Parenteral Nutrition to Prevent Ventilator-Associated Pneumonia in the Intensive Care Unit

    Directory of Open Access Journals (Sweden)

    Meltem Türkay Aydoğmuş

    2012-12-01

    Full Text Available Objective: Ventilator-associated pneumonia (VAP is a form of nosocomial pneumonia that increases patient morbidity and mortality, length of hospital stay, and healthcare costs. Glutamine preserves the intestinal mucosal structure, increases immune function, and reduces harmful changes in gut permeability in patients receiving total parenteral nutrition (TPN. We hypothesized that TPN supplemented by glutamine might prevent the development of VAP in patients on mechanical ventilator support in the intensive care unit (ICU. Material and Methods: With the approval of the ethics committee and informed consent from relatives, 60 patients who were followed in the ICU with mechanical ventilator support were included in our study. Patients were divided into three groups. The first group received enteral nutrition (n=20, and the second was prescribed TPN (n=20 while the third group was given glutamine-supplemented TPN (n=20. C-reactive protein (CRP, sedimentation rate, body temperature, development of purulent secretions, increase in the amount of secretions, changes in the characteristics of secretions and an increase in requirement of deep tracheal aspiration were monitored for seven days by daily examination and radiographs. Results: No statistically significant difference was found among groups in terms of development of VAP (p=0.622. Conclusion: Although VAP developed at a lower rate in the glutamine-supplemented TPN group, no statistically significant difference was found among any of the groups. Glutamine-supplemented TPN may have no superiority over unsupplemented enteral and TPN in preventing VAP.

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

    Energy Technology Data Exchange (ETDEWEB)

    Rolle, A.; Buhlemann, L. [Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin (Germany)

    2004-07-01

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

  7. 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...

  8. 76 FR 63614 - Agua Caliente Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2011-10-13

    ...-000] Agua Caliente Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes... proceeding of Agua Caliente Solar, LLC's application for market-based rate authority, with an...

  9. 78 FR 18585 - Energy Technology Savings LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes...

    Science.gov (United States)

    2013-03-27

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

  10. Simultaneous analysis of steviol and steviol glycosides by liquid chromatography with ultraviolet detection on a mixed-mode column: application to Stevia plant material and Stevia-containing dietary supplements.

    Science.gov (United States)

    Jaworska, Karolina; Krynitsky, Alexander J; Rader, Jeanne I

    2012-01-01

    Simultaneous separation of steviol and steviol glycosides is challenging because of differences in their polarity and chemical structure. In this study, simultaneous analysis of steviol and steviol glycosides was achieved by LC with UV detection using a mixed-mode RP weak anion exchange chromatography column. Steviol and seven steviol glycosides were analyzed on an Acclaim Mixed-Mode Wax-1 (Dionex) column with a linear gradient of deionized water adjusted to pH 3.00 with phosphoric acid and acetonitrile. The extraction was performed by sonicating dry plant material at 40 degreesC in acetonitrile-water (30 + 70, v/v). LOQ values (mg/g dry weight of plant material) were rebaudioside B, 0.50; steviol, 0.70, dulcoside A, 1.0; steviolbioside, 1.2; stevioside and rebaudioside C, 2.0; rebaudioside D, 3.3; and rebaudioside A, 5.0. The method demonstrated suitable performance for all analytes tested with respect to accuracy (mean recoveries 95-99%), intraday and interday precision for retention times (0.070-0.28% and 0.33-1.0% RSD, respectively), and linearity. The method was used to authenticate steviol glycosides in several samples of Stevia plant material as well as to quantitate steviol glycosides in dietary supplements containing Stevia.

  11. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

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

  12. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  13. Approved Practices in Dairy Reproduction. Slide Script.

    Science.gov (United States)

    Roediger, Roger D.; Barr, Harry L.

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

  14. 42 CFR 422.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

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

  15. 42 CFR 423.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

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

  16. 7 CFR 322.4 - Approved regions.

    Science.gov (United States)

    2010-01-01

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

  17. 7 CFR 1425.4 - Approval.

    Science.gov (United States)

    2010-01-01

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

  18. Perkins Bill is Approved by Congress

    Science.gov (United States)

    Cavanagh, Sean

    2006-01-01

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

  19. Program and Course Approval Handbook. Fifth Edition

    Science.gov (United States)

    California Community Colleges, Chancellor's Office, 2013

    2013-01-01

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

  20. 7 CFR 3565.103 - Approval requirements.

    Science.gov (United States)

    2010-01-01

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

  1. Approval of Spouse in Middle Age.

    Science.gov (United States)

    Troll, Lillian E.

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

  2. 28 CFR 48.15 - Temporary approval.

    Science.gov (United States)

    2010-07-01

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

  3. 7 CFR 3015.112 - Approval procedures.

    Science.gov (United States)

    2010-01-01

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

  4. 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…

  5. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

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

  6. 40 CFR 1042.210 - Preliminary approval.

    Science.gov (United States)

    2010-07-01

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

  7. 40 CFR 52.373 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  8. 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.

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

    Science.gov (United States)

    Del Rosso, James Q

    2007-08-01

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

  10. Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on...

  11. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

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

  12. FDA Approves New Treatment for Dust Mite Allergies

    Science.gov (United States)

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

  13. [Magnesium as a food supplement].

    Science.gov (United States)

    Haber, Paul

    2004-05-01

    Magnesium is a Cofactor in all enzymes transfering phosphate. It is therefore necessary for the energymetabolism and for many synthesis, i.e. DNA and RNA. Mg is one of the most widespread elements of the earthcrust and is found in many nutritients. Nevertheless the daily intake in the western countries is often under the recommended level, due to the western life stile. Regular alcohol intake lessens the resorption and regular sport enhances the excretion via the sweat. Especially in elderly people this can lead to a lack of Magnesium. This may promote muscular cramps and weakness, cardiac arrhythmias, hypertension or bronchial hyperreactivity. It seems to be reasonable to recommend liberally a oral supplementation with magnesium.

  14. Dietary Supplements and Sports Performance: Amino Acids

    Directory of Open Access Journals (Sweden)

    Williams Melvin

    2005-12-01

    Full Text Available 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.

  15. 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....

  16. 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....

  17. Antioxidant supplements for prevention of gastrointestinal cancers

    DEFF Research Database (Denmark)

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

    2004-01-01

    Oxidative stress can cause cancer. Our aim was to establish whether antioxidant supplements reduce the incidence of gastrointestinal cancer and mortality.......Oxidative stress can cause cancer. Our aim was to establish whether antioxidant supplements reduce the incidence of gastrointestinal cancer and mortality....

  18. 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…

  19. 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.

  20. Should infant girls receive micronutrient supplements?

    DEFF Research Database (Denmark)

    Benn, Christine Stabell; Lund, Sofia; Fisker, Ane

    2009-01-01

    BACKGROUND: We have proposed the hypothesis that the combination of vitamin A supplementation and diphtheria-tetanus-pertussis (DTP) vaccination may be associated with increased mortality in girls. Recent zinc/folic acid (FA) and iron supplementation trials did not find any beneficial effects on ...

  1. 40 CFR 152.132 - Supplemental distribution.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Supplemental distribution. 152.132... Supplemental distribution. The registrant may distribute or sell his registered product under another person's name and address instead of (or in addition to) his own. Such distribution and sale is...

  2. 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.

  3. Lipase supplementation therapy: standards, alternatives, and perspectives.

    Science.gov (United States)

    Layer, Peter; Keller, Jutta

    2003-01-01

    Treatment of steatorrhea by lipase supplementation therapy has become more successful in the last decade due to better understanding of the physiology and pathophysiology of the digestive process. Porcine lipase has been the therapeutic standard for several decades and will continue to be the treatment of choice in pancreatic exocrine insufficiency. Modern therapeutic concepts recommend administration of 25,000-40,000 units of porcine lipase per meal using pH-sensitive pancreatin microspheres. In case of treatment failure, the dose should be increased, compliance should be checked, and other reasons for malabsorption should be excluded. Still, in most patients, lipid digestion cannot be completely normalized by current standard therapy, and future developments are needed for optimizing treatment. In this article, pathophysiologic characteristics of pancreatic exocrine insufficiency, prerequisites for use of alternative lipase sources as well as currently available lipases of nonporcine origin, and new developments are discussed. Current literature suggests that bovine lipase products present a theoretical alternative but play no major role in the western world. Fungal lipase has inferior properties compared with conventional products. Bacterial lipase products show promising potential and offer future therapeutic alternatives. Moreover, human pancreatic lipase gene transfer and application of bioengineered human gastric lipase appear on the horizon.

  4. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    2010-07-01

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

  5. 29 CFR 4221.14 - PBGC-approved arbitration procedures.

    Science.gov (United States)

    2010-07-01

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

  6. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

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

  7. 33 CFR 115.70 - Advance approval of bridges.

    Science.gov (United States)

    2010-07-01

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

  8. 14 CFR 21.269 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

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

  9. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-26

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

  10. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

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

  11. 27 CFR 24.26 - Authority to approve.

    Science.gov (United States)

    2010-04-01

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

  12. 48 CFR 32.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

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

  13. 8 CFR 207.6 - Control over approved refugee numbers.

    Science.gov (United States)

    2010-01-01

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

  14. 29 CFR 4211.21 - Changes subject to PBGC approval.

    Science.gov (United States)

    2010-07-01

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

  15. 44 CFR 78.9 - Planning grant approval process.

    Science.gov (United States)

    2010-10-01

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

  16. 48 CFR 1845.607-170 - Contractor's approved scrap procedure.

    Science.gov (United States)

    2010-10-01

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

  17. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

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

  18. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    2010-01-01

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

  19. 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

  20. 78 FR 2415 - Agency Information Collection Activities: Application for Family Unity Benefits, Form Number I...

    Science.gov (United States)

    2013-01-11

    ... for Family Unity Benefits, Form Number I-817; Revision of a Currently Approved Collection ACTION: 30... approved information. (2) Title of the Form/Collection: Application for Family Unity Benefits. (3)...