WorldWideScience

Sample records for application supplement approvals

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

    Science.gov (United States)

    2004-04-08

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

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

    Science.gov (United States)

    DiMasi, Joseph A

    2013-06-01

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

  3. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Science.gov (United States)

    2010-06-21

    ...] Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension AGENCY... Laboratories, Ltd. The supplemental NADA provides for a revised formulation of penicillin G procaine injectable... of NOROCILLIN (penicillin G procaine) Injectable Suspension by intramuscular injection in cattle...

  4. 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 feed...

  5. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.

    Science.gov (United States)

    Wang, Bo; Kesselheim, Aaron S

    2015-09-23

    To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs' originally approved indications. Systematic review. Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs' supplemental and original indication approvals. The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (Pindications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. © Wang et al 2015.

  6. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

    Science.gov (United States)

    Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

    2017-08-15

    High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were

  7. Methylsulfonylmethane: Applications and Safety of a Novel Dietary Supplement

    Directory of Open Access Journals (Sweden)

    Matthew Butawan

    2017-03-01

    Full Text Available Methylsulfonylmethane (MSM has become a popular dietary supplement used for a variety of purposes, including its most common use as an anti-inflammatory agent. It has been well-investigated in animal models, as well as in human clinical trials and experiments. A variety of health-specific outcome measures are improved with MSM supplementation, including inflammation, joint/muscle pain, oxidative stress, and antioxidant capacity. Initial evidence is available regarding the dose of MSM needed to provide benefit, although additional work is underway to determine the precise dose and time course of treatment needed to provide optimal benefits. As a Generally Recognized As Safe (GRAS approved substance, MSM is well-tolerated by most individuals at dosages of up to four grams daily, with few known and mild side effects. This review provides an overview of MSM, with details regarding its common uses and applications as a dietary supplement, as well as its safety for consumption.

  8. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned...

  9. 45 CFR 1340.13 - Approval of applications.

    Science.gov (United States)

    2010-10-01

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

  10. Safety Evaluation Report related to the final design approval of the GESSAR II BWR/6 Nuclear Island Design (Docket No. 50-447). Supplement No. 3

    International Nuclear Information System (INIS)

    1985-01-01

    Supplement 3 to the Safety Evaluation Report (SER) for the application filed by General Electric Company for the final design approval for the GE BWR/6 nuclear island design has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. This report supplements the GESSAR II SER (NUREG-0979), issued in April 1983, summarizing the results of the staff's safety review of the GESSAR II BWR/6 nuclear island design. Subject to favorable resolution of the items discussed in this supplement, the staff concludes that the GESSAR II design satisfactorily addresses the severe-accident concerns described in draft NUREG-1070

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

    Science.gov (United States)

    2010-01-01

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

  12. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

    Science.gov (United States)

    2008-07-10

    The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

  13. 75 FR 71187 - Wolverine Bank, MI; Approval of Conversion Application

    Science.gov (United States)

    2010-11-22

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

  14. 22 CFR 64.7 - Approval of application.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Approval of application. 64.7 Section 64.7 Foreign Relations DEPARTMENT OF STATE PUBLIC DIPLOMACY AND EXCHANGES PARTICIPATION BY FEDERAL EMPLOYEES IN... shall review the application and if satisfied that the criteria of § 516.5 are met shall inform the...

  15. 42 CFR 8.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-10-01

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

  16. 75 FR 24774 - Fairmount Bank, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2010-05-05

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

  17. 7 CFR 1955.22 - State supplements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 14 2010-01-01 2009-01-01 true State supplements. 1955.22 Section 1955.22 Agriculture... Real and Chattel Property § 1955.22 State supplements. State Supplements will be prepared with the... supplements will be submitted to the National Office for post approval in accordance with FmHA or its...

  18. 78 FR 45152 - Approval and Promulgation of Implementation Plans and Designation of Areas; North Carolina...

    Science.gov (United States)

    2013-07-26

    ... North Carolina SIP meets the requirements of section 182(b)(5) applicable for purposes of redesignation...] Approval and Promulgation of Implementation Plans and Designation of Areas; North Carolina; Redesignation... supplemented on March 28, 2013, the State of North Carolina, through the North Carolina Department of...

  19. 42 CFR 422.102 - Supplemental benefits.

    Science.gov (United States)

    2010-10-01

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

  20. 75 FR 9276 - Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion Application

    Science.gov (United States)

    2010-03-01

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-35: OTS No. H-4649] Harvard Illinois Bancorp, Inc., Harvard, Illinois; Approval of Conversion Application Notice is hereby given that on February 12, 2010, the Office of Thrift Supervision approved the application of Harvard Savings Bank...

  1. 75 FR 31511 - Ideal Federal Savings Bank, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2010-06-03

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-46: OTS No. 08283] Ideal Federal Savings Bank, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on May 24, 2010, the Office of Thrift Supervision approved the application of Ideal Federal Savings Bank...

  2. 76 FR 27753 - American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application

    Science.gov (United States)

    2011-05-12

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-61: OTS Nos. 07212] American Eagle Savings Bank, Boothwyn, PA; Approval of Conversion Application Notice is hereby given that on May 3, 2011, the Office of Thrift Supervision approved the application of American Eagle Savings Bank, Boothwyn...

  3. 18 CFR 1304.4 - Application review and approval process.

    Science.gov (United States)

    2010-04-01

    ... hearing is requested by the USACE pursuant to the TVA/Corps joint processing Memorandum of Understanding... the application as appropriate. (b) If a hearing is held for any of the reasons described in paragraph... contained in the hearing notice. (c) Hearings concerning approval of applications are conducted (in...

  4. 75 FR 52065 - SharePlus Federal Bank, Plano, TX; Approval of Conversion Application

    Science.gov (United States)

    2010-08-24

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-50: OTS Nos. 17972 and H4743] 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 of SharePlus Federal Bank, Piano...

  5. 21 CFR 515.20 - Approval of medicated feed mill license applications.

    Science.gov (United States)

    2010-04-01

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

  6. 76 FR 9407 - Fraternity Federal Savings & Loan Association, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2011-02-17

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-58 OTS No. 01292 and H 4762] Fraternity Federal Savings & Loan Association, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on February 10, 2011, the Office of Thrift Supervision approved the application of...

  7. 75 FR 51333 - Madison Square Federal Savings Bank, Baltimore, MD; Approval of Conversion Application

    Science.gov (United States)

    2010-08-19

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-49: OTS Nos. 08156 and H4736] Madison Square Federal Savings Bank, Baltimore, MD; Approval of Conversion Application Notice is hereby given that on August 12, 2010, the Office of Thrift Supervision approved the application of Madison Square...

  8. 25 CFR 1001.4 - Application review and approval.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Application review and approval. 1001.4 Section 1001.4 Indians OFFICE OF THE ASSISTANT SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR SELF-GOVERNANCE... package and determine whether or not it is complete. Upon determination that it is complete, the name of...

  9. 49 CFR 107.709 - Processing of an application for approval, including an application for renewal or modification.

    Science.gov (United States)

    2010-10-01

    ... TRANSPORTATION HAZARDOUS MATERIALS AND OIL TRANSPORTATION HAZARDOUS MATERIALS PROGRAM PROCEDURES Approvals... before the disposition of an application. (b) At any time during the processing of an application, the...

  10. 18 CFR 300.10 - Application for confirmation and approval.

    Science.gov (United States)

    2010-04-01

    ... REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS FOR FEDERAL POWER MARKETING ADMINISTRATIONS CONFIRMATION AND APPROVAL OF THE RATES OF FEDERAL POWER MARKETING ADMINISTRATIONS Filing Requirements § 300.10... with applicable laws and that it is the lowest possible rate consistent with sound business principles...

  11. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    Science.gov (United States)

    2010-01-01

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

  12. 30 CFR 285.913 - What happens if I fail to comply with my approved decommissioning application?

    Science.gov (United States)

    2010-07-01

    ... approved decommissioning application? 285.913 Section 285.913 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Decommissioning Compliance with An Approved Decommissioning Application § 285.913 What...

  13. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Science.gov (United States)

    2010-04-01

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

  14. 75 FR 70363 - Minden Bancorp, Inc., Minden, LA; Approval of Conversion Application

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-53: OTS No. H-4756] Minden Bancorp..., the Office of Thrift Supervision approved the application of Minden Mutual Holding Company and MBL Bank, Minden, Louisiana, to convert to the stock form of organization. Copies of the application are...

  15. 78 FR 33426 - Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX

    Science.gov (United States)

    2013-06-04

    ...] Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX AGENCY: Food and Drug... new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets, held by Eli Lilly and Co. (Lilly), Lilly Corporate Center, Indianapolis, IN 46285. Lilly has voluntarily requested that approval of this...

  16. 21 CFR 99.205 - Application for exemption from the requirement to file a supplemental application.

    Science.gov (United States)

    2010-04-01

    ... minus the costs of goods sold and marketing and administrative expenses attributable to the new use of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Application for exemption from the requirement to file a supplemental application. 99.205 Section 99.205 Food and Drugs FOOD AND DRUG ADMINISTRATION...

  17. 77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

    Science.gov (United States)

    2012-08-20

    ...] Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70 AGENCY: Food and Drug... new drug application (NDA) for DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 mL Glass... that FDA withdraw approval of NDA 080-819, DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 m...

  18. 49 CFR 107.705 - Registrations, reports, and applications for approval.

    Science.gov (United States)

    2010-10-01

    ... format may be filed by facsimile (fax) to: (202) 366-3753 or (202) 366-3308 or by electronic mail (e-mail... mailing addresses, e-mail address optional, and telephone number of the person on whose behalf the... proposed duration of the approval; (3) The transport mode or modes affected, as applicable; (4) Any...

  19. 7 CFR 1436.9 - Loan amount and loan application approvals.

    Science.gov (United States)

    2010-01-01

    ... approving authority to be ineligible for loan. (c) The maximum total principal amount of the farm storage... facility; (ii) By a yield determined reasonable by the county committee; (iii) Multiply by two (for 2 years... first time. (e) When a storage structure has a larger capacity than the applicant's needed capacity, as...

  20. 29 CFR 3.5 - Payroll deductions permissible without application to or approval of the Secretary of Labor.

    Science.gov (United States)

    2010-07-01

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

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

    Science.gov (United States)

    2013-08-23

    ... 558 [Docket No. FDA-2013-N-0839] New Animal Drugs; Withdrawal of Approval of New Animal Drug...: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request...

  2. 75 FR 28686 - FedFirst Financial Corporation, Monessen, PA; Approval of Conversion Application

    Science.gov (United States)

    2010-05-21

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-40: OTS No. H-4708] FedFirst Financial... Office of Thrift Supervision approved the application of FedFirst Financial MHC and First Federal Savings Bank, Monessen, Pennsylvania, to convert to the stock form of organization. Copies of the application...

  3. Adverse Effects of Nutraceuticals and Dietary Supplements.

    Science.gov (United States)

    Ronis, Martin J J; Pedersen, Kim B; Watt, James

    2018-01-06

    Over 70% of Americans take some form of dietary supplement every day, and the supplement industry is currently big business, with a gross of over $28 billion. However, unlike either foods or drugs, supplements do not need to be registered or approved by the US Food and Drug Administration (FDA) prior to production or sales. Under the Dietary Supplement Health and Education Act of 1994, the FDA is restricted to adverse report monitoring postmarketing. Despite widespread consumption, there is limited evidence of health benefits related to nutraceutical or supplement use in well-nourished adults. In contrast, a small number of these products have the potential to produce significant toxicity. In addition, patients often do not disclose supplement use to their physicians. Therefore, the risk of adverse drug-supplement interactions is significant. An overview of the major supplement and nutraceutical classes is presented here, together with known toxic effects and the potential for drug interactions.

  4. 18 CFR 131.20 - Application for approval of transfer of license.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Application for approval of transfer of license. 131.20 Section 131.20 Conservation of Power and Water Resources FEDERAL... a citizen of the United States of America. Subscribed and sworn to before me, a notary public of the...

  5. Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.

    Directory of Open Access Journals (Sweden)

    Derek So

    Full Text Available Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR, which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

  6. Application for approval to construct the Waste Receiving And Processing facility

    International Nuclear Information System (INIS)

    1993-02-01

    The following Application For Approval Of Construction is being submitted by the US Department of Energy, Richland Field Office pursuant to 40 CFR 61.07, ''Application for Approval of Construction or Modification,'' for the Waste Receiving and Processing (WRAP) Module 1 facility (also referred to as WRAP 1). The WRAP 1 facility will be a new source of radioactive emissions to the atmosphere. The WRAP 1 facility will be housed in the new 2336-W Building, which will be located in the 200 West Area south of 23rd Street and west of Dayton Avenue. The 200 West Area is located within the boundary of the Hanford Site. The mission of the WRAP 1 facility is to examine, assay, characterize, treat, and repackage solid radioactive and mixed waste to enable permanent disposal of the waste in accordance with all applicable regulations. The solid wastes to be handled in the WRAP 1 facility include low-level waste (LLW), Transuranic (TRU) waste, TRU mixed waste, and low-level mixed waste (LLMW). The WRAP 1 facility will only accept contact handled (CH) waste containers. CH waste is a waste category whose external surface dose rate does not exceed 200 mrem/h. These containers have a surface dose rate of less than 200 mrem/h

  7. 75 FR 30481 - Jacksonville Bancorp, Inc., Jacksonville, IL; Approval of Conversion Application

    Science.gov (United States)

    2010-06-01

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-42: OTS No. H-4706] Jacksonville..., 2010, the Office of Thrift Supervision approved the application of Jacksonville Bancorp, MHC, and Jacksonville Savings Bank, Jacksonville, Illinois, to convert to the stock form of organization. Copies of the...

  8. 78 FR 77470 - Health Insurance Exchanges; Approval of an Application by the Accreditation Association for...

    Science.gov (United States)

    2013-12-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9953-FN] Health Insurance Exchanges; Approval of an Application by the Accreditation Association for Ambulatory...\\ Health Insurance Exchanges; Application by the Accreditation Association for Ambulatory Health Care To Be...

  9. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-10-26

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

  10. 76 FR 10088 - Sunshine Financial, Inc., Tallahassee Florida; Approval of Conversion Application

    Science.gov (United States)

    2011-02-23

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-60: OTS Nos. H-4757, H-4519, and 17971... that on February 11, 2011, the Office of Thrift Supervision approved the application of Sunshine Savings MHC, Tallahassee, Florida, the federal mutual holding company for Sunshine Savings Bank...

  11. Chemical Reaction Engineering Applications in Non-traditional Technologies. A Textbook Supplement.

    Science.gov (United States)

    Savage, Phillip E.; Blaine, Steven

    1991-01-01

    A set of educational materials that have been developed which deal with chemical engineering applications in emerging technologies is described. The organization and the content of the supplemental textbook materials and how they can be integrated into an undergraduate reaction engineering course are discussed. (KR)

  12. 75 FR 51167 - Bank of Ruston, Ruston, Louisiana; Approval of Conversion Application

    Science.gov (United States)

    2010-08-18

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-48 OTS Nos. 03912 and H4739] Bank of..., 2010, the Office of Thrift Supervision approved the application of Bank of Ruston, Ruston, Louisiana.... Dated: August 11, 2010. By the Office of Thrift Supervision. Sandra E. Evans, Federal Register Liaison...

  13. 75 FR 31511 - Oneida Financial Corp., Oneida, NY; Approval of Conversion Application

    Science.gov (United States)

    2010-06-03

    ... Office of Thrift Supervision approved the application of Oneida Financial, MHC and Oneida Savings Bank... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-44: OTS No. H-4704] Oneida Financial... of Thrift Supervision. Sandra E. Evans, Federal Register Liaison. [FR Doc. 2010-13209 Filed 6-2-10; 8...

  14. Weakly distributive modules. Applications to supplement submodules

    Indian Academy of Sciences (India)

    Abstract. 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 ...

  15. 75 FR 28685 - Colonial Bankshares, MHC, Vineland, NJ; Approval of Conversion Application

    Science.gov (United States)

    2010-05-21

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-41: OTS Nos. 04983, H-3879, and H-4714... May 14, 2010, the Office of Thrift Supervision approved the application of Colonial Bankshares, MHC, and Colonial Bank, Vineland, New Jersey, to convert to the stock form of organization. Copies of the...

  16. 5 CFR 6401.103 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    .... 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior approval... her Deputy Ethics Official before engaging in outside employment, with or without compensation, that...

  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. 24 CFR 886.107 - Approval of applications.

    Science.gov (United States)

    2010-04-01

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

  19. 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...

  20. 34 CFR 200.45 - Supplemental educational services.

    Science.gov (United States)

    2010-07-01

    ... day; (2) Specifically designed to— (i) Increase the academic achievement of eligible students as... supplemental educational services from a State-approved provider selected by the student's parents. (2) Except... services to each student whose parents request these services, the LEA must give priority to the lowest...

  1. 75 FR 51167 - Northfield Bancorp, Inc., Staten Island, NY; Approval of Conversion Application

    Science.gov (United States)

    2010-08-18

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-47: OTS No. H-4732] Northfield Bancorp..., 2010, the Office of Thrift Supervision approved the application of Northfield Bancorp, MHC and Northfield Bank, Staten Island, New York, to convert to the stock form of organization. Copies of the...

  2. 75 FR 31511 - Peoples Federal Bancshares, Inc., Brighton, MA; Approval of Conversion Application

    Science.gov (United States)

    2010-06-03

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-45: OTS No. H-4715] Peoples Federal..., 2010, the Office of Thrift Supervision approved the application of Peoples Federal MHC and Peoples Federal Savings Bank, Brighton, Massachusetts, to convert to the stock form of organization. Copies of the...

  3. 75 FR 70081 - Home Federal Bancorp, Inc., Shreveport, LA; Approval of Conversion Application

    Science.gov (United States)

    2010-11-16

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-52: OTS No. H-4749] Home Federal... 5, 2010, the Office of Thrift Supervision approved the application of Home Federal Mutual Holding Company of Louisiana and Home Federal Bank, Shreveport, Louisiana, to convert to the stock form of...

  4. 75 FR 71187 - Atlantic Coast Financial Corporation, Waycross, GA; Approval of Conversion Application

    Science.gov (United States)

    2010-11-22

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-56 OTS No. H-4438] Atlantic Coast... November 12, 2010, the Office of Thrift Supervision approved the application of Atlantic Coast Federal, MHC and Atlantic Coast Bank, Waycross, Georgia, to convert to the stock form of organization. Copies of...

  5. 75 FR 75548 - SI Financial Group, Inc., Willimantic, CT; Approval of Conversion Application

    Science.gov (United States)

    2010-12-03

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-57: OTS Nos. H-4750, H-4082, and 17978... that on November 10, 2010, the Office of Thrift Supervision approved the application of SI Bancorp, MHC, Willimantic, Connecticut, the federal mutual holding company for the Savings Institute Bank and Trust Company...

  6. Effect of taking dietary supplement on hematological and biochemical parameters in male bodybuilders an equation model

    Directory of Open Access Journals (Sweden)

    Rokhsareh Meamar

    2015-01-01

    Conclusions: It is strongly advised that there should be some concerns about possible supplement-induced changes in the laboratory exams for bodybuilders. The available supplements are unchecked and not approved by the US Food and Drug Administration (FDA. More studies should be designed for a better and precise administration of each supplement in athletes.

  7. Athletes and Supplements: Prevalence and Perspectives.

    Science.gov (United States)

    Garthe, Ina; Maughan, Ronald J

    2018-03-01

    In elite sport, where opponents are evenly matched, small factors can determine the outcome of sporting contests. Not all athletes know the value of making wise nutrition choices, but anything that might give a competitive edge, including dietary supplements, can seem attractive. Between 40% and 100% of athletes typically use supplements, depending on the type of sport, level of competition, and the definition of supplements. However, unless the athlete has a nutrient deficiency, supplementation may not improve performance and may have a detrimental effect on both performance and health. Dietary supplements are classified as a subcategory of food, so manufacturers are not required to provide evidence of product safety and efficacy, nor obtain approval from regulatory bodies before marketing supplements. This creates the potential for health risks, and serious adverse effects have been reported from the use of some dietary supplements. Athletes who compete in sports under an anti-doping code must also realize that supplement use exposes them to a risk of ingesting banned substances or precursors of prohibited substances. Government systems of regulations do not include specific laboratory testing for banned substances according to the WADA list, so a separate regulatory framework to evaluate supplements for their risk of provoking a failed doping test is needed. In the high-performance culture typical of elite sport, athletes may use supplements regardless of possible risks. A discussion around medical, physiological, cultural, and ethical questions may be warranted to ensure that the athlete has the information needed to make an informed choice.

  8. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Science.gov (United States)

    2010-12-16

    ...; Securities Exchange Act of 1934 Release No. 63526/December 10, 2010] Order Approving Public Company... Company Accounting Oversight Board (the ``PCAOB'') to oversee the audits of companies and related matters..., subject to approval by the Commission, auditing and related attestation, quality control, ethics, and...

  9. 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

    2017-04-01

    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. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Guidance for package approvals in the United Kingdom

    International Nuclear Information System (INIS)

    Morgan-Warren, E.J.

    2004-01-01

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

  11. 5 CFR 6201.103 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 6201.103 Section 6201.103 Administrative Personnel EXPORT-IMPORT BANK OF THE UNITED STATES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXPORT-IMPORT BANK OF THE UNITED STATES § 6201.103 Prior...

  12. 75 FR 70363 - Alliance Bancorp, Inc. of Pennsylvania, Broomall, PA; Approval of Conversion Application

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-54: OTS No. H-4752] Alliance Bancorp... November 10, 2010, the Office of Thrift Supervision approved the application of Alliance Mutual Holding Company and Greater Delaware Valley Savings Bank, dba Alliance Bank, Broomall, Pennsylvania, to convert to...

  13. 76 FR 9636 - Franklin Financial Corporation, Inc., Glen Allen, VA; Approval of Conversion Application

    Science.gov (United States)

    2011-02-18

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-59: OTS No. H-4761] Franklin Financial... 11, 2011, the Office of Thrift Supervision approved the application of Franklin Financial Corporation MHC and Franklin Federal Savings Bank, Glen Allen, Virginia, to convert to the stock form of...

  14. 77 FR 35455 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2012-06-13

    ...-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed Rule Change Amending NYSE Rule 107B To Add a Class of Supplemental Liquidity Providers That Are Registered as Market... proposed rule change to amend NYSE Rule 107B to add a class of Supplemental Liquidity Providers (``SLP...

  15. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

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

  16. 7 CFR 1710.406 - Loan approval.

    Science.gov (United States)

    2010-01-01

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

  17. 75 FR 61246 - Kaiser Federal Financial Group, Inc., Covina, CA; Approval of Conversion Application

    Science.gov (United States)

    2010-10-04

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-51: OTS No. H-4729] Kaiser Federal... September 28, 2010, the Office of Thrift Supervision approved the application of K-Fed Mutual Holding Company and Kaiser Federal Bank, Covina, California, to convert to the stock form of organization. Copies...

  18. Decision 97.02 : Application for approval of the Terra Nova Canada-Newfoundland benefits plan and the Terra Nova development plan

    International Nuclear Information System (INIS)

    1997-12-01

    Petro-Canada applied to the Canada-Newfoundland Offshore Petroleum Board (the Board) for approval of its plan for the development of the Terra Nova oil and gas field of the Jeanne d'Arc Formation located about 35 km southeast of the Hibernia oilfield. Petro-Canada also submitted a benefits plan. The Board established the Terra Nova Project Environmental Assessment Panel to conduct a public review of the application and to ensure that the potential effects of the project upon the natural environment would be minimal. The Panel recommended approval of the application, subject to 75 recommendations. The Board considered the recommendations of the Panel and approved the Benefits Plan and the Development Plan subject to certain conditions being met. This document provides the details of the application, the bases for the Board's decision, the conditions imposed, and the 75 recommendations made by the Environmental Assessment Panel. . 6 tabs., 6 figs

  19. 75 FR 27119 - ViewPoint Financial Group, Inc., Plano, Texas; Approval of Conversion Application

    Science.gov (United States)

    2010-05-13

    ..., 2010, the Office of Thrift Supervision approved the application of ViewPoint MHC and ViewPoint Bank... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-37: OTS No. H-47111] ViewPoint... Carpenter Freeway, Suite 500, Irving, Texas 75062-2326. Dated: May 7, 2010. By the Office of Thrift...

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

    Science.gov (United States)

    Gelling, Leslie

    2016-01-13

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

  1. Supplemental design requirements document, Project W026

    International Nuclear Information System (INIS)

    Weidert, J.R.

    1993-01-01

    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. 76 FR 41864 - Home Federal Savings and Loan Association, Ashland, KY; Approval of Conversion Application

    Science.gov (United States)

    2011-07-15

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-24 OTS Nos. 04246 and H4776] Home Federal Savings and Loan Association, Ashland, KY; Approval of Conversion Application Notice is hereby... Savings and Loan Association, Ashland, Kentucky, to convert to the stock form of organization. Copies of...

  3. 76 FR 71926 - Defense Federal Acquisition Regulation Supplement: Applicability of Hexavalent Chromium Policy to...

    Science.gov (United States)

    2011-11-21

    ... 0750-AH39 Defense Federal Acquisition Regulation Supplement: Applicability of Hexavalent Chromium... the use of materials containing hexavalent chromium. DATES: Comment Date: Comments on the proposed... human health and environmental risks related to the use of hexavalent chromium. Hexavalent chromium is a...

  4. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    Science.gov (United States)

    2010-01-01

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

  5. 34 CFR 200.47 - SEA responsibilities for supplemental educational services.

    Science.gov (United States)

    2010-07-01

    .... (3)(i) Maintain by LEA an updated list of approved providers, including any technology-based or distance-learning providers, from which parents may select; and (ii) Indicate on the list those providers... the LEA and the SEA; (ii) Addresses students' individual needs as described in students' supplemental...

  6. 75 FR 80061 - Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA

    Science.gov (United States)

    2010-12-21

    ... withdrawing approval of a new drug application (NDA) for MERIDIA (sibutramine hydrochloride (HCl)) oral... requested that Abbott voluntarily withdraw MERIDIA (sibutramine HCl) oral capsules from the market, based on FDA's recent analysis of clinical trial data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT...

  7. 21 CFR 515.25 - Revocation of order refusing to approve a medicated feed mill license application or suspending...

    Science.gov (United States)

    2010-04-01

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

  8. 75 FR 28685 - Oritani Financial Corp., MHC, Township of Washington, NJ; Approval of Conversion Application

    Science.gov (United States)

    2010-05-21

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-39: OTS Nos. H-2944 and H-4701... hereby given that on May 10, 2010, the Office of Thrift Supervision approved the application of Oritani Financial Corp., MHC, and Oritani Bank, Township of Washington, New Jersey, to convert to the stock form of...

  9. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    2000-01-01

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

  10. 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.

  11. 48 CFR 2922.103-4 - Approvals.

    Science.gov (United States)

    2010-10-01

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

  12. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Science.gov (United States)

    2010-04-01

    ... RESERVATION ROADS PROGRAM Miscellaneous Provisions Emergency Relief § 170.925 Is ERFO funding supplemental to... construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are used... used to reimburse the construction or maintenance funds expended. ...

  13. Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

    Science.gov (United States)

    Gibson, James E; Taylor, David A

    2005-09-01

    The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

  14. 78 FR 34151 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2013-06-06

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2013-0050] Notice... of a signal system. FRA assigned the petition Docket Number FRA-2013-0050. Applicant: Wisconsin... Railway (CN), seeks approval of the proposed discontinuance and removal of a traffic control system (TCS...

  15. 78 FR 57857 - Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of...

    Science.gov (United States)

    2013-09-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3287-PN] Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of its Rural Health Clinic Accreditation Program AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION...

  16. 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

  17. 21 CFR 514.106 - Approval of supplemental applications.

    Science.gov (United States)

    2010-04-01

    ...) The sale, purchase, or construction of manufacturing facilities. (iii) The sale or purchase of an NADA... prescription drug advertising. (x) A change in the drug withdrawal period prior to slaughter or in the milk... effect) that give increased assurance that the drug will have the characteristics of identity, strength...

  18. 77 FR 35705 - Notice of Submission of Proposed Information Collection to OMB; Supplement to Application for...

    Science.gov (United States)

    2012-06-14

    ..., address, telephone number, and other relevant information of a family member, friend, or person associated... Proposed Information Collection to OMB; Supplement to Application for Federally Assisted Housing AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information...

  19. 20 CFR 416.305 - You must file an application to receive supplemental security income benefits.

    Science.gov (United States)

    2010-04-01

    ... benefits will be stopped because you are no longer eligible and you again meet the requirements for... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false You must file an application to receive supplemental security income benefits. 416.305 Section 416.305 Employees' Benefits SOCIAL SECURITY...

  20. Supplement to the Disposal Criticality Analysis Methodology

    International Nuclear Information System (INIS)

    Thomas, D.A.

    1999-01-01

    The methodology for evaluating criticality potential for high-level radioactive waste and spent nuclear fuel after the repository is sealed and permanently closed is described in the Disposal Criticality Analysis Methodology Topical Report (DOE 1998b). The topical report provides a process for validating various models that are contained in the methodology and states that validation will be performed to support License Application. The Supplement to the Disposal Criticality Analysis Methodology provides a summary of data and analyses that will be used for validating these models and will be included in the model validation reports. The supplement also summarizes the process that will be followed in developing the model validation reports. These reports will satisfy commitments made in the topical report, and thus support the use of the methodology for Site Recommendation and License Application. It is concluded that this report meets the objective of presenting additional information along with references that support the methodology presented in the topical report and can be used both in validation reports and in answering request for additional information received from the Nuclear Regulatory Commission concerning the topical report. The data and analyses summarized in this report and presented in the references are not sufficient to complete a validation report. However, this information will provide a basis for several of the validation reports. Data from several references in this report have been identified with TBV-1349. Release of the TBV governing this data is required prior to its use in quality affecting activities and for use in analyses affecting procurement, construction, or fabrication. Subsequent to the initiation of TBV-1349, DOE issued a concurrence letter (Mellington 1999) approving the request to identify information taken from the references specified in Section 1.4 as accepted data

  1. Electronic Approval of Invoices (AEF)

    CERN Document Server

    2004-01-01

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

  2. 76 FR 54078 - Cotton Board Rules and Regulations: Adjusting Supplemental Assessment on Imports

    Science.gov (United States)

    2011-08-31

    ... requirements previously approved. List of Subjects in 7 CFR Part 1205 Advertising, Agricultural research... purpose of calculating supplemental assessments collected for use by the Cotton Research and Promotion...: Effective Date: September 30, 2011. FOR FURTHER INFORMATION CONTACT: Shethir M. Riva, Chief, Research and...

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

    Science.gov (United States)

    Beitz, J

    2001-04-01

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

  4. 78 FR 48177 - Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin

    Science.gov (United States)

    2013-08-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0883] Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin AGENCY: Food and Drug... Purdue Pharma L.P. (Purdue), One Stamford Forum, Stamford, CT 06901-3431. Purdue has voluntarily...

  5. HSE statement on the approval of dosimetry services

    International Nuclear Information System (INIS)

    1992-09-01

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

  6. Application for approval of the Cold Lake Expansion Project

    International Nuclear Information System (INIS)

    1997-02-01

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

  7. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

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

  8. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    Science.gov (United States)

    2010-04-01

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

  9. 76 FR 19173 - Self-Regulatory Organizations; the Options Clearing Corporation; Order Granting Approval of...

    Science.gov (United States)

    2011-04-06

    ... to list and trade options on the CBOE Gold ETF Volatility Index.\\6\\ The March 2011 Supplement amends... on the CBOE Gold ETF Volatility Index and similarly structured equity-based volatility indexes that...) (order approving CBOE's proposed rules to list and trade CBOE Gold ETF Volatility Index options). \\7\\ For...

  10. 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

    ...] Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New... Tablets... Abbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157. NDA... (diphenhydramine Healthcare. HCl)) Injection Preservative Free. NDA 010021 Placidyl Abbott Laboratories...

  11. 30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

    Science.gov (United States)

    2010-07-01

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

  12. Effect of taking dietary supplement on hematological and biochemical parameters in male bodybuilders an equation model

    Science.gov (United States)

    Meamar, Rokhsareh; Maracy, Mohammad; Nematollahi, Shahrzad; Yeroshalmi, Shemouil; Zamani-Moghaddam, Ali; Ghazvini, Mohammad Reza Aghaye

    2015-01-01

    Background: The improved physical action following administration of supplements to bodybuilders was supported by changes in laboratory parameters. Despite the fact that these supplements are sometimes associated both advantage and side effects, this study were conducted for the purpose of evaluating the possible effects of some commonly used supplements in bodybuilders on the hematological and biochemical parameters. Materials and Methods: In this study, we included 40 male bodybuilders as cases and 40 controls in the age group of 20-40 years. They used different kinds of supplements for 1 year. In general, all the supplements used were classified into two groups: hormonal and non-hormonal. Laboratory tests were requested for evaluation of hematological and biochemical parameters. Results: In an equation model, we found that weight (P = 0.024), duration of bodybuilding (P bodybuilders. The available supplements are unchecked and not approved by the US Food and Drug Administration (FDA). More studies should be designed for a better and precise administration of each supplement in athletes. PMID:26793253

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

    International Nuclear Information System (INIS)

    Spencer, W.A.

    2000-01-01

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

  14. 44 CFR 78.9 - Planning grant approval process.

    Science.gov (United States)

    2010-10-01

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

  15. Avelumab: First Global Approval.

    Science.gov (United States)

    Kim, Esther S

    2017-05-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2010-01-01

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

  17. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

    Markman, D.W.

    1999-01-01

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

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

    Science.gov (United States)

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

    2012-06-01

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

  19. 50 CFR 37.22 - Approval of exploration plan.

    Science.gov (United States)

    2010-10-01

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

  20. Methylsulfonylmethane: Applications and Safety of a Novel Dietary Supplement

    OpenAIRE

    Matthew Butawan; Rodney L. Benjamin; Richard J. Bloomer

    2017-01-01

    Methylsulfonylmethane (MSM) has become a popular dietary supplement used for a variety of purposes, including its most common use as an anti-inflammatory agent. It has been well-investigated in animal models, as well as in human clinical trials and experiments. A variety of health-specific outcome measures are improved with MSM supplementation, including inflammation, joint/muscle pain, oxidative stress, and antioxidant capacity. Initial evidence is available regarding the dose of MSM needed ...

  1. 77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-12-13

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

  2. 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.

  3. 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.

  4. 75 FR 31510 - Fox Chase Bancorp, Inc., Hatboro, PA; Approval of Conversion

    Science.gov (United States)

    2010-06-03

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

  5. 77 FR 74820 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplemental Motor...

    Science.gov (United States)

    2012-12-18

    ... Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday... maintenance plan to increase the safety margin as a result of new emissions model, VMT projection models, and... Promulgation of Implementation Plans; Tennessee: Knox County Supplemental Motor Vehicle Emissions Budget Update...

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

    International Nuclear Information System (INIS)

    Morgan-Warren, E.J.

    1999-01-01

    Type B packages and all packages containing fissile material, as well as special form radioactive materials, special arrangements and certain shipments, are required to be approved by the competent authority. In the United Kingdom competent authority approval is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division (RMTD) of the Department of the Environment, Transport and the Regions (DETR). Competent authority approval of a package design is given only after a detailed assessment of the design by the specialist staff of RMTD. There are three facets to the assessment procedure, namely engineering, criticality and radiation protection, and quality assurance. The engineering assessor ensures that the designer has demonstrated the integrity of the containment and shielding systems under the regulatory conditions. The criticality assessor examines criticality safety and radiation protection measures, and together with the engineering assessor, decides whether this is maintained under regulatory conditions. The quality assurance assessor verifies that the applicant has established the necessary controls to ensure that the design requirements are met. The applicant is responsible for making the case for approval, but the assessment is facilitated if the competent authority is involved with the designer at an early stage in development and during the construction of any test prototype. When a regulatory test programme is required, it is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test programme, the applicant submits a formal application, supported by a design safety report (DSR). The DSR provides a full analysis of the design and the test results, including the behaviour of the package under normal and accident conditions of transport, the manufacturing and maintenance procedures, quality assurance and the emergency provisions for the operation of the package

  7. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

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

  8. [Applications and approved projects on traditional Chinese medicine in National Natural Science Foundation of China in 2010].

    Science.gov (United States)

    Shang, Hong-cai; Huang, Jin-ling; Han, Li-wei; Pei, Ling-peng; Guo, Lin; Lin, Na; Wang, Chang-en

    2011-10-01

    In this article, the authors firstly summarized the number of applications submitted to and projects supported by the National Natural Science Foundation of China (NSFC) in the field of traditional Chinese medicine research in 2010. Then they described the district distribution, research direction layout and allotment of the approved projects in the three primary disciplines (traditional Chinese medicine, Chinese materia medica and integrated traditional Chinese and Western medicine) and their 43 subdisciplines. The targeting suggestions for improvement were given respectively by concluding the reason of disapproved projects from the point of view of applicants and supporting institution, and by stating the common problems existing in the review process from the perspectives of fund managers and evaluation experts. Lastly, the major funding fields in the near future were predicted in the hope of providing guidance for applicants.

  9. 13 CFR 108.380 - Final approval as a NMVC Company.

    Science.gov (United States)

    2010-01-01

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

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

    International Nuclear Information System (INIS)

    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

  11. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-10-04

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

  12. [Quality control in herbal supplements].

    Science.gov (United States)

    Oelker, Luisa

    2005-01-01

    Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

  13. Growing evidence of the beneficial effects of a marine protein-based dietary supplement for treating hair loss.

    Science.gov (United States)

    Hornfeldt, Carl S

    2018-04-01

    Hair loss is a common condition among women with a range of causes including nutritional deficiencies. To review the clinical data supporting the use of an oral marine supplement designed to promote hair growth. Adult women with temporary thinning hair. Following an initial pilot study, five randomized, double-blind studies assessed the effectiveness of the oral marine supplement for promoting hair growth. Each study was approved by one or more institutional review boards. Together, these studies demonstrated the ability of oral marine supplements to increase the growth of terminal and vellus hairs, increase the diameter of terminal and vellus hairs, and decrease hair loss. This product is beneficial for men as well as women. A dietary supplement containing a marine complex and other natural ingredients can safely and effectively promote hair growth and decrease hair shedding in women and men with thinning hair. © 2017 Wiley Periodicals, Inc.

  14. 44 CFR 78.10 - Project grant approval process.

    Science.gov (United States)

    2010-10-01

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

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

    Science.gov (United States)

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

    2012-09-01

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

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

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

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

  17. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

    ... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... propulsion and is directly engaged in or proposes to engage in a substantial research and development program in such field of work; or (ii) Is engaged in or proposes to engage in a substantial study program in...

  18. 77 FR 429 - Clarification and Further Guidance on the Fireworks Approvals Policy

    Science.gov (United States)

    2012-01-05

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

  19. Sanitary Landfill Supplemental Test Final Report

    International Nuclear Information System (INIS)

    Altman, D.J.

    1999-01-01

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

  20. 32 CFR 199.16 - Supplemental Health Care Program for active duty members.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Supplemental Health Care Program for active duty... (CHAMPUS) § 199.16 Supplemental Health Care Program for active duty members. (a) Purpose and applicability... the supplemental health care program for active duty members of the uniformed services, the provision...

  1. 50 CFR 223.207 - Approved TEDs.

    Science.gov (United States)

    2010-10-01

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

  2. 13 CFR 115.62 - Prohibition on participation in Prior Approval program.

    Science.gov (United States)

    2010-01-01

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

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

    Science.gov (United States)

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

    2015-04-01

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

  4. A Document Imaging Technique for Implementing Electronic Loan Approval Process

    Directory of Open Access Journals (Sweden)

    J. Manikandan

    2015-04-01

    Full Text Available The image processing is one of the leading technologies of computer applications. Image processing is a type of signal processing, the input for image processor is an image or video frame and the output will be an image or subset of image [1]. Computer graphics and computer vision process uses an image processing techniques. Image processing systems are used in various environments like medical fields, computer-aided design (CAD, research fields, crime investigation fields and military fields. In this paper, we proposed a document image processing technique, for establishing electronic loan approval process (E-LAP [2]. Loan approval process has been tedious process, the E-LAP system attempts to reduce the complexity of loan approval process. Customers have to login to fill the loan application form online with all details and submit the form. The loan department then processes the submitted form and then sends an acknowledgement mail via the E-LAP to the requested customer with the details about list of documents required for the loan approval process [3]. The approaching customer can upload the scanned copies of all required documents. All this interaction between customer and bank take place using an E-LAP system.

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

    Science.gov (United States)

    Brese, Falk, Ed.

    2012-01-01

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

  6. Quality assurance of approved out of programme psychiatry training and research over the past 5 years

    Science.gov (United States)

    Osman-Hicks, Victoria; Graham, Hannah; Leadbetter, Peter; Brittlebank, Andrew

    2015-01-01

    Aims and method This paper intends to analyse the number of applications, trainee demographic and approval rate of those applying for out of programme training (OOPT) or out of programme research (OOPR) between January 2008 and April 2013 using the committee’s anonymised database. We also describe the process of application and approval by the Quality Assurance Committee. Results There were 90 applications, including 10 resubmissions during the 64-month period. Most applicants (77%) were higher trainees; 53% of applicants were from the London deanery; 60% of applications were for research posts and higher degrees (OOPR). Overall, 64% were approved by the committee: 70% for OOPRs and 53% for OOPTs. Clinical implications This paper shows with transparency the breakdown of applications to the Quality Assurance Committee. Around two-thirds of applications to the committee are supported (64%). Relatively few psychiatry trainees (2.5%) have applied for an OOPT or an OOPR over the past 5 years. PMID:26191450

  7. 77 FR 5028 - Withdrawal of Approval of New Animal Drug Applications

    Science.gov (United States)

    2012-02-01

    .... DATES: Withdrawal of approval is effective February 13, 2012. FOR FURTHER INFORMATION CONTACT: John...- 3115. NADA 100-689 DIFIL Syrup (diethylcarbamazine Evsco Pharmaceuticals, an Affiliate of citrate). IGI...

  8. Classification of calcium supplements through application of principal component analysis: a study by inaa and aas

    International Nuclear Information System (INIS)

    Waheed, S.; Rahman, S.; Siddique, N.

    2013-01-01

    Different types of Ca supplements are available in the local markets of Pakistan. It is sometimes difficult to classify these with respect to their composition. In the present work principal component analysis (PCA) technique was applied to classify different Ca supplements on the basis of their elemental data obtained using instrumental neutron activation analysis (INAA) and atomic absorption spectrometry (AAS) techniques. The graphical representation of principal component analysis (PCA) scores utilizing intricate analytical data successfully generated four different types of Ca supplements with compatible samples grouped together. These included Ca supplements with CaCO/sub 3/as Ca source along with vitamin C, the supplements with CaCO/sub 3/ as Ca source along with vitamin D, Supplements with Ca from bone meal and supplements with chelated calcium. (author)

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

    International Nuclear Information System (INIS)

    Plotan, Monika; Elliott, Christopher T.; Scippo, Marie Louise; Muller, Marc; Antignac, Jean-Philippe; Malone, Edward; Bovee, Toine F.H.; Mitchell, Samuel; Connolly, Lisa

    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 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 50 of 0.01 ng mL -1 and 0.16 ng mL -1 respectively. The developed assays were applied in a survey of 63 sport supplements samples obtained across the Island of Ireland with an additional seven reference samples previously investigated using LC-MS/MS. Androgen and estrogen bio-activity was found in 71% of the investigated samples. Bio-activity profiling was further broken down into agonists, partial agonists and antagonists. Supplements (13) with the strongest estrogenic bio-activity were chosen for further investigation. LC-MS/MS analysis of these samples determined the presence of phytoestrogens in seven of them. Supplements (38) with androgen bio-activity were also selected for further investigation. Androgen agonist bio-activity was detected in 12 supplements, antagonistic bio-activity was detected in 16 and partial antagonistic bio-activity was detected in 10. A further group of supplements (7) did not present androgenic bio-activity when tested alone but enhanced the androgenic agonist bio-activity of dihydrotestosterone when combined. The developed assays offer advantages in detection of known, unknown and low-level mixtures of endocrine disruptors over existing analytical screening techniques. For the detection and identification of constituent hormonally active compounds the

  10. Sports Supplements

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Sports Supplements KidsHealth / For Teens / Sports Supplements What's in ... really work? And are they safe? What Are Sports Supplements? Sports supplements (also called ergogenic aids ) are ...

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

    Science.gov (United States)

    Lystrup, Robert M; Leggit, Jeffery C

    2015-08-01

    Thousands of military members self-medicate with dietary supplements containing unknown quantities of pharmacologically active compounds. These poorly regulated substances can cause real harm to the military population, especially when they contain stimulants such as caffeine. When taken regularly, caffeine has several performance-enhancing benefits. However, when used excessively or in vulnerable populations, caffeine can cause several unwanted side effects such as nervousness, sensory disturbances, insomnia, arrhythmia, excitability, inattentiveness, restlessness, mood changes, gastrointestinal disturbances, and even psychosis. Vulnerable patients include the caffeine-naïve, physiologically stressed, young, and mentally ill patients. One such case describes a caffeine-naïve service member who suffered an adverse reaction after taking an allegedly moderate dose of caffeine from a pill he obtained from a teammate. This case highlights the importance of supplement awareness among service members, increased provider vigilance, third party verification, and enhanced regulation on the approval and marketing of dietary supplements. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

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

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

    This document has been prepared to define the specific environmental requirements applicable to Project W-521. The document describes the permits and approvals necessary for the project to design, construct, and install planned upgrades, and provides a schedule of activities and provides cost estimates to complete the required permitting and approval activities

  13. 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.

  14. Credit Risk Management - Loan Approval Process

    Directory of Open Access Journals (Sweden)

    Lulzim Rashiti

    2016-03-01

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

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

    International Nuclear Information System (INIS)

    1999-01-01

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

  16. Dietary supplementation with a superoxide dismutase-melon concentrate reduces stress, physical and mental fatigue in healthy people: a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Carillon, Julie; Notin, Claire; Schmitt, Karine; Simoneau, Guy; Lacan, Dominique

    2014-06-19

    We aimed to investigate effects of superoxide dismutase (SOD)-melon concentrate supplementation on psychological stress, physical and mental fatigue in healthy people. A randomized, double-blind, placebo-controlled trial was performed on 61 people divided in two groups: active supplement (n = 32) and placebo (n = 29) for 12 weeks. Volunteers were given one small hard capsule per day. One capsule contained 10 mg of SOD-melon concentrate (140 U of SOD) and starch for the active supplement and starch only for the placebo. Stress and fatigue were evaluated using four psychometric scales: PSS-14; SF-36; Stroop tests and Prevost scale. The supplementation with SOD-melon concentrate significantly decreased perceived stress, compared to placebo. Moreover, quality of life was improved and physical and mental fatigue were reduced with SOD-melon concentrate supplementation. SOD-melon concentrate supplementation appears to be an effective and natural way to reduce stress and fatigue. trial approved by the ethical committee of Poitiers (France), and the ClinicalTrials.gov Identifier is NCT01767922.

  17. 76 FR 60721 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin

    Science.gov (United States)

    2011-09-30

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin AGENCY: Food and... amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA...

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

    International Nuclear Information System (INIS)

    2009-01-01

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

  19. 75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products

    Science.gov (United States)

    2010-12-29

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

  20. 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

  1. Radioactive air emissions notice of construction and application for approval to construct the Hanford Waste Vitrification Plant

    International Nuclear Information System (INIS)

    1992-10-01

    The Hanford Site is owned by the US Government and operated by the US Department of Energy, Richland Field Office. The Hanford Site manages and produces dangerous waste and mixed waste. (containing both radioactive and dangerous components). The US Department of Energy, Richland Field Office, currently stores mixed waste, resulting from various processing operations, in underground storage tanks. The Hanford Waste Vitrification Plant will be constructed and operated to process the high-activity fraction of mixed waste stored in these underground tanks. The Hanford Waste Vitrification Plant will solidify pretreated tank waste into a glass product that will be packaged for disposal in a national repository. Emissions from the Hanford Waste Vitrification Plant will be regulated by both the federal and state Clean Air Acts. The proposed Hanford Waste Vitrification Plant represents a new source of radioactive air emissions. Construction of the plant will require approval from both federal and state agencies. The Notice of Construction and Application for Approval to Construct the Hanford Waste Vitrification Plant contains information required under Title 40 of the Code of Federal Regulations, Chapter 61; and Chapter 246-247 of the Washington Administrative Code for a proposed new source of radioactive air emissions. The document contents are based on information contained in the Hanford Waste Vitrification Plant Reference Conceptual Design Report, the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report, Revision 0, and subsequent design changes made before August 1, 1992. The contents of this document may be modified to include more specific information generated during subsequent detailed design phases. Modifications will be submitted for regulatory review and approval, as appropriate

  2. From initial application to routine operation: Reviewing the Applications for Power Uprates

    International Nuclear Information System (INIS)

    Garis, Ninos; Skaanberg, Lars

    2007-01-01

    Current plans for power uprates in Swedish nuclear power plants will lead to significant increases in seven units and a lesser increase in one unit. To date SKI has received six applications, and two more are due in 2007. A power uprate process is initiated by the application to the Government by a licensee for approval to increase the thermal output of a reactor unit. This request is addressed to the Government and is forwarded to SKI for a preliminary safety review. The result of the review is then provided by SKI as a basis for a governmental decision. Six applications have been taken through the first stage of the process; of these, three have received governmental approval and three are currently awaiting a decision. If the licensee's application is approved by the Government, deeper analyses and studies are required in order to modify the plant and update the safety analysis report and the associated technical specifications. SKI reviews this material on a continuous basis prior to test and routine operation at the increased power level. There are four stages that require attention and review by SKI; 1. Review of the application to the Government for approval to operate at increased power levels, and preparation of a suitable answer. 2. Review and approval of the preliminary safety analysis report (PSAR) 3. Review and approval of the application for testing at the higher power level 4. Review and approval of routine operation at the higher power level. A thorough description of the handling of a power uprate process can be found in the SKI PM (SKI-PM 04:11) that is available on the SKI website (in Swedish)

  3. [Subjective Level of Information and Information Needs of Patients with an Approved Rehabilitation Application and Patients at the End of Rehabilitation Results of a Written Survey].

    Science.gov (United States)

    Walther, Anna Lena; Schreiber, Dora; Falk, Johannes; Deck, Ruth

    2017-08-01

    Aim The aim of the study was to identify the subjective level of information and information needs of patients with an approved rehabilitation application and patients at the end of rehabilitation with regard to preferred subjects and kind of information transfer. Method Written survey with N=283 patients with approved rehabilitation application and N=388 patients at the end of rehabilitation. Results Both groups reported high information needs particularly regarding treatments during rehabilitation, rehabilitation aftercare and rehabilitation aims. A conversation with their physician, a brochure and a website are the preferred information pathways. Conclusion Taking into account the topics for which both groups require information and the preference regarding the kind of information transfer can make a valuable contribution for the development of needs-oriented information material. © Georg Thieme Verlag KG Stuttgart · New York.

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

    Science.gov (United States)

    Kofoed, Christina L F; Christensen, Jane; Dragsted, Lars O; Tjønneland, Anne; Roswall, Nina

    2015-06-28

    The prevalence of dietary supplement use varies largely among populations, and previous studies have indicated that it is high in the Danish population compared with other European countries. The diversity in supplement use across countries indicates that cultural and environmental factors could influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54,948 Danes, aged 50-64 years, who completed self-administrated questionnaires on diet, dietary supplements and 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 to the intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher likelihood of being user of any, more common and less common supplements, respectively. In the metabolic risk index, one additional point was associated with 17 and 16 % lower likelihood of being user of any supplement and more common supplements, respectively. No significant association was found for less 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.

  5. 76 FR 41154 - Review and Approval of Projects

    Science.gov (United States)

    2011-07-13

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

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

    Science.gov (United States)

    Krishnan, Govindarajapuram Subramaniam

    1997-12-01

    The National Aeronautics & Space Administration (NASA), the European Space Agency (ESA), and the Canadian Space Agency (CSA) missions involve the performance of scientific experiments in Space. Instruments used in such experiments are fabricated using electronic parts such as microcircuits, inductors, capacitors, diodes, transistors, etc. For instruments to perform reliably the selection of commercial parts must be monitored and strictly controlled. The process used to achieve this goal is by a manual review and approval of every part used to build the instrument. The present system to select and approve parts for space applications is manual, inefficient, inconsistent, slow and tedious, and very costly. In this dissertation a computer based decision support model is developed for implementing this process using artificial intelligence concepts based on the current information (expert sources). Such a model would result in a greater consistency, accuracy, and timeliness of evaluation. This study presents the methodology of development and features of the model, and the analysis of the data pertaining to the performance of the model in the field. The model was evaluated for three different part types by experts from three different space agencies. The results show that the model was more consistent than the manual evaluation for all part types considered. The study concludes with the cost and benefits analysis of implementing the models and shows that implementation of the model will result in significant cost savings. Other implementation details are highlighted.

  7. [Simultaneous analysis of four diuretic drugs by HPLC and its application to health food supplements advertising weight reduction].

    Science.gov (United States)

    Goto, Tomomi; Mikami, Eiichi; Ohno, Tsutomu; Matsumoto, Hiroshi

    2002-04-01

    A high-performance liquid chromatographic (HPLC) method for the simultaneous analysis of triamterene, trichlormethiazide, furosemide and spironolactone is presented for application in the examination of health food supplements advertising weight reduction and in the analysis of pharmaceuticals. The HPLC assay was performed under gradient conditions using a Wakosil ODS 5C18 column (5 microns, 150 x 4.6 mm i.d.). The mobile phase consisted of a gradient program with a mixture of water and acetonitrile containing 0.1% triethylamine adjusted with phosphoric acid to pH 3.0: from 0 to 6 min, 15% acetonitrile; from 6 to 20 min, linear gradient from 15 to 50% acetonitrile; and from 20 to 40 min, 50% acetonitrile. The column effluent was monitored from 0 to 20 min at 260 nm and from 20 to 40 min at 235 nm. The calibration curves of the four drugs showed good linearity and the correlation coefficients were better than 0.999 in all cases. The lower limits of detection were approximately 40 ng for each drug. Commercially available health food supplements and pharmaceuticals were analyzed after extraction with a mixture of methanol and acetic acid (99:1). The procedure described here is suitable for the screening of four diuretic drugs in adulterated supplements and for the quality control of pharmaceuticals with minimal sample preparation.

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

    Science.gov (United States)

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

    2011-04-20

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

  9. 75 FR 27863 - Savings Bank of Maine, MHC and Savings Bank of Maine, Gardiner, Maine; Approval of Conversion...

    Science.gov (United States)

    2010-05-18

    ... DEPARTMENT OF THE TREASURY Office of Thrift Supervision [AC-38: OTS Nos. 06947 and H 4709] Savings Bank of Maine, MHC and Savings Bank of Maine, Gardiner, Maine; Approval of Conversion Application Notice is hereby given that on May 7, 2010, the Office of Thrift Supervision approved the application of...

  10. Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Signature, ratification, acceptance, approval or accession. Status as of 31 December 1996

    International Nuclear Information System (INIS)

    1997-01-01

    The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 31 December 1996. The Joint Protocol entered into force on 27 April 1992

  11. Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Signature, ratification, acceptance, approval or accession. Status as of 31 December 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-02-28

    The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 31 December 1996. The Joint Protocol entered into force on 27 April 1992.

  12. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    Science.gov (United States)

    2010-07-01

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

  13. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Science.gov (United States)

    2011-03-03

    ... subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than... 23, 1983, notice, the manufacturer had submitted supplemental applications proposing to reformulate... Laboratories, a subsidiary of Elan Corp., PLC, 800 Gateway Blvd., South San Francisco, CA 94080; Copley...

  14. SPORT SUPPLEMENTATION

    OpenAIRE

    Alexandаr Marinkov

    2016-01-01

    Sport supplementation is essential for athletes performance and achievements. The well balanced and structured supplementation is a challenge for sport medicine because must be done a balance between potential benefits and potential risks (anti-doping rule violations and others). In this review are structured the most used categories sport supplementations. Nutritional supplements used in sport could be divided in some main categories like: amino acids, vitamins, proteins and antioxidants. Fo...

  15. 30 CFR 7.83 - Application requirements.

    Science.gov (United States)

    2010-07-01

    ...) Injector nozzle; (9) Injection fuel pump; (10) Governor; (11) Turbocharger, if applicable; (12) Aftercooler... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in Underground Coal Mines § 7.83 Application requirements. (a) An application for approval of a diesel engine...

  16. 47 CFR 80.651 - Supplemental eligibility requirements.

    Science.gov (United States)

    2010-10-01

    ... Section 80.651 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Maritime Support Stations § 80.651 Supplemental eligibility requirements. (a) An applicant for a maritime support station must demonstrate a requirement for training...

  17. Dense breasts: a review of reporting legislation and available supplemental screening options.

    Science.gov (United States)

    Ho, Jessica M; Jafferjee, Nasima; Covarrubias, Gabriel M; Ghesani, Munir; Handler, Bradley

    2014-08-01

    The objectives of this article are to discuss the Mammography Quality Standards Act (MQSA) and what it means for patients, define breast density and explain how it is measured, review the new state-based legislation regarding the reporting of dense breast tissue directly to patients and the possibility of an adjunct screening examination, describe possible supplemental screening options and the advantages and disadvantages of each, and outline the current shortcomings and unanswered questions regarding new legislation. Breast density is now established as an independent risk factor for developing breast cancer irrespective of other known risk factors. Women with breast density in the upper quartile have an associated four to five times greater risk of developing breast cancer relative to women with breast density in the lower quartile. Many states have enacted or proposed legislation requiring mammographers to report to patients directly if they have dense breast tissue and recommend discussing the possibility of a supplemental screening examination with their physicians. However, there is currently no consensus as to whether a supplemental screening examination should be pursued or which modality to use. Possible supplemental screening modalities include ultrasound, MRI, digital breast tomosynthesis, and molecular breast imaging. The U.S. Food and Drug Administration recently approved an automated breast ultrasound system for screening whole-breast ultrasound in patients with dense breasts. However, many questions are still unanswered including the impact on morbidity and mortality, cost-effectiveness, and insurance coverage.

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

    International Nuclear Information System (INIS)

    1999-01-01

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

  19. Addendum to the post-closure permit application for the Bear Creek hydrogeologic regime at the Y-12 plant: Walk-in pits

    International Nuclear Information System (INIS)

    1995-04-01

    In June 1987, the Resource Conservation and Recovery Act (RCRA) Closure/Post-Closure Plan for the Bear Creek Burial Grounds (BCBG) located at the Y-12 Plant on the Oak Ridge Reservation in Oak Ridge, Tennessee was submitted to the Tennessee Department of Environment and Conservation (TDEC) for review and approval.The Closure Plan has been modified and revised several times. This document is an addendum to the Post-Closure Permit Application submitted to TDEC in June, 1994. This addendum contains information on the Walk-In Pits of the BCBG which is meant to supplement the information provided in the Post-Closure Permit Application submitted for the BCBG. This document is not intended to be a stand-alone document.

  20. Dietary Supplementation with a Superoxide Dismutase-Melon Concentrate Reduces Stress, Physical and Mental Fatigue in Healthy People: A Randomised, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Julie Carillon

    2014-06-01

    Full Text Available Background: We aimed to investigate effects of superoxide dismutase (SOD-melon concentrate supplementation on psychological stress, physical and mental fatigue in healthy people. Methods: A randomized, double-blind, placebo-controlled trial was performed on 61 people divided in two groups: active supplement (n = 32 and placebo (n = 29 for 12 weeks. Volunteers were given one small hard capsule per day. One capsule contained 10 mg of SOD-melon concentrate (140 U of SOD and starch for the active supplement and starch only for the placebo. Stress and fatigue were evaluated using four psychometric scales: PSS-14; SF-36; Stroop tests and Prevost scale. Results: The supplementation with SOD-melon concentrate significantly decreased perceived stress, compared to placebo. Moreover, quality of life was improved and physical and mental fatigue were reduced with SOD-melon concentrate supplementation. Conclusion: SOD-melon concentrate supplementation appears to be an effective and natural way to reduce stress and fatigue. Trial registration: trial approved by the ethical committee of Poitiers (France, and the ClinicalTrials.gov Identifier is NCT01767922.

  1. Mood-Stabilizing Anticonvulsants, Spina Bifida, and Folate Supplementation: Commentary.

    Science.gov (United States)

    Patel, Neil; Viguera, Adele C; Baldessarini, Ross J

    2018-02-01

    High risks of neural tube defects and other teratogenic effects are associated with exposure in early pregnancy to some anticonvulsants, including in women with bipolar disorder. Based on a semistructured review of recent literature, we summarized findings pertaining to this topic. Valproate and carbamazepine are commonly used empirically (off-label) for putative long-term mood-stabilizing effects. Both anticonvulsants have high risks of teratogenic effects during pregnancy. Risks of neural tube defects (especially spina bifida) and other major malformations are especially great with valproate and can arise even before pregnancy is diagnosed. Standard supplementation of folic acid during pregnancy can reduce risk of spontaneous spina bifida, but not that associated with valproate or carbamazepine. In contrast, lamotrigine has regulatory approval for long-term use in bipolar disorder and appears not to have teratogenic effects in humans. Lack of protective effects against anticonvulsant-associated neural tube defects by folic acid supplements in anticipation of and during pregnancy is not widely recognized. This limitation and high risks of neural tube and other major teratogenic effects, especially of valproate, indicate the need for great caution in the use of valproate and carbamazepine to treat bipolar disorder in women of child-bearing age.

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

    International Nuclear Information System (INIS)

    Stanley, H.H.

    2001-01-01

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

  3. 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. Copyright © 2010 John Wiley & Sons, Ltd.

  4. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Science.gov (United States)

    2010-04-01

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

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

    International Nuclear Information System (INIS)

    1993-10-01

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

  6. 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.

  7. 15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

    Science.gov (United States)

    2010-01-01

    ... approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations... REGULATIONS OF THE FOREIGN-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.32 Procedure for review of request for approval of manufacturing or processing. (a) Request as part of application...

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

    International Nuclear Information System (INIS)

    2000-01-01

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

  9. Joint Protocol relating to the application of the Vienna Convention and the Paris Convention. Status list as of 30 September 2002. Signature, ratification, acceptance, approval or accession

    International Nuclear Information System (INIS)

    2002-01-01

    The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 30 September 2002. The Joint Protocol entered into force on 27 April 1992

  10. 14 CFR 121.909 - Approval of Advanced Qualification Program.

    Science.gov (United States)

    2010-01-01

    ... criteria. Each AQP must have separate curriculums for indoctrination, qualification, and continuing... the training and evaluation of CRM and technical skills and knowledge. An application for approval of... must meet all the requirements of this subpart. (2) Each indoctrination, qualification, and continuing...

  11. Complementarity in dietary supplements and foods: are supplement users vegetable eaters?

    Science.gov (United States)

    Kang, Hyoung-Goo; Joo, Hailey Hayeon; Choi, Kyong Duk; Lee, Dongmin; Moon, Junghoon

    2017-01-01

    Background : The consumption of fruits, vegetables, and dietary supplements correlate. Most previous studies have aimed to identify the determinants of supplement uses or the distinct features of supplement users; this literature lacks a discussion on dietary supplement consumption as a predictor of fruit and vegetable consumption. Objective : This study examines how dietary supplement consumption correlates with fruit and vegetable consumption by combining scanner data and surveys of Korean household grocery shopping. Methods : Propensity score matching (PSM) is used to identify the relationship between dietary supplement consumption and fruit and vegetable consumption in a household. A logit regression using supplement consumption as the dependent variable is used. Then, the supplement takers (the treatment group) are matched with non-takers (the control group) based on the propensity scores estimated in the logit regression. The fruit and vegetable consumption levels of the groups are then compared. Results : We found that dietary supplement use is associated with higher fruit and vegetable consumption. This supports the health consciousness hypothesis based on attention bias, availability heuristics, the focusing effect, and the consumption episode effect. It rejects the health substitute hypothesis based on economic substitutes and mental accounting. Conclusions : Future research on the health benefits of dietary supplements should address the complementary consumption of fruits/vegetables and their health benefits to avoid misstating the health effects of supplements.

  12. 78 FR 40270 - Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New York; Approval of...

    Science.gov (United States)

    2013-07-03

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency [OCC Charter Number 702397] Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New York; Approval of Conversion...) approved the application of Sunnyside Federal Savings and Loan Association of Irvington, Irvington, New...

  13. Nutritional supplement products: Does the label information influence purchasing decisions for the physically active?

    Science.gov (United States)

    Gabriels, Gary; Lambert, Mike

    2013-10-02

    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. 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. 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. This study, (i) identifies short-comings in current labelling information practices, (ii) provides opportunities to improve label and non-label information and communication, and, (iii) presents the case for

  14. 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

    influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54 948 Danes, aged 50-64 years, who completed self-administrated questionnaires on diet, dietary supplements...... and 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...... to the intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher...

  15. 75 FR 12251 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2010-03-15

    ... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  16. 78 FR 17937 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2013-03-25

    ... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  17. 77 FR 63323 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2012-10-16

    ... Lenders OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  18. 20 CFR 416.360 - Cancellation of a request to withdraw.

    Science.gov (United States)

    2010-04-01

    ....360 Section 416.360 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Filing of Applications Withdrawal of Application § 416.360... received after we have approved the withdrawal, the cancellation request is filed no later than 60 days...

  19. 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

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

    Science.gov (United States)

    Ivanova, Natalia V; Kuzmina, Maria L; Braukmann, Thomas W A; Borisenko, Alex V; Zakharov, Evgeny V

    2016-01-01

    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 involve an

  1. 12 CFR 225.12 - Transactions not requiring Board approval.

    Science.gov (United States)

    2010-01-01

    ... Merger Act. The merger or consolidation of a subsidiary bank of a bank holding company with another bank... application under this subpart if it determines that the merger or consolidation would have a significant adverse impact on the financial condition of the bank holding company, or otherwise requires approval...

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

    International Nuclear Information System (INIS)

    Jonker, Leon; Cox, Diane; Marshall, Gill

    2011-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Jonker, Leon, E-mail: leon.jonker@cumbria.ac.uk [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom); Research and Development Department, North Cumbria University Hospitals NHS Trust, Carlisle CA2 7HY (United Kingdom); Cox, Diane; Marshall, Gill [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom)

    2011-08-15

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

  4. Mining Adverse Events of Dietary Supplements from Product Labels by Topic Modeling

    Science.gov (United States)

    Wang, Yefeng; Gunashekar, Divya R.; Adam, Terrence J.; Zhang, Rui

    2018-01-01

    The adverse events of the dietary supplements should be subject to scrutiny due to their growing clinical application and consumption among U.S. adults. An effective method for mining and grouping the adverse events of the dietary supplements is to evaluate product labeling for the rapidly increasing number of new products available in the market. In this study, the adverse events information was extracted from the product labels stored in the Dietary Supplement Label Database (DSLD) and analyzed by topic modeling techniques, specifically Latent Dirichlet Allocation (LDA). Among the 50 topics generated by LDA, eight topics were manually evaluated, with topic relatedness ranging from 58.8% to 100% on the product level, and 57.1% to 100% on the ingredient level. Five out of these eight topics were coherent groupings of the dietary supplements based on their adverse events. The results demonstrated that LDA is able to group supplements with similar adverse events based on the dietary supplement labels. Such information can be potentially used by consumers to more safely use dietary supplements. PMID:29295169

  5. Requirements, guidance and logic in planning environmental investigations: Approval versus implementation

    International Nuclear Information System (INIS)

    Brice, D.A.; Meredith, D.V.; Harris, M.Q.

    1993-01-01

    In today's litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency's mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan

  6. Redfield Energy Approval

    Science.gov (United States)

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

  7. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

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

  8. Approval of devices and facilities using ionizing radiations for medical purposes

    International Nuclear Information System (INIS)

    1977-01-01

    This Order made by the Ministers of Health and Social Security, Agriculture and Labour amends a previous Decree of 23 April 1969 in particular concerning the classification of medical or dental radiodiagnostic devices subject to approval. The technical conditions to be complied with for such devices and facilities have also been amended. Finally, it is provided that, as regards facilities with heavy equipment subject to licensing (Act of 31 December 1970), approval is subject to compliance with the licensing conditions and is requested together with the application for a licence. (NEA) [fr

  9. 22 CFR 3a.4 - Procedure for requesting approval.

    Science.gov (United States)

    2010-04-01

    ... is also required by law for the applicant's acceptance of civil employment from a foreign government... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure for requesting approval. 3a.4 Section 3a.4 Foreign Relations DEPARTMENT OF STATE GENERAL ACCEPTANCE OF EMPLOYMENT FROM FOREIGN GOVERNMENTS...

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

    Science.gov (United States)

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

    2017-01-01

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

  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 60763 - Clarification on Fireworks Policy Regarding Approvals or Certifications for Firework Series

    Science.gov (United States)

    2013-10-02

    ... 173 [Docket No. PHMSA-2013-0205; Notice No. 13-14] Clarification on Fireworks Policy Regarding Approvals or Certifications for Firework Series AGENCY: Pipeline and Hazardous Materials Safety... applications for firework device series. PHMSA has required separate applications for each individual firework...

  13. 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.

  14. Glutamine supplemented parenteral nutrition to prevent ventilator-associated pneumonia in the intensive care unit.

    Science.gov (United States)

    Aydoğmuş, Meltem Türkay; Tomak, Yakup; Tekin, Murat; Katı, Ismail; Hüseyinoğlu, Urfettin

    2012-12-01

    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). 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. No statistically significant difference was found among groups in terms of development of VAP (p=0.622). 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.

  15. 30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

    Science.gov (United States)

    2010-07-01

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

  16. 7 CFR 762.130 - Loan approval and issuing the guarantee.

    Science.gov (United States)

    2010-01-01

    ... complete until all information required to make an approval decision, including the information for an... lender's loan or line of credit conditions and requirements since submission of the application (except... compensation, and personal life insurance (when required) are in effect; (iii) Truth in lending requirements...

  17. 40 CFR 57.405 - Formulation, approval, and implementation of requirements.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY NONFERROUS SMELTER ORDERS Supplementary Control System...) Each NSO application shall include a complete description of any supplementary control system in... operational manual). (b) SCS content of the order. (1) Each NSO shall include an approved version of the plan...

  18. 30 CFR 57.22304 - Approved equipment (II-A mines).

    Science.gov (United States)

    2010-07-01

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

  19. Safety evaluation report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323)

    International Nuclear Information System (INIS)

    1984-06-01

    Supplement 23 to the Safety Evaluation Report for Pacific Gas and Electric Company's application for licenses to operate Diablo Canyon Nuclear Power Plants, Units 1 and 2 (Docket Nos. 50-275 and 50-323) has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses the applicant's requests for approval of 22 deviations from the requirements of Section III.G of Appendix R of Title 10 of the Code of Federal Regulations Part 50

  20. Waste feed delivery environmental permits and approvals plan

    International Nuclear Information System (INIS)

    Papp, I.G.

    1998-01-01

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

  1. 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

  2. 78 FR 77203 - Agency Requests for Renewal of a Previously Approved Information Collection(s): War Risk...

    Science.gov (United States)

    2013-12-20

    ... Previously Approved Information Collection(s): War Risk Insurance, Applications and Related Information... determine the eligibility of the applicant and the vessel(s) for participation in the war risk insurance... Control Number: 2133-0011. Title: War Risk Insurance, Applications and Related Information. Form Numbers...

  3. Drugs Approved for Breast Cancer

    Science.gov (United States)

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

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

    International Nuclear Information System (INIS)

    2002-01-01

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

  5. Calcium supplements

    Science.gov (United States)

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

  6. Safety regulation for the design approval of special form radioactive sources

    International Nuclear Information System (INIS)

    Cho, Woon-Kap

    2009-01-01

    Several kinds of special form radioactive sources for industrial, medical applications are being produced in Korea. Special form radioactive sources should meet strict safety requirements specified in the domestic safety regulations and the design of the sources should be certified by the regulatory authority, the Ministry of Education, Science and Technology (MEST). Several safety tests such as impact, percussion, heating, and leak tests are performed on the sources according to the domestic regulations and the international safety standards such as ANSI N542-1977 and ISO 2919-1999(E). As a regulatory expert body, Korea Institute of Nuclear Safety (KINS) assesses various types of application documents, such as safety analysis report, quality assurance program, and other documents evidencing fulfillment of requirements for design approval of the special form radioactive sources, submitted by a legal person who intends to produce special form radioactive sources and then reports the assessment result to MEST. A design approval certificate is issued to the applicant by MEST on the basis of a technical evaluation report presented by KINS.

  7. 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 ...

  8. 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...

  9. 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.

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

    International Nuclear Information System (INIS)

    O'Donovan, N.; Hone, C.

    1988-11-01

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

  11. 13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT... § 302.18 of this chapter: (a) Strategy Grants shall comply with the applicable provisions of part 303 of...

  12. Contribution of nitrogen derived from mineral supplementation for soybean seedlings

    Directory of Open Access Journals (Sweden)

    Gerusa Massuquini Conceição

    Full Text Available ABSTRACT Seeds can absorb N from mineral supplementation, thus stimulating seedling development in soybeans (Glycine max (L. Merrill. This study aimed to evaluate the contribution to soybean seedlings of N derived from mineral supplementation in seeds with different nutritional contents. Seeds of the cultivar BMX Potência RR received mineral supplementation enriched with 2.5% excess 15N. The treatments were performed in seeds in two lots, one with high and one with low nutritional content. At 2, 6 and 10 days after sowing on paper towels, the seedlings were collected and separated into cotyledons, roots and shoots. Dry matter production, root length and root volume were assessed. Total N and 15N values were analyzed in the seedling organ tissues. The seeds from the lot with lower nutritional content absorbed more N from the mineral supplement, which was accumulated in the cotyledons and redistributed to the root systems and cotyledons. At 10 days after sowing, most of the N in the organs of soybean seedlings was derived from the seed reserves, regardless of nutritional content. Thus, application of N through mineral supplementation is of low importance for the development and nutrition of seedlings.

  13. 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

  14. Evaluation of congruence among dietary supplement use and motivation for supplementation in young, Canadian athletes.

    Science.gov (United States)

    Parnell, Jill A; Wiens, Kristin; Erdman, Kelly Anne

    2015-01-01

    Dietary supplement use is endemic in young athletes; however, it is unclear if their choices are congruent with their motivation for supplementation and the established benefits of the dietary supplements. The aim of this study was to evaluate the relationships between dietary supplement use and self-reported rationale in young athletes. Canadian athletes (n = 567; 11-25 years; 76% club or provincial level, 24% national or higher) completed a questionnaire designed to assess supplementation patterns and motivation for supplementation. Chi square tests examined associations between dietary supplements and self-reported rationale for use. Vitamin and mineral supplements, including vitamin-enriched water, were associated with several health- and performance- related reasons (p performance reasons, as were performance foods (protein powder, sport bars, sport gels, etc.). Plant extracts and fatty acids were primarily associated with health reasons, particularly immune support (p performance rationales and supplementation for common ergogenic aids, however, less so for vitamin and mineral supplements, vitamin-enriched water, and plant extracts. Incongruences were found between fatty acids, protein supplements, vitamin and mineral supplements, vitamin-enriched water, and plant extracts and health motivators for supplementation. Educational interventions are essential to ensure young athletes are using dietary supplements safely and effectively.

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

    Science.gov (United States)

    2010-04-01

    ... change in the drug substance, drug product, production process, quality controls, equipment, or..., purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the... profile of the drug product. (vii) Changes solely affecting a natural product, a recombinant DNA-derived...

  16. 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 in...

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

    International Nuclear Information System (INIS)

    Tam, P.S.

    1995-06-01

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

  18. Randomized controlled trial of docosahexaenoic acid supplementation in midwestern U.S. human milk donors.

    Science.gov (United States)

    Valentine, Christina J; Morrow, Georgia; Pennell, Michael; Morrow, Ardythe L; Hodge, Amanda; Haban-Bartz, Annette; Collins, Kristin; Rogers, Lynette K

    2013-02-01

    Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid important for neonatal neurodevelopment and immune homeostasis. Preterm infants fed donor milk from a Midwestern source receive only 20% of the intrauterine accretion of DHA. We tested the hypothesis that DHA supplementation of donor mothers would provide preterm infants with DHA intake equivalent to fetal accretion. After Institutional Review Board approval and informed consent, human milk donors to the Mother's Milk Bank of Ohio were randomized to receive 1 g of DHA (Martek(®) [now DSM Nutritional Lipids, Columbia, MD]) or placebo soy oil. Dietary intake data were collected and analyzed by a registered dietitian. Fatty acids were measured by gas chromatography/flame ionization detection. Statistical analysis used linear mixed models. Twenty-one mothers were randomly assigned to either the DHA group (n=10) or the placebo group (n=11). Donor age was a median of 31 years in both groups with a mean lactational stage of 19 weeks. Dietary intake of DHA at baseline in both groups was a median of 23 mg/day (range, 0-194 mg), significantly (p<0.0001) less than the minimum recommended intake of 200 mg/day. The DHA content of milk increased in the DHA-supplemented group (p<0.05). The women enrolled in this study had low dietary DHA intake. Supplementation with preformed DHA at 1 g/day resulted in increased DHA concentrations in the donor milk with no adverse outcomes. Infants fed donor milk from supplemented women receive dietary DHA levels that closely mimic normal intrauterine accretion during the third trimester.

  19. United States Nuclear Regulatory Commission Staff Practice and Procedure Digest. Supplement 3 to Digest No. 1

    International Nuclear Information System (INIS)

    1978-04-01

    This is the third of a series of Supplements to the NRC Practice and Procedure Digest. This Supplement updates the Digest by including pertinent Commission, Appeal Board, and Licensing Board rulings for the period October 1, 1977 to December 31, 1977. The Supplement also adds several new topics. The Supplement is structured in the same manner as the Digest. For the convenience of users, the text of the Supplement is preceded by an index which lists the Digest topic headings which are supplemented. In using the main Digest, this index to Supplement 3 as well as those to Supplements 1 and 2 should be consulted to assure that the Digest discussion has not been superseded or updated by information in the Supplements. Supplement 3 is intended for use as a ''pocket part''. It should be inserted after Supplements 1 and 2, following the main Digest. Notice is hereby given that all disclaimers with respect to content, accuracy and completeness of information, express or implied warranties, and use of or reliance upon information presented, set forth in regard to the Digest itself, are equally applicable to this Supplement

  20. Determination of selenium mineral in health supplement products: Applications of nuclear methods in pharmaceuticals fields

    International Nuclear Information System (INIS)

    Titiek Martati; Mellawati

    2010-01-01

    Recently, many health supplement products that are useful as an antioxidant available in the market, and one of them is selenium (Se) tablet. Issue on the falsification of drug due to control to health supplement product becomes very important. There is also some problem in Se analysis, especially in chemical reagent preparation. In this research, determination of Se in health supplement tablet using neutron activation analysis (NAA) was carried out. The advantages of methods are due to nondestructive materials, simple sample preparation, and no chemical reagent for analysis. The sample was irradiated using thermal neutron with 10"1"3 neutron cm"-"2 seconds"-"1 fluxes during 15 minutes, and based on n, γ reaction "7"5Se isotope would be formed that could identified using gamma spectrometer on 136, 264, and 279 keV energies. The result showed that NAA method can be used for Se analysis contained in health supplement tablets with accuracy ranged between 101.81 and 102.29 % and precision 99.02-99.37 %. The recovery test of Se mineral concentration to the labeled attached showed 105.79-116.66 %, and this value still in the range described in the United States Pharmacopoeias 28 (90-125 %). (author)

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

    International Nuclear Information System (INIS)

    Nitsche, F.; Roedel, R.

    2004-01-01

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

  2. Botanical supplements: detecting the transition from ingredients to supplements

    Science.gov (United States)

    Methods were developed using flow injection mass spectrometry (FIMS) and chemometrics for the comparison of spectral similarities and differences of 3 botanical ingredients and their supplements: Echinacea purpurea aerial samples and solid and liquid supplements, E. purpurea root samples and solid s...

  3. Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

    Directory of Open Access Journals (Sweden)

    von Dadelszen Peter

    2010-07-01

    Full Text Available Abstract Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs. In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN, to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9 had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days. Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

  4. Safety Evaluation Report related to the operation of Millstone Nuclear Power Station, Unit No. 3 (Docket No. 50-423). Supplement No. 4

    International Nuclear Information System (INIS)

    1985-11-01

    This report supplements the Safety Evaluation Report (NUREG-1031) issued in July 1984, Supplement 1 issued in March 1985, Supplement 2 issued in September 1985, and Supplement 3 issued in November 1985, by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by Northeast Nuclear Energy Company (applicant and agent for the owners) for a license to operate Millstone Nuclear Power Station, Unit No. 3 (Docket 50-423). The facility is located in the Town of Waterford, New London County, Connecticut, on the north shore of Long Island Sound. This supplement provides more recent information supporting the license for initial criticality and power ascension to 5% power operation for Millstone 3. 37 refs., 10 tabs

  5. Oral calorie supplements for cystic fibrosis.

    Science.gov (United States)

    Smyth, Rosalind L; Rayner, Oli

    2017-05-04

    concerns surrounding allocation concealment. There were no significant differences between people receiving supplements or dietary advice alone for change in weight, height, body mass index, z score or other indices of nutrition or growth. Changes in weight (kg) at three, six and 12 months respectively were: mean difference (MD) 0.32 (95% confidence interval (CI) -0.09 to 0.72); MD 0.47 (95% CI -0.07 to 1.02 ); and MD 0.16 (-0.68 to 1.00). Total calorie intake was greater in people taking supplements at 12 months, MD 265.70 (95% CI 42.94 to 488.46). There were no significant differences between the groups for anthropometric measures of body composition, lung function, gastro-intestinal adverse effects or activity levels. Moderate quality evidence exists for the outcomes of changes in weight and height and low quality evidence exists for the outcomes of change in total calories, total fat and total protein intake as results are applicable only to children between the ages of 2 and 15 years and many post-treatment diet diaries were not returned. Evidence for the rate of adverse events in the treatment groups was extremely limited and judged to be of very low quality AUTHORS' CONCLUSIONS: Oral calorie supplements do not confer any additional benefit in the nutritional management of moderately malnourished children with cystic fibrosis over and above the use of dietary advice and monitoring alone. While nutritional supplements may be used, they should not be regarded as essential. Further randomised controlled trials are needed to establish the role of short-term oral protein energy supplements in people with cystic fibrosis and acute weight loss and also for the long-term nutritional management of adults with cystic fibrosis or advanced lung disease, or both.

  6. Utility of supplemental screening with breast ultrasound in asymptomatic women with dense breast tissue who are not at high risk for breast cancer

    OpenAIRE

    Klevos, Geetika A; Collado-Mesa, Fernando; Net, Jose M; Yepes, Monica M

    2017-01-01

    Objective: To assess the results of an initial round of supplemental screening with hand-held bilateral breast ultrasound following a negative screening mammogram in asymptomatic women with dense breast tissue who are not at high risk for breast cancer. Materials and Methods: A retrospective, Health Insurance Portability and Accountability Act compliant, Institutional Research Board approved study was performed at a single academic tertiary breast center. Informed consent was waived. A system...

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

    International Nuclear Information System (INIS)

    1994-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

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

    International Nuclear Information System (INIS)

    1996-02-01

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

  9. Vitamin and Mineral Supplement Fact Sheets

    Science.gov (United States)

    ... website Submit Search NIH Office of Dietary Supplements Vitamin and Mineral Supplement Fact Sheets Search the list ... Supplements: Background Information Botanical Dietary Supplements: Background Information Vitamin and Mineral Fact Sheets Botanical Supplement Fact Sheets ...

  10. 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

  11. 76 FR 37110 - ORNI 39 LLC;Supplemental Notice That Initial Market-Based Rate Filing Includes Request for...

    Science.gov (United States)

    2011-06-24

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER11-3808-000] ORNI 39 LLC;Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization This is a supplemental notice in the above-referenced proceeding of ORNI 39 LLC's application for...

  12. 77 FR 42301 - W Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for...

    Science.gov (United States)

    2012-07-18

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER12-2219-000] W Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization This is a supplemental notice in the above-referenced proceeding, of W Power, LLC's application...

  13. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

    Science.gov (United States)

    Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

    2017-12-05

    To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

  14. 78 FR 28275 - Office of Commercial Space Transportation; Safety Approval Performance Criteria

    Science.gov (United States)

    2013-05-14

    ... provide as a service, scenario based physiology training, which includes hypobaric chamber training. BST may offer its scenario based physiology altitude training as a service to a prospective launch and...: Notification of criteria used to evaluate the Black Sky Training, Inc. (BST) safety approval application...

  15. 78 FR 57208 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-09-17

    ... notice also includes information on four applications, one approved in July 2012 and the other three... carousel 9 and oversized bag belt TU3. Terminal redevelopment program--design and associated technical.... Rehabilitate terminal access road. Administration fees. DECISION DATE: October 18, 2012. FOR FURTHER...

  16. Safety Evaluation Report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 7

    International Nuclear Information System (INIS)

    1986-09-01

    Supplement No. 7 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since Supplement No. 6 was issued

  17. Safety evaluation report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 5

    International Nuclear Information System (INIS)

    1986-01-01

    Supplement No. 5 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc. as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since supplement No. 4 was issued

  18. Safety Evaluation Report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 4

    International Nuclear Information System (INIS)

    1985-02-01

    Supplement No. 4 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since Supplement No. 3 was issued

  19. Safety Evaluation Report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 6

    International Nuclear Information System (INIS)

    1986-07-01

    Supplement No. 6 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since Supplement No. 5 was issued

  20. Directory of certificates of compliance for radioactive materials packages; Summary Report of NRC Approved Packages

    International Nuclear Information System (INIS)

    1980-12-01

    This directory contains a Summary Report of NRC approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. To assist in identifying packaging, and index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material using these packagings must be in accordance with the provisions of 49 CFR 173.393a and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure them--that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  1. Taking iron supplements

    Science.gov (United States)

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

  2. Prevention and treatment of erectile dysfunction using lifestyle changes and dietary supplements: what works and what is worthless, part II.

    Science.gov (United States)

    Moyad, Mark A; Barada, James H; Lue, Tom F; Mulhall, John P; Goldstein, Irwin; Fawzy, Ahmed

    2004-05-01

    ability of certain agents to have a synergistic effect with prescription agents for ED, thereby improving response rates in men that have failed approved ED therapy initially, especially with oral agents. Randomized clinical trials are the best method of determining which dietary supplements will become a part of conventional medicine. Therefore, more randomized trials for dietary supplements are needed so that they may have the opportunity to become a part of the mainstream milieu, which means that more funding needs to be made available for ED research. The coming years of research should bring enormous excitement and objectivity to this area of medicine.

  3. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  4. 40 CFR 52.2122 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  5. Commercially available media for flushing extracorporeal bioartificial liver systems prior to connection to the patient's circulation: an in vitro comparative study in two and three dimensional porcine hepatocyte cultures

    NARCIS (Netherlands)

    Flendrig, L. M.; Sommeijer, D.; Ladiges, N. C.; te Velde, A. A.; Maas, M. A.; Jörning, G. G.; Daalhuisen, J.; Chamuleau, R. A.

    1998-01-01

    Extracorporeal bioartificial liver (BAL) systems based on hepatocytes need to be flushed before clinical application, as hepatocyte culture media are not approved for medical use. Commercially available 0.9% NaCl solution and hemofiltration solution (both supplemented with 10% human albumin) were

  6. 77 FR 9865 - Clarification on the Division 1.1 Fireworks Approvals Policy

    Science.gov (United States)

    2012-02-21

    ... 173 [Docket No. PHMSA-2011-0157; Notice No. 11-6] Clarification on the Division 1.1 Fireworks.... 11-6 clarifying PHMSA's policy regarding the fireworks approvals program. Furthermore, in this... applications for Division 1.1 fireworks that have been examined and assigned a recommended shipping description...

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

    Science.gov (United States)

    2010-08-10

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

  8. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2013-09-05

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

  9. 77 FR 74129 - Approval and Promulgation of Implementation Plans; Texas; Public Participation for Air Quality...

    Science.gov (United States)

    2012-12-13

    ...'s policy is that all comments received will be included in the public docket without change and may... Plant-Wide Applicability Limit (PAL) Permit Applications 1. Analysis of Submitted Rules 2. How do the... 116. Chairman Bryan W. Shaw, Ph.D., submitted these amendments to EPA for approval as revisions to the...

  10. 40 CFR 52.1772 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  11. Safety Evaluation Report related to the operation of Millstone Nuclear Power Station, Unit No. 3 (Docket No. 50-423). Supplement No. 3

    International Nuclear Information System (INIS)

    1985-11-01

    This report supplements the Safety Evaluation Report (NUREG-1031) issued in July 1984, Supplement 1 issued in March 1985, and Supplement 2 issued in September 1985 by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by Northeast Nuclear Energy Company (applicant and agent for the owners) for a license to operate Millstone Nuclear Power Station, Unit No. 3 (Docket 50-423). The facility is located in the Town of Waterford, New London County, Connecticut, on the north shore of Long Island Sound. This supplement provides more recent information regarding resolution or updating of some of the open and confirmatory items and license conditions identified in the Safety Evaluation Report

  12. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2018-01-15

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

  13. Issues in Nutrition: Dietary Supplements.

    Science.gov (United States)

    Thompson, Margaret E; Noel, Mary Barth

    2017-01-01

    The majority of American adults report use of one or more dietary supplements every day or occasionally. The Dietary Supplement Health and Education Act of 1994 defines dietary supplements and regulates their manufacture and distribution. One of the most commonly used supplements is vitamin D. Measurement of serum levels of vitamin D must be undertaken with the caveats that different laboratories define normal levels differently, and that there is rarely a clinical correlation with the actual level. Patients should understand that supplements should not be used to excess, as there are toxicities and other adverse effects associated with most of them. There currently is considerable research being performed on probiotics and how the gut microbiome affects health and disease states. Protein supplements may be useful in reducing mortality rates in elderly patients but they do not appear to increase quality of life. If used, protein supplements should contain essential amino acids. Casein and whey supplements, derived from dairy sources, help transport essential amino acids to tissues. Although there have been many studies investigating the role of vitamin supplements in disease prevention, there have been few conclusive positive results. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

  14. Lead in calcium supplements (abstract)

    International Nuclear Information System (INIS)

    Rehman, S.; Khalid, N.

    2011-01-01

    Lead present in calcium supplements is of grave concern as some lead levels have been measured up to the extent of regulatory limit set by the United States. Calcium supplements inevitably get contaminated with lead as both are naturally occurring elements. Therefore, it is imperative to indicate its level in these supplements in order to create awareness among consumers. In this study, a sophisticated analytical technique, atomic absorption spectrometry was used to analyze Pb contents in 27 commonly consumed Ca supplements manufactured by different national and multinational companies. The daily intake of lead through these supplements was calculated. Only 10% of the calcium supplements analyzed met the criteria of acceptable Pb levels (1.5 mu g/daily dose) in supplements/consumer products set by the United States. It was also found that Pb intake was highest in chelated calcium supplements 28.5 mu g/daily dose, whereas lowest 0.47 mu g/daily dose through calcium supplements with vitamin D formulation. In order to validate our results from the study conducted, IAEA-certified reference material (animal bone, H-5) was analyzed for its Pb levels. The levels of Pb determined were quite in good agreement with the certified values. (author)

  15. Physician-Patient Communication about Dietary Supplements

    Science.gov (United States)

    Tarn, Derjung M.; Paterniti, Debora A.; Good, Jeffrey S.; Coulter, Ian D.; Galliher, James M.; Kravitz, Richard L.; Karlamangla, Arun; Wenger, Neil S.

    2013-01-01

    Objective Describe the content and frequency of provider-patient dietary supplement discussions during primary care office visits. Methods Inductive content analysis of 1477 transcribed audio-recorded office visits to 102 primary care providers was combined with patient and provider surveys. Encounters were collected in Los Angeles, California (2009–2010), geographically-diverse practice settings across the United States (2004–2005), and Sacramento, CA (1998–1999). Results Providers discussed 738 dietary supplements during encounters with 357 patients (24.2% of all encounters in the data). They mentioned: 1) reason for taking the supplement for 46.5% of dietary supplements; 2) how to take the supplement for 28.2%; 3) potential risks for 17.3%; 4) supplement effectiveness for 16.7%; and 5) supplement cost or affordability for 4.2%. Of these five topics, a mean of 1.13 (SD=1.2) topics were discussed for each supplement. More topics were reviewed for non-vitamin non-mineral supplements (mean 1.47 (SD=1.2)) than for vitamin/mineral supplements (mean 0.99 (SD=1.1); psupplements are occurring, it is clear that more discussion might be needed to inform patient decisions about supplement use. Practice Implication Physicians could more frequently address topics that may influence patient dietary supplement use, such as the risks, effectiveness, and costs of supplements. PMID:23466249

  16. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

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

  17. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

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

  18. 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.

  19. Impact of supplemental instruction leader on the success of supplemental instruction model

    Science.gov (United States)

    Mahabaduge, Hasitha; Haslam, Jeanne

    Supplemental instruction utilizes peer-assisted study sessions to provide review sessions on course material and an opportunity to discuss and work out problems. The impact of supplemental instruction on student performance is well researched and used in a large number of universities around the world due to its proven success. However, the impact of the student leader who plays a significant role in this model is rarely discussed in the literature. We present a case study on the impact of student leader on the success of supplemental instruction model. This case study was done for an Introductory Physics course correlating student performance and the supplemental instruction sessions they attended. Further analysis revealed that the academic performance and work ethics of the student leader has a significant impact on the success of the supplemental instruction model. Important factors to consider when selecting a student leader, the challenges and possible remedies will also be discussed.

  20. Safety Evaluation Report related to the operation of Waterford Steam Electric Station, Unit No. 3 (Docket No. 50-382). Supplement No. 8

    International Nuclear Information System (INIS)

    1984-12-01

    Supplement 8 to the Safety Evaluation Report for the application filed by Louisiana Power and Light Company for a license to operate the Waterford Steam Electric Station, Unit 3 (Docket No. 50-382), located in St. Charles Parish, Louisiana, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation Report by providing the staff's evaluation of information submitted by the applicant since the Safety Evaluation Report and its seven previous supplements were issued

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

    Energy Technology Data Exchange (ETDEWEB)

    Tam, P.S.

    1994-12-01

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

  2. 42 CFR 8.21 - Applicability.

    Science.gov (United States)

    2010-10-01

    ... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CERTIFICATION OF OPIOID... Adverse Action Regarding Withdrawal of Approval of an Accreditation Body § 8.21 Applicability. The... body of an adverse action taken regarding withdrawal of approval of the accreditation body under the...

  3. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

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

  4. Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

    Science.gov (United States)

    Vujić, Mario; Pollak, Lea

    2015-12-01

    The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

  5. 28 CFR 58.26 - Procedures for inclusion on the approved provider list.

    Science.gov (United States)

    2010-07-01

    ... provider list. (a) As used in this section the term “provider” means a provider of a personal financial... of a Personal Financial Management Course” (application), including all appendices, and submit it at... directors; and a merger or consolidation with another entity; (2) The provider shall request approval by...

  6. 75 FR 30861 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2010-06-02

    ... industrial homework as necessary to prevent circumvention or evasion of the minimum wage requirements of the... at not less than 85 percent of the applicable minimum wage or less than $1.60, whichever is higher... DEPARTMENT OF LABOR Wage and Hour Division Proposed Extension of the Approval of Information...

  7. Ada developers' supplement to the recommended approach

    Science.gov (United States)

    Kester, Rush; Landis, Linda

    1993-01-01

    This document is a collection of guidelines for programmers and managers who are responsible for the development of flight dynamics applications in Ada. It is intended to be used in conjunction with the Recommended Approach to Software Development (SEL-81-305), which describes the software development life cycle, its products, reviews, methods, tools, and measures. The Ada Developers' Supplement provides additional detail on such topics as reuse, object-oriented analysis, and object-oriented design.

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

    International Nuclear Information System (INIS)

    Kontić, Branko; Kontić, Davor

    2012-01-01

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

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

    International Nuclear Information System (INIS)

    1985-03-01

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

  10. 76 FR 65109 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin

    Science.gov (United States)

    2011-10-20

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin AGENCY...) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The...

  11. Indico CONFERENCE: Candidate participant's registration/application

    CERN Multimedia

    CERN. Geneva; Ferreira, Pedro

    2017-01-01

    In this tutorial you are going to learn how to apply as a candidate participant (if the event requires approval from the event manager) or to register (if participation to the event doesn't require approval from an event manager) to the conference using the registration form for the event. You are also going to learn how to approve a candidate participant's application as an event manager.

  12. 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. 4

    International Nuclear Information System (INIS)

    1985-03-01

    This report supplements the Safety Evaluation Report, NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), and Supplement No. 3 (January 1985) 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 open and confirmatory items and license conditions identified in the Safety Evaluation Report

  13. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

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

  14. 78 FR 4124 - Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR

    Science.gov (United States)

    2013-01-18

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-107-2012] Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR On October 9, 2012, the Executive Secretary of the Foreign-Trade... the proposed operator, Coamo Property & Investments, LLC, in Coamo, Puerto Rico. The application was...

  15. Dietary supplements for football.

    Science.gov (United States)

    Hespel, P; Maughan, R J; Greenhaff, P L

    2006-07-01

    Physical training and competition in football markedly increase the need for macro- and micronutrient intake. This requirement can generally be met by dietary management without the need for dietary supplements. In fact, the efficacy of most supplements available on the market is unproven. In addition, players must be cautious of inadequate product labelling and supplement impurities that may cause a positive drug test. Nonetheless, a number of dietary supplements may beneficially affect football performance. A high endurance capacity is a prerequisite for optimal match performance, particularly if extra time is played. In this context, the potential of low-dose caffeine ingestion (2 - 5 mg . kg body mass(-1)) to enhance endurance performance is well established. However, in the case of football, care must be taken not to overdose because visual information processing might be impaired. Scoring and preventing goals as a rule requires production of high power output. Dietary creatine supplementation (loading dose: 15 - 20 g . day(-1), 4 - 5 days; maintenance dose: 2 - 5 g g . day(-1)) has been found to increase muscle power output, especially during intermittent sprint exercises. Furthermore, creatine intake can augment muscle adaptations to resistance training. Team success and performance also depend on player availability, and thus injury prevention and health maintenance. Glucosamine or chondroitin may be useful in the treatment of joint pain and osteoarthritis, but there is no evidence to support the view that the administration of these supplements will be preventative. Ephedra-containing weight-loss cocktails should certainly be avoided due to reported adverse health effects and positive doping outcomes. Finally, the efficacy of antioxidant or vitamin C intake in excess of the normal recommended dietary dose is equivocal. Responses to dietary supplements can vary substantially between individuals, and therefore the ingestion of any supplement must be assessed

  16. 14 CFR 414.11 - Application.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Application. 414.11 Section 414.11 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...

  17. Herbs, Supplements and Alternative Medicines

    Science.gov (United States)

    ... A A Listen En Español Herbs, Supplements and Alternative Medicines It is best to get vitamins and minerals ... this section Medication Other Treatments Herbs, Supplements, and Alternative Medicines Types of Dietary Supplements Side Effects and Drug ...

  18. 30 CFR 14.7 - Approval marking and distribution records.

    Science.gov (United States)

    2010-07-01

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

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

    Science.gov (United States)

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

    2016-06-01

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

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

    International Nuclear Information System (INIS)

    1993-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  1. Why US children use dietary supplements

    Science.gov (United States)

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

    2013-01-01

    Background: Dietary supplements are used by one-third of children. We examined motivations for supplement use in children, the types of products used by motivations, and the role of physicians and health care practitioners in guiding choices about supplements. Methods: We examined motivations for dietary supplement use reported for children (from birth to 19 y of age; n = 8,245) using the National Health and Nutrition Examination Survey 2007–2010. Results: Dietary supplements were used by 31% of children; many different reasons were given as follows: to “improve overall health” (41%), to “maintain health” (37%), for “supplementing the diet” (23%), to “prevent health problems” (20%), and to “boost immunity” (14%). Most children (~90%) who use dietary supplements use a multivitamin–mineral or multivitamin product. Supplement users tend to be non-Hispanic white, have higher family incomes, report more physical activity, and have health insurance. Only a small group of supplements used by children (15%) were based on the recommendation of a physician or other health care provider. Conclusion: Most supplements used by children are not under the recommendation of a health care provider. The most common reasons for use of supplements in children are for health promotion, yet little scientific data support this notion in nutrient-replete children. PMID:24002333

  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. 19

    International Nuclear Information System (INIS)

    1995-11-01

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

  3. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

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

  4. 77 FR 59090 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and...

    Science.gov (United States)

    2012-09-26

    ... Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and Sealants Rule AGENCY... manufacture, sale, use, or application of adhesives, sealants, primers, and solvents. The SIP revision also... proposed rulemaking (NPR) which proposed approval of Pennsylvania's adhesives and sealants regulations in...

  5. 78 FR 60766 - Clarification on Fireworks Policy Regarding Approvals or Certifications for Specialty Fireworks...

    Science.gov (United States)

    2013-10-02

    ... 173 [Docket No. PHMSA-2013-0206; Notice No. 13-15] Clarification on Fireworks Policy Regarding Approvals or Certifications for Specialty Fireworks Devices AGENCY: Pipeline and Hazardous Materials Safety... applications for specialty fireworks devices. Specialty fireworks devices are fireworks devices in various...

  6. Safety evaluation report related to the operation of River Bend Station (Docket No. 50-458). Supplement No. 2

    International Nuclear Information System (INIS)

    1985-08-01

    Supplement No. 2 to the Safety Evaluation Report on the application filed by Gulf States Utilities Company as applicant and for itself and Cajun Electric Power Cooperative, as owners, for a license to operate River Bend Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in West Feliciana Parish, near St. Francisville, Louisiana. This supplement reports the status of certain items that had not been resolved at the time the Safety Evaluation Report was published

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. Annual Statistical Supplement, 2016

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2016 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  12. 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...

  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, 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...

  15. 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...

  16. Annual Statistical Supplement, 2017

    Data.gov (United States)

    Social Security Administration — The Annual Statistical Supplement, 2017 includes the most comprehensive data available on the Social Security and Supplemental Security Income programs. More than...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the Offspring A Randomized Clinical Trial

    DEFF Research Database (Denmark)

    Chawes, Bo L.; Bonnelykke, Klaus; Stokholm, Jakob

    2016-01-01

    with a goal of 708 participants, but due to delayed ethical approval, only 623 women were recruited at 24 weeks of pregnancy. Follow-up of the children (N = 581) was completed when the youngest child reached age 3 years in March 2014. INTERVENTIONS Vitamin D3 (2400 IU/d; n = 315) or matching placebo tablets......IMPORTANCE: Observational studies have suggested that increased dietary vitamin D intake during pregnancy may protect against wheezing in the offspring, but the preventive effect of vitamin D supplementation to pregnant women is unknown. OBJECTIVE: To determine whether supplementation of vitamin D3...... during the third trimester of pregnancy reduces the risk of persistent wheeze in the offspring. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, single-center, randomized clinical trial conducted within the Copenhagen Prospective Studies on Asthma in Childhood 2010 cohort. Enrollment began March 2009...

  4. 77 FR 8865 - Recent Postings of Broadly Applicable Alternative Test Methods

    Science.gov (United States)

    2012-02-15

    ... Applicable Alternative Test Methods AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: This notice announces the broadly applicable alternative test method approval decisions... INFORMATION CONTACT: An electronic copy of each alternative test method approval document is available on the...

  5. 75 FR 20917 - New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine

    Science.gov (United States)

    2010-04-22

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine... (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The...

  6. Safety Evaluation Report related to the operation of Limerick Generating Station, Units 1 and 2 (Docket Nos. 50-352 and 50-353). Supplement 3

    International Nuclear Information System (INIS)

    1984-10-01

    In August 1983 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0991) regarding the application of the Philadelphia Electric Company (the applicant) for licenses to operate the Limerick Generating Station, Units 1 and 2. Supplement 1 was issued in December 1983 and addressed several outstanding issues. Supplement 1 also contains the comments made by the Advisory Committee on Reactor Safeguards in its report dated October 18, 1983. Supplement 2 was issued in October 1984 and addressed fourteen outstanding and fifty-three confirmatory issues and closed them put. This Supplement 3 addresses the remaining issues that require resolution before issuance of the operating license for Unit 1 and closes them out

  7. Feeding Supplementation And Radioimmunoassay (RIA) Technique For The Improvement Of artificial Insemination (AI) Efficiency

    International Nuclear Information System (INIS)

    Tjiptosumirat, Totti; Supandi, Dadang; Firsoni

    2002-01-01

    Recent research activities have showed that RIA techniques may be use as a tool in the improvement of dairy cattle AI in . Cisurupan district, Garut. Although already indicate in the previous research, with a small number of dairy cattle tested, a more in depth study on the utilization of RIA for the improvement of AI efficiency is still required. It is indicated from the previous experiment results that administration of feeding supplementation might improved the efficiency of reproductive performance of dairy cattle. The current Study is a continuation from the previous study with a larger number of dairy cattle and wider area covered. The experiment is aimed to monitor the impact of feeding supplementation on the reproductive performance of dairy cattle using Artificial Insemination Database Application (AIDA) and RIA technique. Result from this study indicated that feeding supplementation improved conception rate between pre-supplemented and post-supplemented dairy cattle; 25% vs 40%, respectively, therefore improve ratio of Service per Conception of 4.0 vs 2.3, respectively for pre-supplemented and post-supplemented dairy cattle. Result of this experiment also showed that RIA might be use as an effective tool in monitoring the early failure of AI compared to if just relying on the conventional method, the rectal palpation. However, due to an increase in milk production as a result of feeding supplementation, tanners tend to lengthen the lactation period from 10.20 ± 0.5 months to 11.8 ± 0.6 months, respectively in dairy cattle pre-supplemented and post-supplemented. It can be conclude from this study that supplementation feeding improve reproductive performance. However, even AIDA and RIA may be of effective tool in monitoring the reproductive performance of dairy cattle, as an holistic approach for an improvement dairy farm management is still required due to other factors play important role for AI efficiency

  8. Supplement consumption in body builder athletes

    Science.gov (United States)

    Karimian, Jahangir; Esfahani, Parivash Shekarchizadeh

    2011-01-01

    BACKGROUND: Widespread use of supplements is observed among world athletes in different fields. The aim of this study was to estimate the prevalence and determinants of using supplements among body builder athletes. METHODS: This cross-sectional study was conducted on 250 men and 250 women from 30 different bodybuilding clubs. Participants were asked to complete a self-administered standardized anonymous check-list. RESULTS: Forty nine percent of the respondents declared supplement use. Men were more likely to take supplements than women (86.8% vs. 11.2%, p = 0.001). Reasons for using supplements were reported to be for health (45%), enhancing the immune system (40%) and improving athletic performance (25%). Most athletes (72%) had access to a nutritionist but underused this resource. Coaches (65%) had the greatest influence on supplementation practices followed by nutritionists (30%) and doctors (25%) after them. CONCLUSIONS: The prevalence of supplement use among bodybuilders was high. Sex, health-related issues and sport experts were determinant factors of supplement use. PMID:22973330

  9. 7 CFR 1942.5 - Application review and approval.

    Science.gov (United States)

    2010-01-01

    ... Collection Policies for Consumer or Commercial Debts,” organization, business operations, insurance and..., management agreements, or other agreements when facility management will be provided by other than the... applicant bears a close and genuine relationship to the original applicant (such as two organizations that...

  10. Assessing patients' attitudes towards dietary supplements.

    Science.gov (United States)

    Wierzejska, Regina; Jarosz, Mirosław; Siuba, Magdalena; Rambuszek, Michał

    2014-01-01

    There is currently many over the counter products on the market that exert nutritional or physiological effects on the human body. The differences between dietary supplements and non-prescription drugs are however poorly understood by the average consumer and may thus affect their expectations as to the desired effect produced on the body. To evaluate patients' knowledge and attitudes towards dietary supplements as compared to non-prescription drugs. Subjects were 335 patients of the Mazowiecki Voivodeship Hospital in Warsaw, Poland. The data were collected from a face-to-face interview using a single and multiple choice questionnaire with 10 questions on dietary supplements. Statistical analysis used the Chi-square (χ2) test. The majority of respondents were found to be familiar with the term 'dietary supplements', but had difficulties in classifying these products into appropriate categories. Over 55% do not consider dietary supplements to be foodstuffs and more than 40% considered such products to be drugs. Most respondents thought that the main purpose of taking dietary supplements is to improve nutrition, but over one third expected them to also treat disease. Over 70% declared taking notice to which category the non-prescription products they bought belongs to ie. whether non-prescription drugs (medicinal products) or dietary supplements. Many patients mistakenly believe that dietary supplements are drugs and can be used to treat disease and health disorders. dietary supplements, opinion on dietary supplements, nutrition, dietary supplement vs. medicinal product.

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

    International Nuclear Information System (INIS)

    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

  12. A Safety Management Model for FAR 141 Approved Flight Schools

    OpenAIRE

    Mendonca, Flavio A. C.; Carney, Thomas Q

    2017-01-01

    The Safety Management Annex (Annex 19), which became applicable in November 2013, consolidates safety management provisions previously contained in six other International Civil Aviation Organization (ICAO) Annexes, and will serve as a resource for overarching state safety management responsibilities. Through Annex 19, ICAO has required that its member states develop and implement safety management systems (SMS) to improve safety. This mandate includes an approved training organization that i...

  13. 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.

  14. 40 CFR 52.2352 - Change to approved plan.

    Science.gov (United States)

    2010-07-01

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

  15. 75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

  16. 76 FR 78706 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2011-12-19

    ... incorporated NYSE Rule 2A (Jurisdiction) as part of the process of developing a consolidated rulebook..., among other things, rulemaking, examinations, disciplinary actions, and listing applications. NYSE Rule... executives, employees and approved persons in connection with their conduct of the business of member...

  17. 78 FR 17633 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2013-03-22

    ... on the quality of the human environment during agency planning and decision-making processes. For... processing the application for financial assistance or request for approval. Having environmental information... consideration during planning and decision-making as required by NEPA. The analysis of potential environmental...

  18. The Evolution of Approval Services.

    Science.gov (United States)

    Warzala, Martin

    1994-01-01

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

  19. 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

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

    International Nuclear Information System (INIS)

    Pearson, F.J.; Berner, U.; Hummel, W.

    1992-05-01

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

  1. Safety evaluation report related to the operation of Hope Creek Generating Station (Docket No. 50-354). Supplement 2

    International Nuclear Information System (INIS)

    1985-08-01

    Supplement No. 2 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company as applicant for itself and Atlantic City Electric Company, as owners, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

  2. 30 CFR 256.12 - Supplemental sales.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Supplemental sales. 256.12 Section 256.12..., General § 256.12 Supplemental sales. (a) The Secretary may conduct a supplemental sale in accordance with the provisions of this section. (b) Supplemental sales shall be governed by the regulations in this...

  3. 40 CFR 725.370 - EPA review of the TME application.

    Science.gov (United States)

    2010-07-01

    ... unreasonable risk of injury to health and the environment as a result of test marketing. ... Marketing § 725.370 EPA review of the TME application. General procedures for review of all submissions... with test marketing activities after receipt of EPA approval. (c) In approving a TME application, EPA...

  4. Safety Evaluation Report related to the operation of Shearon Harris Nuclear Power Plant, Unit No. 1 (Docket No. STN 50-400). Supplement No. 4

    International Nuclear Information System (INIS)

    1986-10-01

    This report, Supplement No. 4 to the Safety Evaluation Report for the application filed by the Carolina Power and Light Company and North Carolina Eastern Municipal Power Agency (the applicants) for a license to operate the Shearon Harris Nuclear Power Plant Unit 1 (Docket No. 50-400), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1, 2, and 3

  5. Safety Evaluation Report related to the operation of Shearon Harris Nuclear Power Plant, Unit No. 1 (Docket No. STN 50-400). Supplement No. 2

    International Nuclear Information System (INIS)

    1985-06-01

    This report, Supplement No. 2 to the Safety Evaluation Report for the application filed by the Carolina Power and Light Company and North Carolina Eastern Municipal Power Agency (the applicants) for a license to operate the Shearon Harris Nuclear Power Plant Unit 1 (Docket No. 50-400), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement No. 1

  6. Safety Evaluation Report related to the operation of Shearon Harris Nuclear Power Plant, Unit No. 1 (Docket No. STN 50-400). Supplement No. 3

    International Nuclear Information System (INIS)

    1986-05-01

    This report, Supplement No. 3 to the Safety Evaluation Report for the application filed by the Carolina Power and Light Company and North Carolina Eastern Municipal Power Agency (the applicants) for a license to operate the Shearon Harris Nuclear Power Plant Unit 1 (Docket No. 50-400), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1 and 2

  7. Safety Evaluation Report related to the operation of Braidwood Station, Units 1 and 2 (Docket Nos. 50-456 and 50-457). Supplement No. 2

    International Nuclear Information System (INIS)

    1986-10-01

    In November 1983, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1002) regarding the application filed by the Commonwealth Edison Company, as applicant and owner, for a license to operate Braidwood Station, Units 1 and 2 (Docket Nos. 50-456 and 50-457). The first supplement to NUREG-1002 was issued in September 1986. This second supplement to NUREG-1002 reports the status of certain items that remained unresolved at the time Supplement 1 was published. The facility is located in Reed Township, Will County, Illinois

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

    Science.gov (United States)

    2017-11-22

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

  9. 48 CFR 750.7105 - Approving authorities.

    Science.gov (United States)

    2010-10-01

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

  10. 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.

  11. Selenium supplementation of Portuguese wheat cultivars through foliar treatment in actual field conditions

    International Nuclear Information System (INIS)

    Catarina Galinha; Pacheco, A.M.G.; Maria do Carmo Freitas; Jose Coutinho; Benvindo Macas; Ana Sofia Almeida

    2013-01-01

    Selenium (Se) is a trace element essential to the well-being and health quality of humankind. Plant-derived foodstuffs, namely cereals, are the major dietary sources of Se in most countries throughout the world, even if Se contents are strongly dependent upon the corresponding levels in cereal-growing soils. Therefore, wheat is one of the staple crops that appears as an obvious candidate for Se biofortification, considering its gross-tonnage production and nutritional relevance worldwide. The present paper focuses on the ability of bread and durum wheat-Triticum aestivum L. and Triticum durum Desf., respectively-to accumulate Se after supplementation via a foliar-addition procedure. Two of the most representative wheat cultivars in Portugal - Jordao (bread) and Marialva (durum) - have been selected for supplementation trials, following the same agronomic practices and field schedules as the regular (non-supplemented) crops of those varieties (sowing: November 2010; harvesting: July 2011). Foliar additions were performed at the booting and grain-filling stages, using sodium selenate and sodium selenite solutions at three different Se concentrations-equivalent to field supplementation rates of 4, 20 and 100 g of Se per ha-with and without potassium iodide. Selenium contents in wheat grains obtained under foliar application are compared to data from regular wheat samples (field blanks) grown at the same soil/season, yet devoid of any Se supplementation. Total Se in all field samples was determined by cyclic neutron activation analysis (CNAA), via the short-lived nuclide 77m Se (half-life time: 17.5 s), in the Portuguese Research Reactor (RPI; CTN-IST, Sacavem). Quality control of the analytical procedure was asserted through concurrent analyses of NIST-SRM R 1567a (Wheat Flour). Results show that foliar additions can increase Se contents in mature grains up to 15 and 40 times for Marialva and Jordao, respectively, when compared to non-supplemented crops. Jordao and

  12. 10 CFR 455.140 - Approval of applications from institutions and coordinating agencies for technical assistance and...

    Science.gov (United States)

    2010-01-01

    ... DEPARTMENT OF ENERGY ENERGY CONSERVATION GRANT PROGRAMS FOR SCHOOLS AND HOSPITALS AND BUILDINGS OWNED BY.... (h) Funds which become available to a grantee after the installation of all approved measures, due to...

  13. An innovative model for regulating supplement products: Natural health products in Canada

    International Nuclear Information System (INIS)

    Nestmann, Earle R.; Harwood, Melody; Martyres, Stephanie

    2006-01-01

    On 1 January 2004, Health Canada officially added a new term to the global list of synonyms for dietary supplements: natural health products (NHP). Developed with the intent of providing Canadian consumers with ready access to NHP that are safe, effective, and of high quality, the Natural Health Products Regulations (the NHP regulations) are applicable to the sale, manufacture, packaging, labelling, importation, distribution, and storage of NHP, and are administered by the recently formed Natural Health Products Directorate (NHPD) within Health Canada. This paper provides an overview of the process for regulating supplement products in Canada

  14. Safety of Therapeutic Fever Induction in Cancer Patients Using Approved PAMP Drugs

    Directory of Open Access Journals (Sweden)

    Uwe Rudolf Max Reuter

    2018-04-01

    Full Text Available William Coley, between 1895 and 1936, treated hundreds of cancer patients using infusions of fever inducing bacerial extracts. Similar experiments were done by Klyuyeva and co-workers in the 1940ies in Russia using trypanosoma extracts. Many remissions and cures were reported. We have conjectured that pathogen associated molecular pattern substances (PAMP are the molecular explanation for the beneficial treatments in both groups. We could show that a combination of PAMP can eradicate solid tumours in cancer mice if applied several times. Accordingly, we suggested to combine PAMP containing approved drugs to treat cancer patients using a protocol similar to the old fever induction regimen. In this retrospective phase-1 study we report on the fever induction capacity and safety of applications of bacterial extracts, combinations of bacterial extracts with approved drugs, and combinations of approved drugs in 131 mainly cancer patients. Adverse reactions were those which can be expected during a feverish infection and mild. Over 523 fever inductions, no severe adverse reaction was observed.

  15. 47 CFR 61.86 - Supplements.

    Science.gov (United States)

    2010-10-01

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

  16. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-07-02

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...

  17. 78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-06-12

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

  18. 76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-06-02

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

  19. Vedolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-07-01

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

  20. 76 FR 76894 - New Animal Drugs for Use in Animal Feeds; Tilmicosin

    Science.gov (United States)

    2011-12-09

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Tilmicosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  1. 75 FR 9334 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline

    Science.gov (United States)

    2010-03-02

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Chlortetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by ADM...

  2. 75 FR 54019 - New Animal Drugs for Use in Animal Feed; Ractopamine

    Science.gov (United States)

    2010-09-03

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feed; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by...

  3. 75 FR 34361 - New Animal Drugs for Use in Animal Feeds; Florfenicol

    Science.gov (United States)

    2010-06-17

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  4. 77 FR 24138 - New Animal Drugs for Use in Animal Feeds; Tiamulin

    Science.gov (United States)

    2012-04-23

    .... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  5. 75 FR 60308 - New Animal Drugs for Use in Animal Feeds; Melengestrol

    Science.gov (United States)

    2010-09-30

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Melengestrol AGENCY: Food and Drug... amending the animal drug regulations to more accurately reflect the recent approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The...

  6. 77 FR 4228 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2012-01-27

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  7. 76 FR 79064 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2011-12-21

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  8. Re-enactment of the Radiation Protection ordinance - explanations for its application in practice. 2. ed.

    International Nuclear Information System (INIS)

    Hoegl, A.; Bischof, W.

    2001-01-01

    The Radiation Protection Association (Fachverband fuer Strahlenschutz) decided to publish explanations for the practical application of the amended Radiation Protection Ordinance, if possible immediately at the time of promulgation. The purpose of this publication is to provide as many advice seekers as possible with whatever information they need for their purposes. The material has therefore been divided into chapters each dedicated to a specific user group. Dedicated chapters containing all the important information for the respective target group have been provided for hospitals and physicians, general and special applications of ionising radiation in industry and trade, companies that perform services in areas or installations exposed to radiation, nuclear power plants and companies affected by the new protective regulations concerning natural radiation. These chapters are supplemented with contributions on generic topics such as the principles of radiation protection, new developments in dosimetry, transport and storage of radioactive substances, expertise and instruction and qualification approval. The section on general topics is rounded off by the transitory regulations, which are crucially important

  9. 77 FR 59679 - Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving...

    Science.gov (United States)

    2012-09-28

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0044; Docket No. 50-423] Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving Application Regarding Corporate Restructuring and Conforming Amendment I Dominion Nuclear Connecticut, Inc. (DNC), Central Vermont Public Service...

  10. 19 CFR 115.55 - Termination of approval.

    Science.gov (United States)

    2010-04-01

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

  11. 20 CFR 617.22 - Approval of training.

    Science.gov (United States)

    2010-04-01

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

  12. 77 FR 22789 - Withdrawal of Approval of Part of a New Animal Drug Application; Tiamulin

    Science.gov (United States)

    2012-04-17

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

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

    Science.gov (United States)

    Nema, Sandeep; Brendel, Ronald J

    2011-01-01

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

  14. Children and Dietary Supplements

    Science.gov (United States)

    ... Clinical Digest for health professionals Children and Dietary Supplements Share: September 2012 © Matthew Lester Research has shown that many children use herbs and other dietary supplements. However, there are little data available on their ...

  15. Interactions of commonly used dietary supplements with cardiovascular drugs: a systematic review

    Directory of Open Access Journals (Sweden)

    Kanji Salmaan

    2012-05-01

    Full Text Available Abstract Background The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. Methods The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed. Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s with the drug(s alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Results Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Conclusions Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets and garlic (plus nitrates or warfarin on triglycerides and HDL-C, respectively. Safety concerns, however, persist.

  16. 30 CFR 75.1108 - Approved conveyor belts.

    Science.gov (United States)

    2010-07-01

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

  17. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

    Science.gov (United States)

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

  18. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

    Directory of Open Access Journals (Sweden)

    Jing Hao

    Full Text Available Fixed-dose combinations (FDC contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed.Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients.New molecular entities (NMEs, new therapeutic biologics license applications (BLAs and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC and only already marketed drugs (Non-NMEs-FDC. Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed.During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31 after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39 before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24 years to the patent and exclusivity life of the single active ingredients in the combination.FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

  19. 24 CFR 266.105 - Application requirements.

    Science.gov (United States)

    2010-04-01

    ... HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Housing Finance Agency Requirements § 266.105 Application requirements. (a) Applications for approval as a HUD...

  20. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-03-21

    ... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

  1. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-08-19

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...

  2. 75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-06-24

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...

  3. 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 Staff...

  4. 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...

  5. Development of a supplemental surveillance program for reactor pressure vessel thermal annealing

    International Nuclear Information System (INIS)

    Server, W.L.; Rosinski, S.T.

    1997-01-01

    The technical decision to thermally anneal a nuclear reactor pressure vessel (RPV) depends upon the level of embrittlement in the RPV steels, the amount of recovery of fracture toughness properties expected from the anneal, and the rate of re-embrittlement after the vessel is placed back into service. The recovery of Charpy impact toughness properties after annealing can be estimated initially by using a recovery model developed using experimental measurements of recovery (such as that developed by Eason et al. for U.S. vessel materials). However, actual validation measurements on plant-specific archived vessel materials (hopefully in the existing surveillance program) are needed; otherwise, irradiated surrogate materials, essentially the same as the RPV steels or bounding in expected behavior, must be utilized. The efficient use of any of these materials requires a supplemental surveillance program focused at both recovery and reirradiation embrittlement. Reconstituted Charpy specimens and new surveillance capsules will most likely be needed as part of this supplemental surveillance program. A new version of ASTM E 509 has recently been approved which provides guidance on thermal annealing in general and specifically for the development of an annealing supplemental surveillance program. The post-anneal re-embrittlement properties are crucial for continued plant operation, and the use of a re-embrittlement model, such as the lateral shift approach, may be overly conservative. This paper illustrates the new ASTM E 509 Standard Guide methodology for an annealing supplemental surveillance program. As an example, the proposed program for the Palisades RPV beltline steels is presented which covers the time from annealing to the end of operating license and beyond, if license renewal is pursued. The Palisades nuclear power plant RPV was planned to be annealed in 1998, but that plant is currently being re-evaluated. The proposed anneal was planned to be conducted at a

  6. Safety Evaluation Report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 8

    International Nuclear Information System (INIS)

    1984-12-01

    Supplement 8 (SSER 8) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

  7. Safety evaluation report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 7

    International Nuclear Information System (INIS)

    1984-09-01

    Supplement 7 (SSER 7) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

  8. Safety evaluation report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 6

    International Nuclear Information System (INIS)

    1984-07-01

    Supplement 6 (SSER 6) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

  9. Safety Evaluation Report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 9

    International Nuclear Information System (INIS)

    1985-12-01

    Supplement 9 (SSER 9) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

  10. 14 CFR 21.621 - Issuance of letters of TSO design approval: import articles.

    Science.gov (United States)

    2010-01-01

    ... performance standards of the State of Design and any other performance standards the FAA may prescribe to... to the FAA one copy of the technical data required in the applicable performance standard through its State of Design. (b) The FAA issues the letter of TSO design approval that lists any deviation granted...

  11. 27 CFR 5.55 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

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

  12. Regional Assessment of Supplementation Project

    International Nuclear Information System (INIS)

    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

  13. Safety Evaluation Report related to the operation of Beaver Valley Power Station, Unit 2 (Docket No. 50-412). Supplement No. 2

    International Nuclear Information System (INIS)

    1986-08-01

    This report, Supplement No. 2 to the the Safety Evaluation Report for the application filed by the Duquesne Light Company, et al. (the applicant) for a license to operate the Beaver Valley Power Station Unit 2 (Docket No. 50-412), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time the Safety Evaluation Report was published

  14. Safety Evaluation Report related to the operation of Hope Creek Generating Station (Docket No. 50-354). Supplement No. 1

    International Nuclear Information System (INIS)

    1985-03-01

    Supplement No. 1 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company as applicant for itself and Atlantic City Electric Company, as owners, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

  15. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

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

  16. 78 FR 16159 - Application Procedures and Criteria for Approval of Providers of a Personal Financial Management...

    Science.gov (United States)

    2013-03-14

    ... and Criteria for Approval of Providers of a Personal Financial Management Instructional Course by... personal financial management instructional course (``providers'') satisfy all prerequisites of the United... in an instructional course concerning personal financial management (``instructional course'' or...

  17. Vitamin C supplementation in pregnancy.

    Science.gov (United States)

    Rumbold, Alice; Ota, Erika; Nagata, Chie; Shahrook, Sadequa; Crowther, Caroline A

    2015-09-29

    Vitamin C supplementation may help reduce the risk of pregnancy complications such as pre-eclampsia, intrauterine growth restriction and maternal anaemia. There is a need to evaluate the efficacy and safety of vitamin C supplementation in pregnancy. To evaluate the effects of vitamin C supplementation, alone or in combination with other separate supplements on pregnancy outcomes, adverse events, side effects and use of health resources. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies. All randomised or quasi-randomised controlled trials evaluating vitamin C supplementation in pregnant women. Interventions using a multivitamin supplement containing vitamin C or where the primary supplement was iron were excluded. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Twenty-nine trials involving 24,300 women are included in this review. Overall, 11 trials were judged to be of low risk of bias, eight were high risk of bias and for 10 trials it was unclear. No clear differences were seen between women supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control for the risk of stillbirth (risk ratio (RR) 1.15, 95% confidence intervals (CI) 0.89 to 1.49; 20,038 participants; 11 studies; I² = 0%; moderate quality evidence), neonatal death (RR 0.79, 95% CI 0.58 to 1.08; 19,575 participants; 11 studies; I² = 0%), perinatal death (average RR 1.07, 95% CI 0.77 to 1.49; 17,105 participants; seven studies; I² = 35%), birthweight (mean difference (MD) 26.88 g, 95% CI -18.81 to 72.58; 17,326 participants; 13 studies; I² = 69%), intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06; 20,361 participants; 12 studies; I² = 15%; high quality evidence), preterm birth (average RR 0.99, 95% CI 0.90 to 1.10; 22,250 participants; 16 studies; I² = 49%; high quality evidence

  18. Supplemental irrigation to improve wheat production and water use efficiency under rainfed farming conditions

    International Nuclear Information System (INIS)

    Hussain, Q.; Bhatti, A.A.; Ahmad, M.M.

    2007-01-01

    The stochastic behaviors of rainfall pose serious limitations for sustained and profitable crop production in rainfed areas; farmers hesitate to apply fertilizers when they are not sure about rainfall. In view of these limitations a research study was conducted for three years (2003-2006) at field station of Water Resources Research Institute (WRRI), National Agricultural Research Centre(NARC), Islamabad to examine the effects of supplemental irrigation (SI) on wheat production and water use efficiency (WUE). Irrigation treatments employed under the experiment were: i) Rainfed without irrigation and fertilizer application (I/sub 0/); ii) SI of 25 mm was applied to non-fertilizer field at 75% management allowed deficit (MAD)(I/sub 1/); iii) Rainfed with fertilizer application at sowing time (I/sub 2/); and iv) SI of 25 mm was applied at 75% MAD and at the time of fertilizer application as top dressing (I/sub 3/). Supplemental irrigation increased the crop yield during the years 2003-2006 under both fertilizer and non-fertilizer conditions. Increased in grain yield under non-fertilizer conditions (I/sub 1/) ranges between 770-980 kg/ha, which is 27 to 48% higher than the rainfed yield (I/sub 0/). Supplemental irrigation and split application of fertilizer (treatment I/sub 3/) increased in grain yield within the range of 1000-1350 kg/ha, which is 27-49% higher than yield under treatment I/sub 2/. Whereas, due to synergetic effect of supplemental irrigation and fertilizer application, increased in grain yield ranges between 1550-2030 kg/ha, which is 49% to 100% higher than the rainfed and non-fertilizer field. WUE was calculated for rain (WUE/sub r/) for total water (grass: previous soil water storage + rain + irrigation) (WUE/sub g/), for SI water only (WUE/sub si/) and for synergetic effect (SI water + fertilizer application) (WUE/sub sis/) Water use efficiencies namely the WUE/sub r/, WUE/sub g/ and WUE/sub si/ during the period of three years under non fertilizer

  19. 324 building safety analysis report supplement

    International Nuclear Information System (INIS)

    Dodd, A.O.; Wittenbrock, N.G.

    1977-01-01

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

  20. Safety Evaluation Report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 3

    International Nuclear Information System (INIS)

    1985-01-01

    This report supplements the Safety Evaluation Report, NUREG-0847 (June 1982), Supplement No. 1 (September 1982), and Supplement No. 2 (January 1984) 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 open and confirmatory items and license conditions identified in the Safety Evaluation Report

  1. Safety-evaluation report related to the final design of the Standard Nuclear Steam Supply Reference System - CESSAR System 80. Docket No. STN 50-470

    International Nuclear Information System (INIS)

    1983-03-01

    Supplement No. 1 to the Safety Evaluation Report for the application filed by Combustion Engineering, Inc. for a Final Design Approval for the Combustion Engineering Standard Safety Analysis Report (STN 50-470) has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation by providing: (1) the evaluation of additional information submitted by the applicant since the Safety Evaluation Report was issued, (2) the evaluation of the matters the staff had under review when the Safety Evaluation Report was issued, and (3) the response to comments made by the Advisory Committee on Reactor Safeguards

  2. 75 FR 39932 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-07-13

    ...; Comment Request; Recognition Application for Sustainable Water Leadership Program (Renewal) AGENCY... Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval... to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention...

  3. Resolution 2/2004 Guidelines for the implementation of regulations for the safe transport of radioactive materials

    International Nuclear Information System (INIS)

    2004-01-01

    This guide is intended to supplement the provisions of Resolution no. 121/2000 of the Ministry of Science Technology and Environment Regulations the Security of Radioactive Materials Transport, hereinafter Regulation, Regarding the administrative requirements for the application process Certificates of Approval for the shipments of radioactive material and for Special arrangements.

  4. 76 FR 16534 - New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction

    Science.gov (United States)

    2011-03-24

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction AGENCY: Food and...) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained...

  5. Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project

    Science.gov (United States)

    Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

    2016-01-01

    Objective Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Design Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. Participants 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Results Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. Limitations This study was a non-randomised comparison cohort study. Some data were missing. Conclusions An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. PMID:27580832

  6. Progress in developing analytical and label-based dietary supplement databases at the NIH Office of Dietary Supplements

    Science.gov (United States)

    Dwyer, Johanna T.; Picciano, Mary Frances; Betz, Joseph M.; Fisher, Kenneth D.; Saldanha, Leila G.; Yetley, Elizabeth A.; Coates, Paul M.; Milner, John A.; Whitted, Jackie; Burt, Vicki; Radimer, Kathy; Wilger, Jaimie; Sharpless, Katherine E.; Holden, Joanne M.; Andrews, Karen; Roseland, Janet; Zhao, Cuiwei; Schweitzer, Amy; Harnly, James; Wolf, Wayne R.; Perry, Charles R.

    2013-01-01

    Although an estimated 50% of adults in the United States consume dietary supplements, analytically substantiated data on their bioactive constituents are sparse. Several programs funded by the Office of Dietary Supplements (ODS) at the National Institutes of Health enhance dietary supplement database development and help to better describe the quantitative and qualitative contributions of dietary supplements to total dietary intakes. ODS, in collaboration with the United States Department of Agriculture, is developing a Dietary Supplement Ingredient Database (DSID) verified by chemical analysis. The products chosen initially for analytical verification are adult multivitamin-mineral supplements (MVMs). These products are widely used, analytical methods are available for determining key constituents, and a certified reference material is in development. Also MVMs have no standard scientific, regulatory, or marketplace definitions and have widely varying compositions, characteristics, and bioavailability. Furthermore, the extent to which actual amounts of vitamins and minerals in a product deviate from label values is not known. Ultimately, DSID will prove useful to professionals in permitting more accurate estimation of the contribution of dietary supplements to total dietary intakes of nutrients and better evaluation of the role of dietary supplements in promoting health and well-being. ODS is also collaborating with the National Center for Health Statistics to enhance the National Health and Nutrition Examination Survey dietary supplement label database. The newest ODS effort explores the feasibility and practicality of developing a database of all dietary supplement labels marketed in the US. This article describes these and supporting projects. PMID:25346570

  7. Treatment of petroleum drill cuttings using bioaugmentation and biostimulation supplemented with phytoremediation.

    Science.gov (United States)

    Kogbara, Reginald B; Ogar, Innocent; Okparanma, Reuben N; Ayotamuno, Josiah M

    2016-07-28

    This study sought to compare the effectiveness of bioaugmentation and biostimulation, as well as the combination of both techniques, supplemented with phytoremediation, in the decontamination of petroleum drill cuttings. Drill cuttings with relatively low concentration of total petroleum hydrocarbons (TPH) and metals were mixed with soil in the ratio 5:1 and treated with three different combinations of the bioremediation options. Option A entailed bioaugmentation supplemented with phytoremediation. Option B had the combination of biostimulation and bioaugmentation supplemented with phytoremediation. While biostimulation supplemented with phytoremediation was deployed in option C. Option O containing the drill cuttings-soil mixture without treatment served as untreated control. Fertilizer application, tillage and watering were used for biostimulation treatment, while spent mushroom substrate (Pleurotus ostreatus) and elephant grass (Pennisetum purpureum) were employed for bioaugmentation and phytoremediation treatment, respectively. The drill cuttings-soil mixtures were monitored for TPH, organic carbon, total nitrogen, pH, metal concentrations, and fungal counts, over time. After 56 days of treatment, there was a decline in the initial TPH concentration of 4,114 mg kg(-1) by 5.5%, 68.3%, 75.6% and 48% in options O, A, B and C, respectively. Generally, higher TPH loss resulted from the phytoremediation treatment stage. The treated options also showed slight reductions in metal concentrations ranging from 0% to 16% of the initial low concentrations. The results highlight the effectiveness of bioaugmentation supplemented with phytoremediation. The combination of bioaugmentation and biostimulation supplemented with phytoremediation, however, may prove better in decontaminating petroleum drill cuttings to environmentally benign levels.

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

    International Nuclear Information System (INIS)

    Ramsey, A.A.; Thorson, M.R.

    2010-01-01

    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.

  9. The family name Solimonadaceae Losey et al. 2013 is illegitimate, proposals to create the names 'Sinobacter soli' comb. nov. and 'Sinobacter variicoloris' contravene the Code, the family name Xanthomonadaceae Saddler and Bradbury 2005 and the order name Xanthomonadales Saddler and Bradbury 2005 are illegitimate and notes on the application of the family names Solibacteraceae Zhou et al. 2008, Nevskiaceae Henrici and Johnson 1935 (Approved Lists 1980) and Lysobacteraceae Christensen and Cook 1978 (Approved Lists 1980) and order name Lysobacteriales Christensen and Cook 1978 (Approved Lists 1980) with respect to the classification of the corresponding type genera Solibacter Zhou et al. 2008, Nevskia Famintzin 1892 (Approved Lists 1980) and Lysobacter Christensen and Cook 1978 (Approved Lists 1980) and importance of accurately expressing the link between a taxonomic name, its authors and the corresponding description/circumscription/emendation.

    Science.gov (United States)

    Tindall, B J

    2014-01-01

    In a recent publication the name Solimonadaceae Losey et al. 2013 has been proposed as a replacement name for the family name Sinobacteraceae Zhou et al. 2008. This course of action contravenes the current Code governing the nomenclature of prokaryotes, making Solimonadaceae Losey et al. 2013 an illegitimate name that neither has claim to priority nor can be used as a correct name. Closer examination of publications dealing with the taxonomy of members of the genera Solimonas and Sinobacter and the placement of these taxa at the rank of family and order reveal problems associated with the application of the family names Sinobacteraceae Zhou et al. 2008, Nevskiaceae Henrici and Johnson 1935 (Approved Lists 1980) and Lysobacteraceae Christensen and Cook 1978 (Approved Lists 1980) and the order names Lysobacterales Christensen and Cook 1978 (Approved Lists 1980) and Xanthomonadales Saddler and Bradbury 2005.

  10. Safety Evaluation Report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). Supplement No. 5

    International Nuclear Information System (INIS)

    1986-10-01

    This report supplements the Safety Evaluation Report (NUREG-1047, February 1985) for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate Nine Mile Point Nuclear Station, Unit 2 (Docket No. 50-410). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. Supplement 1 to the Safety Evaluation Report was published in June 1985 and contained the report from the Advisory Committee on Reactor Safeguards as well as the resolution of a number of outstanding issues from the Safety Evaluation Report. Supplement 2 was published in November 1985 and contained the resolution of a number of outstanding and confirmatory issues. Supplement 3 was published in July 1986 and contained the resolution of a number of outstanding and confirmatory items, one new confirmatory item, the evaluation of the Engineering Assurance Program, and the evaluation of a number of exemption requests. Supplement 4 was published in September 1986 and contained the resolution of a number of outstanding and confirmatory issues and the evaluation of a number of exemption requests. This report contains the resolution of a number of issues that have been resolved since Supplement 4 was issued. It also contains the evaluation of a number of requests for exemption from the applicant. This report also supports the issuance of the low-power license for Nine Mile Point Nuclear Station, Unit 2

  11. 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.

  12. Streamlining the Capstone Process: A Time-Saving Approval System for Graduate Theses/Projects

    Science.gov (United States)

    Grooms, James; Kline, Douglas; Cummings, Jeffrey

    2016-01-01

    Capstones have become an integral part of many information systems programs, both at the undergraduate and graduate level. One of the challenges can be tracking the process from the start of the capstone to completion. This paper describes the analysis, design and implementation of a web application for the approval workflow of a master's program…

  13. Creatine supplementation in the aging population: effects on skeletal muscle, bone and brain.

    Science.gov (United States)

    Gualano, Bruno; Rawson, Eric S; Candow, Darren G; Chilibeck, Philip D

    2016-08-01

    This narrative review aims to summarize the recent findings on the adjuvant application of creatine supplementation in the management of age-related deficits in skeletal muscle, bone and brain metabolism in older individuals. Most studies suggest that creatine supplementation can improve lean mass and muscle function in older populations. Importantly, creatine in conjunction with resistance training can result in greater adaptations in skeletal muscle than training alone. The beneficial effect of creatine upon lean mass and muscle function appears to be applicable to older individuals regardless of sex, fitness or health status, although studies with very old (>90 years old) and severely frail individuals remain scarce. Furthermore, there is evidence that creatine may affect the bone remodeling process; however, the effects of creatine on bone accretion are inconsistent. Additional human clinical trials are needed using larger sample sizes, longer durations of resistance training (>52 weeks), and further evaluation of bone mineral, bone geometry and microarchitecture properties. Finally, a number of studies suggest that creatine supplementation improves cognitive processing under resting and various stressed conditions. However, few data are available on older adults, and the findings are discordant. Future studies should focus on older adults and possibly frail elders or those who have already experienced an age-associated cognitive decline.

  14. 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.

  15. Inszenierung eines Supplements / Staging a Supplement

    Directory of Open Access Journals (Sweden)

    Thomas-M. Seibert

    2006-06-01

    Full Text Available Richter Adam, Anwalt Liebling und William, der Detektiv. Die Rechtspraxis setzt etwas voraus, das sie nicht nur begründet oder ergänzt, sondern grundsätzlich in Frage stellt. So macht der Zwang, in einem Verfahren zu entscheiden und zu begründen, zugleich deutlich, dass jede Form der Entscheidung unangemessen, unbegründet und in ganz anderer Weise neu herzustellen ist. Das ist das juridische Supplement im Geiste von Jacques Derrida. Supplementiert wird die Wahrheit des Rechts in anderen Medien: in Drama, Film und Literatur etwa. Dort wird in Szene gesetzt, was in der real erlebbaren Rechtswelt nicht wirklich erlebt werden kann, was aber doch – wie kein Amtsträger bestreiten würde – zum Verfahrensergebnis gehört. Judge Adam, Advocate “Liebling” and William, the Detective. Legal practice is based on something that is not only an integral part of it and complements it, but also puts it into question generally. The compulsion to argue and reach decisions in a legal trial clarifies simultaneously that all forms of decision are inapproprate, unreasonable, and can be recreated in an entirely new manner [to suit the needs of the trial]. This is the legalistic supplement in the spirit of Jacques Derrida. The legal truth is supplemented by other forms of media such as drama, film and literature, which are able to stage scenes that cannot be experienced in a real life legal world, but – as no legal official would deny – are an integral part of the trial and verdict procedure.

  16. On some properties of ⊕-supplemented modules

    Directory of Open Access Journals (Sweden)

    A. Idelhadj

    2003-01-01

    Full Text Available A module M is ⊕-supplemented if every submodule of M has a supplement which is a direct summand of M. In this paper, we show that a quotient of a ⊕-supplemented module is not in general ⊕-supplemented. We prove that over a commutative ring R, every finitely generated ⊕-supplemented R-module M having dual Goldie dimension less than or equal to three is a direct sum of local modules. It is also shown that a ring R is semisimple if and only if the class of ⊕-supplemented R-modules coincides with the class of injective R-modules. The structure of ⊕-supplemented modules over a commutative principal ideal ring is completely determined.

  17. Safety evaluation report related to the operation of WPPSS Nuclear Project No. 2, (Docket No. 50-397). Supplement No. 4

    International Nuclear Information System (INIS)

    1983-12-01

    Supplement No. 4 to the Safety Evaluation Report on the application filed by Washington Public Power Supply System for a license to operate the WPPSS Nuclear Project No. 2, located in Richland, Washington, has been prepared by the Division of Licensing, Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1, 2 and 3

  18. Trends in global approvals of biotech crops (1992–2014)

    Science.gov (United States)

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

    2015-01-01

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

  19. 23 CFR 1200.10 - Application.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Application. 1200.10 Section 1200.10 Highways NATIONAL... PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS Application, Approval, and Funding of the Highway Safety Program § 1200.10 Application. Each fiscal year, a State's...

  20. Benefits of standard format and content for approval of packaging for radioactive material

    International Nuclear Information System (INIS)

    Pstrak, D.; Osgood, N.

    2004-01-01

    The U.S. Nuclear Regulatory Commission (NRC) uses Regulatory Guide 7.9, ''Standard Format and Content of Part 71 Applications for Approval of Packaging for Radioactive Material'' to provide recommendations on the preparation of applications for approval of Type B and fissile material packages. The purpose of this Regulatory Guide is to assist the applicant in preparing an application that demonstrates the adequacy of a package in meeting the 10 CFR Part 71 packaging requirements. NRC recently revised Regulatory Guide 7.9 to reflect current changes to the regulations in Part 71 as a result of a recent rulemaking that included changes to the structural, containment, and criticality requirements for packages. Overall, the NRC issues Regulatory Guides to describe methods that are acceptable to the NRC staff for implementing specific parts of the NRC's regulations, to explain techniques used by the NRC staff in evaluating specific problems, and to provide guidance to applicants. It is important to note the specific purpose of this Regulatory Guide. As the name indicates, this Guide sets forth a standard format for application submission that is acceptable to the NRC staff that, when used by the applicant, will accomplish several objectives. First, use of the guide provides a consistent and repeatable approach that indicates the information to be provided by the applicant. Second, the organization of the information in the application will assist the reviewer(s) in locating information. Ultimately, accomplishing these objectives will help to ensure the completeness of the information in the application as well as decrease the review time. From an international perspective, use of a standard format approach could enhance the efficiency with which Competent Authorities certify and validate packages for use in the packaging and transportation of radioactive material worldwide. This streamlined approach of preparing package applications could ultimately lead to uniform

  1. 75 FR 64248 - Approval for Manufacturing Authority Foreign-Trade Zone 196 ATC Logistics & Electronics (Cell...

    Science.gov (United States)

    2010-10-19

    ... Authority Foreign-Trade Zone 196 ATC Logistics & Electronics (Cell Phone Kitting) Fort Worth, TX Pursuant to... Foreign-Trade Zones Board (the Board) adopts the following Order: Whereas, ATC Logistics & Electronics... Logistics & Electronics, as described in the application and Federal Register notice, is approved, subject...

  2. 76 FR 38992 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update to Materials...

    Science.gov (United States)

    2011-07-05

    ... for Pennsylvania. Since the publication of the last IBR update, EPA has approved the following... revision'' and ``Applicable geographic area'' columns for the entry ``Continuous Source Testing Manual.'' 2... section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding ``good cause...

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

    Science.gov (United States)

    2013-05-06

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

  4. Prohibited Contaminants in Dietary Supplements.

    Science.gov (United States)

    Mathews, Neilson M

    With the increasing use of unregulated dietary supplements, athletes are at continued risk from adverse medical events and inadvertent doping. A review of Clinical Key, MEDLINE, and PubMed databases from 2012 to 2017 was performed using search terms, including dietary supplement, contamination, doping in athletes, inadvertent doping, and prohibited substances. The references of pertinent articles were reviewed for other relevant sources. Clinical review. Level 3. Poor manufacturing processes and intentional contamination with many banned substances continue to occur in dietary supplements sold in the United States. Certain sectors, such as weight loss and muscle-building supplements, pose a greater threat because they are more likely to be contaminated. Athletes will continue to be at risk for adverse events and failed doping tests due to contaminated dietary supplements until legislation changes how they are regulated. In the interim, there are several steps that can be taken to mitigate this risk, including improved education of medical staff and athletes and use of third party-certified products.

  5. 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 and...

  6. Use of dietary supplements among Brazilian athletes

    Directory of Open Access Journals (Sweden)

    Hellen Clair Garcez NABUCO

    Full Text Available ABSTRACT Objective: To investigate the prevalence and establish the profile of the consumption of dietary supplements among Brazilian athletes. Methods: A total of 182 athletes of both genders from 20 different sports participated in this study. The athletes answered a questionnaire containing sociodemographic and sports-related questions and were interviewed about the consumption of dietary supplements. Results: Forty seven percent of athletes reported having consumed at least one type of dietary supplement and 38% said they use more than three different types of supplements concurrently. Whey protein was the most commonly consumed supplement, and the most frequently mentioned reason for its consumption was performance improvement. The main source of information was coaches, and individual sport athletes were the greatest consumers and the most likely to seek dietary supplement. Conclusion: Approximately half of the participants used dietary supplements, which on most occasions were recommended by coaches. The consumption profile also revealed multiple supplementation practice and showed that nutrition education is essential for this specific population.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2007-05-15

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

  8. 78 FR 59754 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2013-09-27

    ..., LLC, Ms. Rhonda Nicoloff, Managing Member, 1505 South Redwood Road, Salt Lake City, UT 84104. GRYR seeks approval of the proposed discontinuance and removal of the automatic block signal (ABS) system...

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

    Directory of Open Access Journals (Sweden)

    Neety Sahu

    2016-01-01

    Full Text Available Silk protein sericins, in the recent years, find application in cosmetics and pharmaceuticals and as biomaterials. We investigate the potential of sericin, extracted from both mulberry Bombyx mori and different non-mulberry sources, namely, tropical tasar, Antheraea mylitta; muga, Antheraea assama; and eri, Samia ricini, as growth supplement in serum-free culture medium. Sericin supplemented media containing different concentrations of sericins from the different species are examined for attachment, growth, proliferation, and morphology of fibrosarcoma cells. The optimum sericin supplementation seems to vary with the source of sericins. The results indicate that all the sericins promote the growth of L929 cells in serum-free culture media; however, S. ricini sericin seems to promote better growth of cells amongst other non-mulberry sericins.

  10. 76 FR 79537 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Adhesives and Sealants Rule

    Science.gov (United States)

    2011-12-22

    ... Promulgation of Air Quality Implementation Plans; Delaware; Adhesives and Sealants Rule AGENCY: Environmental..., sale, use, or application of adhesives, sealants, primers, and solvents. EPA is approving this SIP... miscellaneous industrial adhesives control techniques guideline (CTG) category in accordance with the...

  11. 77 FR 7946 - Regulatory Agenda

    Science.gov (United States)

    2012-02-13

    ... Nutrition and Supplement Facts Labels. 351 Over-the-Counter (OTC) 0910-AF40 Drug Review-Oral Health [email protected] . RIN: 0910-AF22 351. Over-the-Counter (OTC) Drug Review--Oral Health Care Products... approved new drug application, may be legally marketed. The NPRM and final action will address oral health...

  12. 42 CFR 59.8 - How is a grant awarded?

    Science.gov (United States)

    2010-10-01

    ...) Generally the grant will initially be for one year and subsequent continuation awards will also be for one... is in the best interest of the government. (c) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental...

  13. Digital Breast Tomosynthesis versus Supplemental Diagnostic Mammographic Views for Evaluation of Noncalcified Breast Lesions

    Science.gov (United States)

    Bandos, Andriy I.; Ganott, Marie A.; Sumkin, Jules H.; Kelly, Amy E.; Catullo, Victor J.; Rathfon, Grace Y.; Lu, Amy H.; Gur, David

    2013-01-01

    Purpose: To compare the diagnostic performance of breast tomosynthesis versus supplemental mammography views in classification of masses, distortions, and asymmetries. Materials and Methods: Eight radiologists who specialized in breast imaging retrospectively reviewed 217 consecutively accrued lesions by using protocols that were HIPAA compliant and institutional review board approved in 182 patients aged 31–60 years (mean, 50 years) who underwent diagnostic mammography and tomosynthesis. The lesions in the cohort included 33% (72 of 217) cancers and 67% (145 of 217) benign lesions. Eighty-four percent (182 of 217) of the lesions were masses, 11% (25 of 217) were asymmetries, and 5% (10 of 217) were distortions that were initially detected at clinical examination in 8% (17 of 217), at mammography in 80% (173 of 217), at ultrasonography (US) in 11% (25 of 217), or at magnetic resonance imaging in 1% (2 of 217). Histopathologic examination established truth in 191 lesions, US revealed a cyst in 12 lesions, and 14 lesions had a normal follow-up. Each lesion was interpreted once with tomosynthesis and once with supplemental mammographic views; both modes included the mediolateral oblique and craniocaudal views in a fully crossed and balanced design by using a five-category Breast Imaging Reporting and Data System (BI-RADS) assessment and a probability-of-malignancy score. Differences between modes were analyzed with a generalized linear mixed model for BI-RADS–based sensitivity and specificity and with modified Obuchowski-Rockette approach for probability-of-malignancy–based area under the receiver operating characteristic (ROC) curve. Results: Average probability-of-malignancy–based area under the ROC curve was 0.87 for tomosynthesis versus 0.83 for supplemental views (P tomosynthesis, the false-positive rate decreased from 85% (989 of 1160) to 74% (864 of 1160) (P tomosynthesis, more cancers were classified as BI-RADS category 5 (39% [226 of 576] vs 33% [188

  14. Cardiovascular Effects of Calcium Supplements

    Directory of Open Access Journals (Sweden)

    Ian R. Reid

    2013-07-01

    Full Text Available Calcium supplements reduce bone turnover and slow the rate of bone loss. However, few studies have demonstrated reduced fracture incidence with calcium supplements, and meta-analyses show only a 10% decrease in fractures, which is of borderline statistical and clinical significance. Trials in normal older women and in patients with renal impairment suggest that calcium supplements increase the risk of cardiovascular disease. To further assess their safety, we recently conducted a meta-analysis of trials of calcium supplements, and found a 27%–31% increase in risk of myocardial infarction, and a 12%–20% increase in risk of stroke. These findings are robust because they are based on pre-specified analyses of randomized, placebo-controlled trials and are consistent across the trials. Co-administration of vitamin D with calcium does not lessen these adverse effects. The increased cardiovascular risk with calcium supplements is consistent with epidemiological data relating higher circulating calcium concentrations to cardiovascular disease in normal populations. There are several possible pathophysiological mechanisms for these effects, including effects on vascular calcification, vascular cells, blood coagulation and calcium-sensing receptors. Thus, the non-skeletal risks of calcium supplements appear to outweigh any skeletal benefits, and are they appear to be unnecessary for the efficacy of other osteoporosis treatments.

  15. 30 CFR 36.6 - Application procedures and requirements.

    Science.gov (United States)

    2010-07-01

    ... diesel engine, including joints and gaskets; the turbulence or precombustion chamber, if applicable; injector assembly and nozzle details; and any surfaces that form the combustion chamber or part thereof..., EVALUATION, AND APPROVAL OF MINING PRODUCTS APPROVAL REQUIREMENTS FOR PERMISSIBLE MOBILE DIESEL-POWERED...

  16. Supplemental Information for New York State Standardized Interconnection Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Ingram, Michael [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Narang, David J. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Mather, Barry A. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Kroposki, Benjamin D. [National Renewable Energy Laboratory (NREL), Golden, CO (United States)

    2017-10-24

    This document is intended to aid in the understanding and application of the New York State Standardized Interconnection Requirements (SIR) and Application Process for New Distributed Generators 5 MW or Less Connected in Parallel with Utility Distribution Systems, and it aims to provide supplemental information and discussion on selected topics relevant to the SIR. This guide focuses on technical issues that have to date resulted in the majority of utility findings within the context of interconnecting photovoltaic (PV) inverters. This guide provides background on the overall issue and related mitigation measures for selected topics, including substation backfeeding, anti-islanding and considerations for monitoring and controlling distributed energy resources (DER).

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

    International Nuclear Information System (INIS)

    Tam, P.S.

    1995-10-01

    In June 1982, the Nuclear Regulatory Commission staff (NRC staff or staff) issued a Safety Evaluation Report, NUREG-0847, regarding the application by the Tennessee Valley Authority (TVA or the applicant) for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2. Each of the following sections and appendices of this supplement is numbered the same as the section or appendix of the SER that is being updated, and the discussions are supplementary to, and not in lieu of, the discussion in the SER, unless otherwise noted. Accordingly, Appendix A continues the chronology of the safety review. Appendix E lists principal contributors to this supplement. Appendix FF is added in this supplement. The other appendices are not changed by this supplement

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

    Science.gov (United States)

    Fountaine, Charles A.; And Others

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

  19. 7 CFR 1610.4 - Loan applications.

    Science.gov (United States)

    2010-01-01

    ... Regulations of the Department of Agriculture (Continued) RURAL TELEPHONE BANK, DEPARTMENT OF AGRICULTURE LOAN POLICIES § 1610.4 Loan applications. No application for a loan will be considered for approval by the Bank... of the applicant for a Bank loan and the amount thereof. Loan application forms are available from...

  20. 20 CFR 227.2 - Initial supplemental annuity rate.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Initial supplemental annuity rate. 227.2... COMPUTING SUPPLEMENTAL ANNUITIES § 227.2 Initial supplemental annuity rate. The supplemental annuity rate... supplemental annuity rate is $43 for an employee with 30 or more years of service. ...

  1. 77 FR 29335 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-05-17

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

  2. Dietary supplements and team-sport performance.

    Science.gov (United States)

    Bishop, David

    2010-12-01

    A well designed diet is the foundation upon which optimal training and performance can be developed. However, as long as competitive sports have existed, athletes have attempted to improve their performance by ingesting a variety of substances. This practice has given rise to a multi-billion-dollar industry that aggressively markets its products as performance enhancing, often without objective, scientific evidence to support such claims. While a number of excellent reviews have evaluated the performance-enhancing effects of most dietary supplements, less attention has been paid to the performance-enhancing claims of dietary supplements in the context of team-sport performance. Dietary supplements that enhance some types of athletic performance may not necessarily enhance team-sport performance (and vice versa). Thus, the first aim of this review is to critically evaluate the ergogenic value of the most common dietary supplements used by team-sport athletes. The term dietary supplements will be used in this review and is defined as any product taken by the mouth, in addition to common foods, that has been proposed to have a performance-enhancing effect; this review will only discuss substances that are not currently banned by the World Anti-Doping Agency. Evidence is emerging to support the performance-enhancing claims of some, but not all, dietary supplements that have been proposed to improve team-sport-related performance. For example, there is good evidence that caffeine can improve single-sprint performance, while caffeine, creatine and sodium bicarbonate ingestion have all been demonstrated to improve multiple-sprint performance. The evidence is not so strong for the performance-enhancing benefits of β-alanine or colostrum. Current evidence does not support the ingestion of ribose, branched-chain amino acids or β-hydroxy-β-methylbutyrate, especially in well trained athletes. More research on the performance-enhancing effects of the dietary supplements

  3. "Les Grangettes" no longer approved hospital as of 1.1.2012

    CERN Multimedia

    HR Department

    2012-01-01

    The negotiations for a new tariff agreement with "Les Grangettes", conducted jointly by CERN and partner international organizations, did not reach a positive conclusion. As a result, "Les Grangettes" ceased being an approved hospital on 31 December 2011.   This means that for hospitalizations in "Les Grangettes" as of 1 January 2012 the conditions applicable to unapproved hospitals will apply. In particular: no third-party payment (i.e. you will be charged directly); reimbursement at a fixed 80% rate, whatever the expenses incurred; and expenses incurred will not contribute towards increasing FCA. CHIS members looking for an alternative are invited to consider “Clinique Générale Beaulieu” (located in the same area of Geneva and with which the existing agreement has been extended for 2012 and 2013) or another approved hospital (see the list on the CHIS web site). Note that, as a transitory measur...

  4. 13 CFR 120.1824 - How will an SISMBD receive notice of an approval or denial of a loan or request for an advance...

    Science.gov (United States)

    2010-01-01

    ... advance under an SISMBD Loan? (a) Applicants will receive notice of approval or denial of an SISMBD Loan... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false How will an SISMBD receive notice of an approval or denial of a loan or request for an advance under an SISMBD Loan? 120.1824 Section...

  5. 75 FR 66077 - Mahoning Creek Hydroelectric Company, LLC; Notice of Availability of Supplemental Environmental...

    Science.gov (United States)

    2010-10-27

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12555-004-PA] Mahoning Creek Hydroelectric Company, LLC; Notice of Availability of Supplemental Environmental Assessment... Energy Projects has reviewed the application for an original license for the Mahoning Creek Hydroelectric...

  6. 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 importance...

  7. 22 CFR 71.12 - Dietary supplements.

    Science.gov (United States)

    2010-04-01

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

  8. 76 FR 64237 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants Rule

    Science.gov (United States)

    2011-10-18

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

  9. 28 CFR 58.25 - Qualifications for approval as providers of a personal financial management instructional course.

    Science.gov (United States)

    2010-07-01

    ... of a personal financial management instructional course. 58.25 Section 58.25 Judicial Administration... Qualifications for approval as providers of a personal financial management instructional course. (a) Definition... personal financial management instructional course must be in compliance with all applicable laws and...

  10. Factors affecting initial disability allowance rates for the Disability Insurance and Supplemental Security Income programs: the role of the demographic and diagnostic composition of applicants and local labor market conditions.

    Science.gov (United States)

    Rupp, Kalman

    2012-01-01

    Various factors outside the control of decision makers may affect the rate at which disability applications are allowed or denied during the initial step of eligibility determination in the Social Security Disability Insurance (DI) and Supplemental Security Income (SSI) programs. In this article, using individual-level data on applications, I estimate the role of three important factors--the demographic characteristics of applicants, the diagnostic mix of applicants, and the local unemployment rate--in affecting the probability of an initial allowance and state allowance rates. I use a random sample of initial determinations from 1993 through 2008 and a fixed-effects multiple regression framework. The empirical results show that the demographic and diagnostic characteristics of applicants and the local unemployment rate substantially affect the initial allowance rate. An increase in the local unemployment rate tends to be associated with a decrease in the initial allowance rate. This negative relationship holds for adult DI and SSI applicants and for SSI childhood applicants.

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

    Science.gov (United States)

    Mattingly, T Joseph; Simoni-Wastila, Linda

    2017-10-01

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

  12. Comparison between human serum and Albuminar-20 (TM) supplement for in-vitro fertilization.

    Science.gov (United States)

    Staessen, C; Van den Abbeel, E; Carlé, M; Khan, I; Devroey, P; Van Steirteghem, A C

    1990-04-01

    Patient or fetal cord serum is commonly used as a protein supplement to culture media used in in-vitro fertilization (IVF). To eliminate the variability and possible hazards related to the use of human serum, a well-defined protein supplement, Albuminar-20 (Armour Pharmaceutical Cy) was evaluated as a substitute for serum. Prior to its application in the human, Earle's culture media supplemented with 0.5% (w/v) bovine serum albumin, 8% (v/v) decomplemented patient serum or 2.25% (v/v) Albuminar-20 were compared in a mouse bioassay. For the three different conditions, the percentages of blastocysts formed after 120 h in-vitro culture were respectively 91.2, 85.2 and 87.8% (NS). In the human IVF, a controlled comparison was performed from October to December 1988, between Earle's medium supplemented with patients' serum or Albuminar-20. When oocytes and spermatozoa were cultured in these two media, the fertilization rates were similar, 58.9% in human serum versus 59.4% in Albuminar-20. After further culture, the morphological quality of the cleaved embryos was better in the embryos cultured in Albuminar-20. The higher pregnancy rate in Albuminar-20 was correlated with the better morphological appearance of the embryos and their more advanced cleavage stage at the time of transfer. Therefore, Albuminar-20 can be considered as a suitable protein supplement in human IVF.

  13. Treatment Of Chronic Kidney Disease Patients With A Supplemented Low Protein Diet And A Supplemented Very Low Protein Diet

    Directory of Open Access Journals (Sweden)

    SV Subhramanyam

    2012-06-01

    Full Text Available The primary results of the Modification of Diet in Renal Disease were inconclusive and did confuse a lot of physicians about the dietary approach to CKD management. The study design was flawed and thus compromised the results and conclusions. Re-analysis of the MDRD study however clearly showed the benefits of dietary protein restriction and also more importantly an additional benefit by ketoanalogue supplementation in delaying progression of CKD. Despite the obvious benefits of protein restriction, concern has been raised recently especially patients on very low dietary protein (very-low-protein diets; VLPDs, which could lead to deterioration in the nutritional status of CKD patients. To address this particular issue of whether a sVLPD diet induces malnutrition the present study has been taken up 132 adult patients with Stage 3 to Stage 5 (Predialysis were initiated on a protein restricted ketoanalogue supplemented diet after informed consent and the necessary Institutional Ethics Committee approvals. Based on their affordability, 92 patients randomly were assigned to the sLPD group whereby they received 0.6 G/Kg BW of dietary proteins supplemented by ketoanalogues at a dosage of one tablet per 10 Kg body weight. 40 patients received 0.3 G/Kg BW supplemented by ketoanalogues at a dose of one tablet per 5 Kg body weight. Renolog® tablets manufactured by La Renon Healthcare Ltd, Ahmebabad, India were prescribed as the ketoanalogue supplements. Renal, Metabolic, Nutritional parameters and Anthropometric analysis were done in both groups at the start of the study and at the end of 6 months of follow up. The mean blood urea in the SLPD group showed a decrease from 81.17+_ 00 mg/dl to 74.45+_30.75 mg/dl (p0.05 at the end of six months indicating an improvement in renal function . The serum creatinine also showed a decrease from 3.52+_00 mg/dl to 3.30 +_1.63 mg/dl(p>0.05 in the SLPD group and a decrease from 3.74+_00 mg/dl to 3.55+_1.67

  14. Medication and Supplement Use in Disability Football World Championships.

    Science.gov (United States)

    Broman, Daniel; Ahmed, Osman Hassan; Tscholl, Philippe M; Weiler, Richard

    2017-10-01

    overuse of medication and supplements in disability football, particularly in the use of nonsteroidal anti-inflammatory drugs. These trends are comparable to previous research in Fédération Internationale de Football Association World Cup competitions. Not applicable. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  15. 49 CFR 1522.109 - TSA review and approval.

    Science.gov (United States)

    2010-10-01

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

  16. 49 CFR 1522.115 - Renewal of TSA approval.

    Science.gov (United States)

    2010-10-01

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

  17. 29 CFR 1952.157 - Changes to approved plan.

    Science.gov (United States)

    2010-07-01

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

  18. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

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

  19. 78 FR 47822 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2013-08-06

    ..., Glendale, NY 11386. LIRR and NYA jointly seek approval of the proposed discontinuance of the automatic..., S72, and S73 will be removed, as well as the pipe-connected center-lock crossover equipment on...

  20. Incorporating consideration of health impacts into land use development approval processes: Development of a Health Background Study Framework.

    Science.gov (United States)

    Moloughney, Brent W; Bursey, Gayle E; Neumann, Jana; Leeming, Daniel H; Gutmann, Christine E; Sivanand, Bhavna; Mowat, David L

    2014-09-12

    This project involved development of a Health Background Study (HBS) Framework to support consideration of health impacts within municipalities' approval process for land use development. Peel Public Health and Toronto Public Health led the project with the participation of planners, urban designers, engineers, public health staff and development industry representatives. Historical growth in the Region of Peel and suburban Toronto has resulted in extensive low-density development, creating car-dependent communities with disconnected streets and segregated land uses. The inclusion of an HBS in developers' applications to municipalities is one approach by which health-related expectations for the built environment can be established within the approval process. Development of the HBS Framework used the six core elements of the built environment with the strongest evidence for impact on health and was informed by analysis of the provincial and local policy contexts, practices of other municipalities and stakeholder interviews. The Framework's contents were refined according to feedback from multidisciplinary stakeholder workshops. The HBS Framework identifies minimum standards for built environment core elements that developers need to address in their applications. The Framework was created to be simple and instructive with applicability to a range of development locations and scales, and to various stages of the development approval process. Peel Public Health is leading several initiatives to support the use of the HBS as a part of the development application process. The HBS Framework is a tool that public health and planning can use to support the consideration of health impacts within municipalities' land use development processes.

  1. Mineral supplementation for grazing ruminants

    International Nuclear Information System (INIS)

    McDowell, L.R.; Conrad, J.H.; Ellis, G.L.

    1986-01-01

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

  2. 76 FR 44583 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-07-26

    ... designated method are manufactured in an ISO 9001-registered facility. Also, an applicant must submit a minor... of Management and Budget (OMB) for review and approval. This is a request to renew an existing... and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725...

  3. 75 FR 69658 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-11-15

    ... Activities; Submission to OMB for Review and Approval; Comment Request; Experimental Use Permits (EUPs) for... activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of... instrument or form, if applicable. Abstract: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA...

  4. 20 CFR 226.16 - Supplemental annuity.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Supplemental annuity. 226.16 Section 226.16... EMPLOYEE, SPOUSE, AND DIVORCED SPOUSE ANNUITIES Computing an Employee Annuity § 226.16 Supplemental annuity. A supplemental annuity is payable in addition to tiers I and II and the vested dual benefit to an...

  5. 33 CFR 115.70 - Advance approval of bridges.

    Science.gov (United States)

    2010-07-01

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

  6. The effectiveness of a mobile application for the development of palpation and ultrasound imaging skills to supplement the traditional learning of physiotherapy students.

    Science.gov (United States)

    Fernández-Lao, Carolina; Cantarero-Villanueva, Irene; Galiano-Castillo, Noelia; Caro-Morán, Elena; Díaz-Rodríguez, Lourdes; Arroyo-Morales, Manuel

    2016-10-19

    Mobile learning (m-learning) has becoming very popular in education due to the rapidly advancing technology in our society. The potentials of the mobile applications should be used to enhance the education process. Few mobile applications have been designed to complement the study of physical therapy skills for physiotherapy students. The aim of this study was to investigate whether a mobile application, as a supplement to traditional learning, is useful for physiotherapy students in the acquisition of palpation and ultrasound skills in the shoulder area. Forty-nine students participated in this single-blinded, randomized controlled study. They were randomly distributed into two groups: experimental, with free access to the mobile application; and control, with access to traditional learning materials on the topic. Objective structured clinical evaluation (OSCE) and multiple-choice questionnaire (MCQ) were used to assess the educational intervention. Then, we also assessed the time taken to get a reliable ultrasound image and to localize a specific shoulder structure by palpation. There was no significant intergroup difference in the acquisition of theoretical knowledge (p = .089). Scores were significantly higher in the experimental group than in the control group for the majority items in the ultrasound assessment; positioning of patient (p physiotherapy students.

  7. Oral potassium supplementation in surgical patients.

    Science.gov (United States)

    Hainsworth, Alison J; Gatenby, Piers A

    2008-08-01

    Hospital inpatients are frequently hypokalaemic. Low plasma potassium levels may cause life threatening complications, such as cardiac arrhythmias. Potassium supplementation may be administered parenterally or enterally. Oral potassium supplements have been associated with oesophageal ulceration, strictures and gastritis. An alternative to potassium salt tablets or solution is dietary modification with potassium rich food stuffs, which has been proven to be a safe and effective method for potassium supplementation. The potassium content of one medium banana is equivalent to a 12 mmol potassium salt tablet. Potassium supplementation by dietary modification has been shown to be equally efficacious to oral potassium salt supplementation and is preferred by the majority of patients. Subsequently, it is our practice to replace potassium using dietary modification, particularly in surgical patients having undergone oesophagogastrectomy or in those with peptic ulcer disease.

  8. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Science.gov (United States)

    2013-12-27

    ... FDA's review of the change. The proposed rule published without a reference or a link to the... comments received, go to http://www.regulations.gov and insert the docket number(s), found in brackets in... rulemaking. The proposed rule published without reference or a link to the accompanying Regulatory Impact...

  9. 78 FR 67985 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

    Science.gov (United States)

    2013-11-13

    ... add or strengthen a statement about drug abuse, dependence, psychological effect, or overdosage; To... other aspect of labeling protected by patent or exclusivity. FDA has generally taken the position that a... patients with diabetes. Source: Published literature, epidemiologic study.'' iii. The basis for the...

  10. Directory of certificates of compliance for radioactive materials packages. Volume 3, Revision 14: Report of NRC approved quality assurance programs for radioactive materials packages

    International Nuclear Information System (INIS)

    1994-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  11. Creatine supplementation and swim performance: a brief review.

    Science.gov (United States)

    Hopwood, Melissa J; Graham, Kenneth; Rooney, Kieron B

    2006-03-01

    Nutritional supplements are popular among athletes participating in a wide variety of sports. Creatine is one of the most commonly used dietary supplements, as it has been shown to be beneficial in improving performance during repeated bouts of high-intensity anaerobic activity. This review examines the specific effects of creatine supplementation on swimming performance, and considers the effects of creatine supplementation on various measures of power development in this population. Research performed on the effect of creatine supplementation on swimming performance indicates that whilst creatine supplementation is ineffective in improving performance during a single sprint swim, dietary creatine supplementation may benefit repeated interval swim set performance. Considering the relationship between sprint swimming performance and measurements of power, the effect of creatine supplementation on power development in swimmers has also been examined. When measured on a swim bench ergometer, power development does show some improvement following a creatine supplementation regime. How this improvement in power output transfers to performance in the pool is uncertain. Although some evidence exists to suggest a gender effect on the performance improvements seen in swimmers following creatine supplementation, the majority of research indicates that male and female swimmers respond equally to supplementation. A major limitation to previous research is the lack of consideration given to the possible stroke dependant effect of creatine supplementation on swimming performance. The majority of the research conducted to date has involved examination of the freestyle swimming stroke only. The potential for performance improvements in the breaststroke and butterfly swimming strokes is discussed, with regards to the biomechanical differences and differences in efficiency between these strokes and freestyle. Key PointsCreatine supplementation does not improve single sprint

  12. Enhancement of sperm motility and viability by turmeric by-product dietary supplementation in roosters.

    Science.gov (United States)

    Yan, Wenjing; Kanno, Chihiro; Oshima, Eiki; Kuzuma, Yukiko; Kim, Sung Woo; Bai, Hanako; Takahashi, Masashi; Yanagawa, Yojiro; Nagano, Masashi; Wakamatsu, Jun-Ichi; Kawahara, Manabu

    2017-10-01

    Improving sperm motility and viability are major goals to improve efficiency in the poultry industry. In this study, the effects of supplemental dietary turmeric by-product (TBP) from commercial turmeric production on sperm motility, viability, and antioxidative status were examined in domestic fowl. Mature Rhode Island Red roosters were divided into two groups - controls (groupC) without TBP administration and test subjects (groupT) fed a basal diet supplemented with 0.8g of TBP/day in a temperature-controlled rearing facility (Experiment 1) and 1.6g/day under heat stress (Experiment 2) for 4 weeks. In Experiment 1, TBP dietary supplementation increased the sperm motility variables straight-line velocity, curvilinear velocity, and linearity based on a computer-assisted semen analysis, 2 weeks following TBP supplementation. In Experiment 2, using flow cytometry, sperm viability at 3 and 4 weeks following TBP supplementation was greater in Group T than C, and this increase was consistent with a reduction in reactive oxygen species (ROS) production at 2 and 4 weeks. The results of both experiments clearly demonstrate that dietary supplementation with TBP enhanced sperm motility in the controlled-temperature conditions as well as sperm viability, and reduced ROS generation when heat stress prevailed. Considering its potential application in a range of environments, TBP may serve as an economical and potent antioxidant to improve rooster fertility. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Should You Take Dietary Supplements?

    Science.gov (United States)

    ... 2013 Print this issue Should You Take Dietary Supplements? A Look at Vitamins, Minerals, Botanicals and More ... Gut in Check Wise Choices Safe Use of Supplements Tell all of your health care providers about ...

  14. Trends in approval times for genetically engineered crops in the United States and the European Unio

    NARCIS (Netherlands)

    Smart, Richard D.; Blum, Matthias; Wesseler, J.H.H.

    2017-01-01

    Genetically engineered (GE) crops are subject to regulatory oversight to Ensure their safety for humans and the environment. Their approval in the European Union (EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political

  15. 77 FR 50936 - Approval and Promulgation of Air Quality Implementation Plans; Nevada; Regional Haze State and...

    Science.gov (United States)

    2012-08-23

    ... Letter at page 6. EPA's BART guidelines did not establish bright-line thresholds for cost- effectiveness... applicable thresholds for incremental cost-effectiveness or visibility improvement for the reasons discussed... thresholds for cost-effectiveness or visibility improvement, or challenge EPA's authority to approve a BART...

  16. E-Approval Plans in Research Libraries

    Science.gov (United States)

    Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

    2014-01-01

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

  17. Clarification of TMI action plan requirements. Requirements for emergency response capability

    International Nuclear Information System (INIS)

    1983-01-01

    This document, Supplement 1 to NUREG-0737, is a letter from D. G. Eisenhut, Director of the Division of Licensing, NRR, to licensees of operating power reactors, applicants for operating licenses, and holders of construction permits forwarding post-TMI requirements for emergency response capability which have been approved for implementation. On October 30, 1980, the NRC staff issued NUREG-0737, which incorporated into one document all TMI-related items approved for implementation by the Commission at that time. In this NRC report, additional clarification is provided regarding Safety Parameter Display Systems, Detailed Control Room Design Reviews, Regulatory Guide 1.97 (Revision 2) - Application to Emergency Response Facilities, Upgrade of Emergency Operating Procedures, Emergency Response Facilities, and Meteorological Data

  18. 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...

  19. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Science.gov (United States)

    2010-05-24

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

  20. Safety evaluation report related to the operation of Catawba Nuclear Station, Units 1 and 2 (Docket Nos. 50-413 and 50-414). Supplement 2

    International Nuclear Information System (INIS)

    1984-06-01

    This report supplements the Safety Evaluation Report (NUREG-0954) and Supplement 1 with respect to the application filed by Duke Power Company, North Carolina Municipal Power Agency Number 1, North Carolina Membership Corporation, and Saluda River Electric Cooperative, Inc., as applicants and owners, for licenses to operate the Catawba Nuclear Station, Units 1 and 2 (Docket Nos., 50-413 and 50-414, respectively). The facility is located in York County, South Carolina, approximately 9.6 km (6 mi) north of Rock Hill and adjacent to Lake Wylie. This supplement provides more recent information regarding resolution or updating of some of the open and confirmatory issues and license conditions identified in the Safety Evaluation Report

  1. 25 CFR 224.82 - What activities will the Department continue to perform after approval of a TERA?

    Science.gov (United States)

    2010-04-01

    ... assist the tribe in evaluating the physical, economic, financial, cultural, social, environmental, and... AND SELF DETERMINATION ACT Implementation of Tribal Energy Resource Agreements Applicable Authorities and Responsibilities § 224.82 What activities will the Department continue to perform after approval...

  2. 25 CFR 103.16 - How does BIA approve or reject a loan guaranty or insurance application?

    Science.gov (United States)

    2010-04-01

    ..., or if necessary, from liquidating loan collateral. Lenders are expected to obtain a first lien security interest in enough collateral to reasonably secure repayment of each loan guaranteed or insured... 25 Indians 1 2010-04-01 2010-04-01 false How does BIA approve or reject a loan guaranty or...

  3. Safety Evaluation Report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). Supplement No. 4

    International Nuclear Information System (INIS)

    1986-09-01

    This report supplements the Safety Evaluation Report (NUREG-1047, February 1985) for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate Nine Mile Point Nuclear Station, Unit 2 (Docket No. 50-410). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. Supplement 1 to the Safety Evaluation Report was published in June 1985, and contained the report from the Advisory Committee on Reactor Safeguards as well as the resolution of a number of outstanding issues from the Safety Evaluation Report. Supplement 2 was published in November 1985, and contained the resolution of a number of outstanding and confirmatory issues. Supplement 3 was published in July 1986, and contained the resolution of a number of outstanding and confirmatory items, one new confirmatory item, the evaluation of the Engineering Assurance Program, and evaluation of a number of exemption requests

  4. Dietary Supplements: What You Need to Know

    Science.gov (United States)

    ... Food Home Food Resources for You Consumers Dietary Supplements: What You Need to Know Share Tweet Linkedin ... and nutrients you personally need. What are dietary supplements? Dietary supplements include such ingredients as vitamins, minerals, ...

  5. 7 CFR 1710.105 - State regulatory approvals.

    Science.gov (United States)

    2010-01-01

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

  6. 14 CFR 414.9 - Pre-application consultation.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Pre-application consultation. 414.9 Section 414.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.9 Pre-application...

  7. 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...

  8. 24 CFR 232.505 - Application and application fee.

    Science.gov (United States)

    2010-04-01

    ... approval. An application for insurance of a fire safety loan under this part shall be considered only in... HOUSING AND URBAN DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND...

  9. Perspectives used for gaining approval of budgets.

    Science.gov (United States)

    Franks-Joiner, G L

    1990-01-01

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

  10. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

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

  11. 78 FR 15402 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-11

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

  12. 78 FR 11947 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-02-20

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

  13. 78 FR 17281 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-20

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

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

    Science.gov (United States)

    2012-03-20

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

  15. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

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

  16. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

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

  17. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

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

  18. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-06-11

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

  19. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

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

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

    Science.gov (United States)

    2012-09-11

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