WorldWideScience

Sample records for claims draft guidance

  1. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) t to draft guidance on scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. This guidance has been drawn from scientific...... opinions of the NDA Panel on such health claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document should include an exhaustive list of beneficial effects...

  2. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to physical performance

    DEFF Research Database (Denmark)

    Tetens, Inge

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) to draft guidance on scientific requirements for health claims related to physical performance. This guidance has been drawn from scientific opinions of the NDA Panel on such health...... claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in this area. It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which...

  3. Guidance on the scientific requirements for health claims related to gut and immune function

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to gut and immune function. This guidance has been drawn from scientific opinions of the NDA Panel on such health......, was subjected to public consultation (28 September 2010 to 22 October 2010), and was also discussed at a technical meeting with experts in the field on 2 December 2010 in Amsterdam....

  4. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Science.gov (United States)

    2012-06-11

    ... recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in..., submit either electronic or written comments on the draft guidance by September 10, 2012. ADDRESSES... electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http...

  5. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health

    DEFF Research Database (Denmark)

    Tetens, Inge

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) has been asked by the European Food Safety Authority (EFSA) to draft guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. This guidance has been drawn from scientific opinions...

  6. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Science.gov (United States)

    2010-09-27

    ... fermented dairy products, such as yogurt, belong to a separate category that is not relevant to the... the draft guidance, processors of non-acidified foods (e.g., some acid foods or fermented foods) who... regulations. Under the draft guidance, processors of acid foods and fermented foods who conclude that such...

  7. EFSA Panel on Dietetic Products, Nutrition and Allerg ies (NDA) ; Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations

    DEFF Research Database (Denmark)

    Tetens, Inge

    The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. This guidance has been drawn from scientific...... and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out in order to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document, endorsed...

  8. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Science.gov (United States)

    2010-10-14

    ...] Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance provides... Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance...

  9. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Science.gov (United States)

    2011-02-28

    ...] Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication... a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion... Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance is...

  10. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2010-08-16

    ... provides this draft guidance for public review and comment to ensure accessibility of Federal accounting... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting... recommended Federal GHG reporting and accounting procedures. On April 5, 2010, DOE-FEMP submitted the final...

  11. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Science.gov (United States)

    2013-11-15

    ... placing preparation and cooking instructions on frozen French fry packages. Lastly, the draft guidance is... high-temperature cooking. The draft guidance is intended to suggest a range of possible approaches to... during certain types of high-temperature cooking, and is a concern because it can cause cancer in...

  12. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Science.gov (United States)

    2012-04-25

    ...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in... Cosmetic Products.'' The draft guidance is intended to assist industry in identifying the potential safety...

  13. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Science.gov (United States)

    2013-02-26

    ... components, including Source Plasma. The guidance announced in this notice replaces the draft guidance... before it begins work on the final version of the guidance, submit either electronic or written comments... the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit...

  14. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Science.gov (United States)

    2011-06-29

    ...] International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances... Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International... that a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances'' should be made...

  15. 78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

    Science.gov (United States)

    2013-02-25

    ...; formerly 2005D-0183] Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... 20852. FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug Evaluation and Research, Food...

  16. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

    ... final version of the guidance, submit either electronic or written comments on the draft guidance by... electronic access to the guidance document. Submit electronic comments on the draft guidance to http://www... body tissue or fluid (e.g., blood, plasma, cerebrospinal fluid). Drug response results from the...

  17. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Science.gov (United States)

    2013-12-04

    ... information technology. Under the draft guidance, outsourcing facilities that elect to register should submit... guidance provides information on how an outsourcing facility should submit facility registration...] Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under...

  18. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ...] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability...) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis... of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the...

  19. FSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Guidance on the scientific requirements for health claims related to functions of the ne rvous system, including psycholog ical functions

    DEFF Research Database (Denmark)

    Tetens, Inge

    The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to draft guidance on scientific requirements for health claims related to functions of the nervous system, including psychological functions. This guidance has been drawn from scientific opinions......, and was released for public consultation from 17 October 2011 to 16 December 2011....

  20. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Science.gov (United States)

    2012-11-09

    ... appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time... nucleic acids extracted from a single appropriate human specimen or culture. For the purposes of this... diseases. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good...

  1. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... 20852. FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug Evaluation and Research, Food...

  2. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

  3. 75 FR 32791 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Science.gov (United States)

    2010-06-09

    ... FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will...] Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and...

  4. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Science.gov (United States)

    2013-05-31

    ..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism... final version of the guidance, submit either electronic or written comments on the draft guidance by... INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the...

  5. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Science.gov (United States)

    2011-12-30

    ...] Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Use of Histology in Biomarker... studies for which histology is a reference standard. This guidance discusses the processes that should be...

  6. 76 FR 9529 - Migratory Birds; Draft Eagle Conservation Plan Guidance

    Science.gov (United States)

    2011-02-18

    ...-1231-9BPP] RIN 1018-AX53 Migratory Birds; Draft Eagle Conservation Plan Guidance AGENCY: Fish and... mail to: Attention: Eagle Conservation Plan Guidance; Division of Migratory Bird Management; U.S. Fish... implementing statutes including the Bald and Golden Eagle Protection Act (BGEPA), the Migratory Bird Treaty Act...

  7. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Science.gov (United States)

    2012-07-06

    ... the draft guidance are not applicable to donors of Source Plasma. DATES: Although you can comment on... electronic or written comments on the draft guidance by September 4, 2012. ADDRESSES: Submit written requests...-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the...

  8. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Science.gov (United States)

    2013-04-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

  9. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Science.gov (United States)

    2012-07-27

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...

  10. 78 FR 18273 - Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of...

    Science.gov (United States)

    2013-03-26

    .... FDA-2013-D-0269] Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the... availability of a draft guidance entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated With... seafood processors who purchase reef fish how to minimize the risk of ciguatera fish poisoning (CFP) from...

  11. 77 FR 11564 - Draft Policy on Consultation With Alaska Native Claims Settlement Act Corporations

    Science.gov (United States)

    2012-02-27

    ... Claims Settlement Act Corporations AGENCY: Office of the Secretary, Interior. ACTION: Notice of... draft policy on consultation with Alaska Native Claims Settlement Act corporations. DATES: Submit...-199, this consultation policy also applies to corporations established under the Alaska Native Claims...

  12. 75 FR 55797 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Science.gov (United States)

    2010-09-14

    ...] Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral... entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment... announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection...

  13. 75 FR 37450 - Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing...

    Science.gov (United States)

    2010-06-29

    ... animals in order to help minimize antimicrobial resistance development. Based on a consideration of the...] Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals... Medically Important Antimicrobial Drugs in Food- Producing Animals.'' This draft guidance is intended to...

  14. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Science.gov (United States)

    2012-11-23

    ...] Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

  15. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Science.gov (United States)

    2011-08-30

    ...] Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tablet Scoring... should be met to facilitate the evaluation and labeling of tablets that have been scored. (A scoring...

  16. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  17. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

  18. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Science.gov (United States)

    2010-06-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...

  19. 75 FR 1060 - Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure...

    Science.gov (United States)

    2010-01-08

    .... This draft guidance applies to manufacturers of drug and therapeutic biologic products regulated by...: General preparedness through employee education and immunization, Prioritization of manufactured products... of information technology. The draft guidance recommends that manufacturers of drug and therapeutic...

  20. Draft Updates to the Planning for Natural Disaster Debris Guidance and to Related Documents

    Science.gov (United States)

    EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.

  1. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Science.gov (United States)

    2011-02-03

    ...; formerly Docket No. 00D-0892] Draft Guidance on Positron Emission Tomography Drug Applications--Content and... Applications for Certain Positron Emission Tomography Drug Products; Availability,'' issued on March 10, 2000... and ANDAs.'' The draft guidance is intended to assist manufacturers of certain positron emission...

  2. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ...] Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers... Solvents in Animal Drug Products; Questions and Answers.'' The draft questions and answers (Q&A) guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human...

  3. The UK's Draft Guidance for Health in SEA in light of HIA community priorities and the UNECE SEA Protocol

    International Nuclear Information System (INIS)

    Posas, Paula J.

    2011-01-01

    The Protocol on Strategic Environmental Assessment (SEA) to the United Nations Economic Commission for Europe (UNECE) Espoo Convention came into force on 11 July 2010. This Protocol, to which the European Union is party, gives a legal basis for enhanced attention to human health in the SEA process. In this context, the United Kingdom's (UK's) 2007 Draft Guidance on Health in Strategic Environmental Assessment represents an important early government-led effort to bring health issues and public health considerations more significantly into the SEA process. Since the UK is a worldwide leader in environmental and various other types of impact assessment, and since other countries may eventually consider its example in efforts to meet UNECE SEA Protocol requirements, scrutiny of its outputs is warranted. This paper thus examines the UK's Draft Guidance from both HIA academic and practitioner perspectives. First it assesses the extent to which the Draft Guidance reflects recent issues and lessons learned in the academic literature. In order to make the assessment, a meta-analysis of 70 HIA-related peer-reviewed articles was undertaken to extract authors' priority recommendations. These recommendations were subsequently compared with the contents of the Draft Guidance. Secondly, the Draft Guidance was assessed for its accordance with recommendations of the UNECE SEA Protocol background paper written by two HIA practitioners. Overall, the Draft Guidance's accordance with both sets of recommendations was found to be high, with only a few easily-remedied gaps. This evaluation suggests that the UK's Draft Guidance can be a useful starting point in the creation of future guidance on health in SEA in both the UK and other countries.

  4. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Science.gov (United States)

    2011-05-02

    ..., you may submit written requests for single copies of the draft guidance to the Office of Communication... critical to ensuring a reusable device is appropriately prepared for its next use. II. Significance of.... 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on...

  5. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Science.gov (United States)

    2011-12-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  6. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Science.gov (United States)

    2010-08-12

    ...] Draft Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production... entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... on how to comply with certain provisions contained in FDA's final rule ``Prevention of Salmonella...

  7. 77 FR 48990 - Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility...

    Science.gov (United States)

    2012-08-15

    ...] Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and... industry entitled ``Necessity of the Use of Food Categories in Food Facility Registrations and Updates to... announcing the availability of a draft guidance for industry entitled ``Necessity of the Use of Food...

  8. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Science.gov (United States)

    2012-02-27

    ... proposed information collected is necessary for the proper performance of FDA's functions, including... the draft guidance for industry entitled: ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products'' (Absenteeism Draft Guidance) published in the Federal...

  9. 78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance

    Science.gov (United States)

    2013-07-03

    .... ML13056A516. NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21... current or future applicants The NRC staff has no intention to impose the draft ISG positions on existing... of the effective date of this guidance The NRC staff has no intention to impose the draft ISG...

  10. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Science.gov (United States)

    2011-03-15

    ...] Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With...

  11. General scientific guidance for stakeholders on health claim applications

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2016-01-01

    of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5, 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need...... based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, when additional issues are addressed.......The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to update the General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims published in March 2011. Since then, the NDA Panel has completed the evaluation...

  12. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... draft guidance before it begins work on the final version of the guidance, submit written or electronic..., prescribing, advertising, manufacturing, promotion, marketing, and use in the practice of medicine. Not...

  13. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  14. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...

  15. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Science.gov (United States)

    2011-03-23

    .... in human foods and direct-human-contact animal foods. It does not create or confer any rights for or... Animal Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... ``Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods.'' The draft guidance...

  16. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

  17. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability AGENCY... guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies...

  18. 78 FR 17660 - Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles...

    Science.gov (United States)

    2013-03-22

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9792-9] Draft Guidance for E85 Flexible Fuel Vehicle... draft EPA guidance to auto manufacturers for weighting the greenhouse gas (GHG) emissions of a flexible... all federal government work days from 8:30 a.m. to 4:30 p.m.; generally, it is open Monday through...

  19. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

  20. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

  1. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Science.gov (United States)

    2010-01-20

    ... conferencing and electronic submissions, Mammography Matters, and other device-oriented information. A search... or electronic comments on the draft guidance by April 20, 2010. ADDRESSES: Submit written requests... the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit...

  2. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Science.gov (United States)

    2012-02-24

    ...] Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment... Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (c...

  3. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2010-07-16

    ... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting... Greenhouse Gas Accounting and Reporting.'' SUMMARY: On October 5, 2009, President Obama signed Executive Order (E.O.) 13514--Federal Leadership in Environmental, Energy, and Economic Performance (74 FR 52117...

  4. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Science.gov (United States)

    2012-03-13

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.

  5. 78 FR 14791 - Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and...

    Science.gov (United States)

    2013-03-07

    ... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation AGENCY...) has issued a Federal Financial Accounting Technical Release Exposure Draft entitled Implementation...

  6. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Science.gov (United States)

    2010-08-31

    ...] Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and... guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document is intended to describe FDA's current policies with respect to civil money penalties and no...

  7. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Science.gov (United States)

    2013-06-26

    ... Therapy.'' This draft guidance is being issued consistent with FDA's good guidance practices regulation... all promotional materials including promotional labeling as well as advertisements intended for... the intended time of initial dissemination of the labeling or initial publication of the advertisement...

  8. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

    ... performance of medical devices in women. This information can be of benefit to patients and their medical... draft guidance before it begins work on the final version of the guidance, submit either electronic or...

  9. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  10. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

  11. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Science.gov (United States)

    2010-08-17

    ...] (formerly Docket No. 1999D-4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary...) entitled ``Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients... 2001 final guidance), has been developed for veterinary use by the International Cooperation on...

  12. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-09-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0928] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive... guidance for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food...

  13. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Science.gov (United States)

    2011-08-24

    ...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug...

  14. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ... electronic or written comments on the draft guidance by April 5, 2011. ADDRESSES: Submit written requests for... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not...

  15. Public Comment Period Open for the Draft Update to the Planning for Natural Disaster Debris Guidance and to Related Documents

    Science.gov (United States)

    EPA is requesting comment on the draft Planning for Natural Disaster Debris Guidance, and two other documents. The Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.

  16. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2010-09-28

    ... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

  17. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  18. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage... ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA... trials that are specifically focused on the treatment of patients with established Alzheimer's disease...

  19. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...

  20. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Science.gov (United States)

    2013-07-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0322... of good manufacturing practices. It also describes FDA's intended sampling and enforcement approach... the guidance, submit either electronic or written comments on the draft guidance by September 13, 2013...

  1. 76 FR 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

    Science.gov (United States)

    2011-03-14

    ...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...

  2. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-05-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and...

  3. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... organization. These 16 Panels have largely been the driving force for CDRH's internal organizational structure...). The draft guidance, when finalized, will represent the Agency's current thinking on medical device...

  4. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

  5. Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health (Revision 1)

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2018-01-01

    of additional health claim applications related to antioxidants, oxidative damage and cardiovascular health, and the information collected from a Grant launched in 2014. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the antioxidants......EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. The update takes into accounts experiences gained with evaluation......, oxidative damage and cardiovascular health. The document was subject to public consultation (from 12 July to 3 September 2017). This document supersedes the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011...

  6. Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2)

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2017-01-01

    EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim published in 2011. Since then, the NDA Panel has gained considerable experience...... developments in this area. This guidance document presents a common format for the organisation of information for the preparation of a well-structured application for authorisation of health claims which fall under Articles 13(5), 14 and 19 of Regulation (EC) No 1924/2006. This guidance outlines...... the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim....

  7. Implications of the new Food and Drug Administration draft guidance on human factors engineering for diabetes device manufacturers.

    Science.gov (United States)

    Wilcox, Stephen B; Drucker, Daniel

    2012-03-01

    This article discusses the implications of the new Food and Drug Administration's draft guidance on human factors and usability engineering for the development of diabetes-related devices. Important considerations include the challenge of identifying users, when the user population is so dramatically broad, and the challenge of identifying use environments when the same can be said for use environments. Another important consideration is that diabetes-related devices, unlike many other medical devices, are used constantly as part of the user's lifestyle--adding complexity to the focus on human factors and ease of use emphasized by the draft guidance. © 2012 Diabetes Technology Society.

  8. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0433; (formerly Docket No. 2007D-0169)] Draft Guidance for Industry on Bioequivalence Recommendation for...) Acceptable fasting and fed bioequivalence studies on the 25 mg strength, (2) proportional similarity of the...

  9. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Science.gov (United States)

    2012-04-25

    ...] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes... Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food... determining whether changes in manufacturing process, including the intentional reduction in particle size to...

  10. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  11. 77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Science.gov (United States)

    2012-11-29

    ...] Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy... Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,'' dated November... Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this...

  12. 75 FR 78705 - Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP...

    Science.gov (United States)

    2010-12-16

    ... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP&E and Implementation Guidance for Estimating the Historical Cost of G-PP&E AGENCY: Federal Accounting Standards Advisory Board. ACTION: Notice. Board Action...

  13. 77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

    Science.gov (United States)

    2012-02-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0081] Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  14. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ...] Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm...

  15. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Science.gov (United States)

    2012-08-15

    ...] Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in... ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of... suicidal ideation and behavior in clinical trials of drug and biological products, including drugs for...

  16. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-11-07

    ... Microbiology Devices Advisory Panel (the panel) recommended that in vitro diagnostic devices for Yersinia spp...). The draft guidance, when finalized will represent the Agency's current thinking on in vitro diagnostic...

  17. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Science.gov (United States)

    2012-03-02

    ... considers your comment on this draft guidance before it begins work on the final version of the guidance... National Health and Nutrition Examination Survey (NHANES) indicate widespread exposure of the general... effects. The ubiquitous presence of phthalates in the environment and the potential consequences of human...

  18. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...

  19. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Science.gov (United States)

    2013-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  20. 77 FR 5415 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents, Certified...

    Science.gov (United States)

    2012-02-03

    ... in order to be excluded from the organic certification requirements of Part 205. The NOSB recommended... handling operations that are or are not excluded from organic certification. The draft guidance proposes... excluded from certification and, therefore, must be certified organic operations. \\1\\ NOSB Recommendation...

  1. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... Ministry of Health, Labour and Welfare system. This notice of availability and draft guidance satisfy the... collection of information is necessary for the proper performance of FDA's functions, including whether the...

  2. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Science.gov (United States)

    2013-09-20

    ... the endocrine system. This draft guidance also discusses factors to consider in determining the need... interfere with some aspect of the endocrine system of an organism or its progeny. Any component of the endocrine system can be a target of endocrine disruptors, although the systems most commonly affected...

  3. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Science.gov (United States)

    2013-04-01

    ..., or Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and... biological product. This draft guidance describes the Agency's current thinking on how it intends to... review of biosimilar biological products. Because these meetings often will represent critical points in...

  4. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  5. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  6. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-12-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0928] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive... for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food...

  7. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

  8. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Science.gov (United States)

    2011-01-07

    ... appropriate FDA organizational unit responsible for adverse event reporting compliance when these conditions... regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking... appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions...

  9. 78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

    Science.gov (United States)

    2013-02-28

    ... FDA review staff in making decisions about the placement and content of pediatric information in human... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic...] Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

  10. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Science.gov (United States)

    2012-02-27

    ... Oversight of PET Drug Products--Questions and Answers.'' The draft guidance provides questions and answers... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... PET Drug Products--Questions and Answers.'' In 1997, Congress passed the Food and Drug Administration...

  11. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Science.gov (United States)

    2013-12-04

    ... reporting of product information by registered outsourcing facilities under section 503B of the FD&C Act... collection techniques, when appropriate, and other forms of information technology. Under the draft guidance... report should include the following information for all drugs compounded by the outsourcing facility...

  12. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Science.gov (United States)

    2013-03-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0168] Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  13. 75 FR 29350 - Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as...

    Science.gov (United States)

    2010-05-25

    ...] Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established.... The agency is also seeking comments from industry on the Reportable Food Registry requirements, and... the implementation of the Reportable Food Registry on September 8, 2009, and informs industry about...

  14. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  15. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...

  16. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...

  17. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  18. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  19. 78 FR 9709 - Draft Guidance Regarding Voluntary Inspection of Vessels for Compliance With the Maritime Labour...

    Science.gov (United States)

    2013-02-11

    ... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2012-1066] Draft Guidance Regarding Voluntary Inspection of Vessels for Compliance With the Maritime Labour Convention, 2006 AGENCY: Coast Guard... Labour Convention, 2006 (Convention), which enters into force on August 20, 2013. The NVIC will provide...

  20. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Science.gov (United States)

    2012-10-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...

  1. 78 FR 63218 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Science.gov (United States)

    2013-10-23

    ...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6360, Silver...

  2. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Science.gov (United States)

    2013-11-20

    ...] Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and... entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.'' When... promotional labeling and advertising for prescription human drugs, including biological drug products, and...

  3. General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    to nutrition and health claims, and establishes rules governing the Community authorisation of health claims made on foods. This general guidance is a combined and updated version of two previous briefing documents (frequently asked question document related to the assessment of Article 14 and 13.5 health...... of available scientific evidence, pertinent studies for substantiation of health claims, wording of claims, the extent to which a food needs to be characterised for the claimed effect, claimed effects which are beneficial physiological effects, definition of a risk factor for the development of a human disease...

  4. 77 FR 40354 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft

    Science.gov (United States)

    2012-07-09

    ... through the UIC Class II Program, the well class for oil and gas activities. Geothermal activities are not... inject diesel fuels during hydraulic fracturing related to oil, gas, or geothermal operations must obtain... geothermal activities, the draft guidance only covers hydraulic fracturing using diesel fuels related to oil...

  5. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  6. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  7. 77 FR 36273 - Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

    Science.gov (United States)

    2012-06-18

    ... duration and well closure; area of review; information submitted with the permit application; and... Fracturing Activities Using Diesel Fuels--Draft: Underground Injection Control Program Guidance 84.'' The... permits under the Safe Drinking Water Act to ensure protection of underground sources of drinking water...

  8. 78 FR 44483 - Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of...

    Science.gov (United States)

    2013-07-24

    ... written requests for single copies of the draft guidance to the Division of Plant and Dairy Food Safety/Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-315), Food and Drug..., Center for Food Safety and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 Paint Branch...

  9. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Science.gov (United States)

    2011-08-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

  10. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  11. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Science.gov (United States)

    2013-11-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  12. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  13. 76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

    Science.gov (United States)

    2011-08-29

    ... 200N, Rockville, MD 20852-1448; or the Office of Communication, Education and Radiation Programs... describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies... appropriate, and other forms of information technology. Title: Draft Guidance for Industry: Oversight of...

  14. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0090] Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability... familiar and less familiar approaches. As more experience is obtained with the less familiar designs...

  15. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “Consideration of the Effects of Climate...

    Science.gov (United States)

    2010-02-23

    ..., ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Consideration of the Effects of Climate Change... visionary and versatile law that can be used effectively to address new environmental challenges facing our...

  16. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ...] Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for...

  17. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  18. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Science.gov (United States)

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  19. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...

  20. 77 FR 31858 - Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk...

    Science.gov (United States)

    2012-05-30

    ... of the drug. This draft guidance is intended to assist applicants in designing trials to support...., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that... Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tatiana...

  1. 78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-07-02

    ... collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT...-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be...-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER...

  2. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

  3. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  4. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Science.gov (United States)

    2010-11-12

    ... annually from approximately 25 application holders. FDA professionals familiar with Dear Health Care... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0319] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters...

  5. General Drafting. Technical Manual.

    Science.gov (United States)

    Department of the Army, Washington, DC.

    The manual provides instructional guidance and reference material in the principles and procedures of general drafting and constitutes the primary study text for personnel in drafting as a military occupational specialty. Included is information on drafting equipment and its use; line weights, conventions and formats; lettering; engineering charts…

  6. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Science.gov (United States)

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  7. 76 FR 60937 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-02; Aging Management Program for Steam...

    Science.gov (United States)

    2011-09-30

    ...-2011-02; Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION... License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam... using Revision 3 of NEI 97-06 to manage steam generator aging. The Draft LR-ISG revises the NRC staff's...

  8. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  9. Ethical and social implications of microdosing clinical trial (2). The draft guidance and the future tasks

    International Nuclear Information System (INIS)

    Kurihara, Chieko

    2008-01-01

    Draft of the guidance (GD) for conducting the trial in the title (MCT) was officially announced by Ministry of Health, Labour and Welfare (MHLW) in Dec., 2007, but where the trial part alone was described without the research purposes involved in the starting idea of MCT. The authority invited opinions on the draft until Feb., 2008. This paper describes the detailed content of GD draft and discusses problems in future. GD draft contains: basic concept, range of non-clinical studies necessary for beginning MCT, methods to decide the maximal dose, concept for internal exposure of volunteers when radio-labeled compound is to be administered (for methods by accelerator mass spectrometry (AMS) and positron emission tomography (PET)), quality assurance of the test compound, other notices, and references. The last item contains outlines of concerned laws and regulations (e.g., The Law Concerning Prevention from Radiation Hazards due to Radioisotopes, Etc. and Medical Law); nuclides for AMS (mainly, 14 C) (manufacturing and transporting the test compound containing 14 C, its distribution from MCT client to hospitals, handling in the hospital, and transporting of samples from hospital to AMS facility); and nuclides for PET. Public opinions collected by MHLW will decide the directions hereafter of GD, i.e. the omitted research purposes are additionally incorporated in the present GD draft or are independently described in another newer GD. (R.T.)

  10. Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1)

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    The scientific and technical guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies for the preparation and presentation of an application for authorisation of a health claim presents a common format for the organisation of information for the preparation of a well......-structured application for authorisation of health claims which fall under Article 14 (referring to children’s development and health, and to disease risk reduction claims), or 13(5) (which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data......), or for the modification of an existing authorisation in accordance with Article 19 of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs...

  11. Regulatory guidance for license renewal

    International Nuclear Information System (INIS)

    Thoma, John A.

    1991-01-01

    The proposed 10 CFR Part 54 rule proceduralizes the process for license renewal by identifying both the administrative and technical requirements for a renewal application. To amplify and support this regulation, written guidance has been provided in the form of a draft Regulatory Guide (DG 1009) and a draft Standard Review Plan for License Renewal (NUREG 1299). This guidance is scheduled to be finalized in 1992. Similar guidance will be provided for the proposed revisions to 10 CFR Part 51 concerning the environmental aspects of license renewal. (author)

  12. Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

    Science.gov (United States)

    Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee

    2018-05-01

    Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.

  13. 76 FR 66925 - Guidance for 1-Hour SO2

    Science.gov (United States)

    2011-10-28

    ...The EPA is announcing an extension of the public comment period for its draft non-binding guidance titled, ``Guidance for 1-Hour SO2 SIP Submissions.'' The draft of the guidance document is currently on the EPA's Web site. The EPA is extending the comment period for an additional 30-day period and invites public comments on this guidance during this period. The EPA plans to issue an updated version of the guidance after reviewing timely submitted comments.

  14. Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A. [Nuclear Regulatory Commission, Washington, DC (United States). Div. of Industrial and Medical Nuclear Safety; Tingle, W. [Dept. of Environment, Health, and Natural Resources, Raleigh, NC (United States). Div. of Radiation Protection

    1997-05-01

    As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ``Applications for the Use of Sealed Sources in Portable Gauging Devices,`` and in NMSs Policy and guidance Directive 2-07, ``Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.`` This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications.

  15. Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

    International Nuclear Information System (INIS)

    Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A.; Tingle, W.

    1997-05-01

    As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ''Applications for the Use of Sealed Sources in Portable Gauging Devices,'' and in NMSs Policy and guidance Directive 2-07, ''Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.'' This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications

  16. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...

  17. CIVIL PROTECTION MECHANISM OF THE ASSIGNEE RIGHTS BASED ON THE PATENT CLAIM

    Directory of Open Access Journals (Sweden)

    N. V. Marchenko

    2014-04-01

    Full Text Available Purpose. Statistical analysis of inventive activity in Ukraine shows that the largest number of applications is submitted by employees of universities and research institutions – almost 60% of all inventions. Practice of inventions execution proves that for researchers, especially for students, the most difficult part of the application and author documents is the claim. The purpose of research is a synthesis and supplying the general principles of quality drafting the patent claim, providing further legal protection of the patent. Methodology. Monitoring and analysis of the world documentary informational flow through the civil protection mechanism of the assignee rights on the basis of the patent claim allows us to compare the world systems of formulas development and summarize some key moments concerning the point in question. The example analysis of the correct patent claim drafting and its interpretation in court cases on intellectual property was made. Findings. The specific properties of the patent claim were described. They are conciseness, latitude, completeness and certainty, compliance with unity requirements and novelty of the invention. On the basis of the research it is established that there is a great difference between Ukrainian and American patent claims. A number of common mistakes and shortcomings during the claim drafting were identified. The need to restore the various forms of the invention training in universities of Ukraine was emphasized, since on this basis one should train a number of specialists who are able to carry out the commercialization of intellectual property results into productive findings. Originality. A number of issues and techniques was investigated and summarized. They can be applied by the courts in interpreting of the patent claim in the processing of intellectual property cases. Especially it concerns determining the correct drafting of the patent claim. Practical value. This work may be used

  18. Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2016-01-01

    The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to gut and immune function published in 2011. Since then, the NDA Panel has completed the evaluation...... the shortcomings that prevented the substantiation of these claims. The general document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, in the light of experiences gained from the evaluation...

  19. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Science.gov (United States)

    2013-02-22

    ... medical devices to take timely action to correct violative devices or remove them from the marketplace...] Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for... draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting...

  20. 76 FR 61098 - Guidance for 1-Hour SO2

    Science.gov (United States)

    2011-10-03

    ...Notice is hereby given that the EPA has posted its draft non- binding guidance titled, ``Guidance for 1-Hour SO2 NAAQS SIP Submissions'' on its Web site. The EPA invites public comments on this guidance document during the comment period specified below, and plans to issue an updated version of the guidance after reviewing timely submitted comments.

  1. 78 FR 49782 - Interim Staff Guidance on Changes During Construction

    Science.gov (United States)

    2013-08-15

    ... Construction AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment... During Construction.'' This ISG provides guidance to the NRC staff on the Preliminary Amendment Request...-ISG-025 ``Interim Staff Guidance on Changes during Construction under 10 CFR Part 52'' is available...

  2. [International trend of guidance for nanomaterial risk assessment].

    Science.gov (United States)

    Hirose, Akihiko

    2013-01-01

    In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

  3. Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

    DEFF Research Database (Denmark)

    Satya, Sneha; Wade, Mike; Hass, Ulla

    This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing and Asses......This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing...... on testing and assessment of endocrine disrupters (EDTA AG). In November 2010, comments were requested from the WNT, the EDTA AG, the Task Force on Hazard Assessment and experts involved in the assessment of chemicals. The EDTA AG addressed the comments from the WNT at a meeting held in April 2011...... the conclusions and next steps recommended in the draft guidance document are sensible and helpful when assessed in light of comprehensive datasets. The draft guidance document and the three case studies were reviewed again and revised at a meeting of the EDTA AG in December 2011. The draft guidance document...

  4. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Science.gov (United States)

    2013-08-07

    ... guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. ``Qualifying for... to the pharmaceutical industry. In most cases, FDA has developed other guidances and resources to... guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients''--issued April 1998...

  5. Draft Guidance for Protective Action Strategies Development

    Energy Technology Data Exchange (ETDEWEB)

    Park, Sang Hyun; Jeong, Seung Young; Kim, Wanjoo [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2016-10-15

    National nuclear emergency preparedness and response (EPR) framework has been improved since the Fukushima accident in 2011. There are still many needs to be amended and improved in regulatory requirements and technical criteria to warrant efficacy of the EPR framework. As an important part of the framework, protective actions have to be implemented with optimized and justified manner during whole emergency phases. In this study, to enhance protective action strategies in response to severe accident or general emergency, existing procedures were reviewed. And generic guidance to develop protective action recommendations (PARs) was proposed considering revised EPZ and recent technical information on protective action strategies. The generic guidance for PARs based on facility status was introduced. Revision of EPZ and some recent information on protective action strategies, such as staged evacuation, specific approach for rapidly progressing accident were considered. It would be employed as a basis to develop site-specific strategies of PARs and regulatory guidance for emergency plan by nuclear licensee. It was focused on an early phase of nuclear emergency. Further efforts to develop site specific strategies of PARs and strategies which cover full range of nuclear emergency would be followed by several stake holders.

  6. Claim prevention at reactor facilities

    International Nuclear Information System (INIS)

    Colby, B.P.

    1987-01-01

    Why does a radiation worker bring a claim alleging bodily injury from radiation exposure? Natural cancer, fear of radiation induced cancer, financial gain, emotional distress and mental anguish are some reasons for workers' claims. In this paper the author describes what power reactor health physicists are doing to reduce the likelihood of claims by establishing programs which provide sound protection of workers, prevent radiological events, improve workers' knowledge of radiological conditions and provide guidance for radiological incident response

  7. 76 FR 64327 - Office of Oceanic and Atmospheric Research Draft Strategic Plan

    Science.gov (United States)

    2011-10-18

    ...: 111003608-1608-01] Office of Oceanic and Atmospheric Research Draft Strategic Plan AGENCY: Office of Oceanic... notice announces that OAR's draft Strategic Plan (FY12- 18) is available for public review and comment... next six years. These goals and objectives will provide guidance and strategic direction for program...

  8. 75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-04-09

    ... Guide, DG-8036, ``Personnel Monitoring Device--Direct-Reading Pocket Dosimeters.'' FOR FURTHER.... The draft regulatory guide (DG), entitled, ``Personnel Monitoring Device--Direct-Reading Pocket... this guide included guidance on indirect-reading pocket dosimeters, this guide excludes such dosimeters...

  9. Canada’s Guideline 9: improving SOGIE claims assessment?

    Directory of Open Access Journals (Sweden)

    Moira Dustin

    2017-10-01

    Full Text Available Asylum seekers making claims relating to their sexual orientation and gender identity often face unfair refusal. New guidance from the Immigration and Refugee Board of Canada takes admirable steps towards improving claims assessment, and offers a model for practitioners elsewhere.

  10. Regulatory systems-based licensing guidance documentation

    International Nuclear Information System (INIS)

    Delligatti, M.S.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) has developed a series of licensing guidance documents based on the regulatory requirements in Part 60 of Title 10 of the Code of Federal Regulations (10 CFR Part 60). This regulatory systems-based approach to licensing guidance documentation relies on the definition of the high-level waste repository in 10 CFR Part 60. A document which is important for the frame-work it gives to other programmatic licensing guidance is the Draft Regulatory Guide open-quotes Format and Content for the License Application for the High-Level Waste Repositoryclose quotes (FCRG). The FCRG describes a format and content acceptable to NRC for a high-level waste repository license application pursuant to the requirements of 10 CFR Part 60. Other licensing guidance documents will be compatible with the FCRG

  11. 77 FR 14507 - Revision to Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2012-03-12

    ... accounting procedures. CEQ provides this draft revision of the guidance for public review and comment to... COUNCIL ON ENVIRONMENTAL QUALITY Revision to Guidance, ``Federal Greenhouse Gas Accounting and..., ``Federal Greenhouse Gas Accounting and Reporting''. SUMMARY: On October 5, 2009, President Obama signed...

  12. Guidance on Port Biological Baseline Surveys (PBBS)

    Digital Repository Service at National Institute of Oceanography (India)

    Awad, A.; Haag, F.; Anil, A.C.; Abdulla, A.

    This publication has been prepared by GBP, IOI, CSIR-NIO and IUCN in order to serve as guidance to those who are planning to carry out a port biological baseline survey, in particular in the context of Ballast Water Management. It has been drafted...

  13. 78 FR 54949 - Major Project Financial Plan Guidance

    Science.gov (United States)

    2013-09-06

    ...'' (GA-090-751). That report recommended that Financial Plans include the cost of financing the project... Project Financial Plan Guidance AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice; Request for comments. SUMMARY: This notice requests comments on draft Major Project Financial Plan...

  14. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Science.gov (United States)

    2012-03-08

    ...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...

  15. 77 FR 64999 - Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility...

    Science.gov (United States)

    2012-10-24

    ...] Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and... industry entitled ``Necessity of the Use of Food Product Categories in Food Facility Registrations and... made available a draft guidance entitled ``Guidance for Industry: Necessity of the Use of Food [[Page...

  16. 76 FR 11506 - Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind Energy...

    Science.gov (United States)

    2011-03-02

    ...] RIN 1018-AX45 Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind... Impacts from Wind Turbines (Interim Guidance). As stated in the notice, the comment period on the draft... Minimizing Wildlife Impacts from Wind Turbines. We expect to issue final Guidelines for public use after...

  17. 75 FR 78231 - Management of Energy and Water Efficiency in Federal Buildings: Availability of Guidance

    Science.gov (United States)

    2010-12-15

    ... Water Efficiency in Federal Buildings: Availability of Guidance AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of availability. SUMMARY: This notice of availability... regarding Federal agency implementation of energy and water efficiency requirements. The draft Guidance for...

  18. PRN 2002-X Draft: False or Misleading Pesticide Product Brand Name

    Science.gov (United States)

    This notice provides guidance to registrants and distributors on pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. It is a draft.

  19. Use of health care claims data to study patients with ophthalmologic conditions.

    Science.gov (United States)

    Stein, Joshua D; Lum, Flora; Lee, Paul P; Rich, William L; Coleman, Anne L

    2014-05-01

    To describe what information is or is not included in health care claims data, provide an overview of the main advantages and limitations of performing analyses using health care claims data, and offer general guidance on how to report and interpret findings of ophthalmology-related claims data analyses. Systematic review. Not applicable. A literature review and synthesis of methods for claims-based data analyses. Not applicable. Some advantages of using claims data for analyses include large, diverse sample sizes, longitudinal follow-up, lack of selection bias, and potential for complex, multivariable modeling. The disadvantages include (a) the inherent limitations of claims data, such as incomplete, inaccurate, or missing data, or the lack of specific billing codes for some conditions; and (b) the inability, in some circumstances, to adequately evaluate the appropriateness of care. In general, reports of claims data analyses should include clear descriptions of the following methodological elements: the data source, the inclusion and exclusion criteria, the specific billing codes used, and the potential confounding factors incorporated in the multivariable models. The use of claims data for research is expected to increase with the enhanced availability of data from Medicare and other sources. The use of claims data to evaluate resource use and efficiency and to determine the basis for supplementary payment methods for physicians is anticipated. Thus, it will be increasingly important for eye care providers to use accurate and descriptive codes for billing. Adherence to general guidance on the reporting of claims data analyses, as outlined in this article, is important to enhance the credibility and applicability of findings. Guidance on optimal ways to conduct and report ophthalmology-related investigations using claims data will likely continue to evolve as health services researchers refine the metrics to analyze large administrative data sets. Copyright

  20. 78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

    Science.gov (United States)

    2013-11-13

    ... New Reactors and Specific Environmental Guidance for Integral Pressurized Water Reactors Reviews... Environmental Issues Associated with New Reactors'' and draft ISG ESP/ COL-ISG-027, ``Interim Staff Guidance on...://www.regulations.gov and search for Docket ID NRC-2013-0212 for ESP/COL- ISG-026 or NRC-2013-0211 for...

  1. A concept taxonomy and an instrument hierarchy: tools for establishing and evaluating the conceptual framework of a patient-reported outcome (PRO) instrument as applied to product labeling claims.

    Science.gov (United States)

    Erickson, Pennifer; Willke, Richard; Burke, Laurie

    2009-01-01

    To facilitate development and evaluation of a PRO instrument conceptual framework, we propose two tools--a PRO concept taxonomy and a PRO instrument hierarchy. FDA's draft guidance on patient reported outcome (PRO) measures states that a clear description of the conceptual framework of an instrument is useful for evaluating its adequacy to support a treatment benefit claim for use in product labeling the draft guidance, however does not propose tools for establishing or evaluating a PRO instrument's conceptual framework. We draw from our review of PRO concepts and instruments that appear in prescription drug labeling approved in the United States from 1997 to 2007. We propose taxonomy terms that define relationships between PRO concepts, including "family,"compound concept," and "singular concept." Based on the range of complexity represented by the concepts, as defined by the taxonomy, we propose nine instrument orders for PRO measurement. The nine orders range from individual event counts to multi-item, multiscale instruments. This analysis of PRO concepts and instruments illustrates that the taxonomy and hierarchy are applicable to PRO concepts across a wide range of therapeutic areas and provide a basis for defining the instrument conceptual framework complexity. Although the utility of these tools in the drug development, review, and approval processes has not yet been demonstrated, these tools could be useful to improve communication and enhance efficiency in the instrument development and review process.

  2. 75 FR 29768 - Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of...

    Science.gov (United States)

    2010-05-27

    ... manufacturers of plasma derivatives with comprehensive FDA recommendations intended to minimize the possible...CJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance). DATES: Submit electronic... the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit...

  3. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

  4. 75 FR 63551 - Guides for the Use of Environmental Marketing Claims

    Science.gov (United States)

    2010-10-15

    ... general principles that apply to all environmental marketing claims and provide specific guidance... Part II Federal Trade Commission 16 CFR Part 260 Guides for the Use of Environmental Marketing... Marketing Claims AGENCY: Federal Trade Commission. ACTION: Proposed revisions to guidelines. SUMMARY: The...

  5. Draft project management update to the Iowa DOT Project Development Manual : final report.

    Science.gov (United States)

    2016-08-01

    This work supported drafting project management guidance for the Iowa Department of Transportation (DOT). The goal is to : incorporate a greater focus on project management in their project development process. : A technical advisory committee (TAC) ...

  6. Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under Regulation (EC 1924/2006 in the area of oral health

    Directory of Open Access Journals (Sweden)

    Daniela Martini

    2018-03-01

    Clinical significance: The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims related to oral health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such health claims.

  7. Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.

    Science.gov (United States)

    Schneider, Lon S

    2014-03-01

    The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  8. Thinking Differently about Guidance: Power, Children's Autonomy and Democratic Environments

    Science.gov (United States)

    Millei, Zsuzsa

    2012-01-01

    This article critiques guidance approaches to discipline, that are employed in early childhood environments with an aim to create democratic environments for children, and as part of "good" practices. Advocates of guidance claim that this is a more humane or democratic approach to discipline that empowers children, and therefore, power…

  9. Guidance for Reviewing OCSPP 850.2100 Avian Oral Toxicity Studies Conducted with Passerine Birds

    Science.gov (United States)

    Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.

  10. Comments on OECD discussion draft on revisions to Chapter I of the Transfer Pricing Guidelines

    NARCIS (Netherlands)

    Burgers, Irene; van Herwaarden, A.J.

    2015-01-01

    These comments provide recommendations for improved transfer pricing guidance and were submitted in response to an invitation by the OECD to interested parties to submit written comments on a discussion draft regarding the OECD Transfer Pricing Guidelines

  11. 76 FR 4072 - Registration of Claims of Copyright

    Science.gov (United States)

    2011-01-24

    ... of published photographs should contact the Visual Arts Division for permission and guidance on... online registration has been available for basic registration claims, it has not yet been made generally... is registered is primarily photographic in nature. In fact, the Visual Arts Division has accepted...

  12. International investment agreements and public health: neutralizing a threat through treaty drafting.

    Science.gov (United States)

    Mercurio, Bryan

    2014-07-01

    The high profile investment claims filed by Philip Morris challenging Uruguayan and Australian measures that restrict advertising and logos on tobacco packaging awakened the public health community to the existence and potential detrimental impact of international investment agreements (IIAs). More recently, Eli Lilly challenged Canada's invalidation of a pharmaceutical patent under an IIA. All of the cases claim that the intellectual property rights of the investor were infringed. As a result of these cases, many commentators and activists view IIAs as a threat to public health and have lobbied against their inclusion in ongoing trade negotiations. This article does not argue against IIAs. Instead, it seeks to demonstrate how more sophisticated treaty drafting can neutralize the threat to public health. In this regard, the article seeks to engage members of the public health community as campaigners not against IIAs but as advocates of better treaty drafting to ensure that IIAs do not infringe upon the right of a nation to take non-discriminatory measures for the promotion and protection of the health of their populations.

  13. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Science.gov (United States)

    2013-11-07

    ... for such products. These inconsistent interpretations of the definitions may inadvertently result in... amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is... of clarity regarding how the Agency defines a hearing aid versus a personal sound amplification...

  14. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Science.gov (United States)

    2010-11-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0584... Products.'' This guidance updates recommendations regarding degradation products and updates the draft... information on listing of degradation products, setting acceptance criteria, and qualifying degradation...

  15. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Science.gov (United States)

    2012-10-01

    ... bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft... infection caused by bacterial pathogens that show resistance to most antibacterial drugs on in vitro...

  16. Offsite dose calculation manual guidance: Standard radiological effluent controls for boiling water reactors

    International Nuclear Information System (INIS)

    Meinke, W.W.; Essig, T.H.

    1991-04-01

    This report contains guidance which may be voluntarily used by licensees who choose to implement the provision of Generic Letter 89-- 01, which allows Radiological Effluent Technical Specifications (RETS) to be removed from the main body of the Technical Specifications and placed in the Offsite Dose Calculation Manual (ODCM). Guidance is provided for Standard Effluent Controls definitions, Controls for effluent monitoring instrumentation, Controls for effluent releases, Controls for radiological environmental monitoring, and the basis for Controls. Guidance on the formulation of RETS has been available in draft form for a number of years; the current effort simply recasts those RETS into Standard Radiological Effluent Controls for application to the ODCM. 11 tabs

  17. Building America Guidance for Identifying and Overcoming Code, Standard, and Rating Method Barriers

    Energy Technology Data Exchange (ETDEWEB)

    Cole, P. C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Halverson, M. A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2013-09-01

    This guidance document was prepared using the input from the meeting summarized in the draft CSI Roadmap to provide Building America research teams and partners with specific information and approaches to identifying and overcoming potential barriers to Building America innovations arising in and/or stemming from codes, standards, and rating methods.

  18. Evaluation of mercury speciation by EPA (Draft) Method 29

    Energy Technology Data Exchange (ETDEWEB)

    Laudal, D.L.; Heidt, M.K. [Energy & Environmental Research Center, Grand Forks, ND (United States); Nott, B. [Electric Power Research Institute, Palo Alto, CA (United States)

    1995-11-01

    The 1990 Clean Air Act Amendments require that the U.S. Environmental protection Agency (EPA) assess the health risks associated with mercury emissions. Also, the law requires a separate assessment of health risks posed by the emission of 189 tract chemicals (including mercury) for electric utility steam-generating units. In order to conduct a meaningful assessment of health and environmental effects, we must have, among other things, a reliable and accurate method to measure mercury emissions. In addition, the rate of mercury deposition and the type of control strategies used may depend upon the type of mercury emitted (i.e., whether it is in the oxidized or elemental form). It has been speculated that EPA (Draft) Method 29 can speciate mercury by selective absorption; however, this claim has yet to be proven. The Electric Power Research Institute (EPRI) and the U.S. Department of Energy (DOE) have contracted with the Energy & Environmental Research Center (EERC) at University of North Dakota to evaluate EPA (Draft) Method 29 at the pilot-scale level. The objective of the work is to determine whether EPA (Draft) Method 29 can reliably quantify and speciate mercury in the flue gas from coal-fired boilers.

  19. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Science.gov (United States)

    2011-01-07

    ... Web page at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm . FDA guidances are issued and updated regularly. We recommend you check the Web site to ensure that you have the most up-to-date... electronic diaries provided by study subjects. When paper source documents are available for review, tracing...

  20. Offsite dose calculation manual guidance: Standard radiological effluent controls for pressurized water reactors

    International Nuclear Information System (INIS)

    Meinke, W.W.; Essig, T.H.

    1991-04-01

    This report contains guidance which may be voluntarily used by licensees who choose to implement the provision of Generic Letter 89-01, which allows Radiological Effect Technical Specifications (RETS) to be removed from the main body of the Technical Specifications and placed in the Offsite Dose Calculation Manual (ODCM). Guidance is provided for Standard Effluent Controls definitions, Controls for effluent monitoring instrumentation, Controls for effluent releases, Controls for radiological environmental monitoring, and the basis for Controls. Guidance on the formulation of RETS has been available in draft from (NUREG-0471 and -0473) for a number of years; the current effort simply recasts those RETS into Standard Radiological Effluent Controls for application to the ODCM. Also included for completeness are: (1) radiological environmental monitoring program guidance previously which had been available as a Branch Technical Position (Rev. 1, November 1979); (2) existing ODCM guidance; and (3) a reproduction of generic Letter 89-01

  1. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 167.55-1... NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... aft to the location of the draft marks, due to a raked stem or cut away skeg, the draft must be...

  2. An Assessment of the Political and Social Feasibility of a Peacetime Draft

    Science.gov (United States)

    1988-12-01

    exists, individuals who possess the most lucrative job opportunities would be expected "to spend more to avoid payment of the conscript tax ." [Ref. 12...7 c. Social Equity --...- .....-.--.-..............--------- ----------- 8 2. The Draft and the Conscription Tax ------------------ 9 3. The AVF and...47 c. William Blackstone - ----------- ---------------47 3. The Erosion of Popular Acceptance of a Call to Arms------ 47 a. The Military Claim

  3. Draft PRN 2006-A: Use of Antimicrobial Pesticide Products in Heating, Ventilation, Air Conditioning and Refrigeration Systems (HVAC&R)

    Science.gov (United States)

    This draft notice provides guidance to registrants of EPA-registered antimicrobial products whose labels bear general directions related to hard, non-porous or porous surfaces, but which are not but which are not specifically registered for HVAC uses.

  4. Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

    Science.gov (United States)

    Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

    2008-07-01

    The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

  5. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... products. This guidance revises the guidance for industry entitled ``Clinical Development Programs for... Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville...

  6. 75 FR 33629 - Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors...

    Science.gov (United States)

    2010-06-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0168... workshop will be held at the Holiday Inn College Park, 10000 Baltimore Ave., College Park, MD 20740. FOR... intended to assist the agency in developing draft guidance for industry on describing practices for naming...

  7. Health and Stress Management and Mental-health Disability Claims.

    Science.gov (United States)

    Marchand, Alain; Haines, Victor Y; Harvey, Steve; Dextras-Gauthier, Julie; Durand, Pierre

    2016-12-01

    This study examines the associations between health and stress management (HSM) practices and mental-health disability claims. Data from the Salveo study was collected during 2009-2012 within 60 workplaces nested in 37 companies located in Canada (Quebec) and insured by a large insurance company. In each company, 1 h interviews were conducted with human resources managers in order to obtain data on 63 HSM practices. Companies and workplaces were sorted into the low-claims and high-claims groups according to the median rate of the population of the insurer's corporate clients. Logistic regression adjusted for design effect and multidimensional scaling was used to analyse the data. After controlling for company size and economic sector, task design, demands control, gratifications, physical activity and work-family balance were associated with low mental-health disability claims rates. Further analyses revealed three company profiles that were qualified as laissez-faire, integrated and partially integrated approaches to HSM. Of the three, the integrated profile was associated with low mental-health disability claims rates. The results of this study provide evidence-based guidance for a better control of mental-health disability claims. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  8. International guidance activities

    International Nuclear Information System (INIS)

    Richardson, Allan C.B.

    1989-01-01

    International principles for setting Protective Action Guides (PAGs) are contained in two key documents that contain identical statements. One is Publication Number 40 of the ICRP, which was issued in 1985. The title is 'Protection of the Public in the Event of Major Radiation Accidents, Principles for Planning'. The other is the IAEA's Safety Series Publication Number 72, also issued in 1985, written by many of the same authors and titled, 'Principles for Establishing Intervention Levels'. The principles that were set forth in these documents were identical, were incomplete, and they are, unfortunately, the only principles that are now in effect, while proposed revisions go through one draft after another. There are several such draft revisions that are of significance. The most important is that of the ICRP. The basic guidance that applies to most planned exposure to radiation is ICRP Publication 26. That document has been under revision by the Commission for a number of years, and the new version will, for the first time, include recommendations for emergency response. They are now getting close to closure, and I think it should be a very much improved and useful document. But it isn't finished yet. Such guidance doesn't get developed in a vacuum, and there have been a couple of parallel efforts which have provided significant input to the ICRP, which is essentially a behind-closed-doors effort. These other efforts are more open. One of these is being carried out within the IAEA, which has convened annual meetings of national experts for a number of years in Vienna, to generate a replacement for Safety Series No. 72, mentioned earlier. There is a meeting scheduled this December to complete this effort; and, hopefully, we will reach closure at that meeting on at least the basic principles. The Nuclear Energy Agency (NEA) has also been at work. It has convened a group of experts from member nations that have been developing recommendations. There is an overlap

  9. 77 FR 55480 - Draft Compliance Policy Guide Sec. 690.150 on Labeling and Marketing of Nutritional Products...

    Science.gov (United States)

    2012-09-10

    ... purpose of this CPG is to communicate FDA's strategy with respect to dog and cat food products that are... for Use To Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats; Availability AGENCY..., Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is intended to provide guidance to FDA...

  10. Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006

    Science.gov (United States)

    Bedogni, Giorgio; Biasini, Beatrice; Zavaroni, Ivana; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Bonadonna, Riccardo C.; Passeri, Giovanni

    2018-01-01

    Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function. PMID:29443929

  11. Computer Assisted Drafting (CNC) Drawings. Drafting Module 6. Instructor's Guide.

    Science.gov (United States)

    Missouri Univ., Columbia. Instructional Materials Lab.

    This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. This unit contains information on computer-assisted drafting drawings. The guide contains a cross-reference table of instructional materials and 20 worksheets.…

  12. Summary of comments received on staff draft proposed rule on radiological criteria for decommissioning

    International Nuclear Information System (INIS)

    Caplin, J.; Page, G.; Smith, D.; Wiblin, C.

    1994-08-01

    The Nuclear Regulatory Commission (NRC) is conducting an enhanced participatory rulemaking to establish radiological criteria for the decommissioning of NRC licensed facilities. The NRC obtained comments on the scope, issues, and approaches through a series of workshops (57 FR 58727), Generic Environmental Impact Statement (GEIS) scoping meetings (58 FR 33570), a dedicated electronic bulletin board system (58 FR 37760), and written submissions. A summary of workshop and scope-meeting comments was published as NUREG/CR-6156. On February 2, 1994, the Commission published in the Federal Register (59 FR 4868) a notice that the NRC staff had prepared a ''staff draft'' proposed rule on radiological criteria for decommissioning. Copies of the staff draft were distributed to the Agreement States, participants in the earlier meetings, and other interested parties for comment. This report summarizes the comments identified from the 96 docketed letters received on the staff draft. No analysis or response is included in this report. The comments reflect a broad spectrum of viewpoints. Two subjects on which the commenters were in general agreement were (1) that the enhanced participatory rulemaking should proceed, and (2) that the forthcoming GEIS and guidance documents are needed for better understanding of the draft rule

  13. 78 FR 78822 - Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals-Acoustic...

    Science.gov (United States)

    2013-12-27

    ... Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals--Acoustic Threshold Levels for... available in electronic form via the Internet at http://www.nmfs.noaa.gov/pr/acoustics/ . You may submit...: Acoustic Guidance. Instructions: All comments received are a part of the public record and will generally...

  14. New IAEA guidance on safety culture

    International Nuclear Information System (INIS)

    Haage, Monica; )

    2012-01-01

    Monica Haage described a project for Kozloduy Nuclear Power Plant in Bulgaria which was also funded by the Norwegian government. This project included the development of guidance documents and training on self-assessment and continuous improvement of safety culture. A draft IAEA safety culture survey was also developed as part of this project in collaboration with St Mary's University, Canada. This project was conducted in parallel with an IAEA project to develop new safety reports on safety culture self-assessment and continuous improvement. A safety report on safety culture during the pre-operational phases of NPPs has also been drafted. The IAEA approach to safety culture assessment was outlined and core principles of the approach were discussed. These include the use of several assessment methods (survey, interview, observation, focus groups, document review), and two distinct levels of analysis. The first is a descriptive analysis of the observed cultural characteristics from each assessment method and overarching themes. This is followed by a 'normative' analysis comparing what has been observed with the desirable characteristics of a strong, positive, safety culture, as defined by the IAEA safety culture framework. The application of this approach during recent Operational Safety Assessment Review Team (OSART) missions was described along with key learning points

  15. Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under European Community Regulation 1924/2006 in the area of appetite ratings and weight management.

    Science.gov (United States)

    Martini, Daniela; Biasini, Beatrice; Rossi, Stefano; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Del Rio, Daniele

    2018-06-01

    All the requests for authorisation to bear health claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing health claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such claims.

  16. NRC ARDC Guidance Support Status Report

    Energy Technology Data Exchange (ETDEWEB)

    Holbrook, Mark R. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2017-07-01

    This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”

  17. NRC ARDC Guidance Support Status Report

    International Nuclear Information System (INIS)

    Holbrook, Mark R.

    2017-01-01

    This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”

  18. Basic Drafting. Revised.

    Science.gov (United States)

    Schertz, Karen

    This introductory module on drafting includes the technical content and tasks necessary for a student to be employed in an entry-level drafting occupation. The module contains 18 instructional units that cover the following topics: introduction to drafting; tools and equipment; supplies and materials; sketching; scales; drawing format; lettering;…

  19. Guidance and justification in particularistic ethics.

    Science.gov (United States)

    Kihlbom, U

    2000-10-01

    This paper argues that, contrary to a common line of criticism followed by scholars such as Helga Kuhse, a particularistic version of virtue ethics properly elaborated, can provide sound moral guidance and a satisfactory account for moral justification of our opinions regarding, for instance, health care practice. In the first part of the paper, three criteria for comparing normative theories with respect to action-guiding power are outlined, and it is argued that the presented particularistic version of virtue ethics actually can provide more guidance than the universalistic theories followed by Kuhse and others. In the second part of the paper it is claimed that universalist normative theories have serious problems accounting for the role that moral principles are supposed to play in the justification, of moral opinions, whereas the present version of virtue ethics accommodates a plausible alternative idea of justification without invoking moral principles or eschewing objectivity.

  20. Draft guidance notes for the protection of persons against ionising radiations arising from veterinary use

    International Nuclear Information System (INIS)

    1983-01-01

    These guidance notes have been prepared for those who use ionising radiation for diagnostic purposes in veterinary practice, either in private practices or in larger institutions. Ancillary activities such as the testing and calibration of equipment are also covered by these notes so far as they are carried out on the same premises. The guidance notes indicate procedures for the protection of all persons who may be exposed as a result of these practices, that is to say all employed and self-employed persons, apprentices and students, and members of the public. (author)

  1. 76 FR 62087 - Draft Conservation Plan and Draft Environmental Assessment; Dunes Sagebrush Lizard, Texas

    Science.gov (United States)

    2011-10-06

    ...] Draft Conservation Plan and Draft Environmental Assessment; Dunes Sagebrush Lizard, Texas AGENCY: Fish... draft Texas Conservation Plan for the Dunes Sagebrush Lizard (TCP). The draft TCP will function as a... the Applicant for the dunes sagebrush lizard (Sceloporus arenicolus) throughout its range in Texas...

  2. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-11-20

    ... (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical... Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft... 20852-1448. Send one self-addressed adhesive label to assist the office in processing your request. The...

  3. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Science.gov (United States)

    2011-02-03

    ... this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to... Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of...

  4. 31 CFR 500.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 500.406 Section 500.406 Money and Finance: Treasury Regulations Relating to... ASSETS CONTROL REGULATIONS Interpretations § 500.406 Drafts under irrevocable letters of credit...

  5. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 515.406 Section 515.406 Money and Finance: Treasury Regulations Relating to... CONTROL REGULATIONS Interpretations § 515.406 Drafts under irrevocable letters of credit; documentary...

  6. Drafting method of electricity and electron design

    International Nuclear Information System (INIS)

    Gungbon, Junchun

    1989-11-01

    This book concentrates on drafting of electricity and electron design. It deals with The meaning of electricity and electron drafting JIS standard regulation the types of drafting and line and letter, basics drafting with projection drafting method, plan projection and development elevation, Drafting method of shop drawing, practical method of design and drafting, Design and drafting of technic and illustration, Connection diagram, Drafting of wiring diagram for light and illumination, Drafting of development connection diagram for sequence control, Drafting of logic circuit sign of flow chart and manual, drafting for a electron circuit diagram and Drawing of PC board.

  7. 76 FR 34097 - Notice of Availability of the Draft Environmental Impact Statement, Including a Draft...

    Science.gov (United States)

    2011-06-10

    ... Impact Statement, Including a Draft Programmatic Agreement, for the Clark, Lincoln, and White Pine...) has prepared a Draft Environmental Impact Statement (EIS) and a Draft Programmatic Agreement (PA.... 100 N., Nephi Beaver Library, 55 W. Center St., Beaver. The Draft EIS describes and analyzes SNWA's...

  8. Mars Science Laboratory Entry Guidance Improvements for Mars 2018 (DRAFT)

    Science.gov (United States)

    Garcia-Llama, Eduardo; Winski, Richard G.; Shidner, Jeremy D.; Ivanov, Mark C.; Grover, Myron R.; Prakash, Ravi

    2011-01-01

    In 2011, the Mars Science Laboratory (MSL) will be launched in a mission to deliver the largest and most capable rover to date to the surface of Mars. A follow on MSL-derived mission, referred to as Mars 2018, is planned for 2018. Mars 2018 goals include performance enhancements of the Entry, Descent and Landing over that of its predecessor MSL mission of 2011. This paper will discuss the main elements of the modified 2018 EDL preliminary design that will increase performance on the entry phase of the mission. In particular, these elements will increase the parachute deploy altitude to allow for more time margin during the subsequent descent and landing phases and reduce the delivery ellipse size at parachute deploy through modifications in the entry reference trajectory design, guidance trigger logic design, and the effect of additional navigation hardware.

  9. Accelerating Cleanup: Focus on 2006. Discussion draft

    International Nuclear Information System (INIS)

    1997-01-01

    This executive summary addresses the activities associated with the National Transuranic (TRU) Program managed by the Carlsbad Area Office (CAO). The CAO programmatically reports to the Assistant Secretary for Environmental Management and receives administrative support through the Albuquerque Operations Office. The mission of the Carlsbad Area Office (CAO) is to protect human health and the environment by opening and operating the Waste Isolation Pilot Plant for site disposal of TRU waste and by establishing an effective system for management of TRU waste from generation to disposal. It includes personnel assigned to the CAO, the Waste Isolation Pilot Plant (WIPP) site operations, and other activities associated with the National TRU Program. The CAO develops and directs implementation of the program, while the DOE Headquarters establishes policy and guidelines. The CAO assesses compliance with the program guidance, as well as the commonality of activities and assumptions among all the sites. Since the development of the February 28, 1997, database used to develop this Discussion Draft, the opening of the WIPP facility for receipt of Contact Handled waste has been delayed from November 1997 to May 1998. This slippage is significant enough to require a change in the milestones and volumes included in the documents to be reviewed by our stakeholders. Changes have been incorporated into this Discussion Draft and its supporting Project Baseline Summaries (PBSs)

  10. A draft of guidance from the scientific Research Programme GEOTECHNOLOGIEN to underpin the implementation of the CCS Directive in Germany

    Science.gov (United States)

    Streibel, Martin; Schoebel, Birgit

    2015-04-01

    interaction of CO2 with the reservoir and the impact of pressure elevation in saline reservoirs; • cap rock and well integrity; • development and test of monitoring methods from the atmosphere down to the reservoir; • development and improvement of numerical methods to simulate injection and spreading of the CO2 plume. During all three phases the knowledge has been incorporated in the risk assessment approach has been further developed. Within this paper we will present a draft of the guidance document which is based on the compilation of results of the early projects and input provided by project partners of the final funding phase of GEOTECHNOLOGIEN.

  11. 10 CFR 51.74 - Distribution of draft environmental impact statement and supplement to draft environmental impact...

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... Impact Statements § 51.74 Distribution of draft environmental impact statement and supplement to draft...

  12. 32 CFR 536.120 - Claims payable as maritime claims.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Claims payable as maritime claims. 536.120... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.120 Claims payable as maritime claims. A claim is cognizable under this subpart if it arises in or on a maritime location, involves some...

  13. 76 FR 55384 - External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data...

    Science.gov (United States)

    2011-09-07

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA/100/J-11/001; FRL-9460-1] External Peer Review Meeting for... attend this peer review meeting as observers. Time will be set aside for observers to give brief oral... the draft document, EPA intends to consider the comments from the external peer review meeting along...

  14. Mississippi Curriculum Framework for Drafting and Design Technology (Program CIP: 48.0102--Architectural Drafting Technology) (Program CIP: 48.0101--General Drafting). Postsecondary Programs.

    Science.gov (United States)

    Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.

    This document, which is intended for use by community and junior colleges throughout Mississippi, contains curriculum frameworks for the two course sequences of the state's postsecondary-level drafting and design technology program: architectural drafting technology and drafting and design technology. Presented first are a program description and…

  15. Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

    Energy Technology Data Exchange (ETDEWEB)

    Vovk, I.F.; Seitz, R.R.

    1995-12-31

    The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safety assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.

  16. Proposed rule package on fracture toughness and thermal annealing requirements and guidance for light water reactor vessels

    International Nuclear Information System (INIS)

    Allen Hiser, J.R.

    1993-01-01

    In the framework of updating and clarification of the fracture toughness and thermal annealing requirements and guidance for light water reactor pressure vessels, proposed revisions concerning the pressurized thermal shock rule, fracture toughness requirements and reactor vessel material surveillance program requirements, are described. A new rule concerning thermal annealing requirements and a draft regulatory guide on 'Format and Content of Application for Approval for Thermal Annealing of RPV' are also proposed

  17. Proposed rule package on fracture toughness and thermal annealing requirements and guidance for light water reactor vessels

    Energy Technology Data Exchange (ETDEWEB)

    Allen Hiser, J R [UKAEA Harwell Lab. (United Kingdom). Engineering Div.

    1994-12-31

    In the framework of updating and clarification of the fracture toughness and thermal annealing requirements and guidance for light water reactor pressure vessels, proposed revisions concerning the pressurized thermal shock rule, fracture toughness requirements and reactor vessel material surveillance program requirements, are described. A new rule concerning thermal annealing requirements and a draft regulatory guide on `Format and Content of Application for Approval for Thermal Annealing of RPV` are also proposed.

  18. An overview of current NAMA guidance. Policy Brief

    Energy Technology Data Exchange (ETDEWEB)

    Cameron, L.R. [ECN Policy Studies, Amsterdam (Netherlands)

    2013-05-15

    The International Climate Initiative formed a number of working groups within an Enhanced NAMA Cooperation Group. The Tools and Guides working group seeks to coordinate current efforts on NAMA related tools, guidebooks and templates, as well as reduce repetition of such work by different organisations. As a first step towards this goal, this brief analysis looks at the 8 main guides on NAMA development that have been published, or made available in draft form, as of May 2013. This note summarises the approach found in these guides and identifies a number of areas, or gaps, that would benefit from further effort to provide supporting resources and guidance. It also aims to provide the basis for further discussion within the working group.

  19. 78 FR 9702 - Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products...

    Science.gov (United States)

    2013-02-11

    ... approach in both the preclinical and clinical phases of the development of therapeutic protein products to... you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency... entitled ``Immunogenicity Assessment for Therapeutic Protein Products.'' The purpose of this document is to...

  20. 78 FR 73555 - Deepwater Horizon Oil Spill; Draft Programmatic and Phase III Early Restoration Plan and Draft...

    Science.gov (United States)

    2013-12-06

    ... Environmental Impact Statement (Draft Phase III ERP/PEIS). The Draft Phase III ERP/PEIS considers programmatic... programmatic restoration alternatives. The Draft Phase III ERP/PEIS evaluates these restoration alternatives... the Framework Agreement. The Draft Phase III ERP/PEIS also evaluates the environmental consequences of...

  1. Health claims on foods: challenge for clinical research companies

    Directory of Open Access Journals (Sweden)

    Essi Sarkkinen

    2012-06-01

    Full Text Available Background The Nutrition and Health Claim Regulation 1924/2006/EC, together with EFSA guidances on the scientific requirements for different type of health claims, is setting the basis for health claim substantiation in the EU. Aim The aim of this presentation is to bring up the key challenges that the food industry and clinical research organizations are facing when meeting these requirements. Results and discussion Key issues in clinical research planning to meet the requirements set for the health claim substantiation are: (1 Selection of right outcome markers since the selection of outcome marker defines actually the formulation of the health claim to be used on food or food ingredient. (2 Selection of right target population since that determines the target consumer group for the food with a health claim. (3 Selection of dose regime and food matrices used since these largely determine the conditions set for the use of the health claim. One of the major challenges in health claim substantiation is the deviant approach to risk factors or biomarkers. From the regulation point of view, a single risk factor approach is emphasized, but from the clinical and scientific point of view the pattern of different risk markers or biomarkers could, in some cases, be a more relevant choice to reflect the final health outcome. This is especially the case in the nutrition and health area because we are often dealing with weak but multiple health effects of certain food items or ingredients. Also the lack of validated well-established biomarkers potent to be affected by diet is a challenge in health claim substantiation.The selection of right target population is often a compromise between choosing a more potential target group to obtain efficacy (i.e. risk factors elevated vs. patient groups and choosing a rationale to generalize the results to wider population (target consumer group.The selection of optimal dosing regime and matrices for a clinical study is

  2. LEGAL DRAFTING IN CROATIA - CASE STUDY

    Directory of Open Access Journals (Sweden)

    Dario Đerđa

    2017-01-01

    Full Text Available This paper highlights the importance of legal drafting and its essential elements, which has not drawn a lot of attention in the Republic of Croatia so far. The paper emphasises the importance of proportionality in the simplicity and legal distinctness of a legal text in the process of drafting for the purpose of its clarity. The paper also presents objective requirements necessary for quality legal drafting, as well as subjective qualities of the drafters. With the purpose of drawing attention to imperfections in the legal drafting in Croatia, some defi ciencies are presented in the process of drafting and amending of the Utility Services Act. The process of drafting and amending of this Act is a good example of the way how legal drafting should not be done. It contains a lot of defi ciencies and failures that are the result of legal drafting mistakes. At the end, authors expect that the adoption of the Uniform methodology and nomotechnical rules for the drafting of acts enacted by Parliament should contribute to the higher quality of legal texts and to their full adjustment to the general requirements of legal certainty and rule of law.

  3. EPA scientific integrity policy draft

    Science.gov (United States)

    Showstack, Randy

    2011-08-01

    The U.S. Environmental Protection Agency (EPA) issued its draft scientific integrity policy on 5 August. The draft policy addresses scientific ethical standards, communications with the public, the use of advisory committees and peer review, and professional development. The draft policy was developed by an ad hoc group of EPA senior staff and scientists in response to a December 2010 memorandum on scientific integrity from the White House Office of Science and Technology Policy. The agency is accepting public comments on the draft through 6 September; comments should be sent to osa.staff@epa.gov. For more information, see http://www.epa.gov/stpc/pdfs/draft-scientific-integrity-policy-aug2011.pdf.

  4. 78 FR 64493 - Juneau Hydropower, Inc.; Notice of Subsequent Draft License Application (DLA) and Draft...

    Science.gov (United States)

    2013-10-29

    ... Hydropower, Inc.; Notice of Subsequent Draft License Application (DLA) and Draft Preliminary Draft... Hydropower, Inc. e. Name of Project: Sweetheart Lake Hydroelectric Project. f. Location: At the confluence of..., Business Manager, Juneau Hydropower, Inc., P.O. Box 22775, Juneau, AK 99802; 907-789-2775, email: duff...

  5. Pessimism of the Intellect, Optimism of the Will? Troubling the Relationship between Career Guidance and Social Justice

    Science.gov (United States)

    Sultana, Ronald G.

    2014-01-01

    Career guidance claims a lineage to "modernity", where individuals carve dignified lives for themselves, irrespective of social origin. Here, "social justice" has particular connotations, relating to the meritocratic redistribution of resources in ways that reward ability and effort. This article explores alternative…

  6. 75 FR 63519 - Notice of Availability of Draft Environmental Assessment and Draft Finding of No Significant...

    Science.gov (United States)

    2010-10-15

    ... reduced for certain environmental resource areas (i.e., for transportation, public and occupational health... NUCLEAR REGULATORY COMMISSION [NRC-2009-0435] Notice of Availability of Draft Environmental... of Availability of Draft Environmental Assessment and Draft Finding of No Significant Impact; Notice...

  7. 75 FR 73107 - Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated...

    Science.gov (United States)

    2010-11-29

    ... sponsors and investigators in the development of antimicrobial drugs for the treatment of hospital... of antimicrobial drugs for the treatment of HABP and VABP. This guidance revises and replaces the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0589...

  8. 32 CFR 536.121 - Claims not payable as maritime claims.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Claims not payable as maritime claims. 536.121... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.121 Claims not payable as maritime claims... (except at (e) and (k)), and 536.46; (b) Are not maritime in nature; (c) Are not in the best interests of...

  9. 76 FR 60847 - Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission...

    Science.gov (United States)

    2011-09-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0691... manufacturing practice regulations for PET drugs. DATES: Although you can comment on any guidance at any time...

  10. MODERNIZING THE PRIVATE LAW. SOME KEY ISSUES IN THE RECENT DRAFT OF THE SPANISH COMMERCIAL CODE

    Directory of Open Access Journals (Sweden)

    Dan VELICU

    2016-05-01

    Full Text Available The last decades were dominated by the idea that an authentic process to modernize the private law means generally the unification of it by renouncing the distinction between civil and commercial law. A few European countries and some American states or provinces followed this path of the unification. However, beyond the will to change and improve the system one may reflect if this kind of modernization is actually really proper. Of course, there are lots of reasons for unification and reasons against it. Is there a possible and real alternative to this wave of unification? The draft of the Spanish commercial code could be a beginning point in order to settle this controversy. For the first time, the lawmakers are trying to replace the actual code with a new modernized one without renouncing the above mentioned distinction. Without claiming that we have entirely analyzed the topic, we propose a brief critical presentation of the major key issue of the draft.

  11. Draft Technical Position Subtask 1.1: waste package performance after repository closure. Volume 1

    International Nuclear Information System (INIS)

    Davis, M.S.; Schweitzer, D.G.

    1983-08-01

    This document provides guidance to the DOE on the issues and information necessary for the NRC to evaluate waste package performance after repository closure. Minimal performance objectives of the waste package are required by proposed 10 CFR 60. This Draft Technical Position describes the various options available to the DOE for compliance and discusses advantages and disadvantages of various choices. Examples are discussed dealing with demonstrability, predictability and reasonable assurance. The types of performance are considered. The document summarizes presently identified high priority issues needed to evaluate waste package performance after repository closure. 20 references, 7 tables

  12. Economizing justice: Turning equity claims into lower energy tariffs in Chile

    International Nuclear Information System (INIS)

    Alvial-Palavicino, Carla; Ureta, Sebastián

    2017-01-01

    This paper considers the issue of how energy justice is economized; how political and ethical claims about particular energy (in)justices are turned into economic valuations. Drawing on science and technology studies, we present a conceptual framework that understands economization as emerging from three interrelated processes: problematization, framing and overflowing. Applying this framework to the drafting of new energy legislation in Chile, we trace how perceived shortcomings in equity and distributional justice were turned into “market failures,” able to be resolved by market-based mechanisms. This case highlights the dangers implicit in the uncritical economization of energy justice claims, in which ethical considerations regarding the distribution of risks and benefits of energy production and provision are reduced to a redistribution of payments among consumers – something that limits the possibilities for structural reform. - Highlights: • The implementation of an electricity equity tariff is discussed. • A process of economization transforms equity demands into market devices. • Energy justice, as mobilized in the policy process, includes multiple forms of justice. • Competition between these multiple forms fails to deliver a complete form of justice.

  13. Oncology patient-reported claims: maximising the chance for success.

    Science.gov (United States)

    Kitchen, H; Rofail, D; Caron, M; Emery, M-P

    2011-01-01

    To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. "…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo") and equivalence (e.g. "no statistical differences were observed between treatment groups for global QoL"). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical

  14. 32 CFR 536.129 - Claims cognizable as UCMJ claims.

    Science.gov (United States)

    2010-07-01

    ... Personnel Claims Act and chapter 11 of AR 27-20, which provides compensation only for tangible personal... 32 National Defense 3 2010-07-01 2010-07-01 true Claims cognizable as UCMJ claims. 536.129 Section 536.129 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS...

  15. Competency Reference for Computer Assisted Drafting.

    Science.gov (United States)

    Oregon State Dept. of Education, Salem. Div. of Vocational Technical Education.

    This guide, developed in Oregon, lists competencies essential for students in computer-assisted drafting (CAD). Competencies are organized in eight categories: computer hardware, file usage and manipulation, basic drafting techniques, mechanical drafting, specialty disciplines, three dimensional drawing/design, plotting/printing, and advanced CAD.…

  16. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ... industry entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and... data analysis in the context of identifying potential drug interactions. The guidance also addresses... Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling.'' Comments were received...

  17. Guidance to Companies on Referring to Registered Disinfectant Products that Meet the CDC Criteria for Use Against the Ebola Virus

    Science.gov (United States)

    There are no EPA-registered products with label claims against the Ebola virus, but enveloped viruses such as Ebola are susceptible to many hospital disinfectants used to disinfect hard, non-porous surfaces. CDC guidance addresses use of such products.

  18. Patient reported outcomes: looking beyond the label claim

    Directory of Open Access Journals (Sweden)

    Doward Lynda C

    2010-08-01

    Full Text Available Abstract The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ultimately, to improve quality of life. In such cases, patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. In a commercial setting, the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities, payers both in the US and Europe, clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups.

  19. 78 FR 57394 - Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human...

    Science.gov (United States)

    2013-09-18

    ... Drug and Biological Products--Content and Format; Availability AGENCY: Food and Drug Administration... Labeling for Human Prescription Drug and Biological Products--Content and Format.'' The recommendations in... the extent possible, consistent in content and format. DATES: Although you can comment on any guidance...

  20. Long-Term Stewardship Baseline Report and Transition Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Kristofferson, Keith

    2001-11-01

    Long-term stewardship consists of those actions necessary to maintain and demonstrate continued protection of human health and the environment after facility cleanup is complete. As the Department of Energy’s (DOE) lead laboratory for environmental management programs, the Idaho National Engineering and Environmental Laboratory (INEEL) administers DOE’s long-term stewardship science and technology efforts. The INEEL provides DOE with technical, and scientific expertise needed to oversee its long-term environmental management obligations complexwide. Long-term stewardship is administered and overseen by the Environmental Management Office of Science and Technology. The INEEL Long-Term Stewardship Program is currently developing the management structures and plans to complete INEEL-specific, long-term stewardship obligations. This guidance document (1) assists in ensuring that the program leads transition planning for the INEEL with respect to facility and site areas and (2) describes the classes and types of criteria and data required to initiate transition for areas and sites where the facility mission has ended and cleanup is complete. Additionally, this document summarizes current information on INEEL facilities, structures, and release sites likely to enter long-term stewardship at the completion of DOE’s cleanup mission. This document is not intended to function as a discrete checklist or local procedure to determine readiness to transition. It is an overarching document meant as guidance in implementing specific transition procedures. Several documents formed the foundation upon which this guidance was developed. Principal among these documents was the Long-Term Stewardship Draft Technical Baseline; A Report to Congress on Long-Term Stewardship, Volumes I and II; Infrastructure Long-Range Plan; Comprehensive Facility Land Use Plan; INEEL End-State Plan; and INEEL Institutional Plan.

  1. Evaluation of Worktext in Mechanical Drafting

    Directory of Open Access Journals (Sweden)

    Erich D. Cruz

    2015-11-01

    Full Text Available This study aimed to evaluate Worktext in Drafting Technology 4 (Mechanical Drafting for Bachelor of Technology (BT major in Drafting Technology. It was conducted at University of Rizal System with twenty Drafting and Mechanical Technology professors as respondents. The study used the descriptive evaluative method to describe and evaluate the developed Worktext in DT 4 using the questionnaire-checklist in gathering data. They were asked to evaluate the worktext through the following: objectives, contents, activities, presentation and style, organization, creativity, evaluation, accuracy, completeness and appropriateness. It was found out that the developed worktext with respect to objectives was highly agree, contents was highly agree, activities was highly agree, presentation and style was agree, creativity was highly agree and evaluation was highly agree. Meaning that the items with highly agree interpretations attained excellent level of acceptability while those with agree interpretations obtained extensive level of acceptability with fully achieved and above average Drafting standards, respectively. It was also found out that the developed worktext in terms of accuracy was high, completeness was very high and appropriateness was likewise very high. The researcher recommends that the developed Worktext in Drafting Technology 4 may be adopted for use by the Bachelor of Technology major in Drafting Technology students.

  2. Predicted percentage dissatisfied with ankle draft.

    Science.gov (United States)

    Liu, S; Schiavon, S; Kabanshi, A; Nazaroff, W W

    2017-07-01

    Draft is unwanted local convective cooling. The draft risk model of Fanger et al. (Energy and Buildings 12, 21-39, 1988) estimates the percentage of people dissatisfied with air movement due to overcooling at the neck. There is no model for predicting draft at ankles, which is more relevant to stratified air distribution systems such as underfloor air distribution (UFAD) and displacement ventilation (DV). We developed a model for predicted percentage dissatisfied with ankle draft (PPD AD ) based on laboratory experiments with 110 college students. We assessed the effect on ankle draft of various combinations of air speed (nominal range: 0.1-0.6 m/s), temperature (nominal range: 16.5-22.5°C), turbulence intensity (at ankles), sex, and clothing insulation (thermal sensation and air speed at ankles are the dominant parameters affecting draft. The seated subjects accepted a vertical temperature difference of up to 8°C between ankles (0.1 m) and head (1.1 m) at neutral whole-body thermal sensation, 5°C more than the maximum difference recommended in existing standards. The developed ankle draft model can be implemented in thermal comfort and air diffuser testing standards. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Medical reports on persons claiming compensation for personal injury.

    Science.gov (United States)

    Cornes, P; Aitken, R C

    1992-06-01

    An audit of one insurance company's files on all employer's liability and third party motor claims settled over two years for 5000 pounds or more presented an opportunity to review the medical reports on the patients involved. A stratified random sample of files on 203 patients contained 602 reports prepared by 400 consultants. Content analysis was undertaken to evaluate compliance with published guidance on reports prepared for medico-legal purposes and to ascertain how well reports met recipients' requirements. While clinical topics were well covered, generally to a high standard, other functional, psychosocial and occupational topics, reflecting the wider clinical and non-clinical frame of reference within which lawyers and insurers normally seek information and advice, were covered less frequently, extensively and comprehensively--leaving considerable scope to improve these aspects of assessment and reporting. Further review of this aspect of professional practice should include attention to the appropriateness of existing guidance, postgraduate training requirements and the involvement of other agencies or professions in some aspects of assessment for medico-legal purposes.

  4. Essentials of the successful drafting of invention applications on nuclear technology in the view of patent examination

    International Nuclear Information System (INIS)

    Zhai Chenyang

    2010-01-01

    Up to now, there has been a comparatively low ratio of domestic authorization in terms of invention applications in the field of nuclear technology. In this paper, the main reasons according to my experience in the patent examination are revealed in the following three aspects: (1) there is a lack of novelty or inventive step; (2) the scope of some claims is not clearly defined; (3) the description is improperly drafting. Common problems are shown and analyzed. Suggestion for avoiding the problems and corresponding solutions are given. (author)

  5. ClaimAssociationService

    Data.gov (United States)

    Department of Veterans Affairs — Retrieves and updates a veteranÆs claim status and claim-rating association (claim association for current rating) from the Corporate database for a claim selected...

  6. Rating of transport and radiation source events. Draft additional guidance for the INES national officers for pilot use and feedback; Echelle de classement des incidents de radioprotection: document d'application du systeme international propose par l'AIEA pour les sources radioactives et les transports

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-09-15

    The International Nuclear Event Scale (INES) is a means for promptly communicating to the public in consistent terms the safety significance of any reported event associated with radioactive material and/or radiation and to any event occurring during the transport of radioactive material. As described in the 2001 Edition of the INES User.s Manual, events are classified on the scale at seven levels: the upper levels (4-7) are termed accidents. and the lower levels (1-3) incidents. Events which have no safety significance are classified below scale at Level 0 and termed deviations. An overview of the principles for the rating under INES together with flow charts summarizing the rating process is provided in Appendix I. The 2001 Edition of the INES User.s Manual provides some guidance for the rating of transport and radiation source events. At the technical meeting held in 2002 the INES National Officers requested the IAEA/NEA Secretariat to prepare additional guidance. Progress was reported at the Technical Meeting of the INES National Officers in March 2004 where preparation of this draft additional guidance was requested for pilot use. This note provides additional guidance on the rating of transport and radiation source events. It is for pilot use and feedback and is broadly consistent with the INES User.s Manual. It provides more detailed information and an expanded approach for the rating based on actual exposure of workers and members of the public. It is designed to be used as a self-standing document with limited need for reference to the INES User Manual. (author)

  7. 77 FR 17091 - Trust Land Consolidation Draft Plan

    Science.gov (United States)

    2012-03-23

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Trust Land Consolidation Draft Plan AGENCY... reopening the period for commenting on the Cobell Land Consolidation Program Draft Plan (also known as the Trust Land Consolidation Draft Plan), which is the draft plan for accomplishing these goals. DATES...

  8. Defining hip fracture with claims data: outpatient and provider claims matter.

    Science.gov (United States)

    Berry, S D; Zullo, A R; McConeghy, K; Lee, Y; Daiello, L; Kiel, D P

    2017-07-01

    Medicare claims are commonly used to identify hip fractures, but there is no universally accepted definition. We found that a definition using inpatient claims identified fewer fractures than a definition including outpatient and provider claims. Few additional fractures were identified by including inconsistent diagnostic and procedural codes at contiguous sites. Medicare claims data is commonly used in research studies to identify hip fractures, but there is no universally accepted definition of fracture. Our purpose was to describe potential misclassification when hip fractures are defined using Medicare Part A (inpatient) claims without considering Part B (outpatient and provider) claims and when inconsistent diagnostic and procedural codes occur at contiguous fracture sites (e.g., femoral shaft or pelvic). Participants included all long-stay nursing home residents enrolled in Medicare Parts A and B fee-for-service between 1/1/2008 and 12/31/2009 with follow-up through 12/31/2011. We compared the number of hip fractures identified using only Part A claims to (1) Part A plus Part B claims and (2) Part A and Part B claims plus discordant codes at contiguous fracture sites. Among 1,257,279 long-stay residents, 40,932 (3.2%) met the definition of hip fracture using Part A claims, and 41,687 residents (3.3%) met the definition using Part B claims. 4566 hip fractures identified using Part B claims would not have been captured using Part A claims. An additional 227 hip fractures were identified after considering contiguous fracture sites. When ascertaining hip fractures, a definition using outpatient and provider claims identified 11% more fractures than a definition with only inpatient claims. Future studies should publish their definition of fracture and specify if diagnostic codes from contiguous fracture sites were used.

  9. System for implement draft reduction

    DEFF Research Database (Denmark)

    2008-01-01

    Abstract of WO 2008095503  (A1) There is disclosed a system and method of reducing draft forces when working soil with agricultural soil working implements (206, 211) creating draft forces, the soil working implements (208, 206, 211) beingoperable connectable to a frame (204, 304, 404, 504, 604......, the second part of the width comprising an other part of said width (212) than the first part (222), so as e.g. to reduce draft forces compared to working both first and second parts at the same time....

  10. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Science.gov (United States)

    2013-10-01

    ...--Refuse-to-Receive Standards.'' This guidance is intended to assist applicants preparing to submit to FDA.... 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in... Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Johnny Young, Center for...

  11. Comparison of Conventional and Computer-aided Drafting Methods from the View of Time and Drafting Quality

    OpenAIRE

    OZKAN, Aysen; YILDIRIM, Kemal

    2016-01-01

    Problem Statement: Drafting course is essential for students in the design disciplines for becoming more organized and for complying with standards in the educational system. Drafting knowledge is crucial, both for comprehension of the issues and for the implementation phase. In any design project, drafting performance and success are as important as the design process, especially in the educational environments aimed at professional life. However, there have been relatively any studies under...

  12. Mississippi Curriculum Framework for General Drafting (Program CIP: 48.0101--Drafting, General). Secondary Programs.

    Science.gov (United States)

    Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.

    This document, which reflects Mississippi's statutory requirement that instructional programs be based on core curricula and performance-based assessment, contains outlines of the instructional units required in local instructional management plans and daily lesson plans for two secondary-level courses in drafting: drafting I and II. Presented…

  13. 75 FR 29537 - Draft Transportation Conformity Guidance for Quantitative Hot-spot Analyses in PM2.5

    Science.gov (United States)

    2010-05-26

    ... Quantitative Hot- spot Analyses in PM 2.5 and PM 10 Nonattainment and Maintenance Areas AGENCY: Environmental... finalized, this guidance would help state and local agencies complete quantitative PM 2.5 and PM 10 hot-spot... projects. A hot-spot analysis includes an estimation of project-level emissions, air quality modeling, and...

  14. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Science.gov (United States)

    2011-09-09

    ... Advertising Act (FCLAA) when that requirement takes effect. On June 22, 2009, the President signed the Family... Advertising Act, as amended by the Family Smoking Prevention and Tobacco Control Act, when that requirement takes effect. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to...

  15. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    International Nuclear Information System (INIS)

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed

  16. Environmental guidance documents for exploration, development, Production, and transportation of crude oil and natural gas in texas: Quarterly technical report, January 1, 1997-March 31, 1997

    International Nuclear Information System (INIS)

    Savage, L.

    1997-01-01

    The following technical report provides a detailed status report of the DOE grant project entitled ''Environmental Guidance Documents for Exploration, Development, Production, and Transportation of Crude Oil and Natural Gas in Texas.'' The grant funding allocated is for the purpose of provided the Railroad Commission of Texas (Commission) with resources and capabilities to draft, publish and distribute documents that provide guidance to oil and gas operators on issues concerning oil and gas naturally occurring radioactive material (NORM) waste, oil and gas hazardous waste, remediation of crude oil spills, management of non-hazardous oil and gas wastes, and mechanical integrity testing of Class II injection and disposal wells

  17. Greater-than-Class C low-level radioactive waste characterization. Appendix E-5: Impact of the 1993 NRC draft Branch Technical Position on concentration averaging of greater-than-Class C low-level radioactive waste

    International Nuclear Information System (INIS)

    Tuite, P.; Tuite, K.; Harris, G.

    1994-09-01

    This report evaluates the effects of concentration averaging practices on the disposal of greater-than-Class C low-level radioactive waste (GTCC LLW) generated by the nuclear utility industry and sealed sources. Using estimates of the number of waste components that individually exceed Class C limits, this report calculates the proportion that would be classified as GTCC LLW after applying concentration averaging; this proportion is called the concentration averaging factor. The report uses the guidance outlined in the 1993 Nuclear Regulatory Commission (NRC) draft Branch Technical Position on concentration averaging, as well as waste disposal experience at nuclear utilities, to calculate the concentration averaging factors for nuclear utility wastes. The report uses the 1993 NRC draft Branch Technical Position and the criteria from the Barnwell, South Carolina, LLW disposal site to calculate concentration averaging factors for sealed sources. The report addresses three waste groups: activated metals from light water reactors, process wastes from light-water reactors, and sealed sources. For each waste group, three concentration averaging cases are considered: high, base, and low. The base case, which is the most likely case to occur, assumes using the specific guidance given in the 1993 NRC draft Branch Technical Position on concentration averaging. To project future GTCC LLW generation, each waste category is assigned a concentration averaging factor for the high, base, and low cases

  18. Forced draft wet cooling systems

    International Nuclear Information System (INIS)

    Daubert, A.; Caudron, L.; Viollet, P.L.

    1975-01-01

    The disposal of the heat released from a 1000MW power plant needs a natural draft tower of about 130m of diameter at the base, and 170m height, or a cooling system with a draft forced by about forty vans, a hundred meters in diameter, and thirty meters height. The plumes from atmospheric cooling systems form, in terms of fluid mechanics, hot jets in a cross current. They consist in complex flows that must be finely investigated with experimental and computer means. The study, currently being performed at the National Hydraulics Laboratory, shows that as far as the length and height of visible plumes are concerned, the comparison is favorable to some types of forced draft cooling system, for low and medium velocities, (below 5 or 6m/s at 10m height. Beyond these velocities, the forced draft sends the plume up to smaller heights, but the plume is generally more dilute [fr

  19. 75 FR 43922 - Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski...

    Science.gov (United States)

    2010-07-27

    ..., who do not routinely encounter claims that implicate the abstract idea exception. Under the principles... principles: Laws of nature, physical phenomena, and abstract ideas. See id. The Office has been using the so... marketing a product, comprising: Developing a shared marketing force, said shared marketing force including...

  20. 76 FR 381 - Notice of Availability of the Draft Environmental Impact Statement/Draft Environmental Impact...

    Science.gov (United States)

    2011-01-04

    ...In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) and the California Public Utilities Commission (CPUC) have prepared a Draft Environmental Impact Statement (EIS), and Draft Environmental Impact Report (EIR) as a joint environmental analysis document for the Iberdrola Renewable/Pacific Wind Development Tule Wind Project (Tule Project) and the San Diego Gas and Electric's (SDG&E) East County Substation Project (ECO Project) and by this notice are announcing the opening of the comment period on the Draft EIS/EIR.

  1. IRIS Toxicological Review of Ammonia (Revised External Review Draft)

    Science.gov (United States)

    In August 2013, EPA submitted a revised draft IRIS assessment of ammonia to the agency's Science Advisory Board (SAB) and posted this draft on the IRIS website. EPA had previously released a draft of the assessment for public comment, held a public meeting about the draft, and ...

  2. 78 FR 19733 - Draft General Management Plan and Draft Environmental Impact Statement, Fort Raleigh National...

    Science.gov (United States)

    2013-04-02

    ... announce the dates, times, and locations of public meetings on the draft EIS/GMP through the NPS Planning... delivery to the above address. Electronic copies of the Draft EIS/GMP will be available online at http... through additional interpretive efforts, marketing, and facilities. Alternative C, the NPS preferred...

  3. Pediatric radiology malpractice claims - characteristics and comparison to adult radiology claims

    Energy Technology Data Exchange (ETDEWEB)

    Breen, Micheal A.; Taylor, George A. [Boston Children' s Hospital, Department of Radiology, Boston, MA (United States); Dwyer, Kathy; Yu-Moe, Winnie [CRICO Risk Management Foundation, Boston, MA (United States)

    2017-06-15

    Medical malpractice is the primary method by which people who believe they have suffered an injury in the course of medical care seek compensation in the United States and Canada. An increasing body of research demonstrates that failure to correctly diagnose is the most common allegation made in malpractice claims against radiologists. Since the 1994 survey by the Society of Chairmen of Radiology in Children's Hospitals (SCORCH), no other published studies have specifically examined the frequency or clinical context of malpractice claims against pediatric radiologists or arising from pediatric imaging interpretation. We hypothesize that the frequency, character and outcome of malpractice claims made against pediatric radiologists differ from those seen in general radiology practice. We searched the Controlled Risk Insurance Co. (CRICO) Strategies' Comparative Benchmarking System (CBS), a private repository of approximately 350,000 open and closed medical malpractice claims in the United States, for claims related to pediatric radiology. We further queried these cases for the major allegation, the clinical environment in which the claim arose, the clinical severity of the alleged injury, indemnity paid (if payment was made), primary imaging modality involved (if applicable) and primary International Classification of Diseases, 9th revision (ICD-9) diagnosis underlying the claim. There were a total of 27,056 fully coded claims of medical malpractice in the CBS database in the 5-year period between Jan. 1, 2010, and Dec. 31, 2014. Of these, 1,472 cases (5.4%) involved patients younger than 18 years. Radiology was the primary service responsible for 71/1,472 (4.8%) pediatric cases. There were statistically significant differences in average payout for pediatric radiology claims ($314,671) compared to adult radiology claims ($174,033). The allegations were primarily diagnosis-related in 70% of pediatric radiology claims. The most common imaging modality

  4. Pediatric radiology malpractice claims - characteristics and comparison to adult radiology claims

    International Nuclear Information System (INIS)

    Breen, Micheal A.; Taylor, George A.; Dwyer, Kathy; Yu-Moe, Winnie

    2017-01-01

    Medical malpractice is the primary method by which people who believe they have suffered an injury in the course of medical care seek compensation in the United States and Canada. An increasing body of research demonstrates that failure to correctly diagnose is the most common allegation made in malpractice claims against radiologists. Since the 1994 survey by the Society of Chairmen of Radiology in Children's Hospitals (SCORCH), no other published studies have specifically examined the frequency or clinical context of malpractice claims against pediatric radiologists or arising from pediatric imaging interpretation. We hypothesize that the frequency, character and outcome of malpractice claims made against pediatric radiologists differ from those seen in general radiology practice. We searched the Controlled Risk Insurance Co. (CRICO) Strategies' Comparative Benchmarking System (CBS), a private repository of approximately 350,000 open and closed medical malpractice claims in the United States, for claims related to pediatric radiology. We further queried these cases for the major allegation, the clinical environment in which the claim arose, the clinical severity of the alleged injury, indemnity paid (if payment was made), primary imaging modality involved (if applicable) and primary International Classification of Diseases, 9th revision (ICD-9) diagnosis underlying the claim. There were a total of 27,056 fully coded claims of medical malpractice in the CBS database in the 5-year period between Jan. 1, 2010, and Dec. 31, 2014. Of these, 1,472 cases (5.4%) involved patients younger than 18 years. Radiology was the primary service responsible for 71/1,472 (4.8%) pediatric cases. There were statistically significant differences in average payout for pediatric radiology claims ($314,671) compared to adult radiology claims ($174,033). The allegations were primarily diagnosis-related in 70% of pediatric radiology claims. The most common imaging modality implicated in

  5. Pediatric radiology malpractice claims - characteristics and comparison to adult radiology claims.

    Science.gov (United States)

    Breen, Micheál A; Dwyer, Kathy; Yu-Moe, Winnie; Taylor, George A

    2017-06-01

    Medical malpractice is the primary method by which people who believe they have suffered an injury in the course of medical care seek compensation in the United States and Canada. An increasing body of research demonstrates that failure to correctly diagnose is the most common allegation made in malpractice claims against radiologists. Since the 1994 survey by the Society of Chairmen of Radiology in Children's Hospitals (SCORCH), no other published studies have specifically examined the frequency or clinical context of malpractice claims against pediatric radiologists or arising from pediatric imaging interpretation. We hypothesize that the frequency, character and outcome of malpractice claims made against pediatric radiologists differ from those seen in general radiology practice. We searched the Controlled Risk Insurance Co. (CRICO) Strategies' Comparative Benchmarking System (CBS), a private repository of approximately 350,000 open and closed medical malpractice claims in the United States, for claims related to pediatric radiology. We further queried these cases for the major allegation, the clinical environment in which the claim arose, the clinical severity of the alleged injury, indemnity paid (if payment was made), primary imaging modality involved (if applicable) and primary International Classification of Diseases, 9th revision (ICD-9) diagnosis underlying the claim. There were a total of 27,056 fully coded claims of medical malpractice in the CBS database in the 5-year period between Jan. 1, 2010, and Dec. 31, 2014. Of these, 1,472 cases (5.4%) involved patients younger than 18 years. Radiology was the primary service responsible for 71/1,472 (4.8%) pediatric cases. There were statistically significant differences in average payout for pediatric radiology claims ($314,671) compared to adult radiology claims ($174,033). The allegations were primarily diagnosis-related in 70% of pediatric radiology claims. The most common imaging modality implicated in

  6. Security of radioactive sources. Interim guidance for comment

    International Nuclear Information System (INIS)

    2003-06-01

    In previous IAEA publications, there have been only rather general security requirements for non-nuclear radioactive material. These requirements were primarily directed to such issues as unintentional exposure to radiation, negligence and inadvertent loss. However, it is clear that more guidance is needed to not only try and prevent further events involving orphan sources, but also to prevent the deliberate attempt to acquire radioactive sources for malevolent purposes. Member States have requested guidance on the type and nature of security measures that might be put in place and on the methodology to be used in choosing such measures. These requests were also endorsed in the findings of the international conference on 'Security of Radioactive Sources' held in March 2003. Practical advice on assessing and implementing security measures complements the general commitments in the proposed Revised Code of Conduct on Safety and Security of radioactive Sources. A Safety Guide entitled 'Safety and Security of Radiation Sources' that, amongst other things, discusses these issues is being drafted. However, it is recognized that guidance material is required before this document will be finalized in order to allow Member States opportunity to put in place appropriate actions and planning to address current issues. Hence the purpose of the current document is to provide advice on security approaches and to allow comment on detailed recommendations for levels of security on radioactive sources that may be incorporated within the Safety Guide. This report is primarily addressed to Regulatory Authorities but it is also intended to provide guidance to manufacturers, suppliers and users of sources. Its objective is to assist Member States in deciding which security measures are needed to ensure consistency with the International Basic Safety Standards and the Revised Code of Conduct for the Safety and Security of Radioactive Sources. It is recognized that there must be a

  7. 77 FR 74508 - Notice of Availability of the Draft Resource Management Plan Amendment, Draft Environmental...

    Science.gov (United States)

    2012-12-14

    ... eliminated. A maximum of 7,500 summer and winter landings would be permitted in the project area annually... considered, the BLM must receive written comments on the Draft RMP Amendment/Draft EIS within 90 days... meetings or hearings and any other public involvement activities at least 15 days in advance through public...

  8. 76 FR 57760 - Notice of Availability of Draft Resource Management Plan and Draft Environmental Impact Statement...

    Science.gov (United States)

    2011-09-16

    ... approximately 707,000 subsurface acres of Federal mineral estate. Decisions in the Colorado River Valley RMP... Availability of Draft Resource Management Plan and Draft Environmental Impact Statement for the Colorado River Valley Field Office, Colorado AGENCY: Bureau of Land Management, Interior. ACTION: Notice of availability...

  9. 77 FR 5528 - Trust Land Consolidation Draft Plan

    Science.gov (United States)

    2012-02-03

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Trust Land Consolidation Draft Plan AGENCY... draft plan for accomplishing these goals. DATES: Submit comments by March 19, 2012. ADDRESSES: Send comments on the draft plan to: Elizabeth Appel, Bureau of Indian Affairs, 1001 Indian School Road NW...

  10. 78 FR 20690 - Draft Environmental Impact Statement, Draft Habitat Conservation Plan, Draft Programmatic...

    Science.gov (United States)

    2013-04-05

    .... Background The Fowler Ridge application is unusual in that 355 wind turbines are already in place and have... Agreement, and Draft Implementing Agreement; Application for an Incidental Take Permit, Fowler Ridge Wind... application from Fowler Ridge Wind Farm LLC, Fowler Ridge II Wind Farm LLC, Fowler Ridge III Wind Farm LLC...

  11. BenefitClaimWebServiceBean/BenefitClaimWebService

    Data.gov (United States)

    Department of Veterans Affairs — A formal or informal request for a type of monetary or non-monetary benefit. This service provides benefit claims and benefit claim special issues data, allows the...

  12. Ambulatory care and the law: lien claims where none exist as of right.

    Science.gov (United States)

    Balko, G A

    1995-01-01

    The health care provider, whether an individual or an institution, needs to pay attention to appropriate mechanisms to ensure payment for services or repayment for benefits provided. While statutes provide some protection for large institutions, including health care providers, individual health care providers often are left to their own devices. The employment of a well drafted voluntary lien agreement can not only secure a right of recover against a patient, but where the patient pursues a personal injury claim through an attorney, can also give the health care provider recourse to patient's attorney. Knowing how to assert these liens, what funds are reachable by these lien, and what time factors must be adhered to in order to make the liens effective, are vital to a health care provider's financial well-being.

  13. 76 FR 59155 - Notice of Availability of South Coast Draft Resource Management Plan Revision and Draft...

    Science.gov (United States)

    2011-09-23

    ... policies and emphasis on the management of public lands and local land use planning; and new data that have... DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLCAD06000, L16100000.DP0000] Notice of Availability of South Coast Draft Resource Management Plan Revision and Draft Environmental Impact Statement...

  14. Cluster: Drafting. Course: Introduction to Technical Drafting.

    Science.gov (United States)

    Sanford - Lee County Schools, NC.

    The set of 10 units is designed for use with an instructor as an introduction to technical drafting, and is also keyed to other texts. Each unit contains several task packages specifying prerequisites, rationale for learning, objectives, learning activities to be supervised by the instructor, and learning practice. The units cover: drafting…

  15. 19 CFR 207.63 - Circulation of draft questionnaires.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Circulation of draft questionnaires. 207.63... SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.63 Circulation of draft questionnaires. (a) The Director shall circulate draft questionnaires to the parties for comment in each full review. (b...

  16. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Science.gov (United States)

    2013-03-05

    ... implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings... guidance to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA... Commerce of the U.S. House of Representatives setting out the goals of section 201(c) of MDUFA II, Title II...

  17. 10 CFR 51.81 - Distribution of draft environmental impact statement.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.81 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and...

  18. 10 CFR 51.86 - Distribution of draft environmental impact statement.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.86 Distribution of draft environmental impact statement. Copies of the draft environmental impact statement and any...

  19. The Physics of Bump Drafting in Car Racing

    Science.gov (United States)

    Fiolhais, Miguel C. N.; Amor dos Santos, Susana

    2014-01-01

    The technique of bump drafting, also known as two-car drafting in motorsports, is analysed in the framework of Newtonian mechanics and simple aerodynamic drag forces. As an apparent unnatural effect that often pleases the enthusiasts of car racing, bump drafting provides a unique pedagogical opportunity for students to gain insights into the…

  20. 10 CFR 51.80 - Draft environmental impact statement-materials license.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-materials license. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Materials Licenses § 51.80 Draft environmental impact statement—materials license. (a) The NRC staff will either prepare a draft environmental...

  1. Improvement of hydro-turbine draft tube efficiency using vortex generator

    Directory of Open Access Journals (Sweden)

    Xiaoqing Tian

    2015-07-01

    Full Text Available Computational fluid dynamics simulation was employed in a hydraulic turbine (from inlet tube to draft tube. The calculated turbine efficiencies were compared with measured results, and the relative error is 1.12%. In order to improve the efficiency of the hydraulic turbine, 15 kinds of vortex generators were installed at the vortex development section of the draft tube, and all of them were simulated using the same method. Based on the turbine efficiencies, distribution of streamlines, velocities, and pressures in the draft tube, an optimal draft tube was found, which can increase the efficiency of this hydraulic turbine more than 1.5%. The efficiency of turbine with the optimal draft tube, draft tube with four pairs of middle-sized vortex generator, and draft tube without vortex generator under different heads of turbine (5–14 m was calculated, and it was verified that these two kinds of draft tubes can increase the efficiency of this turbine in every situation.

  2. Orientation, Sketching, Mechanical Drawing, Drafting--Basic: 9253.01.

    Science.gov (United States)

    Dade County Public Schools, Miami, FL.

    The course introduces the student to the drafting trade, freehand sketching, and basic mechanical drawing. The course has no prerequisites and will guide the student into drafting concepts and serve as a foundation for further study in vocational drafting. Requiring a total of 45 class hours, eight hours are utilized in orientation, 15 hours are…

  3. The International Safety Framework for nuclear power source applications in outer space-Useful and substantial guidance

    Science.gov (United States)

    Summerer, L.; Wilcox, R. E.; Bechtel, R.; Harbison, S.

    2015-06-01

    In 2009, the International Safety Framework for Nuclear Power Source Applications in Outer Space was adopted, following a multi-year process that involved all major space faring nations under the auspices of a partnership between the UN Committee on the Peaceful Uses of Outer Space and the International Atomic Energy Agency. The Safety Framework reflects an international consensus on best practices to achieve safety. Following the 1992 UN Principles Relevant to the Use of Nuclear Power Sources in Outer Space, it is the second attempt by the international community to draft guidance promoting the safety of applications of nuclear power sources in space missions. NPS applications in space have unique safety considerations compared with terrestrial applications. Mission launch and outer space operational requirements impose size, mass and other space environment limitations not present for many terrestrial nuclear facilities. Potential accident conditions could expose nuclear power sources to extreme physical conditions. The Safety Framework is structured to provide guidance for both the programmatic and technical aspects of safety. In addition to sections containing specific guidance for governments and for management, it contains technical guidance pertinent to the design, development and all mission phases of space NPS applications. All sections of the Safety Framework contain elements directly relevant to engineers and space mission designers for missions involving space nuclear power sources. The challenge for organisations and engineers involved in the design and development processes of space nuclear power sources and applications is to implement the guidance provided in the Safety Framework by integrating it into the existing standard space mission infrastructure of design, development and operational requirements, practices and processes. This adds complexity to the standard space mission and launch approval processes. The Safety Framework is deliberately

  4. An analysis of combustion from a top-lit up-draft (TLUD cookstove

    Directory of Open Access Journals (Sweden)

    Cristian Birzer

    2013-08-01

    Full Text Available It is estimated that three billion people worldwide cook with traditional stoves. These stoves generaly consist of three stones and an open fire, and produce harmful emissions that are known to cause fatal illnesses. Traditional stoves claim the lives of 1.6 million people every year and cause the death of more children under the age of five than any other single cause. In addition, widespread land degradation and deforestation have resulted from inefficient fuel consumption of traditional stoves. This paper presents some results from an extensive investigation into design and experimental evalation of top-lit up-draft (TLUD microgasifier cookstoves aimed at addressing problems associated with traditional cooking approaches. Results indicate that geometric variations of the stove and fuel size influence burn rates and emissions production, and must therefore be considered for any design and implementation.

  5. Optimum Drafting Conditions Of Polyester And Viscose Blend Yarns

    Directory of Open Access Journals (Sweden)

    Hatamvand Mohammad

    2017-09-01

    Full Text Available In this study, we used an experimental design to investigate the influence of the total draft, break draft, distance between the aprons (Clips and production roller pressure on yarn quality in order to obtain optimum drafting conditions for polyester and viscose (PES/CV blend yarns in ring spinning frame. We used PES fibers (1.4 dtex × 38 mm long and CV fibers (1.6 dtex × 38 mm long to spin a 20 Tex blend yarn of PES (70%/CV (30% blend ratio. When the break draft, adjustment of distance between of aprons and roller pressure is not reasonable, controlling and leading of the fibers is not sufficient for proper orientation of the fibers in the yarn structure to produce a high quality yarn. Experimental results and statistical analysis show that the best yarn quality will be obtained under drafting conditions total draft of 38, 1.2 break draft, 2.8 mm distance between of aprons and maximum pressure of the production top roller (18daN.

  6. Report to the NRC on guidance for preparing scenarios for emergency preparedness exercises at nuclear generating stations. Draft report for comment

    International Nuclear Information System (INIS)

    Martin, G.F.; Hickey, E.E.; Moeller, M.P.; Schultz, D.H.; Bethke, G.W.

    1986-03-01

    A scenario guidance handbook was prepared to assist emergency planners in developing scenarios for emergency preparedness exercises at nuclear power plants. The handbook provides guidance for the development of the objectives of an exercise, the descriptions of scenario events and responses, and the instructions to the participants. Information concerning implementation of the scenario, critiques and findings, and generation and format of scenario data are also included. Finally, examples of manual calculational techniques for producing radiological data are included as an appendix

  7. 10 CFR 51.85 - Draft environmental impact statement-rulemaking.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-rulemaking. 51.85... Implementing Section 102(2) Draft Environmental Impact Statements-Rulemaking § 51.85 Draft environmental impact... Commission has determined to prepare an environmental impact statement. ...

  8. Should the District Courts Have Jurisdiction Over Pre-Award Contract Claims? A Claim for the Claims Court

    National Research Council Canada - National Science Library

    Short, John J

    1987-01-01

    This thesis briefly examines the jurisdiction of the federal district courts and the United States Court of Claims over pre-award contract claims before the Federal Courts Improvement Act of October 1...

  9. Assessing risk of draft survey by AHP method

    Science.gov (United States)

    Xu, Guangcheng; Zhao, Kuimin; Zuo, Zhaoying; Liu, Gang; Jian, Binguo; Lin, Yan; Fan, Yukun; Wang, Fei

    2018-04-01

    The paper assesses the risks of vessel floating in the seawater for draft survey by using the analytic hierarchy process. On this basis, the paper established draft survey risk index from the view of draft reading, ballast water, fresh water, and calculation process and so on. Then the paper proposes the method to deal with risk assessment using one concrete sample.

  10. Current status of nutrition labelling and claims in the South-East Asian region: are we in harmony?

    Science.gov (United States)

    Tee, E-Siong; Tamin, Suryani; Ilyas, Rosmulyati; Ramos, Adelisa; Tan, Wei-Ling; Lai, Darwin Kah-Soon; Kongchuntuk, Hataya

    2002-01-01

    This review includes the situation of nutrition labelling and claims in six countries in South-East Asia: Brunei, Indonesia, Malaysia, Philippines, Singapore and Thailand. With the exception of Malaysia, there is no mandatory nutrition labelling requirements for foods in these countries except for special categories of foods and when nutritional claims are made for fortified or enriched foods. Nevertheless, several food manufacturers, especially multinationals, do voluntarily label the nutritional content of a number of food products. There is, therefore, increasing interest among authorities in countries in the region to start formulating regulations for nutrition labelling for a wider variety of foods. Malaysia has proposed new regulations to make it mandatory to label a number of foodstuffs with the four core nutrients, protein, carbohydrate, fat and energy. Other countries have preferred to start with voluntary labelling by the manufacturers, but have spelt out the requirements for this voluntary labelling. The format and requirements for nutrition labelling differ widely for countries in the region. Some countries, such as Malaysia, closely follow the Codex guidelines on nutrition labelling in terms of format, components to be included and mode of expression. Other countries, such as the Philippines and Thailand, have drafted nutrition labelling regulations very similar to those of the Nutrition Labeling and Education Act (NLEA) of the United States. Nutrition and health claims are also not specifically permitted under food regulations that were enacted before 1998. However, various food products on the market have been carrying a variety of nutrition and health claims. There is concern that without proper regulations, the food industry may not be certain as to what claims can be made. Excessive and misleading claims made by irresponsible manufacturers would only serve to confuse and mislead the consumer. In recent years, there has been efforts in countries in

  11. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Science.gov (United States)

    2012-04-11

    ... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum....regulations.gov . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug...

  12. On the Drafting of Confidentiality Agreements

    DEFF Research Database (Denmark)

    Drewsen, Merete; Lando, Henrik; Cummins, Tim

    2006-01-01

    This is not a theoretical paper but an application of existing law and economic contract theory to the issue of how to draft a specific kind of contract. It is addressed to practitioners and is intended for practical use. It will be part of a Wiki (as in Wikipedia) for contract drafting, which...

  13. Scope of claim coverage in patents of fufang Chinese herbal drugs: Substitution of ingredients

    Directory of Open Access Journals (Sweden)

    Tian Jiaher

    2011-08-01

    Full Text Available Abstract Herbal ingredients in a Chinese fufang prescription are often replaced by one or several other herbal combinations. As there have been very few Chinese herbal patent infringement cases, it is still unclear how the Doctrine of Equivalents should be applied to determine the scope of 'equivalents' in Chinese fufang prescriptions. Case law principles from cases in other technical areas such as chemical patents and biological drug patents can be borrowed to ascertain a precise scope of a fufang patent. This article summarizes and discusses several chemical and biopharmaceutical patent cases. In cases where a certain herbal ingredient is substituted by another herb or a combination of herbs, accused infringers are likely to relate herbal drug patents to chemical drug patents with strict interpretation whereas patent owners may take advantage of the liberal application of Doctrine of Equivalence in biopharmaceutical patents by analogizing the complex nature of herbal drugs with biological drugs. Therefore, consideration should be given to the purpose of an ingredient in a patent, the qualities when combined with the other ingredients and the intended function. The scope of equivalents also depends on the stage of the prior art. Moreover, it is desirable to disclose any potential substitutes when drafting the application. Claims should be drafted in such a way that all foreseeable modifications are encompassed for the protection of the patent owner's intellectual property.

  14. 10 CFR 51.70 - Draft environmental impact statement-general.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-general. 51.70... Implementing Section 102(2) Environmental Impact Statements § 51.70 Draft environmental impact statement—general. (a) The NRC staff will prepare a draft environmental impact statement as soon as practicable...

  15. 10 CFR 51.71 - Draft environmental impact statement-contents.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-contents. 51.71... Implementing Section 102(2) Environmental Impact Statements § 51.71 Draft environmental impact statement—contents. (a) Scope. The draft environmental impact statement will be prepared in accordance with the scope...

  16. Accuracy of professional sports drafts in predicting career potential.

    Science.gov (United States)

    Koz, D; Fraser-Thomas, J; Baker, J

    2012-08-01

    The forecasting of talented players is a crucial aspect of building a successful sports franchise and professional sports invest significant resources in making player choices in sport drafts. The current study examined the relationship between career performance (i.e. games played) and draft round for the National Football League, National Hockey League, National Basketball League, and Major League Baseball for players drafted from 1980 to 1989 (n = 4874) against the assumption of a linear relationship between performance and draft round (i.e. that players with the most potential will be selected before players of lower potential). A two-step analysis revealed significant differences in games played across draft rounds (step 1) and a significant negative relationship between draft round and games played (step 2); however, the amount of variance accounted for was relatively low (less than 17%). Results highlight the challenges of accurately evaluating amateur talent. © 2011 John Wiley & Sons A/S.

  17. Cluster: Drafting. Course: Basic Technical Drafting. Research Project.

    Science.gov (United States)

    Sanford - Lee County Schools, NC.

    The set of six units is designed for use with an instructor in basic technical drafting and is also keyed to other texts. Each unit contains several task packages specifying prerequisites, rationale for learning, objectives, learning activities to be supervised by the instructor, and learning practice. The units cover: pictorial drawing; screw…

  18. Health system guidance appraisal--concept evaluation and usability testing.

    Science.gov (United States)

    Ako-Arrey, Denis E; Brouwers, Melissa C; Lavis, John N; Giacomini, Mita K

    2016-01-05

    Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and test its usability. This study involved a two-step survey process. In step 1, respondents rated the 30 concepts for appropriateness to, relevance to, and priority for health system decisions and HSG. This led to a draft tool. In step 2, respondents reviewed HSG documents, appraised them using the tool, and answered a series of questions. Descriptive analyses were computed. Fifty participants were invited in step 1, and we had a response rate of 82 %. The mean response rates for each concept within each survey question were universally favorable. There was also an overall agreement about the need for a high-quality tool to systematically direct the development, appraisal, and reporting of HSG. Qualitative feedback and a consensus process by the team led to refinements to some of the concepts and the creation of a beta (draft) version of the HSG tool. In step 2, 35 participants were invited and we had a response rate of 74 %. Exploratory analyses showed that the quality of the HSGs reviewed varied as a function of the HSG item and the specific document assessed. A favorable consensus was reached with participants agreeing that the HSG items were easy to understand and easy to apply. Moreover, the overall agreement was high for the usability of the tool to systematically direct the development (85 %), appraisal (92 %), and reporting (81 %) of HSG. From this process, version 1.0 of the HSG appraisal tool was generated complete with 32 items (and their descriptions) and 4 domains. The final

  19. Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior.

    Science.gov (United States)

    Brown, Jeffrey R; Kapteyn, Arie; Mitchell, Olivia S

    2016-03-01

    This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a "breakeven analysis" encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others.

  20. SyncClaimService

    Data.gov (United States)

    Department of Veterans Affairs — Provides various methods to sync Claim related data for NWQ processing. It includes web operations to get Claims, get Unique Contention Classifications, get Unique...

  1. Brief Comment on the Draft Land Administration, Use, Registration ...

    African Journals Online (AJOL)

    D_Behailu

    The draft 'Land Administration, Use, Registration and Plan Proclamation (2007. EC)' has been in circulation for a while now. One of the prime objectives of the draft law is to address various counterproductive restrictions in the current federal land proclamation. According to its preamble, the draft aspires to expand the rights ...

  2. Staff supplement to the draft report on human engineering guide to control room evaluation: response to comments, sample checklist, draft systems review guidelines, and evaluation procedures

    International Nuclear Information System (INIS)

    1981-03-01

    This staff supplement to Draft Report NUREG/CR-1580, Human Engineering Guide to Control Room Evaluation, provides staff responses to comments on the draft report and supplemental material not provided in the draft report. The supplemental material includes new draft guidelines for the systems review of nuclear power plant control rooms and sample checklists and corresponding human engineering guidelines

  3. Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

    International Nuclear Information System (INIS)

    Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Easton, E.P.; Coodk, J.R.

    1998-01-01

    The U.S. Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying these regulatory requirements, a detailed set of logic-flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects, (DOT/NRC, 1997). These logic-flow diagrams, as developed, are specific to the U.S. regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic-flow diagrams adapted in the IAEA regulations, and demonstrated how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements. (authors)

  4. Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior

    Science.gov (United States)

    Brown, Jeffrey R.; Kapteyn, Arie; Mitchell, Olivia S.

    2017-01-01

    This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a “breakeven analysis” encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others. PMID:28579641

  5. IRIS Toxicological Review of Methanol (Noncancer) (Interagency Science Discussion Draft)

    Science.gov (United States)

    On May 3, 2013, the Toxicological Review of Methanol (noncancer) (Revised External Review Draft) was posted for public review and comment. Subsequently, the draft Toxicological Review, Appendices, and draft IRIS Summary were reviewed internally by EPA and by other federal agenci...

  6. India's draft nuclear doctrine

    International Nuclear Information System (INIS)

    Kapur, A.

    2000-01-01

    India's draft nuclear doctrine and its nuclear and missile testing are a response to recent international, regional and domestic developments. Nehru's policy of nuclear disarmament, non-discriminatory international arrangements and unilateral restraint has been overturned in favour of self-reliant security and negotiated nuclear restraints. The draft nuclear doctrine is aimed at transparency and formalization of existing capacities. It is anchored in the United Nations Charter, based on the legitimacy of self-defence and espouses minimum nuclear deterrence. After the launching of Pokhran II, the debate in India has been settled on weaponization and deployment. The doctrine is not country-specific with respect to threat perceptions, but the author posits that the long-term focus is on China and the short-term on Pakistan. The doctrine emphasizes civilian command and control. India's decision to test incurred diplomatic and other economic costs, but afforded new opportunities for the country to assert itself militarily and politically in Asia and in the world. There were no diplomatic costs in issuing the draft nuclear doctrine, but the author estimates the economic costs of a full-blown (triad) Indian nuclear deterrent. (author)

  7. Career guidance in communities

    DEFF Research Database (Denmark)

    Thomsen, Rie

    for the development of a critically reflexive career guidance practice. The considerations are organised around seven elements. 1. Creating opportunity, structure and access 2. Entering a community and increasing visibility 3. Providing guidance in communities 4. Exploring potentials in guidance situations 5...... in career guidance practices as well as in the lives of the people in the communities. This paper falls into two parts: The first part considers the collective as the starting point for the development of meaningful career guidance activities. Based on previous research on career guidance in communities......The aim of this paper is to inspire practitioners and professionals to leave their offices to bring career guidance into communities that might not identify with career guidance in the first instance. By making the effort to engage with communities, practitioners may bring about a critical change...

  8. 77 FR 66483 - Public Comment on the Draft Federal Urban Design Element and the Draft Update to the Federal...

    Science.gov (United States)

    2012-11-05

    ... NCPC review required by law. The new Federal Urban Design Element provides policies that will guide the... public comment a draft new Federal Urban Design Element and draft revisions to the Preservation and... Features Element articulates policies that guide federal actions preserving Washington's historic character...

  9. In Brief: Geoengineering draft statement

    Science.gov (United States)

    Showstack, Randy

    2009-04-01

    The American Meteorological Society (AMS) has prepared a draft policy statement on geoengineering the climate system, which the AMS Council is considering for approval. The statement notes, “Geoengineering will not substitute for either aggressive mitigation or proactive adaptation. It could contribute to a comprehensive risk management strategy to slow climate change and alleviate its negative impacts, but the potential for adverse and unintended consequences implies a need for adequate research, appropriate regulation, and transparent consideration.” The statement, if adopted, indicates that AMS recommends enhanced research on the scientific and technological potential for geoengineering the climate system; additional study of the historical, ethical, legal, political, and societal aspects of the geoengineering issues; and the development and analysis of policy options to promote transparency and international cooperation in exploring geoengineering options along with restrictions on reckless efforts to manipulate the climate system. AMS is accepting comments on the draft statement until 23 April. For more information, visit http://ametsoc.org/policy/draftstatements/index.html#draft.

  10. Guidance for Modifying the Definition of Diseases: A Checklist.

    Science.gov (United States)

    Doust, Jenny; Vandvik, Per O; Qaseem, Amir; Mustafa, Reem A; Horvath, Andrea R; Frances, Allen; Al-Ansary, Lubna; Bossuyt, Patrick; Ward, Robyn L; Kopp, Ina; Gollogly, Laragh; Schunemann, Holger; Glasziou, Paul

    2017-07-01

    No guidelines exist currently for guideline panels and others considering changes to disease definitions. Panels frequently widen disease definitions, increasing the proportion of the population labeled as unwell and potentially causing harm to patients. We set out to develop a checklist of issues, with guidance, for panels to consider prior to modifying a disease definition. We assembled a multidisciplinary, multicontinent working group of 13 members, including members from the Guidelines International Network, Grading of Recommendations Assessment, Development and Evaluation working group, and the World Health Organisation. We used a 5-step process to develop the checklist: (1) a literature review of issues, (2) a draft outline document, (3) a Delphi process of feedback on the list of issues, (4) a 1-day face-to-face meeting, and (5) further refinement of the checklist. The literature review identified 12 potential issues. From these, the group developed an 8-item checklist that consisted of definition changes, number of people affected, trigger, prognostic ability, disease definition precision and accuracy, potential benefits, potential harms, and the balance between potential harms and benefits. The checklist is accompanied by an explanation of each item and the types of evidence to assess each one. We used a panel's recent consideration of a proposed change in the definition of gestational diabetes mellitus (GDM) to illustrate use of the checklist. We propose that the checklist be piloted and validated by groups developing new guidelines. We anticipate that the use of the checklist will be a first step to guidance and better documentation of definition changes prior to introducing modified disease definitions.

  11. 10 CFR 51.77 - Distribution of draft environmental impact statement.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement. 51...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.77 Distribution of draft environmental impact statement. (a) In addition to the distribution...

  12. Formalizing Probabilistic Safety Claims

    Science.gov (United States)

    Herencia-Zapana, Heber; Hagen, George E.; Narkawicz, Anthony J.

    2011-01-01

    A safety claim for a system is a statement that the system, which is subject to hazardous conditions, satisfies a given set of properties. Following work by John Rushby and Bev Littlewood, this paper presents a mathematical framework that can be used to state and formally prove probabilistic safety claims. It also enables hazardous conditions, their uncertainties, and their interactions to be integrated into the safety claim. This framework provides a formal description of the probabilistic composition of an arbitrary number of hazardous conditions and their effects on system behavior. An example is given of a probabilistic safety claim for a conflict detection algorithm for aircraft in a 2D airspace. The motivation for developing this mathematical framework is that it can be used in an automated theorem prover to formally verify safety claims.

  13. Debate on the Draft--Helping Students Decide Where They Stand.

    Science.gov (United States)

    Victory, James

    1981-01-01

    Presents four exercises to help secondary school social studies students understand the complex issues of the draft. Students participate in a mock draft lottery, analyze Phil Och's Draft Dodger Rag, examine how individual experiences affect attitudes, and compare writings by Bill Mauldin and Ron Kovic. (KC)

  14. 32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

    Science.gov (United States)

    2010-07-01

    ... contributory negligence be interpreted and applied according to the law of the place of the occurrence... 32 National Defense 3 2010-07-01 2010-07-01 true Applicable law for claims under the Military... Act § 536.77 Applicable law for claims under the Military Claims Act. (a) General principles—(1) Tort...

  15. 10 CFR 51.73 - Request for comments on draft environmental impact statement.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Request for comments on draft environmental impact...-Regulations Implementing Section 102(2) Environmental Impact Statements § 51.73 Request for comments on draft environmental impact statement. Each draft environmental impact statement and each supplement to a draft...

  16. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Science.gov (United States)

    2010-10-01

    ... Section 169.755 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS SAILING SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... projections of the marks onto a vertical plane are of uniform height equal to the vertical spacing between...

  17. 10 CFR 51.72 - Supplement to draft environmental impact statement.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Supplement to draft environmental impact statement. 51.72... Implementing Section 102(2) Environmental Impact Statements § 51.72 Supplement to draft environmental impact statement. (a) The NRC staff will prepare a supplement to a draft environmental impact statement for which a...

  18. Ultra-processed family foods in Australia: nutrition claims, health claims and marketing techniques.

    Science.gov (United States)

    Pulker, Claire Elizabeth; Scott, Jane Anne; Pollard, Christina Mary

    2018-01-01

    To objectively evaluate voluntary nutrition and health claims and marketing techniques present on packaging of high-market-share ultra-processed foods (UPF) in Australia for their potential impact on public health. Cross-sectional. Packaging information from five high-market-share food manufacturers and one retailer were obtained from supermarket and manufacturers' websites. Ingredients lists for 215 UPF were examined for presence of added sugar. Packaging information was categorised using a taxonomy of nutrition and health information which included nutrition and health claims and five common food marketing techniques. Compliance of statements and claims with the Australia New Zealand Food Standards Code and with Health Star Ratings (HSR) were assessed for all products. Almost all UPF (95 %) contained added sugars described in thirty-four different ways; 55 % of UPF displayed a HSR; 56 % had nutrition claims (18 % were compliant with regulations); 25 % had health claims (79 % were compliant); and 97 % employed common food marketing techniques. Packaging of 47 % of UPF was designed to appeal to children. UPF carried a mean of 1·5 health and nutrition claims (range 0-10) and 2·6 marketing techniques (range 0-5), and 45 % had HSR≤3·0/5·0. Most UPF packaging featured nutrition and health statements or claims despite the high prevalence of added sugars and moderate HSR. The degree of inappropriate or inaccurate statements and claims present is concerning, particularly on packaging designed to appeal to children. Public policies to assist parents to select healthy family foods should address the quality and accuracy of information provided on UPF packaging.

  19. Claims-based definition of death in Japanese claims database: validity and implications.

    Science.gov (United States)

    Ooba, Nobuhiro; Setoguchi, Soko; Ando, Takashi; Sato, Tsugumichi; Yamaguchi, Takuhiro; Mochizuki, Mayumi; Kubota, Kiyoshi

    2013-01-01

    For the pending National Claims Database in Japan, researchers will not have access to death information in the enrollment files. We developed and evaluated a claims-based definition of death. We used healthcare claims and enrollment data between January 2005 and August 2009 for 195,193 beneficiaries aged 20 to 74 in 3 private health insurance unions. We developed claims-based definitions of death using discharge or disease status and Charlson comorbidity index (CCI). We calculated sensitivity, specificity and positive predictive values (PPVs) using the enrollment data as a gold standard in the overall population and subgroups divided by demographic and other factors. We also assessed bias and precision in two example studies where an outcome was death. The definition based on the combination of discharge/disease status and CCI provided moderate sensitivity (around 60%) and high specificity (99.99%) and high PPVs (94.8%). In most subgroups, sensitivity of the preferred definition was also around 60% but varied from 28 to 91%. In an example study comparing death rates between two anticancer drug classes, the claims-based definition provided valid and precise hazard ratios (HRs). In another example study comparing two classes of anti-depressants, the HR with the claims-based definition was biased and had lower precision than that with the gold standard definition. The claims-based definitions of death developed in this study had high specificity and PPVs while sensitivity was around 60%. The definitions will be useful in future studies when used with attention to the possible fluctuation of sensitivity in some subpopulations.

  20. Increasing draft capability for retrofit flue gas desulfurization systems

    International Nuclear Information System (INIS)

    Petersen, R.D.; Basel, B.E.; Mosier, R.J.

    1992-01-01

    The retrofit installation of flue gas desulfurization (FGD) systems results in significantly higher draft losses for existing generating stations. Consequently, the means for increasing draft capability must be included in many FGD retrofit projects. Consideration is given to several alternatives for increasing draft capability. Alternatives are developed for new induced draft (ID) fans to replace the existing ID fans and for new booster fans to supplement the existing ID fans. Both centrifugal and axial fans are evaluated, as are different means of fan volume control. Each alternative is evaluated on the basis of technical merit and economics. Presented are the development of fan alternatives and results of the technical and economic evaluations

  1. CFD based draft tube hydraulic design optimization

    International Nuclear Information System (INIS)

    McNabb, J; Murry, N; Mullins, B F; Devals, C; Kyriacou, S A

    2014-01-01

    The draft tube design of a hydraulic turbine, particularly in low to medium head applications, plays an important role in determining the efficiency and power characteristics of the overall machine, since an important proportion of the available energy, being in kinetic form leaving the runner, needs to be recovered by the draft tube into static head. For large units, these efficiency and power characteristics can equate to large sums of money when considering the anticipated selling price of the energy produced over the machine's life-cycle. This same draft tube design is also a key factor in determining the overall civil costs of the powerhouse, primarily in excavation and concreting, which can amount to similar orders of magnitude as the price of the energy produced. Therefore, there is a need to find the optimum compromise between these two conflicting requirements. In this paper, an elaborate approach is described for dealing with this optimization problem. First, the draft tube's detailed geometry is defined as a function of a comprehensive set of design parameters (about 20 of which a subset is allowed to vary during the optimization process) and are then used in a non-uniform rational B-spline based geometric modeller to fully define the wetted surfaces geometry. Since the performance of the draft tube is largely governed by 3D viscous effects, such as boundary layer separation from the walls and swirling flow characteristics, which in turn governs the portion of the available kinetic energy which will be converted into pressure, a full 3D meshing and Navier-Stokes analysis is performed for each design. What makes this even more challenging is the fact that the inlet velocity distribution to the draft tube is governed by the runner at each of the various operating conditions that are of interest for the exploitation of the powerhouse. In order to determine these inlet conditions, a combined steady-state runner and an initial draft tube analysis

  2. CFD based draft tube hydraulic design optimization

    Science.gov (United States)

    McNabb, J.; Devals, C.; Kyriacou, S. A.; Murry, N.; Mullins, B. F.

    2014-03-01

    The draft tube design of a hydraulic turbine, particularly in low to medium head applications, plays an important role in determining the efficiency and power characteristics of the overall machine, since an important proportion of the available energy, being in kinetic form leaving the runner, needs to be recovered by the draft tube into static head. For large units, these efficiency and power characteristics can equate to large sums of money when considering the anticipated selling price of the energy produced over the machine's life-cycle. This same draft tube design is also a key factor in determining the overall civil costs of the powerhouse, primarily in excavation and concreting, which can amount to similar orders of magnitude as the price of the energy produced. Therefore, there is a need to find the optimum compromise between these two conflicting requirements. In this paper, an elaborate approach is described for dealing with this optimization problem. First, the draft tube's detailed geometry is defined as a function of a comprehensive set of design parameters (about 20 of which a subset is allowed to vary during the optimization process) and are then used in a non-uniform rational B-spline based geometric modeller to fully define the wetted surfaces geometry. Since the performance of the draft tube is largely governed by 3D viscous effects, such as boundary layer separation from the walls and swirling flow characteristics, which in turn governs the portion of the available kinetic energy which will be converted into pressure, a full 3D meshing and Navier-Stokes analysis is performed for each design. What makes this even more challenging is the fact that the inlet velocity distribution to the draft tube is governed by the runner at each of the various operating conditions that are of interest for the exploitation of the powerhouse. In order to determine these inlet conditions, a combined steady-state runner and an initial draft tube analysis, using a

  3. Claiming health in food products

    DEFF Research Database (Denmark)

    Lähteenmäki, Liisa

    2013-01-01

    Health-related information is increasingly used on food products to convey their benefits. Health claims as a subcategory of these messages link the beneficial component, functions or health outcomes with specific products. For consumers, health claims seem to carry the message of increased...... healthiness, but not necessarily making the product more appealing. The wording of the claim seems to have little impact on claim perception, yet the health image of carrier products is important. From consumer-related factors the relevance and attitudes towards functional foods play a role, whereas socio......-demographic factors have only minor impact and the impact seems to be case-dependent. Familiarity with claims and functional foods increase perceived healthiness and acceptance of these products. Apparently consumers make rather rational interpretations of claims and their benefits when forced to assess...

  4. Warranty claim analysis considering human factors

    International Nuclear Information System (INIS)

    Wu Shaomin

    2011-01-01

    Warranty claims are not always due to product failures. They can also be caused by two types of human factors. On the one hand, consumers might claim warranty due to misuse and/or failures caused by various human factors. Such claims might account for more than 10% of all reported claims. On the other hand, consumers might not be bothered to claim warranty for failed items that are still under warranty, or they may claim warranty after they have experienced several intermittent failures. These two types of human factors can affect warranty claim costs. However, research in this area has received rather little attention. In this paper, we propose three models to estimate the expected warranty cost when the two types of human factors are included. We consider two types of failures: intermittent and fatal failures, which might result in different claim patterns. Consumers might report claims after a fatal failure has occurred, and upon intermittent failures they might report claims after a number of failures have occurred. Numerical examples are given to validate the results derived.

  5. A study of swirl flow in draft tubes

    Energy Technology Data Exchange (ETDEWEB)

    Dahlhaug, Ole Gunnar

    1997-12-31

    This thesis presents measurements performed inside conical diffuser and bend, draft tubes of model hydro turbines, and draft tube of a prototype hydro turbine. Experimental results for swirling flow in conical diffuser and bend are presented in three different geometries. The axial velocity decreases at the centre of the tube at high swirl numbers because of an axial pressure gradient set up by the downstream frictional damping of the tangential velocities and the pressure increase downstream of the diffuser. Analytical models of the tangential velocity profiles are found and the radial pressure distribution calculated. Good correlation to the measured pressure distribution was achieved. Diffuser efficiency was calculated based on the equations for velocity and pressure profiles, which gave a qualified estimate of the diffuser hydraulic performance. The calculation shows that the bend reduces the efficiency by more than 30%. For a straight tube followed by a diffuser, numerical calculations were done, using K{epsilon}, RNG and RSM turbulence models for all measured swirl numbers. The K{epsilon} model gave best results for the forced vortex profile at low swirl numbers, while the RSM model gave best results at high swirl number. The turbulent kinetic energy at high swirl numbers gave the largest difference between the calculated and the measured values. Measurements on draft tubes in model turbines show the importance of good draft tube design. Prototype measurements on a Francis turbine show how the outlet draft tube flow should be measured for prototype draft tube evaluation. 54 refs., 118 figs., 2 tabs.

  6. A study of swirl flow in draft tubes

    Energy Technology Data Exchange (ETDEWEB)

    Dahlhaug, Ole Gunnar

    1998-12-31

    This thesis presents measurements performed inside conical diffuser and bend, draft tubes of model hydro turbines, and draft tube of a prototype hydro turbine. Experimental results for swirling flow in conical diffuser and bend are presented in three different geometries. The axial velocity decreases at the centre of the tube at high swirl numbers because of an axial pressure gradient set up by the downstream frictional damping of the tangential velocities and the pressure increase downstream of the diffuser. Analytical models of the tangential velocity profiles are found and the radial pressure distribution calculated. Good correlation to the measured pressure distribution was achieved. Diffuser efficiency was calculated based on the equations for velocity and pressure profiles, which gave a qualified estimate of the diffuser hydraulic performance. The calculation shows that the bend reduces the efficiency by more than 30%. For a straight tube followed by a diffuser, numerical calculations were done, using K{epsilon}, RNG and RSM turbulence models for all measured swirl numbers. The K{epsilon} model gave best results for the forced vortex profile at low swirl numbers, while the RSM model gave best results at high swirl number. The turbulent kinetic energy at high swirl numbers gave the largest difference between the calculated and the measured values. Measurements on draft tubes in model turbines show the importance of good draft tube design. Prototype measurements on a Francis turbine show how the outlet draft tube flow should be measured for prototype draft tube evaluation. 54 refs., 118 figs., 2 tabs.

  7. Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications

    Science.gov (United States)

    Ooba, Nobuhiro; Setoguchi, Soko; Ando, Takashi; Sato, Tsugumichi; Yamaguchi, Takuhiro; Mochizuki, Mayumi; Kubota, Kiyoshi

    2013-01-01

    Background For the pending National Claims Database in Japan, researchers will not have access to death information in the enrollment files. We developed and evaluated a claims-based definition of death. Methodology/Principal Findings We used healthcare claims and enrollment data between January 2005 and August 2009 for 195,193 beneficiaries aged 20 to 74 in 3 private health insurance unions. We developed claims-based definitions of death using discharge or disease status and Charlson comorbidity index (CCI). We calculated sensitivity, specificity and positive predictive values (PPVs) using the enrollment data as a gold standard in the overall population and subgroups divided by demographic and other factors. We also assessed bias and precision in two example studies where an outcome was death. The definition based on the combination of discharge/disease status and CCI provided moderate sensitivity (around 60%) and high specificity (99.99%) and high PPVs (94.8%). In most subgroups, sensitivity of the preferred definition was also around 60% but varied from 28 to 91%. In an example study comparing death rates between two anticancer drug classes, the claims-based definition provided valid and precise hazard ratios (HRs). In another example study comparing two classes of anti-depressants, the HR with the claims-based definition was biased and had lower precision than that with the gold standard definition. Conclusions/Significance The claims-based definitions of death developed in this study had high specificity and PPVs while sensitivity was around 60%. The definitions will be useful in future studies when used with attention to the possible fluctuation of sensitivity in some subpopulations. PMID:23741526

  8. 78 FR 26616 - Draft NOAA Five Year Research and Development Plan

    Science.gov (United States)

    2013-05-07

    ... DEPARTMENT OF COMMERCE Draft NOAA Five Year Research and Development Plan AGENCY: National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC). ACTION: Draft NOAA Five Year Research and Development Plan for Public Review. SUMMARY: NOAA's draft Five Year Research and Development...

  9. Numerical simulation of draft tube flow of a bulb turbine

    Energy Technology Data Exchange (ETDEWEB)

    Coelho, J.G. [Federal University of Triangulo Mineiro, Institute of Technological and Exact Sciences, Avenida Doutor Randolfo Borges Junior, 1250 – Uberaba – MG (Brazil); Brasil, A.C.P. Jr. [University of Brasilia, Department of Mechanical Engineering, Campus Darcy Ribeiro, Brasilia – DF (Brazil)

    2013-07-01

    In this work a numerical study of draft tube of a bulb hydraulic turbine is presented, where a new geometry is proposed. This new proposal of draft tube has the unaffected ratio area, a great reduction in his length and approximately the same efficiency of the draft tube conventionally used. The numerical simulations were obtained in commercial software of calculation of flow (CFX-14), using the turbulence model SST, that allows a description of the field fluid dynamic near to the wall. The simulation strategy has an intention of identifying the stall of the boundary layer precisely limits near to the wall and recirculations in the central part, once those are the great causes of the decrease of efficiency of a draft tube. Finally, it is obtained qualitative and quantitative results about the flow in draft tubes.

  10. Draft of regulations for road transport of radioactive wastes

    International Nuclear Information System (INIS)

    Gese, J.; Zizka, B.

    1979-06-01

    A draft regulation is presented for the transport of solid and solidified radioactive wastes from nuclear power plants. The draft takes into consideration dosimetric, safety and fire-fighting directives, transport organization, anticipated amounts of radioactive wastes, characteristics of containers, maintenance of vehicles, and equipment of vehicles and personnel. The draft is based on the provisional regulations governing the transport on public roads issued in 1973, valid directives, decrees, acts and standards, and complies with 1973 IAEA requirements. (J.P.)

  11. Analysis of the Kaplan turbine draft tube effect

    International Nuclear Information System (INIS)

    Motycak, L; Skotak, A; Obrovsky, J

    2010-01-01

    The aim of this paper is to present information about possible problems and errors which can appear during numerical analyses of low head Kaplan turbines with a view to the runner - draft tube interaction. The setting of numerical model, grid size, used boundary conditions are the interface definition between runner and draft tube are discussed. There are available data from physical model tests which gives a great opportunity to compare CFD and experiment results and on the basis of this comparison to determine the approach to the CFD flow modeling. The main purpose for the Kaplan turbine model measurement was to gather the information about real flow field. The model tests were carried out in new hydraulic laboratory of CKD Blansko Engineering. The model tests were focused on the detailed velocity measurements downstream of the runner by differential pressure probe and on the velocity measurement downstream of the draft tube elbow by Particle Image Velocimetry method (PIV). The data from CFD simulation were compared to the velocity measurement results. In the paper also the design of the original draft tube modification due to flow improvement is discussed in the case of the Kaplan turbine uprating project. The results of the draft tube modification were confirmed by model tests in the hydraulic laboratory as well.

  12. Analysis of the Kaplan turbine draft tube effect

    Energy Technology Data Exchange (ETDEWEB)

    Motycak, L; Skotak, A; Obrovsky, J, E-mail: motycak.vhs@cbeng.c [CKD Blansko Engineering, a.s., Capkova 2357/5, Blansko 67801 (Czech Republic)

    2010-08-15

    The aim of this paper is to present information about possible problems and errors which can appear during numerical analyses of low head Kaplan turbines with a view to the runner - draft tube interaction. The setting of numerical model, grid size, used boundary conditions are the interface definition between runner and draft tube are discussed. There are available data from physical model tests which gives a great opportunity to compare CFD and experiment results and on the basis of this comparison to determine the approach to the CFD flow modeling. The main purpose for the Kaplan turbine model measurement was to gather the information about real flow field. The model tests were carried out in new hydraulic laboratory of CKD Blansko Engineering. The model tests were focused on the detailed velocity measurements downstream of the runner by differential pressure probe and on the velocity measurement downstream of the draft tube elbow by Particle Image Velocimetry method (PIV). The data from CFD simulation were compared to the velocity measurement results. In the paper also the design of the original draft tube modification due to flow improvement is discussed in the case of the Kaplan turbine uprating project. The results of the draft tube modification were confirmed by model tests in the hydraulic laboratory as well.

  13. Analysis of the Kaplan turbine draft tube effect

    Science.gov (United States)

    Motycak, L.; Skotak, A.; Obrovsky, J.

    2010-08-01

    The aim of this paper is to present information about possible problems and errors which can appear during numerical analyses of low head Kaplan turbines with a view to the runner - draft tube interaction. The setting of numerical model, grid size, used boundary conditions are the interface definition between runner and draft tube are discussed. There are available data from physical model tests which gives a great opportunity to compare CFD and experiment results and on the basis of this comparison to determine the approach to the CFD flow modeling. The main purpose for the Kaplan turbine model measurement was to gather the information about real flow field. The model tests were carried out in new hydraulic laboratory of CKD Blansko Engineering. The model tests were focused on the detailed velocity measurements downstream of the runner by differential pressure probe and on the velocity measurement downstream of the draft tube elbow by Particle Image Velocimetry method (PIV). The data from CFD simulation were compared to the velocity measurement results. In the paper also the design of the original draft tube modification due to flow improvement is discussed in the case of the Kaplan turbine uprating project. The results of the draft tube modification were confirmed by model tests in the hydraulic laboratory as well.

  14. 16 CFR 1.84 - Draft environmental impact statements: Availability and comment.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Draft environmental impact statements... Environmental Policy Act of 1969 § 1.84 Draft environmental impact statements: Availability and comment. Except for proposals for legislation, environmental impact statements shall be prepared in two stages: Draft...

  15. 10 CFR 51.76 - Draft environmental impact statement-limited work authorization.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-limited work...-Regulations Implementing Section 102(2) Draft Environmental Impact Statements-Production and Utilization Facilities § 51.76 Draft environmental impact statement—limited work authorization. The NRC will prepare a...

  16. 10 CFR 51.117 - Draft environmental impact statement-notice of availability.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Draft environmental impact statement-notice of... environmental impact statement—notice of availability. (a) Upon completion of a draft environmental impact statement or any supplement to a draft environmental impact statement, the appropriate NRC staff director...

  17. 78 FR 77027 - Overhead Clearance (Air-Draft) Accidents

    Science.gov (United States)

    2013-12-20

    ... No. USCG-2013-0466] Overhead Clearance (Air-Draft) Accidents AGENCY: Coast Guard, DHS. ACTION... clearance (air-draft) accidents. In its petition, which calls for vessel masters to be provided with... accidents that it says were avoidable and that resulted in damage to or destruction of waterway...

  18. 76 FR 9210 - Draft DOC National Aquaculture Policy

    Science.gov (United States)

    2011-02-16

    ... DEPARTMENT OF COMMERCE Draft DOC National Aquaculture Policy AGENCY: Commerce. ACTION: Notice of availability of draft aquaculture policy; request for comments. SUMMARY: The Department of Commerce (DOC) is... United States. The intent of the policy is to guide DOC's actions and decisions on aquaculture and to...

  19. 23 CFR 771.123 - Draft environmental impact statements.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Draft environmental impact statements. 771.123 Section... ENVIRONMENT ENVIRONMENTAL IMPACT AND RELATED PROCEDURES § 771.123 Draft environmental impact statements. (a) A... significant impacts on the environment. When the applicant, after consultation with any project sponsor that...

  20. Introduction to Production/Manufacturing Drafting. Drafting Module 8. Instructor's Guide.

    Science.gov (United States)

    Missouri Univ., Columbia. Instructional Materials Lab.

    This module, 1 of 10 in the Drafting curriculum guide developed in Missouri, contains 3 units of study that include some or all of the following components: performance objectives, lesson plans, information sheets, transparency masters, handouts, assignment sheets, job sheets, a unit test, and answers to the unit test. Special instructions on…

  1. Claims in civil engineering contracts

    CERN Document Server

    Speirs, N A

    1999-01-01

    This paper considers claims arising during civil engineering construction contracts. The meaning of the word 'claim' is considered and its possible implications for additional cost and time to completion. The conditions of the construction contract selected will influence the risk apportionment between contractor and client and the price offered by the contractor for the work. Competitive bidding constraints and profit margins in the construction industry, however, may also influence the price offered. This in turn can influence the likelihood of claims arising. The client from his point of view is concerned to complete the work within an agreed time and budget. The circumstances under which claims may arise are reviewed in relation to typical conditions of contract. These circumstances are then related to the CERN LHC civil works. Ways of avoiding claims, where this is possible, are considered. Finally, the means of evaluation of claims and their settlement are considered.

  2. Reduced order model of draft tube flow

    International Nuclear Information System (INIS)

    Rudolf, P; Štefan, D

    2014-01-01

    Swirling flow with compact coherent structures is very good candidate for proper orthogonal decomposition (POD), i.e. for decomposition into eigenmodes, which are the cornerstones of the flow field. Present paper focuses on POD of steady flows, which correspond to different operating points of Francis turbine draft tube flow. Set of eigenmodes is built using a limited number of snapshots from computational simulations. Resulting reduced order model (ROM) describes whole operating range of the draft tube. ROM enables to interpolate in between the operating points exploiting the knowledge about significance of particular eigenmodes and thus reconstruct the velocity field in any operating point within the given range. Practical example, which employs axisymmetric simulations of the draft tube flow, illustrates accuracy of ROM in regions without vortex breakdown together with need for higher resolution of the snapshot database close to location of sudden flow changes (e.g. vortex breakdown). ROM based on POD interpolation is very suitable tool for insight into flow physics of the draft tube flows (especially energy transfers in between different operating points), for supply of data for subsequent stability analysis or as an initialization database for advanced flow simulations

  3. Considerations about noise aspects in the EEC draft directive physical agents

    NARCIS (Netherlands)

    Passchier-Vermeer, W.

    1992-01-01

    This report contains an overview of and considerations about the Working Draft of a future EEC Directive Physical Agents (draft 1991). The overview in this report is limited to noise exposure. The Draft gives minimum regulations concerning the protection of workers and prevention against the risks

  4. Second WCB claims: who is at risk?

    Science.gov (United States)

    Cherry, Nicola M; Sithole, Fortune; Beach, Jeremy R; Burstyn, Igor

    2010-01-01

    Many workers with one Workers' Compensation Board (WCB) claim make further claims. If the characteristics of the job, initial injury or worker were predictive of an early second claim, interventions at the time of return to work after the first claim might be effective in reducing the burden of work-related injury. This report explores the characteristic of those who make a second claim. Records of all Alberta WCB claims from January 1, 1995, to December 31, 2004, for individuals 18 to claim, sex and age of claimant, type of injury, type of accident, occupation, industry, an indicator of company size, and industry claim rate were extracted, as well as the date of any second claim. The likelihood of second claim and mean time to second claim were estimated. Multivariate analyses were performed using Cox regression. 1,047,828 claims were identified from 490,230 individuals. Of these, 49.2% had at least two claims. In the multivariate model a reduced time to second claim was associated with male sex, younger age and some types of injury and accident. Machining trades were at highest risk of early second claim (hazard ratio [HR] 2.54 compared with administration), and of the industry sectors manufacturing was at highest risk (HR 1.37 compared with business, personal and professional services). Some caution is needed in interpreting these data as they may be affected by under-reporting and job changes between claims. Nonetheless, they suggest that there remains room for interventions to reduce the considerable differences in risk of a second claim among workers, jobs and industries.

  5. Workers Compensation Claim Data -

    Data.gov (United States)

    Department of Transportation — This data set contains DOT employee workers compensation claim data for current and past DOT employees. Types of data include claim data consisting of PII data (SSN,...

  6. 32 CFR 842.110 - Claims not payable.

    Science.gov (United States)

    2010-07-01

    ...) Claims for a maritime occurrence covered under U.S. admiralty laws. (o) Claims for: (1) Any tax or... International Agreements Claims Act. (4) The Air Force Admiralty Claims Act and the Admiralty Extensions Act. (5...) Claims from the combat activities of the armed forces during war or armed conflict. (c) Claims for...

  7. 78 FR 66010 - Draft Risk Profile on Pathogens and Filth in Spices; Availability

    Science.gov (United States)

    2013-11-04

    ...] Draft Risk Profile on Pathogens and Filth in Spices; Availability AGENCY: Food and Drug Administration... availability of a draft risk profile entitled ``FDA Draft Risk Profile: Pathogens and Filth in Spices'' (draft... posed by consumption of spices in the United States by identifying the most commonly occurring microbial...

  8. Graphic Turbulence Guidance

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  9. Draft 1988 mission plan amendment

    International Nuclear Information System (INIS)

    1988-06-01

    This draft 1988 amendment to the Mission Plan for the Civilian Radioactive Waste Management Program has been prepared by the US Department of Energy (DOE). The purpose is to inform the Congress of the DOE's plans for implementing the provisions of the Nuclear Waste Policy Amendments Act of 1987 (P.L. 100-203) for the Civilian Radioactive Waste Management Program. This document is being submitted in draft form to Federal agencies, states, previously affected Indian Tribes, affected units of local government, and the public. After the consideration of comments, this amendment will be revised as appropriate and submitted to the Congress. 39 refs., 7 figs., 4 tabs

  10. IBO Claim Taking Project

    Data.gov (United States)

    Social Security Administration — IBO manually tracks all Canadian Claims and DSU claims via this report. It also provides a summary for each region and office of origin that the DSU works with. This...

  11. Guidance Manual for preparing Nuclear and Radiological Emergency Preparedness and Response Plan

    Energy Technology Data Exchange (ETDEWEB)

    Muhammed, Kabiru [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Jeong, Seung-Young [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-10-15

    The Nuclear and Radiological Emergency Preparedness and Response Plan(NREPRP) describes the capabilities, responsibilities and authorities of government agencies and a conceptual basis for integrating the activities of these agencies to protect public health and safety. The NREPRP addresses issues related to actual or perceived radiation hazard requiring a national response in order to: i. Provide co-ordination of a response involving multi-jurisdictions or significant national responsibilities; or ii. Provide national support to state and local governments. The objective of this research is to establish Guidance Manual for preparing a timely, organized and coordinated emergency response plan for Authorities/agencies to promptly and adequately determine and take actions to protect members of the public and emergency workers. The manual will not provide sufficient details for an adequate response. This level of details is contained in standard operating procedures that are being developed based on the plan developed. Base on the data obtain from integrated planning levels and responsibility sharing, the legal document of major government agencies participating in NREPRP form the legal basis for the response plan. Also the following documents should be some international legal binding documents. Base on the international safety requirement and some countries well developed NREPRP, we have drafted a guidance manual for new comer countries for easy development of their countries NREPRP. Also we have taken in to consideration lessons learn from most accident especially Fukushima accident.

  12. Guidance Manual for preparing Nuclear and Radiological Emergency Preparedness and Response Plan

    International Nuclear Information System (INIS)

    Muhammed, Kabiru; Jeong, Seung-Young

    2014-01-01

    The Nuclear and Radiological Emergency Preparedness and Response Plan(NREPRP) describes the capabilities, responsibilities and authorities of government agencies and a conceptual basis for integrating the activities of these agencies to protect public health and safety. The NREPRP addresses issues related to actual or perceived radiation hazard requiring a national response in order to: i. Provide co-ordination of a response involving multi-jurisdictions or significant national responsibilities; or ii. Provide national support to state and local governments. The objective of this research is to establish Guidance Manual for preparing a timely, organized and coordinated emergency response plan for Authorities/agencies to promptly and adequately determine and take actions to protect members of the public and emergency workers. The manual will not provide sufficient details for an adequate response. This level of details is contained in standard operating procedures that are being developed based on the plan developed. Base on the data obtain from integrated planning levels and responsibility sharing, the legal document of major government agencies participating in NREPRP form the legal basis for the response plan. Also the following documents should be some international legal binding documents. Base on the international safety requirement and some countries well developed NREPRP, we have drafted a guidance manual for new comer countries for easy development of their countries NREPRP. Also we have taken in to consideration lessons learn from most accident especially Fukushima accident

  13. On random pressure pulses in the turbine draft tube

    Science.gov (United States)

    Kuibin, P. A.; Shtork, S. I.; Skripkin, S. G.; Tsoy, M. A.

    2017-04-01

    The flow in the conical part of the hydroturbine draft tube undergoes various instabilities due to deceleration and flow swirling at off-design operation points. In particular, the precessing vortex rope develops at part-load regimes in the draft tube. This rope induces periodical low-frequency pressure oscillations in the draft tube. Interaction of rotational (asynchronous) mode of disturbances with the elbow can bring to strong oscillations in the whole hydrodynamical system. Recent researches on flow structure in the discharge cone in a regime of free runner had revealed that helical-like vortex rope can be unstable itself. Some coils of helix close to each other and reconnection appears with generation of a vortex ring. The vortex ring moves toward the draft tube wall and downstream. The present research is focused on interaction of vortex ring with wall and generation of pressure pulses.

  14. Non-cable vehicle guidance

    Energy Technology Data Exchange (ETDEWEB)

    Daugela, G.C.; Willott, A.M.; Chopiuk, R.G.; Thornton, S.E.

    1988-06-01

    The purpose is to determine the most promising driverless mine vehicle guidance systems that are not dependent on buried cables, and to plan their development. The project is presented in two phases: a preliminary study and literature review to determine whether suitable technologies exist to justify further work; and an in-depth assessment and selection of technologies for vehicle guidance. A large number of guidance elements are involved in a completely automated vehicle. The technologies that hold the best potential for development of guidance systems for mine vehicles are ultrasonics, radar, lasers, dead reckoning, and guidance algorithms. The best approach to adaptation of these technologies is on a step by step basis. Guidance modules that are complete in themselves and are designed to be integrated with other modules can provide short term benefits. Two modules are selected for development: the dragline operations monitor and automated machine control for optimized mining (AMCOM). 99 refs., 20 figs., 40 tabs.

  15. Medicaid Drug Claims Statistics

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Medicaid Drug Claims Statistics CD is a useful tool that conveniently breaks up Medicaid claim counts and separates them by quarter and includes an annual count.

  16. An Individual Claims History Simulation Machine

    Directory of Open Access Journals (Sweden)

    Andrea Gabrielli

    2018-03-01

    Full Text Available The aim of this project is to develop a stochastic simulation machine that generates individual claims histories of non-life insurance claims. This simulation machine is based on neural networks to incorporate individual claims feature information. We provide a fully calibrated stochastic scenario generator that is based on real non-life insurance data. This stochastic simulation machine allows everyone to simulate their own synthetic insurance portfolio of individual claims histories and back-test thier preferred claims reserving method.

  17. Radiation protection of medical staff in the latest draft of the revised Euratom Basic Safety Standards directive

    International Nuclear Information System (INIS)

    Simeonov, Georgi; Mundigl, Stefan; Janssens, Augustin

    2011-01-01

    The European Union has a long and successful history of legislating in the area of radiation protection of the public, workers and individuals submitted to medical exposure, the first Euratom “Basic Safety Standards” (BSS) adopted in 1959 and subsequently updated and supplemented with other Directives. The recent revision of this legislation aims to update it in the light of the latest knowledge and experience and to simplify it by consolidating the current legal acts into one Directive. The draft of the revised Euratom BSS Directive has been approved by the group of scientific experts under Euratom Treaty Article 31 and is currently undergoing the European Commission’s procedures. This draft contains several new or amended provisions relating to protection of medical staff, among them: (i) a streamlining of the annual dose limit provisions, (ii) enhancing the use of dose constraints in optimization of protection, and (iii) ensuring better recording and transfer of occupational dose data including in cases of trans-border movement of workers. The Community action to radiation protection of workers is not restricted to passing relevant legislation but also includes ‘soft action’ as issuing guidance, supporting research and stakeholders’ involvement, etc. In August 2010 the Commission issued a Communication to the Council and the European Parliament dealing with the issues in the medical uses of ionizing radiation, including those relating to radiation protection of medical staff.

  18. The National Football League Combine: performance differences between drafted and nondrafted players entering the 2004 and 2005 drafts.

    Science.gov (United States)

    Sierer, S Patrick; Battaglini, Claudio L; Mihalik, Jason P; Shields, Edgar W; Tomasini, Nathan T

    2008-01-01

    The purpose of this study was to examine performance differences between drafted and nondrafted athletes (N = 321) during the 2004 and 2005 National Football League (NFL) Combines. We categorized players into one of 3 groups: Skill, Big skill, and Linemen. Skill players (SP) consisted of wide receivers, cornerbacks, free safeties, strong safeties, and running backs. Big skill players (BSP) included fullbacks, linebackers, tight ends, and defensive ends. Linemen (LM) consisted of centers, offensive guards, offensive tackles, and defensive tackles. We analyzed player height and mass, as well as performance on the following combine drills: 40-yard dash, 225-lb bench press test, vertical jump, broad jump, pro-agility shuttle, and the 3-cone drill. Student t-tests compared performance on each of these measures between drafted and nondrafted players. Statistical significance was found between drafted and nondrafted SP for the 40-yard dash (P ready themselves for the NFL Combine.

  19. 37 CFR 360.25 - Copies of claims.

    Science.gov (United States)

    2010-07-01

    ... Section 360.25 Patents, Trademarks, and Copyrights COPYRIGHT ROYALTY BOARD, LIBRARY OF CONGRESS SUBMISSION OF ROYALTY CLAIMS FILING OF CLAIMS TO ROYALTY FEES COLLECTED UNDER COMPULSORY LICENSE Digital Audio Recording Devices and Media Royalty Claims § 360.25 Copies of claims. A claimant shall, for each claim...

  20. 32 CFR 842.94 - Assertable claims.

    Science.gov (United States)

    2010-07-01

    ..., against a tort-feasor when: (a) Damage results from negligence and the claim is for: (1) More than $100... ADMINISTRATIVE CLAIMS Property Damage Tort Claims in Favor of the United States (31 U.S.C. 3701, 3711-3719) § 842.... (The two claims should be consolidated and processed under subpart N). (d) The Tort-feasor or his...

  1. Ignorance is bliss. How parents of preschool children make sense of front-of-package visuals and claims on food.

    Science.gov (United States)

    Abrams, Katie M; Evans, Caitlin; Duff, Brittany R L

    2015-04-01

    With growing scrutiny over how the food industry advertises products aimed toward children and fewer consumers using nutrition facts panels and ingredient lists, the fronts of food packages have become an increasingly important marketing tool to understand. Front-of-package (FOP) visual and verbal claims play a critical role in capturing consumers' attention and helping them choose foods that fit their goals. Due to only possessing emergent literacy skills, preschool children are attuned to FOP visuals while parents are able to use the visuals in combination with verbal claims to make food choices for their children. The purpose of this focus group study was to explore how parents of preschool children make sense of FOP visual and verbal claims on packaged food products that are intended for their children. Thematic analysis revealed that parents associated aspects that most appeal to their preschool children - the characters and other playful visuals - with higher sugar content and artificial ingredients. However, parents were also easily led to believe the product was healthier based on visuals of fruit, more realistic pictures, health claims, cross-branding with healthier foods, and visuals suggesting the product is more natural. While parents recognized that the health claims and some visuals may not truly mean the food is healthier, they agreed that they rarely think beyond their initial impression. The food industry needs better regulatory guidance on how to communicate flavors and ingredients on package fronts in a way that helps consumers - particularly parents wanting to encourage healthy eating habits for their young children - better match their nutrition goals. Published by Elsevier Ltd.

  2. Nuclear Regulatory Commission staff approaches to improving the integration of regulatory guidance documents and prelicensing reviews

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-01-01

    The Nuclear Regulatory Commission staff is conducting numerous activities to improve the integration of its regulatory guidance documents (i.e., License Application Review Plan (LARP) and open-quotes Format and Content for the License Application for the High-Level Waste repositoryclose quotes (FCRG)) and pre-license application (LA) reviews. Those activities related to the regulatory guidance documents consist of: (1) developing an hierarchy of example evaluation findings for LARP; (2) identifying LARP review plan interfaces; (3) conducting an integration review of LARP review strategies; (4) correlating LARP to the ongoing technical program; and (5) revising the FCRG. Some of the more important strategies the staff is using to improve the integration of pre-LA reviews with the LA review include: (1) use of the draft LARP to guide the staff's pre-LA reviews; (2) focus detailed pre-LA reviews on key technical uncertainties; (3) identify and track concerns with DOE's program; and (4) use results of pre-LA reviews in LA reviews. The purpose of this paper is to describe these ongoing activities and strategies and discuss some of the new work that is planned to be included in LARP Revision 1 and the final FCRG, which are scheduled to be issued in late 1994. These activities reflect both the importance the staff has placed on integration and the staff's approach to improving integration in these areas. The staff anticipates that the results of these activities, when incorporated in the FCRG, LARP, and pre-LA reviews, will improve its guidance for DOE's ongoing site characterization program and LA annotated outline development

  3. A State Articulated Instructional Objectives Guide for Occupational Education Programs. State Pilot Model for Drafting (Graphic Communications). Part I--Basic. Part II--Specialty Programs. Section A (Mechanical Drafting and Design). Section B (Architectural Drafting and Design).

    Science.gov (United States)

    North Carolina State Dept. of Community Colleges, Raleigh.

    A two-part articulation instructional objective guide for drafting (graphic communications) is provided. Part I contains summary information on seven blocks (courses) of instruction. They are as follow: introduction; basic technical drafting; problem solving in graphics; reproduction processes; freehand drawing and sketching; graphics composition;…

  4. Nanomaterial Case Studies: Nanoscale Titanium Dioxide (External Review Draft)

    Science.gov (United States)

    This draft document presents two case studies of nanoscale titanium dioxide (nano-TiO2) used (1) to remove arsenic from drinking water and (2) as an active ingredient in topical sunscreen. The draft case studies are organized around a comprehensive environmental asses...

  5. Guidance for writing permits for the use or disposal of sewage sludge. Draft report

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-01

    Section 405(d) of the Clean Water Act (CWA) directs the U.S. Environmental Protection Agency (EPA) to develop regulations containing guidelines for the use and disposal of sewage sludge. On February 19th, 1993, EPA published final regulations at 40 Code of Federal Regulations (CFR) Part 503 as the culmination of a major effort to develop technical standards in response to Section 405(d). These regulations govern three sewage sludge use and disposal practices: land application, surface disposal, and incineration. A key element in EPA's implementation of the Part 503 regulations is educating Agency and State personnel about these new requirements. Although the regulations are generally directly enforceable against all persons involved in the use and disposal of sewage sludge, they will also be implemented through permits issued to treatment works treating domestic sewage as defined in 40 CFR 122.22. Thus, the primary focus of the manual is to assist permit writers in incorporating the Part 503 requirements into permits; it serves as an update to the Guidance for Writing Case-by-Case Permit Conditions for Municipal Sewage Sludge (PB91-145508/HDM).

  6. Analytical and Experimental Draft Force Evaluation of Plastic Coated Chisel Tines

    Directory of Open Access Journals (Sweden)

    M Barzegar Tabrizi

    2017-10-01

    Full Text Available Introduction Improving the efficiency of all agricultural operations has always been important for farmers and engineers. It is well known that the force required for cutting a soil using narrow blades is a function of soil and environmental physical properties, tool shape geometry and the tool’s surface characteristics like soil-tool adhesion and friction. Soil tool adhesion can reduce ploughing efficiency and quality. It may also halt the movement of tillage machines in more severe conditions. Adhesion can also disable some machine abilities, which can result in a significant reduction of machine performance. Adhesion of the soil to seed-bed preparation tools like furrowers can significantly affect the germination rate. Reducing soil tool adhesion of furrowers can reduce draft force and improve ploughing efficiency. Many researchers have worked on methods of reducing draft force by modifying the surface material and/or surface texture of the plough tools. A good prediction on draft force of a tool before producing it has always been important for farmers and engineers. There are some models for predicting the draft force of narrow blades in soil. McKyes-Ali’s model is widely used because of its accuracy and simplicity. Ultra-high molecular weight polythene (UHMW-PE is a polymer with ultra-high weight and long molecular chains and is well known for its outstanding physical and chemical properties and self-cleaning abilities, which reduce soil-tool adhesion. The aim of this study was to investigate usability of UHMW-PE coated furrower tines for draft force. Analytical and experimental investigations were carried out during the research. A comparison was conducted between the analytical and the experimental method. The results of this comparison can be used to determine reliability of the analytical model for predicting the draft force improvement caused by the surface modification on tines using different surface coatings. Materials and

  7. Comments from the Developmental Neurotoxicology Committee of the Japanese Teratology Society on the OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study, Draft Document (October 2006 version), and on the Draft Document of the Retrospective Performance Assessment of the Draft Test Guideline 426 on Developmental Neurotoxicity.

    Science.gov (United States)

    Ema, Makoto; Fukui, Yoshihiro; Aoyama, Hiroaki; Fujiwara, Michio; Fuji, Junichiro; Inouye, Minoru; Iwase, Takayuki; Kihara, Takahide; Oi, Akihide; Otani, Hiroki; Shinomiya, Mitsuhiro; Sugioka, Kozo; Yamano, Tsunekazu; Yamashita, Keisuke H; Tanimura, Takashi

    2007-06-01

    In October 2006, a new revision of the draft guideline (OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426. Developmental Neurotoxicity Study) and Draft Document of the Retrospective Performance Assessment (RPA) of the Draft Test Guideline 426 on Developmental Neurotoxicity were distributed following incorporation of the results of the Expert Consultation Meeting in Tokyo on May 24-26, 2005. The draft guideline consists of 50 paragraphs and an appendix with 102 references; and the draft RPA consists of 37 paragraphs with 109 references. National coordinators were requested to arrange for national expert reviews of these draft documents in their member countries. Members of the Developmental Neurotoxicology (DNT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed, and commented on the draft Test Guideline Proposal. The DNT Committee of the JTS also commented on the draft document of the RPA. These comments were sent to the OECD Secretariat. The DNT Committee of the JTS expects the comments to be useful for the finalization of these draft documents.

  8. Sea ice draft in the Weddell Sea, measured by upward looking sonars

    Directory of Open Access Journals (Sweden)

    A. Behrendt

    2013-06-01

    Full Text Available The presented database contains time-referenced sea ice draft values from upward looking sonar (ULS measurements in the Weddell Sea, Antarctica. The sea ice draft data can be used to infer the thickness of the ice. They were collected during the period 1990–2008. In total, the database includes measurements from 13 locations in the Weddell Sea and was generated from more than 3.7 million measurements of sea ice draft. The files contain uncorrected raw drafts, corrected drafts and the basic parameters measured by the ULS. The measurement principle, the data processing procedure and the quality control are described in detail. To account for the unknown speed of sound in the water column above the ULS, two correction methods were applied to the draft data. The first method is based on defining a reference level from the identification of open water leads. The second method uses a model of sound speed in the oceanic mixed layer and is applied to ice draft in austral winter. Both methods are discussed and their accuracy is estimated. Finally, selected results of the processing are presented. The data can be downloaded from doi:10.1594/PANGAEA.785565.

  9. 1 CFR 15.10 - Information on drafting and publication.

    Science.gov (United States)

    2010-01-01

    ... 1 General Provisions 1 2010-01-01 2010-01-01 false Information on drafting and publication. 15.10... drafting and publication. The Director of the Federal Register may prepare, and distribute to agencies... chapter. The Director may also develop and conduct programs of technical instruction. ...

  10. Jovan Hadžić's civil procedure code draft (1845

    Directory of Open Access Journals (Sweden)

    Stanković Uroš

    2013-01-01

    Full Text Available The article sheds light on civil procedure code draft prepared by renown Serbian lawmaker Jovan Hadžić in 1845. Contrarily to Hadžić's work on producing civil code, his efforts to write civil procedure code are to a large extent obscure. Original text of the draft has not been found. Therefore, one is imposed to reconstruct it with the aid of auxiliary sources, among which the record kept by the commission tasked with revision of the draft, has prevailing significance. The author made an attempt to determine the structure of the draft, as well as the contents of its provisions as accurately as possible, wherein the remarks that the Commission had made were of most assistance. Hadžić consigned his draft to the Prince Aleksandar Karađorđević on August 4th 1845. The Draft consisted of introduction and three parts. The introduction comprised of general provisions. Therein was stipulated principle of trial by written declaration, determined five kinds of courts before which civil procedure should occur and established vacatio legis. The first and concviningly largest part of the Draft was most likely entitled 'On principal litigations and litigation evidence' ('O parnicama glavnima i parničnim dokazatelstvima'. It included diverse rules, such as proceedings before peace courts, proceedings before district courts, ordinary course of litigation (i. e. rules in terms of filing a complaint, scheduling of hearings, subpoenas delivery, procurement of evidence, trial, bankruptcy proceedings, forms of evidence, presentation of evidence and deliberation of judgment, appellate procedure, new trial and enforcement procedure. The third part subsumed the title named 'likvidacija' (literally 'liquidation', whose contents is undeterminable on the basis of existing text of the draft, resolution of bankruptcy proceedings via settlement, resolution of regular litigations via settlement, title named 'on special proceedings and advantages' ('o osobenom

  11. Draft of textbook focused on indirect taxes

    OpenAIRE

    Nováková, Hana

    2012-01-01

    The diploma thesis is about draft of textbook which is focused on indirect taxes for business school. The thesis is divided into theoretical and practical part. The theoretical part is focused on teaching tax issues at business school. Readers are introduced with basic studying documents, for example framework educational program and school educational program. In the following part I have conducted didactic analysis of curriculum and textbook of economics for business schools. The draft of t...

  12. Drafting. A Bilingual Text = Dibujo Mecanico. Un Texto Bilingue.

    Science.gov (United States)

    Los Angeles Unified School District, CA. Div. of Career and Continuing Education.

    This bilingual instructional text, one in a series of six texts covering various vocational and technical topics, provides secondary level English and Spanish instruction in drafting. Addressed in the individual units are the following topics: safety, drafting tools and techniques, sketching, geometric construction, working drawings, sectioning,…

  13. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

    2013-01-08

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

  14. Consumer attitudes and understanding of cholesterol-lowering claims on food: randomize mock-package experiments with plant sterol and oat fibre claims.

    Science.gov (United States)

    Wong, C L; Mendoza, J; Henson, S J; Qi, Y; Lou, W; L'Abbé, M R

    2014-08-01

    Few studies have examined consumer acceptability or comprehension of cholesterol-lowering claims on food labels. Our objective was to assess consumer attitudes and understanding of cholesterol-lowering claims regarding plant sterols (PS) and oat fibre (OF). We conducted two studies on: (1) PS claims and (2) OF claims. Both studies involved a randomized mock-packaged experiment within an online survey administered to Canadian consumers. In the PS study (n=721), we tested three PS-related claims (disease risk reduction claim, function claim and nutrient content claim) and a 'tastes great' claim (control) on identical margarine containers. Similarly, in the OF study (n=710), we tested three claims related to OF and a 'taste great' claim on identical cereal boxes. In both studies, participants answered the same set of questions on attitudes and understanding of claims after seeing each mock package. All claims that mentioned either PS or OF resulted in more positive attitudes than the taste control claim (Pprofile. How consumers responded to the nutrition claims between the two studies was influenced by contextual factors such as familiarity with the functional food/component and the food product that carried the claim. Permitted nutrition claims are approved based on physiological evidence and are allowed on any food product as long as it meets the associated nutrient criteria. However, it is difficult to generalize attitudes and understanding of claims when they are so highly dependent on contextual factors.

  15. Tobacco industry's ITGA fights FCTC implementation in the Uruguay negotiations.

    Science.gov (United States)

    Assunta, Mary

    2012-11-01

    To illustrate how the tobacco industry' front group, the International Tobacco Growers Association (ITGA), mobilised tobacco farmers to influence the fourth session of the Conference of the Parties (COP4) negotiations and defeat the adoption of Framework Convention on Tobacco Control Articles 9 and 10 Guidelines and Articles 17 and 18 progress report. A review of COP4 documents on Articles 9, 10, 17 and 18 was triangulated with relevant information from tobacco industry reports, websites of British American Tobacco, Philip Morris International and ITGA, presentations by tobacco industry executives and internal industry documents from the Legacy Tobacco Documents Library website. Philip Morris International and British American Tobacco rejected Articles 9 and 10 draft Guidelines claiming that banning ingredients in cigarettes will render burley leaf less commercially viable making tobacco growers in many countries suffer economic consequences. They claimed the terms 'attractiveness' and 'palatability' are not appropriate regulatory standards. The ITGA launched a global campaign to mobilise farmers to reject the draft Guidelines at COP4 in Uruguay. Tobacco producers, Brazil, Philippines, Tanzania, Zambia, Malawi and Zimbabwe, sent large delegations to COP4 and participated actively in the negotiation on the draft Guidelines. Partial Guidelines on Articles 9 and 10 on product regulation and disclosure were adopted. COP4's work on Article 17 provides guidance on viable alternatives, but the ITGA is opposed to this and continues fight crop substitution. Despite ITGA's international campaign to thwart the Guidelines on Articles 9 and 10 and a strong representation from tobacco-growing countries at COP4, the outcome after intense negotiations was the adoption of Partial Guidelines and work on Articles 17 and 18 to proceed.

  16. Determinants of consumer understanding of health claims

    DEFF Research Database (Denmark)

    Grunert, Klaus G; Scholderer, Joachim; Rogeaux, Michel

    2011-01-01

    as safe, risky or other. In addition to the open questions on claim understanding, respondents rated a number of statements on claim interpretation for agreement and completed scales on interest in healthy eating, attitude to functional foods, and subjective knowledge on food and health. Results showed......The new EU regulation on nutrition and health claims states that claims can be permitted only if they can be expected to be understood by consumers. Investigating determinants of consumer understanding of health claims has therefore become an important topic. Understanding of a health claim...... on a yoghurt product was investigated with a sample of 720 category users in Germany. Health claim understanding was measured using open answers, which were subsequently content analysed and classified by comparison with the scientific dossier of the health claim. Based on this respondents were classified...

  17. 32 CFR 537.15 - Statutory authority for maritime claims and claims involving civil works of a maritime nature.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Statutory authority for maritime claims and claims involving civil works of a maritime nature. 537.15 Section 537.15 National Defense Department of....15 Statutory authority for maritime claims and claims involving civil works of a maritime nature. (a...

  18. 77 FR 29317 - Fiscal Year 2012 Draft Work Plan

    Science.gov (United States)

    2012-05-17

    ... DENALI COMMISSION Fiscal Year 2012 Draft Work Plan AGENCY: Denali Commission. ACTION: Notice... Commission develop proposed work plans for future spending and that the annual Work Plan be published in the... Commission Draft Work Plan for Federal Fiscal Year 2012. DATES: Comments and related material to be received...

  19. [Critical evaluation of the first draft of DSM-V].

    Science.gov (United States)

    Frances, A

    2011-02-16

    Critical evaluation of DSM-V first draft This is an evaluation of the first DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) draft from the DSM-IV chairman. First, a brief history of DSM is reported. Then, major reasons for present controversies and the threat they raise to APA leadership in the field are discussed. Third point is careful recollection of the several conflicting aspects of the DSM-V draft, paying attention to drawbacks and their implications for future clinical practice, research and forensic activity. Comment is finally provided about APA (American Psychiatric Association) decisions aimed at reaching more consensus about this basic instrument of American psychiatry.

  20. 32 CFR 536.19 - Disaster claims planning.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Disaster claims planning. 536.19 Section 536.19... AGAINST THE UNITED STATES The Army Claims System § 536.19 Disaster claims planning. All ACOs will prepare... requirements related to disaster claims planning. ...

  1. Operating room fires: a closed claims analysis.

    Science.gov (United States)

    Mehta, Sonya P; Bhananker, Sanjay M; Posner, Karen L; Domino, Karen B

    2013-05-01

    To assess patterns of injury and liability associated with operating room (OR) fires, closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1985 were reviewed. All claims related to fires in the OR were compared with nonfire-related surgical anesthesia claims. An analysis of fire-related claims was performed to identify causative factors. There were 103 OR fire claims (1.9% of 5,297 surgical claims). Electrocautery was the ignition source in 90% of fire claims. OR fire claims more frequently involved older outpatients compared with other surgical anesthesia claims (P fire claims (P fires (n = 93) increased over time (P fires occurred during head, neck, or upper chest procedures (high-fire-risk procedures). Oxygen served as the oxidizer in 95% of electrocautery-induced OR fires (84% with open delivery system). Most electrocautery-induced fires (n = 75, 81%) occurred during monitored anesthesia care. Oxygen was administered via an open delivery system in all high-risk procedures during monitored anesthesia care. In contrast, alcohol-containing prep solutions and volatile compounds were present in only 15% of OR fires during monitored anesthesia care. Electrocautery-induced fires during monitored anesthesia care were the most common cause of OR fires claims. Recognition of the fire triad (oxidizer, fuel, and ignition source), particularly the critical role of supplemental oxygen by an open delivery system during use of the electrocautery, is crucial to prevent OR fires. Continuing education and communication among OR personnel along with fire prevention protocols in high-fire-risk procedures may reduce the occurrence of OR fires.

  2. 38 CFR 3.160 - Status of claims.

    Science.gov (United States)

    2010-07-01

    ..., Compensation, and Dependency and Indemnity Compensation Claims § 3.160 Status of claims. The following definitions are applicable to claims for pension, compensation, and dependency and indemnity compensation. (a... for a benefit received after final disallowance of an earlier claim, or any application based on...

  3. Health Claims Data Warehouse (HCDW)

    Data.gov (United States)

    Office of Personnel Management — The Health Claims Data Warehouse (HCDW) will receive and analyze health claims data to support management and administrative purposes. The Federal Employee Health...

  4. Dissecting Attending Surgeons' Operating Room Guidance: Factors That Affect Guidance Decision Making.

    Science.gov (United States)

    Chen, Xiaodong Phoenix; Williams, Reed G; Smink, Douglas S

    2015-01-01

    The amount of guidance provided by the attending surgeon in the operating room (OR) is a key element in developing residents' autonomy. The purpose of this study is to explore factors that affect attending surgeons' decision making regarding OR guidance provided to the resident. We used video-stimulated recall interviews (VSRI) throughout this 2-phase study. In Phase 1, 3 attending surgeons were invited to review separately 30 to 45 minute video segments of their prerecorded surgical operations to explore factors that influenced their OR guidance decision making. In Phase 2, 3 attending surgeons were observed and documented in the OR (4 operations, 341min). Each operating surgeon reviewed their videotaped surgical performance within 5 days of the operation to reflect on factors that affected their decision making during the targeted guidance events. All VSRI were recorded. Thematic analysis and manual coding were used to synthesize and analyze data from VSRI transcripts, OR observation documents, and field notes. A total of 255 minutes of VSRI involving 6 surgeons and 7 surgical operations from 5 different procedures were conducted. A total of 13 guidance decision-making influence factors from 4 categories were identified (Cohen's κ = 0.674): Setting (case schedule and patient morbidity), content (procedure attributes and case progress), resident (current competency level, trustworthiness, self-confidence, and personal traits), and attending surgeon (level of experience, level of comfort, preferred surgical technique, OR training philosophy, and responsibility as surgeon). A total of 5 factors (case schedule, patient morbidity, procedure attributes, resident current competency level, and trustworthiness) influenced attending surgeons' pre-OR guidance plans. "OR training philosophy" and "responsibility as surgeon" were anchor factors that affected attending surgeons' OR guidance decision-making patterns. Surgeons' OR guidance decision making is a dynamic process

  5. 37 CFR 360.5 - Copies of claims.

    Science.gov (United States)

    2010-07-01

    ... Section 360.5 Patents, Trademarks, and Copyrights COPYRIGHT ROYALTY BOARD, LIBRARY OF CONGRESS SUBMISSION OF ROYALTY CLAIMS FILING OF CLAIMS TO ROYALTY FEES COLLECTED UNDER COMPULSORY LICENSE Cable Claims... hand delivery or by mail, file an original and one copy of the claim to cable royalty fees. ...

  6. Advanced Technical Drafting (Industrial Arts) Curriculum Guide. Bulletin 1751.

    Science.gov (United States)

    Louisiana State Dept. of Education, Baton Rouge. Div. of Vocational Education.

    This curriculum guide contains materials for a 17-unit course in advanced technical drafting, a followup to the basic technical drafting course in the industrial arts curriculum for grades 10-12. It is intended for use by industrial arts teachers, supervisors, counselors, administrators, and teacher educators. A three-page course overview provides…

  7. Raising the Profile of Career Guidance: Educational and Vocational Guidance Practitioner

    Science.gov (United States)

    Hiebert, Bryan

    2009-01-01

    In 2007 the International Association for Educational and Vocational Guidance (IAEVG) launched the Educational and Vocational Guidance Practitioner credential (EVGP) as one means of formally acknowledging the knowledge, skills, and personal attributes that practitioners need in order to provide quality career development services to clients. This…

  8. Drafting Lab Management Guide.

    Science.gov (United States)

    Ohio State Univ., Columbus. Instructional Materials Lab.

    This manual was developed to guide drafting instructors and vocational supervisors in sequencing laboratory instruction and controlling the flow of work for a 2-year machine trades training program. The first part of the guide provides information on program management (program description, safety concerns, academic issues, implementation…

  9. Evaluations for draft reports on geological disposal

    International Nuclear Information System (INIS)

    Maekawa, Keisuke; Igarashi, Hiroshi

    2002-10-01

    This report summarizes the results of the technical evaluations on two reports which are named as 'Overview of the Geological Disposal Facility' and Considerable Factors on Selection of Potential Sites for Geological Disposal' drafted by NUMO (Nuclear Waste Management Organization of Japan). The review of each draft report has been referred to committee (held on 9th September, 2002) and working group (held on 1st October, 2002) which were organized in order to confirm a progress of implementation of geological disposal by government. (author)

  10. Investigations into dynamics of a draft of mine cars with two locomotives during electric braking

    Energy Technology Data Exchange (ETDEWEB)

    Sikora-Iliew, R; Szklarski, L; Thuc, Thai Duy

    1983-03-01

    The computerized simulation of electric braking of a draft of GRANBY-5 mine cars and two locomotives (Ld2 locomotives with LDO30 electric series motors) is discussed. The following stages of simulation are analyzed: constructing a mathematical model of the draft of mine cars during electric (dynamic) braking, equations which describe dynamic states of locomotives, mine cars and electric motors during dynamic braking, equations for stability assessment of the draft during dynamic braking. The analog model for simulation of dynamic braking of the draft is given. Simulation results are shown in 10 diagrams. The WAT-1000 hybrid computer is used. Simulation shows that dynamic braking causes occurrence of maximum forces in the couplers between a locomotive and a mine car. When two locomotives are used the maximum force in couplers is lower than in a draft with one locomotive. Braking distance does not depend on position of locomotives in a draft of mine cars. Doubling draft speed causes braking distance to increase by 4 times. Optimum stability conditions of a draft of mine cars are guaranteed when one locomotive is placed at the draft head and a second is separated from the first one by one third of the draft length. 6 references

  11. Guidance for Developing Principal Design Criteria for Advanced (Non-Light Water) Reactors

    Energy Technology Data Exchange (ETDEWEB)

    Holbrook, Mark [Idaho National Lab. (INL), Idaho Falls, ID (United States); Kinsey, Jim [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-03-01

    In July 2013, the US Department of Energy (DOE) and US Nuclear Regulatory Commission (NRC) established a joint initiative to address a key portion of the licensing framework essential to advanced (non-light water) reactor technologies. The initiative addressed the “General Design Criteria for Nuclear Power Plants,” Appendix A to10 Code of Federal Regulations (CFR) 50, which were developed primarily for light water reactors (LWRs), specific to the needs of advanced reactor design and licensing. The need for General Design Criteria (GDC) clarifications in non-LWR applications has been consistently identified as a concern by the industry and varied stakeholders and was acknowledged by the NRC staff in their 2012 Report to Congress1 as an area for enhancement. The initiative to adapt GDC requirements for non-light water advanced reactor applications is being accomplished in two phases. Phase 1, managed by DOE, consisted of reviews, analyses and evaluations resulting in recommendations and deliverables to NRC as input for NRC staff development of regulatory guidance. Idaho National Laboratory (INL) developed this technical report using technical and reactor technology stakeholder inputs coupled with analysis and evaluations provided by a team of knowledgeable DOE national laboratory personnel with input from individual industry licensing consultants. The DOE national laboratory team reviewed six different classes of emerging commercial reactor technologies against 10 CFR 50 Appendix A GDC requirements and proposed guidance for their adapted use in non-LWR applications. The results of the Phase 1 analysis are contained in this report. A set of draft Advanced Reactor Design Criteria (ARDC) has been proposed for consideration by the NRC in the establishment of guidance for use by non-LWR designers and NRC staff. The proposed criteria were developed to preserve the underlying safety bases expressed by the original GDC, and recognizing that advanced reactors may take

  12. 40 CFR 35.6600 - Contractor claims.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Contractor claims. 35.6600 Section 35... Actions Procurement Requirements Under A Cooperative Agreement § 35.6600 Contractor claims. (a) General... prepared by the contractor to support a claim against the recipient; and (4) The award official determines...

  13. Guidance for evidence-informed policies about health systems: rationale for and challenges of guidance development.

    Directory of Open Access Journals (Sweden)

    Xavier Bosch-Capblanch

    Full Text Available In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

  14. 31 CFR 361.8 - Claim for replacement.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false Claim for replacement. 361.8 Section... § 361.8 Claim for replacement. Claim for replacement shall be made in writing to the Secretary, to the..., Parkersburg, WV 26106-1328. The claim, accompanied by a recommendation regarding the manner of replacement...

  15. Reserving by detailed conditioning on individual claim

    Science.gov (United States)

    Kartikasari, Mujiati Dwi; Effendie, Adhitya Ronnie; Wilandari, Yuciana

    2017-03-01

    The estimation of claim reserves is an important activity in insurance companies to fulfill their liabilities. Recently, reserving method of individual claim have attracted a lot of interest in the actuarial science, which overcome some deficiency of aggregated claim method. This paper explores the Reserving by Detailed Conditioning (RDC) method using all of claim information for reserving with individual claim of liability insurance from an Indonesian general insurance company. Furthermore, we compare it to Chain Ladder and Bornhuetter-Ferguson method.

  16. 75 FR 9613 - Draft NIJ Restraints Standard for Criminal Justice

    Science.gov (United States)

    2010-03-03

    ... DEPARTMENT OF JUSTICE Office of Justice Programs [OJP (NIJ) Docket No. 1512] Draft NIJ Restraints Standard for Criminal Justice AGENCY: National Institute of Justice, Office of Justice Programs, DOJ. ACTION: Notice of Draft NIJ Restraints Standard for Criminal Justice and Certification Program...

  17. 76 FR 61402 - Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan

    Science.gov (United States)

    2011-10-04

    ...-2016 Strategic Plan AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comment... comment on draft NUREG-1614, Volume 5. ``U.S. Nuclear Regulatory Commission, FY 2012-2016 Strategic Plan,'' dated September 2011. The NRC's draft FY 2012-2016 strategic plan describes the agency's mission and...

  18. Measuring Integrated Socioemotional Guidance at School: Factor Structure and Reliability of the Socioemotional Guidance Questionnaire (SEG-Q)

    Science.gov (United States)

    Jacobs, Karen; Struyf, Elke

    2013-01-01

    Socioemotional guidance of students has recently become an integral part of education, however no instrument exists to measure integrated socioemotional guidance. This study therefore examines the factor structure and reliability of the Socioemotional Guidance Questionnaire. Psychometric properties of the Socioemotional Guidance Questionnaire and…

  19. Graphical Turbulence Guidance - Composite

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  20. Design optimization of hydraulic turbine draft tube based on CFD and DOE method

    Science.gov (United States)

    Nam, Mun chol; Dechun, Ba; Xiangji, Yue; Mingri, Jin

    2018-03-01

    In order to improve performance of the hydraulic turbine draft tube in its design process, the optimization for draft tube is performed based on multi-disciplinary collaborative design optimization platform by combining the computation fluid dynamic (CFD) and the design of experiment (DOE) in this paper. The geometrical design variables are considered as the median section in the draft tube and the cross section in its exit diffuser and objective function is to maximize the pressure recovery factor (Cp). Sample matrixes required for the shape optimization of the draft tube are generated by optimal Latin hypercube (OLH) method of the DOE technique and their performances are evaluated through computational fluid dynamic (CFD) numerical simulation. Subsequently the main effect analysis and the sensitivity analysis of the geometrical parameters of the draft tube are accomplished. Then, the design optimization of the geometrical design variables is determined using the response surface method. The optimization result of the draft tube shows a marked performance improvement over the original.

  1. 32 CFR 842.43 - Filing a claim.

    Science.gov (United States)

    2010-07-01

    ... completed Standard Form 95 or other signed and written demand for money damages in a sum certain. A claim... Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION ADMINISTRATIVE... amend a claim at any time prior to final action. To amend a claim, the claimant or his or her authorized...

  2. Contextual cueing improves attentional guidance, even when guidance is supposedly optimal.

    Science.gov (United States)

    Harris, Anthony M; Remington, Roger W

    2017-05-01

    Visual search through previously encountered contexts typically produces reduced reaction times compared with search through novel contexts. This contextual cueing benefit is well established, but there is debate regarding its underlying mechanisms. Eye-tracking studies have consistently shown reduced number of fixations with repetition, supporting improvements in attentional guidance as the source of contextual cueing. However, contextual cueing benefits have been shown in conditions in which attentional guidance should already be optimal-namely, when attention is captured to the target location by an abrupt onset, or under pop-out conditions. These results have been used to argue for a response-related account of contextual cueing. Here, we combine eye tracking with response time to examine the mechanisms behind contextual cueing in spatially cued and pop-out conditions. Three experiments find consistent response time benefits with repetition, which appear to be driven almost entirely by a reduction in number of fixations, supporting improved attentional guidance as the mechanism behind contextual cueing. No differences were observed in the time between fixating the target and responding-our proxy for response related processes. Furthermore, the correlation between contextual cueing magnitude and the reduction in number of fixations on repeated contexts approaches 1. These results argue strongly that attentional guidance is facilitated by familiar search contexts, even when guidance is near-optimal. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. Survey of malpractice claims in dermatology

    International Nuclear Information System (INIS)

    Altman, J.

    1975-01-01

    A statistical survey of malpractice claims asserted against dermatologists was made. The subject matter of the claims was divided into eight major categories: drug reactions, x-ray burns, poor cosmetic result following surgery, poor cosmetic result following medication, failure to diagnose cancer, improper diagnosis, infection from treatment, and miscellaneous. The study showed that a group of ''serious'' damage cases, which accounted for 34 percent of total claims, generated 94 percent of total dollar losses. The problem areas for malpractice claims appeared to be drug reactions, cosmetic chemosurgery, and failure to diagnose cancer. (U.S.)

  4. Independent Orbiter Assessment (IOA): Assessment of the guidance, navigation, and control subsystem FMEA/CIL

    Science.gov (United States)

    Trahan, W. H.; Odonnell, R. A.; Pietz, K. C.; Drapela, L. J.

    1988-01-01

    The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Guidance, Navigation, and Control System (GNC) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison for the Orbiter GNC hardware is documented. The IOA product for the GNC analysis consisted of 141 failure mode worksheets that resulted in 24 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 148 FMEAs and 36 CIL items. This comparison produced agreement on all but 56 FMEAs which caused differences in zero CIL items.

  5. 37 CFR 7.12 - Claim of color.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Claim of color. 7.12 Section... § 7.12 Claim of color. (a) If color is claimed as a feature of the mark in the basic application and/or registration, the international application must include a statement that color is claimed as a...

  6. Business plan: Supplemental draft environmental impact statement. Volume 2. Appendices

    International Nuclear Information System (INIS)

    1995-02-01

    This document contains the appendices for the Bonneville Power Administration (BPA) Business Plan: Supplemental Draft Environmental Impact Statement. Included are: BPA products and services; Rate design; Methodology and assumptions for numerical analysis; Retail utility operations; Comments and responses to the draft business plan EIS

  7. 49 CFR 520.23 - Preparation of draft environmental impact statements.

    Science.gov (United States)

    2010-10-01

    ... social, economic, and environmental consequences. (b) Form and content requirements. Attachment 1 of this... environmental issues involved and take responsibility for the scope and content of draft and final environmental... 49 Transportation 6 2010-10-01 2010-10-01 false Preparation of draft environmental impact...

  8. Business Plan : Supplemental Draft Environmental Impact Statement, Volume 2, Appendices.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1995-02-01

    This document contains the appendices for the Bonneville Power Administration (BPA) Business Plan: Supplemental Draft Environmental Impact Statement. Included are: BPA products and services; Rate design; Methodology and assumptions for numerical analysis; Retail utility operations; Comments and responses to the draft business plan EIS.

  9. Replacement Nuclear Research Reactor. Supplement to Draft Environmental Impact Statement. Volume 3

    International Nuclear Information System (INIS)

    1999-01-01

    The Draft Environmental Impact Statement for a replacement research reactor at Lucas Heights, was available for public examination and comment for some three months during 1998. A Supplement to the Draft Environmental Impact Statement (Draft EIS) has been completed and was lodged with Environment Australia on 18 January 1999. The Supplement is an important step in the overall environmental assessment process. It reviews submissions received and provides the proponent's response to issues raised in the public review period. General issues extracted from submissions and addressed in the Supplement include concern over liability issues, Chernobyl type accidents, the ozone layer and health issues. Further studies, relating to issues raised in the public submission process, were undertaken for the Supplementary EIS. These studies confirm, in ANSTO's view, the findings of the Draft EIS and hence the findings of the Final EIS are unchanged from the Draft EIS

  10. Replacement Nuclear Research Reactor. Supplement to Draft Environmental Impact Statement. Volume 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-01-01

    The Draft Environmental Impact Statement for a replacement research reactor at Lucas Heights, was available for public examination and comment for some three months during 1998. A Supplement to the Draft Environmental Impact Statement (Draft EIS) has been completed and was lodged with Environment Australia on 18 January 1999. The Supplement is an important step in the overall environmental assessment process. It reviews submissions received and provides the proponent`s response to issues raised in the public review period. General issues extracted from submissions and addressed in the Supplement include concern over liability issues, Chernobyl type accidents, the ozone layer and health issues. Further studies, relating to issues raised in the public submission process, were undertaken for the Supplementary EIS. These studies confirm, in ANSTO`s view, the findings of the Draft EIS and hence the findings of the Final EIS are unchanged from the Draft EIS

  11. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...

  12. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

  13. Chiropractic claims in the English-speaking world.

    Science.gov (United States)

    Ernst, Edzard; Gilbey, Andrew

    2010-04-09

    Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence). A review of 200 chiropractor websites and 9 chiropractic associations' World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment. We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain, The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

  14. 12 CFR 627.2750 - Priority of claims-banks.

    Science.gov (United States)

    2010-01-01

    ...) All claims for taxes. (f) All claims of creditors which are secured by specific assets or equities of... accordance with priorities of applicable Federal or State law. (g) All claims of holders of bonds issued by... claims of holders of consolidated and System-wide bonds and all claims of the other Farm Credit banks...

  15. The shape of natural draft cooling towers

    International Nuclear Information System (INIS)

    Grange, J.L.

    1992-07-01

    The shape of cooling towers is more often designed empirically. There, it is considered from a theoretical point of view. The analysis of dynamic of natural draft and of the air flow in a cooling tower shell is presented. It is shown, that although it is convergent, a tower works like a diffuser for pressure recovery. And it is turbulence that produces a transfer of kinetic energy and allows a good operation of the diffusor. The equations permit to define a shell profile which depends upon the operating conditions of the cooling tower. In the same way, a stability criteria for natural draft depending upon operating conditions is established. A heating model of one meter diameter has been built in a thermal similitude. The turbulence rate has been measured with a hot wire anemometer at the tower exit and visualizations have also been made. Natural draft stability has been studied by these means for four different shell shapes and a wide range of operating conditions. Experimental and theoretical results agree satisfactorily and experiments can be considered as a validation of theory

  16. Characteristics of claims in the management of septic arthritis in Japan: Retrospective analyses of judicial precedents and closed claims.

    Science.gov (United States)

    Otaki, Yasuhiro; DaSilva, Makiko Ishida; Saito, Yuichi; Oyama, Yasuaki; Oiso, Giichiro; Yoshida, Tomohiko; Fukuhara, Masakazu; Moriyama, Mitsuru

    2018-03-01

    Septic arthritis (SA) cases can result in claims or litigation because of poor prognosis even if it is unavoidable. Although these claims or litigation are useful for understanding causes and background factors of medical errors, the characteristics of malpractice claims associated with SA remain undetermined in Japan. This study aimed to increase our understanding of malpractice claims in the clinical management of SA. We analyzed 6 civil precedents and 16 closed claims of SA from 8530 malpractice claims processed between July 2004 and June 2014 by the Tokyo office of Sompo Japan Nipponkoa Insurance, Incorporated. We also studied 5 accident and 21 incident reports of SA based on project data compiled by the Japan Council for Quality Health Care. The rate of negligence was 83.3% in the precedents and 75.0% in closed claims. Two main malpractice claim patterns were revealed: SA in a lower extremity joint following sepsis caused by methicillin-resistant Staphylococcus aureus in newborns and SA in an injection site following joint injection. These two patterns accounted for 83.3% and 56.3% of judicial cases and closed claim cases, respectively. Breakdowns in care process of accident and incident reports were clearly differentiated from judicial cases or closed claim cases (Fisher's exact test, p < 0.001). It is important to pay particular attention to SA following sepsis in newborns and to monitor for any signs of SA after joint injection to ensure early diagnosis. Analysis of both malpractice claims and accident and incident reports is essential to ensure a full understanding of the situation in Japan. Copyright © 2017. Published by Elsevier Taiwan LLC.

  17. 78 FR 56271 - FY 2014-2020 Draft VA Strategic Plan

    Science.gov (United States)

    2013-09-12

    ... DEPARTMENT OF VETERANS AFFAIRS FY 2014-2020 Draft VA Strategic Plan AGENCY: Department of Veterans... Affairs (VA) is announcing the availability of the FY 2014-2020 Draft VA Strategic Plan (Strategic Plan... Act of 2010 (GPRAMA) (Pub. L. 111-352). The Strategic Plan provides the Department's long-term...

  18. The Bacteriostasis Study of Nisin for the Raspberry Health Draft Beer

    Science.gov (United States)

    Sun, Jinxu; Zhu, Hui xia; Guo, Jiping; Xiao, Dong Guang

    The raspberry healthy draft beer was obtained by adding the extracting of raspberry into the raw fermentation materials of beer, in order to prolong the shelf life, the different concentrations nisin were added to the the raspberry healthy draft beer, the result shown that nisin could have obvious influence on the shelf life, the shelf life prolonged with nisin concentrations adding, the shelf life raspberry healthy draft beer was 44d after adding 0.02 nisin mg/mL, the shelf life prolonged 36d than blank.

  19. Nutrition labelling, marketing techniques, nutrition claims and health claims on chip and biscuit packages from sixteen countries.

    Science.gov (United States)

    Mayhew, Alexandra J; Lock, Karen; Kelishadi, Roya; Swaminathan, Sumathi; Marcilio, Claudia S; Iqbal, Romaina; Dehghan, Mahshid; Yusuf, Salim; Chow, Clara K

    2016-04-01

    Food packages were objectively assessed to explore differences in nutrition labelling, selected promotional marketing techniques and health and nutrition claims between countries, in comparison to national regulations. Cross-sectional. Chip and sweet biscuit packages were collected from sixteen countries at different levels of economic development in the EPOCH (Environmental Profile of a Community's Health) study between 2008 and 2010. Seven hundred and thirty-seven food packages were systematically evaluated for nutrition labelling, selected promotional marketing techniques relevant to nutrition and health, and health and nutrition claims. We compared pack labelling in countries with labelling regulations, with voluntary regulations and no regulations. Overall 86 % of the packages had nutrition labels, 30 % had health or nutrition claims and 87 % displayed selected marketing techniques. On average, each package displayed two marketing techniques and one health or nutrition claim. In countries with mandatory nutrition labelling a greater proportion of packages displayed nutrition labels, had more of the seven required nutrients present, more total nutrients listed and higher readability compared with those with voluntary or no regulations. Countries with no health or nutrition claim regulations had fewer claims per package compared with countries with regulations. Nutrition label regulations were associated with increased prevalence and quality of nutrition labels. Health and nutrition claim regulations were unexpectedly associated with increased use of claims, suggesting that current regulations may not have the desired effect of protecting consumers. Of concern, lack of regulation was associated with increased promotional marketing techniques directed at children and misleadingly promoting broad concepts of health.

  20. Taxation of Income from Selling Property: Changes of New Income Tax Law Draft

    Directory of Open Access Journals (Sweden)

    Canatay HACIKÖYLÜ

    2016-12-01

    Full Text Available There are provisions in Income Tax Law No. 193 and Corporate Tax Law No. 5520 on the nature and taxation of income that real and legal persons acquire from real estate sales. There have been many changes in these provisions over time, but the changes made didnt meet the needs, and they distorted the systematic structure of the Laws. For these and similar reasons, the income tax law draft has been prepared based on Income Tax Law and Corporate Tax Law. With the draft, the Income Tax Law No. 193 and the Corporate Tax Law No. 5520 will be abolished. Draft is aimed to regulate the procedures and principles regarding the income tax on the income of real persons and institutions. In this study, the current situation and the regulations of the draft will be discussed. Moreover, It will be evaluate whether the regulations in the draft law are sufficient. Suggestions will be put forth to determine and declare the real value of the property in order to achieve the intended objectives in draft.

  1. 75 FR 22162 - Draft NIJ Duty Holster Retention Standard for Law Enforcement

    Science.gov (United States)

    2010-04-27

    ...In an effort to obtain comments from interested parties, the U.S. Department of Justice, Office of Justice Programs, National Institute of Justice will make available to the general public two draft documents: (1) A draft standard entitled, ``NIJ Duty Holster Retention Standard for Law Enforcement'' and (2) a draft companion document entitled, ``NIJ Duty Holster Retention Certification Program Requirements.'' The opportunity to provide comments on these two documents is open to industry technical representatives, law enforcement agencies and organizations, research, development and scientific communities, and all other stakeholders and interested parties. Those individuals wishing to obtain and provide comments on the draft documents under consideration are directed to the following Web site: http://www.justnet.org.

  2. 76 FR 36176 - Fully Developed Claim (Fully Developed Claims-Applications for Compensation, Pension, DIC, Death...

    Science.gov (United States)

    2011-06-21

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0747] Fully Developed Claim (Fully Developed Claims--Applications for Compensation, Pension, DIC, Death Pension, and/or Accrued Benefits); Correction AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice; correction...

  3. The Draft Directive on Consumer Rights: Choices Made and Arguments Used

    Directory of Open Access Journals (Sweden)

    Willem H. van Boom

    2009-11-01

    Full Text Available The 2008 proposal for a Directive on Consumer Rights (hereinafter: the Draft aims at reorganizing the acquis of four specific European directives on consumer protection into a more coherent codification of consumer rights. Specifically, it contains rules on precontractual information duties, on withdrawal rights for distance and off-premises contracts, on consumer sales and on general contract terms in consumer contracts. In replacing the four directives with a minimum harmonization character, the Draft marks a further step towards full harmonization of consumer contract law in Europe. This is an unsettling step because the level of protection offered to consumers in the Draft hardly exceeds the level of protection offered by the four directives mentioned earlier. Instead, it diminishes this protection in some regards. In light of all this, the question arises whether the policy choices underlying the Draft are, in fact, convincingly underpinned by solid argumentation. This article addresses this issue by first analyzing the Draft's use of the generic concept of “contracts between consumers and traders”. It is argued that full harmonization of a badly delineated territory is ill-advised. Subsequently, the argumentative power of the policy considerations forwarded by the European Commission in its Regulatory Assessment Study is tested. The article concludes that the Commission’s assessment of expected costs and benefits of the Draft is waver-thin and geared towards persuading the reader of the aptness of choices already made. In some respects, the evidence presented by the Commission is outright unconvincing. At certain points, the Draft even fuels the reader’s suspicion of foregone conclusions. Overall, the need for reduction of the level of protection offered by the current minimum harmonization directives is poorly argued by the Commission and appears, in a number of important ways, not to reflect the socio-economic relationships that

  4. RCA annual report 1996. Draft

    International Nuclear Information System (INIS)

    1997-02-01

    In accordance with Article VII.4 of the Regional Co-operative Agreement for Research, Development and Training Related to Nuclear Science and Technology 1987 and extended in 1992, a draft report of activities for the calendar year 1996 is submitted

  5. Rules of international law applicable to transfrontier pollution. Draft

    International Nuclear Information System (INIS)

    Anon.

    1983-01-01

    During the 1982 conference of the International Law Association (ILA) in Montreal the ILA discussed and adopted a draft of rules of international law applicable to transfrontier pollution. The draft presents criteria for the definition of transfrontier pollution and sets out rules for the prevention of such pollution and recommendations for a system of multilateral information, consultation, and co-operation in case of energy. (HP) [de

  6. Nature of Medical Malpractice Claims Against Radiation Oncologists

    Energy Technology Data Exchange (ETDEWEB)

    Marshall, Deborah; Tringale, Kathryn [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Connor, Michael [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); University of California Irvine School of Medicine, Irvine, California (United States); Punglia, Rinaa [Department of Radiation Oncology, Brigham and Women' s Hospital, Harvard Medical School, Boston, Massachusetts (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona, E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States)

    2017-05-01

    Purpose: To examine characteristics of medical malpractice claims involving radiation oncologists closed during a 10-year period. Methods and Materials: Malpractice claims filed against radiation oncologists from 2003 to 2012 collected by a nationwide liability insurance trade association were analyzed. Outcomes included the nature of claims and indemnity payments, including associated presenting diagnoses, procedures, alleged medical errors, and injury severity. We compared the likelihood of a claim resulting in payment in relation to injury severity categories (death as referent) using binomial logistic regression. Results: There were 362 closed claims involving radiation oncology, 102 (28%) of which were paid, resulting in $38 million in indemnity payments. The most common alleged errors included “improper performance” (38% of closed claims, 18% were paid; 29% [$11 million] of total indemnity), “errors in diagnosis” (25% of closed claims, 46% were paid; 44% [$17 million] of total indemnity), and “no medical misadventure” (14% of closed claims, 8% were paid; less than 1% [$148,000] of total indemnity). Another physician was named in 32% of claims, and consent issues/breach of contract were cited in 18%. Claims for injury resulting in death represented 39% of closed claims and 25% of total indemnity. “Improper performance” was the primary alleged error associated with injury resulting in death. Compared with claims involving death, major temporary injury (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.29-5.85, P=.009), significant permanent injury (OR 3.1, 95% CI 1.48-6.46, P=.003), and major permanent injury (OR 5.5, 95% CI 1.89-16.15, P=.002) had a higher likelihood of a claim resulting in indemnity payment. Conclusions: Improper performance was the most common alleged malpractice error. Claims involving significant or major injury were more likely to be paid than those involving death. Insights into the nature of liability claims against

  7. 32 CFR 842.95 - Non-assertable claims.

    Science.gov (United States)

    2010-07-01

    ... ADMINISTRATIVE CLAIMS Property Damage Tort Claims in Favor of the United States (31 U.S.C. 3701, 3711-3719) § 842...) Reimbursement for military or civilian employees for their negligence claims paid by the United States. (b) Loss...

  8. 37 CFR 360.12 - Form and content of claims.

    Science.gov (United States)

    2010-07-01

    ... SUBMISSION OF ROYALTY CLAIMS FILING OF CLAIMS TO ROYALTY FEES COLLECTED UNDER COMPULSORY LICENSE Satellite Claims § 360.12 Form and content of claims. (a) Forms. (1) Each claim to compulsory license royalty fees... owner entitled to claim the royalty fees. (ii) A general statement of the nature of the copyright owner...

  9. 37 CFR 360.3 - Form and content of claims.

    Science.gov (United States)

    2010-07-01

    ... SUBMISSION OF ROYALTY CLAIMS FILING OF CLAIMS TO ROYALTY FEES COLLECTED UNDER COMPULSORY LICENSE Cable Claims § 360.3 Form and content of claims. (a) Forms. (1) Each claim to cable compulsory license royalty fees... copyright owner entitled to claim the royalty fees. (ii) A general statement of the nature of the copyright...

  10. Computational study of a low head draft tube and validation with experimental data

    Energy Technology Data Exchange (ETDEWEB)

    Henau, V De; Payette, F A; Sabourin, M [Alstom Power Systems, Hydro 1350 chemin Saint-Roch, Sorel-Tracy (Quebec), J3R 5P9 (Canada); Deschenes, C; Gagnon, J M; Gouin, P, E-mail: vincent.dehenau@power.alstom.co [Hydraulic Machinery Laboratory, Laval University 1065 ave. de la Medecine, Quebec (Canada)

    2010-08-15

    The objective of this paper is to investigate methodologies to improve the reliability of CFD analysis of low head turbine draft tubes. When only the draft tube performance is investigated, the study indicates that draft tube only simulations with an adequate treatment of the inlet boundary conditions for velocity and turbulence are a good alternative to rotor/stator (stage) simulations. The definition of the inlet velocity in the near wall regions is critical to get an agreement between the stage and draft tube only solutions. An average turbulent kinetic energy intensity level and average turbulent kinetic energy dissipation length scale are sufficient as turbulence inlet conditions as long as these averages are coherent with the stage solution. Comparisons of the rotor/stator simulation results to the experimental data highlight some discrepancies between the predicted draft tube flow and the experimental observations.

  11. Environmental Regulatory Compliance Plan for site: Draft characterization of the Yucca Mountain site:Draft

    International Nuclear Information System (INIS)

    1988-01-01

    The objective of the EMMP is to document compliance with the NWPA. To do so, a summary description of site characterization activites is provided, based on the consultation draft of the SCP. Subsequent chpaters identify those technical areas having the potential to be impacted by site characterization activities and the monitoring plans proposed to identify whether those impacts acutally occur. Should monitoring confirm the potential for significant adverse impact, mitigative measures will be developed. In the context of site characterization, mitigation is defined as those changes in site characterization activities that serve to avoid or minimize, to the maximum extent practicle, any significant adverse environmental impacts. Although site characterization activies involve both surface and subsurface activities, it is the surface-based aspect of site characterization that is addressed in detailed by the EMMP. The schedule and duration of these activities is given in the consultation draft of the SCP. A breif summary of all proposed activities is given in the EMMP. 10 refs., 8 figs

  12. 32 CFR Appendix to Part 281 - Claims Description

    Science.gov (United States)

    2010-07-01

    ... advance decision functions for claims under the following statutes: (a) 31 U.S.C. 3702, concerning claims... SETTLING PERSONNEL AND GENERAL CLAIMS AND PROCESSING ADVANCE DECISION REQUESTS Pt. 281, App. Appendix to... Personnel Management performs these functions for claims involving civilian employees' compensation and...

  13. 42 CFR 456.722 - Electronic claims management system.

    Science.gov (United States)

    2010-10-01

    ... Electronic Claims Management System for Outpatient Drug Claims § 456.722 Electronic claims management system...'s Medicaid Management Information System (MMIS) applicable to prescription drugs. (ii) Notifying the... 42 Public Health 4 2010-10-01 2010-10-01 false Electronic claims management system. 456.722...

  14. 28 CFR 32.32 - Time for filing claim.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Time for filing claim. 32.32 Section 32.32 Judicial Administration DEPARTMENT OF JUSTICE PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS Educational Assistance Benefit Claims § 32.32 Time for filing claim. (a...

  15. 12 CFR 516.20 - What information must I include in my draft business plan?

    Science.gov (United States)

    2010-01-01

    ... business plan? 516.20 Section 516.20 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE... What information must I include in my draft business plan? If you must submit a draft business plan... described in the savings association's draft business plan; and (d) Demonstrate how applicable requirements...

  16. 78 FR 44117 - Notice of a Public Comment Period on the Draft IRIS Carcinogenicity Assessment for Ethylene Oxide

    Science.gov (United States)

    2013-07-23

    ... Public Comment Period on the Draft IRIS Carcinogenicity Assessment for Ethylene Oxide AGENCY... Carcinogenicity of Ethylene Oxide'' (EPA/635/R-13/128a) and on the draft peer review charge questions. The draft... on the draft Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide and on the draft peer...

  17. 78 FR 17653 - Upper Great Plains Wind Energy Draft Programmatic Environmental Impact Statement (DOE/EIS-0408)

    Science.gov (United States)

    2013-03-22

    ... Wildlife Service Upper Great Plains Wind Energy Draft Programmatic Environmental Impact Statement (DOE/EIS... Plains Wind Energy Draft Programmatic Environmental Impact Statement (Draft [[Page 17654

  18. 76 FR 65199 - International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case...

    Science.gov (United States)

    2011-10-20

    ... schema files and additional technical information. The draft E2B(R3) implementation guidance and BFC...: Submit written requests for single copies of the draft documents to the Division of Drug Information (HFD... or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft...

  19. Worst-Case-Optimal Dynamic Reinsurance for Large Claims

    DEFF Research Database (Denmark)

    Korn, Ralf; Menkens, Olaf; Steffensen, Mogens

    2012-01-01

    We control the surplus process of a non-life insurance company by dynamic proportional reinsurance. The objective is to maximize expected (utility of the) surplus under the worst-case claim development. In the large claim case with a worst-case upper limit on claim numbers and claim sizes, we fin...

  20. 32 CFR 536.29 - Revision of filed claims.

    Science.gov (United States)

    2010-07-01

    ... AGAINST THE UNITED STATES Investigation and Processing of Claims § 536.29 Revision of filed claims. (a... the writing alleges a new theory of liability, a new tortfeasor, a new party claimant, a different... amendment, not a new claim. Similarly, the addition of required information not on the original claim...

  1. Automatic drafting system for lined tanks used for nuclear power plants

    International Nuclear Information System (INIS)

    Sasaki, Ryoichi; Kikuchi, Nobuo

    1981-01-01

    The concrete vessels lined with metallic sheets are used widely in chemical and food industries and nuclear power plants. Especially in nuclear power plants, rectangular lined tanks have been adopted mainly to store radioactive liquid and solid wastes recently, because of the good volume efficiency. Though the basic structure of the lined tanks is the same, the volume and the form change according to the kinds of stored matters and the positions of pipe connections, and the form of individual lining sheets diversifies. As much labor and time are consumed for the drawing, automatic drafting was planned, and the conditions of application were studied. As for the conditions of application, the following metters are conceivable: the standardized method of design of equipments, the handling of figures numerically or by mathematical formulas, troublesome calculation, the works likely to cause mistake, many drawings for production and so on. The lined tanks almost satisfy these conditions, therefore the automatic drafting was promoted, and good results were obtained. the range of application of the automatic drafting system, the standardization of the form of lined tanks, the size of lining sheets, part number and welding number, the composition of the automatic drafting system, the outline of the program, and the effectiveness of automatic drafting are described. (Kako, I.)

  2. 20 CFR 410.232 - Withdrawal of a claim.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Withdrawal of a claim. 410.232 Section 410.232 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969... Claims and Evidence § 410.232 Withdrawal of a claim. (a) Before adjudication of claim. A claimant (or an...

  3. 27 CFR 70.608 - Action on claims.

    Science.gov (United States)

    2010-04-01

    ... Section 70.608 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT... appropriate TTB officer shall date stamp and examine each claim filed under this subpart and will determine the validity of the claim. Claims and supporting data involving customs duties will be forwarded to...

  4. Are sensory attributes and acceptance influenced by nutritional and health claims of low-sodium salami? Preliminary study with Brazilian consumers

    Directory of Open Access Journals (Sweden)

    Marcio Aurélio de Almeida

    2017-01-01

    Full Text Available The first contact between consumers and the food product is usually the packaging and it’s labelling. Therefore, it is the primary means to generate consumer’s expectations. The aim of the present work was to evaluate the influence of nutritional and health claims on acceptance of salami with reduced sodium content, aimed at finding guidance for the product reformulation. Sixt y consumers evaluated four samples of salami. The overall acceptance was evaluated using a nine - point hedonic scale, and the attributes color, tenderness, characteristic flavor and salt content, were evaluated by 7 – point just - about - right (JAR scale. For the expectation test, overall liking of salami with reduced sodium content was evaluated by consumers under three conditions : (1 blind test (B; (2 expectation generated by nutritional and health claims (E, and (3 consumers re - tasted the salami having the nutrition and health claims available (R. Student’s t - tests performed on data indicated no significant differences (p > 0.05 between the mean acceptance under the blind (B and real (R conditions, although expectation ratings (E were significantly higher than (B (p ≤ 0.05. However, linear regression of (R - B x (E - B ratings revealed a major assimilation effect of expectation, especially under negative disconfirmation (E > B. Contrast effect was also observed, but to a lesser extent . The results showed that saltiness attribute was not decisive in decreased acceptance according to the JAR scale, but it was relevant in the aftertaste generated by adding salt substitutes. Finally, nutritional and health claims had little effect on consumer ac ceptance.

  5. Numerical and Experimental Study on a Model Draft Tube with Vortex Generators

    Directory of Open Access Journals (Sweden)

    Tian Xiaoqing

    2013-01-01

    Full Text Available A model water turbine draft tube containing vortex generators (VG was studied. Numerical simulations were performed to investigate 55 design variations of the vortex generators in a draft tube. After analyzing the shapes of streamlines and velocity distributions in the tube and comparing static pressure recovery coefficients (SPRC in different design variations, an optimum vortex generator layout, which can raise SPRC of the draft tube by 4.8 percent, was found. To verify the effectiveness of the vortex generator application, a series of experiments were carried out. The results show that by choosing optimal vortex generator parameters, such as the installation type, installation position, blade-to-blade distance, and blade inclination angle, the draft tube equipped vortex generators can effectively raise their SPRC andworking stability.

  6. 32 CFR 537.16 - Scope for maritime claims.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Scope for maritime claims. 537.16 Section 537.16... BEHALF OF THE UNITED STATES § 537.16 Scope for maritime claims. The Army Maritime Claims Settlement Act... claims for damage to: (1) DA-accountable properties of a kind that are within the federal maritime...

  7. 32 CFR 536.119 - Scope for maritime claims.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Scope for maritime claims. 536.119 Section 536... CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.119 Scope for maritime claims. The AMCSA applies...) Damage that is maritime in nature and caused by tortious conduct of U.S. military personnel or federal...

  8. CAREER GUIDANCE EXPERIENCE ABROAD

    Directory of Open Access Journals (Sweden)

    Sergey N. Tolstoguzov

    2015-01-01

    Full Text Available The aim of this paper is to describe the experience of careeroriented activities carried out with students of schools in developed and developing countries. Career Guidance in Russia, despite the vast experience of its implementation, is experiencing serious difficulties. In this regard, it is important to take into account the international experience career-oriented activities, such as in the developed countries of North America and the European Union as well as in several Asian countries with rapidly growing economies and a large demographic potential, taking into account the best variants for the Russian education system. Methods. The experience of career-oriented work undertaken with pupils of the USA, Canada, Israel, France, UK, Germany, Denmark, Sweden, Japan, Singapore, China and India is shown on the basis of the comparative analysis of different publications and information sources. The author has made an attempt to generalize the principles of psycho-pedagogical and administrative assistance in professional self-determination of senior pupils abroad. Scientific novelty. The approaches to career-oriented activities in countries with different levels of economic development are compared for the first time. Some principles are revealed. Firstly, the higher the income level per capita in the country, the greater attention is given to vocational guidance. The politics in the developed countries is based on interests of the individual: children’s acquaintance with the world of professions begins already at younger school and the moment of definitive selfdetermination is postponed till the end of their senior stage of education; the possibility of direction change of professional preparation in case of detection of discrepancy of qualities of the pupil to originally selected profile is provided. Career-oriented activity in developing countries, on the contrary, is rigidly coordinated to requirements of economy and a labour market

  9. Three draft genomes of Vibrio coralliilyticus strains isolated from bivalve hatcheries

    Science.gov (United States)

    Reported here are the draft genomes of three Vibrio coralliilyticus isolates RE87, AIC-7, and 080116A. Each strain was isolated in association with diseased oyster larvae in commercial aquaculture systems. These draft genomes will be useful for further studies in understanding the genomic features...

  10. Traditional Engineering Graphics versus Computer-Aided Drafting: A View from Academe.

    Science.gov (United States)

    Foster, Robert J.

    1987-01-01

    Argues for a legitimate role of manually expressed engineering graphics within engineering education as a needed support for computer-assisted drafting work. Discusses what and how students should learn as well as trends in engineering graphics education. Compares and contrasts manual and computer drafting methods. (CW)

  11. 77 FR 22247 - Veterinary Feed Directive; Draft Text for Proposed Regulation

    Science.gov (United States)

    2012-04-13

    .... FDA-2010-N-0155] Veterinary Feed Directive; Draft Text for Proposed Regulation AGENCY: Food and Drug... the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text..., rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary...

  12. 31 CFR 360.29 - Adjudication of claims.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false Adjudication of claims. 360.29 Section 360.29 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FISCAL... the ordinary course of business. (b) Claims filed 10 years after payment. Any claim filed 10 years or...

  13. 32 CFR 842.76 - Filing a claim.

    Science.gov (United States)

    2010-07-01

    ... by a demand for money damages in a sum certain. A claim incorrectly presented to the Air Force will... Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION ADMINISTRATIVE.... A claim has been filed when a federal agency receives from a claimant or the claimant's duly...

  14. CLAIMS FOR REINBURSEMENT OF EDUCATION FEES

    CERN Multimedia

    PE-ADS

    1999-01-01

    You are reminded that, in accordance with Article R A 8.07 of the Staff Regulations 'the relevant bills shall be grouped so that not more than three claims in respect of each child are submitted in an academic year'.For this purpose:-\tthe academic year is defined as the period going from 1st September to 31st August,-\tonly paid bills can be subject to reimbursement,-\ta claim for reimbursement of education fees may only include bills for expenses incurred during a given academic year for a given child,-\tbills for one child may be grouped on a claim by periods of term, semester or academic year,-\tthe months of July and August should be included in the third term, or the second semester, or the academic year,-\tfor each dependent child, a maximum of 3 claims can be submitted for the reimbursement of expenses incurred during one academic year, therefore, any bill submitted for reimbursement after the third claim will not be reimbursed.Please make sure that you have receive...

  15. CLAIMS FOR REIMBURSEMENT OF EDUCATION FEES

    CERN Multimedia

    Personnel Division

    1999-01-01

    REMINDERYou are reminded that, in accordance with Article R A 8.07 of the Staff Regulations 'the relevant bills shall be grouped so that not more than three claims in respect of each child are submitted in an academic year'.For this purpose:the academic year is defined as the period going from 1st September to 31st August, only paid bills can be subject to reimbursement, a claim for reimbursement of education fees may only include bills for expenses incurred during a given academic year for a given child, bills for one child may be grouped on a claim by periods of term, semester or academic year, the months of July and August should be included in the third term, or the second semester, or the academic year, for each dependent child, a maximum of 3 claims can be submitted for the reimbursement of expenses incurred during one academic year, therefore, any bill submitted for reimbursement after the third claim will not be reimbursed.Please make sure that you have received and paid all bills, including those for...

  16. 76 FR 51034 - Availability of Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy...

    Science.gov (United States)

    2011-08-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Availability of Draft NTP Monograph on Potential... Meeting To Peer Review Draft Monograph AGENCY: Division of the National Toxicology Program (DNTP...: Availability of Draft Monograph; Request for Comments; Announcement of a Peer Review Panel Meeting. SUMMARY...

  17. 32 CFR 536.117 - Statutory authority for maritime claims.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Statutory authority for maritime claims. 536.117... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.117 Statutory authority for maritime claims. The Army Maritime Claims Settlement Act (AMCSA) (10 U.S.C. 4801-04, 4806, as amended) authorizes the...

  18. Draft guidance notes for the protection of persons against ionising radiations arising from medical and dental use

    International Nuclear Information System (INIS)

    1983-01-01

    These guidance notes are presented under the following headings: 1) Limitation of radiation dose. 2) Administrative measures for radiological protection. 3) Medical surveillance. 4) Operational measures for radiological protection. 5) The request for a radiological examination or treatment, whether directly associated or not with illness or injury, together with consideration of the problems of dealing with patients of a reproductive age. 6) Diagnostic use of X-rays. 7) Dental radiography. 8) Therapeutic uses of radiation beams, remotely-operated after-loading equipment and extra-corporeal blood irradiators and neutron activation analysis. 9) Brachytherapy. 10) Diagnostic and therapeutic uses of unsealed radioactive substances. 11) Diagnostic uses of closed sources. 12) The use of nuclear-powered cardiac pacemakers. 13) Patients leaving a hospital after administration of radioactive substances. 14) Precautions after death.. 15) Storage and movement of radioactive materials. 16) Disposal of radioactive waste. 17) Emergency procedures. (U.K.)

  19. 32 CFR 842.129 - Settlement of claims against NAFIs.

    Science.gov (United States)

    2010-07-01

    ... LITIGATION ADMINISTRATIVE CLAIMS Nonappropriated Fund Claims § 842.129 Settlement of claims against NAFIs. (a) This subpart does not establish legal theories for adjudication of claims. Refer to the appropriate...

  20. 48 CFR 33.208 - Interest on claims.

    Science.gov (United States)

    2010-10-01

    ... otherwise would be due, if that date is later, until the date of payment. (b) Simple interest on claims... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Interest on claims. 33.208... REQUIREMENTS PROTESTS, DISPUTES, AND APPEALS Disputes and Appeals 33.208 Interest on claims. (a) The Government...

  1. 32 CFR 842.24 - Filing a claim.

    Science.gov (United States)

    2010-07-01

    ... properly completed AF Form 180, DD Form 1842 or other written and signed demand for a specified sum of money. (b) Amending a claim. A claimant may amend a claim at any time prior to the expiration of the... Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION ADMINISTRATIVE...

  2. 16 CFR 260.7 - Environmental marketing claims.

    Science.gov (United States)

    2010-01-01

    ... pieces if left uncovered in sunlight.” The claim is supported by competent and reliable scientific... sunlight and into sufficiently small pieces to become part of the soil. The qualified claim is not... time. The claim is not deceptive. Example 4: A plastic six-pack ring carrier is marked with a small...

  3. Quality in career guidance: The Danish case

    DEFF Research Database (Denmark)

    Plant, Peter

    2011-01-01

    Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach......Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach...

  4. 76 FR 22721 - Notice of Availability of Draft Resource Management Plans and Associated Environmental Impact...

    Science.gov (United States)

    2011-04-22

    ...] Notice of Availability of Draft Resource Management Plans and Associated Environmental Impact Statement for the Bighorn Basin Resource Management Plan Revision Project, Cody and Worland Field Offices... Draft Resource Management Plan (RMP) for the Cody Field Office, a Draft RMP for the Worland Field Office...

  5. Preliminary application of the draft code case for alloy 617 for a high temperature component

    International Nuclear Information System (INIS)

    Lee, Hyeong Yeon; Kim, Yong Wan; Song, Kee Nam

    2008-01-01

    The ASME draft Code Case for Alloy 617 was developed in the late 1980s for the design of very-high-temperature gas cooled reactors. The draft Code Case was patterned after the ASME Code Section III Subsection NH and was intended to cover Ni-Cr-Co-Mo Alloy 617 to 982 .deg. C (1800 .deg. F). But the draft Code Case is still in an incomplete status, lacking necessary material properties and design data. In this study, a preliminary evaluation on the creep-fatigue damage for a high temperature hot duct pipe structure has been carried out according to the draft Code Case. The evaluation procedures and results according to the draft Code Case for Alloy 617 material were compared with those of the ASME Subsection NH and RCC-MR for Alloy 800H material. It was shown that many data including material properties, fatigue and creep data should be supplemented for the draft Code Case. However, when the evaluation results on the creep-fatigue damage according to the draft Code Case, ASME-NH and RCC-MR were compared based on the preliminary evaluation, it was shown that the Alloy 617 results from the draft Code Case tended to be more resistant to the creep damage while less resistant to the fatigue damage than those from the ASME-NH and RCC-MR

  6. Perception of health claims among Nordic consumers

    DEFF Research Database (Denmark)

    Grunert, Klaus G.; Lähteenmäki, Liisa; Boztug, Yasemin

    2009-01-01

    . Claims were constructed from an underlying universe combining different active ingredients (familiar, unfamiliar), type of claim (combination of information about ingredient, physiological function and health benefit), framing (positive, negative) and use of qualifier (with, without 'may'). Across pairs...... of active ingredient, physiological function and health benefit, whereas the other prefers 'short' claims consisting of the health benefit only. Results also showed that the familiar ingredient is preferred to the unfamiliar one, whereas effects of positive vs. negative framing depended on the type......Health claim perception was investigated by a web-based instrument with a sample of 4612 respondents in the Nordic countries (Denmark, Finland, Iceland, Norway, Sweden). Respondents decided which of a pair of claims sounded better, was easier to understand, and was more convincing in their opinion...

  7. 75 FR 54637 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-09-08

    ... conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH... approval) into class II (special controls). DATES: Submit written or electronic comments on this guidance... electronic access to the guidance. Submit electronic comments on the guidance to http://www.regulations.gov...

  8. 78 FR 49318 - Availability of Draft Advisory Circular (AC) 90-106A and AC 20-167A

    Science.gov (United States)

    2013-08-13

    ...] Availability of Draft Advisory Circular (AC) 90-106A and AC 20- 167A AGENCY: Federal Aviation Administration... of draft Advisory Circular (AC) 90-106A, Enhanced Flight Vision Systems and draft AC 20- 167A... Federal holidays. FOR FURTHER INFORMATION CONTACT: For technical questions concerning draft AC 90-106A...

  9. Lifelong guidance: How guidance and counselling support lifelong learning in the contrasting contexts of China and Denmark

    Science.gov (United States)

    Zhang, Zhixin

    2016-10-01

    Due to the effects of globalisation and rapid technological development, traditional linear life course patterns of the past are gradually disappearing, and this affects education and learning systems as well as labour markets. Individuals are forced to develop lifestyles and survival strategies to manage job insecurity and make their skills and interests meet labour market needs. In modern attempts to develop and implement institutional provision for lifelong learning, guidance and counselling play an important role. The current Danish guidance system is well-organised, highly structured and professionalised. By contrast, Chinese guidance is still fragmented and "sectorisational". This paper explores whether elements of the highly structured and professionalised Danish guidance system and practice might be applicable to the Chinese context. The author begins by outlining international and national factors which are affecting citizens' life and career planning. She then presents and discusses the evolution of guidance and the different elements of provision in each of the two countries. Next, She compares the concepts and goals of "lifelong guidance" in Denmark and China, pointing out their similarities and differences and their respective strengths and weaknesses. The paper concludes with some suggestions for the further development of guidance in China.

  10. Video-Guidance Design for the DART Rendezvous Mission

    Science.gov (United States)

    Ruth, Michael; Tracy, Chisholm

    2004-01-01

    NASA's Demonstration of Autonomous Rendezvous Technology (DART) mission will validate a number of different guidance technologies, including state-differenced GPS transfers and close-approach video guidance. The video guidance for DART will employ NASA/Marshall s Advanced Video Guidance Sensor (AVGS). This paper focuses on the terminal phase of the DART mission that includes close-approach maneuvers under AVGS guidance. The closed-loop video guidance design for DART is driven by a number of competing requirements, including a need for maximizing tracking bandwidths while coping with measurement noise and the need to minimize RCS firings. A range of different strategies for attitude control and docking guidance have been considered for the DART mission, and design decisions are driven by a goal of minimizing both the design complexity and the effects of video guidance lags. The DART design employs an indirect docking approach, in which the guidance position targets are defined using relative attitude information. Flight simulation results have proven the effectiveness of the video guidance design.

  11. Threshold guidance update

    International Nuclear Information System (INIS)

    Wickham, L.E.

    1986-01-01

    The Department of Energy (DOE) is developing the concept of threshold quantities for use in determining which waste materials must be handled as radioactive waste and which may be disposed of as nonradioactive waste at its sites. Waste above this concentration level would be managed as radioactive or mixed waste (if hazardous chemicals are present); waste below this level would be handled as sanitary waste. Last years' activities (1984) included the development of a threshold guidance dose, the development of threshold concentrations corresponding to the guidance dose, the development of supporting documentation, review by a technical peer review committee, and review by the DOE community. As a result of the comments, areas have been identified for more extensive analysis, including an alternative basis for selection of the guidance dose and the development of quality assurance guidelines. Development of quality assurance guidelines will provide a reasonable basis for determining that a given waste stream qualifies as a threshold waste stream and can then be the basis for a more extensive cost-benefit analysis. The threshold guidance and supporting documentation will be revised, based on the comments received. The revised documents will be provided to DOE by early November. DOE-HQ has indicated that the revised documents will be available for review by DOE field offices and their contractors

  12. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  13. Re: “Comments on draft rules for granting Foreign Tax Credit”

    NARCIS (Netherlands)

    Sanghavi, Dhruv

    2016-01-01

    This letter to the Indian Ministry of Finance critically reviews the proposed rules for the grant of credit in India for taxes paid in a foreign country (Draft Rules). It points out what is perhaps the most egregious drawback in the Draft Rules - they do not consider the erosive impact foreign

  14. The importance of subjective claims management.

    Science.gov (United States)

    Beger, C S

    1997-01-01

    This article discusses the causes and effects of "subjective disability" on today's workforce and employers. As employees feel out of control with both their careers and demands placed upon them, the number of claims characterized by self-reported symptoms are increasing. Subjective disabilities include chronic syndrome, fibromyalgia, psychiatric claims and chronic pain. The author discusses creative strategies in case studies that have helped employers contain the costs of disability claims, while empowering the employee to take control of their own situation and return to work sooner.

  15. IRIS Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE) (Public Comment Draft)

    Science.gov (United States)

    In September 2016, the U.S. Environmental Protection Agency's (USEPA) released the draft Integrated Risk Information System (IRIS) Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE). Consistent with the 2013 IRIS Enhancements, draft IRIS assessments are released prior to e...

  16. AGILE DRAFTING OF OUTSOURCING CONTRACTS

    DEFF Research Database (Denmark)

    Schlichter, Bjarne Rerup; Storgaard, Kristian

    2015-01-01

    and in several parallel tracks using different competencies. By the use of an illustrative case-study, this paper explores how scrum can be applied to enhance the process of drafting outsourcing contracts. The analysis indicates that the use of an agile method, such as Scrum, can be beneficial in this context...

  17. Food claims and nutrition facts of commercial infant foods.

    Science.gov (United States)

    Koo, Yu-Chin; Chang, Jung-Su; Chen, Yi Chun

    2018-01-01

    Composition claim, nutrition claim and health claim are often found on the commercial complementary food packaging. The introduction of complementary foods (CFs) to infants is a turning point in the development of their eating behavior, and their commercial use for Taiwanese infants is growing. In Taiwan, lots of the advertisements for CFs employed health or nutrition claims to promote the products, but the actual nutritional content of these CFs is not clear. The aim of this study was to compare the food claims of commercial complementary food products with their actual nutrition facts. A sample of 363 commercial CFs was collected from websites, local supermarkets, and other food stores, and their nutrition-related claims were classified into composition, nutrition, and health categories. Although the World Health Organization recommends that infants should be exclusively breastfed for the first 6 months, 48.2% of the commercial CFs were targeted at infants younger than 6 months. Therefore, marketing regulations should be implemented to curb early weaning as a result of products targeted at infants younger than 6 months. More than 50% of Taiwanese commercial CFs have high sugar content and more than 20% were high in sodium. Products with health claims, such as "provides good nutrition to children" or "improves appetite," have higher sodium or sugar content than do those without such claims. Moreover, products with calcium or iron content claims did not contain more calcium or iron than products without such claims. Additionally, a significantly greater proportion of the products with "no added sugar" claims were classified as having high sugar content as compared to those without such claims. Parents cannot choose the healthiest food products for their children by simply focusing on food claims. Government should regulate the labeling of nutrition facts and food claims for foods targeted at infants younger than 12 months.

  18. Shape optimization of draft tubes for Agnew microhydro turbines

    International Nuclear Information System (INIS)

    Shojaeefard, Mohammad Hasan; Mirzaei, Ammar; Babaei, Ali

    2014-01-01

    Highlights: • The draft tube of Agnew microhydro turbine was optimized. • Pareto optimal solutions were determined by neural networks and NSGA-II algorithm. • The pressure recovery factor increases with height and angle over design ranges. • The loss coefficient reaches the minimum values at angles about 2 o . • Swirl of the incoming flow has great influence on the optimization results. - Abstract: In this study, the shape optimization of draft tubes utilized in Agnew type microhydro turbines has been discussed. The design parameters of the draft tube such as the cone angle and the height above the tailrace are considered in defining an optimization problem whose goal is to maximize the pressure recovery factor and minimize the energy loss coefficient of flow. The design space is determined by considering the experimental constraints and parameterized by the method of face-centered uniform ascertain distribution. The numerical simulations are performed using the boundary conditions found from laboratory tests and the obtained results are analyzed to create and validate a feed-forward neural network model, which is implemented as a surrogate model. The optimal Pareto solutions are finally determined using the NSGA-II evolutionary algorithm and compared for different inlet conditions. The results predict that the high swirl of the incoming flow drastically reduces the performance of the draft tube

  19. A Formal Investigation of the Organization of Guidance Behavior: Implications for Humans and Autonomous Guidance

    Science.gov (United States)

    Kong, Zhaodan

    Guidance behavior generated either by artificial agents or humans has been actively studied in the fields of both robotics and cognitive science. The goals of these two fields are different. The former is the automatic generation of appropriate or even optimal behavior, while the latter is the understanding of the underlying mechanism. Their challenges, though, are closely related, the most important one being the lack of a unified, formal and grounded framework where the guidance behavior can be modeled and studied. This dissertation presents such a framework. In this framework, guidance behavior is analyzed as the closed-loop dynamics of the whole agent-environment system. The resulting dynamics give rise to interaction patterns. The central points of this dissertation are that: first of all, these patterns, which can be explained in terms of symmetries that are inherent to the guidance behavior, provide building blocks for the organization of behavior; second, the existence of these patterns and humans' organization of their guidance behavior based on these patterns are the reasons that humans can generate successful behavior in spite of all the complexities involved in the planning and control. This dissertation first gives an overview of the challenges existing in both scientific endeavors, such as human and animal spatial behavior study, and engineering endeavors, such as autonomous guidance system design. It then lays out the foundation for our formal framework, which states that guidance behavior should be interpreted as the collection of the closed-loop dynamics resulting from the agent's interaction with the environment. The following, illustrated by examples of three different UAVs, shows that the study of the closed-loop dynamics should not be done without the consideration of vehicle dynamics, as is the common practice in some of the studies in both autonomous guidance and human behavior analysis. The framework, the core concepts of which are

  20. First Draft of the Research Agenda

    DEFF Research Database (Denmark)

    Dahl, Hanne Marlene; Pieper, Michael; Fahnøe, Kristian

    This report is a draft of a research agenda that the consortium INNOSERV has provided to the European Commission. It is the result of the work of researchers and insights provided by users, practitioners, experts and policy-makers involving around 20 examples of innovative practices from different...... and provide one of several sources of input from social platforms for HORISON 2020. INNOSERV is a social platform consisting of experts from various EU countries and key stakeholders and is itself an innovation in how researchers work together with representatives from various parts of society, thereby...... ensuring the relevance of the suggested draft of a research agenda. The seven themes identified are: User-centeredness innovation in social services, Innovation in institutional development, Framing of social services in relation to innovation, The governance of innovation, Influence of regional and local...